Automated method and apparatus for manufacturing balloon catheter tube

Abstract

To provide an automated method and apparatus for manufacturing balloon catheter tube.SOLUTION: In an automated method and apparatus for manufacturing balloon catheter tube, a variable extrusion die is used to prevent the catheter tube from warping when a balloon is inflated, and parts of the tube are cut or removed at a certain distance from each other in a rubber anti-adhesive coating section to mark individual unit sections of a continuously produced tube while efficiently discharging inflated air, thereby preventing an accumulation of length measurement errors that may occur in a continuous process and enabling continuous production.SELECTED DRAWING: Figure 9

Description

[Technical field]

[0001] The present invention relates to an automatic manufacturing method and apparatus for a balloon catheter tube, and more particularly to an automatic manufacturing method and apparatus for a balloon catheter tube, which uses a variable extrusion die to prevent the catheter tube from warping when a balloon is inflated, and cuts or removes a portion of the tube a certain length away from a section where a rubber anti-adhesive agent is applied to indicate individual unit sections of the continuously produced tube, while efficiently discharging the inflated air, thereby preventing the accumulation of length measurement errors that may occur in a continuous process and enabling continuous production. [Background technology]

[0002] As is well known, a balloon catheter is a medical device that is used to insert a tube into a human organ, inflate a balloon using air or liquid injected through inflation, and then fix it inside the human body. Then, medicines are injected through the tube or the formed drainage tube or medicine injection tube, or to remove various liquid excrement.

[0003] As shown in Figure 1, a typical balloon catheter is structured around an extruded tube with a two-way structure in which an inflation lumen for inflating or deflating the balloon and a drainage lumen for injecting medicine or removing liquid waste are extruded into one tube.

[0004] The extrusion tube is manufactured by extruding soft synthetic resin through an extruder. A predetermined portion of the inflation tube of the extrusion tube is perforated, and a separately manufactured balloon is assembled, and the balloon is completed through adhesion and coating. A separate hole is drilled in the discharge tube for injecting medicine or removing liquid waste, and the main part of the balloon catheter tube is completed.

[0005] The above-mentioned catheter tube manufacturing method is complicated and expensive to manufacture, so patent applications have already been filed for technologies that improve the process and eliminate the balloon assembly, bonding, and coating processes. Representative examples include patent registration numbers 10-0333264, 10-0434720, 10-0689238, 10-1922800, 10-2168072, and 10-2056983.

[0006] When classifying the above patents according to the characteristics of the tube structure, registration numbers 10-0333264, 10-0434720 and 10-0689238 can be classified into Group 1, and registration numbers 10-1922800, 10-2168072 and 10-2056983 can be classified into Group 2. Group 1 is a structure in which the inflation tube of the catheter tube exists inside the tube, so a separate operation of drilling holes in the tube is required to connect the inflation tube to the balloon, while Group 2 is a structure in which the inflation tube is exposed to the outside of the inner tube, so a separate operation of drilling holes is not required.

[0007] The Group 1 patents require the extrusion of the catheter tube, followed by cutting and then separating the tube into individual units for the perforation process, which makes continuous production impossible and inevitably results in higher production costs than Group 2. On the other hand, the Group 2 patents omit the perforation process and allow continuous production, but the catheter tube warps when the catheter balloon is inflated due to the structure of the inflation tube exposed to the outside of the inner tube. This occurs because the relatively hard inner tube cannot symmetrically offset the longitudinal tensile force generated as the soft catheter balloon expands. In other words, in terms of cross-sectional structure, the Group 2 patents have the structure of the inflation tube exposed to the outside of the inner tube, so the surface of the inner tube on the inflation tube side does not have a structure that can withstand the longitudinal tensile force, and therefore stretches more than the opposite side of the inflation tube where the structure is present. As a result, the catheter tube warps to the opposite side of the inflation tube as the balloon expands. This phenomenon becomes more severe the smaller the outer diameter of the catheter is.

[0008] Such curved catheters, when used, can cause unnecessary irritation inside the patient's organs, and considering that smaller catheters are generally used by children, infants and young patients, this can result in longer treatment periods for the patient due to added pain for younger patients who have poorer tolerance.

