KR101256360B1 - 의료 장치에 사용하기 위한 강화된 흡수성 다층 직물 및 이의 제조방법 - Google Patents

의료 장치에 사용하기 위한 강화된 흡수성 다층 직물 및 이의 제조방법 Download PDF

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KR101256360B1
KR101256360B1 KR1020077011443A KR20077011443A KR101256360B1 KR 101256360 B1 KR101256360 B1 KR 101256360B1 KR 1020077011443 A KR1020077011443 A KR 1020077011443A KR 20077011443 A KR20077011443 A KR 20077011443A KR 101256360 B1 KR101256360 B1 KR 101256360B1
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South Korea
Prior art keywords
fabric
absorbent
staples
nonwoven
glycolide
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KR1020077011443A
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English (en)
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KR20070084400A (ko
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다누라즈 에스. 쉐티
산욕 마노하 펜다르카
앤 제시카 고어맨
심미 칼리라이
제리 무어
스리데비 다나라즈
힙 도
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에디컨인코포레이티드
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    • B32B2262/06—Vegetal fibres
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/726—Permeability to liquids, absorption
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2459/00—Nets, e.g. camouflage nets
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2535/00—Medical equipment, e.g. bandage, prostheses, catheter
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00—Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/30—Woven fabric [i.e., woven strand or strip material]
    • Y10T442/3707—Woven fabric including a nonwoven fabric layer other than paper
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00—Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/40—Knit fabric [i.e., knit strand or strip material]
    • Y10T442/494—Including a nonwoven fabric layer other than paper

Abstract

본 발명은 제1 흡수성 부직포와 제2 흡수성 직물 또는 편물을 포함하는 다층 직물 및 이의 제조방법에 관한 것이다.
다층 직물, 제1 흡수성 부직포, 제2 흡수성 직물 또는 편물, 글리콜라이드/락타이드 공중합체, 산화된 재생 셀룰로스.

Description

의료 장치에 사용하기 위한 강화된 흡수성 다층 직물 및 이의 제조방법{A reinforced absorbable multilayered fabric for use in medical devices and method of manufacture}
본원은 2004년 10월 20일자로 출원된 미국 가특허원 제60/620,624호에 대한 우선권을 주장한다.
본 발명은 의료 장치에 유용한 강화된 흡수성 다층 직물 및 이의 제조방법에 관한 것이다.
의료 시술과 관련하여 다층 직물을 사용하는 것은 일반적으로 공지되어 있다. 예를 들면, 다층 직물은 다목적용 패드, 상처용 드레싱, 탈장교정술용 메쉬, 부착 방지용 메쉬 및 조직 강화 메쉬를 포함한 수술용 메쉬, 결손부 봉합용 장치 및 지혈기로서 사용한다.
리히텐슈타인(Lichtenstein) 등의 미국 특허 제5,593,441호에는 바람직하게는, 말렉스(Marlex?) 메쉬 등의 조직 내부 성장을 허용하는 폴리프로필렌 메쉬 시트를 갖는 복합 보철물이 기재되어 있다. 당해 문헌에는 폴리글락틴 910(Vicryl?) 메쉬 등의 흡수성 메쉬를 포함하는, 조직 강화 및 결손부 봉합에 적합한 기타의 수술용 재료를 이용할 수 있음이 기재되어 있다. 리히텐슈타인 등의 복합 보철물에는 또한 부착 배리어, 바람직하게는 실리콘 탄성중합체 시트가 포함된다. 당해 문헌에는 일반적으로 인터시드(Interceed?)(TC7) 흡수성 부착 배리어(제조원: 에디컨 인코포레이티드(Ethicon Inc.), 미국 뉴저지주 서머빌 소재) 등의 산화된 재생 셀룰로스를, 단기간 효과가 있는 복합 보철물을 제조하기 위해 부착 배리어로서 사용할 수 있음이 제안되어 있다. 리히텐슈타인 등의 복합 보철물은 약해진 근육 벽을 강화 및 복구하는 데 사용하기 위한 것인 반면, 수술후 부착 범위가 제한된다.
쉴더(Schilder) 등의 미국 특허 제5,686,090호에는 플리스(fleece)와 비흡수성 또는 흡수성 필름을 배합하여 인접 조직으로의 이상 성장을 방지하고 부착성을 감소시키는, 필름과 배합한 플리스의 용도가 기재되어 있다. 쉴더 등은 일반적으로 폴리프로필렌, 폴리에스테르, 폴리글락틴, 폴리디옥산온 또는 폴리글레카프론 25가 플리스 재료 또는 필름 재료로서 사용될 수 있음을 기재하였다. 당해 문헌에 사용된 용어 "플리스"는 다공도로서 기재되어 있으며, 다공도는 200Pa의 유입구 압력, 시험 표면 50㎠ 및 시험 두께 1mm로 측정하여 기류 1m2s당 100 내지 1000ℓ의 범위인 것으로 기재되어 있다. 쉴더 등의 복합재는 일반적으로 다층 이식편인 것으로 기재되어 있다.
