KR20210054012A - 제어된 배향을 갖는 중합체 튜브 - Google Patents
제어된 배향을 갖는 중합체 튜브 Download PDFInfo
- Publication number
- KR20210054012A KR20210054012A KR1020217012597A KR20217012597A KR20210054012A KR 20210054012 A KR20210054012 A KR 20210054012A KR 1020217012597 A KR1020217012597 A KR 1020217012597A KR 20217012597 A KR20217012597 A KR 20217012597A KR 20210054012 A KR20210054012 A KR 20210054012A
- Authority
- KR
- South Korea
- Prior art keywords
- tube
- polymeric material
- polymer
- stretched
- poly
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
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Images
Classifications
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Abstract
Description
도 1은 단층의 배향된 중합체 튜브의 제조를 위한 전형적인 압출/팽창 방법의 배경기술 (종래 기술) 개략도이고;
도 2는 평면 배향 및 환형 위치설정을 통해 배향된 중합체 튜브의 제조를 위한 본원에 개시된 방법의 개략도이고;
도 3a-3c는 중합체 필름을 랩핑하여 중합체 튜브를 형성하는 상이한 기술들에 대한 개략적 도해이고;
도 4a 및 4b는 인접한 중합체 필름들을 정렬하여 중합체 튜브를 형성하는 방법에 대한 개략적 도해이고;
도 5a 및 5b는 다층 환형 배향 및 환형 위치설정을 통해 배향된 중합체 튜브의 제조를 위한 본원에 개시된 특정 방법에 대한 개략도이고;
도 6a, 6b 및 6c는 대조군 튜브와 비교한 실시예 3 및 실시예 4의 튜브에 대한 사이클릭 압축 시험(cyclic compression test)으로부터의 최대 응력, 정규화된 에너지 및 X-절편(intercept)을 나타내고;
도 7a, 7b 및 7c는 예 1, 3, 5 및 7의 튜브에 대한 사이클릭 압축 시험으로부터의 최대 응력, 정규화된 에너지 및 X-절편을 나타내고;
도 8a, 8b 및 8c는 예 2, 4, 6 및 8의 튜브에 대한 사이클릭 압축 시험으로부터의 최대 응력, 정규화된 에너지 및 X-절편을 나타낸다.
Claims (34)
- 튜브의 제조 방법이며,
적어도 부분적인 분자 배향을 나타내는 적어도 1종의 신장된 중합체 재료를 수득하는 단계로서, 여기서,
적어도 1종의 신장된 중합체 재료를 수득하는 단계는 적어도 1종의 중합체 재료를 신장시키는 단계를 포함하고,
적어도 1종의 중합체 재료는 제1 치수, 및 적어도 1종의 결정화가능한 생분해성 중합체 재료를 포함하고,
적어도 1종의 중합체 재료는 제1 치수를 증가시키는 방식으로 신장되는, 단계; 및
적어도 1종의 신장된 중합체 재료를 사용하여 튜브를 형성하는 단계
를 포함하는, 방법. - 제1항에 있어서, 신장은 평면(planar) 신장을 포함하는, 방법.
- 제1항에 있어서, 적어도 1종의 중합체 재료 중 1종 이상이 중합체 필름, 중합체 모노필라멘트, 중합체 테이프 및 중합체 막대 중 1종 이상인, 방법.
- 제1항에 있어서,
적어도 1종의 중합체 재료가 제2 치수를 갖고,
적어도 1종의 중합체 재료를 신장시키는 단계는 제2 치수가 증가하도록 적어도 1종의 중합체 재료를 신장시키는 단계를 포함하고,
적어도 1종의 신장된 중합체 재료는 2축 신장된 중합체 재료를 포함하는, 방법. - 제1항에 있어서, 형성하는 단계는 적어도 1종의 신장된 중합체 재료 및 적어도 1종의 접착성 중합체 재료를 사용하는 단계를 포함하는, 방법.
