KR20070095870A - 흡수성 지혈제 - Google Patents
흡수성 지혈제 Download PDFInfo
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- KR20070095870A KR20070095870A KR1020077010895A KR20077010895A KR20070095870A KR 20070095870 A KR20070095870 A KR 20070095870A KR 1020077010895 A KR1020077010895 A KR 1020077010895A KR 20077010895 A KR20077010895 A KR 20077010895A KR 20070095870 A KR20070095870 A KR 20070095870A
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- Prior art keywords
- cellulose
- foam
- agent according
- sulfate
- hemostatic agent
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Classifications
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Abstract
본 발명은 흡수성 발포체, 흡수성 직물 또는 편물, 트롬빈 및 피브리노겐을 포함하는 지혈제에 관한 것이다.
흡수성 발포체, 흡수성 직물, 편물, 트롬빈, 피브리노겐, 지혈제
Description
본원은 2004년 10월 20일에 출원된 미국 가특허원 제60/620,539호 및 2005년 7월 1일에 출원된 미국 가특허원 제60/696,258호로부터의 우선권을 주장한다.
발명의 분야
본 발명은 지혈제에 관한 것이다.
발명의 배경
공기 및 각종 체액의 봉쇄 뿐만 아니라 출혈의 억제는 혈액 손실을 최소화하고, 조직 및 기관 구조물을 봉쇄하며, 외과 수술후 합병증을 감소시키고, 수술실에서 수술 시간을 단축시키기 위해서는 외과 수술 과정에서 필수적이며 중요하다.
지혈 및 조직 봉쇄과 접착 특성이 향상된 트레싱을 제공하려는 노력으로, 트롬빈, 피브린 및 피브리노겐을 포함하지만, 이로써 제한되지 않는 치료제는 젤라틴계 캐리어, 폴리사카라이드계 캐리어, 글리콜산 또는 락트산계 캐리어 및 콜라겐 매트릭스를 포함하는 드레싱 캐리어 또는 기재와 배합되어 왔다. 이러한 드레싱의 예로는 미국 특허공보 제6,762,336호, 미국 특허공보 제6,733,774호 및 국제 공개공보 제WO 2004/064878 A1호에 기재되어 있다.
이의 생분해능 및 살균성, 조직 봉쇄, 조직 회복, 약물 전달 및 지혈 특성으로 인해, 이후로는 뇌수술, 복강 수술, 심혈관 수술, 흉부 수술, 머리 및 목 수술, 골반 수술, 및 피부 및 피하 조직 절차를 포함하는 각종 외과수술 절차에서 국소 드레싱과 같은 카복시-산화된 셀룰로즈라고 하는 특정한 카복시산 잔사로 산화되는 셀룰로즈를 사용하는 것이 바람직하다.
그러나, 카복시-산화된 셀룰로즈가 트롬빈과 피브리노겐과의 배합에 사용되는 경우, 셀룰로즈 속에 존재할 수 있는 산성 잔사는 트롬빈 및 피브리노겐의 활성을 변성시킨다. 따라서, 이의 지혈 활성을 유지하기 위해, 이러한 산성 잔사로부터 트롬빈 및 피브리노겐을 차폐하는 것이 바람직하다.
발명의 요약
본 발명은 흡수성 발포체, 흡수성 직물 또는 편물, 트롬빈 및 피브리노겐을 포함하는 지혈제에 관한 것이다.
발명의 상세한 설명
본원에 기재되는 지혈제는 지혈작용을 요하는 상처에 도포되는 경우 효과적인 지혈작용을 제공하고 유지한다. 본원에서 사용되는 효과적인 지혈작용은 지혈작용 분야의 숙련가에게 인식되는 바와 같이 유효한 시간내에 모세관, 정맥 또는 소동맥 출혈을 억제 및/또는 완화하는 능력이다. 효과적인 지혈작용의 추가의 예시는 정부 조절기 표준 등에 의해 제공할 수 있다.
