Automatic manufacturing method and automatic manufacturing device for balloon catheter tubes

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 automated method and apparatus for manufacturing a balloon catheter tube. More particularly, the present invention relates to an automated method and apparatus for manufacturing a balloon catheter tube, which uses a variable extrusion die to prevent the catheter tube from warping during balloon inflation, and cuts or removes a portion of the tube a certain length away from the section where a rubber anti-adhesive agent is applied to mark individual unit sections of the continuously produced tube, while efficiently discharging inflation 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 inserted into a human organ, inflates a balloon using air or liquid injected through an inflator, and fixes it inside the human body. Then, medicines are injected through the tube or the formed drainage or medicine injection tube, or various liquid excrements are removed.

[0003] As shown in Figure 1, a typical balloon catheter is constructed with an extruded tube as the main body, which has a double-tube (2-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 extruded tube is manufactured by extruding a soft synthetic resin through an extruder. A predetermined portion of the inflation tube of the extruded tube is perforated, and a separately manufactured balloon is assembled. The balloon is then completed through bonding and coating. A separate hole is drilled in the discharge tube for injecting medicine or removing liquid excrement, completing the main part of the balloon catheter tube.

[0005] The catheter tube manufacturing method described above 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 is inside the tube, so a separate hole drilling operation is required to connect the inflation tube to the balloon line, while Group 2 is a structure in which the inflation tube is exposed to the outside of the inner tube, so a separate hole drilling operation is not required.

[0007] The Group 1 patents require the extrusion of the catheter tube, which must then be cut and separated into individual units for the perforation process, making continuous production impossible and resulting in higher production costs than Group 2. While the Group 2 patents omit the perforation process and allow continuous production, the structure of the inflation tube exposed to the outside of the inner tube causes the catheter tube to warp when the catheter balloon is inflated. This occurs because the relatively rigid inner tube is unable to symmetrically counteract the longitudinal tensile force generated by the inflation of the soft catheter balloon. In other words, in the Group 2 patents, the structure of the inflation tube exposed to the outside of the inner tube means that the surface of the inner tube facing the inflation tube does not have a structure capable of withstanding the longitudinal tensile force, and therefore stretches more than the opposite side of the inflation tube where the structure is located. As a result, the catheter tube warps toward the opposite side of the inflation tube as the balloon is inflated. This phenomenon becomes more severe as the catheter outer diameter becomes smaller.

[0008] Such a curved catheter can cause unnecessary irritation inside the patient's organs when in use, and considering that smaller catheters are generally used in children, infants, and young patients, this can add to the pain of younger patients who have poor tolerance, potentially resulting in a longer treatment period for the patient.

[0009] In addition to the warping issue, the Group 2 production process presents additional challenges. Balloon catheters typically use silicone rubber as their raw material. The extrusion process for silicone rubber tubes, which are thermosetting materials, requires heating after extrusion to initiate a crosslinking reaction of the silicone rubber raw material. Under these conditions, the air present in the inflation tube (exposed to the outside of the Group 2 inner tube) inevitably expands during the heating process. If the expanding air cannot be smoothly vented to the front and rear of the tube, it can cause deformation and expansion of the covering material before or during the crosslinking reaction, making it impossible to produce a tube with the desired shape. While the inflation air can be smoothly vented to the rear of the tube continuously, the venting of the inflation air to the front of the tube becomes more difficult as the tube length increases due to increased pipeline resistance. Ultimately, while good-quality products are produced initially, the longer the tube, the more difficult it becomes to vent the inflation air. As the tube length increases, the air expands at the inflation tube side, inflating the soft, thin balloon covering material, resulting in the balloon covering material floating up along the inflation tube.

[0010] This problem can be solved by continuously cutting the tube into individual unit tubes in the final step of the continuous production process, thereby maintaining continuous and smooth discharge of inflation air to the front of the tube. However, the patent does not cite any specific technology for cutting the tube in an automated production process. In particular, when cutting the tube using a conventional length measurement method, not only is it impossible to consistently cut the tube to the desired length due to the accumulation of measurement errors in the length measurement device, but also, because catheter tubes are made of elastic rubber, even if the length is measured using a precise measuring device, the elasticity of the tube itself makes the measurement meaningless. Therefore, small measurement errors are inevitable, and in a continuous production method where these errors accumulate, parts that should not be cut end up being cut.

