WO2019013577A1 - 벌룬 카테타 제조방법 - Google Patents

벌룬 카테타 제조방법 Download PDF

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Publication number
WO2019013577A1
WO2019013577A1 PCT/KR2018/007937 KR2018007937W WO2019013577A1 WO 2019013577 A1 WO2019013577 A1 WO 2019013577A1 KR 2018007937 W KR2018007937 W KR 2018007937W WO 2019013577 A1 WO2019013577 A1 WO 2019013577A1
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WIPO (PCT)
Prior art keywords
tube
primary
extruded
extrusion
balloon catheter
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Application number
PCT/KR2018/007937
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English (en)
French (fr)
Inventor
이제권
Original Assignee
이제권
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Publication of WO2019013577A1 publication Critical patent/WO2019013577A1/ko

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Classifications

    • 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
    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • 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
    • 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
    • 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
    • A61M25/1029—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

Definitions

  • the present invention relates to a method of manufacturing a balloon catheter, and more particularly, it relates to a method for manufacturing a balloon catheter, which comprises a step of forming a mold on the outside of a lyse and drying and extrusion of a soft material through a continuous automatic process,
  • the present invention relates to a balloon catheter manufacturing method and a balloon catheter manufacturing method.
  • a balloon catheter is a medical device used to infiltrate a balloon into a human body after inserting a tube form into a medical vessel, to inject drugs through the tube, or to remove various liquid excrements.
  • FIG. 6 The general structure of the balloon catheter is as shown in FIG. 1, and a tube for inflation or contraction of the balloon (hereinafter referred to as an air inlet tube 6)
  • a main extruding tube 2 having a structure of a two-way structure which is extruded into a tube or a drain tube for removing liquid excrement is formed as a main body.
  • the primary pressure outlet bar 2 is manufactured by extruding a soft synthetic resin through an extruder (not shown).
  • the pressurized primary extrusion tube 2 is manufactured by drilling a small or medium portion of the extruded main entrance (6) of the primary extrusion tube 2
  • the balloon is assembled after the separately manufactured balloon is assembled, and the balloon is completed through the adhesion and coating.
  • a separate hole is formed in the discharge pipe (4) to inject the drug or remove the liquid excrement
  • the major part of the catheter is completed by processing.
  • the problem of the manufacturing method is that the soot remains in the perforated portion when the air-
  • the typical catheter extrusion rate is 20 cm / s, and the process of drying the brothers through an intermittent operation is carried out in an oven at 150 o C If it is converted to a continuous process, it is an inefficient and huge process that requires keeping 240m tube at 150 ° C. This problem makes it difficult to apply 10-0689238 to mass production of products.
  • FIGS. 10-0434720 which is a conventional representative technology capable of mass production
  • a first extrusion lyse 2 having a longitudinal section as shown in FIG. 2A is produced through an extruder, After cutting, a piercing operation is performed to form the piercing hole 8 in the air injection pipe 6 as shown in Fig. 2B.
  • the mold release agent 10 is applied around the perforated cylinder 8 of the air injection pipe 6, the mold release agent 10 is dried in the mold cavity,
  • a balloon catheter is prepared in the direction of the diaper.
  • the process a includes an outer die 22 formed at the inner peripheral edge of the tube forming protrusion 24 and the outer die 22 at the center thereof,
  • the inner die (26) is a process of injecting the extruded material into the inner die (26).
  • the step d) includes the steps of:
  • the overlapped extruded material is injected through the overlapped extruded material injection path 34 formed at the edge of the conveyance path 32 so that the overlapped material is not adhered to the primary extruded tube 42 , And the part where the release agent 10 is not applied is extruded so that the material is adhered to the primary extrusion tube 42, so that a plurality of units of catheters are produced in a continuous process.
  • the balloon catheter manufacturing method according to the present invention completes the first extruded tube through the automatic process without cutting, thereby completing the over-laying extrusion process. Therefore, the processing cost can be reduced. In addition, since there is no waiting period for work-in-process for machining, defective factors due to contamination are reduced and defects are also reduced, so that a balloon catheter tube having a low manufacturing cost can be manufactured quickly.
  • FIG. 1 is a cross-sectional view showing a primary differential pressure exiting valve included in a balloon catheter according to a conventional embodiment
  • FIG. 2A is a vertical cross-sectional view of a conventional first extrusion tube
  • FIG. 2B is a longitudinal cross-sectional view of the air injection duct in the conventional first extrusion tube
  • FIG. 2C is a cross-sectional view of the mold and the tendon of the conventional I-order extrusion tube
  • FIG. 2D is a longitudinal sectional view of a conventional balloon catheter
  • FIG. 3 is a process diagram showing a balloon catheter manufacturing process according to an embodiment of the present invention.