특정 양태에서, 본 발명의 지혈제는 심각하거나 거품나는 출혈의 경우, 지혈작용을 제공 및 유지하는 데 효과적이다. 본원에서 사용되는 바와 같이, 본원에서 사용되는 바와 같이, 심각한 출혈은 비교적 고용적의 혈액이 비교적 높은 비율로 손실되는 경우 출혈하는 이러한 경우를 포함함을 의미한다. 심각한 출혈의 예로는 동맥 천자, 간 절제, 둔기 간 외상, 둔기 비장 외상, 대동맥 동맥류로 인한 출혈, 과도한 항응고를 앓고 있는 환자로부터의 출혈, 또는 혈우병과 같은 응고병증을 앓고 있는 환자로부터의 출혈을 포함하지만, 이로써 제한되지는 않는다.
지혈제는 일반적으로 흡수성 발포체 및 보강 직물을 포함한다. 보강 직물은 발포체가 직접적으로 또는 간접적으로 부착될 수 있는 지지재를 제공하며, 트롬빈 및 피브리노겐은 발포체 전체에 걸쳐서 실질적으로 균질하게 분산되고/되거나 발포체 표면에 배치된다. 보강 직물은 사용자가 상처 위 또는 내부에, 또는 지혈작용, 또는 조직 봉쇄 및 접착을 요하는 환자의 조직에 직접 지혈제를 위치시키고 조작하도록 허용하기 위해 지혈제에 대한 충분한 강도를 제공한다.
트롬빈 및 피브리노겐에 대한 캐리어로서 사용하는 외에도, 발포체는 또한 카복시-산화된 셀룰로즈가 보강 직물로서 사용되는 경우와 같은 보강 직물 속에 존재할 수 있는 산성 잔사로부터 트롬빈 및 피브리노겐을 차폐하는 데 사용한다.
발포체는 생체 친화성, 수용성 또는 수팽윤성 중합체 및 발포제/계면활성제일 수 있다. 발포체를 제조하는 데 사용되는 바람직한 생체 친화성, 수용성 또는 수팽윤성 중합체는 폴리사카라이드를 포함한다. 이러한 폴리사카라이드는 셀룰로즈, 알킬 셀룰로즈, 예를 들면, 메틸셀룰로즈, 알킬하이드록시알킬 셀룰로즈, 하이 드록시알킬 셀룰로즈, 셀룰로즈 설페이트, 카복시메틸 셀룰로즈 염, 카복시메틸 셀룰로즈 및 카복시에틸 셀룰로즈를 포함하지만, 이로써 제한되지는 않는다. 추가로, 알부민, 키틴, 카복시메틸 키틴, 히알루론산, 히알루론산 염, 알기네이트, 알긴산, 프로필렌 글리콜 알기네이트, 글리코겐, 덱스트란, 덱스트란 설페이트, 쿠르들란, 펙틴, 풀룰란, 크산탄, 콘드로이틴, 설콘드로이틴페이트 카복시메틸 덱스트란, 카복시메틸 헤파토산, 헤파린, 헤파린 설페이트, 헤파란, 헤파란 설페이트, 더마탄 설페이트, 케라탄 설페이트, 카라기난, 키토산, 전분, 아밀로즈, 아밀로펙틴, 폴리-N-글루코사민, 폴리만누론산, 폴리글루쿠론산 폴리걸루론산 및 상기한 것 중의 어느 하나의 유도체가 사용될 수 있다. 훨씬 보다 바람직하게는, 생체 친화성, 수용성 또는 수팽윤성 중합체는 카복시메틸 셀룰로즈, 가장 바람직하게는 나트륨 카복시메틸 셀룰로즈(CMC-Na)의 알칼리 또는 알칼리 토금속 염이다.
발포제/계면활성제는 양이온성, 음이온성, 양쪽성, 쯔비터이온성 또는 비이온성 계면활성제, 또는 알부민, 나트륨 라우릴 설페이트, 나트륨 라우레쓰 설페이트, 또는 암모니아 라우릴 설페이트를 포함하지만, 이로써 제한되지는 않는 천연 또는 개질된 단백질일 수 있다. 바람직한 발포제/계면활성제는 알부민, 보다 바람직하게는, 사람 혈청 알부민(HSA)이다.