[0011] As mentioned above, such conventional techniques have many problems, such as a complicated manufacturing process that makes continuous manufacturing impossible, resulting in high manufacturing costs, and even in an improved process with high manufacturing efficiency, the catheter tube warps when the balloon is inflated. Therefore, 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-described problems in the prior art, and aims to provide an automated method and apparatus for manufacturing balloon catheter tubes that uses a variable extrusion die to prevent the catheter tube from warping during balloon inflation, and that cuts or removes a portion of the tube a certain length away from the section where the rubber anti-adhesive agent is applied to mark individual unit sections of the continuously produced tube while efficiently discharging the inflation 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] To achieve the above object, a preferred embodiment of the present invention provides an automated manufacturing method for a balloon catheter tube, comprising: (a) an inner tube manufacturing process in which an adjustable die is provided connected to an inner tube extruder, which alternately performs an expansion tube forming section and an unformed section, and an expansion tube is formed at regular intervals along the length of the outer periphery; (b) a process in which a boundary between the formed and unformed sections of the inner tube is identified and a rubber anti-adhesive agent is repeatedly applied; and (c) a balloon material is repeatedly coated and extruded onto the outside of the inner tube to manufacture a longitudinal balloon catheter tube with a balloon formed thereon.

[0014] Preferably, the method for automatically manufacturing a balloon catheter tube is characterized in that 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 onto the surface of the inner tube.

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

[0016] Preferably, there is provided an automated manufacturing method for a balloon catheter tube, wherein the cutting or removal of the portion 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 the cutting or removal of the portion of the inner tube in step a) comprises cutting or removing the portion of the inner tube 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 pass through each other.

[0019] The present invention also provides an automated balloon catheter tube manufacturing apparatus, comprising: an inner tube extruder having a variable die for manufacturing an inner tube that reflects the repeated formation and non-formation of an inflation tube; an anti-adhesive agent applicator disposed at the rear end of the inner tube extruder for repeatedly applying a rubber anti-adhesive agent to the boundary of the inner tube where the inflation tube is formed; and a coating extruder for extruding a coating layer onto the 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 conjunction with a length measuring device or a timer for measuring the length of the extruded tube.

[0021] Preferably, the rubber anti-adhesion agent applicator is either a non-contact applicator comprising multiple rubber anti-adhesion agent sprayers installed at a fixed distance from the inner tube and a shielding film located close to the inner tube, or a stamping-type contact applicator incorporating a stamp containing the rubber anti-adhesion agent and capable of repeatedly transferring 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 that repeatedly cuts and removes a portion of the inner tube during production; a coating extruder located at the rear end of the partial cutter and extruding a balloon coating layer onto the outer periphery of the partially cut inner tube; and a final cutter located at the rear end of the coating extruder or the next process, that contacts the outer periphery of the catheter tube during production or detects the partial cutting position of the inner tube through a vision sensor and cuts the catheter tube.

[0023] Preferably, the automatic balloon catheter tube manufacturing apparatus is characterized in that the partial cutter receives an actuation signal from another device, such as a timer or a device for measuring the extrusion length of the tube or a device for applying a rubber anti-adhesive agent, and operates to detect the position and cut the tube.

[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 prevent twisting through a vision sensor. [Effects 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 unform an inflation tube, thereby preventing warping of the catheter during balloon inflation. Furthermore, by marking tube sections on the inner tube and cutting the finished product, it is possible to prevent the accumulation of length measurement errors that occur during continuous production, thereby enabling continuous production of quality products. [Brief explanation 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. [Figure 2] 1 is a diagram illustrating 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. [Figure 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 manufactured using the variable die of FIG. 2 has not yet been formed. [Figure 5] 1 is a perspective view showing the shape of an inner tube in which an inflation tube is repeatedly formed and unformed by an automatic manufacturing apparatus for a balloon catheter tube according to an embodiment of the present invention; FIG. [Figure 6] FIG. 1 is a perspective view showing the state in which a rubber anti-adhesion agent is applied by an automatic balloon catheter tube manufacturing apparatus according to an embodiment of the present invention. [Figure 7] FIG. 1 is a perspective view showing a state in which an inner tube is partially cut by the automatic balloon catheter tube manufacturing apparatus according to one embodiment of the present invention. [Figure 8] 1 is a diagram showing a processing table on which an inner tube anti-twist rotation guide is formed, 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] 1 is a view illustrating a state in which a tube manufactured by an automatic manufacturing apparatus for a balloon catheter tube according to an embodiment of the present invention is cut at regular intervals. DETAILED DESCRIPTION OF THE INVENTION