- 제1항에 있어서,
적어도 1종의 접착성 중합체 재료와 적어도 1종의 결정화가능한 생분해성 중합체 재료를 조합하는 것에 적어도 부분적으로 기반하여 적어도 1종의 중합체 재료를 수득하는 단계를 추가로 포함하는, 방법. - 제6항에 있어서, 적어도 1종의 중합체 재료가, 적어도 1종의 결정화가능한 생분해성 중합체 재료 및 적어도 1종의 접착성 중합체 재료를 층상 형태로 포함하는 복합 중합체 재료인, 방법.
- 제6항에 있어서, 적어도 1종의 접착성 중합체 재료 및 적어도 1종의 결정화가능한 생분해성 중합체 재료는 적어도 1종의 중합체 재료가 신장되기 전에 또는 그 동안에 또는 그 후에 조합되는, 방법.
- 제1항에 있어서, 튜브를 형성하는 단계는, 적어도 1종의 신장된 중합체 재료 및 적어도 1종의 접착성 중합체 재료를 지지체 주위로 랩핑하는 단계를 포함하는, 방법.
- 제9항에 있어서, 지지체가 원통형 형상, 둥근 형상, 직사각형 형상, 삼각형 형상, 타원형 형상, 다각형 형상, 및 튜브 형태 중 1종 이상을 갖는, 방법.
- 제9항에 있어서, 랩핑하는 단계는, 튜브가 다수 층의 적어도 1종의 신장된 중합체 재료 및 다수 층의 적어도 1종의 접착성 중합체 재료를 포함하도록, 적어도 1종의 신장된 중합체 재료 및 적어도 1종의 접착성 중합체 재료를 지지체 주위로 다수 회 랩핑하는 단계를 포함하는, 방법.
- 제9항에 있어서,
적어도 1종의 신장된 중합체 재료가 복수의 유닛의 신장된 중합체 재료를 포함하고,
복수의 유닛의 신장된 중합체 재료는 상이한 중합체 재료 또는 동일한 중합체 재료를 포함하며;
튜브를 형성하는 단계는, 복수의 유닛의 신장된 중합체 재료를 스택킹 방식 및 스태거링 방식 중 적어도 1종으로 배열하는 단계, 및 배열된 복수의 유닛의 신장된 중합체 재료를 바이어스 각도로 랩핑하는 단계를 포함하는, 방법. - 제9항에 있어서, 지지체가 맨드릴이고, 상기 방법은 맨드릴로부터 튜브를 제거하는 단계를 추가로 포함하는, 방법.
- 제9항에 있어서, 지지체는 디바이스를 포함하는, 방법.
- 제14항에 있어서, 튜브 및 지지체에 적어도 부분적으로 기반하는 결과적인 복합체를 형성하는 단계를 추가로 포함하며, 결과적인 복합체는 의료용 디바이스인, 방법.
- 제1항에 있어서, 튜브에 적어도 부분적으로 기반하는 의료용 디바이스를 형성하는 단계를 추가로 포함하는, 방법.
- 제16항에 있어서, 의료용 디바이스를 형성하는 단계는 튜브를 스텐트(stent)로 절단하는 단계를 포함하는, 방법.
- 제17항에 있어서, 스텐트에 치료제, 피복물 및 코팅 중 1종 이상을 적용하는 단계를 추가로 포함하는, 방법.
- 제1항에 있어서, 튜브를 형성하는 단계는, 적어도 1종의 신장된 중합체 재료에 열 및 압력 중 적어도 1종을 가하는 단계를 포함하는, 방법.