보강 직물은 흡수성 직물 또는 편물이며 산화된 폴리사카라이드, 특히 산화된 셀룰로즈 및 이의 중화된 유도체를 포함한다. 예를 들면, 셀룰로즈는 카복시-산화된 또는 알데히드-산화된 셀룰로즈일 수 있다. 보다 바람직하게는, 산화된 재생 셀룰로즈를 포함하지만, 이로써 제한되지는 않는 산화된 재생 폴리사카라이드는 제2 흡수성 직물 또는 편물을 제조하는 데 사용할 수 있다. 재생되지 않는 셀룰로즈에 대한 고도의 균질성으로 인해, 재생 셀룰로즈가 바람직하다. 재생 셀룰로즈 및 산화된 재생 셀룰로즈를 제조하는 방법에 대한 상세한 설명은 본원에 전문이 참고로 인용되어 있는 미국 특허공보 제3,364,200호, 미국 특허공보 제5,180,398호 및 미국 특허공보 제4,626,253호에 기재되어 있다.
보강 직물로서 사용할 수 있는 직물의 예는 인터씨드(Interceed)R 흡수성 접착 장벽, 써지셀(Surgicel)R 흡수성 지혈제, 써지셀 Nu-KnitR 흡수성 지혈제 및 써지셀R 피브릴러(Fibrillar) 흡수성 지혈제[각각 미국 뉴 저지주 섬머빌에 소재하는 에디컨인코포레이티드(Ethicon, Inc.)의 부서인 존슨 앤드 존슨 운드 매니지먼트 월드와이드(Johnson & Johnson Wound Management Worldwide) 또는 진케어 월드와이드(Gynecare Worldwide)가 시판한다]를 포함하지만, 이로써 제한되지는 안는다.
본 발명에서 사용되는 보강 직물은 직물이 복잡한 용도에서 사용하기에 필수적인 물리적인 특성을 갖는 한, 직조되거나 편직될 수 있다. 이러한 직물은, 예를 들면, 전문이 본원에 참고로 인용되어 있는 미국 특허공보 제4,626,253호, 미국 특허공보 제5,002,551호 및 미국 특허공보 제5,007,916호에 기재되어 있다. 바람직한 양태에 있어서, 보강 직물은 후속적으로 산화되어 카복시 또는 알데히드 잔사를 직물에 생분해능을 제공하기에 유효한 양으로 포함하는 밝은 레이온 사로 구성되는 트리코트 경편물이다.
또 다른 양태에 있어서, 보강 직물은 지방족 폴리에스테르 중합체, 공중합체 또는 이들의 블렌드로 구성되는 섬유와 배합되는 산화된 폴리사카라이드 섬유를 포함한다.
보강 직물은 바람직하게는 산화된 재생 셀룰로즈를 포함하며, 근량 범위가 약 0.001 내지 0.2g/in2, 바람직하게는 약 0.01 내지 0.1g/in2, 가장 바람직하게는 약 0.04 내지 0.07g/in2일 수 있다.
지혈제의 제조시, 발포체 슬러리는, 예를 들면, CMC-Na 및 HSA로부터 제조할 수 있으며, 이때 표면, 예를 들면, 산화된 재생 셀룰로즈 직물 위에 전개시킨다. 발포제에 대한 수용성 또는 수팽윤성 중합체의 중량비 범위는 약 1:8 내지 8:1, 바람직하게는 약 2:1 내지 1:2이다. 발포체 슬러리는 동결건조에 의해 건조시키거나 승온에서 오븐 속에서 건조시켜 고형물 발포체 기재를 형성한다. 발포체 기재는 증가된 강도에 대해 글루타르알데히드와 같은 화학적 가교결합제로 처리하거나, 가열하여 부분적으로 가교결합될 수 있다. 지혈제의 밀도는 약 5 내지 20mg/cm3일 수 있다.
