WO1989000059A1 - Balloon catheter and production thereof - Google Patents

Abstract

The balloon catheter of this invention includes a main lumen, a side lumen and a balloon, and a balloon fixing portion of a catheter body and nearby portions are small-diameter portions so as to have substantially the same outer diameter as the outer diameter of the remaining portions of the catheter body when the balloon is fixed. A soft resin is packed between both ends of the balloon and both ends of the small-diameter portion of the catheter body. Accordingly, a catheter tube containing the balloon has substantially the same outer diameter as a whole and can reduce any pain that might occur at the balloon insertion portion of a patient. The present invention relates also to a method of producing a balloon catheter including the steps of forming a catheter tube having a main lumen and a side lumen, forming a small-diameter portion as the fixing portion of a balloon and fixing the balloon to the small-diameter portion and packing a soft resin in a molten state between both ends of the balloon and both ends of the small-diameter portion of the catheter tube.

Description

 Itoda Rune-Cateter and its manufacturing method

 The present invention relates to a balloon catheter and a method for producing the balloon catheter. Background technology

 Balloon catheters are used primarily for the treatment of urological disorders. The purpose of this is to discharge urine from the bladder, compress hemostasis after surgery on the prostate, urine from patients with sphincter relaxation, such as the elderly, and discharge from the renal pelvis through the nephrostomy tube after renal stone surgery. , Bladder washing, urethral washing, etc.

As the balloon catheter used for the purpose described above, there is a balloon catheter made of silicone with good biocompatibility. . As shown in Fig. 5, the balloon catheter is composed of a main lumen 37 for draining body fluids and injecting chemicals, etc., and a small diameter side rail. It has 38 members. Further, the outer peripheral surface of the distal end portion of the catheter body 31 is exposed to sterilized water or the like injected through the side lumen 38 after being placed in the living body. A norm 34 is provided to be inflated. The no-run 34 is formed by fitting a separately molded case body 31 to the outer peripheral surface of the force body 31 and bonding the same. It is formed more. This For this reason, a step is generated between the force-teeter body 31 and both ends of the valve 34. This step may damage the living tissue at the time of insertion and removal, and may also cause pain to the patient. Therefore, the applicant has provided a balloon catheter in which this step has been corrected to a smooth slope (Japanese Patent Publication No. 61-24242, Japanese Patent Publication No. 6 1-2 4 0 2 3).

 Damage to living tissue that could be caused when the balloon catheter is inserted and removed, and the potential discomfort to the patient However, it has been considerably improved by the balloon catheter described above.

However, in the above-mentioned no-run catheter, since the no-run 34 expands outside the main body 31 of the cassette, the no-run catheter is not closed. At the admissions department, there is a possibility that the patient will be distressed. Also, since the balloon 34 has an enlarged diameter, the outer diameter is smaller than the actual application size. In some cases, it has to be used, and there is a problem in that the efficiency of draining bodily fluids and injecting medical fluids is low.

であ る 。 発 明 の 開 示 Therefore, the purpose of the present invention is to solve the above-mentioned problems, and to provide a balloon of a type in which a balloon formed separately is fixed to the outer peripheral surface of the catheter body. In the run-out catheter, the outer diameter of the part of the balloon fixed to the main body is almost the same as that of the other power main body. We provide Norwegian catheters and methods for their manufacture.

It is. Disclosure of the invention

 The present invention provides a main lumen having a closed front end and a side lumen having a closed front end formed in parallel with each other, and a main lumen having a closed front end. A catheter body having a side hole for communication between the room and the outside, and a base end near the side hole and higher than the side hole. And a valve surrounding the predetermined length of the main body of the catheter and fixed to communicate with the side lumen. In the catheter, the fixed portion of the valve and the vicinity of the balloon of the force table body are fixed with the balloon fixed thereto. The small diameter portion is formed so as to have substantially the same outside diameter as the outside diameter of the other part of the one-meter main body, and a part of the small diameter portion is formed as described above. The rune is fixed, and a soft resin is filled between both ends of the rune and both ends of the small-diameter portion of the catheter body. This is a balloon catheter.

Further, the present invention provides a case having a main lumen having an open end formed parallel to each other and a saddle member having a closed end. The cartridge body is fixed to the vicinity of the distal end of the cartridge body so as to surround a predetermined length of the catheter body and communicate with the side lumen. In a balloon catheter having a balloon, a front end of the catheter body is fixed to the balloon with the balloon secured thereto. -A small diameter part formed so that the outer diameter is approximately the same as the outside diameter of the other part of the main body, and the balloon is fixed to a part of the small diameter part. Sa In addition, a taper is provided between the tip of the balloon and the tip of the main body of the catheter toward the tip of the main body of the catheter. It is a balloon catheter in which a soft resin is captured so as to reduce its diameter.

In addition, the present invention provides a main lumen having a closed front end and a side lumen having a closed front end formed in parallel with each other. A catheter body having a side hole for communicating the main lumen with the outside, and a base body near the side hole and at the side hole. At a position on the end side, a balloon that surrounds a predetermined length of the force telemeter main body and is fixed so as to communicate with the side lumen. In the balloon catheter manufacturing method, the main body and the side body are provided, and the tip and the body have substantially the same outer diameter. A step of forming a catheter tube, and closing the main lumen with a tip sealing member at a tip end of the catheter tube; Forming a main body of the catheter by forming a small-diameter portion at a position slightly proximal to the distal end of the catheter tube, which serves as a balloon fixing portion. Forming a communication hole for communicating the side lumen with the outside at the small-diameter portion or at a position to be the small-diameter portion of the catheter tube. And fixing both ends of the balloon to a part of the small-diameter portion of the catheter tube provided with the communication hole, and further connecting the both ends of the balloon to each other. A step of refilling and solidifying a molten soft resin between both ends of the small-diameter portion of the catheter tube; and solidifying the tip of the catheter tube. Forming a side hole communicating between the main lumen and the outside between the small-diameter portion and the small-diameter portion. .

 Further, the present invention has a main lumen having a tip opened and a side lumen having a tip closed, which are formed in parallel with each other. The main body of the catheter and the vicinity of the distal end of the main body of the catheter surround a predetermined length of the main body of the catheter and communicate with the side lumen. In a method for manufacturing a balloon catheter having a fixed balloon, the main and side lumens are provided. Forming a catheter body having a communication hole for communicating the side lumen with the outside, and having a small-diameter portion at the end including the communication hole; and A step of fixing both ends of the balloon to a part of a small diameter portion of the catheter tube provided with the communication hole; Between the tip of the balloon and the tip of the catheter body, the soft resin in the molten state shrinks in a tapered shape toward the tip of the power catheter body. This is a method for producing a balloon catheter having a process of supplementing and solidifying as described above. BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a cross-sectional view of one embodiment of a balloon catheter according to the present invention. FIG. 2 is a cross-sectional view of the balloon catheter of FIG. 1 taken along the line I-I. FIG. 3 is a sectional view of another embodiment of the balloon catheter of the present invention. FIG. 4 is a view showing the structure of the present invention. It is an expanded sectional view of the tip part of other examples of a run catheter. Fig. 5 is a cross-sectional view of a conventional balloon catheter.

BEST MODE FOR CARRYING OUT THE INVENTION A balloon catheter according to the present invention will be described with reference to an embodiment shown in the drawings.