[0009] Apart from the problem of the warping phenomenon, the production process of group 2 has other problems. Generally, balloon catheters use silicone rubber as a raw material, and in the extrusion process of silicone rubber tubes, which are thermosetting materials, the silicone rubber raw material must be heated after extrusion to cause a crosslinking reaction. In this situation, the air present in the inflation tube part exposed to the outside of the inner tube of group 2 inevitably expands during the heating process, and if the expanding air is not smoothly discharged to the front and rear of the tube, it will cause deformation and expansion in the covering material before or during the crosslinking reaction, making it impossible to produce a tube of the desired shape. The expansion air can be continuously and smoothly discharged to the rear of the tube, but the longer the tube production length, the more difficult it becomes to discharge the expansion air to the front of the tube because the pipeline resistance increases. Finally, good products are produced at the beginning of production, but the longer the tube length, the more difficult it becomes to discharge the expansion air, and the air expansion on the expansion tube side inflates the soft and thin balloon covering material, resulting in the balloon covering material floating up along the expansion tube.

[0010] This problem can be solved by continuously cutting the tube into individual unit tubes in the last step of the continuous production process, thereby maintaining continuous smooth discharge of the expanded air to the front of the tube, but the patent does not mention any specific technology for cutting the tube in an automatic production process. In particular, when cutting the tube using a general length measurement method, not only is it impossible to continuously cut the tube to the desired length due to the accumulation of measurement errors in the length measurement device, but in particular, since catheter tubes are made of elastic rubber material, no matter how precise the measurement device is, the measurement will be meaningless due to the elasticity of the tube itself. Therefore, minute measurement errors are inevitable, and in a continuous production method where these errors accumulate, parts that should not be cut will end up being cut.

[0011] As described above, the conventional techniques have many problems, such as a complicated manufacturing process that makes continuous manufacturing impossible, resulting in high manufacturing costs, and an improved process with high manufacturing efficiency that causes the catheter tube to warp when the balloon is inflated. Thus, improvements are urgently needed. Summary of the Invention [Problem to be solved by the invention]

[0012] The present invention has been made in consideration of the above-mentioned problems in the prior art, and has an object to provide an automatic manufacturing method and apparatus for a balloon catheter tube, which uses a variable extrusion die to prevent the catheter tube from warping when the balloon is inflated, and cuts or removes a part of the tube a certain length away from the section where the rubber anti-adhesive agent is applied to indicate individual unit sections of the continuously produced tube, while efficiently discharging the inflated air, thereby preventing the accumulation of measurement errors that may occur in a continuous process and enabling continuous production. [Means for solving the problem]

[0013] In order to achieve the above object, according to a preferred embodiment of the present invention, there is provided an automated manufacturing method for a balloon catheter tube, comprising: a) an inner tube production process in which an inflation tube is formed at regular intervals along the length of the outer periphery by providing a variable die connected to an inner tube extruder, the variable die having an expansion tube formed and unformed section repeated; b) a process in which a boundary between an expansion tube formed section and an unformed section of the inner tube is recognized and a rubber anti-adhesive agent is repeatedly applied; and c) a balloon material is coated and extruded onto the outside of the inner tube to manufacture a balloon catheter tube having a longitudinal direction in which a balloon is repeatedly formed.

[0014] Preferably, the application of the rubber anti-adhesive agent in step b) is a non-contact application process using a spray and a masking film, or a contact application process using a stamping method in which the rubber anti-adhesive agent is directly transferred and applied to the surface of the inner tube.

[0015] The present invention provides an automated manufacturing method for balloon catheter tubes, comprising the steps of: a) cutting or removing a portion (D-D') of the inner tube at a certain distance from a position where a rubber anti-adhesive agent is applied to the surface of the inner tube being continuously produced, thereby indicating a section of the catheter tube; b) continuously covering or extruding a balloon material onto the outside of the inner tube from which the portion has been cut or removed; and c) detecting the portion where the inner tube of the catheter tube covered and extruded with the balloon material has been cut or removed, and finally cutting the catheter tube at a certain section.

[0016] Preferably, there is provided an automated manufacturing method for a balloon catheter tube, wherein the cutting or removal of the part of the inner tube in the step a) is carried out simultaneously with the application of the rubber anti-adhesive agent.

[0017] Preferably, the method for automatically manufacturing a balloon catheter tube is characterized in that in the step a), the part of the inner tube is cut or removed in the shape of a curved surface such as a sector or circle.