[0028] The present invention will now be described in detail with reference to the accompanying 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 inflation tube formed using the variable die of FIG. 2; FIG. 4 is a side cross-sectional view showing an inner tube portion (B) with an inflation tube not yet 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 inflation tube repeatedly formed using the automatic balloon catheter tube manufacturing apparatus according to an embodiment of the present invention; and FIG. 6 shows the state of application of a rubber anti-adhesion agent using the automatic balloon catheter tube manufacturing apparatus according to an embodiment of the present invention. FIG. 7 is a perspective view showing a state in which an inner tube is partially cut by the automatic balloon catheter tube manufacturing apparatus according to one embodiment of the present invention; FIG. 8 is a view of a processing table formed with an inner tube twist-preventing rotation guide configured in the automatic balloon catheter tube manufacturing apparatus according to one embodiment of the present invention; FIG. 9 is a view showing a state in which the partially cut inner tube is coated and extruded by the automatic balloon catheter tube manufacturing apparatus according to one embodiment of the present invention; and FIG. 10 is a view showing a state in which a tube manufactured by the automatic balloon catheter tube manufacturing apparatus according to one embodiment of the present invention is cut at regular intervals.

[0030] Referring to these figures, an automated 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 during balloon inflation, cuts or removes portions of the tube at predetermined intervals in the rubber anti-adhesive coating section, marks individual unit sections of the continuously produced tube, and efficiently discharges inflation 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 one embodiment of the present invention has an outer mold with a circular hollow portion formed therein. 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 an 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 protrusion 3 which moves in and out by the drive of the motor 5.

[0033] When the inner tube 14 is manufactured using this tube manufacturing mold 8, the inflation tube 16 is formed so as to be exposed to the outside of the inner tube 14, and the inflation 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, in a preferred embodiment of the present invention, a pre-treatment step is required before the balloon material coating extrusion process: a rubber anti-adhesive agent is applied to a predetermined portion of the surface of the inner tube 14 to prevent the extrusion coating material from adhering to the inner tube, thereby enabling the balloon to inflate. Therefore, a rubber anti-adhesive agent applicator is located between the inner tube extruder and the balloon coating extruder.

[0035] Since this type of rubber anti-adhesive agent application device is a process that 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 coated with the anti-adhesive agent in the form shown in Figure 6 can be placed in a heater to dry the rubber anti-adhesive agent. At this point, the inner tube contains enough heat for the cross-linking reaction, so it can dry quickly after the rubber anti-adhesive agent is applied, but 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 preventive agent. 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 from the inner tube 14 that is too long, and at the same time, marking the final cutting position on each tube.

[0038] After the anti-adhesive agent has dried and cured, the inner tube 14 is placed in a coating extruder for external coating. Since the inner tube 14 has been cured and the anti-adhesive agent has dried in the previous process, it can be immediately placed in the coating extruder without any additional processing, allowing the production of a balloon catheter tube.

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

[0040] In more detail, a tube manufacturing die 8 having the configuration 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 during extrusion is sensed, or the position of the variable die core pin is controlled by a pneumatic cylinder, hydraulic cylinder, or motor linked with a timer, to continuously produce inner tubes as shown in FIG. 5, in which the cross sections of FIGS. 3 and 4 are repeatedly formed.

[0041] The shape of this inner tube 14 is such that the portion where the inflation tube 16 is formed becomes the inflation tube after coating extrusion, and the balloon is formed from the portion where the inflation tube 16 is not formed, with the purpose of creating an inner tube structure that can prevent 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 identify the boundary between where the expansion tube 16 is not yet formed and where it is formed, and an anti-adhesive coating 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 by a non-contact method using a spray and a shielding film, or by transferring a stamp coated with the rubber anti-adhesive agent onto the surface of the inner tube.

[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, to ensure an efficient manufacturing process through rapid drying, the inner tube is sufficiently heated using the heater before and after application, as described above, so that the rubber anti-adhesive agent is applied in a hot state and simultaneously dried.

[0045] Next, the inner tube coated with the rubber anti-adhesive and dried is placed in the coating extruder for extruding the balloon covering, and the balloon material is coated. The inflation tube 16, which was previously open to the outside of the inner tube, becomes tubular due to the coating material and begins to function as an inflation tube. The rubber anti-adhesive coated section 17, where the coating material is no longer attached to the inner tube, begins to function as 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 Figure 4 at most positions except for a part of the end portion that is included for inflation and deflation of the balloon.

[0047] As shown in the cross section above, the material of the inner tube 14 is filled on the inflation tube 16 side, so that the catheter 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 balloon coating extrusion is produced in roll form without cutting each section, production may be possible without any problems in the early stages of production. However, as the length of the produced tube increases, the air inside the expansion tube that expands due to the curing heat cannot be smoothly discharged, eventually deforming the coating material that has not yet completed the cross-linking reaction, resulting in the production of defective products in which the balloon coating is deformed and lifted along the expansion tube in the length direction.