트롬빈 및 피브리노겐은 동물, 바람직하게는 사람으로부터 유래할 수 있거나, 재조합될 수 있다. 지혈제에 대한 트롬빈 활성 범위는 약 20 내지 500IU/cm2, 바람직하게는 약 20 내지 200IU/cm2, 가장 바람직하게는 약 50 내지 200IU/cm2일 수 있다. 지혈제에 대한 피브리노겐 활성 범위는 약 2 내지 15mg/cm2, 바람직하게는 약 3 내지 10mg/cm2, 가장 바람직하게는 약 4 내지 7mg/cm2일 수 있다.
트롬빈 분말은 트롬빈 용액을 동결건조시켜 제조할 수 있다. 피브리노겐은 미국 특허공보 제6,121,232호 및 국제 공개공보 제WO 02/095019호에 기재되어 있는 바와 같은 피브리노겐을 함유하는 용액을 동결건조시켜 제조할 수 있다. PF5060 또는 HFE 7000-7300 시리즈와 같은 유기 용매 속에 현탁되는 피브리노겐 및 트롬빈의 무수 분말은 발포체의 표면면에 분무된다. 대안으로, 트롬빈 및 피브리노겐은 발포체 제조 동안에 발포체 속으로 혼입할 수 있다.
또 다른 양태에 있어서, 지혈제는 제1 치료제, 예를 들면, 피브리노겐 위로 또는 속으로 혼입되는 제1 발포체, 및 제2 치료제, 예를 들면, 트롬빈 분말 위에 존재하거나 트롬빈 분말 속으로 혼입될 수 있는 당해 제1 발포체로부터 분리된 (접착되지 않은) 제2 발포체를 포함할 수 있다. 대안으로, 지혈제는 여기에 인접해 있는 제1 발포체 및 당해 제1 발포체의 다른 면에 위치한 제2 발포체를 갖는 보강 직물을 포함할 수 있다. 트롬빈 또는 피브리노겐이 제1 발포체 속으로 혼입될 수 있으나, 피브리노겐이 바람직하다. 트롬빈 또는 피브리노겐이 제2 발포체와 혼입될 수 있으나, 트롬빈이 바람직하다. 이러한 양태에 있어서, 제1 발포체와 제2 발포체를 제조하는 데 사용되는 발포체 슬러리는 제2 발포체가 제1 발포체보다 덜 조밀하므로, 상처 부위에서 혈액과 접촉한 후 신속하게 액화되거나 용해되어 응고 공정을 개시하도록 선택된다. 제2 발포체는 먼저 출혈 부위와 접촉한 다음, 결합된 보강 층과 제1 발포체는 응고물이 혈액 유동에 의해 세척되게 한다.
지혈제는 임의로 프로코굴런트 효소, 단백질 및 펩티드를 포함할 수 있으나, 이로써 제한되지는 않으며, 천연, 재조합, 또는 합성될 수 있으며, 프로트롬빈, 피브린, 피브로넥틴, 헤파리나제, 팩터(Factor) X/Xa, 팩터 VII/VIIa, 팩터 IX/IXa, 팩터 XI/XIa, 팩터 XII/XIIa, 조직 팩터, 바트록소빈, 앤크로드, 에스카린, 폰 윌브랜드(von Willebrand) 팩터, 콜라겐, 엘라스틴, 알부민, 젤라틴, 혈소판 표면 글리코단백질, 바소프레신 및 바소프레신 동족체, 에피네프린, 셀렉틴, 프로코굴런트 독, 플라스미노겐 활성제 억제제, 혈소판 활성화제, 지혈 활성을 갖는 합성 펩티드, 상기의 및 임의의 이들의 조합물의 유도체로 이루어진 그룹으로부터 선택될 수 있다.