추가로, 다층 직물은 조직 공학 및 정형외과 적용 용도에 유용하다. 조직 공학의 최근의 출현으로 손상/발병 조직을 복구 및 재생하는 다수의 방법이 제공되었다. 조직 공학 전략은 궁극적으로 조직 기능을 회복하고 개선시킬 수 있는 생체 물질의 용도를 탐구하였다. 집락형성성 및 재형성성 비계(scaffolding) 재료의 사용은 조직 주형, 통로, 배리어 및 저장소로서 광범위하게 연구되어 왔다. 특히, 발포체, 스폰지, 겔, 하이드로겔, 텍스타일 및 부직포 형태의 합성 및 천연 재료는 생물학적 조직을 재건/재생할 뿐만 아니라, 조직 성장을 유도하기 위한 주화소(chemotactic agent)를 전달하기 위해 생체내 및 시험관내에서 사용되어 왔다. 상이한 형태의 비계를 적층시켜 다층 조직 공학 비계를 형성할 수 있다.
그러나, 선행 기술분야에서는 제2 흡수성 직물 또는 편물에 의해 강화된 제1 흡수성 부직포를 갖는 강화된 흡수성 다층 직물이 기재되거나 제안되지 않았다.
본원에 사용된 용어 "부직포"는 방사, 제직 또는 편직 이외의 방법으로 제조한, 접착포, 성형포(formed fabric) 또는 가공포를 포함하지만, 이에 한정되지는 않는다. 보다 구체적으로, 용어 "부직포"는 웹, 시트 또는 배트(batt)로 결집시킨 스테이플 섬유로 주로 또는 전체적으로 구성된, 통상적으로 편평한 시트 형태의 다공성의 텍스타일형 재료를 말한다. 부직포의 구조는 예를 들면, 통상적으로 거의 무작위로 배열된 스테이플 섬유의 배열을 기본으로 한다. 부직포의 장력, 응력 변형 및 촉감 특성은 통상적으로, 예를 들면, 스테이플 섬유의 얽힘(entanglement) 및 강화에 의해 발생된 섬유 대 섬유의 마찰 및/또는 부착성, 화학적 또는 물리적 결합으로부터 유래한다. 그럼에도 불구하고, 부직포를 제조하는 데 사용된 원료는 방사, 제직 또는 편직을 포함한 공정으로 제조된 사, 스크림, 망(netting) 또는 필라멘트일 수 있다.
발명의 요약
본 발명은 제2 흡수성 직물 또는 편물에 의해 강화된 제1 흡수성 부직포를 포함하는 강화된 흡수성 다층 직물 및 이의 제조방법에 관한 것이다. 보다 구체적으로, 제1 흡수성 부직포는 지방족 폴리에스테르 중합체, 공중합체 또는 이들의 블렌드를 포함하는 섬유를 포함하는 한편, 제2 흡수성 직물 또는 편물은 산화된 재생 셀룰로스 섬유를 포함한다.
강화된 흡수성 다층 직물은 일반적으로 부직포와 강화 직물을 포함한다. 강화 직물은 부직포가 직접적으로 또는 간접적으로 부착될 수 있는 배킹(backing)을 제공한다.
부직포는 본원에 기재된 강화된 흡수성 다층 직물의 제1 흡수성 부직포로서 기능한다. 제1 흡수성 부직포는 지방족 폴리에스테르 중합체, 공중합체 또는 이들의 블렌드를 포함하는 섬유로 구성된다. 지방족 폴리에스테르는 통상적으로 락트산, 락타이드(L형, D형, 메소형 및 D형과 L형의 혼합물 포함), 글리콜산, 글리콜라이드, ε-카프로락톤, p-디옥산온(1,4-디옥산-2-온) 및 트리메틸렌 카보네이트(1,3-디옥산-2-온)을 포함하지만, 이에 한정되지는 않는 단량체의 개환 중합으로 합성한다.
바람직하게는, 제1 흡수성 부직포는 글리콜라이드와 락타이드의 공중합체를, 약 70 내지 95몰% 범위의 글리콜라이드 및 잔여 락타이드의 양으로 포함한다.
대체 양태에서, 제1 흡수성 부직포는 지방족 폴리에스테르 중합체, 공중합체 또는 이들의 블렌드와 산화된 다당류 섬유로 구성된 섬유를 포함한다.
