WO2019240542A1 - 열경화성 수지를 이용한 벌룬 카테타 제조방법 및 그 장치 - Google Patents

열경화성 수지를 이용한 벌룬 카테타 제조방법 및 그 장치 Download PDF

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Publication number
WO2019240542A1
WO2019240542A1 PCT/KR2019/007219 KR2019007219W WO2019240542A1 WO 2019240542 A1 WO2019240542 A1 WO 2019240542A1 KR 2019007219 W KR2019007219 W KR 2019007219W WO 2019240542 A1 WO2019240542 A1 WO 2019240542A1
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WO
WIPO (PCT)
Prior art keywords
tube
release agent
balloon catheter
thermosetting resin
manufacturing
Prior art date
Application number
PCT/KR2019/007219
Other languages
English (en)
French (fr)
Inventor
이제권
Original Assignee
이제권
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 이제권 filed Critical 이제권
Priority to CN201980037566.2A priority Critical patent/CN112368123B/zh
Priority to EP19818682.7A priority patent/EP3808533B1/en
Priority to JP2020569004A priority patent/JP7109598B2/ja
Priority to US16/972,805 priority patent/US20210244921A1/en
Publication of WO2019240542A1 publication Critical patent/WO2019240542A1/ko

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/91—Heating, e.g. for cross linking
    • B29C48/9105—Heating, e.g. for cross linking of hollow articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1034—Joining of shaft and balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1036—Making parts for balloon catheter systems, e.g. shafts or distal ends
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C33/00—Moulds or cores; Details thereof or accessories therefor
    • B29C33/56—Coatings, e.g. enameled or galvanised; Releasing, lubricating or separating agents
    • B29C33/58—Applying the releasing agents
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/001—Combinations of extrusion moulding with other shaping operations
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/001—Combinations of extrusion moulding with other shaping operations
    • B29C48/0013—Extrusion moulding in several steps, i.e. components merging outside the die
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
    • B29C48/10—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels flexible, e.g. blown foils
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/12—Articles with an irregular circumference when viewed in cross-section, e.g. window profiles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/15—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor incorporating preformed parts or layers, e.g. extrusion moulding around inserts
    • B29C48/151—Coating hollow articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/16—Articles comprising two or more components, e.g. co-extruded layers
    • B29C48/18—Articles comprising two or more components, e.g. co-extruded layers the components being layers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/16—Articles comprising two or more components, e.g. co-extruded layers
    • B29C48/18—Articles comprising two or more components, e.g. co-extruded layers the components being layers
    • B29C48/21—Articles comprising two or more components, e.g. co-extruded layers the components being layers the layers being joined at their surfaces
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/91—Heating, e.g. for cross linking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • A61M2207/10—Device therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/30—Extrusion nozzles or dies
    • B29C48/32—Extrusion nozzles or dies with annular openings, e.g. for forming tubular articles
    • B29C48/34—Cross-head annular extrusion nozzles, i.e. for simultaneously receiving moulding material and the preform to be coated
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2101/00—Use of unspecified macromolecular compounds as moulding material
    • B29K2101/10—Thermosetting resins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7542—Catheters
    • B29L2031/7543—Balloon catheters

Definitions

  • the present invention relates to a method for manufacturing a balloon catheter using thermosetting resin, and in detail, it is possible to use a curing property of a thermosetting resin to integrate a releasing and post-drying post-drying process with a curing process so that it can be manufactured very quickly through a continuous process. It is about a method of manufacturing a balloon catheter using a thermosetting resin.
  • thermosetting resin refers to a substance which becomes a polymer of three-dimensional network structure by crosslinking reaction by heating of low molecular resin, catalyst, ultraviolet rays, etc., typically, silicone rubber.
  • thermosetting resin Due to the characteristics of the thermosetting resin, when it is a low molecular resin state before curing, it is an amorphous material and can be deformed by external force. However, it becomes insoluble and insoluble after solidification due to cross-linking reaction by heat. .
  • the balloon catheter 2 is a tube-type medical device which is inserted into a human organ.
  • Air balloon (6) is used to inflate a balloon and to inject the drug through the discharge pipe (4) or the drug injection pipe, or a device used to remove various liquid excretion, the structure of the general balloon catheter (2) Inflation Lumen (6) for expansion or contraction of the balloon and drainage tube (Drainage Lumen, 4) for drug injection or liquid waste removal as shown in FIG.
  • the extruded tube has a structure of).
  • the extruded tube is manufactured by extruding a soft synthetic resin through an extruder.