  • FIG. 4 is a view illustrating a process of manufacturing a balloon catheter according to an embodiment of the present invention.
  • FIG. 5 is a cross-sectional view showing a primary pressure outlet port according to an embodiment of the present invention.
  • FIG. 6 is a view showing the sibling drying process
  • FIG. 7 is a cross-sectional view of a die and a manufacturing state of the overlay extrusion process
  • FIG. 8 is a cross-sectional view of a catheter that has undergone overgrowth
  • FIG. 9 is a structural view of an entire process according to an embodiment of the present invention. Best Mode for Carrying Out the Invention
  • FIG. 4 is a cross-sectional view of an extruder die for producing a first extruded tube according to an embodiment of the present invention
  • FIG. 5 is a cross-sectional view of an extruder die according to one embodiment of the present invention.
  • FIG. 6 is a cross-sectional view showing a first extruded tube according to an embodiment
  • FIG. 6 is a view showing a sibling drying process
  • FIG. 7 is a cross-sectional view and a manufacturing state of the overmolding extrusion process
  • FIG. 8 is a cross- Sectional view of the catheter
  • Fig. 9 is a structural view of the whole process according to one embodiment of the present invention.
  • a balloon catheter manufacturing method includes:
  • a first-order pressure exharmon having the shape of FIG. 5 is produced instead of the conventional first pressure exharmonic as shown in FIG. 1. 5, if the air injection tube is exposed to the outside of the first extrusion tube and is finally turned into an air injection tube by the second overlaying extrusion, No process is required, and therefore it is not necessary to cut the first extruded long lobe for piercing the air inlet tube.
  • the primary extruded tube having the shape shown in FIG. 5 has a tube-shaped outer die 22 formed in the inner main portion of the tube-forming projection 24 for forming the main inlet tube 36 of FIG. 4, Is manufactured using an extrusion die 20 with an internal die 26 to form the discharge tube 4, having various cross-sectional shapes such as semicircular or elliptical shapes located within the die 22.
  • the balloon catheter manufacturing method includes a first extrusion
  • the process of manufacturing the first extruded tube 42 by passing the soft material extruded by using a molding machine (not shown) through the outer dice 22 and the inner dice 26 is first preceded.
  • the air injection tube 36 in the form of a groove is formed by the tube formation projection 24, and the primary extrusion molding machine
  • a discharge pipe 4 for discharging body fluids or foreign substances is formed by the space of the garment inner dice 22 and the outer dice 26.
  • the mold release process is a process of uniformly applying the mold release agent 10 to the outer periphery of the primary extrusion tube 42 at regular intervals and in a cylindrical shape. In most cases, the primary extrusion tube 42, Therefore, the primary extrusion process in which the continuous extrusion is performed continuously, and the application process of the sibling in which the application and the transfer are repeatedly carried out are different from each other, so that a primary extrusion tube 42) for a short period of time.
  • the mold release agent drying process is a process in which a plurality of hot winders 30 are installed in accordance with the predetermined intervals of the louvers, and is a step for drying the sibling 10 by concentrated hot air at the moment of stopping the transfer in the previous process.
  • the structure of the hot air nozzle is preferably less than 2 cm in width and less than 5 cm in length so that the high temperature can concentrate on the release structure of the release mold, and the protrusion can be changed according to the thickness of the final product and the length of the balloon.
  • the temperature and air velocity of the sludge can be changed according to external factors such as the temperature and humidity of the workplace, and the sibling is completely dried while passing through several hot winds (30).
  • the drying process can be shortened to several tens of seconds or a few seconds, which takes more than 20 minutes. In addition, It takes a few seconds to several seconds to dry, but the drying time can be adjusted by drying with one hot air blower. There may be a waste to wait for the application process by scissors. Therefore, it is possible to produce product more quickly by drying several times using several hot air fans.
  • the dried lobes of the brothers 10 are put into the overlaying extruder shown in FIG. 7 to continuously perform over-extrusion at the outflow periphery.
  • the over-laying extruder is equipped with the primary pressure-
  • the tube conveying path 32 is formed in the edge portion of the tube conveying path 32.
  • the tube conveying path 32 is branched from the tube conveying path 32 so that the overturned extruded material is supplied from the outside to the tube conveying path 32 side
  • the overflowing extrusion material injection path 34 is formed.
  • the overlapped extruder is extruded continuously for a long time, Since the drying and transferring are performed repeatedly, there should be a period of waiting between the two processes for a moment to wait for the dried primary extrusion lobes 42.
  • the final balloon catheter 50 is completed by appropriately cutting the necessary parts of the continuously manufactured tube and processing the necessary parts.
  • the method of manufacturing a balloon catheter according to an embodiment of the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the technical gist of the present invention.

