Automatic manufacturing device and method for balloon catheter

Abstract

The present invention relates to an apparatus and a method for automatically manufacturing a balloon catheter, and aims to provide an apparatus and a method for automatically manufacturing a balloon catheter by using a variable extrusion die to prevent a catheter from bending when a balloon is inflated, cutting or removing a portion of a tube separated by a certain length from a rubber release agent coating section, and marking a single unit section of a continuously produced tube. The present invention relates to an apparatus and a method for automatically manufacturing a balloon catheter, which can effectively discharge expanded air and prevent accumulation of measured length errors which may occur in a continuous process, thereby enabling continuous production of the balloon catheter.

Description

Technical Field

[0001] The present invention relates to an automatic manufacturing device and method for a balloon catheter, and more specifically, to an automatic manufacturing device and method for a balloon catheter that uses a variable extrusion die to prevent the catheter from bending when the balloon is expanded, cuts or removes a portion of the tube separated by a certain length from the rubber anti-adhesive coating interval to mark a single unit interval of the continuously produced tube, and effectively discharges the expanded air to prevent the accumulation of length measurement errors that may occur in the continuous process, thereby achieving continuous production. Background Art

[0002] As is known to all, a balloon catheter is an instrument used for medical treatment, which refers to an instrument that is inserted into a human organ in a tubular shape, inflated with air or liquid infused through an inflation tube and fixed inside the human body, and then injected with drugs or discharged with various liquid excreta through a discharge tube or drug injection tube formed separately on the tube.

[0003] The structure of a common balloon catheter is as follows Figure 1 As shown in the figure, the main body is composed of an extruded tube having a double tube (2-way) structure in which an inflation tube (Inflation Lumen) for inflating or deflating a balloon and a drainage tube (Drainage Lumen) for injecting drugs or draining liquid excreta are extruded into one tube.

[0004] The extruded tube is manufactured by extruding a soft synthetic resin through an extruder, a hole is punched in a predetermined portion of the expansion tube of the extruded tube, and a separately manufactured balloon is assembled, and then a balloon is formed by pasting or coating, and another hole is processed on the discharge tube for injecting drugs or discharging liquid excrement, thereby completing the main part of the balloon catheter.

[0005] The balloon catheter manufacturing method is a complicated process with high manufacturing cost. Therefore, a patent has been applied for the technology of removing the balloon assembly, adhesion and coating processes by improving the process. Typical examples are patent registration numbers 10-0333264, 10-0434720, 10-0689238, 10-1922800, 10-2168072, 10-2056983, etc.

[0006] The multiple patents are classified according to the characteristics of the tube structure, and the registration numbers 10-0333264, 10-0434720 and 10-0689238 can be classified as the first group, and the registration numbers 10-1922800, 10-2168072 and 10-2056983 can be classified as the second group. The first group is the shape of the expansion tube of the balloon catheter inside the tube, so in order to connect the expansion tube and the balloon pipeline, the pipeline needs to be perforated separately. The characteristic of the second group is that the expansion tube is exposed outside the inner tube, so there is no need for a separate perforation operation.

[0007] The first group of patents is that before the perforation operation, after the catheter is extruded, it must be cut and separated into individual units before the operation can be carried out. Therefore, it becomes a production method that cannot be carried out continuously, and the production cost is bound to be higher than the second group. On the contrary, the second group of patents omits the perforation operation, so it can be operated continuously, but due to the structure of the expansion tube exposed outside the inner tube, the catheter will bend when the catheter balloon is expanded. This phenomenon occurs because the tensile force in the length direction generated when the soft catheter balloon is expanded cannot be symmetrically offset on the relatively hard inner tube in the tube cross section. Further, from the perspective of the cross-sectional structure, the second group of patents is that due to the structure of the expansion tube exposed outside the inner tube, the inner tube surface on the expansion tube side does not have a structure that can support the tensile force in the length direction, so it expands further than the opposite side of the expansion tube where the structure exists. As a result, as the balloon expands, the catheter bends to the opposite side of the expansion tube.

[0008] This phenomenon indicates that the smaller the outer diameter of the catheter is, the more serious the phenomenon is. If such a curved catheter is used, unnecessary stimulation will be generated inside the patient's organs, and considering that small-sized catheters are used for children, infants and children, the pain of children with impatience will be aggravated, resulting in a prolonged treatment time for the patients.