[0018] Preferably, the cutting of the portion of the inner tube in step a) comprises cutting and removing a portion of the inner tube so that the inflation tube and the exhaust tube penetrate each other.

[0019] The present invention provides an automatic balloon catheter tube manufacturing apparatus, comprising: an inner tube extruder having a variable die for manufacturing an inner tube reflecting repeated formation and non-formation of an expansion tube; an anti-adhesive agent applicator provided at the rear end of the inner tube extruder for repeatedly applying a rubber anti-adhesive agent to a boundary of the expansion tube forming portion of the inner tube; and a coating extruder for extruding a coating layer onto an outer periphery of the inner tube that has passed through the anti-adhesive agent applicator.

[0020] Preferably, the variable die of the inner tube extruder is connected to a pneumatic cylinder, a hydraulic cylinder or a motor, and is configured to control the position of the variable die in cooperation with a length measuring device for the extruded tube or a timer.

[0021] Preferably, the rubber anti-adhesive agent applicator is either a non-contact applicator comprising a plurality of rubber anti-adhesive agent sprayers installed at a fixed distance from the inner tube and a shielding membrane located close to the inner tube, or a stamping-type contact applicator incorporating a stamp that contains the rubber anti-adhesive agent and can repeatedly transfer the agent to a predetermined portion of the outer periphery of the inner tube.

[0022] Meanwhile, the present invention provides an automatic manufacturing apparatus for balloon catheter tubes, further comprising: a partial cutter which repeatedly cuts and removes a portion of an inner tube during production; a coating extruder which is located at the rear end of the partial cutter and extrudes a balloon coating layer onto an outer periphery of the partially cut inner tube; and a final cutter which is located at the rear end of the coating extruder or the next process and cuts the catheter tube by contacting the outer periphery of the catheter tube during production or by detecting a partial cutting position of the inner tube through a vision sensor.

[0023] Preferably, the partial cutter receives an actuation signal from another device, such as a timer or a device for measuring the tube extrusion length or a device for applying a rubber anti-adhesive agent, and detects the position to cut the partial cutter.

[0024] Preferably, there is provided an automatic balloon catheter tube manufacturing apparatus, characterized in that the partial cutter uses a circular or curved blade to cut or remove a portion of the inner tube.

[0025] Preferably, the partial cutter prevents the inner tube from twisting in the partial cutter through a guide having a protrusion that is recessed into the inflation tube of the inner tube, or controls the tube to not twist through a vision sensor. Effect of the Invention

[0026] The automated balloon catheter tube manufacturing method and apparatus according to the present invention uses a variable die to form or not form an inflation tube, thereby preventing warping of the catheter during balloon inflation. Also, by marking tube sections on the inner tube and cutting the finished product, it is possible to prevent accumulation of length measurement errors that occur during continuous production and enable continuous production of quality products. [Brief description of the drawings]

[0027] [Figure 1] 1 is a side cross-sectional view of a typical balloon catheter tube having a double tube structure according to a conventional embodiment. [Diagram 2] 1 is a diagram showing a structure of a variable die included in an automatic manufacturing apparatus for a balloon catheter tube according to an embodiment of the present invention. [Diagram 3] 3 is a side cross-sectional view showing an inner tube portion (A) in which an expansion tube manufactured using the variable die of FIG. 2 is formed. [Figure 4] 3 is a side cross-sectional view showing an inner tube portion (B) where an expansion tube is not yet formed, manufactured using the variable die of FIG. 2. [Diagram 5] 1 is a perspective view showing the shape of an inner tube in which an inflation tube is repeatedly formed and not formed by an automatic manufacturing apparatus for a balloon catheter tube according to an embodiment of the present invention; FIG. [Figure 6] FIG. 2 is a perspective view showing the application of a rubber anti-adhesive agent by the automatic balloon catheter tube manufacturing apparatus according to one embodiment of the present invention. [Figure 7] FIG. 2 is a perspective view showing a state in which an inner tube is partially cut by the automatic manufacturing apparatus for a balloon catheter tube according to an embodiment of the present invention. [Figure 8] 1 is a diagram showing a processing table having an inner tube anti-twisting guide formed thereon, which is configured in an automatic manufacturing apparatus for a balloon catheter tube according to an embodiment of the present invention; [Figure 9] 1 is a view showing a state in which a partially cut inner tube is coated and extruded by an automatic balloon catheter tube manufacturing apparatus according to an embodiment of the present invention. [Figure 10] 4 is a diagram illustrating a state in which a tube manufactured by an automatic balloon catheter tube manufacturing apparatus according to an embodiment of the present invention is cut at regular intervals. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] Hereinafter, the present invention will be described in detail with reference to the drawings.

