KR100729415B1 - 모노필라멘트를 이용한 유연성 및 생체적합성이 향상된수술용 메쉬 및 이의 제조방법 - Google Patents
모노필라멘트를 이용한 유연성 및 생체적합성이 향상된수술용 메쉬 및 이의 제조방법 Download PDFInfo
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- KR100729415B1 KR100729415B1 KR1020050134168A KR20050134168A KR100729415B1 KR 100729415 B1 KR100729415 B1 KR 100729415B1 KR 1020050134168 A KR1020050134168 A KR 1020050134168A KR 20050134168 A KR20050134168 A KR 20050134168A KR 100729415 B1 KR100729415 B1 KR 100729415B1
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- degradable polymer
- monofilament
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- polymer
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract
Description
구분 | 폴리프로필렌 | 글리콜라이드(75) / 카프로락톤(25) 공중합체 | |
용융지수 (g/10min, 230℃) | 10 | 13 | |
방사 조건 | |||
압출기 | Ext. 1 | Ext. 2 | |
제 2 성분의 세그멘트 수 | 6 | - | |
선단압 (kgf/cm2) | 80 | 80 | |
압출기 온도 (℃) | 1 존 | 150 | 150 |
2 존 | 160 | 165 | |
3 존 | 170 | 180 | |
4 존 | 175 | 190 | |
5 존 | 175 | 195 | |
매니폴드 온도 (℃) | 180 | 198 | |
정량펌프 온도 (℃) | 180 | 186 | |
노즐팩 다이 온도 (℃) | 204 | ||
정량펌프 용량 (cc/rev) | 0.3 | 0.6 | |
정량펌프 회전수 (rpm) | 8.75 | 5.35 | |
냉각조 온도 (℃) | 25 | ||
연신 조건 | |||
1차 로울러 (m/min) | 6.7 | ||
1차 연신 오븐 온도(℃) | 70 | ||
2차 로울러 (m/min) | 47 | ||
2차 연신 오븐 온도(℃) | 100 | ||
3차 로울러 (m/min) | 55 | ||
3차 연신 오븐 온도(℃) | 140 | ||
4차 로울러 (m/min) | 46 | ||
총 연신비 | 6.86 | ||
메쉬 제조 조건 | |||
정경 조건 | 150본/ 7'' 빔 | ||
경편 조직 | 예 1 | ||
열처리 조건 | 150℃, 5분 |
구분 | 프로필렌(97)/에틸렌(3) 랜덤공중합체 | 글리콜라이드(75) / 카프로락톤(25) 공중합체 | |
용융지수 (g/10min, 230℃) | 8 | 12 | |
방사 조건 | |||
압출기 | Ext. 1 | Ext. 2 | |
제 2 성분의 세그멘트 수 | 6 | - | |
선단압 (kgf/cm2) | 80 | 80 | |
압출기 온도 (℃) | 1 존 | 150 | 150 |
2 존 | 160 | 165 | |
3 존 | 165 | 180 | |
4 존 | 170 | 190 | |
5 존 | 170 | 195 | |
매니폴드 온도 (℃) | 175 | 198 | |
정량펌프 온도 (℃) | 175 | 186 | |
노즐팩 다이 온도 (℃) | 203 | ||
정량펌프 용량 (cc/rev) | 0.3 | 0.6 | |
정량펌프 회전수 (rpm) | 8.75 | 5.35 | |
냉각조 온도 (℃) | 25 | ||
연신 조건 | |||
1차 로울러 (m/min) | 6.1 | ||
1차 연신 오븐 온도(℃) | 70 | ||
2차 로울러 (m/min) | 47 | ||
2차 연신 오븐 온도(℃) | 100 | ||
3차 로울러 (m/min) | 55 | ||
3차 연신 오븐 온도(℃) | 140 | ||
4차 로울러 (m/min) | 46 | ||
총 연신비 | 7.54 | ||
메쉬 제조 조건 | |||
정경 조건 | 120본/ 7'' 빔 | ||
경편 조직 | 예 2 | ||
열처리 조건 | 155℃, 3분 |
폴리머 | 폴리프로필렌 | 다이옥사논(90)/트리메틸렌카보네이트(9)/카프로락톤(1) 트리블록공중합체 | |
용융지수 (g/10min, 230℃) | 10 | 10 | |