[0009] In addition to the bending problem, there are other problems in the production process of the second group. Generally speaking, the raw material used for balloon catheters is silicone rubber. As a thermosetting material, the extrusion process of the silicone rubber tube is to extrude it first and then heat it to make the silicone rubber raw material produce a cross-linking reaction. In this case, the air in the second group of the expansion tube part exposed to the outside of the inner tube will inevitably expand during the heating process. If the expanded air cannot be smoothly discharged to the front and rear of the tube, the coating material before or during the cross-linking reaction will be deformed and expanded, resulting in the inability to produce the desired tubular shape. The expanded air in the rear part of the tube can be continuously discharged smoothly, but the expanded air in the front part of the tube becomes difficult to discharge as the tube production length increases and the pipeline resistance increases. Finally, good products can be produced in the early stage of production, but as the tube length becomes longer, the discharge of the expanded air becomes difficult, and the air expansion on one side of the expansion tube causes the soft and thin balloon coating material to bulge, resulting in the produced balloon coating material floating along the expansion tube.

[0010] This problem can be solved by cutting the tubes one by one in the final step of the continuous production process so that the expanded air in the front end of the tube can be discharged smoothly, but the patent does not mention the specific method of cutting the tube in the automatic production process. Furthermore, if the tube is cut using the conventional length measurement method, due to the accumulation of measurement errors of the length measuring instrument, not only can it not be cut continuously according to the required length, but also because the catheter is made of elastic rubber material, no matter how precise the measuring instrument is used to detect the length, the measurement will become invalid due to the elasticity of the tube itself. Therefore, slight measurement errors are bound to occur, so through this continuous production method with accumulated errors, the part that cannot be cut is eventually cut.

[0011] As mentioned above, this traditional technology has many problems such as complex manufacturing process and the inability to carry out the process continuously, resulting in high manufacturing cost. Even if an improved manufacturing efficiency process is used, catheter bending still occurs when the balloon is inflated. Therefore, improvement is urgently needed. Summary of the invention

[0012] In view of the problems existing in the above-mentioned prior art, the present invention provides an automatic manufacturing device and method for a balloon catheter, which uses a variable extrusion die to prevent the catheter from bending when the balloon is inflated, cuts or removes a portion of the tube separated by a certain length from the rubber anti-sticking agent coating interval to mark the single unit interval of the continuously produced tube, and effectively discharges the expanded air to prevent the accumulation of length measurement errors that may occur in the continuous process, thereby achieving continuous production.

[0013] To achieve the above object, an automatic manufacturing method of a balloon catheter is provided according to a preferred embodiment of the present invention, preferably, the inner tube production process of forming the expansion tube at certain intervals in the length direction of the outer periphery is performed by a) connecting to an inner tube extruder a variable mold that can repeatedly implement the formed section and the unformed section of the expansion tube; b) identifying the boundary between the formed part and the unformed part of the expansion tube of the inner tube to repeatedly apply a rubber anti-sticking agent; c) coating and extruding the outside of the inner tube with a balloon material to manufacture a long balloon catheter in which the balloon is repeatedly formed.

[0014] Preferably, in the process b), the rubber anti-sticking agent coating is a non-contact coating using a sprayer and a masking film, or an automatic manufacturing method for a balloon catheter in which the rubber anti-sticking agent is directly transferred and coated on the inner tube surface by a printing film contact coating process.

[0015] On the one hand, the present invention provides an automatic manufacturing method for a balloon catheter, preferably comprising: a) a process of cutting or removing a portion D-D' of an inner tube that is separated by a certain distance from the position where a rubber anti-adhesive agent is coated on the surface of the inner tube in continuous production to mark the interval of the balloon catheter; b) a process of continuously coating and extruding a balloon material on the outside of the inner tube whose portion has been cut or removed; c) a process of detecting the cut or removed portion of the inner tube of the catheter coated with the extruded balloon material, and finally cutting the catheter separately according to certain intervals.

[0016] Preferably, an automatic method for manufacturing a balloon catheter is provided in which the cutting or removal of a portion of the inner tube in the step a) is performed simultaneously with the application of the adhesive anti-adhesive agent.

[0017] Preferably, the cutting or removing of a portion of the inner tube in the step a) is an automatic method for manufacturing a balloon catheter in which a portion of the inner tube is cut or removed in a curved surface such as a sector or a circle.

