KR950007878A - 생물분해성 이식제 전구체 - Google Patents

생물분해성 이식제 전구체 Download PDF

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KR950007878A
KR950007878A KR1019940019893A KR19940019893A KR950007878A KR 950007878 A KR950007878 A KR 950007878A KR 1019940019893 A KR1019940019893 A KR 1019940019893A KR 19940019893 A KR19940019893 A KR 19940019893A KR 950007878 A KR950007878 A KR 950007878A
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South Korea
Prior art keywords
implant precursor
implant
precursor
polymer
polymer solution
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KR1019940019893A
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KR100248326B1 (ko
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에스. 피터손 케네디
엘. 둔 리차드
피. 콕스 찰스
엘. 노오톤 리차드
엠. 폴손 알랜
케이. 로우 브라이언
디. 스완봄 데랄
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엘. 둔 리차드
아트릭스 라보라토리스, 아이엔씨.
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Publication of KR950007878A publication Critical patent/KR950007878A/ko
Priority to KR1019990049028A priority Critical patent/KR100263443B1/ko
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Abstract

본 발명은 외부 주머니와 액체 내용물로 구성되는 두부분 구조물을 갖는 생물 분해성 이식제 전구체에 관한 것이다.
이식제 전구체는 생물분해성이며, 수응고성인 열가소성 중합체 및 물 혼화성 유기용매로 구성되어 있다.
동물에서 이식부위에 투여되면, 이식제 전구체는 주위 조직액으로 유기용매의 분산 및 중합체의 응고에 의하여 고체 미세다공성 매트릭스로 제위치에서 응고하게 된다.
또한 본 발명은 이식제 전구체를 제조하는 방법, 상기 전구체를 형성하는 장치 및 상기 장치를 갖는 키트를 포함한다.
또한 본 발명은 예컨대 세포성장 및 조직재생, 상처 및 기관회복, 신경재생, 연질 및 경질 조직 재생등을 증대시키기 위하여 동물에서 조직결함부를 치료하고, 조직 또는 기관에 생물활성제를 이송하고, 기타 이와 유사한 치료를 위하여 이식제 전구체를 사용하는 방법을 제공하여 준다.

Description

생물분해성 이식제 전구체
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
제1도는 본 발명의 전구체 형성장치의 일예의 사시도,
제2도는 일련의 스페이서의 배치를 보여주는 제1도의 전구체 형성장치의 사시도,
제3도는 스페이서 사이의 대역에 수성층과 중합체 용액층의 배치를 보여주는 제2도의 전구체 형성장치의 측면도,
제4도는 이식제 전구체의 형성중 페쇄위치에 전구체 형성장치를 보여주는 제3도의 전구체 형성장치의 측면도.

Claims (37)