  • the extruded extruded tube is made through a small and medium-sized government, assembled with a separately manufactured balloon, and then the balloon is completed through adhesion and coating.
  • the main part of the catheter is completed by drilling a separate hole in the drain tube for drug injection or liquid stool removal.
  • the thinner than the thickness (hereinafter referred to as the first extrusion) and then cut to the appropriate length, air injection pipe perforation, release coating, release mold drying and overlay extrusion (hereafter secondary extrusion) to produce a balloon-embedded catheter
  • This method is simplified from the conventional method by omitting the complicated process related to the balloon, but it is inevitable to cut and process the primary extruded tube as a necessity by cutting the air injection pipe drilling and the release application and drying process. According to work process
  • Patent Registration No. 10-0689238 supplements the disadvantages of 10-0434720.
  • the problem with this patent is that when drilling the air injection pipe with a laser, there is a risk of sooting in the perforation area, the tube may catch fire during the manufacturing process, and the drying process after release release agent is not specified. to be.
  • the air injection pipe drilling process was omitted, and it was proposed to complete the mold drying process in a few seconds using the hot air intensive method.
  • this method is only the automation of the existing manual work process.
  • the process of drying the foam and the release agent and the second extrusion remained intact, and there was a problem in that there was a limit in reducing manufacturing costs since investment in automation equipment was required.
  • the first extruded tube is directly put into the second extruder to perform overlay extrusion, and the position of the adhesion guide tube or the anti-adhesion tube is controlled at the end of the extruder die.
  • Each section provided a method for continuously producing the tubes of the balloon part and the body part, but this method had a problem that the thickness of the balloon could not be secured due to the thickness of the adhesion guide tube or the anti-adhesion tube itself.
  • the thickness of a balloon varies between manufacturers of catheters, but is generally in the range of 0.3501111 to 0.501111.
  • the recommended production method is that the primary pressure line tube is produced once and then introduced into the secondary extruder.
  • the outside diameter of the extruded tube is already determined and is introduced into the secondary extruder. Since the anti-stick tube reciprocates between the secondary extruded material and the primary extruded tube and repeatedly produces the balloon and the body, the inner diameter of the adhered tube is at least It is larger than the outer diameter of the primary extruded tube so that the primary tube can be fed into the secondary extruder smoothly.
  • the anti-stick tube having an inner diameter larger than that of the primary extruded tube and the outer layer covered with the soft material of the balloon by the thickness of the tube should be extruded at least as much as the thickness of the non-stick tube.
  • the final thickness after the differential extrusion is determined by the final thickness of the outer die of the secondary extruder and the planned catheter and cannot be changed.
  • the thickness of the balloon must be as thin as the thickness of the anti-stick tube.
  • the first tube to be introduced must be made as thin as the thickness of the anti-stick tube, and this method also cannot be made infinitely thin of the car tube. It is not applicable.
  • Application No. 10-2017-0165637 recommends that the first extruded tube is extruded through a deformable die together with the second extruded material without curing the first extruded tube. In this way, the time of hardening of the first extruded tube does not occur. In this case, the same concept of the anti-adhesion tube will be passed through, so the constraints on the thickness of the primary extruded tube and the thickness of the anti-adhesion tube can be eliminated to solve the problem of the above application No. 10-2017-37885.
  • the balloon is formed by the variable dice, the primary extrusion material and the secondary extrusion material cannot contact each other to form a balloon unless the curing is performed directly at the end of the extruder die. This is directly related to the speed of production and causes the unit cost to go up.
  • the present invention was made in consideration of the above-described prior art technology, and it is an economical thermosetting resin which can be manufactured very quickly through a continuous process by integrating a post-drying defoamer drying process with a curing process using the curing characteristics of a thermosetting resin.
  • the purpose is to provide a balloon catheter manufacturing method.
  • the spraying is carried out through the injection spray limiting membrane 26 during the spraying of the release agent in the above-mentioned process.
  • a balloon catheter manufacturing method using a thermosetting resin which further comprises distinguishing a region from a non-injection region.
  • the releasing agent is sprayed through the suction hole 34 formed in the spray limiting film 26.
  • a balloon catheter manufacturing method using a thermosetting resin is provided, which further includes a step of periodically inhaling the remaining amount.
  • a heating wire is provided on the spray limiting film 26 to accumulate the remaining amount.
  • a balloon catheter manufacturing method using a thermosetting resin is provided, which may further include evaporating the release agent.