 The balloon catheter of the embodiment shown in FIGS. 1 and 2 will be described.

 The balloon catheter according to the present invention comprises a main lumen 10 formed in parallel with each other and having a closed end, and a side lumen having a closed end. The main body of the catheter 1 has a side hole 13 near the distal end, a side hole 13 communicating the main lumen 10 with the outside, and a side hole 1 near the side hole. Secured to a position closer to the proximal end of the main body 1 than 3 to surround the predetermined length of the main body 1 and to communicate with the side lumen 12 It has a balloon 4 and In addition, the portion where the balloon 4 is fixed on the catheter body 1 and the vicinity thereof are in the protruding state where the balloon 4 is fixed and other portions of the catheter body 1 The small diameter portion 7 is formed so as to have substantially the same outer diameter as the outside diameter of the small diameter portion 7, and the part 4 is fixed to a part of the small diameter portion 7, and furthermore, the A soft resin 8 is filled between both ends of the rune 4 and both ends of the small diameter portion 7 of the main body 1 of the catheter.

More specifically, the parkin catheter of the present invention comprises: A cable comprising a force tube 2 and a tip sealing member 3 attached to one open end of the catheter tube 2. It has a main body 1, a balloon 4, and a connector member 5 attached to the other end of the main body 1.

Each of these members is formed of a flexible synthetic resin or rubber. Examples of the flexible synthetic resin include a soft vinyl chloride resin and a poly resin. Fine elastomers, polyamide elastomers, and polystyrene-based elastomers can be suitably used. As the rubber, silicone rubber, butyral rubber, isoprene rubber, styrene, butadiene rubber, etc. can be preferably used. . In particular, silicone rubber is preferred. As the silicone rubber, those having a M of 200 and a 200% modulus of about 50 to 70 / f2 / c2z ² are preferred.

The catheter tube 2 has a main nozzle # 0 and a side nozzle 12 in parallel, and is formed by extrusion and molding. It is formed.

The main domain 1G is open from one end to the other. A side hole 13 is formed in the side surface near the tip of the catheter tube 2. The main lumen 10 is communicated with the outside by a side hole 13. The side panel 12 is provided along the main section 1Q in the wall of the force storage tube 2 forming the main section 10. I'm nervous. The distal end sealing member 3 is fixed to the open end on the distal end side of the catheter tube 2, and The opening at the tip of the main 10 is closed. As shown in FIG. 1, the tip sealing member 3 has a head and a shaft. The rear end of the head has an outer diameter almost equal to the outer diameter of the catheter tube 2 and has a curved surface such as a hemisphere or a bullet from the rear end toward the front. It is forming. The shaft extends from the rear end of the head toward the rear of the catheter tube in the axial direction, and the main tube 1 of the catheter tube 2 It has an outer diameter almost equal to the inner diameter of 0, and is fitted to a depth that does not reach the side hole 13. More preferably, the maximum outer diameter of the tip sealing member formed of the resin mixed with the X-ray contrast agent is the outer diameter of the tip of the catheter tube 2. When the tip sealing member is attached to the catheter tube 2, a step is created between the catheter tube and the tip sealing member. It is set up in the same way. In addition, the step is supplemented with a synthetic resin in which no X-ray contrast agent is mixed, and a thinner film is formed toward the front end. . By doing so, it is assumed that the X-ray contrast function is also provided at the tip and the X-ray contrast agent is hardly exposed to the outer surface. You can do it. Therefore, at the time of introduction into a living body, it is possible to reduce the damage to living tissues and the pain to the patient due to the roughness of the X-ray contrast agent. When a coating is formed on the tip sealing member, the base resin used for forming the coating has a small volume shrinkage after curing, has good dimensional stability, and has elasticity. It is preferable to use a material that has adhesiveness to the tip sealing member and the main body of the catheter. Also, It is preferable that the material has the same elasticity as that of the material constituting the tip sealing member, and it is preferable that the material be made of polyurethan, petite rubber, acrylic resin, or the like. Soft vinyl chloride resin and silicone rubber can be suitably used.

 Also, at a position slightly proximal to the side hole 13 of the main body 1 of the catheter, there is a communication hole 15 for the valve shaft that communicates with the side lumen 12 and the outside. It has been drilled. The vicinity of the communication hole 15 is a portion to which a balloon 4 described later is fixed, and the external damage of the catheter body 1 in this portion is a catheter tube. The smaller diameter portion 7 has a smaller diameter than the other portions of FIG. The small-diameter portion 7 is fitted with the balloon 4. In this state, the thickness of the balloon is adjusted so that it has substantially the same outer diameter as the other parts of the main body of the catheter. It has a small diameter by a thickness approximately equal.

The balloon 4 is formed in a short cylindrical shape having an inner diameter substantially equal to the outer diameter of the small diameter portion 7 of the catheter body 1. It is fitted on the small diameter portion 7 so as to cover the communication hole 15. The inner surfaces of both ends of the balloon 4 are hermetically sealed and fixed by an adhesive. With the balloon 4 fixed, the catheter body 1 has substantially the same outer diameter as the other parts. A soft resin 8 is filled between both ends of the balloon 4 and both ends of the small diameter portion 7 of the catheter body 1. As the soft resin, use a resin that has little volume shrinkage after curing, has good dimensional stability, has elasticity, and has adhesiveness to the catheter body. Is preferred. Also, force data It is preferable that the material has the same elasticity as the material that composes the plastic body. Polyurethane, butyl rubber, isoprene rubber, and ac Reel resin, silicone rubber, and the like can be suitably used, and those having the same quality as the catheter tube material are particularly preferable. In addition, it is preferable that the pruning 4 is formed by silicone rubber. In particular, if the catheter tube is made of silicone rubber, silicone rubber is preferred. Further, it is preferable that the no. Run-out 4 expands evenly, and for that purpose, it is preferable that the wall thickness is made uniform with high precision. Shi If you Ru using the Li co-over down rubber, the physical properties of the Soviet Union, M - 3 0 0, 3 0 0% mode di Interview La scan 5~ 1 0 ^ / c ^2, tensile elongation at break 6 0 0 It is desirable to use up to 1200% of silicone rubber. In addition, the normal 4 is provided with several endless linear ribs (not shown) on the inner surface in the circumferential direction, and the inner surface of the valve is the small diameter of the force-telemeter body. It may not be in close contact with the outer surface of the part.

The tip of the side lumen 12 of the catheter body 1 is closed, and only communicates with the inside of the valve 4 via the communication hole 15. . The distal end of the side lumen 12 may be closed by the above-described distal end sealing member 3. Also, when the catheter tube 2 is formed by extruding it, for example, the side member 12 does not open up to the tip, but rather closes to the tip. It may be formed from the back or from the back. Preferably, as shown in Fig. 1, a position extending from the open end of the catheter tube 2 to the side hole 13 within the side panel 12 is provided. Up to the filler 20 is enclosed, and the distal end of the side lumen 12 is closed by closing it. It is preferable that this filling be performed to the vicinity of the communication hole 15 beyond the rear end of the side hole 13. Such filler 2 (3) has a small volume shrinkage after curing, has good dimensional stability, has elasticity, and has a high degree of elasticity, and is capable of supporting the body 1 of the catheter. It is preferable that the material has adhesiveness, and that it has a hardness equal to or higher than that of the material forming the catheter body. For example, polyurethanes, petinoles, atalyl resins, flexible vinyl chloride resins, and silicones are good examples. Necklaces and the like are suitable for use, especially those that are the same as the catheter tube material, for example, a catheter tube with a high strength. If it is made of rubber, silicon rubber is preferred, and the catheter tube 2 is placed in the sidebar 12. By filling the filler 2Q from the end opening end to the position beyond the side hole 13, the catheter body 1 breaks at the side hole 13 In particular, if the filler is made of a material that has a higher hardness than the material that makes up the main body of the catheter, it can bend. The prevention effect is further improved.