  1. 외부 주머니와 액체 내용물로 이루어지는 두부분 구조물을 가지며, 생물화합성, 생물분해성, 수응고성의 열가소성 중랍체와 제약적으로 허용가능한 수용성 유기용매의 혼합물로 구성되는, 동물에서 조직결함부에 이식하기 위한 이식제 전구체.
  2. 제1항에 있어서, 이식제 전구체의 액체 내용물은 물의 형태로 부터 끈끈한 형태의 점성을 가지며, 외부 주머니는 젤라틴 형태로 부터 왁스 형태의 점성을 가짐을 특징으로 하는 이식제 전구체.
  3. 제1항에 있어서, 이식제 전구체는 형성되어 그후 수성매체와의 접촉이 없는 경우 약 30-90분 후에 완전 액채형태로 복귀될 수 있음을 특징으로 하는 이식제 전구체.
  4. 제1항에 있어서, 열가소성 중합체는 폴리락티드, 폴리글리콜라이드, 폴리카프로락톤, 폴리언하이드라이드, 폴리아미드, 폴리우레탄, 폴리에스테르아미드, 폴리오르로에스테르, 폴리디옥사논, 폴리아세탈, 폴리케탈, 폴리카보네이트, 폴리오르트카보네이트, 폴리포스파젠, 폴리하이드록시부티레이트, 폴리하이드록시발레레이트, 폴리알킬렌 옥살레이트, 폴리알킬렌 석시네이드, 폴리말린산, 폴리아미노산, 폴리메털 비닐에테르, 키틴, 키토산 및 공중합체, 테르폴리머 및 이들의 화합물로 구성되는 기로부터 선택됨을 특징으로 하는 이식제 진구체.
  5. 제1항에 있어서, 용매는 N-메틸-2-피롤리돈, 2-피롤리돈, 에탄올, 프로필렌 글리콜, 프로필렌 카보네이트, 아세톤, 아세트산, 에틸아세테이트, 에틸 락테이트, 메틸 아세테이트, 메틸에틸케톤, 디메틸포름아미드, 디메틸 설폭사이드, 디메틸 설폰, 테트라하이드로푸란, 카프로락탐, 데실메틸설폭사이드, 올레인산, N, N-디에틸-m-톨루아미드 및 1-도데실아자사이클로헵탄-2-온 및 이들의 화합물로 구성되는 기로부터 선택됨을 특징으로 하는 이식제 전구체.
  6. 제1항에 있어서, 설탕, 염, 수용성 중합체 및 수용성 물질로 신속히 분해되는 수불용성 물지로 구성되는 기로부터 선택되는 기공형성제를 또한 포함함을 특징으로 하는 이식제 전구체.
  7. 제1항에 있어서, 항균제, 항진균제 및 항바이러스제로 구성되는 기로부터 선택되는 생물활성제를 또한 포함함을 특징으로 하는 이식제 전구체.
  8. 제1항에 있어서, 소염제, 구충제, 항종양제, 진통제, 마취제, 왁찐, 중추신경계 약제, 성장인자, 흐르몬, 항히스타민, 뼈 형성 유도제, 심장혈관제, 항궤양제, 기관지 확장제, 혈관확장제, 산아조절제 및 임신촉진제로 구성되는 기로부터 선택되는 생물 활성제를 또한 포함함을 특징으로 하는 이식제 전구체.
  9. 제1항에 있어서, 생체내에서 이식제 매트릭스로 부터 생물활성제의 방출속도를 조절하기 위한 방출속도 조절제를 또한 포함함을 특징으로 하는 이식제 전구체.
  10. 제9항에 있어서, 방출속도 조절제는 모노카르복실산의 에스테르, 디카르복실산의 에스테르, 트리카르복실산의 에스테르, 폴리하이드록시 알콜, 지방산, 글리세롤의 트리에스테르, 스테롤, 알콜 및 이들의 화합물로 구성되는 기로부터 선택됨을 특징으로 하는 이식제 전구체.
  11. 제10항에 있어서, 방출속도 조절제는 2-에톡시에틸 아세테이트, 메딜아세테이트, 에틸아세테이트, 디메틸 프탈레이트, 디메틸 프탈레이트, 디부틸 프탈레이트, 디메틸 아디페이트, 디메틸 석시네이트, 디메틸 옥살레이트, 디메틸 시트레이트, 트리에틸 시트레이트, 아세틸 트리부틸 시트레이트, 아세틸 트리에딜 시트레이트, 글리셀롤 트리아세테이트, 디(n-부틸) 세버케이트, 프로필렌 글리콜, 폴리에틸렌 글리콜, 글리세린, 소르비톨, 트리글리세라이드, 에폭시화 콩기름, 콜레스테롤, C6-C12알칸올, 2-에톡시 에탄올 또는 이들의 화합물로 구성되는 기로부터 선택됨을 특징으로 하는 이식제 전구체.
  12. 제10항에 있어서, 방출속도 조절제는 디메틸 시트레이트, 트리에틸 시트레이트, 에틸 헵타노에이트, 글리세린, 헥산디올 및 이들의 화합물로 구성되는 기로부터 선택됨을 특징으로 하는 이식제 전구체.
  13. (a) 유효량의 수성매체를 고체 지지기질의 표면에 가하여 수성층을 형성하고; (b) 수응고성, 생물화합성, 생물분해성의 열가소성 중합체 및 물 혼화성이며 제약적으로 허용가능한 유기용매로 구성되는 유효량의 액체 중합체 용액을 수성층에 분배하고; (c) 유효량의 수성매체를 중합체 용액의 표면에 가하고; (d) 수성매체에 인접한중합체를 방치하여 응고시켜 외부 주머니와 액체 내용물로 이루어지는 두부분 구조물로 구성되는 이식제 전구체를 형성하되; 상기 단계 (a) 및 (c)에서 수성매체는 중합체의 표면을 응고시켜 이식제 전구체의 외부 주머니를 형성하기에 효과적인 양으로 가함을 특징으로 하는 이식제 전구체를 제조하는 방법.