바람직하게는, 부직포는 방사, 제직 또는 편직 이외의 공정으로 제조한다. 예를 들면, 부직포는 방사, 제직 또는 편직을 포함하는 공정으로 제조한 사, 스크림, 망 또는 필라멘트로부터 제조할 수 있다. 사, 스크림, 망 및/또는 필라멘트는 권축(crimping)시켜 서로와의 얽힘 및 제2 흡수성 부직포 또는 편물과의 부착성을 강화한다. 이어서, 이러한 권축 사, 스크림, 망 및/또는 필라멘트는 얽히기에 충분히 긴 스테이플로 절단할 수 있다. 스테이플은 길이가 약 0.1 내지 3.0in, 바람직하게는 약 0.75 내지 2.5in, 가장 바람직하게는 약 1.5 내지 2.0in일 수 있다. 스테이플은 소면(carding)시켜 부직 배트를 생성할 수 있으며, 이어서 이를 제1 흡수성 부직포로 니들펀칭(needlepunching) 또는 캘린더링(calendaring)시킬 수 있다. 추가로, 스테이플은 꼬거나 파일링(piling)시킬 수 있다.
부직포의 제조에 대하여 공지된 기타 방법이 이용될 수 있으며 공기 적층(air laying), 습윤 성형(wet forming) 및 스티치 결합(stitch bonding) 등의 방법이 포함된다. 이러한 공정은 일반적으로 전문이 본원에 참조로 인용된 문헌[참조: Encyclopedia of Polymer Science and Engineering, Vol. 10, pp. 204-253 (1987); Introduction to Nonwovens by Albin Turbank (Tappi Press, Atlanta GA 1999)]에 논의되어 있다.
부직포의 두께는 약 0.25 내지 2mm의 범위일 수 있다. 부직포의 평량은 약 0.01 내지 0.2g/in2, 바람직하게는 0.03 내지 0.1g/in2, 가장 바람직하게는 약 0.04 내지 0.08g/in2의 범위이다. 제1 흡수성 부직포의 중량%는, 강화된 흡수성 다층 직물의 총 중량을 기준으로, 약 10 내지 80%의 범위일 수 있다.
제2 흡수성 직물 또는 편물은 강화 직물로서 기능하고 산화된 다당류, 특히 산화된 셀룰로스 및 이의 중화 유도체를 포함한다. 예를 들면, 셀룰로스는 카복실 산화 또는 알데히드 산화된 셀룰로스일 수 있다. 보다 바람직하게는, 산화된 재생 셀룰로스를 포함하지만, 이에 한정되지는 않는 산화된 재생 다당류는 제2 흡수성 직물 또는 편물을 제조하는 데 사용할 수 있다. 재생되지 않은 셀룰로스에 비하여 높은 균일도로 인하여 재생 셀룰로스가 바람직하다. 재생 셀룰로스 및 산화된 재생 셀룰로스의 제조방법에 대한 상세한 설명은 미국 특허 제3,364,200호, 제5,180,398호 및 제4,626,253호에 기재되어 있으며, 이들 문헌은 전체가 본원에 참조로 인용된다.
강화 직물로서 이용될 수 있는 직물의 예로는 인터시드 흡수성 부착 배리어, 서지셀(Surgicel?) 흡수성 지혈기, 서지셀 Nu-Knit? 흡수성 지혈기 및 서지셀 피브릴러(Fibrillar) 흡수성 지혈기(각각의 제조원: Johnson & Johnson Wound Management Worldwide 또는 Gynecare Worldwide, 각각 미국 뉴저지주 서머빌 소재의 에디컨 인코포레이티드의 지부)가 포함된다.
본 발명에서 이용되는 강화 직물은 직물 또는 편물일 수 있으며, 다만 직물은 고려하는 적용 용도에 사용하는 데 필요한 물리적 특성을 갖는다. 이러한 직물은, 예를 들면, 미국 특허 제4,626,253호, 제5,002,551호 및 제5,007,916호에 기재되어 있으며, 당해 문헌들은 전체가 본원에 참조로 인용된다. 바람직한 양태에서, 강화 직물은 후속적으로 산화되어 생분해성을 직물에 제공하기에 효과적인 양의 카복실 또는 알데히드 잔기를 포함하는 광택사로 구성된 경트리코트 편직물이다.
대체 양태에서, 제2 흡수성 직물 또는 편물은 산화된 다당류 섬유와 함께 지방족 폴리에스테르 중합체, 공중합체 또는 이들의 블렌드로 구성된 섬유를 포함한다.
제2 흡수성 직물 또는 편물은 바람직하게는 산화된 재생 셀룰로스를 포함하며 평량이 약 0.001 내지 0.2g/in2, 바람직하게는 0.01 내지 0.1g/in2, 가장 바람직하게는 0.04 내지 0.07g/in2의 범위일 수 있다.