In addition, as shown in FIG. 2, an X-ray contrast ray 23 may be embedded in the inner wall forming the main lumen 10 of the force table 2. And are preferred. In particular, when an X-ray contrast agent is mixed in the tip sealing member 3, it is possible to clearly distinguish the calculus from the tip sealing member 3 during X-ray imaging. The connector member 5 is fixed to the rear end of the catheter body 1 and has a liquid injection / discharge channel 16 and a balloon expansion fluid injection channel 18. . The inner surface of the opening 16a of the liquid injection / discharge channel 16 has a tapered surface with a large diameter toward the opening end. The balloon expansion liquid injection passage 18 communicates with the side lumen 12. A check valve 17 is forcibly fitted into the large diameter portion at the end of the liquid-body injection path 18. The check valve 17 is normally in a closed state in which the valve body 17b is pressed by the valve seat of the valve housing by the coil spring 17a.

 Next, a method for manufacturing the balloon catheter of the present invention will be described.

The production method of the present invention comprises: a main lumen 10 having a closed tip formed side by side with each other; and a side wall 12 having a closed tip, The main body 1 has a side hole 13 near the distal end that connects the main lumen 10 to the outside, and the side of the housing 13 near the side hole 13 At a position on the proximal end side of the catheter body 1, it is fixed so as to surround a predetermined length of the force catheter body 1 and communicate with the saddle body 12. This is a method for producing a balloon catheter having a balloon 4 and a balloon 1 including a main lumen 10 and a side lumen 12. Then, the process of forming the catheter tube 2 having a tip portion and a main body portion having substantially the same outer diameter, and a process of forming the catheter tube 2 at the tip end of the catheter tube 2ー Seal the top of main 10 A step of forming the catheter main body 1 by closing with the material 3, and a balloon provided at a position slightly proximal to the distal end of the catheter tube 2. A process of forming a small diameter portion 7 to be a fixing portion of 4 and a case A step of providing a communication hole 15 for communicating the side lumen 12 with the outside at a small diameter portion of the tubing or a position where the small diameter portion is formed; The balloon 4 is fixed to the small-diameter portion 7 of the catheter tube 2 provided with 5, and both ends of the balloon 4 and the force tube are further fixed. A step of capturing and solidifying the soft resin 8 in a molten state between both ends of the small-diameter portion 7 of FIG. 2 and a gap between the tip of the catheter tube 2 and the small-diameter portion 7. The method includes a step of forming a side hole 13 that communicates the room 10 with the outside. Therefore, each step will be described.

First, a catheter tube that has a main lumen 10 and a side lumen 12, and whose tip and main body have substantially the same outer diameter Form 2. The molding of the catheter tube 2 can be performed by a known method such as extrusion molding or die molding. Preferably, a resin that forms a catheter tube while introducing gas into the main and side lumen portions. In a molten state, it is extruded from a die (for example, a ring-shaped die) and molded. Further, it is preferable to embed the X-ray contrast ray 23 in the inner wall forming the main tube 10 of the catheter tube 2. In this method, a wire made by adding and mixing an X-ray contrast agent to a resin of the same material as that of the catheter tube 2 is made in advance, and this is made into a catheter. This can be done by extruding tube 2 at the same time as extrusion. Alternatively, a resin made of the same material as that of the catheter tube 2 mixed with an X-ray contrast agent and kneaded is the same as the extrusion of the catheter tube. Sometimes it can be done by extruding it into the wall and molding it in one piece.

After the catheter tube 2 is formed, the main lumen 10 is closed by the distal end sealing member 3 at the distal end of the catheter tube 2 and closed. Form the body 1 of the tail. In this step, the tip sealing member 3 formed in advance is inserted into the tip opening end of the force tube 2 and is fixed by an adhesive or the like. You More preferably, a tip sealing member mixed with an X-ray contrast agent is formed so that its maximum outer diameter is slightly smaller than the outer diameter of the tip of the force teeter tube 2. When the tip sealing member is attached to the catheter tube 2, a step is created between the catheter tube, the tip sealing, and the member. In addition, the step portion is supplemented with a synthetic resin in which the X-ray contrast agent is not mixed, and a thin film is formed toward the tip. As for this method, after fixing the tip sealing member to the tip of the catheter tube, the core metal that works with the motor is attached to the main section. After inserting and rotating the catheter tube, drop the desired amount of molten synthetic resin onto the step between the catheter tube and the tip sealing member, and then rotate. Air is blown from the back of the step using a nozzle or the like to melt the resin, and a thin film is formed toward the tip. You can do it by doing it.

Then, a small-diameter portion 7 serving as a fixing portion of the balloon 4 provided slightly rearward from the front end of the catheter tube 2 is formed. This step may be performed before the tip sealing member 3 is fixed to the force tube. The formation of the small-diameter portion 7 can be performed by polishing, chemical treatment, heat treatment, stretching, or the like, of the catheter tube, or a combination thereof. Wear . The small-diameter portion 7 has a thickness corresponding to the wall thickness of the par- The diameter is reduced by the same thickness.

 A method for forming the small diameter portion will be described.

As a method of polishing, for example, a core metal is inserted into a catheter tube, and the catheter tube is rotated together with the core metal. Then, apply a whetstone to the small diameter part, pass the catheter tube around the entire circumference, and add the thickness and almost the thickness of the balloon to be applied later. This is done by cutting only equal thicknesses.

The chemical treatment method is to use a solvent that can dissolve the material that forms the catheter tube, and reduce the diameter of the catheter tube. The above solvent is applied to the part, and the catheter tube is spread over the entire circumference.The thickness is almost equal to the thickness of the balloon to be applied later. Dissolution and removal. If the catheter tube is made of urethane resin, for example, use tetrahydrofuran as the solvent, for example. You can do it.

As a method of heat treatment, the material forming the catheter tube is made of a vinyl chloride resin, a thermoplastic urethane resin, a polyolefin elastomer. Ma, Poly Mide Ma This can be performed in the case of a thermoplastic resin such as a styrene elastomer. The core metal is inserted into the catheter tube, and the small-diameter portion is melted over the entire circumference of the force-teletube using a thermal mold, and later covered. The thickness of the balloon to be worn is almost equal to the thickness of the balloon.

The method of stretching is to use a force-tele tube when the force-tele tube is formed by silicone rubber. At the time of extrusion molding, in the semi-vulcanized state, only the portion that becomes the small diameter portion is stretched and stretched to a thickness almost equal to the thickness of the later attached vanarene. If the material forming the catheter tube is made of thermoplastic resin by reducing the outer diameter, it will be inserted into the catheter tube. Insert the metal core, heat the small diameter part, melt it over the entire circumference of the catheter tube, and pull out the catheter tube in this area. By stretching the outer diameter, the outer diameter can be reduced by a thickness almost equal to the thickness of the balloon to be applied later. . As a method of forming the small diameter portion, a method of stretching or polishing is preferable.