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

Abstract

본 발명은 벌룬 카테타 제조방법에 관한 것으로, 연속생산방식을 적용할 수 없는 문제점을 보완하여 첫 공정인 1차 압출부터 마지막 공정인 덧씌우기 압출까지 연속적으로 작업이 가능하게 하고, 작업 속도가 현저하게 개선되게 함으로서 자동화가 적용 가능한 벌룬 카테타 제조방법을 제공함에 그 목적이 있다.

Description

명세서
발명의명칭:벌룬카테타제조방법 기술분야
[1] 본발명은벌룬카테타제조방법에관한것으로，보다상세하게류브의외부에 이형제도포및건조와연질재료의덧씌우기 압출을연속적인자동공정을 통하여작업함으로써공정시간의단축및원재료손실최소화를통한효율적인 생산이가능한벌룬카테타제조방법에관한것이다.
배경기술
[2] 주지된바와같이，벌룬카테타란의학용기구로서관형태를인체기관에끼운 후풍선을부풀려고정시킨뒤그관을통하여 약물을주입하거나각종 액상배설물을제거하는데사용하는기구를일컫는다.
[3] 일반적인벌룬카테타의구조는도 1에도시된바와같이풍선의팽창또는 수축을위한관 (Inflation Lumen,이하공기주입관: 6)과약물주입또는
액상배설물제거를위한관 (Drainage Lumen,이하배출관: 4)이하나의류브로 압출되는이중관 (2-way)의구조를갖는 1차압출튜브 (2)를본체로구성한다.
[4] 상기 1차압출류브 (2)는압출기 (미도시)를통해연질의합성수지를압출하여 제조하는바,압출된상기 1차압출튜브 (2)의공기주입관 (6)중소정부를 천공하고별도로제작한풍선을조립한뒤접착과코팅을통해풍선이완성되며, 약물주입또는액상배설물제거를위해배출관 (4)에별도의구멍을
가공함으로써카테타의주요부분이완성된다.
[5] 상기의카테타제조방법은공정이복잡하여제조단가가높기때문에，최근에는 공정을더욱개선하여풍선의조립,접착,코팅과정을없앤기술이특허 등록번호 10-0333264와 10-0434720의벌룬카테테르의제조방법에명시되어 있다.
[6] 상기 10-0333264의 경우액상실리콘을이용한디핑공정을통해풍선을
형성하므로풍선이경화되기 전까지카테타류브를해수면과정확히수직으로 유지하지않으면풍선의대칭성에문제가생겨비대칭풍선에의한불량이 빈번하게발생하기때문에공정을매우민감하게통제하지않으면양산이 불가능한방법이다.
[7] 상기 10-0434720의 경우도 1과같은단면의 1차압출류브를먼저압출한뒤 적당한길이로절단후，공기주입관천공，이형제도포,이형제건조및덧씌우기 압출을통하여풍선이류브에내장된카테타를생산하는방법이다.아방법은 종래의방법보다단순화되었지만，공기주입관천공과이형제건조공정이 필요함에따라필연적으로 1차압출튜브를절단하여가공할수밖에 없고 단속적인작업공정에따른연속생산이불가능하여제조단가가여전히높은 편이다. [8] 한편，특허등록번호 10-0689238은상기 10-0434720의단점을보완하여 연속생산방식을제안하고있으나，이특허의문제점은레이저로공기주입관을 천공할때천공부위에그을음이남고제조공정증류브에불이붙을위험이 있으며，이형제도포후건조공정이구체화되어있지않은점이다.일반적인 카테타압출속도는 20cm/s수준이며단속적인작업을통해이형제를건조하는 공정은 150oC의오븐에 20분간가열하여건조시키는데，이를연속적인공정으로 환산하면 240m의튜브를 150°C오본에서유지시켜야하는비효율적이고거대한 공정이된다.이러한문제로인해 10-0689238은제품양산에적용이힘들다.