제1 흡수성 부직포는 제2 흡수성 직물 또는 편물에 직접적으로 또는 간접적으로 부착된다. 예를 들면, 부직포는 제2 흡수성 직물 또는 편물에 니들펀칭, 캘린더링, 엠보싱 또는 고수압직조(hydroentanglement), 또는 화학적 또는 열적 결합을 통하여 혼입시킬 수 있다. 제1 흡수성 부직포의 스테이플은 서로 얽혀서 제2 흡수성 직물 또는 편물에 매봉된다. 보다 특히, 화학적 또는 열적 결합 이외의 방법의 경우, 제1 흡수성 부직포가 제2 흡수성 직물 또는 편물에 부착되어, 제1 흡수성 부직포의 스테이플의 약 1% 이상, 바람직하게는 약 10 내지 20%, 바람직하게는 약 50% 이하가 제2 흡수성 직물 또는 편물의 다른 면에 노출될 수 있다. 이는 제1 흡수성 부직포와 제2 흡수성 직물 또는 편물이 접합된 상태로 잔존하고 통상의 취급 조건하에 이층되지 않도록 보장한다. 강화된 흡수성 다층 직물은 제2 흡수성 직물 또는 편물중 실질적으로 어느 것도 제1 흡수성 부직포에 의한 도포율이 육안으로 부족하지 않도록 균일하다.
본원에 기재된 다층 직물의 한 가지 제조방법은 다음 공정에 따른다. 섬유당 약 1 내지 4데니어의 흡수성 중합체 섬유를 약 80 내지 120데니어의 멀티필라멘트 사, 이어서 약 800 내지 1200데니어의 사에 통합시키고, 열 권축시킨 다음, 길이 약 0.75 내지 1.5in의 스테이플로 절단할 수 있다. 당해 스테이플을 다중 롤러 건조 적층 소면기에 1회 이상 공급하고 균일한 부직 배트로 소면시키는 한편, 습도를 60 내지 75℃의 실온에서 약 40 내지 60%로 조절한다. 예를 들면, 균일한 부직 배트를, 대체 롤러 및 스트립퍼 롤러로 커버링된 주 실린더를 갖는 단일 실린더 롤러 탑 카드를 사용하여 제조할 수 있으며, 여기서 배트는 도퍼(doffer) 롤러에 의해 실린더의 표면으로부터 도핑되어 수집 롤러 위에 부착된다. 상기 배트를 니들펀칭 또는 캘린더링 등의 임의의 다른 수단을 통하여 추가로 가공할 수 있다. 이후, 제1 흡수성 부직포를 니들펀칭 등의 다양한 기술에 의해 제2 흡수성 직물 또는 편물로 부착시킬 수 있다. 이어서, 강화된 흡수성 다층 직물을 적합한 용매 중에서 세척하여 정련시키고 약 30분 동안 온화한 조건하에 건조시킬 수 있다.
스테이플 길이, 스테이플의 개방, 스테이플 공급 속도 및 상대 습도 등의 공정 파라미터를 조절하는 것이 바람직하다. 예를 들면, 통합 사는 약 5 내지 50크림프/in, 바람직하게는 약 10 내지 30크림프/in를 가질 수 있다. 임의의 길고 불완전하게 절단된 스테이플은 소면기에 달라 붙어 필링(pilling)을 유발하는 경향이 있으므로, 권축 사의 효율적인 절단이 바람직하다. 스테이플 길이의 바람직한 범위는 약 0.75 내지 2.5in, 보다 바람직하게는 약 1.5 내지 2.0in이다.
균일성을 최적화시키고 정전기의 축적을 최소화시키기 위하여, 상대 습도를 배트 가공 동안, 바람직하게는 소면시켜 균일한 부직 배트를 형성하는 동안 조절할 수 있다. 바람직하게는 부직 배트를 약 60 내지 75℃의 실온에서 약 40% 이상의 상대 습도하에 건조 적층 소면 공정을 사용하여 가공한다. 보다 바람직하게는, 부직 배트를 약 50 내지 60%의 상대 습도에서 가공한다.
다층 직물은 임의의 방사유제(spin finish)를 용해시키기에 적합한 용매를 사용하여 정련시킨다. 용매는 이소프로필 알콜, 헥산, 에틸 아세테이트 및 메틸렌 클로라이드를 포함하지만, 이에 한정되지는 않는다. 이어서, 다층 직물을 충분한 건조를 제공하는 한편, 수축을 최소화시키는 조건하에 건조시킨다.