[0029] FIG. 2 is a diagram showing the structure of a variable die included in an automatic balloon catheter tube manufacturing apparatus according to an embodiment of the present invention. FIG. 3 is a side cross-sectional view showing an inner tube portion (A) with an expansion tube formed using the variable die of FIG. 2. FIG. 4 is a side cross-sectional view showing an inner tube portion (B) with no expansion tube formed using the variable die of FIG. 2. FIG. 5 is a perspective view showing the shape of an inner tube with and without an expansion tube repeatedly formed using the automatic balloon catheter tube manufacturing apparatus according to an embodiment of the present invention. FIG. 6 shows the state of application of a rubber anti-adhesive agent using the automatic balloon catheter tube manufacturing apparatus according to an embodiment of the present invention. FIG. 8 is a drawing of a processing table having an anti-twist rotation guide for an inner tube formed in the automatic balloon catheter tube manufacturing apparatus according to an embodiment of the present invention. FIG. 9 is a drawing showing a state in which the partially cut inner tube is coated and extruded by the automatic balloon catheter tube manufacturing apparatus according to an embodiment of the present invention. FIG. 10 is a drawing showing a state in which a tube manufactured by the automatic balloon catheter tube manufacturing apparatus according to an embodiment of the present invention is cut at regular intervals.

[0030] Referring to these, the automatic balloon catheter tube manufacturing apparatus according to one embodiment of the present invention uses a variable extrusion die to prevent the catheter tube from warping when the balloon is inflated, cuts or removes parts of the tube spaced apart by a certain length in the rubber anti-adhesive coating section, indicates individual unit sections of the continuously produced tube, and efficiently discharges the inflated air, thereby preventing the accumulation of length measurement errors that may occur in a continuous process and enabling continuous production.

[0031] A tube manufacturing mold 8 according to a preferred embodiment included in an automatic balloon catheter tube manufacturing apparatus according to an embodiment of the present invention is provided with an outer mold having a circular hollow portion formed therein, and a material 1 extruded into the tube manufacturing mold 8 through an inner tube extruder (not shown) passes through the inside of the mold and an expansion tube 16 is formed by the expansion tube engraving portion 7, thereby manufacturing an inner tube 14.

[0032] At this time, the expansion pipe engraving section 7 can engrave the expansion pipe 16 only in the required area by the pipe engraving projection 3 which moves in and out by the drive of the motor 5.

[0033] When the inner tube 14 is manufactured using such a tube manufacturing mold 8, the expansion tube 16 is formed so as to be exposed to the outside of the inner tube 14, and the expansion tube is finally completed through the covering process of the balloon material extrusion. Therefore, a separate drilling process for air injection is not required, and continuous production is possible.

[0034] However, according to a preferred embodiment of the present invention, a pretreatment process is required prior to the balloon material covering extrusion process in which a rubber anti-adhesive is applied to a specific portion of the surface of the inner tube 14 to prevent the covering extrusion material from adhering to the inner tube, thereby enabling the balloon to be inflated. Therefore, a rubber anti-adhesive applicator is located between the inner tube extruder and the balloon covering extruder.

[0035] Since this type of rubber anti-adhesive agent application process is carried out after the inner tube has undergone a crosslinking reaction, a spray type is applicable, but a method of applying the anti-adhesive agent using a stamp method is also fully applicable to the present invention.

[0036] Next, a rubber anti-adhesive agent is applied at regular intervals, and the inner tube 14 with the anti-adhesive agent applied in the form shown in Fig. 6 can be put into a heater to dry the rubber anti-adhesive agent. The inner tube at this point can be dried immediately after the rubber anti-adhesive agent is applied because it already contains enough heat for the crosslinking reaction, but in order to reduce the reject rate of the process, it can be passed through the heater again after the application of the rubber anti-adhesive agent.

[0037] A partial cutter (not shown) is provided at the front or rear end of the device for applying the adhesion inhibitor. As shown in FIG. 7, the partial cutter cuts a portion of the inner tube 14 at a predetermined position every certain length, thereby smoothly discharging heated air inside the inner tube 14 that is too long, and at the same time, indicating the position to be finally cut on the individual tube.