  • the present invention is a thermosetting resin tube for manufacturing the primary tube (14)
  • a thermoset comprising a secondary extruder 40 which extrudes and covers the coating layer 46 through the coating mold 41 at the outer periphery of the one tube; and a secondary heater 42 for curing the tube on which the coating layer is formed.
  • a balloon catheter production apparatus using resin is provided.
  • the release agent spraying device 22 includes a nozzle 24 for spraying the release agent, and a spray limiting film bent to limit the spraying range of the release agent sprayed by the nozzle 24.
  • a balloon catheter manufacturing apparatus using a thermosetting resin characterized by consisting of a).
  • the spray restricting film 26 is formed in a pipe shape inside.
  • a balloon catheter manufacturing apparatus using a thermosetting resin characterized by further comprising a mold release agent recovery device 30 consisting of a hose 36 connected to a vacuum pump.
  • the injection limiting film 26 is accumulated in the remaining portion of the subprecision therein.
  • a balloon catheter manufacturing apparatus using a thermosetting resin is provided, which may further include heating means for evaporating a release agent.
  • thermosetting resin hardens the primary tube and immediately inserts it into the secondary extruder to complete the balloon catheter tube, which saves manufacturing time and cost than a separate process. It can be produced faster than manufacturing with variable dice, etc. In addition, there is no waiting time in the process, which prevents defects caused by contamination.
  • FIG. 1 is a cross sectional view of a balloon catheter tube having a conventional double tube structure
  • FIG. 2 is a cross sectional view showing a primary extrusion tube according to an embodiment of the present invention
  • Figure 33 is a spray coating applied with a spray limiting film according to an embodiment of the present invention 2019/240542 1 »(: 1 ⁇ 1 ⁇ 2019/007219
  • Figure 3 ⁇ 4 shows the structure of the release coating device and the spray limiting film
  • FIG. 4 shows an example of installing a mold release agent residual amount recovery device according to an embodiment of the present invention
  • FIG. 5 is a cross-sectional view of manufacturing a second extrusion process according to an embodiment of the present invention
  • FIG. 6 is a cross-sectional view of a section of a secondly extruded tube according to one embodiment of the present invention.
  • FIG. 7 is a schematic structural diagram of an apparatus according to an embodiment of the present invention.
  • the residual amount of the release agent flowing down the inner wall of the spray restricting film 26 can be sucked through the suction hole 34.
  • a method of immediately evaporating the spray-restriction film 26 of the sprayed release agent by heating the spray-restriction film 26 itself That is, if a heating wire (not shown) is installed in the small part of the spray limiting membrane 26 and heated above the boiling point of the release agent, the remaining amount of the sprayed release agent immediately evaporates in contact with the spray limiting membrane 26, causing a subsequent defect. Don't let that happen.
  • this method can harden the primary tube 14 to some extent by the heat of the spray limiting membrane 26, which also has the advantage of reducing the burden of the primary heater 38 after the release agent coating.
  • the spraying step of the release agent is carried out by monitoring the extrusion speed of the tube.
  • Repeat spraying is performed by spraying each length or spraying at regular time intervals.
  • the uncured tube coated with the release agent at regular intervals is introduced into the primary heater 38.
  • the heater 38 is generally at 600 ° (: level) and is irradiated without contact with the tube. And the tube is heated in a convection manner to cause a crosslinking reaction of the thermosetting material to harden. At this time, the sprayed release agent is also dried by sufficient heat.
  • [4 is a secondary tube having the structure of FIG.
  • the primary tube 14 is injected into the extruder 40 and coated with a balloon material. Since the curing of the mold release mold has been completed by a previous process, the primary tube 14 is directly injected into the secondary extruder 40 without any additional processing. Production of 50 is possible.
  • the balloon material of the coating layer 46 formed by being covered by the secondary extruder 40 is also a thermosetting resin, the secondary material is subjected to another secondary heater 42 after the second extruder 40.
  • the extruded material is cured.
  • This also has a structure similar to that of the heater 38 located in the primary extruder 20, and even if the balloon material is cured in a non-contact state, a tube in which a balloon catheta tube of the form 6 is repeatedly connected is completed. Appropriately cutting this tube, taking into account the release agent cell section set above, the balloon catheter tube is finally completed. 2019/240542 1 »(: 1/10 ⁇ 019/007219
  • the section covered with the release agent is detected by the camera and cut or a more accurate classification.
  • an ink spraying process may be included in the release agent spraying process described above to continuously produce a tube, and the ink portion may be detected and cut, and the ink printed portion may be discarded.
