WO2019135481A1 - 카테터용 풍선 제조 지그 및 이를 이용한 풍선 제조 방법 - Google Patents

카테터용 풍선 제조 지그 및 이를 이용한 풍선 제조 방법 Download PDF

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Publication number
WO2019135481A1
WO2019135481A1 PCT/KR2018/013428 KR2018013428W WO2019135481A1 WO 2019135481 A1 WO2019135481 A1 WO 2019135481A1 KR 2018013428 W KR2018013428 W KR 2018013428W WO 2019135481 A1 WO2019135481 A1 WO 2019135481A1
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WO
WIPO (PCT)
Prior art keywords
balloon
center
jig
catheter
manufacturing
Prior art date
Application number
PCT/KR2018/013428
Other languages
English (en)
French (fr)
Korean (ko)
Inventor
주돈수
Original Assignee
아이메디컴(주)
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 아이메디컴(주) filed Critical 아이메디컴(주)
Priority to JP2020513479A priority Critical patent/JP6880314B2/ja
Publication of WO2019135481A1 publication Critical patent/WO2019135481A1/ko

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • A61M25/1029Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • A61M25/1029Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A61M2025/1031Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2207/00Methods of manufacture, assembly or production
    • A61M2207/10Device therefor

Definitions

  • the present invention relates to a jig for manufacturing a balloon for a catheter and a balloon manufacturing method using the same.
  • a catheter balloon is a medical device that is used in areas where it helps to drain the pus from the patient's lesion or where it needs to be frictioned. It serves to move the catheter forward, backward, or rotate around the lesion using a catheter.
  • the catheter balloon manufacturing method disclosed in U.S. Patent No. 8,382,931 discloses a method of preparing a material of a resilient PTU material, aging it in a dryer at 50 to 55 ° C for 20 days And cut the material to a length suitable for each application so that it can be used as the first and second tubes and the expandable member (balloon). Thereafter, the index ring is placed in the second tube, the cut material is welded to the first and second tubes for connection to the use of the expandable member, the first and second tubes are connected to various ports, To a manifold having a manifold.
  • the cut material is connected to the first and second tubes individually through welding so that the workability is poor.
  • the upper and lower forming molds are configured to form the expandable member, even if the taper angle of both sides of the expandable member needs to be slightly changed, the entire upper and lower forming molds must be replaced to reflect the change , There is a problem that the cost due to the change in the taper angle is excessively generated. Further, since a separate forming mechanism butting mechanism for matching the upper and lower forming molds is required, not only the equipment cost is increased but also the yield is lowered by addition of a process for confronting the same.
  • An object of the present invention is to provide a balloon manufacturing jig for a catheter which does not need to be welded and can easily change a taper angle of the balloon, and a method for manufacturing an inflatable balloon using the same.
  • a catheter balloon manufacturing jig for manufacturing a catheter balloon using a tube material, A cylindrical center-jig member having a center forming portion at a portion thereof; A first side jig member provided in the longitudinal direction of the center jig member through a first opening of the center jig member to form a first tapered portion therebetween so that one end of the balloon tapers between the center portions of the balloon; And a second side jig member provided in the longitudinal direction of the center jig member through the other end opening of the center jig member to form a second tapered portion between the other end of the balloon and a center portion of the balloon, .
  • a plurality of dimples may be formed in the center forming part.
  • the center jig member includes a first pull-in / out guide portion extending from one end of the center forming portion to the one-end opening portion and guiding the pull-out of the first side jig member; And a second inlet / outlet guide portion extending from the other end of the center forming portion to the other end opening portion and guiding the pulling-out of the second side jig member.
  • the center forming part has an inner diameter relatively smaller than that of the first and second pull-out guide parts, and can have a stepped shape with the first and second pull-out guide parts.
  • the first side jig member includes: a first draw-in / ejection body that is pulled out along the first draw-in / out guide portion; A first tube insertion hole formed in the center of the first draw-in / out body and elongated in the longitudinal direction, into which the tube material is inserted; And a first taper molding part that is extended in a cone shape at the end of the first tube insertion path and connected to one end of the center forming part, and the second side jig member includes a second insertion / A second take-in / take-out body to be brought in and out; A second tube insertion hole formed in the center of the second draw-in / out body and elongated in the longitudinal direction, into which the tube material is inserted; And a second taper molding part extending from the end of the second tube insertion path in a cone shape and connected to the other end of the center forming part.
  • the balloon manufacturing jig for a catheter may include a first closing member provided at an exposed end of the first draw-in / ejection body and having a first through-hole communicating with the first tube insertion path; And a second closing member provided at an exposed end of the second draw-out body and having a second through-hole communicating with the second tube insertion path.
  • the second through-hole may have a smaller inner diameter than the first through-hole, and the rear end of the second tube insertion path may be connected to the second through-hole so that the tube has the same inner diameter as the second through-
  • Each of the first and second closure members may be made of a polyether ether ketone (PEEK).
  • PEEK polyether ether ketone