[0018] Preferably, the cutting of a portion of the inner tube in the step a) is an automatic method for manufacturing a balloon catheter in which a portion of the inner tube is cut or removed so that the inflation tube and the exhaust tube penetrate each other.

[0019] On the other hand, the present invention provides an automatic manufacturing device for a balloon catheter, preferably, comprising: an inner tube extruder, which is equipped with a variable mold and is used to manufacture an inner tube in which an expansion tube is repeatedly formed and unformed; an anti-sticking agent coating device, which is arranged at the rear end of the inner tube extruder and repeatedly coats a rubber anti-sticking agent on the boundary of the expansion tube forming part of the inner tube; and a coating extruder, which extrude a coating layer on the outer periphery of the inner tube passing through the anti-sticking agent coating device.

[0020] Preferably, an automatic manufacturing device for balloon catheters is provided in which the variable die of the inner tube extruder is connected to a pneumatic cylinder, a hydraulic cylinder or a motor, and is linked to an extruded tube length measuring device or a timer to control the position of the variable die.

[0021] Preferably, an automatic manufacturing device for a balloon catheter is provided in which the rubber anti-adhesive agent coating device is composed of a non-contact coating device consisting of a plurality of rubber anti-adhesive agent sprayers arranged at a certain distance from the inner tube and a shielding mold close to the inner tube, or a contact coating device having a laminating method in which a printing film can be repeatedly transferred onto a predetermined portion of the outer periphery of the inner tube while being loaded with rubber anti-adhesive.

[0022] On the one hand, the present invention provides an automatic manufacturing device for a balloon catheter, preferably, also including: a partial cutting machine, which can repeatedly cut and remove a portion of the inner tube in production; a coating extruder, which is located at the rear end of the partial cutting machine and extrude the balloon coating layer to the outer periphery of the partially cut inner tube; a final cutting machine, which is located at the rear end of the coating extruder or the next process, and detects the partial cutting position of the inner tube by contacting the outer periphery of the catheter in production or a visual sensor and cuts the catheter.

[0023] Preferably, the partial cutting machine is an automatic manufacturing device for balloon catheters that receives operation signals from other devices such as a timer or a tube extrusion length measurement device or a rubber anti-adhesive coating device, and performs cutting after detecting its position.

[0024] Preferably, the portion cutter is provided as an automatic manufacturing device for a balloon catheter that utilizes a circular or curved blade to cut or remove a portion of the inner tube.

[0025] Preferably, the partial cutter is provided as an automatic manufacturing device for a balloon catheter by preventing the inner tube from being twisted in the partial cutter by a guide having a protrusion recessed into the inner tube expansion tube, or controlling the tube not to be twisted by a visual sensor.

[0026] The automatic manufacturing device and method of the balloon catheter according to the present invention have the beneficial effect of using a variable mold to form or not form the expansion tube, thereby preventing the catheter from bending when the balloon is inflated, marking the tube section on the inner tube, and cutting the finished product, thereby preventing the accumulation of length measurement errors that occur with continuous production and allowing the production of qualified products to continue. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 is a side sectional view of a conventional balloon catheter having a double tube structure according to a previous embodiment;

[0028] Figure 2is a schematic diagram illustrating the structure of a variable mold included in an automatic manufacturing device for a balloon catheter according to an embodiment of the present invention;

[0029] Figure 3 For illustration purposes Figure 2 A side sectional view of an inner tube portion A formed by an expansion tube manufactured by a variable die;

[0030] Figure 4 For illustration purposes Figure 2 A side sectional view of an unformed inner tube portion B of an expansion tube manufactured by a variable die;

[0031] Figure 5 is a perspective view showing the state of the inner tube repeatedly formed and not formed by the automatic manufacturing device of the balloon catheter according to one embodiment of the present invention;

[0032] Figure 6 is a perspective view illustrating a rubber release agent coating state of an automatic manufacturing apparatus for a balloon catheter according to an embodiment of the present invention;

[0033] Figure 7 is a perspective view showing a partially cut state of the inner tube of the automatic manufacturing apparatus of the balloon catheter according to one embodiment of the present invention;

[0034] Figure 8 It is a schematic diagram of a processing table provided with a guide device for preventing the inner tube from twisting and rotating, which is constructed on an automatic manufacturing device for a balloon catheter according to an embodiment of the present invention;

[0035] Fig. 9 is a schematic diagram showing a partially cut inner tube being extruded and coated by an automatic manufacturing device for a balloon catheter according to an embodiment of the present invention;

[0036] Fig.10 It is a schematic diagram showing a state where a tube manufactured by an automatic manufacturing apparatus for a balloon catheter according to an embodiment of the present invention is cut at regular intervals.