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

[0050] Each individual error is small and does not cause a major problem when it first occurs, but as these errors accumulate through continuous production, they eventually result in cutting unintended parts, 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 externally formed expansion pipe 16 and the internal exhaust pipe 4 are penetrated as shown in FIG. 7, but the cutting and removal is performed in a curved shape such as a semicircle or fan shape without any sharp parts so that the inner tube is not cut by the tensile force of the tube that may occur during the manufacturing process.

[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 cross-linking reaction of the coating material during coating extrusion can be smoothly discharged through the expansion tube 16 and the exhaust tube 4, allowing the coating process to be carried out without deformation of the coating material.

[0054] Therefore, this method also makes it 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 the inner tube 14 passing through this part is prevented from rotating within the partial cutter, and cutting and removal can be performed so that the inflation tube 16 and the discharge tube 4 are continuously penetrated.

[0056] As shown in FIG. 8, this problem of preventing rotation of the inner tube can be solved by installing a guide on the processing table 10 that 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 rotation of the tube, and by installing the partial cutter so that it operates 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 travel direction also passes through the partially cut inner tube 14, and therefore, if the anti-rotation protrusion 13 is present, there is a possibility that it may get caught. Therefore, a closed guide without a protrusion is installed solely to fix the tube position.

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

[0059] When a circular or fan-shaped blade is operated in a partial cutter equipped with this type of processing table 10 to cut and remove a portion of the tube (D-D'), a partial cut can be made continuously through which the expansion pipe 16 and the discharge 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] In general, balloon catheter tubes are produced with a contrast line that can be detected by X-ray embedded in the catheter tube to prepare for the possibility of the catheter breaking inside the patient's body.

[0062] This can be sensed by a vision camera (not shown) and a device can be provided that senses the inflation tube 16 directly and acts to correct if it moves out of 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, the final cutting is performed on both sides (E-E') as shown in Figure 10, and the partially cut parts are discarded, while the remaining parts are aligned as good products, resulting in the final 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 moving forward as shown in FIG.

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

[0066] The final cutting can be performed together with the overall equipment according to an embodiment of the present invention to produce individual balloon catheter tubes, or the balloon catheter tube can be produced in roll form and supplied to the next process in the form of a long continuous tube, and a separate final cutter can be 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-described embodiments, and various modifications are possible within the scope of the technical gist thereof. [Explanation of symbols]

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

Claims

1. a) an inner tube production process in which a variable die is provided connected to an inner tube extruder and alternately performs a forming section and a non-forming section of an expansion tube, and an expansion tube is formed at regular intervals along the length of the outer periphery; b) a process of repeatedly applying a rubber anti-adhesion agent by recognizing the boundary between the formed and unformed portions of the inner tube; c) An automated method for manufacturing a balloon catheter tube, comprising repeatedly extruding a balloon material onto the outside of an inner tube to manufacture a longitudinal balloon catheter tube having a balloon formed thereon.

2. 2. The automated manufacturing method for 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 onto the surface of the inner tube.

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

4. 4. The automated manufacturing method for a balloon catheter tube according to claim 3, wherein the cutting or removal of the portion of the inner tube in step a) is performed simultaneously with the application of the rubber anti-adhesive agent.

5. 4. The method for automatically manufacturing a balloon catheter tube according to 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 the shape of a curved surface such as a fan shape or a circle.

6. 4. The automated method for manufacturing a balloon catheter tube according to claim 3, wherein 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 can penetrate each other.

7. an inner tube extruder equipped with a variable die for producing an inner tube that reflects the repeated forming and unforming of the expansion tube; an anti-adhesive agent applying device provided at a rear end of the inner tube extruder, for repeatedly applying a rubber anti-adhesive agent to a boundary of an expansion tube forming portion of the inner tube; 10. An automatic balloon catheter tube manufacturing apparatus comprising: a coating extruder for extruding a coating layer onto the outer periphery of the inner tube that has passed through the adhesion preventive agent applying 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 or a timer for measuring the length of the extruded tube.

9. 10. The automated balloon catheter tube manufacturing apparatus according to claim 7, wherein the rubber anti-adhesive agent applicator is either a non-contact applicator comprising a plurality of rubber anti-adhesive agent sprayers installed at a predetermined distance from the inner tube and a shielding film located close to the inner tube, or a stamping-type contact applicator incorporating 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 that serves to repeatedly cut and remove portions of the inner tube during production; a coating extruder located at the rear end of the partial cutter for extruding a balloon coating layer onto the 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 which 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. 11. The automatic balloon catheter tube manufacturing apparatus according to claim 10, wherein the partial cutter receives an activation signal from another device, such as a timer or a device for measuring the length of extrusion of the tube or a device for applying a rubber anti-adhesive agent, and detects 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 to prevent twisting through a vision sensor.

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