[9] 결론적으로양산적용이가능한종래의대표기술인상기 10-0434720을도면올 참조하여설명하면，종래에는압출기를통해도 2a와같은종단면을가진 1차 압출류브 (2)를생산하여 적절한길이로절단한후도 2b와같은모습으로 공기주입관 (6)에천공부 (8)를형성하는천공작업을실시한다.
[10] 이후,도 2c와같이공기주입관 (6)의천공부 (8)주위에 이형제 (10)를도포하고 오본에서 이형제 (10)를건조시킨후덧씌우기압출을통해덧씌우기
압출부 (12)를형성하게함으로써도 2d와같은종단면을가진최종류브를 생산한다.
[1 1] 이러한종래의기술은앞서설명한바와같이,공기주입관천공과이형제건조 공정이필요함에따라필연적으로 1차압출튜브를절단하여가공할수밖에 없고 단속적인작업공정에따른연속생산이불가능하여제조단가가매우높아서 개선이 절실히요구되는실정이다.
발명의상세한설명
기술적과제
[12] 본발명은상기한종래기술의사정을감안하여이루어진것으로,
연속생산방식을적용할수없는문제점을보완하여첫공정인 1차압출부터 마지막공정인덧씌우기압출까지연속적으로작업이가능하게하고，작업 속도가현저하게개선되게함으로서자동화가적용가능한벌룬카테타 제조방법을제공함에그목적이 있다.
과제해결수단
[13] 상기한목적을달성하기위해，본발명의바람직한실시예에따르면 a)
공기주입관 (36)이외상기한목적을달성하기위해，본발명의바람직한실시예에 따르면 a)공기주입관 (36)이외부로형성된 1차압출튜브 (42)를생산하는과정과; b) 1차압출튜브 (42)의외주연에일정간격마다이형제 (10)를연속적으로 도포하는과정과; c)열풍기 (30)를이용하여이형제 (10)를일정간격마다 연속적으로건조시키는과정과; d)덧씌우기압출을통해반복적으로벌룬이 형성된장방향의벌룬카테타가제조되는것을특징으로하는벌룬카테타 제조방법이제공된다.
[14] 바람직하게，상기 a)와 b)과정사이에가공중인 1차압출튜브 (42)를 대기시키며연속적인작업이 이루어지는것을특징으로하는벌룬카테타 제조방법이제공된다.
[15] 바람직하게，상기 c)와 d)과정사이에 가공중인 1차압출튜브 (42)를
대기시키며연속적인작업이 이루어지는것을특징으로하는벌룬카테타 제조방법이제공된다.
[16] 바람직하게，상기 a)과정은관형성돌기 (24)가내주연소정부에형성된외부 다이스 (22)와,그외부다이스 (22)의중앙에요입되어져 있으며,배출구 (4)의 형상으로이루어진내부다이스 (26)의사이로압출재료를투입하는과정인것을 특징으로하는벌룬카테타제조방법이제공된다.
[17] 바람직하게,상기 d)과정은상기 1차압출류브 (42)가이송되는튜브
이송로 (32)의가장자리에형성된덧씌우기압출재주입로 (34)를통해덧씌우기 압출재가주입되면서，이형제 (10)가도포되었던부분은덧씌우기 재료가 1차 압출튜브 (42)에접착되지아니하고，이형제 (10)가도포되지않은부분은재료가 1.차압출튜브 (42)에 접착되게압출되어연속공정으로다수단위의카테타가 제조되는것을특징으로하는벌룬카테타제조방법이제공된다.
발명의효과
[18] 본발명에따른벌룬카테타제조방법은 1차압출튜브를절단없이자동화된 공정을통해덧씌우기압출까지완료하므로가공인건비를절감할수있으며， 최종완성품설계길이에정확히맞춰가공하므로재료의낭비가없다.또한， 가공을위해재공품으로대기하는기간이없으므로오염에의한불량요인이 줄어들어불량를도감소시키기때문에최종적으로제조원가가낮은벌룬 카테타튜브를신속하게제조할수있다.
도면의간단한설명
[19] 도 1은종래의실시예에따른벌룬카테타에포함된 1차압출류브를도시한 횡단면도,
[20] 도 2a는종래의 1차압출튜브의종단면도，