강화된 흡수성 다층 직물은 평균 두께가 약 0.75 내지 3.0nn, 바람직하게는 약 1.00 내지 2.5mm, 가장 바람직하게는 약 1.2 내지 2.0mm이다. 강화된 흡수성 다층 직물의 평량은 약 0.05 내지 0.25g/in2, 바람직하게는 약 0.08 내지 0.2g/in2, 가장 바람직하게는 약 0.1 내지 0.18g/in2이다. 강화된 흡수성 다층 직물은 각각의 평방 인치에 걸쳐 평량 또는 두께에 있어서 약 10% 이하의 변동(평균의 상대 표준 편차)이 존재하도록 균일하다.
추가로, 부직포는 지혈제 등의 생물학적 활성제를 포함할 수 있다. 사용될 수 있는 지혈제로는 천연, 재조합 또는 합성 응혈 촉진 효소, 단백질 및 펩티드가 포함되지만, 이에 한정되지는 않는다. 보다 구체적으로는, 프로트롬빈, 트롬빈, 피브리노겐, 피브린, 피브로넥틴, 인자 X/Xa, 인자 VII/VIIa, 인자 IX/IXa, 인자 XI/XIa, 인자 XII/XIIa, 조직 인자, 폰 빌레브란트(von Willebrand) 인자, 콜라겐, 엘라스틴, 젤라틴, 지혈 활성을 갖는 합성 펩티드, 이들의 유도체 및 배합물이 이용될 수 있다. 바람직한 지혈제는 트롬빈, 피브리노겐 및 피브린이다.
추가로, 부직포는 상처 치유제, 항균제, 항미생물제, 성장 인자, 진통제 및 마취제를 포함하지만, 이에 한정되지는 않는 약리학적 및 생물학적 활성제를 포함할 수 있다. 강화된 흡수성 다층 직물은, 조직 비계로서 사용되는 경우, 표적 조직에 대하여 이식하기 전에 적합한 세포 유형으로 씨딩하고 배양할 수 있다.
실시예 1. PGL 부직포와 ORC 직물
폴리(글리콜라이드-코-락타이드)(PGL, 90/10mol/mol)를 섬유에 용융 방사하였다. 멀티필라멘트 사를 통합하고, 권축시키고, 길이가 1.75in인 스테이플로 절단하였다. 스테이플을 소면시켜 부직 배트를 제조한 다음, 두께 약 1.25mm 및 밀도 약 98.1mg/cc로 압축하였다. 이어서, 부직포를 편직 카복실 산화된 재생 셀룰로스(ORC)(제조원: 에디컨 인코포레이티드; 상표명: 인터시드)에 니들펀칭하여 부직포를 ORC 직물에 고정시켰다. 최종 다층 직물은 부직포를 약 60중량% 포함하였다.
실시예 2. PGL 부직포와 ORC 직물
폴리(글리콜라이드-코-락타이드)(PGL, 90/10mol/mol)를 섬유에 용융 방사하였다. 멀티필라멘트 사를 통합하고, 권축시키고, 길이가 1.75in인 스테이플로 절단하였다. 스테이플을 소면시켜 부직 배트를 제조한 다음, 두께 약 1.22mm 및 밀도 약 103.4mg/cc로 압축하였다. 이어서, 부직포를 편직 카복실 산화된 재생 셀룰로스(ORC)(제조원: 에디컨 인코포레이티드; 상표명: 서지셀 NuKnit?)에 니들펀칭하여 부직포를 ORC 직물에 고정시켰다. 최종 다층 직물은 부직포를 약 25중량% 포함하였다.
실시예 3. PGL 부직포와 ORC 직물
폴리(글리콜라이드-코-락타이드)(PGL, 90/10mol/mol)를 섬유에 용융 방사하였다. 멀티필라멘트 사를 통합하고, 권축시키고, 길이가 1.75in인 스테이플로 절단하였다. 스테이플을 소면시켜 부직 배트를 제조한 다음, 두께 약 1.1mm 및 밀도 약 102.8mg/cc의 펠트로 압축하였다. 이어서, 부직포를 편직 카복실 산화된 재생 셀룰로스(ORC)(제조원: 에디컨 인코포레이티드; 상표명: 서지셀)에 니들펀칭하여 부직포를 ORC 직물에 고정시켰다. 최종 다층 직물은 부직포를 약 60중량% 포함하였다.