Next, a communication hole 15 is provided at a position slightly proximal to the distal end of the catheter tube to allow communication between the balloon 4 and the side panel 12. . This step may be performed before the step of forming the small diameter portion 7 and the step of fixing the distal end sealing member 3. The communication hole 15 is formed by forming a hole that communicates with the side lumen 12 from the outside of the catheter tube 2. Next, the runner 4 and the runner 4 are fixed to the catheter tube 2 having the communication hole 15 and the small diameter portion 7 formed thereon, and the runner 4 and the runner 4 are further fixed. A soft resin 8 in a molten state is filled between both ends and both ends of a small diameter portion 7 of the force tube 2 to be solidified. This step may be performed before the step of fixing the tip sealing member 3.

The balloon 4 is made of a short cylinder having an inner diameter almost equal to the outer diameter of the small diameter portion 7 of the main body 1 of a synthetic resin (for example, silicone). ). Then, a balloon 4 is fitted over the small-diameter portion 7 of the catheter tube so as to cover the communication hole 15, and the inner surfaces of both ends are liquid-tight with an adhesive. To be fixed. With the knob 4 fixed, the catheter tube has substantially the same outer diameter as the other parts. The molten soft resin is filled between both ends of the balloon 4 and both ends of the small-diameter portion 7 of the catheter tube. Preferably, insert a metal core that works with the motor into the main frame and rotate the catheter tube to both ends of the balloon 4. The part and the force tape are supplemented between the two ends of the small diameter part 7 of the tenor tube so that the entire catheter tube has substantially the same outer diameter. More preferably, the synthetic resin is supplemented by rotating the catheter tube, and air nozzles are added to the supplemented molten synthetic resin. The air is sprayed to make up the synthetic resin evenly over the entire circumference between both ends. As a synthetic resin, one that has a small volume shrinkage after curing, has good dimensional stability, has elasticity, and has an adhesive property to the above-mentioned catheter body. Use This is preferred. Also, it is preferable that the material has the same elasticity as the material constituting the main body of the catheter, such as polyuretatsu, butyl rubber, and acrylic. Resin, vinyl chloride resin, silicone rubber, etc. are suitable for use.

— Preferable is the same material as the brass material. For example, if the catheter tube is made of silicone rubber, silicone rubber is preferred. As the silicone rubber, a room temperature curing (RTV) silicone rubber is preferable, and any of a one-pack type and a two-pack type may be used. As a two-pack type, the raw material monomer or oil contains a butyl group and / or hydrogen, and after mixing, it is cross-linked between C and H to form a two-dimensional product. It is generally a solid rubber that is a polymer. For example, as a two-part RTV silicone rubber, a polymer of butylmethylsiloxan and a polymer of methylhydridylsiloxane is preferred. Yes. In these curing and crosslinking, a simple substance, an oxide, a compound, or the like of a platinum group metal, for example, chloroplatinic acid or the like is used. The curing temperature is about 20 ° C to 30 ° C.

Then, a side hole 13 is formed between the tip of the catheter tube 2 and the small-diameter portion 7 to communicate the main lumen 10 with the outside. . This step may be performed at any time after the catheter tube has been formed.

The side hole 13 is formed by forming a hole that communicates with the main lumen from the outside of the catheter tube.

Next, the balloon catheter of the embodiment shown in FIG. 3 will be described. It is explained.

 In the balloon catheter according to the present invention, the main lumen 10 and the front end, which are formed in parallel with each other, have open ends 22. A catheter body 1 having a closed side lumen 12 and a predetermined length of the catheter body near the distal end of the catheter body 1. And a balloon 4 secured to the side lumen 12 so as to communicate with the run lumen 12 The tip of the catheter main body 1 is formed so that the outer diameter of the other part of the power main body 1 is almost the same as that of the other part when the balloon 4 is fixed. The small diameter portion 7 is formed, and the valve 4 is fixed to a part of the small diameter portion 7, and further, the tip of the valve 4 and the catheter are fixed. Body 1 tip Between, lessee over Te Lumpur in Tsu suited to the distal end of the main body 1 tape over path over like Let 's contracted to Ni soft resin 8 that has been compensated.

 More specifically, the balloon catheter according to the present invention includes a catheter tube 2 forming the catheter body 1 and a balloon tube. And a connector member 5 attached to the rear end of the main body 1. Each of these members is formed of a flexible synthetic resin or rubber. As the flexible synthetic resin and rubber, those described in the description of the embodiment shown in FIG. 1 can be suitably used.

The catheter tube 2 has a main section 10 and a side section 12 in parallel, and can be formed by extrusion and molding. It is molded. The main rule 10 extends from one end to the other. It is open. Further, a side hole 13 communicating with the outside may be formed on the side surface near the tip. The side lumen 12 is provided along the main lumen 10 in the catheter tube wall forming the main lumen 10. It is. A balloon communication hole 15 for communicating the side lumen 12 with the outside is provided at a position slightly rearward from the front end of the main body 1 of the catheter. Yes. From the position near this communication hole 15 slightly to the rear end side, the part up to the front end of the power main body 1 is the outer diameter of the other part of the main body 1. The smaller diameter portion 7 has a smaller diameter. The small-diameter portion 7 has a thickness corresponding to the thickness of the balloon so that the outer diameter of the small-diameter portion 7 is substantially the same as the other portion of the catheter body when the balloon 4 is fitted. The diameter is set to be as small as the thickness equivalent to the thickness.

The balloon 4 is formed in a short cylindrical shape having a diameter substantially equal to the outer diameter of the small diameter portion 7 of the catheter body 1. It is fitted over the small diameter portion 7 of 1 so as to cover the communication hole 15, and the inner surfaces at both ends are fixed in a liquid-tight manner with an adhesive and fixed. With the balloon 4 fixed, the catheter body 1 has substantially the same outer diameter as the other parts. Between the tip of the balloon 4 and the tip of the catheter body 1, reduce the diameter in a taper shape toward the tip of the force catheter body 1. Is supplemented with soft resin 8. In this way, the front of balloon 4 is made into a somewhat tapered surface, so that the balloon catheter can be easily introduced into the living body. It becomes something. The materials of the soft resin 8 and the pour line 4 are the same as those of the embodiment shown in FIG. What is described in the description can be suitably used. In addition, the balloon 4 is provided with several endless linear ribs (not shown) on the inner surface in the circumferential direction, and the inner surface of the balloon is provided with a small diameter portion of the catheter body. It may not be in close contact with the outer surface.

 In addition, a curved portion that reduces the tip of the catheter body 1 to a taper shape so as to be continuous with the taper surface formed by the soft resin 8. A value of 6 is preferred. By doing so, the entire taper surface in front of the balloon 4 becomes a continuous taper surface, and insertion into the living body becomes easier. In addition, as shown in FIG. 4, if a recess 9 is formed between the rear end of the balloon 4 and the rear end of the small diameter portion 7, It is preferable that the concave portion 9 is also filled with the soft resin 8 so that the outer diameter is substantially the same even on the rear end side from the balloon 4. As the soft resin 8 to be filled in the concave portion 9, the one used for filling the tip of the balloon 4 described above can be suitably used.