[0037] Explanation of symbols

[0038] 4: discharge pipe; 10: processing table; 14: inner pipe; 16: expansion pipe;

[0039] 17: Anti-adhesive coating section. DETAILED DESCRIPTION

[0040] The present invention will be described in detail below with reference to the accompanying drawings.

[0041] Figure 2 is a schematic diagram illustrating the structure of a variable mold included in an automatic manufacturing device for a balloon catheter according to an embodiment of the present invention, Figure 3 For illustration purposes Figure 2A side sectional view of an inner tube portion A formed by an expansion tube manufactured by a variable die, Figure 4 For illustration purposes Figure 2 A side sectional view of an unformed inner tube portion B of an expansion tube manufactured by a variable die, Figure 5 This is a perspective view showing the state of the inner tube repeatedly formed and not formed by the automatic manufacturing device of the balloon catheter according to one embodiment of the present invention. Figure 6 is a perspective view showing a rubber release agent coating state of an automatic manufacturing apparatus for a balloon catheter according to an embodiment of the present invention, Figure 7 is a perspective view showing a partially cut state of the inner tube of the automatic manufacturing apparatus for the balloon catheter according to one embodiment of the present invention, Figure 8 It is a schematic diagram of a processing table provided with a guide device for preventing the inner tube from twisting and rotating, which is constructed on an automatic manufacturing device for a balloon catheter according to an embodiment of the present invention. Fig. 9 is a schematic diagram showing a partially cut inner tube being extruded and coated by an automatic manufacturing device for a balloon catheter according to an embodiment of the present invention, Fig.10 It is a schematic diagram showing a state where a tube manufactured by an automatic manufacturing apparatus for a balloon catheter according to an embodiment of the present invention is cut at regular intervals.

[0042] Based on this, an automatic manufacturing device for a balloon catheter according to one embodiment of the present invention serves as an automatic manufacturing device for a balloon catheter, which uses a variable extrusion die to prevent the catheter from bending when the balloon is inflated, and while cutting or removing a portion of the tube of a certain length separated by the rubber anti-adhesive coating section to display a single unit section of the continuously produced tube, effectively discharges the expanded air, thereby preventing the accumulation of length measurement errors that may occur in a continuous process and achieving continuous production.

[0043] The tube manufacturing mold 8 of a preferred embodiment included in the automatic manufacturing device of a balloon catheter according to one embodiment of the present invention has an external mold with a circular hollow portion inside. The material 1 extruded into the tube manufacturing mold 8 by an inner tube extruder (not shown) is formed into an expansion tube 16 by the expansion tube engraving portion 7 when passing through the inside of the mold, thereby manufacturing the inner tube 14.

[0044] Here, the expansion tube engraving unit 7 can engrave the protrusion 3 through the pipeline that is driven in and out by the motor 5, so as to engrave the expansion tube 16 only on the necessary area.

[0045] When the inner tube 14 is manufactured using the tube manufacturing mold 8 as described above, the expansion tube 16 is exposed outside the inner tube 14, and the expansion tube is finally completed through a coating process of balloon material extrusion. Therefore, no other perforation process for injecting air is required, and continuous production can be achieved.

[0046] However, according to a preferred embodiment of the present invention, before the balloon material coating extrusion process, a rubber anti-sticking agent is coated on a predetermined portion of the surface of the inner tube 14 to prevent the coating extrusion material from adhering to the inner tube, thereby performing a pretreatment process for balloon bulging. Therefore, the rubber anti-sticking agent coating device is located between the inner tube extruder and the balloon coating extruder.

[0047] This rubber anti-adhesion agent coating device is a process that the inner tube undergoes after the cross-linking reaction occurs. It can also be sprayed, but the method of applying the anti-adhesion agent by embossing can also be fully applicable to the present invention.