  • the balloon catheter tube 50 can be manufactured quickly and simply using the equipment of the preferred embodiment described above as shown in FIG.
  • the balloon catheter manufacturing method using the thermosetting resin according to the embodiment of the present invention is not limited only to the above-described embodiment, various modifications can be made within the scope without departing from the technical gist.

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Physics & Mathematics (AREA)
  • Thermal Sciences (AREA)
  • Manufacturing & Machinery (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

본 발명은 열경화성 수지를 이용한 벌룬 카테타 제조방법에 관한 것으로, 열경화성 수지의 경화 특성을 이용하여 이형제 도포 후 건조 공정을 경화 공정과 통합함으로써 연속공정을 통해 매우 신속하게 제조할 수 있는 경제적인 열경화성 수지를 이용한 벌룬 카테타 제조방법을 제공함에 그 목적이 있다.

Description

2019/240542 1»（：1^1{2019/007219
1
명세서
발명의명칭:열경화성수지를이용한벌룬카테타제조방법및그 장치
기술분야
[1 ] 본발명은열경화성수지를이용한벌룬카테타제조방법에관한것으로，보다 상세하게열경화성수지의 경화특성을이용하여 이형제도포후건조공정을 경화공정과통합함으로써 연속공정을통해매우신속하게제조할수있는 경제적인열경화성수지를이용한벌룬카테타제조방법에관한것이다.
배경기술
[2] 주지된바와같이，열경화성수지란저분자수지가열，촉매，자외선등에의해 가교반응을일으켜 3차원망상구조의고분자가되는물질을일컫는바, 대표적으로실리콘고무등이 있다.
[3] 이러한열경화성수지의특성으로경화전의저분자수지상태일때는비정형 물질로서외력에의해변형이가능하지만,열등에의한가교반응으로고분자 물질이된이후에는불용,불융상태가되어고화되는특성이 있다.
[4] 한편，벌룬카테타 (2)는튜브형태의의학용기구로서 인체기관에끼운후
공기주입관 (6)을이용하여풍선을부풀려고정시킨뒤배출관 (4)이나약물 주입관을통하여 약물을주입하거나각종액상배설물을제거하는데사용하는 기구를말하고，일반적인벌룬카테타 (2)의구조는도 1에도시탄바와같이 풍선의팽창또는수축을위한공기주입관 (Inflation Lumen, 6)과약물주입또는 액상배설물제거를위한배줄관 (Drainage Lumen, 4)이하나의튜브로압줄되는 이중관 (2-way)의구조를갖는압출튜브를본체로구성한다.
[到 상기압출튜브는압출기를통해연질의합성수지를압출하여제조하는바, 압출된상기 압출튜브의공기주입관중소정부를천공하고별도로제작한 풍선을조립한뒤접착과코팅을통해풍선이완성되며，약물주입또는액상 배설물제거를위해배출관에별도의구멍을가공함으로써카테타의주요 부분이완성된다.
[6] 상기의카테타제조방법은공정이복잡하여 제조단가가높기 때문에,최근에는 공정을더욱개선하여풍선의조립,접착,코팅과정을없앤기술이특허 등록번히 0-0333264와 10-0434720의벌룬카테테르의제조방법에명시되어 있다.
[7] 상기 10-0333264의경우액상실리콘을이용한디핑공정을통해풍선을
형성하므로풍선이경화되기전까지카테타튜브를해수면과정확히수직으로 유지하지않으면풍선의대칭성에문제가생겨비대칭중선에의한불량이 빈번하게발생하기 때문에공정을매우민감하게통제하지않으면양산이 불가능한방법이다. 2019/240542 1»（：1^1{2019/007219
2
[8] 상기 ] 0-0434720의경우도 1과같은단면의압출튜브를최종완성품의
굵기보다얇게먼저압출（이하 1차압출）한뒤적당한길이로절단후， 공기주입관천공，이형제도포,이형제건조및덧씌우기압출（이하 2차압출）을 통하여풍선이튜브에내장된카테타를생산하는방법이다.이방법은풍선과 관련한복잡한공정을생략함으로써종래의방법보다단순화되었지만， 공기주입관천공과이형제도포및건조공정이필요함에따라필연적으로 1차 압출튜브를절단하여가공할수밖에 없고단속적인작업공정에따른
연속생산이불가능하여제조단가가여전히높은편이다.