The tip of the side lumen 12 of the main body 1 of the catheter is closed, and it communicates only with the inside of the balloon 4 through the communication hole 15. . When the distal end of the side lumen 1 2 is formed by pushing the catheter tube 2 out or the like, the side lumen 1 2 may not be opened to the tip, but may be formed from a position slightly behind the tip. Preferably, the filler 20 is filled in the side lumen 12 from the open end of the catheter tube 2 so that the side lumen 12 is closed. It is preferable to close the distal end of 1 and 2 by closing it. When making side holes 13 It is preferable that this filling be performed to the vicinity of the communication hole 15 beyond the rear end of the side hole 13. As such filler 20, those described in the description of the embodiment shown in FIG. 1 can be preferably used. Fill filler 22 in the side lumen 12 from the open end of the force tube 2 to the position beyond the side hole 13. This can prevent the catheter body 1 from being bent at the side hole 13. If a filler having a higher hardness than the material constituting the catheter body is used as the filler, the effect of preventing bending is further improved. The cross-sectional view of the balloon catheter shown in FIG. 3 taken along the communication hole 15 is the same as FIG. Then, as shown in FIG. 2, an X-ray contrast ray 23 is embedded in the inner wall forming the main lumen 10 of the catheter tube 2. It is preferable that it is done.

 The connector member 5 is the same as the embodiment shown in FIG.

 Next, a method for manufacturing the balloon catheter of the present invention will be described.

The production method of the present invention provides a main lumen 10 formed in parallel with each other and having an open end, and a side lumen having a closed end.

A main body 1 having a main body 1 and a main body 1 surrounding the predetermined length of the main body 1 near the front end of the main body 1 A method for manufacturing a balloon catheter having a balloon 4 secured so as to be in communication with 1 2. 10 and a side lumen 12, and a communication hole 15 for communicating the side lumen 12 with the outside, and a tip including the communication hole 15. The shape of the catheter body 1 having a small-diameter portion 7 and one of the small phantom portions 7 of the catheter body 1 provided with the communication holes 15 are provided. Fixing the balloon 4 to the portion, and applying the soft resin 8 in the molten state between the tip of the fixed balloon 4 and the tip of the catheter body 1. The process includes a step of compensating the diameter of the tape body 1 toward the tip of the tape body 1 so as to reduce the diameter in a taper shape and solidifying the tapered shape.

 Therefore, each step will be described.

 The process of molding the catheter body 1 is, for example, to firstly open the mail main body 10 and the side main body 12 that are opened from the front end to the rear end. A step of molding the existing catheter tube 1, a step of closing the tip of the side lumen 12, and a step of closing the tip of the catheter tube 2. Forming a communication hole communicating with the side lumen 12 at the tip of the catheter tube 2. It is possible to do this. In addition, as for the order of the above steps, the other steps may be performed in any order as long as the catheter tube 2 is formed. Further, the step of closing the side lumen 12 includes the step of fixing the balloon described later and / or the step of replenishing the soft resin described later. You can go after the.

Therefore, a case where each of the above steps is used will be described as an example.

First, we have a main domain 10 and a side domain 12, The distal end and the body form a catheter tube 2 having substantially the same outer diameter. The molding of the catheter tube 2 can be performed by a known method such as extrusion molding or die molding. Preferably, the resin that forms the catheter tube is melted while introducing gas into the main and side portions. It can be extruded from a base (for example, a ring base) and molded. In addition, similarly to the one shown in FIG. 2, an X-ray contrast line 23 is buried in the inner wall forming the main lumen 10 of the catheter tube 2. This is preferred. After forming the catheter tube 2 having the same outer diameter from the tip to the main body as described above, the catheter tube 2 is slightly rearward from the front end of the catheter tube 2. A small-diameter portion 7 serving as a fixing portion of the balloon 4 provided on the side is formed. The formation of the small diameter portion 7 can be achieved by polishing, chemical treatment, heat treatment, stretching, or a combination thereof, of the catheter tube. Wear . The small-diameter portion 7 has a thickness corresponding to the thickness of the balloon so that when the balloon 4 is fitted, the outer diameter of the small-diameter portion 7 is substantially the same as that of the other catheter body. Make the diameter smaller by an equal thickness. As the method by polishing, the method by chemical treatment, the method by heat treatment and the method by stretching, the above-mentioned methods are suitably used.

The preferred method of forming the small diameter portion is by stretching or polishing.

A communication connecting the balloon 4 provided on the rear end side of the catheter tube 2 with the side of the catheter tube 2 to the side wall member 1 2. A hole 15 is provided. This step may be performed before the step of forming the small diameter portion. The communication hole 15 can be formed by drilling a hole that communicates with the side lumen 12 from the outside of the catheter tube 2. it can .

 Then, the filler 22 is sealed in the side lumen 12 from the open end of the catheter tube 2, sealed, and sealed. Block main 12. In the case where the side hole 13 is provided, it is preferable that the sealing is performed to extend to the vicinity of the communication hole 15 beyond the rear end of the side hole 13.

 The molding of the catheter body 1 is not limited to the steps described above. For example, when the catheter tube 2 is formed by extruding, etc., the side lumen 12 does not open to the tip, but rather closes to the tip. Alternatively, a method may be used in which after forming a force-teletube formed from the position behind and behind, the communication hole 15 and the small-diameter portion 7 are formed. Also, when the catheter tube 2 is formed by extruding it, for example, the catheter tube having the small-diameter portion 7 at the tip end is removed. After the formation, a method of closing the side lumen 12 and forming the communication hole 15 may be used. Also, when the catheter tube 2 is formed by extruding or the like, the side lumen 12 does not open to the front end, but rather than the front end. After forming a catheter tube that is formed from a position slightly behind and has a small-diameter portion 7 at the tip, a communication hole 15 is formed. Any is fine.

Next, a catheter tube in which the communication hole 15 and the small diameter portion 7 are formed. — A balloon 4 is fixed to the valve 2, and a soft resin 8 in a molten state is applied between the tip of the balloon 4 and the tip of the catheter body 1 to force the body 1 It is supplemented so as to reduce the diameter in a taper shape toward the tip of the tube, and is solidified.