본원에 기재되는 지혈제는 또한 가스, 액체 또는 고형물의 누출을 잠재적인 봉쇄할 뿐만 아니라 지혈작용을 제공하기 위해 일차적인 상처 폐포 장치, 예를 들면, 동맥 폐포 장치, 스테이플, 및 봉합물에 대한 부가물로서 사용할 수 있다. 예를 들면, 지혈제는 조직으로부터 공기를 봉쇄하거나, 기관 및 조직으로부터 담즙, 림프, 뇌척수액, 위장액, 사이질액 및 소변을 포함하지만, 이로써 제한되지 않는 유체를 봉쇄하는 데 사용할 수 있다.
본원에 기재되는 지혈제는 추가의 의료 용도를 가질 수 있으며, 즉 위장 또는 혈관 문합을 위한 조직 보강 및 버트리싱(buttressing), 즉 수행하기 어려운(즉, 인장하에) 문합 및 인장 방출을 연결하기 위한 접근운동을 포함하지만, 이로써 제한되지 않는 각종 임상적 기능에 사용될 수 있다. 지혈제는 추가로 촉진시킬 수 있으며 가능하게는 상기의 모든 경우에 천연 조직 치유 과정을 강화시킬 수 있다. 이러한 지혈제는 심혈관, 말초-혈관, 심장-흉부, 부인과학, 신경- 및 일반적 인 수술을 포함하지만, 이로써 제한되지 않는 다수의 수술 유형에 내부에사용할 수 있다. 지혈제는 또한 의료 장치(예를 들면, 메시, 클립 및 막)를 조직에, 조직을 조직에, 또는 의료 장치를 의료 장치에 접착시키는 데 사용할 수 있다.
실시예 1. ORC 직물을 갖는 동결건조된 CMC-Na/HSA 발포체
혼합 보울에 2% 나트륨 카복시 메틸셀룰로즈(CMC-Na)[아쿠알론(aqualon), 카다록 번호: 7M8SFPH] 용액 190㎖ 및 사람 혈청 알부민(HSA)[알부틴(ALBUTEIN)TM 알파 테라퓨틱 코포레이션(Alpha Therapeutic Corporation)] 20% 용액 10㎖를 가한다. 혼합물을 기계적으로 휘핑하여 발포된 슬러리를 생성한다. 발포된 슬러리를 기저부에 배치되어 있는 상표명 인터시드(Interceed)R하에 에디컨인코포레이티드가 시판하는 편직된 카복시-산화된 재생 셀룰로즈 직물 한 조각을 갖는 장방형 프레임으로 옮긴다. 이어서, 발포된 슬러리를 전체 프레임을 따라 편평하게 전개시켜 약 3mm의 두께를 수득한다. 이어서, 발포된 슬러리를 동결건조시켜 용매를 건조시킴으로써 ORC 직물에 접착된 인접한 고형물 CMC-Na/HSA 발포체를 수득한다.
실시예 2. ORC 직물을 갖는 가열-처리된 CMC-Na/ HSA 발포체
혼합 보울에 2% 나트륨 카복시 메틸셀룰로즈(CMC-Na)(아쿠알론, 카다록 번호 7M8SFPH) 용액 190㎖ 및 20% 사람 혈청 알부민(HSA)(ALBUTEINTM, 알파 테라퓨틱 코포레이션) 10㎖를 가한다. 혼합물을 기계적으로 휘핑시켜 발포된 슬러리를 생성한 다. 발포된 슬러리를 기저부에서 상표명 인터씨드R하에 에디컨인코포레이티드가 시판하는 카복시-산화된 재생 셀룰로즈 직물 한 조각을 갖는 장방형 프레임으로 옮긴다. 이어서, 발포된 슬러리를 전체 프레임을 따라 편평하게 전개시켜 약 3mm의 두께를 수득한다. 이어서, 발포된 슬러리를 65℃의 오븐에서 1 시간 동안 가열하여 용매를 제거함으로써 ORC 직물에 덥착된 인접한 고형물 CMC-Na/HSA 발포체를 수득한다.