[0048] Then, a rubber release agent is applied at regular intervals, and the release agent is applied as follows. Figure 6 The inner tube 14 of the shown form is for drying the rubber anti-adhesion agent and can be placed in a heater. At this time, the inner tube has enough heat required for the cross-linking reaction, so it can be dried immediately after applying the rubber anti-adhesion agent, but in order to reduce the defective rate of the process, it can be passed through the heater again after applying the rubber anti-adhesion agent.

[0049] A partial cutter (not shown) is provided at the front end or rear end of the device for applying the anti-sticking agent. Figure 7 As shown in the figure, according to a certain length category of the inner tube 14, a part is cut at a predetermined position, so that the heated air inside the excessively long inner tube 14 can be discharged smoothly, and at the same time, the position to be finally cut into a single tube product is marked.

[0050] The inner tube 14 after the anti-adhesive agent is dried and solidified is put into the coating extruder to form the outer coating. Since the inner tube 14 is solidified and the anti-adhesive agent is dried through the previous process, it does not need to be processed separately and can be directly put into the coating extruder to produce the balloon catheter.

[0051] In addition, implementation of Fig.10 The final cutting shown is a cutting portion that includes two perpendicular portions EE' in the length direction of the partial cutting portion.

[0052] More specifically, a device having a plurality of inner tubes is installed on the inner tube extruder for extruding the inner tube 14. Figure 3 The tube manufacturing die 8 of the shape and running structure is then monitored for the length of the inner tube during extrusion, or the position of the variable die core pin is controlled by a pneumatic cylinder, a hydraulic cylinder or a motor linked to a timer, so as to produce Figure 3 and Figure 4 The cross section is repeatedly formed Figure 5 The inner tube.

[0053] The purpose of the shape of the inner tube 14 is to form a portion formed by the expansion tube 16 which is covered and extruded to become an expansion tube, and the balloon is formed with the portion forming the expansion tube 16 as the starting point. When the balloon is expanded, the inner tube 14 can be prevented from bending due to the tensile force in the length direction.

[0054] Then, the expansion tube 16 portion of the inner tube 14 being produced is continuously identified by using a contact probe or a visual sensor to identify the boundary of the expansion tube 16 not formed / formed, such as Figure 7 As shown, a release agent coating portion 17 is formed in which a rubber release agent is coated on a portion slightly including a part of the expansion tube.

[0055] The rubber release agent is applied in a non-contact manner using a sprayer and a masking film, or by transferring a printing film with the rubber release agent to the inner tube surface.

[0056] The rubber anti-adhesive is in a liquid state after application, and may lose its function when it contacts other parts before drying. Therefore, in order to implement an efficient manufacturing process by rapid drying, as described above, the inner tube is sufficiently heated by the heater before and after application, and the rubber anti-adhesive is dried immediately after application in a hot state.

[0057] The inner tube coated with the rubber anti-sticking agent and dried is then placed into the coating extruder for extruding the balloon coating. After the balloon material is coated, the expansion tube 16 open to the outside of the inner tube is formed into a tube shape due to the coating material, and thus plays the role of an expansion tube. The rubber anti-sticking agent coating portion 17 plays the role of a balloon because the coating material does not stick to the inner tube. Therefore, the balloon catheter can be completed by cutting each section.

[0058] The cross section of the inner tube 14 of the balloon portion of the balloon catheter produced by the method has a cross section such as Figure 4 Cross-section of the morphology shown.

[0059] As shown in the cross section, since the inflation tube 16 is filled with the material of the inner tube 14, the balloon is inflated to form a shape that can symmetrically support the tensile force occurring along the length direction, thereby preventing the catheter from bending due to balloon inflation.

[0060] On the one hand, if the balloon catheter is not cut into sections after the balloon coating is extruded, but is produced in the form of a roll, there will be no problems in the initial production. However, the length of the production tube will become longer and longer, resulting in poor discharge of the air inside the expansion tube that has expanded due to the heat of curing, and ultimately causing the coating material that has not completed the cross-linking reaction to deform, thereby producing defective products in which the balloon coating is deformed and the expansion tube floats along the length direction.

[0061] To prevent this phenomenon, when the balloon catheter is automatically cut in each section by detecting the length or linking with a timer, an error occurs between the measured value and the actual length, or between the timer and the actual extrusion speed, due to slight errors in the measuring device and the elasticity of the tube itself.