실시예 4. PGL 부직포와 ORC 직물
폴리(글리콜라이드-코-락타이드)(PGL, 90/10mol/mol)를 섬유에 용융 방사하였다. 80데니어의 멀티필라멘트 사를 800데니어의 통합 사에 통합시켰다. 통합 사를 약 110℃에서 권축시켰다. 권축 사를 길이 약 1.25"의 스테이플로 절단하였다. 권축 스테이플 20g을 정확하게 계량하여 다중 롤러 소면기의 공급 컨베이어 벨트 위에 균일하게 펼쳐 놓았다. 환경 조건(온도: 70℉/RH 55%)을 조절하였다. 이어서, 스테이플을 소면시켜 부직 배트를 제조하였다. 당해 배트를 픽업 롤러로부터 제거하고 4개의 동일한 부분으로 절단하였다. 이들을 수집 방향과 수직인 소면기에 재공급하였다. 이번의 제2 통과 후 배트를 계량한 다음(19.8g: 직물 수율 99%) 펠트로 압축하였다. 압축 펠트를 ORC 직물 위에 정확하게 놓고 니들펀칭 장치에서 2회의 통과를 통하여 단단히 부착시켰다. 다층 직물을 트리밍(trimming)하고 3개의 개별적인 이소프로필 알콜 욕에서 정련시켜 방사유제와 임의의 기계유를 제거하였다. 정련 다층 직물을 70℃의 오븐 속에서 30분 동안 건조시키고, 냉각시키고 계량하였다.
다층 직물의 "두께"를 본원에 기재된 바와 같이 측정하였다. 측정 기구는 다음과 같았다:
(1) 미투토요 절대 게이지 모델(Mitutoyo Absolute gauge Model) 번호 ID-C125EB [코드 번호-- 543-452B]. 1" 직경 풋(foot)을 게이지 위에서 사용하였다.
(2) 자기 홀더를 사용하여 캘리퍼(caliper)를 제자리에서 가두고 다이 압판에 설치하였다.
(3) 40.8 내지 41.5g으로 중량 계량한 2개의 금속판 약 2.75"×2"×0.60"[총 합은 약 82.18g임].
다층 직물을 평활하고 기계 가공한 표면인 압판 표면에 놓았다. 2개의 금속판을 다층 직물 위에 서로의 상부에 놓고 이의 가장자리에서 가볍게 눌러서 다층 직물이 편평해지도록 하였다. 게이지 풋을 금속판의 상부에 놓은 다음, 다시 들어올리고 재위치시키며, 이때 판독하였다.
12개의 1"×1" 조각을 정련 다층 직물로부터 다이 절단하고 정확히 계량하였다. 각각의 1"×1" 조각의 두께를 신뢰할만한 평균을 수득하기 위하여 금속판의 상이한 영역에서 4 내지 5회 측정하였다. 각각의 조각의 중량 및 두께를 표 1에 나타낸다. 값은 두 층 모두의 도포율이 전 방향에서 유사함을 나타낸다.
샘플 번호 시트 1번
중량 (g) 두께 (mm)		 시트 2번
중량 (g) 두께(mm)
1 .132 1.53 .13 1.58
2 .132 1.58 .124 1.57
3 .131 1.59 .13 1.62
4 .129 1.55 .134 1.64
5 .126 1.58 .126 1.56
6 .125 1.5 .131 1.59
7 .129 1.56 .136 1.7
8 .127 1.52 .131 1.62
9 .132 1.55 .131 1.57
10 .123 1.58 .136 1.58
11 .128 1.58 .135 1.65
12 .13 1.51 .133 1.55
평균 0.1287 1.5525 0.1314 1.6025
표준 편차 0.0029 0.031 0.0037 0.044
CV (%) 2.304 2.002 2.837 2.767
실시예 5. 폴리글락틴 910 스테이플의 가공에 대한 습도의 효과
80데니어 폴리글락틴 910 통합 사를 권축시키고 1.75in의 스테이플로 절단하였다. 실온을 69 내지 70℉로 유지시키고 상대 습도를 실내 가습기에 의해 36 내지 60%로 변화되도록 조절하였다. 권축 스테이플을 약 32"×8"의 배트로 소면시켰다. 소면기로 2회 통과 후 배트에 혼입시킨 스테이플의 백분율, 즉 수율은 습도의 증가에 따라 증가하며, 배트의 품질은 수율에 따라 개선되었다.
가공에 대한 상대 습도의 효과
스테이플
중량(g)
RH(%)		 배트
중량(g)
수율(%)		 배트
품질*
27 36 17 63 3.5
27 38 내지 45 18.4 68 4.0
20.9 40 13.8 66 3.0
20.1 49 14.9 74 4.5
33 49 24.4 74 5.0
25.5 60 21.9 86 5.0
*품질은 육안 검사를 기초로 1 내지 5의 등급으로 평가하였다.