[0038] The inner tube 14, in which the anti-adhesive agent has dried and hardened, is fed into a coating extruder for external coating. Since the inner tube 14 has been hardened and the anti-adhesive agent has been dried in the previous process, it can be fed immediately into the coating extruder without additional processing to produce a balloon catheter tube.

[0039] The final cut is performed as shown in FIG. 10, and the cut sites are two sites (EE') perpendicular to the longitudinal direction including the partial cut site (DD').

[0040] In more detail, a tube manufacturing die 8 having the form and operating structure of FIG. 3 is installed in an inner tube extruder for extruding the inner tube 14, and the length of the inner tube being extruded is sensed, and the position of the variable die core pin is controlled by an air pressure cylinder, a hydraulic cylinder, or a motor linked with a timer, to continuously produce the inner tube of FIG. 5 in which the cross sections of FIG. 3 and FIG. 4 are repeatedly formed.

[0041] The shape of this inner tube 14 is such that the portion where the expansion tube 16 is formed becomes the expansion tube after coating and extrusion, and a balloon is formed starting from the portion where the expansion tube 16 is not formed, thereby creating an inner tube structure that prevents the inner tube 14 from warping due to the longitudinal tensile force when the balloon is inflated.

[0042] Next, the expansion tube 16 portion of the inner tube 14 being continuously produced is identified using a contact probe or a vision sensor to recognize the boundary where the expansion tube 16 is not yet formed / formed, and an anti-adhesive applied portion 17 is formed by applying a rubber anti-adhesive to an area that slightly includes a part of the expansion tube, as shown in Figure 7.

[0043] The rubber anti-adhesive agent can be applied in a non-contact manner using a spray and a masking film, or by transferring a stamp coated with the rubber anti-adhesive agent onto the inner tube surface.

[0044] Since the rubber anti-adhesive agent is in a liquid state immediately after application, it may lose its function if it comes into contact with other parts before drying. Therefore, in order to ensure an efficient manufacturing process through rapid drying, as described above, the inner tube is sufficiently heated using the heater before and after application so that the rubber anti-adhesive agent is applied in a hot state and dried at the same time.

[0045] Next, the inner tube coated with the rubber anti-adhesive agent and dried is put into the coating extruder for extruding the balloon coating to coat it with the balloon material. The inflation tube 16, which was open to the outside of the inner tube, becomes tubular due to the coating material and plays the role of the inflation tube. The rubber anti-adhesive agent applied section 17 does not have the coating material attached to the inner tube and plays the role of a balloon. Each section is then cut to complete the balloon catheter tube.

[0046] The cross section of the inner tube 14 of the balloon of the balloon catheter tube produced by the above method has a cross section as shown in FIG. 4 in most locations except for a part of the end portion that is included for the inflation and deflation of the balloon.

[0047] As shown in the above cross section, the material of the inner tube 14 is filled on the inflation tube 16 side, so that the catheter tube can symmetrically withstand the tensile force generated in the longitudinal direction when the balloon is inflated. This prevents the catheter tube from warping due to balloon inflation.

[0048] On the other hand, if the balloon catheter tube after the balloon covering extrusion is produced in the form of a roll without cutting each section, it may be possible to produce the balloon catheter without any problems at the beginning of production. However, as the length of the produced tube increases, the air inside the expansion tube expanding due to the curing heat cannot be smoothly discharged, and the covering material in which the cross-linking reaction is not yet complete is deformed, and the balloon covering is raised along the expansion tube in the length direction, resulting in the production of defective products.

[0049] In order to prevent this, if the balloon catheter tube of each section is automatically cut by detecting its length or by linking it to a timer, slight errors in the measuring device and the elasticity of the tube itself will cause errors between the measured value and the actual length, or between the timer and the actual extrusion speed.

[0050] Each individual error is tiny and does not cause a major problem when it first occurs, but as these errors accumulate through continuous production, they ultimately result in unintended parts being cut off, resulting in the production of a large number of defective products.

[0051] To prevent this, using an automatic balloon catheter manufacturing apparatus according to one embodiment of the present invention, a portion of the inner tube is partially cut (D-D') at a certain distance from the area where the rubber anti-adhesive agent is applied, as shown in Figure 7, and the cut portion is removed.