[9] 한편，특허등록번호 10-0689238은상기 10-0434720의단점을보완하여
연속생산방식을제안하고있으나,이특허의문제점은레이저로공기주입관을 천공할때천공부위에그을음이남고제조공정중튜브에불이붙을위험이 있으며，이형제도포후건조공정이구체화되어있지않은점이다.
[10] 이 점을보완하고자출원번호 10-2017-89480에서는내부형상을변화시켜
공기주입관천공공정을생략했으며，이형제건조공정을열풍집중방식으로 수초이내로공정을완료시킬것을고안하였다.하지만,이방법은기존수작업 방식의가공공정을자동화한것에불과하므로 1차압출，이형제도포，이형제 건조및 2차압출의공정자체는그대로유지되며,자동화설비에 대한투자가 필요하므로제조단가를절감하는데한계가있을수밖에없다는문제가있었다.
[11] 이외에，출원번호 10-2017-37885에서는 1차압출된튜브를바로 2차압출기에 투입하여덧씌우기압출을수행하되，압출기다이스끝부분에서부착유도관 또는부착방지관의위치를제어하여구간별로풍선부분과몸체부분의튜브를 연속적 생산하는방법을제공하였다.하지만,이방법은부착유도관또는 부착방지관자체의두께때문에풍선의두께를확보할방법이마땅치않을수 있다는문제가있었다.
[12] 예를들어,풍선의두께는카테타의제조사마다각기다르지만，일반적으로 0.3501111 ~ 0.501111수준이다.상기발명에서권장하는생산방식은 1차압줄 튜브를일단생산한뒤에 2차압출기에투입하므로 ]차압출튜브의외경은이미 확정된상태로 2차압출기에투입하게된다.이후부착방지관이 2차압출재료와 1차압출튜브사이를왕복하며풍선과몸체를반복생산하므로부착방지관의 내경은적어도 1차압출튜브의외경보다커야 1차튜브가원활하게 2차 압출기에투입되어 생산할수있다.
[13] 이러한 1차압출튜브의외경보다큰내경을갖는부착방지관과그관의두께에 의해서풍선의연질재료로덧씌워지는바깥층은적어도부착방지관의두께만큼 빈공간을두고압출되어야하고， 2차압출후최종굵기는 2차압출기의외부 다이스및계획된카테타의최종굵기로정해져 있으므로변경이불가능하다.
[14] 따라서，부착방지관의두께만큼풍선의두께가얇아질수밖에없는데，
부착방지관을너무얇게하면부착방지관자체의내구성이확보되지않아 양산이불가능하며,너무굵게하면풍선층이얇아져서원하는풍선용량을 2019/240542 1»（：1^1{2019/007219
3 만들지못하게된다.이를해결하기위해서는애초에투입하는 1차튜브를 부착방지관의두께만큼얇게만들수밖에 없으며，이방법또한】차튜브의 무한정얇게만들수는없으므로일정수준이하의 얇은카테타의 경우해당 발명의적용이불가능하다.
[15] 마지막으로，상기출원번호 10-2017-37885의문제점을해결하기위하여
출원번호 10-2017-0165637에서는 1차압출튜브를경화시키지않은상태에서 2차 압출재료와함께가변형다이스를통해압출하여제조할것을권장하는데，이 방법으로는 1차압출튜브의경화가일어나지 않은시점에서위의부착방지관과 유사한개념인가변다이스를통과하게되므로 1차압출튜브의굵기와 부착방지관의두께에관한제약조건이사라져상기출원번호 10-2017-37885의 문제점을해결할수있다.다만,가변다이스에의해풍선을형성할때압출기 다이스끝부분에서곧바로경화를시키지않으면 1차압출재료와 2차압출 재료가서로접촉하여풍선을형성할수없으므로토출즉시경화를위해압출 속도를어느정도이상으로빠르게하는것이불가능하다.이는곧생산속도와 직결되며단위원가가올라갈수밖에없는원인이된다.
[16] 이러한종래의기술은앞서설명한바와같이，제조공정이복잡하여
제조단가가높거나，여러가지제약조건으로인하여제한적으로만적용이 가능한상황이므로개선이절실히요구되는실정이다.