填す る と と も に、 fe填 さ れた溶融状 態の合成樹脂にバル一 ン 4 方向よ り 力 テ ー テ ル チ ュ ー ブの 先端方向に ェ ア ー ノ ズルな どを用 いて エ ア ー を吹 き 付け合 成樹脂を先端に向か う ほ ど肉薄 と な る テ 一 パ一伏に補填す る こ と であ る 。 ま た、 上記の よ う に 力 テ ー テ ルチ ュ ー ブを 回転 さ せつ つ溶融状態の合成樹脂を補填す る 樹脂補填用 ノ ズル を カ テ ー テ ル チ ュ ー ブの軸方向に相対移動 さ せ 、 力 テ 一テ ルチ ュ ー ブの先端方向に向か う ほ ど肉薄 と な る テ ー パ 一状 に補填す る こ と も 好 ま し い。 合成樹脂を補填す る 樹脂 捕填用 ノ ズルを カ テ ー テ ルチ ュ ー ブの軸方向 に栢対移動 さ せ る こ と と は、 上記ノ ズ ルを移動 さ せ る こ と 、 ま た ノ ズ ル を固定 し てお き カ テ ー テ ルチ ュ ー ブを移動 さ せ る こ と さ ら に ノ ズ ル お よ び カ テ ー テ ル チ ュ ー ブの両者を移動 さ せ る こ であ る 。 軟質樹脂 と し て は、 第 1 図に示 し た実施例の説明 に お いて述べた も の が好適に使用で き る 。 The balloon 4 is made of a short cylindrical material having an inner diameter almost equal to the outer diameter of the small diameter portion 7 of the main body 1 of a synthetic resin (for example, silicone resin). ), And fitted over the small-diameter portion 7 of the force-teletube so as to cover the communication hole 15, and the inner surfaces of both ends are fixed in a liquid-tight manner with an adhesive. . With the balloon 4 fixed, the catheter tube has substantially the same outer diameter as the other parts. Then, a soft resin 8 in a molten state is applied between the tip of the balloon and the tip of the catheter body 1 toward the tip of the catheter body 1 to taper. The molten soft resin is charged so as to reduce the diameter of the resin. Preferably, insert the core bar that works with the motor into the main frame and rotate the catheter tube to adjust the tip of the balloon 4 and the power cable. -Fill between the tip of the tube 1 and make it thinner toward the tip. More preferably, the synthetic resin is rotated while rotating the force-television tube.

At the same time, use a hair nozzle etc. in the tip of the force-teeter tube rather than the balloon 4 direction on the synthetic resin in the molten state loaded with fe. The air is sprayed to compensate for the resin that becomes thinner toward the tip. In addition, as described above, the molten metal is supplemented by rotating the force-teeter tube to supplement the molten resin. Move the nozzle relative to the axial direction of the catheter tube, and make up for the taper that becomes thinner toward the tip of the force tube. This is also good. To move the resin capturing nozzle for supplementing the synthetic resin in the axial direction of the catheter tube means to move the nozzle. With the nozzle fixed, you can move the catheter tube, and you can also move both the nozzle and the catheter tube. It is. As the soft resin, those described in the description of the embodiment shown in FIG. 1 can be preferably used.

In addition, as shown in FIG. 4, when a recess 9 is formed between the rear end of the balloon 4 and the rear end of the small part 7, It is preferable that the concave portion 9 is also filled with a soft resin. As the soft resin, those described above can be suitably used. As the filling method, the synthetic resin in the molten state is filled in the concave portion 9 while rotating the catheter tube as described above, and the shaft of the catheter tube is rotated. Air is blown on the resin supplemented from the direction perpendicular to the resin using an air nozzle, etc., and the outer diameter of the recess 9 is almost the same as that of the other force-teletube. It is preferable to make up for it to be more uniform throughout. In addition, the distal end of the catheter tube 2 is bent so that the taper surface is continuous with the taper surface formed by the soft resin 8. A value of 6 is preferred. As this method, a method of taking the tip of the catheter tube 2 in a tapered shape can be considered. Specifically, the core metal is inserted into the force table 2 and rotated, and This can be done by applying a whetstone to the tip of the catheter tube 2 and shaving it in a taper shape. Also, a relatively large amount of soft resin to be supplemented between the tip of the balloon 4 and the tip of the catheter tube 2 is supplemented, and the soft resin is used to replace the catheter tube. The tip of the valve may be supplemented so that it is covered smoothly so as to form a taper. This step can be performed at any time after the catheter tube has been formed.

Further, a side hole 13 for communicating the main lumen 10 with the outside may be provided at a position between the distal end of the catheter tube 2 and the small diameter portion 7. This step can be performed at any time after the molding of the catheter tube. The side hole 13 can be formed by drilling a hole that communicates with the main lumen from the outside of the catheter tube. .

Next, examples of the present invention 'will be described.

 [Example 1]

 Silicon rubber (Shin-Etsu Polymer Co., Ltd., MP-21,

M- 200, 200% Mo di Interview la scan, 7QKg / cm ^2, tio § A hardness of about 60 °, the breaking strength an amount of 75 kg / cm ^2, Shinpi 700%) using a main Lee emissions le over main emission ( A catheter tube that has a diameter 2.S EE) and a side lumen (diameter 0. ππ ~), and has an X-ray contrast line within the wall thickness.

(Outer diameter 5.2ππ) was extruded and formed by molding. The X-ray contrast line uses a catheter tube to extrude the extruder nozzles that push out silicone rubber mixed with barium sulfate as the X-ray contrast agent. To the extruder nozzle of silicone rubber that forms By connecting and extruding simultaneously, an X-ray contrast line was formed within the thickness of the force-teeter tube.

 The silicone rubber is in a semi-vulcanized state over the entire circumference of 20 to ¾ to 45i¾ from the end of the catheter tube. At this time, only the part to which the balloon is to be attached is stretched out, and that part is made to have a smaller outside diameter than the other part by about 1; Vulcanized and cured. A communication hole communicating with the outside of the saddle main body was punched out of the small diameter part using a punch. In addition, put the filler (silicon RTV rubber) into the syringe, insert the tip of the syringe into the tip of the side lumen, and insert the catheter tip. Inject filler into the sidebar from the end of the tube and seal the top of the sidebar.

/ 0

Then, silicone rubber (manufactured by Shin-Etsu Polymer Co., Ltd., MP-34T. M-300, 300% modulus, 8 kg / cm ² , Shore A hardness approx. 30 °, breaking strength 60Kg / cm ² , elongation 840%), cylindrical tube with a diameter of ππ, inner diameter 4.0, wall thickness 0.5, outer diameter 5.0; The rune was fitted on the small diameter part of the catheter tube, and both ends were fixed in a liquid-tight manner with adhesive (silicon R RV rubber). Then, insert the metal core into the catheter tube, apply force not to rotate the catheter tube, and use the base end of the catheter tube. With the air flowing from the side to the tip, the molten state in the recess between both ends of the balloon and both ends of the small diameter portion of the catheter tube. Silicone The RTV rubber was captured to form a smooth capture surface, and the outer diameter was almost the same throughout the entire force-teel tube including the balloon. .

 Then, attach silicone rubber to the tip of the catheter tube.

(Shin-Etsu Polymer Co., Ltd., MS-15TB) was fitted with a tip sealing member formed using a material containing barium sulfate as an X-ray contrast agent and fixed. . Insert the metal core into the catheter tube, rotate the catheter tube, and rotate the catheter tube toward the proximal end of the catheter tube. With the air flowing down from the tip to the tip, the molten silicone RTV rubber is placed on the step between the tip sealing member and the tip of the catheter tube. And a smooth coating was formed.

 Then, between the balloon and the tip sealing member, use a punch to connect a communication hole that communicates with the main lumen from outside, using a punch. Pierced. Then, the connector member formed on the silicone rubber is attached to the rear end of the catheter tube, and its liquid injection and discharge path is connected to the main lumen. And the balloon inflation fluid injection passage was fixed so as to communicate with the side lumen. A check valve was housed at the end of the balloon expansion liquid injection path.