[0062] The error between individual parts is so small that it will not cause a big problem in the early stage. However, when the error accumulates due to continuous production, non-target parts will be cut, resulting in a large number of defective products.

[0063] In order to prevent this phenomenon from occurring, a portion of the inner tube separated by a certain distance from the location where the rubber anti-adhesive agent is applied is separated by an automatic manufacturing device for a balloon catheter according to an embodiment of the present invention. Figure 7 Partial cutting D-D' is performed as shown, and the cutting site is removed.

[0064] The partial cutting and removal is as follows Figure 7 As shown, the expansion tube 16 formed on the outside and the discharge tube 4 formed on the inside are connected, but in order to prevent the inner tube from being broken due to the tensile force of the tube during the production process, it is cut and removed in the form of a curved surface such as a semicircle or a fan to avoid sharp parts.

[0065] When the expansion tube and the internal discharge tube are connected while the partial cutting is performed, the air heated and expanded by the cross-linking reaction of the coating material during the coating extrusion is discharged very smoothly through the discharge tube 4 along with the expansion tube 16, so the coating material will not be deformed during the coating process.

[0066] Therefore, the balloon catheter can be continuously produced in the form of a roll by this method.

[0067] On the other hand, since the curved blade (not shown) of the partial cutter can only run in a certain direction, the inner tube 14 passing through the portion must be prevented from rotating in the partial cutter so that it can be cut and removed so that the expansion tube 16 and the discharge tube 4 continue to be connected.

[0068] This inner tube is prevented from rotating if Figure 8 As shown, a guide having a size that matches the outer diameter of the inner tube 14 and having a protrusion that prevents the tube from rotating by inserting the expansion tube 16 is installed on the processing table 10, and a part of the cutting machine is installed so that it runs based on the processing table 10.

[0069] like Figure 8As shown, the guide portion 52 formed on the processing table 10 is provided with three guides 12A, 12B, and 12C in total. The guide 12C at the upper end in the direction of tube travel is because the partially cut inner tube 14 also passes through. Therefore, if the anti-rotation protrusion 13 is present, jamming may occur. Therefore, in order to fix the position of the tube, a closed guide without a protrusion is provided.

[0070] The middle guide 12B is designed to be open on the front for the movement of the blade of a partial cutter (not shown) and partial cutting (not shown) as well as the discharge of the removed pipe segment blocks. The lower guide 12A is designed to fix the position of the pipe and prevent twisting and rotation, and is formed as a closed guide with a protrusion 13.

[0071] The partial cutting machine provided with the processing table 10 of this form operates a circular or fan-shaped blade to cut and remove a portion DD' of the pipe, thereby continuously cutting the portion where the expansion pipe 16 and the discharge pipe 4 pass through.

[0072] As yet another method, the object of the present invention can be fully achieved by directly checking the expansion tube 16 or the contrast line with a visual sensor to control the position of the inner tube 14 when it is rotated.

[0073] Typically, balloon catheters are produced to prepare for accidents in which the catheter may break in the patient's body, and an X-ray-sensible contrast line is implanted in the catheter.

[0074] The pipe may be prevented from rotating in a section cutter (not shown) by installing a mechanism that detects the section by means of a vision camera (not shown) or directly detects the expanded pipe 16 and can correct it if it deviates from the desired position.

[0075] When the balloon is partially cut in this form and coated by the coating extrusion process, the Fig.10 The morphology shown in the production tube is Fig.10 As shown, after the two side parts E-E' are finally cut with this as the reference point, part of the cut parts are discarded, and the rest are arranged as good products, and the balloon catheter is finally completed.

[0076] By means of the final cutting, it is possible to Fig.10 On the surface of the tube where the coating is being performed in the form shown, each section is detected using a roller equipped with a spring or a circular roller equipped with an adjuster.

[0077] Furthermore, when a certain force is applied to the surface of the tube and the tube is moved, the roller position in the non-partially cut section and the partially cut section will change. By detecting this, the sections of the tube can be identified and finally implemented as a reference point. Fig.10 Final cut shown.

[0078] The final cutting can be equipped together with the overall equipment of one embodiment of the present invention to produce individual units of balloon catheters. Otherwise, it can be produced in a roll form and supplied to the next process in a continuous tube form, and a final cutting machine can be equipped separately to perform the final cutting in the next process.