방사 조건 | |||
압출기 | Ext. 1 | Ext. 2 | |
제 2 성분의 세그멘트 수 | 6 | - | |
선단압 (kgf/cm2) | 80 | 80 | |
압출기 온도 (℃) | 1 존 | 150 | 150 |
2 존 | 160 | 155 | |
3 존 | 165 | 160 | |
4 존 | 165 | 160 | |
5 존 | 165 | 160 | |
매니폴드 온도 (℃) | 170 | 165 | |
정량펌프 온도 (℃) | 170 | 165 | |
노즐팩 다이 온도 (℃) | 175 | ||
정량펌프 용량 (cc/rev) | 0.3 | 0.6 | |
정량펌프 회전수 (rpm) | 8.75 | 5.35 | |
냉각조 온도 (℃) | 25 | ||
연신 조건 | |||
1차 로울러 (m/min) | 5.8 | ||
1차 연신 오븐 온도(℃) | 70 | ||
2차 로울러 (m/min) | 45 | ||
2차 연신 오븐 온도(℃) | 100 | ||
3차 로울러 (m/min) | 53 | ||
3차 연신 오븐 온도(℃) | 120 | ||
4차 로울러 (m/min) | 42 | ||
총 연신비 | 7.24 | ||
메쉬 제조 조건 | |||
정경 조건 | 120본/ 7'' 빔 | ||
경편 조직 | 예 3 | ||
열처리 조건 | 95℃, 10분 |
물성 | 측정 방법 및 측정 기기 |
직경, mm | EP 규정(regulation), 직경 |
인장강도, kgf | EP 규정, 인장강도, 인스트론사(Instron corporation) 제 |
물성 | 측정 방법 및 측정 기기 |
두께(㎛) | EP 규정(regulation), 직경 |
중량(g/m2) | 10 cm X10 cm 의 메쉬의 무게를 측정 후 m2로 환산함 |
인장강도(Kgf/inch) | 1"×6"의 메쉬를 경편 제조시의 수평 또는 수직방향으로 샘플링하여 인장강도 시험기(Instron사- 4204, 미국)에 50 mm의 인장거리로 장착하여 50 mm/min의 속도로 인장하여 측정 |
강직성 (Stiffness, mgf) | 1"×1"로 메쉬를 절단하여 강직성 시험기(Gurley Precision Instrument, 미국 )에서 하중 5 g, 위치 2로 셋팅하여 측정함 |
측정 항목 | 실시예 | 비교예 | |||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 4 | 5 | ||||
섬유 물성 | 직경 ( ㎛ ) | 150 | 145 | 140 | 150 | 150 | 200 | 150 | 150 | 150 | 100~150 | ||
인장강도 ( Kgf ) | 1 | 0.8 | 1.1 | 0.9 | 0.9 | 1.8 | 1 | 1 | 1 | 1~2 | |||
메쉬 물성 | 초기 물성 | 두께 ( ㎛ ) | 550 | 540 | 540 | 550 | 550 | 600 | 510 | 530 | 600 | 650 | |
중량 ( g/m2 ) | 64 | 62 | 60 | 64 | 64 | 80 | 65 | 70 | 85 | 88 | |||
인장강도 (Kgf) | 수직 | 20 | 18 | 21 | 18 | 20 | 22 | 20 | 22 | 26 | 20 | ||
수평 | 6 | 5 | 6 | 5 | 6 | 8 | 13 | 16 | 16 | 6 | |||
강직성 (mgf) | 수직 | 22 | 19 | 24 | 18 | 20 | 24 | 18 | 20 | 28 | 18 | ||
수평 | 10 | 9 | 12 | 9 | 10 | 11 | 16 | 18 | 25 | 10 | |||
분해후 물성 | 두께 ( ㎛ ) | 450 | 450 | 440 | 470 | 470 | 420 | 410 | 430 | 600 | 470 | ||
중량 ( g/m2 ) | 25 | 25 | 24 | 25 | 27 | 30 | 27 | 29 | 85 | 35 | |||
인장강도 (Kgf) | 수직 | 12 | 9 | 8 | 10 | 13 | 12 | 12 | 13 | 26 | 12 | ||
수평 | 5 | 4 | 4 | 4 | 5 | 6 | 8 | 10 | 16 | 4 | |||
강직성 (mgf) | 수직 | 2 | 2 | 2 | 1.5 | 2 | 2 | 1.5 | 2 | 28 | 9 | ||
수평 | 1 | 0.8 | 0.5 | 0.5 | 1 | 0.5 | 0.5 | 0.5 | 25 | 2 |
Claims (20)
- 분해성 고분자와 비분해성 고분자를 세그멘티드 파이(segmented pie) 형태로 복합방사한 모노필라멘트를 포함하는 것을 특징으로 하는 생체적합성과 유연성이 향상된 탈장 수술용 메쉬.