  14. 제13항에 있어서, 약400-1500㎛의 두께로 이식제 전구체를 유지시키는 단계 (e)를 또한 포함함을 특징으로 하는 이식제 전구체를 제조하는 방법.
  15. 제13항에 있어서, 이식제 전구체의 두께는 단계 (d)중에 응고되는 중합체 용액을 압착시킴으로서 유지시킴을 특징으로 하는 이식제 전구체를 제조하는 방법.
  16. 제13항에 있어서, 이식제 전구체를 생체외에서 형성함을 특징으로 하는 이식제 전구체를 제조하는 방법.
  17. 제13항에 있어서, 지지기질은 유리, 다공성 플라스틱, 소결 스테인레스강, 자기, 뼈 재료, 뼈, 산화셀룰로오스 기포, 생물화합성 중합체 기포, 생물화합성 중합체의 입자, 트리칼슘 포스페이트 및 혈액물질로 구성됨을 특징으로 하는 이식제 전구체를 제조하는 방법.
  18. 제13항에 있어서, 이식제 전구체를 생체내에서 형성함을 특징으로 하는 이식제 전구체를 제조하는 방법.
  19. 제13항에 있어서, 지지기질은 경질조직임을 특징으로 하는 이식제 전구체를 제조하는 방법.
  20. 제19항에 있어서, 지지기질은 뼈 조직임을 특징으로 하는 이식제 전구체를 제조하는 방법.
  21. 제13항에 있어서, 단계 (a)전에, (i) 소량이지만 유효량의 수성매체를 지지 기질의 표면에 하나의 층으로 가하고; (ii) 생물화합성, 생물분해성, 수응고성의 열가소성 중합체 및 제약적으로 허용가능한 수용성 유기용매로 구성되는 유효량의 중합체 용액을 수성층에 분배하여 그 위에 대역을 한정하는 선을 형성하고; (iii) 유효량의 수성매체를 선의 표면에 가하고; (iv) 중합체를 방치하여 응고시켜 액채 내용물을 갖는 외부 주머니로 이루어지는 두부분 구조물로 구성되는 경계선을 형성하는 단계를 또한 포함하며; 이식제 전구체를 경계선에 의하여 한정된 대역내에서 지지기질에 형성함을 특징으로 하는 이식제 전구체를 제조하는 방법.
  22. 제13항에 있어서, 단계 (a)전에, 생물흡수성 또는 생물부식성 재료로 구성되는 지지층을 조직결합부의 표면에 적용되는 단계를 또한 포함하며; 이식제 전구체를 지지층의 표면에 형성함을 특징으로 하는 이식제 전구체를 제조하는 방법.
  23. 제22항에 있어서, 지지층은 조직결함부의 표면에 피복되는 생물화합성, 생물분해성, 수응고성의 열가소성중합체와 제약적으로 허용가능한 물 혼화성 유기 용매로 이루어지는 중합체 용액으로 구성됨을 특징으로 하는 이식제 전구체를 제조하는 방법.
  24. 제23항에 있어서, 가스형성제를 중합체 용액에 혼합하고, 지지층을 다공성 기포형 구조로 형성하는 것을 또한 포함함을 특징으로 하는 이식제 전구체를 제조하는 방법.
  25. 제22항에 있어서, 지지층은 선천적인 몸체 물질로 구성됨을 특징으로 하는 이식제 전구체를 제조하는 방법.
  26. 제22항에 있어서, 지지층은 응혈로 구성됨을 특징으로 하는 이식제 전구체를 제조하는 방법.
  27. 제22항에 있어서, 지지층은 산화 셀룰로오스 또는 젤라틴으로 구성됨을 특징으로 하는 이식제 전구체를 제조하는 방법.
  28. 제22항에 있어서, 지지층은 수용성 중합체로 구성됨을 특징으로 하는 이식제 전구체를 제조하는 방법.
  29. 제22항에 있어서, 지지층은 트리칼슘 포스페이트, 칼슘 설페이트 또는 하이드록시 아파다이트로 구성됨을 특징으로 하는 이식제 전구체를 제조하는 방법.
  30. 제28항에 있어서, 지지층은 폴리락티드, 폴리글리클라이드, 폴리카프로락톤, 폴리언하이드라이드, 폴리아미드, 폴리우레탄, 폴리에스테르아미드, 폴리오르토에스테르, 폴리디옥사논, 폴리아세탈, 폴리케탈, 폴리카보네이트, 폴리오르토카보네이트, 폴리포스파젠, 폴리하이드록시부티레이트, 폴리하이드록시발레레이트, 폴리알킬렌 옥살레이트, 폴리알킬렌 석시네이트, 폴리말린산, 폴리에틸렌 글리콜, 하이드록시프로필 셀룰로오스, 폴리비닐 피롤리돈, 폴리아미노산, 폴리메틸 비닐 에테르, 키틴, 키토산 및 공중합체, 테르폴리머 및 이들의 화합물로 구성됨을 특징으로 하는 이식제 전구체를 제조하는 방법.
  31. (a) 외부 주머니와 액체 내용물로 이루어지는 두부분 구조물을 가지며, 생물화합성, 생물분해성, 수응고성의 열가소성 중합체와 제약적으로 허용가능한 수용성 유기용매의 혼합물로 구성되는 이식제 전구체를 조직 결함부에 투여하고; (b) 조직 결함부를 치료하는 데 유효한 이식제 전구체를 방치하여 그 위치에서 응고시켜 고체 미세다공성 매트릭스로 구성되는 이식제가 형성되도록 구성시킨 동물에서 조직 결함부를 치료하는 방법.