 [Example 2]

Silicon rubber (Shin-Etsu Polymer Co., Ltd., MP-21, M-200, 200% modulus, 70 kg / cm ² , Shore A hardness about 60. Breaking strength 75 kg / cm ² , elongation 700%) A catheter tube that has a main (diameter 2.8ffi¾z) and a side-norm (diameter 0.6) ¾2, and has an X-ray contrast line in the wall thickness. (Outside

'. ϊπτι was extruded and formed by molding. The X-ray contrast line is a catheter tube that extrudes a silicon rubber mixture of barium sulfate as an X-ray contrast agent. The X-ray imaging line is connected to the nozzle of the extruder of the silicone rubber that forms the tube, and is extruded at the same time. It was formed within the wall thickness. '

 Then, about 25 from the tip of the force-teeter tube is uniformly polished to a thickness of about 0.5 over the entire circumference, and is shaved off to form a small part. Was. For polishing, insert a metal core into the catheter tube, rotate it, and place a mouth-opening type on the tip of the catheter tube. Polishing was performed with contact.

 A communication hole communicating with the side lumen from the outside was drilled in this small diameter part using a punch. In addition, put the filler (silicon RTV rubber) into the syringe, insert the tip of the syringe into the tip of the saddle main body, and insert the cartridge into the syringe. Filler was injected into the side lumen from the leading end of the tube, and the tip of the side lumen was sealed.

Its to, Shi Li co-over down rubber (Shin-Etsu port Li Ma over Co., _{Ltd., MP -34T S M- 300, 300} % mode di Interview La scan, 8 Kg / cm ^2, tio § A hardness of about A cylindrical valve with a length of 22zz¾, an inner diameter of 4.0ϋζ, a wall thickness of 0.5, and an outer diameter of 5.0κζ¾, formed at 30 °, breaking strength 60Kg / cm ² , elongation 840% ') To the small diameter part of the catheter tube. Then, both ends were fixed in a liquid-tight manner with an adhesive (silicon RTV rubber).

Then, insert the mandrel into the catheter tube, rotate the force tube, and further move the base end of the catheter tube. With the pour flowing from the side to the tip, a molten synthetic resin (silicon) is placed between the tip of the plunger and the tip of the catheter tube. The RTV rubber) was captured, and a portion was formed that contracts from the tip of the balloon to the tip of the force-teletube.

In addition, with the core metal inserted into the catheter tube, rotate the catheter tube while further rotating the power tube. With the air flowing from the base end to the tip, melt between the rear end of the balun and the rear end of the small diameter portion of the force-tele tube. The silicone RTV rubber in the condition is supplemented to form a smooth catching surface, and the outer diameter of the catheter tube at the rear end of the balloon is almost the same. did. In addition, insert the core into the force-table tube, rotate it, and contact the tip of the force-table tube with a flat-type polisher. The tip of the catheter tube was machined into a rounded taper shape.

Then, between the nozzle and the tip of the catheter tube, use a punch to connect a communication hole that communicates with the main lumen from outside. And two were drilled so as to face each other. Then, the connector member formed of silicone rubber is replaced with a catheter tube. At the rear end of the valve, its liquid injection and discharge passage is fixed so that it communicates with the main lumen, and the balloon expansion fluid injection passage communicates with the side lumen. .

 A check valve was housed at the end of the balloon expansion liquid injection path.

 -The operation of the balloon catheter of the present invention will be described with reference to the balloon catheter of the embodiment shown in FIG.

The balloon catheter is inserted into the urethra from its tip. If necessary for this insertion, insert the stylet into the main knob 1G, and the balloon catheter will bend and bend. Insert it so that it does not exist. Then, after balloon 4 reaches a state in which it has entered the bladder (this is confirmed, for example, by X-ray imaging), a syringe not shown is not shown. The syringe is connected to the check valve 17 and the inflation liquid such as sterile water or physiological saline in the syringe is injected through the side lumen 12. Due to the injection of the inflation liquid, balloon 4 expands as shown by the dotted line in FIG. 1, and balloon balloon 4 expands and balloon balloon 4 expands. It prevents tufts from leaving the bladder and urethra and is placed in the bladder. After this placement, the tip of the tube connected to the urine storage bag (not shown) is connected to the connection port 16a of the connector member 5. Waste such as urine in the bladder passes through the main lumen 1G through the side hole 13 and further through the liquid discharge passage 16 of the connector member 5 to be stored. It flows into the urine knock. To remove the balloon catheter from the urethra, connect the syringe to the check valve 17 and open it. Aspirate the inflation liquid with a syringe, shrink the balloon 4, and remove it.

Balloon catheters are also used in the treatment of intravesical stones to remove finely ground stones from the urethra. After the balloon catheter is placed in the bladder and urethra, sterile water or washing water such as saline is stored in the connection port 16a of the connector member 5. By connecting a large syringe, the washing water is sent through the balloon catheter into the bladder, and then the syringe is aspirated. The irrigation water in the bladder is collected in the syringe together with the calculi. Change the washing water in the syringe and repeat until the stones are collected.

-Industrial applicability

The balloon catheter according to the present invention comprises a main lumen formed in parallel with each other and having a closed end, and a side lumen having a closed end. A catheter body having a side hole near the distal end for communicating the main lumen with the outside; and a catheter body near the side hole and higher than the side hole. A balloon attached at a position on the proximal end side of the catheter main body so as to surround a predetermined length of the catheter main body and communicate with the side main body. In the run-out catheter, the balloon fixing portion and the vicinity of the balloon fixing portion of the force-teeter body fix the balloon. In this state, the small diameter portion is formed so as to have substantially the same outer diameter as the outer diameter of the other portion of the main body of the cassette in the closed state. Diameter part The balloon is partially fixed, and a soft resin is provided between both ends of the balloon and both ends of the small-diameter portion of the catheter body. It is what has been done.

 In addition, the balloon catheter according to the present invention includes a main lumen formed in parallel with each other and having an open end, and a side having a closed end. A catheter body having a lumen and a predetermined length of the catheter body near a distal end of the catheter body; In the case of a run-out catheter having a run-down fixed so as to communicate with the case, the tip of the catheter body is The small diameter portion is formed so that the outer diameter of the other portion of the force-teeter body is substantially the same as the outer diameter of the balloon when the balloon is fixed. The balloon is fixed to a part of the phantom part, and furthermore, between the tip of the balloon and the tip of the catheter body. , Ru Oh is also the lessee over Te le this body Tsu suited to tip tape over path over like Let 's you Chijimikai to Ni soft resin of that has been compensated.

Therefore, the balloon catheter of the present invention is a balloon catheter of a type in which the balloon is fixed to the outer periphery of the catheter body. Nevertheless, the catheter tubing, including the nose and the rune, has almost the same outer diameter throughout, and the balun does not protrude outward. . Therefore, in the insertion portion where the protruding balloon portion is inserted, it is possible to reduce pain to the patient who may occur. In addition, since the balloon portion does not protrude, use a run-down cassette that is one size lower. In addition, the drainage of bodily fluids can be performed without considering the size of the balloon and using a balloon catheter of an actually applicable size. In addition to improving the injection efficiency of the chemical solution and the washing water, etc., the method for producing a balloon catheter according to the present invention has a problem in that the tips formed in parallel with each other are closed. It has a main lumen and a side lumen whose tip is closed, and a side hole near the tip that allows communication between the main lumen and the outside. A catheter body surrounding the predetermined length of the catheter body near the side hole at a position closer to the base end of the catheter body than the flexible side hole; And a balloon fixed so as to be in communication with the side lumen. And a process for forming a catheter tube having a main lumen and a side lumen, and having a tip portion and a main body portion having substantially the same outer diameter. A step of closing the main lumen with a tip sealing member at a tip end of the catheter tube to form a force-teeter body; Forming a small-diameter portion at a position slightly closer to the proximal end than the distal end of the tube, as a fixed portion of the palm; and forming the small-diameter portion or the small-diameter portion of the catheter tubing. Forming a communication hole at a position to be a small-diameter portion for communicating the side lumen with the outside; and forming a catheter tip provided with the communication hole with a catheter. A balun is fixed to the small diameter part, and further, between both ends of the balloon and both ends of the small diameter part of the catheter tube. A step of replenishing and solidifying a soft resin in a molten state; Because even the in that having a the step you form the main Lee emissions le over main emission and side holes that the outer passage communicating between the tip and the small diameter portion of the Chi-menu Bed ₀