발명의상세한설명
기술적과제
[1刀 본발명은상기한종래기술의사정을감안하여 이루어진것으로,열경화성 수지의 경화특성을이용하여 이형제도포후건조공정을경화공정과 통합함으로써 연속공정을통해매우신속하게제조할수있는경제적인 열경화성수지를이용한벌룬카테타제조방법을제공함에그목적이 있다. 과제해결수단
[18] 상기한목적을달성하기위해，본발명의바람직한실시예에따르면 ¾)
공기주입관 (16)이외주연에길이방향으로형성된 1차튜브 (14)를압출하여 생산하는과정과;비비접촉방식으로이형제를분사하여 1차튜브 (14)외주연 소정부일정구간에 이형제를교번적으로도포하는과정과; (;)가열기를통하여 수지의 열경화및이형제를건조시키는과정과; (1)풍선재료를상기 1차 튜브 (14)의외부에피복함으로써반복적으로벌룬끼형성된장방향의벌룬 카테타튜브 (50)를제조하는것을특징으로하는열경화성수지를이용한벌룬 카테타제조방법이제공된다.
[19] 바람직하게 ,상기비과정에서 이형제분사시분사제한막 (26)을통해분사
영역과，비분사영역을구분하는과정이더포함된것을특징으로하는열경화성 수지를이용한벌룬카테타제조방법이제공된다.
[20] 바람직하게，상기분사제한막 (26)에형성된흡입공 (34)을통해이형제분사 2019/240542 1»（：1^1{2019/007219
4 잔량을주기적으로흡입하는과정이더포함된것을특징으로하는열경화성 수지를이용한벌룬카테타제조방법이제공된다.
[21] 바람직하게，상기분사제한막 (26)에 열선을설치하여 잔량으로누적된
이형제를증발시키는과정이더포함될수있는것을특징으로하는열경화성 수지를이용한벌룬카테타제조방법이제공된다.
[22] 한편,본발명은 1차튜브 (14)를제조하기위해열경화성수지를튜브
제조금형 (8)에대해압출하는 1차압출기 (20)와;상기튜브제조금형 (8)의후단에 구비되며,상기 1차튜브 (14)의외주연소정부에교번적으로이형제를도포하는 이형제분사장치 (22)와;상기 이형제분사장치 (22)를통과한 1차튜브 (14)및 도포된이형제를경화및건조시키는 1차가열기 (38)와;상기 ]차가열기 (38)를 통과한튜브의외주연에피복금형 (41 )을통해피복층 (46)을압출하여씌우는 2차 압출기 (40)와;피복층이형성된튜브를경화시키는 2차가열기 (42)를포함하여 이루어진것을특징으로하는열경화성수지를이용한벌룬카테타제조장치가 제공된다.
[23] 바람직하게，상기 이형제분사장치 (22)는이형제를분사하는노즐 (24)과;그 노즐 (24)로인해분사되는이형제의분사범위를제한하기위해절곡된분사 제한막 (26)으로구성된것을특징으로하는열경화성수지를이용한벌룬카테타 제조장치가제공된다.
[24] 바람직하게,상기분사제한막 (26)에는내부에관로형상으로이루어진
흡입관로 (32)와;그흡입관로 (32)의내측면에다수개형성되어 이형제잔량을 흡입하는흡입공 (34)과;그흡입관로 (32)는음압을상기흡입관로 (32)에가하기 위해진공펌프와연결된호스 (36)로이루어진이형제잔량회수장치 (30)가더 부가되어구성된것을특징으로하는열경화성수지를이용한벌룬카테타 제조장치가제공된다.
[25] 바람직하게,상기분사제한막 (26)은그내부소정부에잔량으로누적된
이형제를증발시키는가열수단이더포함될수있는것을특징으로하는 열경화성수지를이용한벌룬카테타제조장치가제공된다.
발명의효과
[26] 본발명에따른열경화성수지를이용한벌룬카테타제조방법은 1차튜브를 경화시키고곧바로 2차압출기에투입하여벌룬카테타튜브를완성시키므로 별도의공정을거치는방법보다제조시간과비용이절약되며,가변다이스등을 사용하여제조하는방법보다빠르게생산이가능하다.또한，공정상대기시간이 없으므로오염에의한불량을방지할수있다.
도면의간단한설명
[27] 도 1은종래의 이중관구조를가진벌룬카테타튜브의횡단면도，
[28] 도 2는본발명의일실시예에따른 1차압출튜브를도시한횡단면도，
[29] 도 33는본발명의 일실시예에따른분사제한막이적용된스프레이도포 2019/240542 1»（：1^1{2019/007219
5 공정의 예시，
[30] 도 ¾는이형제도포장치와분사제한막의구조를도시한도면,
[31] 도 4는본발명의 일실시예에따른이형제잔량회수장치를설치한예시，
[32] 도 5는본발명의 일실시예에따른 2차압출공정의다이스단면도와제조
상태의 예시，
[33] 도 6은본발명의 일실시예에따른 2차압출이완료된튜브의구간별단면도，
[34] 도 7은본발명의 일실시예에따른전체설비구조도이다.