  • the balloon manufacturing method using the balloon manufacturing jig for catheter according to the present invention is a balloon manufacturing method using the balloon making jig for catheter according to the embodiment of the present invention, wherein the first and second side jig members Guiding the center jig member to the first and second pull-in / out guide portions, respectively; Sequentially inserting the tube material into the first tube insertion path, the center forming section, and the second tube insertion path; Closing the rear end of the tube material so that the tube material is formed into the balloon by the first and second taper forming parts and the center forming part and applying an inflation pressure to the tip end of the tube material; And withdrawing the balloon after drawing the first and second side jig members out of the first and second inlet / outlet guide portions when the balloon is formed.
  • the balloon manufacturing method using the balloon manufacturing jig for catheter according to another embodiment of the present invention may further include cutting both ends of the balloon after the step of removing the balloon.
  • the balloon manufacturing jig for catheter according to the embodiment of the present invention and the balloon manufacturing method using the same can have the following effects.
  • a long tube material can be formed into a balloon without welding, and by replacing only the first and second side jig members with another while leaving the center jig member intact, the first and second The taper portion can be diversified.
  • a plurality of embossing protrusions can be formed in the central part of the balloon formed through the center molding part.
  • the effects of the present invention are not limited to these, and include other effects that can be derived from the constitution of the present invention.
  • FIG. 1 is a partially cutaway perspective view schematically illustrating a balloon manufacturing jig for a catheter according to an embodiment of the present invention.
  • Fig. 2 is a cross-sectional view schematically showing the balloon-producing jig for catheter of Fig. 1;
  • FIG 3 is a view schematically showing a state in which the first and second side jig members are inserted into and ejected from the center jig member.
  • FIG. 4 is a partial cutaway view schematically showing a state in which first and second closing members are further provided in the balloon manufacturing jig for catheter of FIG. 1;
  • FIG. 5 is a schematic view of a balloon manufactured by the balloon manufacturing jig for catheter of FIG. 1; FIG.
  • FIG. 6 is a flowchart showing a balloon manufacturing method using a balloon manufacturing jig for catheter according to another embodiment of the present invention.
  • FIG. 1 is a partially cutaway perspective view schematically showing a catheter manufacturing jig according to an embodiment of the present invention
  • FIG. 2 is a cross-sectional view schematically showing a catheter manufacturing jig of FIG. 1
  • FIG. 3 is a cross- In which the first and second side jig members are drawn in and out.
  • FIG. 4 is a partial cutaway view schematically showing a state in which first and second closing members are further provided in the balloon manufacturing jig for catheter of FIG. 1
  • FIG. 5 is a cross-sectional view of the balloon manufactured by the catheter- Fig.
  • the balloon manufacturing jig 100 for a catheter includes a catheter 100 for manufacturing a catheter balloon 200 using a long tube material 10 as shown in Figs. And includes a center jig member 110, a first side jig member 120, and a second side jig member 130, as shown in FIG.
  • a center jig member 110 for manufacturing a catheter balloon 200 using a long tube material 10 as shown in Figs.
  • a center jig member 110 includes a center jig member 110, a first side jig member 120, and a second side jig member 130, as shown in FIG.
  • the center jig member 110 is a component that not only shapes the center portion 210 of the balloon 200 but also guides the first and second side jig members 120 and 130 along the longitudinal direction thereof . 1 to 3, the center jig member 110 may have a cylindrical shape having both ends thereof penetrated, and a center portion 210 of the balloon 200 may be formed in the center portion of the center jig member 110 And a weft-center forming part 111 may be provided.
  • a plurality of dimples 111a may be formed in the center forming part 111.
  • a plurality of dimples 111a may be formed in the center forming part 111.
  • the central portion 210 of the balloon 200 manufactured by the above-described catheter balloon manufacturing jig 100 of the present invention due to the plurality of dimples 111a, And may have protrusions 211 that may provide greater friction around the patient's lesion, such as helping to drain the pus from the patient's lesion when the balloon 200 is used in connection with the catheter.
  • the center jig member 110 includes a first and a second inlet for guiding in and out of the first and second side jig members 120 and 130, respectively, And an exit guide unit 112 (113).
  • the first inlet / outlet guide portion 112 extends from one end of the center forming portion 111 to one end opening portion 110a of the center jig member 110 and can guide the first side jig member 120 in and out
  • the second inlet / outlet guide portion 113 extends from the other end of the center forming portion 111 to the other end opening portion 110b of the center jig member 110 and guides the second side jig member 130 can do.
  • the center forming portion 111 has an inner diameter relatively smaller than that of the first and second pulling-out guide portions 112 and 113 so that the first and second pulling-out guide portions 112 and 113, Shape. Therefore, a plurality of dimples 111a can be sufficiently formed in the center molding portion 111 having a relatively large thickness (i.e., a large thickness), and the first and second side jig members 120 and 130 can be inserted The first and second side jig members 120 and 130 can be brought into tight contact with both ends of the center forming portion 111 through such a stepped shape.
  • the size and number of the plurality of dimples 111a may vary depending on individual balloons.
  • the first side jig member 120 has a first tapered portion 231 (see FIG. 5) between the center portion (210 in FIG. 5) and one end portion (221 in FIG. 5) ). 3, the first side jig member 120 is inserted through the one end opening 110a of the center jig member 110 and the first pull-in / out guide portion 112 in the longitudinal direction thereof. .
  • the first side jig member 120 includes a first inlet / outlet body 121, a first tube insertion passage 122, and a first tapered molding portion 123).
  • the first inlet / outlet body 121 can be pulled in and out along the first inlet / outlet guide 112, and the first tube insertion tube 122 can be inserted into the center of the first inlet /