1 = 폴리글락틴 910이 부족한 넓은 영역, 줄무늬 필링
3 = 폴리글락틴 910이 부족한 일부 작은 노출 지점 또는 폴리글락틴 910 도포율이 최소인 매우 얇은 지점
5 = 육안 검사에 의하면 균일함 - 노출 지점 없음, 매우 얇은 지점 없음, 필링 없음
실시예 6. 폴리글락틴 910 스테이플의 가공에 대한 스테이플 길이의 효과
80데니어의 폴리글락틴 910 통합 사를 권축시키고 1,25", 1.5" 및 1.75" 길이의 스테이플로 절단하였다. 실온을 69 내지 71℉로 유지시키고 상대 습도를 실내 가습기에 의해 약 55%로 조절하였다. 권축 스테이플을 약 32"×8"의 배트로 소면시켰다.
55% RH에서 배트 품질 및 수율에 대한 스테이플 길이의 효과
스테이플
길이(in)		 스테이플
중량(g)		 배트
중량(g)
수율(%)		 배트
품질*
1.75 25 13.94 56 4.0
1.75 25 16.0 64 5.0
1.5 30.7 28.0 91 ND
1.5 25 21.8 87 ND
1.25 25 24.1 96 5.0
1.25 25 24.2 97 5.0
*품질은 육안 검사를 기초로 1 내지 5의 등급으로 평가하였다.
1 = 폴리글락틴 910이 부족한 넓은 영역, 줄무늬 필링
3 = 폴리글락틴 910이 부족한 일부 작은 노출 지점 또는 폴리글락틴 910 도포율이 최소인 매우 얇은 지점
5 = 육안 검사에 의하면 균일함 - 노출 지점 없음, 매우 얇은 지점 없음, 필링 없음
실시예 7. 강화된 흡수성 다층 직물을 사용한 회전근개 복구
회전근개 문제의 경우, 외과의는 우선 관절경을 사용하여 상처의 범위를 관찰한다. 이어서, 일반적인 마취하에, 환자는 절개술을 거쳐 인열 부위를 복구하도록 한다.
마취제를 투여하고 어깨를 수술할 준비를 한 후, 어깨의 전방 코너의 상부에 걸쳐 미용적인 절개를 실시한다. 이러한 절개는 삼각근의 전방부와 중간부 사이의 연결선에 접근하도록 한다. 이 연결선을 이분하여 어깨 힘의 중요한 부분을 책임지는, 중요한 삼각근을 분리시키거나 손상시키지 않고 회전근개에 접근하도록 한다. 모든 상처 조직을 삼각근과 견봉(삼각근이 결합된 견갑골의 일부) 아래의 공간으로부터 제거한다. 두꺼워진 낭과 회전근개 및 상완골(상부 팔 뼈)의 거친 가장자리를 또한 평활하게 하여 이들이 견봉과 삼각근 아래에서 평활하게 통과하도록 보장한다.
소매 힘줄의 가장자리를 확인하고 소매 조직의 품질과 양을 측정한다. 복구 목표는 찢어진 팔 뼈 위의 위치로 우수한 품질의 힘줄을 재부착시키는 것이다. 홈 또는 골을 소매에 대한 통상의 부착 부위에서 만든다. 힘줄을 지지하고 치유를 돕기 위하여, 외과의는 강화된 흡수성 다층 직물의 패치를 그 위의 위치로 봉합한다. 봉합(외과용 실의 길이)으로 힘줄의 가장자리를 안전하게 치유하는 홈 쪽으로 끌어당긴다.
이어서, 외과의는 삼각근과 피부 절개부를 폐쇄시켜 수술을 완료한다. 시간 경과 후, 신체는 주위 조직과 맞는 영역에 새로운 조직을 생성한다. 신체는 또한 이식 패치를 2 내지 4개월 내에 흡수한다.
실시예 8. 강화된 흡수성 다층 직물을 사용한 무릎 연골 복구
우선, 외과의는 관절경(의사로 하여금 무릎 관절을 볼 수 있도록 하는 작은 장치)을 통하여 무릎을 검사한다. 환부가 발견되면, 외과 시술을 수행한다.
마취제를 투여한 후, 무릎 수술을 준비하고, 미용적 절개를 무릎뼈의 상부 전방 코너 위로 피부를 통하여 실시한다. 우선, 손상된 연골을 제거한다. 이어서, 강화된 흡수성 다층 직물을 환부에 이식한다. 직물을 봉합사, 택 또는 다수의 임의 생체적합성 접착제와 함께 환부에 접착시킬 수 있다.
이어서, 외과의는 피부 절개부를 폐쇄하여 수술을 완료한다. 연골 세포를 이식 직물에 이동시키고 여기에서 증식시키고, 세포/직물 이식편을 주위의 연골과 통합한다. 시간이 지나면, 세포는 성숙하여 유리질 연골로 환부를 메울 것이다.
실시예는 본 발명의 특정 양태를 나타내지만, 이는 본 발명의 범위를 한정하려는 것이 아니라, 본 발명의 완전한 설명에 기여하기 위한 것이다. 상기 실시예에 기재된 모든 강화 직물은 상표명으로 언급된 상응하는 시판 제품의 비멸균 재료이다.