발명의실시를위한최선의형태
[35] 따라서,컴프레셔 (미도시)와같은흡입수단을통해상기흡입관로 (32)에
주기적으로음압을가하면상기분사제한막 (26)의내벽에흘러내리는이형제 잔량을상기흡입공 (34)을통해흡입할수있게된다.
[36] 또다른본발명의일실시예에따르면，상기분사제한막 (26)자체를가열시켜 분사된이형제의분사제한막 (26)누적부분을즉시증발시키는방법이제공된다. 즉，분사제한막 (26)의소정부에 열선 (미도시)을설치하여 이형제의끓는점 이상으로가열시키면분사된이형제의잔량은분사제한막 (26)에접촉하는즉시 증발하여 이후의불량을야기시키지않는다.
[37] 또한，이방법은분사제한막 (26)의열로써어느정도 1차튜브 (14)를경화시킬 수있으므로이형제도포이후의 1차가열기 (38)의부담을줄이는장점도있다.
[38] 상기 이형제의분사도포공정은튜브의압출속도를감안하여 일정튜브
길이마다분사도포하거나，일정시간간격으로분사도포하는방식으로반복 수행한다.
[39] 다음으로，일정간격으로이형제가도포된미경화튜브는 1차가열기 (38)에 투입된다.본가열기 (38)는일반적으로 600° (:수준이며,튜브와접촉하지않은 상태로복사및대류의방식으로튜브를가열하여 열경화소재의가교반응을 일으켜경화시킨다.이때상기분사도포된이형제도충분한열에의하여 건조된다.
[4이 이형제가건조되고경화가완료된 1차튜브 (14)는도 5의구조를갖는 2차
압출기 (40)에투입되어풍선재료로피복된다.상기 1차튜브 (14)는이전의 공정에의하여경화와이형제건조가완료되었으므로별도의가공없이도 2차 압출기 (40)에바로투입하여벌룬카테타튜브 (50)의 생산이가능하다.
[41] 2차압출기 (40)에서피복되어형성되는피복층 (46)의풍선재료역시 열경화성 수지이므로 2차압출기 (40)이후에또다른 2차가열기 (42)를거쳐 2차
압출재료를경화시킨다.이 역시상기 1차압출기 (20)에위치한가열기 (38)와 유사한구조이며비접촉상태로풍선재료를경화시켜도 6과같은형태의벌룬 카테타튜브가반복적으로연결된튜브가완성된다.이튜브를위에서설정한 이형제도포구간을감안하여적절하게절단하면최종적으로벌룬카테타 튜브가완성된다. 2019/240542 1»（：1/10公019/007219
6 만일,절단하는적절한길이의설정이벌룬카테타튜브 (50)자체의 탄성에 의해오차를발생시켜안정적인양품의 생산이불가능하다면，이형제가도포된 구간을카메라로감지하여 절단하거나,또는좀더확실한구분을위하여위의 이형제분사도포공정에잉크분사공정을포함시켜튜브를연속생산한후 잉크부분을감지하여절단하고잉크가인쇄된부분은폐기하는방법을사용할 수있다.
최종적으로본발명의바람직할실시예에따르면，도 7과같이상기설명한 바람직한실시예의설비를이용하여벌룬카테타의튜브 (50)를빠르고간단하게 제조할수있다.
한편，본발명의실시예에따른열경화성수지를이용한벌룬카테타 제조방법은단지상기한실시예에한정되는것이아니라그기술적요지를 이탈하지않는범위내에서다양한변경이가능하다.
*부호의설명*
8:튜브제조금형, 9:중공부,
10:외부금형， 12:배출관형성금형，
13:공기주입관형성돌기， 14:1차튜브，
20: 1차압출기， 22:이형제도포장치，
24:노즐， 26:분사제한막，
30:이형제잔량회수장치， 32:흡입관로,
34:톱입공, 36:호스，
38:1차가열기, 40:2차압출기，
41:피복금형, 42:2차가열기,
50:벌룬카테타튜브.