  • the material for forming the balloon 200 may be inserted in the longitudinal direction and the first tapered portion 123 may be formed at the end of the first tube insertion path 122
  • the tube may be expanded in a cone shape and connected to one end of the center forming part 111. Accordingly, the first tapered portion 231 can be formed between the center portion 210 and the one end portion 221 of the balloon 200 through the first tapered portion 123.
  • the second side jig member 130 has a second tapered portion 232 (see FIG. 5) so as to be tapered between the center portion (210 in FIG. 5) and the other end portion ). 3, the second side jig member 130 is inserted and extracted in the longitudinal direction thereof through the other end opening portion 110b of the center jig member 110 and the second pull-out guide portion 113, .
  • the second side jig member 130 includes a second inlet / outlet body 131, a second tube insertion passage 132, and a second tapered molding portion 133).
  • the second inlet / outlet body 131 can be pulled in and out along the second inlet / outlet guide portion 113, and the second tube insertion tube 132 can be inserted into the center of the second inlet /
  • the tube material 10 may be inserted in the longitudinal direction and the second tapered part 133 may be formed in a shape of a cone at the end of the second tube insertion path 132 to form a center molding part 111).
  • the second tapered portion 232 can be formed between the center portion 210 and the other end portion 222 of the balloon 200 through the second tapered portion 133.
  • the balloon manufacturing jig 100 for a catheter according to an embodiment of the present invention described above may further include first and second closing members 140 and 150 as shown in FIG. 4 .
  • the first closing member 140 may have a first through hole 141 provided at the exposed end of the first drawing body 121 and connected to the first tube insertion path 122, 150 may have a second through hole 151 provided at the exposed end of the second draw-in / ejection body 131 and connected to the second tube insertion path 132.
  • the second through hole 151 can have a smaller inner diameter than the first through hole 141, and the rear end portion of the second tube insertion path 132 is reduced in diameter to have the same inner diameter as the second through hole 151, Two through holes 151 can be connected.
  • Each of the first and second closing members 140 and 150 may be formed of a material such as polyetheretherketone (PEEK) or polyetheretherketone (PEEK) to prevent the first and second side jig members 120 and 130 from being heated. ether ketone).
  • PEEK polyetheretherketone
  • PEEK polyetheretherketone
  • FIG. 1 a balloon manufacturing method using a balloon manufacturing jig for catheter according to another embodiment of the present invention will be described with reference to FIGS. 1, 2, 3, and 6.
  • FIG. 1 a balloon manufacturing method using a balloon manufacturing jig for catheter according to another embodiment of the present invention will be described with reference to FIGS. 1, 2, 3, and 6.
  • FIG. 1 a balloon manufacturing method using a balloon manufacturing jig for catheter according to another embodiment of the present invention
  • FIG. 6 is a flowchart showing a balloon manufacturing method using a balloon manufacturing jig for catheter according to another embodiment of the present invention.
  • the balloon manufacturing method using the balloon manufacturing jig for catheter according to another embodiment of the present invention is a balloon manufacturing method using the balloon manufacturing jig 100 for catheter according to the embodiment of the present invention described above,
  • the first and second side jig members 120 and 130 are drawn into the first and second input and output guide portions 112 and 113 of the center jig member 110 respectively at step S110.
  • the first side jig member 120 is drawn into the first pull-in / out guide portion 112 to be closely contacted with one end of the center forming portion 111
  • the guide portion 130 is drawn into the second pull-in / out guide portion 113 and is brought into close contact with the other end of the center forming portion 111.
  • the tube material 10 is sequentially inserted into the first tube insertion path 122, the center forming part 111, and the second tube insertion path 132 (see FIG. 2) (S120).
  • the rear end of the tube material 10 is closed with a clamp (see the vertical arrow in Fig. 2) or the like, and an expansion pressure is applied to the tip of the tube material 10 (S130). Then, the tube material 10 is inflated and formed into a balloon that conforms to the shape of the tube material 10 through the first and second tapered portions 123 and 133 and the center forming portion 111.
  • the first and second side jig members 120 and 130 are drawn out from the first and second pull-out guide portions 112 and 123 of the center jig member 110 3), the balloon 200 is pulled out from the center jig member 110 in the longitudinal direction thereof (S140).
  • the embossing protrusion 211 formed at the central portion 210 of the balloon 200 can be easily removed from the dimple 111a of the center forming portion 111 by only pulling the balloon 200 by the self- ).
  • the balloon manufacturing method using the balloon manufacturing jig for catheter according to another embodiment of the present invention is characterized in that when both the end portions 221 and 222 of the balloon 200 are completed, A cutter or the like with a set length that can be used.
  • the balloon manufacturing jig 100 for catheter according to the embodiment of the present invention and the balloon manufacturing method using the same can have the following effects.
  • the long tube material 10 can be formed into the balloon 200 without welding, and the first and second side jig members 120
  • the first and second tapered portions 231 and 232 of the balloon 200 can be diversified.
  • a plurality of embossing projections 211 are formed in the center part 210 of the balloon 200 which can further assist in the discharge of the pus from the patient's lesion, and can cause greater friction around the patient's lesion.
  • the present invention may be used to manufacture balloons for catheters.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Anesthesiology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
PCT/KR2018/013428 2018-01-02 2018-11-07 카테터용 풍선 제조 지그 및 이를 이용한 풍선 제조 방법 WO2019135481A1 (ko)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2020513479A JP6880314B2 (ja) 2018-01-02 2018-11-07 カテーテル用風船の製造治具及びこれを利用した風船の製造方法