 Further, the production method of the present invention includes a main lumen having an open end and a side lumen having a closed end formed in parallel with each other. The main body of the catheter and a predetermined length of the main body of the catheter near the tip of the main body of the catheter and communicate with the side lumen. In a method for manufacturing a balloon catheter having a balloon fixed to a main body, a main lumen and a side nomenclature are provided. Forming a catheter body having a communication hole for communicating the side lumen with the outside and having a small-diameter portion at the tip end including the communication hole; and Fixing a balloon to a part of a small tube of the catheter tube provided with the communication hole; The molten soft resin is tapered between the tip of the balloon and the tip of the force-teeter body toward the tip of the catheter body. A process of compensating for solidification and solidifying.

Therefore, the balloon catheter of the present invention described above can be easily and reliably manufactured.

Claims

 Scope of the Claim A main lumen closed at the tip and a side lumen closed at the tip formed in parallel with each other, and the main lumen near the tip. A catheter body having a side hole communicating the interior with the outside, and a proximal end of the catheter body near the side hole and higher than the side hole At a side position of the main body of the catheter, which surrounds a predetermined length of the main body of the catheter, and is fixed so as to communicate with the side lumen. In the run-out catheter, the balloon fixing portion of the force-teeter body and the vicinity thereof are fixed with the balloon fixed thereto. The small diameter portion is formed so as to have substantially the same outer diameter as the outer diameter of the other portion of the valve body, and the valve is partially formed in the small diameter portion. And that the soft resin is filled between both ends of the balloon and both ends of the small-diameter portion of the catheter body. A unique feature of the Ballet Katenora. A force-teeter body having a main lumen having an open end and a side lumen having a closed end formed in parallel with each other; A balloon that surrounds a predetermined length of the catheter main body and is fixed so as to communicate with the side lumen near the distal end of the catheter main body; In a ball valve catheter, the distal end of the force-tele body is connected to the other end of the force-tele body with the ball fixed. The small diameter portion is formed so as to have substantially the same outer diameter as the outer diameter of the portion, and the balloon is fixed to a part of the small diameter portion. In addition, between the tip of the norm and the tip of the catheter body, the diameter of the tapered shape is reduced toward the tip of the catheter body. A balloon catheter characterized in that a soft resin is added to the balloon catheter.  3. The soft resin according to claim 1, wherein the soft resin has good dimensional stability, has elasticity, and has adhesiveness to the main body of the catheter. Is the balloon cassette described in paragraph 2.  4. The valve according to claim 1 or 2, wherein the soft resin has elasticity equivalent to a material constituting the catheter body. Open container. - 5: The soft resin is selected from the group consisting of polyurethane, butyl rubber, .. acryl resin, and silicone rubber. A rune catheter according to claim 1 or 2 which is a kind of claim.  6. The bag according to claim 1 or 2, wherein the catheter body is formed of a flexible synthetic resin or rubber. Routine catheter. 7. The flexible synthetic resin is made of urethane resin, soft vinyl chloride resin, polyolefin elastomer, polyamide elastomer, polyether The balloon catheter according to claim 6, wherein the balloon catheter is a force of a restylane-based elastomer. The claim is a rubber, silicone rubber, butylene rubber, isoprene rubber, or styrene, butadiene rubber. The balloon catheter described in the section.  The tip of the catheter main body is tapered toward the tip continuously with the tapered surface of the soft resin supplemented so as to reduce the diameter in the taper shape. The balloon catheter according to claim 2, wherein the balloon catheter is reduced in diameter. A main lumen closed at the tip and a side lumen closed at the tip formed in parallel with each other, and the main lumen near the tip and near the tip. A catheter body having a side hole for communication between the inner lumen and the outside; and a proximal end of the catheter body near the side hole and more than the side hole. At the side position, surrounding the predetermined length of the catheter body and having a balloon fixed so as to communicate with the side lumen. In the method of manufacturing a routine catheter, the main and side lumens are provided, and the tip and the body have substantially the same outer diameter. After the teletube is formed, the main lumen is closed with a tip sealing member at the tip of the catheter tube, and the cassette is closed. A step of forming a tail main body, and a step of forming a small diameter portion serving as a fixing portion of the balloon at a position slightly proximal to a distal end of the force-teletube. Forming a communication hole for communicating the side lumen with the outside at the small-diameter portion or at a position to be the small-diameter portion of the force-teeter tube. , -Category with the communication hole Attach both ends of the balloon to a part of the small-diameter part of the tube, and melt between both ends of the balloon and both ends of the small-diameter part of the catheter tube. A step of replenishing and solidifying the soft resin in a state, and connecting the main lumen to the outside between the tip of the catheter tube and the small-diameter portion. A method of manufacturing a balloon catheter, characterized by having a step of forming a side hole. 1. a force-teeter body having a main lumen having an open end and a side lumen having a closed end formed in parallel with each other; A balloon that surrounds a predetermined length of the catheter body and is fixed near the tip of the catheter body so as to communicate with the side lumen; In a method for manufacturing a balloon catheter having a main lumen and a side lumen, the side lumen and an external Forming a catheter body having a communication hole having a small diameter portion having a communication hole with the communication hole, and including the communication hole; and providing the communication hole. The process of fixing both ends of the balloon to a part of the small diameter portion of the catheter tube, and the tip of the fixed balloon The molten soft resin is supplemented between the tip of the force-teeter body and the tip of the force-teeter body so as to be tapered toward the tip of the force-teeter body. A method for producing a balloon catheter, characterized by having a step of solidifying. 2. The step of molding the main body of the catheter has a main section and a side section that are open from the front end to the rear end. Forming the catheter tube to be closed, closing the distal end of the saddle member, and reducing the distal end of the catheter tube to a small diameter portion. Claim 1 which comprises a step and a step of forming a communication hole communicating with the side lumen at the front end of the catheter tube. A method for manufacturing the described balloon catheter.  1 3. The step of closing the side lumen is performed after the step of fixing the balloon or the step of supplementing the soft resin. 3. A method for producing a balloon catheter according to paragraph 1 or 2.  14. The pallet according to claim 10 or claim 11, wherein the soft resin is supplemented while rotating the catheter tube. Manufacturing method of container.  15. The small diameter of the catheter tube should be adjusted by polishing, chemical treatment, heat treatment, stretching, or a combination thereof, of the catheter tube. The method for producing a balloon catheter according to claim 10 or 11, wherein the method is further performed.  16. The soft resin according to claim 10, wherein the soft resin has good dimensional stability, has elasticity, and has an adhesive property to the catheter body. Or a method for producing a balloon catheter according to item 11;