Claims

2019/240542 1»（：1/10公019/007219 7 청구범위
[청구항 1] 幻공기주입관 (16)이외주연에길이방향으로형성된 1차튜브 (14)를
압출하여생산하는과정과;
비비접촉방식으로이형제를분사하여 1차튜브 (14)외주연소정부 일정구간에이형제를교번적으로도포하는과정과;
0)가열기를통하여수지의열경화및이형제를건조시키는과정과; 到풍선재료를상기 1차튜브 (14)의외부에피복함으로써반복적으로 벌룬이형성된장방향의벌룬카테타튜브 (50)를제조하는것을특징으로 하는열경화성수지를이용한벌룬카테타제조방법.
[청구항 2] 제 1항에있어서，
상기비과정에서이형제분사시분사제한막 (26)을통해분사영역과, 비분사영역을구분하는과정이더포함된것을특징으로하는열경화성 수지를이용한벌룬카테타제조방법 .
[청구항 3] 제 2항에있어서，
상기분사제한막 (26)에형성된흡입공 (34)을통해이형제분사잔량을 주기적으로흡입하는과정이더포함된것을특징으로하는열경화성 수지를이용한벌룬카테타제조방법.
[청구항 4] 제 2항에있어서，
상기분사제한막 (26)에열선을설치하여잔량으로누적된이형제를 증발시키는과정이더포함될수있는것을특징으로하는열경화성 수지를이용한벌룬카테타제조방법.
[청구항 5] 1차튜브 (14)를제조하기위해열경화성수지를튜브제조금형 (8)에대해 압출하는 1차압출기 (20)와;
상기튜브제조금형 (8)의후단에구비되며,상기 1차튜브 (14)의외주연 소정부에교번적으로이형제를도포하는이형제분사장치 (22)와;
상기이형제분사장치 (22)를통과한 1차튜브 (14)및도포된이형제를 경화및건조시키는 1차가열기 (38)와;
상기 1차가열기 (38)를통과한튜브의외주연에피복금형 (41)을통해 피복층 (46)을압출하여씌우는 2차압출기 (40)와;
피복층이형성된튜브를경화시키는 2차가열기 (42)를포함하여 이루어진것을특징으로하는열경화성수지를이용한벌룬카테타 제조장치.
[청구항 6] 제 5항에있어서 ,
상기이형제분사장치 (22)는이형제를분사하는노즐 (24)과; 그노즐 (24)로인해분사되는이형제의분사범위를제한하기위해 절곡된분사제한막 (26)으로구성된것을특징으로하는열경화성수지를 이용한벌룬카테타제조장치 . 2019/240542 1»（：1^1{2019/007219
8
［청구항 7］ 제 6항에있어서，
상기분사제한막 (26)에는내부에관로형상으로이루어진 흡입관로 (32)와;
그흡입관로 (32)의내측면에다수개형성되어이형제잔량을흡입하는 흡입공 (34)과;
그흡입관로 (32)는음암을상기흡입관로 (32)에가하기위해진공펌프와 연결된호스 (36)로이루어진이형제잔량회수장치 (30)가더부가되어 구성된것을특징으로하는열경화성수지를이용한벌룬카테타 제조장치.
［청구항到 제 6항에있어서，
상기분사제한막 (26)은그내부소정부에잔량으로누적된이형제를 증발시키는가열수단이더포함될수있는것을특징으로하는열경화성 수지를이용한벌룬카테타제조장치.
PCT/KR2019/007219 2018-06-15 2019-06-14 열경화성 수지를 이용한 벌룬 카테타 제조방법 및 그 장치 WO2019240542A1 (ko)

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KR20170037885A (ko) 2014-07-22 2017-04-05 니폰 제온 가부시키가이샤 전기 화학 소자 전극용 복합 입자, 전기 화학 소자 전극, 전기 화학 소자, 전기 화학 소자 전극용 복합 입자의 제조 방법 및 전기 화학 소자 전극의 제조 방법
KR101527340B1 (ko) * 2015-04-02 2015-06-09 이윤호 일체형 도뇨관 풍선 제조방법
KR101666944B1 (ko) * 2015-05-06 2016-10-17 주식회사 노아닉스 약물용출풍선 카테터의 코팅장치 및 코팅방법
KR20170089480A (ko) 2016-01-27 2017-08-04 삼성전자주식회사 전자 장치 및 그의 동작 방법

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022013611A (ja) * 2020-07-03 2022-01-18 貝斯美▲徳▼股▲ふん▼有限公司 バルーンカテーテルの製造方法及びバルーンカテーテル
JP7106166B2 (ja) 2020-07-03 2022-07-26 貝斯美▲徳▼股▲ふん▼有限公司 バルーンカテーテルの製造方法及びバルーンカテーテル

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