실시예 3. 활성 응고 팩터를 갖는 보강된 발포체
지혈제를 아래와 같이 실시예 1 및 실시예 2에서 제조한 구조물에 도포시킨다. 이 구조물을 3" × 4" 조각로 절단한다. 피브리노겐을 함유하는 생물학적 활성 성분 2(BAC-2) 및 동결건조된 트롬빈을 별도로 분말로 분쇄시킨다. 45㎛ 체를 통해 트롬빈 분말과 BAC-2 분말을 통과시킨다. 최종 피브리노겐 농도 6mg/cm2, 7mg/cm2 또는 8mg/cm2 및 트롬빈 활성 50IU/cm2를 제공하기 위해 두 가지 분말을 칭량한다. 이어서, 분말을 플라스크에서 과불화 용매 HFE 7000 속에서 혼합하고 현탁시킨다. 당해 현탁액을 각종 구조물에 분무시킨 다음, 실온에서 1시간 동안 질소하에 건조시킨다.
실시예 4. 돼지 비장 직선형 절개 모델에서의 지혈작용 시험
돼지 비장에 직선형 절개(1.5cm 길이 및 0.3cm 깊이)를 한다. 상처를 0.9% 식염수 용액으로 분무한 후, 실시예 3으로부터의 각종 시험 재료를 상처에 도포시킨다. 탐포네이트를 30초 동안 도포시킨 다음, 30초 동안 관찰한다. 지혈작용이 달성되지 않는 경우, 추가의 탐포네이트를 도포시켜 출혈을 멈추게 한다. 한 조각의 수술 거즈 및 통상의 제조 타코콤브(Tachocomb)R 수술 패치[통상 니콤드 파르마 게엠베하(Nycomed Pharma GmbH)가 시판한다]를 대조군으로 사용한다. 표 1은 시험 결과를 열거한다.
시험 재료 | 탐포네이트의 평균 수 | 지혈작용에 대한 평균 시간 (분/초) |
수술용 거즈 | 21 | >12:00 |
CMC-Na/HSA 동결건조된 발포체/인터시드R 직물 지지재 피브리노겐 6mg/cm2, 트롬빈 50IU/cm2 | 4 | 2:33 |
CMC-Na/HSA 동결건조된 발포체/인터시드R 직물 지지재 피브리노겐 8mg/cm2, 트롬빈 50IU/cm2 | 3 | 2:13 |
CMC-Na/HSA 열처리된 발포체/인터시드R 직물 지지재 피브리노겐 7mg/cm2, 트롬빈 50IU/cm2 | 2 | 1:03 |
탐포콤브R 수술용 패치(피브리노겐 5.5mg/cm2, 트롬빈 2.0IU/cm2) | 7 | 5:55 |
실시예 5. 트롬빈을 사용하는 CMC-Na/HSA 발포체
혼합 보울에 2% 나트륨 카복시 메틸셀룰로즈(CMC-Na)(아쿠알론, 카다록 번호 7M8SFPH) 용액 190㎖ 및 20% 사람 혈청 알부민(HSA) (ALBUTEINTM, 알파 테라퓨틱 코포레이션) 용액 10㎖를 가한다. 혼합물을 기계적으로 휘핑하여 발포된 슬러리를 생성한다. 한 조각의 발포된 슬러리를 유리 비이커에 옮긴다. 트롬빈 분말을 발포된 슬러리에 서서히 섞어 넣어서 예상 활성 1,000IU/cm3을 수득한다. 최종 혼합물을 높이가 0.5cm인 알루미늄 칭량 접시에 동결건조시켜 여기에 분산되어 있는 트롬빈을 포함하는 고형물 발포체를 형성한다.
실시예 6. 피브리노겐을 사용하는 CMC-Na/HSA 발포체
혼합 보울에 2% 나트륨 카복시 메틸셀룰로즈(CMC-Na)(아쿠알론, 카다록 번호 7M8SFPH) 190㎖ 및 20% 사람 혈청 알부민(HSA)(ALBUTEINTM 알파 테라퓨틱 코포레이션) 10㎖를 가한다. 혼합물을 기계적으로 휘핑하여 발포된 슬러리를 생성한다. 한 조각의 발포된 슬러리를 유리 비이커에 옮긴다. 피브리노겐 분말 5g을 발포체에 서서히 섞어서 넣는다. 최종 혼합물을 기저부에서 ORC 직물 한 조각을 갖는 높이가 0.5cm인 알루미늄 칭량 접시에 위치시킨다. 이어서, 발포된 슬러리를 동결건조시켜 여기에 분산되어 있는 피브리노겐을 포함하는 고형물 발포체를 형성한다.