Applications Claiming Priority (2)

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KR10-2018-0000149 2018-01-02
KR1020180000149A KR102072058B1 (ko) 2018-01-02 2018-01-02 카테터용 풍선 제조 지그 및 이를 이용한 풍선 제조 방법

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KR (1) KR102072058B1 (ja)
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112793172A (zh) * 2020-12-21 2021-05-14 科塞尔医疗科技(苏州)有限公司 球囊成型装置

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08299445A (ja) * 1995-03-08 1996-11-19 Cordis Europ Nv 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
KR20140037157A (ko) * 2011-06-23 2014-03-26 더블유.엘. 고어 앤드 어소시에이트스, 인코포레이티드 고강도 풍선 커버 및 제조 방법
JP5502986B2 (ja) * 2010-02-25 2014-05-28 テルモ株式会社 バルーンの製造方法
JP2015029562A (ja) * 2013-07-31 2015-02-16 フクダ電子株式会社 バルーンカテーテル及びバルーンカテーテルに用いられるバルーンの製造方法
KR20170042604A (ko) * 2014-08-20 2017-04-19 바이오트로닉 아게 혈관성형술용 풍선 제조 방법

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JPH05192408A (ja) * 1991-09-06 1993-08-03 C R Bard Inc 膨張バルーン製造方法
US6561788B1 (en) * 2000-05-31 2003-05-13 Advanced Cardiovascular Systems, Inc. Modular mold designs
US20060175739A1 (en) * 2005-02-08 2006-08-10 Medtronic Vascular, Inc. Hybrid balloon mold and method of using the mold to form a balloon that is used to manufacture a medical dilatation catheter
JP4777036B2 (ja) 2005-10-14 2011-09-21 テルモ株式会社 バルーンの製造方法およびバルーン
EP2974766B1 (en) 2013-03-12 2022-09-21 Terumo Kabushiki Kaisha Balloon and production method for same

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08299445A (ja) * 1995-03-08 1996-11-19 Cordis Europ Nv 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
JP5502986B2 (ja) * 2010-02-25 2014-05-28 テルモ株式会社 バルーンの製造方法
KR20140037157A (ko) * 2011-06-23 2014-03-26 더블유.엘. 고어 앤드 어소시에이트스, 인코포레이티드 고강도 풍선 커버 및 제조 방법
JP2015029562A (ja) * 2013-07-31 2015-02-16 フクダ電子株式会社 バルーンカテーテル及びバルーンカテーテルに用いられるバルーンの製造方法
KR20170042604A (ko) * 2014-08-20 2017-04-19 바이오트로닉 아게 혈관성형술용 풍선 제조 방법

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112793172A (zh) * 2020-12-21 2021-05-14 科塞尔医疗科技(苏州)有限公司 球囊成型装置

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JP6880314B2 (ja) 2021-06-02
JP2020520291A (ja) 2020-07-09
KR102072058B1 (ko) 2020-01-31
KR20190082490A (ko) 2019-07-10

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