  32. 제31항에 있어서, 이식제 전구체는 항세균제, 항진균제 및 항바이러스제로 구성되는 기로부터 선택되는 생물활성제를 또한 포함함을 특징으로 하는 조직 결함부를 치료하는 방법.
  33. 제32항에 있어서, 이식제 전구체는 소염제, 구충제, 항종양제, 진통제, 마취제, 왁찐, 중추신경계 약제, 성장인자, 호르몬, 항히스타민, 뼈 형성 유도제, 심장혈관제, 항궤양제, 기관지 확장제, 혈관 확장제, 산아조절제 및 임신촉진제로 구성되는 기로부터 선택되는 생물활성제를 또한 포함함을 특징으로 하는 조직결함부를 치료하는 방법.
  34. 제32항에 있어서, 이식제 전구체는 생체내에서 이식제 매트릭스로 부터 생물 활성제의 방출속도를 조절하기 위한 방출속도 조절제를 또한 포함함을 특징으로 하는 조직 결함부를 치료하는 방법.
  35. (a) 이식제 전구체의 형성중에 중합체 용액을 유지시키기 위한 지지수단; (b) 이식제 전구체의 형성중에 중합체 용액을 압착시키기 위한 수단; 및 (c) 지지수단을 압착수단에 힌지연결하기 위한 수단으로 구성시키되; 힌지연결 수단은 지지수단 및 압착수단중의 하나의 변부를 따라 위치되게 하고, 압착수단은 지지수단의 중합체용액으로 회전하여 위치될 수 있게 구성시켜서 된 이식제 전구체를 형성하는 장치.
  36. (a) (i) 이식제 전구체의 형성중에 중합체 용액을 유지시키기 위한 지지수단, (ii) 이식제 전구체의 형성중에 중합체 용액을 압착시키기 위한 수단 및 (iii) 지지수단을 압착수단에 힌지연결하기 위한 수단으로 구성시키되, 힌지연결수단은 지지수단 및 압착 수단중의 하나의 변부를 따라 위치되게 하고, 압착수단은 지지수단의 중합체용액으로 회전하여 위치될 수 있게 구성시켜서 된 생체외에서 이식제 전구체를 형성하는 장치; (b) 압착수단이 지지수단으로 회진되어 위치되면 지지수단과 압착수단 사이에 간격을 유지시키기 위한 최소한 하나의 스페이서수단; (c) 생물화합성, 생물분해성, 수응고성의 열가소성 중합체와 제약적으로 허용가능한 물 혼화성 유기용매로 구성되는 중합체 혼합물을 함유하는 바이알; 및 (d) 수성매체원을 함유하는 바이알로 구성되는 키트.
  37. 제36항에 있어서, (e) 형성된 이식제 전구체를 들어올려 유지시키기 위한 수단; (f) 조직결함부 또는 이식제 전구체의 치수를 측정하기 위한 수단; (g) 이식제 전구체의 치수를 측정하기 위한 격자수단; (h) 이식제 전구체를 절단하기 위한 수단; 또는 (i) 이식제 전구체의 표면으로 부터 수성매체를 제거하기 의한 수단중 하나 이상을 또한 포함함을 특징으로 하는 키트.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
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US6071530A (en) 2000-06-06
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EP1147781A1 (en) 2001-10-24
DK0649662T3 (da) 2002-05-13
SI0649662T1 (en) 2002-06-30
JP3451259B2 (ja) 2003-09-29
US6395293B2 (en) 2002-05-28
DE69433843T2 (de) 2005-06-23
DK1147781T3 (da) 2004-10-18
DE69433843D1 (de) 2004-07-15
ATE212866T1 (de) 2002-02-15
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US5487897A (en) 1996-01-30
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ATE268611T1 (de) 2004-06-15
ES2225364T3 (es) 2005-03-16
DE69429801D1 (de) 2002-03-21
EP1147781B1 (en) 2004-06-09
JP2003093498A (ja) 2003-04-02
EP0649662B1 (en) 2002-02-06
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PT649662E (pt) 2002-07-31
US20020001608A1 (en) 2002-01-03

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