[0052] The partial cutting and removal is performed so that the expansion pipe 16 formed on the outside and the exhaust pipe 4 on the inside penetrate each other as shown in FIG. 7, but in order to prevent the inner tube from being cut by the tensile force of the tube that may occur during the manufacturing process, the cutting and removal is performed in a curved shape such as a semicircle or sector shape without any sharp parts.

[0053] If the expansion tube is partially cut so that it penetrates the internal exhaust tube, the air that heats and expands due to the crosslinking reaction of the coating material during coating extrusion can be smoothly discharged through the expansion tube 16 and the exhaust tube 4, so that the coating process can be performed without deformation of the coating material.

[0054] Therefore, using this method, it is also possible to continuously produce balloon catheter tubes in roll form.

[0055] Meanwhile, the curved blade (not shown) of the partial cutter can only operate in a certain direction, so that the inner tube 14 passing through this portion does not rotate within the partial cutter, and cutting and removal can be performed so that the expansion tube 16 and the discharge tube 4 are continuously penetrated.

[0056] The problem of preventing the inner tube from rotating can be solved by installing a guide on the processing table 10, which has a size that matches the outer diameter of the inner tube 14 and has a protrusion that is inserted into the expansion tube 16 to prevent the tube from rotating, as shown in FIG. 8, and setting the partial cutter to operate based on this processing table 10.

[0057] As shown in FIG. 8, the guide section 52 formed on the processing table 10 has a total of three guides 12A, 12B, and 12C. The upper guide 12C in the tube traveling direction also passes through the partially cut inner tube 14. If the rotation prevention protrusion 13 is present, there is a possibility that a jamming phenomenon may occur. Therefore, a closed guide without a protrusion is installed only to fix the tube position.

[0058] The middle guide 12B is installed with its front open to allow movement of the blade of the partial cutter and to allow for the discharge of the partially cut and removed tube pieces, while the lower guide 12A is a closed guide having a protrusion 13 to fix the tube position and prevent twisting and rotation.

[0059] When a circular or sector-shaped blade is operated in a partial cutter equipped with this type of processing table 10 to cut and remove a portion (D-D') of the tube, a partial cut can be made continuously through which the expansion pipe 16 and the exhaust pipe 4 pass.

[0060] Alternatively, the object of the present invention can be sufficiently achieved by directly checking the inflation tube 16 or the contrast line with a vision sensor and controlling the rotational position of the inner tube 14.

[0061] Conventional balloon catheter tubes are produced with contrast lines that can be detected by X-ray embedded in them to prepare for the possibility of catheter breakage inside the patient's body.

[0062] This can be sensed by a vision camera (not shown) and by providing a device which senses the inflation tube 16 directly and acts to correct if it deviates from the desired position, preventing the tube from rotating within the partial cutter.

[0063] When partial cutting is performed in this manner and balloon coating is performed in the coating extrusion process, a tube is produced as shown in Figure 10. Using this as a reference point, both sides (E-E') are finally cut as shown in Figure 10, the partially cut parts are discarded, and the remaining parts are aligned as non-defective products to complete the balloon catheter tube.

[0064] The final cut can be performed by detecting each section using a roller equipped with a spring or an air cylinder roller equipped with a regulator on the surface of the tube that is covered and proceeds as shown in FIG.

[0065] In other words, when the tube is advanced while applying a constant external force to the tube surface, the roller positions in the partial cutting section and the non-partial cutting section are different. By detecting this, each section of the progressing tube can be distinguished, and the final cut is performed as shown in Figure 10 using this as a reference point.

[0066] The final cutting can be performed by using the entire equipment according to an embodiment of the present invention to produce individual balloon catheter tubes, or by producing the tubes in a roll form and supplying them to the next process in the form of a long continuous tube, and at the same time, a final cutter can be separately provided to perform the final cutting in the next process.