Claims (30)

  1. 제1 흡수성 부직포와 제2 흡수성 직물 또는 편물을 포함하는 다층 직물로서,
    상기 제1 흡수성 부직포는 글리콜라이드와 락타이드의 공중합체를, 70 내지 95몰% 범위의 글리콜라이드 및 잔여 락타이드의 양으로 포함하고,
    상기 제2 흡수성 직물 또는 편물은 산화된 재생 셀룰로스를 포함하고,
    상기 다층 직물은 1.00 내지 2.5 mm의 평균 두께를 갖는 것인 다층 직물.
  2. 삭제
  3. 삭제
  4. 삭제
  5. 삭제
  6. 삭제
  7. 제1항에 있어서, 상기 제2 흡수성 직물 또는 편물이 산화된 재생 셀룰로스를 포함하는 흡수성 편물인 다층 직물.
  8. 삭제
  9. 제1항에 있어서, 상기 제1 흡수성 부직포가, 길이가 0.75 내지 2.5in인 스테이플을 포함하는 다층 직물.
  10. 제9항에 있어서, 상기 스테이플이 권축된 다층 직물.
  11. 제1항에 있어서, 상기 제1 흡수성 부직포가, 길이가 1.5 내지 2in인 스테이플을 포함하는 다층 직물.
  12. 제11항에 있어서, 상기 스테이플이 권축된 다층 직물.
  13. 삭제
  14. 제11항에 있어서, 상기 스테이플이 필라멘트당 1 내지 4데니어의 섬유로부터 유래되는 다층 직물.
  15. 제14항에 있어서, 제1 흡수성 부직포의 평량이 0.01 내지 0.2g/in2이고, 제2 흡수성 직물 또는 편물의 평량이 0.001 내지 0.2g/in2인 다층 직물.
  16. 제1 흡수성 부직포, 제2 흡수성 직물 또는 편물, 및 항균제, 항미생물제, 성장 인자, 진통제 및 마취제로 이루어진 그룹으로부터 선택된 하나 이상의 제제를 포함하는 다층 직물로서,
    상기 제1 흡수성 부직포는 글리콜라이드와 락타이드의 공중합체를, 70 내지 95몰% 범위의 글리콜라이드 및 잔여 락타이드의 양으로 포함하고,
    상기 제2 흡수성 직물 또는 편물은 산화된 재생 셀룰로스를 포함하며,
    상기 다층 직물은 1.00 내지 2.5 mm의 평균 두께를 갖는 것인 다층 직물.
  17. 흡수성의 글리콜라이드/락타이드 공중합체 섬유(fibers) 또는 사(yarns)를 10 내지 30크림프/in의 범위로 권축시키는 단계(a),
    상기 권축된 섬유 또는 사를, 길이가 0.1 내지 2.5in인 스테이플로 절단하는 단계(b),
    상기 스테이플을 소면(carding)시켜 제1 흡수성 부직포를 형성하는 단계(c),
    상기 제1 흡수성 부직포를 제2 흡수성 직물 또는 편물에 부착시키는 단계(d) 및
    상기 단계(c)에 대한 환경의 습도를 60 내지 75℃의 실온에서 40 내지 60%로 조절하는 단계(e)를 포함하는, 제1항에 따르는 다층 직물의 제조방법.
  18. 삭제
  19. 삭제
  20. 삭제
  21. 삭제
  22. 삭제
  23. 제17항에 있어서, 상기 제2 흡수성 직물 또는 편물이 산화된 재생 셀룰로스를 포함하는 흡수성 편물인, 다층 직물의 제조방법.
  24. 삭제
  25. 제17항에 있어서, 상기 제1 흡수성 부직포가, 길이가 0.75 내지 2.5in인 스테이플을 포함하는, 다층 직물의 제조방법.
  26. 제25항에 있어서, 상기 제1 흡수성 부직포가, 길이가 1.5 내지 2in인 스테이플을 포함하는, 다층 직물의 제조방법.
  27. 삭제
  28. 제17항에 있어서, 상기 제1 흡수성 부직포가 니들펀칭(needlepunching)을 통하여 상기 제2 흡수성 직물 또는 편물에 부착되는, 다층 직물의 제조방법.
  29. 제28항에 있어서, 흡수성의 글리콜라이드/락타이드 공중합체 섬유가 필라멘트당 1 내지 4데니어의 범위인, 다층 직물의 제조방법.
  30. 제29항에 있어서, 제1 흡수성 부직포의 평량이 0.01 내지 0.2g/in2이고, 제2 흡수성 직물 또는 편물의 평량이 0.001 내지 0.2g/in2인, 다층 직물의 제조방법.
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