실시예 7. CMC-Na/HSA/트롬빈 발포체 및 CMC-Na/HSA/피브리노겐. 발포체를 사용한 지혈작용 시험
돼지 간에 심각한 출혈 상처를 낸다. 외과용 스캘펠로 삼각형 절단물을 제조함으로써 결점을 만들어낸다. 각각의 측면은 약 1in로 측정되고 깊이는 5mm로 측정된다. 삼각형 간 조직을 제거한 후, CMC-Na/HSA/트롬빈 발포체(I" × 1")를 상처에 신속하게 도포시킨다. 이어서, 한 조각의 CMC-Na/HSA/피브리노겐 발포체를 트롬빈 발포체의 상부에 도포시킨 다음, 손으로 압착시킨다. 지혈작용은 2분내에 달성한다.
Claims (10)
- 흡수성 발포체, 흡수성 직물 또는 편물, 트롬빈 및 피브리노겐을 포함하는 지혈제.
- 제1항에 있어서, 발포체가 폴리사카라이드, 알부민, 키틴, 카복시메틸 키틴, 히알루론산, 히알루론산 염, 알기네이트, 알긴산, 프로필렌 글리콜 알기네이트, 글리코겐, 덱스트란, 덱스트란 설페이트, 쿠르들란, 펙틴, 풀룰란, 크산탄, 콘드로이틴, 콘드로이틴 설페이트, 카복시메틸 덱스트란, 카복시메틸 키토산, 키토산, 헤파린, 헤파린 설페이트, 헤파란, 헤파란 설페이트, 더마탄 설페이트, 케라탄 설페이트, 카라기난, 키토산, 전분, 아밀로즈, 아밀로펙틴, 폴리-N-글루코사민, 폴리만누론 산, 폴리글루쿠론산, 폴리걸루론산 및 임의의 상기 유도체로 이루어진 그룹으로부터 선택된 하나 이상의 중합체를 포함하는 지혈제.
- 제2항에 있어서, 발포체가 메틸셀룰로즈, 알킬하이드록시알킬 셀룰로즈, 하이드록시알킬 셀룰로즈, 셀룰로즈 설페이트, 카복시메틸 셀룰로즈 염, 카복시메틸 셀룰로즈 및 카복시에틸 셀룰로즈로 이루어진 그룹으로부터 선택된 폴리사카라이드를 포함하는 지혈제.
- 제3항에 있어서, 흡수성 직물 또는 편물이 산화된 폴리사카라이드를 포함하 는 지혈제.
- 제4항에 있어서, 흡수성 직물 또는 편물이 산화된 셀룰로즈를 포함하는 지혈제.
- 제5항에 있어서, 흡수성 직물 또는 편물이 산화된 재생 셀룰로즈를 포함하는 지혈제.
- 제5항에 있어서, 흡수성 직물 또는 편물이 산화된 재생 셀룰로즈를 포함하는 흡수성 편물인 지혈제.
- 제1항에 있어서, 발포체가 카복시메틸 셀룰로즈 및 알부민을 포함하고, 흡수성 직물 또는 편물이 산화된 재생 셀룰로즈를 포함하고, 트롬빈 및 피브리노겐이 발포체로 혼입되거나 분무되는 지혈제.
- 제8항에 있어서, 알부민에 대한 카복시메틸 셀룰로즈의 중량비 범위가 약 1:8 내지 8:1인 지혈제.
- 제8항에 있어서, 트롬빈 활성 범위가 약 20 내지 500IU/cm2이고, 피브리노겐 활성 범위가 약 2 내지 15mg/cm2인 지혈제.
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