[21] 도 2b는종래의 1차압출튜브에공기주입관천공공정후종단면도，
[22] 도 2c는종래의 I차압출튜브에 이형제도포및건조후종단면도，
[23] 도 2d는종래의벌룬카테타종단면도,
[24] 도 3은본발명의 일실시예에따른벌룬카테타제조공정을도시한공정도， [25] 도 4는본발명의일실시예에따른 1차압출류브를제조하기위한압출기
다이스단면도,
[26] 도 5는본발명의일실시예에따른 1차압출류브를도시한횡단면도，
[27] 도 6은이형제건조공정을도시한도면，
[28] 도 7은덧씌우기압출공정의다이스단면도와제조상태를도시한도면，
[29] 도 8은덧씌우기공정이완료된카테타의구간별단면도,
[30] 도 9는본발명의 일실시예에따른전체공정의구조도이다. 발명의실시를위한최선의형태
[31] 이하，본발명메대해도면을참조하여상세하게설명한다.
[32] 도 3은본발명의 일실시예에따른벌룬카테타제조공정을도시한공정도,도 4는본발명의 일실시예에따른 1차압출튜브를제조하기위한압출기다이스 단면도，도 5는본발명의 일실시예에따른 1차압출튜브를도시한횡단면도,도 6은이형제건조공정을도시한도면,도 7은덧씌우기 압출공정의다이스 단면도와제조상태를도시한도면,도 8은덧씌우기공정이완료된카테타의 구간별단면도，도 9는본발명의 일실시예에따른전체공정의구조도이다.
[33] 이를참조하면，본발명의일실시예에따른벌룬카테타제조방법은 1차
압출류브를별도의절단가공을거치지않고연속적으로이형제도포와건조를 함으로써덧씌우기압출공정까지자동화가가능하여쉽고빠르게벌룬 카테타를제조할수있는방법이다.
[34] 보다상세하게，우선도 1과같은기존의 1차압출류브가아닌도 5의형상을 갖는 1차압출류브를생산한다.이러한 1차압출류브를사용하면공기주입관 천공공정을생략할수있다.즉，바람직한실시 예에따라도 5와같은 1차 압출류브를이용하면공기주입관이 1차압출튜브의외부에노출되어 있고 2차 덧씌우기압출로서최종적으로공기주입관이되므로별도의천공공정이필요 없으며，따라서공기주입관의천공을위해 1차압출된긴류브를절단할필요가 없어진다.
[35] 도 5의형상을갖는 1차압출튜브는도 4의공기주입관 (36)을형성하기위한 관형성돌기 (24)가내주연소정부에형성된관형태의외부다이스 (22)와，그 외부다이스 (22)내부에위치한반원이나타원형과같은다양한단면형상을 가지고상기배출관 (4)을형성하기위한내부다이스 (26)로이 어진압출 다이스 (20)를이용하여제조한다.
[36] 즉,본발명의 일실시예에따른벌룬카테타제조방법은 1차압출
성형기 (미도시)를이용하여압출된연질의재료를상기외부다이스 (22)와내부 다이스 (26)의사이로통과시켜 1차압출튜브 (42)를제조하는과정이우선 선행되어야한다.
[37] 상기한선행과정을통해，벌룬카테타의중심부가되는상기 1차
압출튜브 (42)를제조할수있는바，재료를 1차압출성형기를통과시키면상기 관형성돌기 (24)에의해그루브 (Groove)형태의상기공기주입관 (36)이형성되고， 상기 1차압출성형기 (미도시)의상기내부다이스 (22)와외부다이스 (26)의 공간으로인해체액이나이물질등을배출하는배출관 (4)이 형성된다.
[38] 이어서,상기 1차압출류브는이형제도포공정을거친다.이형제 (10)는
덧씌우기압출시덧씌우기압출재료와 1차압출류브 (42)의접착을방지하여그 부분에풍선부 (1.4)를형성하는역할을하는물질로서비눗물등을사용할수 있다. [39] 이형제도포공정은일정간격마다 1차압출튜브 (42)의외주연에 이형제 ( 10)를 원통형모양으로고르게도포하는공정으로서，도포방법에따라다르지만 대부분의 경우 1차압출튜브 (42)가이형제도포를위해고정되어야한다.따라서, 길게연속적으로압출되는 1차압출공정과，도포와이송이반복적으로 수행되는이형제도포공정은진행의형태가다르므로두공정사이에 1차 압출튜브 (42)를잠깐대기시키는구간이 있어야한다.