[0079] On the other hand, the automatic manufacturing apparatus and method of a balloon catheter according to an embodiment of the present invention are not limited to the above-described embodiment, and various modifications can be made without departing from the technical gist.

Claims

1. An automatic manufacturing method for a balloon catheter, characterized in that: The process of producing an inner tube by a) connecting to an inner tube extruder a variable die which repeatedly forms an expansion tube formation section and an unformed section, and forming the expansion tube at certain sections in the length direction of the outer circumference; b) identifying the boundary between the formed section and the unformed section of the expansion tube of the inner tube to repeatedly apply a rubber anti-sticking agent; and c) coating and extruding the outer side of the inner tube with a balloon material, and manufacturing a long balloon catheter in which a balloon is repeatedly formed.

2. The automatic manufacturing method of a balloon catheter according to claim 1, characterized in that: In the process b), the rubber anti-sticking agent is applied by non-contact coating using a sprayer and a masking film, or by contact coating using a printing film method in which the rubber anti-sticking agent is directly transferred and applied onto the inner tube surface.

3. An automatic manufacturing method for a balloon catheter, characterized in that: The method comprises the following steps: a) cutting or removing a portion D-D' of the inner tube which is separated by a certain distance from the position where the rubber anti-adhesive agent is applied to the surface of the inner tube in continuous production to mark the interval of the balloon catheter; b) continuously coating and extruding the balloon material on the outside of the inner tube from which the portion has been cut or removed; and c) detecting the portion of the inner tube of the catheter coated with the extruded balloon material which has been cut or removed, and finally cutting the catheter into certain intervals.

4. The automatic manufacturing method of a balloon catheter according to claim 3, characterized in that: The cutting or removal of a portion of the inner tube in the process a) is carried out simultaneously with the coating of the adhesive anti-adhesive.

5. The automatic manufacturing method of a balloon catheter according to claim 3, characterized in that: The cutting or removal of a portion of the inner tube in the step a) is to cut or remove a portion of the inner tube in the form of a curved surface such as a sector or a circle.

6. The automatic manufacturing method of a balloon catheter according to claim 3, characterized in that: The cutting of a portion of the inner tube in the step a) is to cut or remove a portion of the inner tube so that the expansion tube and the discharge tube penetrate each other.

7. An automatic manufacturing device for a balloon catheter, characterized in that: The composition includes: an inner tube extruder, which is equipped with a variable die and is used to manufacture an inner tube in which an expansion tube is repeatedly formed and unformed; an anti-sticking agent coating device, which is arranged at the rear end of the inner tube extruder and repeatedly coats a rubber anti-sticking agent on the boundary of the expansion tube forming part of the inner tube; and a coating extruder, which extrude a coating layer on the outer periphery of the inner tube passing through the anti-sticking agent coating device.

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

9. The automatic manufacturing device for a balloon catheter according to claim 7, characterized in that: The rubber anti-adhesive coating device is composed of a non-contact coating device consisting of a plurality of rubber anti-adhesive sprayers arranged at a certain distance from the inner tube and a shielding mold close to the inner tube, or a contact coating device with a lamination method that can repeatedly transfer a printing film onto a predetermined portion of the outer periphery of the inner tube while the rubber anti-adhesive is built in.

10. An automatic manufacturing device for a balloon catheter, characterized in that: Also includes: A partial cutter, which serves to repeatedly cut and remove a portion of the inner tube in production; a coating extruder, which is located at the rear end of the partial cutter, and extrude the balloon coating layer to the outer periphery of the partially cut inner tube; a final cutter, which is located at the rear end of the coating extruder or the next process, detects the partial cutting position of the inner tube by contacting the outer periphery of the catheter in production or a visual sensor and cuts the catheter.

11. The automatic manufacturing device for a balloon catheter according to claim 10, characterized in that: The partial cutting machine receives the operation signal of other devices such as a timer or a tube extrusion length measurement or a rubber anti-adhesive coating device, and cuts after detecting its position.

12. The automatic manufacturing device for a balloon catheter according to claim 10, characterized in that: The part cutter utilizes a circular or curved blade to cut or remove a part of the inner tube.

13. The automatic manufacturing device for a balloon catheter according to claim 10, characterized in that: The partial cutter prevents the inner tube from twisting in the partial cutter by using a guide having a protrusion recessed into the inner tube expansion tube, or controls the tube not to twist by using a visual sensor.

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