[0067] Meanwhile, the automatic balloon catheter tube manufacturing apparatus and method according to the embodiments of the present invention are not limited to the above-mentioned embodiments, and various modifications are possible without departing from the technical gist of the present invention. [Explanation of symbols]

[0068] 4 Discharge pipe 10 Processing table 14 Inner tube 16 Expansion tube 17 Anti-adhesive coating section

Claims

1. a) an inner tube production process in which a variable die is provided connected to an inner tube extruder and repeats a forming section and a non-forming section of an expansion tube to form an expansion tube at regular intervals along the length of the outer periphery; b) a process of repeatedly applying a rubber anti-adhesive agent by recognizing the boundary between the formed and unformed portions of the expansion tube of the inner tube; c) A method for automatically manufacturing a balloon catheter tube, comprising the steps of: coating and extruding a balloon material onto the exterior of an inner tube to produce a longitudinal balloon catheter tube having a balloon formed thereon.

2. 2. The method for automatically manufacturing a balloon catheter tube according to claim 1, wherein the application of the rubber anti-adhesive agent in step b) is a non-contact application process using a spray and a masking film, or a contact application process using a stamping method in which the rubber anti-adhesive agent is directly transferred and applied to the surface of the inner tube.

3. a) a step of cutting or removing a portion (D-D') of the inner tube at a certain distance from the position where the rubber anti-adhesive agent is applied to the surface of the inner tube during continuous production to mark a section of the catheter tube; b) continuously extruding a balloon material onto the exterior of the cut or removed inner tube; c) An automatic manufacturing method for a balloon catheter tube, comprising the steps of: detecting a cut or removal portion of an inner tube of the catheter tube coated with a balloon material and finally cutting the catheter tube at regular intervals.

4. 4. The method for automatically manufacturing a balloon catheter tube according to claim 3, wherein the cutting or removing of the part of the inner tube in step a) is performed simultaneously with the application of the rubber adhesion inhibitor.

5. 4. The method of claim 3, wherein the cutting or removing of the portion of the inner tube in step a) comprises cutting or removing the portion of the inner tube in a curved shape such as a sector shape or a circle shape.

6. 4. The method of claim 3, wherein in the step a), a portion of the inner tube is cut and removed so that the inflation tube and the exhaust tube are mutually penetrated.

7. an inner tube extruder having a variable die for producing an inner tube reflecting the repeated forming and unforming of the expansion tube; an anti-adhesive agent application device provided at a rear end of the inner tube extruder and configured to repeatedly apply a rubber anti-adhesive agent to a boundary of an expansion tube forming portion of the inner tube; 13. An automatic balloon catheter tube manufacturing apparatus comprising: a coating extruder for extruding a coating layer onto the outer periphery of the inner tube which has passed through the adhesion inhibitor coating device.

8. 8. The automatic balloon catheter tube manufacturing apparatus according to claim 7, wherein the variable die of the inner tube extruder is connected to a pneumatic cylinder, a hydraulic cylinder or a motor, and is configured to control the position of the variable die in conjunction with a length measuring device for the extruded tube or a timer.

9. 8. The automatic balloon catheter tube manufacturing apparatus according to claim 7, wherein the rubber anti-adhesive agent applicator is either a non-contact applicator including a plurality of rubber anti-adhesive agent sprayers installed at a certain distance from the inner tube and a shielding film adjacent to the inner tube, or a stamping-type contact applicator including a stamp containing the rubber anti-adhesive agent and capable of repeatedly transferring the rubber anti-adhesive agent to a predetermined portion of the outer periphery of the inner tube.

10. a partial cutter which serves to repeatedly cut and remove a portion of the inner tube during production; a coating extruder located at a rear end of the partial cutter for extruding a balloon coating layer onto an outer periphery of the partially cut inner tube; The automatic balloon catheter tube manufacturing apparatus further comprises a final cutter which is located at the rear end of the coating extruder or the next process and contacts the outer periphery of the catheter tube being produced or detects a partial cutting position of the inner tube through a vision sensor and cuts the catheter tube.

11. The automatic balloon catheter tube manufacturing apparatus according to claim 10, wherein the partial cutter receives an actuation signal from another device, such as a timer, a device for measuring the length of tube extrusion, or a device for applying a rubber anti-adhesive agent, and senses the position of the device to cut the tube.

12. 11. The automatic balloon catheter tube manufacturing apparatus according to claim 10, wherein the partial cutter uses a circular or curved blade to cut or remove a portion of the inner tube.

13. 11. The automatic balloon catheter tube manufacturing apparatus according to claim 10, wherein the partial cutter prevents the inner tube from twisting in the partial cutter through a guide having a protrusion recessed into the inflation tube of the inner tube, or controls the tube not to twist through a vision sensor.

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