- 분해성 고분자와 비분해성 고분자를 세그멘티드 파이(segmented pie) 형태로 복합방사한 모노필라멘트를 포함하는 것을 특징으로 하는 생체적합성과 유연성이 향상된 질 슬링(vaginal sling procedures), 인공 인대 또는 인공 힘줄 (artificial ligament or tendon) 수술, 또는 강화 물질 또는 연결 물질의 첨가가 필요한 근막 결핍(fascial deficiencies)의 처치용 메쉬.
- 제1항 또는 제2항에 있어서, 상기 분해성 고분자의 함량이 30 내지 70 부피%이고, 상기 비분해성 고분자의 함량이 30 내지 70 부피%인 것을 특징으로 하는 메쉬.
- 제1항 또는 제2항에 있어서, 상기 분해성 고분자는 글리콜라이드(glycolide), 글리콜산(glycolic acid), 락타이드(lactide), 락트산(lactic acid), 카프로락톤(ε-caprolactone), 다이옥사논(p-dioxanone), 트리메틸렌카보네이트(trimethylene carbonate), 폴리언히드라이드 및 폴리히드록시알카노에이트로 이루 어진 군 중에서 선택된 모노머의 단독 중합체 또는 2종 이상을 포함하는 공중합체인 것을 특징으로 하는 메쉬.
- 제4항에 있어서, 상기 분해성 고분자는 글리콜라이드와 카프로락톤의 공중합체, 또는 다이옥사논과 트리메틸렌카보네이트와 카프로락톤의 공중합체인 것을 특징으로 하는 메쉬.
- 제1항 또는 제2항에 있어서, 상기 비분해성 고분자는 폴리올레핀, 폴리아마이드(polyamides), 폴리우레탄 및 플루오로폴리머로 이루어진 군 중에서 선택된 것을 특징으로 하는 메쉬.
- 제6항에 있어서, 상기 비분해성 고분자는 폴리프로필렌, 또는 프로필렌과 에틸렌의 공중합체인 것을 특징으로 하는 메쉬.
- 제1항 또는 제2항에 있어서, 상기 분해성 고분자의 용융지수가 비분해성 고분자의 용융지수와 같거나 높은 것을 특징으로 하는 메쉬.
- 제8항에 있어서, 상기 분해성 고분자와 비분해성 고분자의 용융지수 차이가 10 이하인 것을 특징으로 하는 메쉬.
- 제1항 또는 제2항에 있어서, 상기 비분해성 고분자가 4 내지 10 가닥으로 분할된 것인 메쉬.
- 제1항 또는 제2항에 있어서, 상기 모노 필라멘트의 직경이 100 내지 250 ㎛인 메쉬.
- 제1항 또는 제2항에 있어서, 상기 분해성 고분자의 분해 후 강직성이 분해 전과 비교하여 70% 이상 감소하는 것을 특징으로 하는 메쉬.
- 제1항 또는 제2항에 있어서, 상기 비분해성 고분자는 분해성 고분자에 의해 성분이 분리되고 분해성 고분자는 연결된 것을 특징으로 하는 메쉬.
- 제7항에 있어서, 상기 메쉬의 조직이 사각, 육각 또는 그물망 모양인 것을 특징으로 하는 메쉬.
- 제1항 또는 제2항에 있어서, 상기 메쉬의 구멍 크기는 0.1 내지 4.0 mm이고, 두께는 200 내지 800 ㎛인 메쉬.