[40] 상기이형제도포가완료된류브는이송집게 (28)를이용하여이형제건조
공정으로이송된다.이형제가건조되기 전에이형제도포부위에 접촉이 있으면 오염및이형제의소실로인한불량이발생하므로이형제가도포되지않은 부분을잡아류브를이동시키는이송집게를이용하여건조공정으로이송한다. 이형제건조공정은열풍기 (30)수개가류브의설정된간격에따라설치된 공정으로서 이형제도포를위해전공정에서이송을멈추는순간집중된 열풍으로이형제 (10)를건조시키는공정이다.
[41] 이때，열풍기노즐의구조는고열이 이형제도포부분에집중할수있도록폭 2cm미만에길이 5cm미만이적절하며,이구조는최종완성품의굵기와풍선 길이에따라변화시킬수있다.열풍기 (30)의온도와송풍속도는작업장의 온도와습도등외부요인에따라변경될수있으며，수개의열풍기 (30)를거치는 동안이형제는완벽하게건조된다.
[42] 이러한열풍기를이용한집증가열방식을이용하면오본을이용하여건조하는 종래의방식으로는 20분이상이소요되는건조공정을수십초또는수초이내로 단축시킬수있고，단시간에덧씌우기압출이가능할정도로층분히건조되게 되므로수율이극대화된다.앞서 이형제도포공정에서이형제를도포하는 시간은약 1초내외에완료할수있으나건조를위해수초내지는수십초가 소요되므로한개의열풍기를이용하여건조시키면건조시간을맞추가위하여 도포공정또한대기해야하는낭비가있을수있다.따라서수개의 열풍기를 이용하여여러번에걸쳐 건조시키는방법이제품을더빠르게생산할수있다.
[43] 상기이형제 (10)가건조된류브는도 7에도시된덧씌우기압출기에투입되어 연속적으로류브외주연에 덧씌우기압출을수행하는바，그덧씌우기압출기는 중앙에상기 1차압출류브 (42)가이송되는튜브이송로 (32)가형성되어져 있고， 가장자리소정부에는그튜브이송로 (32)의소정부로부터분기되어외부로부터 덧씌우기압출재료를투입받아그튜브이송로 (32)측으로이송시키는덧씌우기 압출재주입로 (34)가형성된다.
[44] 상기덧씌우기재료가상기 덧씌우기압출재주입로 (34)를통해서상기류브 이송로 (32)상으로이송되는 1차압출튜브 (42)의외주연으로주입될때， 이형제 (10)가도포되었던부분은덧씌우기 재료가 1차압출튜브 (42)에접착되지 아니하고이형제 (10)가도포되지않은부분은재료가 1차압출튜브 (42)에 접착되어압출되므로벌룬카테타 (50)가연속적으로생산되게된다.
[45] 이때,덧씌우기압출기는길게연속적으로압출되는반면이형제건조공정은 건조와이송이반복적으로수행되므로두공정사이에는건조된 1차 압출류브 (42)를잠깐대기시키는구간이 있어야한다.
[46] 연속적으로생산이완료된튜브를설정한길이에따라적절히 절단하고기타 필요한부분을가공함으로써최종적인벌룬카테타 (50)가완성된다.
[47] 한편，본발명의실시예에따른벌룬카테타제조방법은단지상기한실시예에 한정되는것이아니라그기술적요지를이탈하지않는범위내에서다양한 변경이가능하다.
[48] *부호의설명
[49] 4:배출관， 10:이형제，
[50] 20:압출다이스， 22:외부다이스,
[51] 24:관형성돌기， 26:내부다이스,
[52] 28:이송집게, 30:열풍기，
[53] 32:튜브이송로, 34:덧씌우기압출재주입로，
[54] 36:공기주입관, 42: 1차압출류브,
[55] 50:벌룬카테타.

Claims

청구범위
[청구항 Π a)공기주입관 (36)이외부로형성된 1차압출튜브 (42)를생산하는과정과;
b) 1차압출튜브 (42)의외주연에일정간격마다이형제 (10)를연속적으로 도포하는과정과;
c)열풍기 (30)를이용하여 이형제 (10)를연속적으로건조시키는과정과; d)덧씌우기 압출을통해반복적으로벌룬이형성된장방향의벌룬 카테타가제조되는것을특징으로하는벌룬카테타제조방법.
[청구항 2] 제 1항에 있어서，
상기 a)와 b)과정사이에가공중인 1차압출튜브 (42)를대기시키며 연속적인작업이이루어지는것을특징으로하는벌룬카테타제조방법ᅳ
[청구항 3] 제 1항에 있어서,
상기 c)와 d)과정사이에가공중인 1차압출튜브 (42)를대기시키며 연속적인작업이이루어지는것을특징으로하는벌룬카테타제조방법 .
[청구항 4] 제 1항에 있어서，
상기 a)과정은관형성돌기 (24)가내주연소정부에형성된외부
다이스 (22)와，그외부다이스 (22)의중앙에요입되어져 있으며， 배출구 (4)의형상으로이루어진내부다이스 (26)의사이로압출재료를 투입하는과정인것을특징으로하는벌룬카테타제조방법.
[청구항 5] 제 1항에 있어서，
상기 d)과정은상기 1차압출튜브 (42)가이송되는류브이송로 (32)의 가장자리에형성된덧씌우기 압출재주입로 (34)를통해덧씌우기 압출재가주입되면서，
이형제 (10)가도포되었던부분은덧씌우기 재료가 1차압출류브 (42)에 접착되지아니하고，
이형제 (10)가도포되지않은부분은재료가 1차압출류브 (42)에접착되게 압출되어연속공정으로다수단위의카테타가제조되는것을특징으로 하는벌룬카테타제조방법ᅳ
PCT/KR2018/007937 2017-07-14 2018-07-13 벌룬 카테타 제조방법 WO2019013577A1 (ko)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0730879A1 (en) * 1995-03-08 1996-09-11 Cordis Europa N.V. Balloon catheter and method for manufacturing such a catheter
JP2984368B2 (ja) * 1990-01-10 1999-11-29 ロチェスター・メディカル・コーポレーション バルーン式カテーテルの製造方法
JP2001037868A (ja) * 1999-05-16 2001-02-13 Ys Medical:Kk バルーンカテーテルおよびその製造方法並びにカテーテルチューブへのバルーンの装着方法
KR100434720B1 (ko) * 2001-01-03 2004-06-07 이근호 발룬 카테테르의 제조방법
KR20050071453A (ko) * 2005-06-17 2005-07-07 이근호 발룬 카테테르 제조장치 및 그 방법

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2984368B2 (ja) * 1990-01-10 1999-11-29 ロチェスター・メディカル・コーポレーション バルーン式カテーテルの製造方法
EP0730879A1 (en) * 1995-03-08 1996-09-11 Cordis Europa N.V. Balloon catheter and method for manufacturing such a catheter
JP2001037868A (ja) * 1999-05-16 2001-02-13 Ys Medical:Kk バルーンカテーテルおよびその製造方法並びにカテーテルチューブへのバルーンの装着方法
KR100434720B1 (ko) * 2001-01-03 2004-06-07 이근호 발룬 카테테르의 제조방법
KR20050071453A (ko) * 2005-06-17 2005-07-07 이근호 발룬 카테테르 제조장치 및 그 방법

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