- 제1항 또는 제2항에 있어서, 상기 메쉬의 밀도는 경편기의 바늘간격 기준으로 8 내지 20 gauges/inch인 메쉬.
- 제1항 또는 제2항에 있어서, 상기 분해성 고분자 부분이 염색된 것을 특징으로 하는 메쉬.
- 방사, 고화, 결정화 및 연신 과정으로 모노필라멘트를 제조하고, 정경, 경편, 열처리를 수행하여 탈장용 메쉬를 제조하는 방법에 있어서,상기 방사시 분해성 고분자 30 내지 70 부피%와 비분해성 고분자 30 내지 70 부피%를 각각 용융시켜 세그멘티드 파이 형태로 복합방사하고,응력완화(relaxation)를 주어 연신하여 모노필라멘트를 제조하고,상기 모노필라멘트를 90 내지 160 ℃에서 1 내지 30 분 동안 열처리하는 단계를 포함하는 것을 특징으로 하는 탈장 수술용 메쉬의 제조방법.
- 방사, 고화, 결정화 및 연신 과정으로 모노필라멘트를 제조하고, 정경, 경편, 열처리를 수행하여 탈장용 메쉬를 제조하는 방법에 있어서,상기 방사시 분해성 고분자 30 내지 70 부피%와 비분해성 고분자 30 내지 70 부피%를 각각 용융시켜 세그멘티드 파이 형태로 복합방사하고,응력완화(relaxation)를 주어 연신하여 모노필라멘트를 제조하고,상기 모노필라멘트를 90 내지 160 ℃에서 1 내지 30 분 동안 열처리하는 단계를 포함하는 것을 특징으로 하는 질 슬링(vaginal sling procedures), 인공 인대 또는 인공 힘줄 (artificial ligament or tendon) 수술, 또는 강화 물질 또는 연결 물질의 첨가가 필요한 근막 결핍(fascial deficiencies)의 처치용 메쉬의 제조방법.
- 제18항 또는 제19항에 있어서, 상기 응력완화를 10 내지 20 % 주는 것을 특징으로 하는 제조방법.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
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KR20040115443 | 2004-12-29 | ||
KR1020040115443 | 2004-12-29 | ||
PCT/KR2005/004455 WO2006071023A1 (en) | 2004-12-29 | 2005-12-22 | Monofilament, surgical mesh having improved flexibility and biocompatibility, and process for preparing the same |
WOPCT/KR2005/004455 | 2005-12-22 |
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KR20060076252A KR20060076252A (ko) | 2006-07-04 |
KR100729415B1 true KR100729415B1 (ko) | 2007-06-15 |
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KR1020050134168A KR100729415B1 (ko) | 2004-12-29 | 2005-12-29 | 모노필라멘트를 이용한 유연성 및 생체적합성이 향상된수술용 메쉬 및 이의 제조방법 |
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US (2) | US20070219568A1 (ko) |
EP (1) | EP1830734B1 (ko) |
JP (1) | JP4827838B2 (ko) |
KR (1) | KR100729415B1 (ko) |
CN (1) | CN100506185C (ko) |
BR (1) | BRPI0510336B8 (ko) |
MX (1) | MXPA06012475A (ko) |
WO (1) | WO2006071023A1 (ko) |
ZA (1) | ZA200608755B (ko) |
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Also Published As
Publication number | Publication date |
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US20150374476A1 (en) | 2015-12-31 |
EP1830734B1 (en) | 2017-03-01 |
BRPI0510336B8 (pt) | 2021-06-22 |
JP2008501075A (ja) | 2008-01-17 |
US20070219568A1 (en) | 2007-09-20 |
WO2006071023A1 (en) | 2006-07-06 |
US9883935B2 (en) | 2018-02-06 |
JP4827838B2 (ja) | 2011-11-30 |
ZA200608755B (en) | 2008-01-08 |
BRPI0510336A (pt) | 2007-10-30 |
EP1830734A1 (en) | 2007-09-12 |
MXPA06012475A (es) | 2007-05-31 |
EP1830734A4 (en) | 2014-09-17 |
CN100506185C (zh) | 2009-07-01 |
BRPI0510336B1 (pt) | 2018-10-09 |
KR20060076252A (ko) | 2006-07-04 |
CN1950036A (zh) | 2007-04-18 |
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