- 제1항에 있어서, 튜브를 형성하는 단계는
층상 구조물을 형성하는 단계로서, 층상 구조물을 제공하기 위해 적어도 1종의 신장된 중합체 재료의 적어도 일부 주위로 수축 튜브 또는 수축 필름을 적용하는 단계를 포함하는, 층상 구조물을 형성하는 단계, 및
층상 구조물에 열 및 압력 중 적어도 1종을 가하는 단계
를 포함하는, 방법. - 제1항에 있어서, 튜브를 형성하는 단계는,
적어도 1종의 신장된 중합체 재료의 적어도 일부를 금형에 삽입하는 단계;
적어도 1종의 신장된 중합체 재료를 팽창성 지지체 위에 위치설정하는 단계; 및
적어도 1종의 신장된 중합체 재료에 열 및 압력 중 적어도 1종을 가하는 단계
를 포함하는, 방법. - 제1항에 있어서, 적어도 1종의 결정화가능한 생분해성 중합체 재료 중 1종 이상이 폴리(L-락티드) (PLLA), 폴리(D-락티드) (PDLA), 폴리(ε-카프로락톤) (PCL), 폴리글리콜산 (PGA), 폴리(파라-디옥사논) (PDO), 폴리(히드록시부티레이트), 폴리(히드록시발레레이트), 폴리(테트라메틸 카르보네이트), 폴리(에틸렌 옥시드) (PEO), 폴리(에틸렌 글리콜) (PEG), 폴리(프로필렌 글리콜) (PPG), 및 이들의 공중합체 및 유도체 및 조합물로 이루어진 군으로부터 선택되는, 방법.
- 제1항에 있어서, 튜브를 형성하는 단계는 적어도 1종의 신장된 중합체 재료 및 적어도 1종의 접착성 중합체 재료를 사용하는 단계를 포함하며, 여기서 접착성 중합체 재료는 폴리(ε-카프로락톤), 폴리(트리메틸렌 카르보네이트), 폴리(D,L-락티드), 폴리(L-락티드)-코(co)-ε-카프로락톤), 폴리(L-락티드-코-트리메틸렌 카르보네이트), 폴리(ε-카프로락톤-코-트리메틸렌 카르보네이트), 폴리(에틸렌 글리콜), 폴리(L-락티드-코-폴리(에틸렌 글리콜)), 및 이들의 공중합체 및 유도체 및 조합물로 이루어진 군으로부터 선택되는, 방법.
- 제5항에 있어서, 튜브를 형성하는 단계는 적어도 1종의 신장된 중합체 재료 및 적어도 1종의 접착성 중합체 재료를 사용하는 단계를 포함하고, 적어도 1종의 결정화가능한 생분해성 중합체 재료 및 적어도 1종의 접착성 중합체 재료는 동일한 중합체 재료를 포함하는, 방법.
- 제1항에 있어서, 적어도 1종의 신장된 중합체 재료는, 적어도 1종의 중합체 재료에 각각 상응하는 최대 신장률의 적어도 10% 신장되는, 방법.
- 제1항에 있어서, 적어도 1종의 중합체 재료를 신장시키는 단계는, 신장 동안에, 적어도 1종의 중합체 재료의 기계적 특성, 열역학적 특성, 화학적 특성, 전기적 특성 및 분해 속도 중 1종 이상을 제어하는 단계를 포함하는, 방법.
- 제1항에 있어서, 적어도 1종의 중합체 재료는 적어도 1종의 중합체 재료의 원래 치수의 300% 내지 1,000% 신장되는, 방법.
- 방법이며,
적어도 부분적인 분자 배향을 나타내는 적어도 1종의 신장된 중합체 재료를 수득하는 단계로서, 여기서,
적어도 1종의 신장된 중합체 재료는 제1 치수, 및 적어도 1종의 결정화가능한 생분해성 중합체 재료를 포함하는 적어도 1종의 중합체 재료에 상응하고,
적어도 1종의 중합체 재료는 제1 치수를 증가시키는 방식으로 신장되는, 단계; 및
적어도 1종의 신장된 중합체 재료를 사용하여 튜브를 형성하는 단계
를 포함하는, 방법. - 튜브이며,
적어도 부분적인 분자 배향을 나타내는 적어도 1종의 신장된 중합체 재료를 포함하고, 상기 적어도 1종의 신장된 중합체 재료는 적어도 1종의 중합체 재료를 신장시키는 것에 적어도 부분적으로 기반하여 수득되고, 여기서 적어도 1종의 중합체 재료는 제1 치수, 및 적어도 1종의 결정화가능한 생분해성 중합체 재료, 적어도 1종의 중합체 재료를 포함하고, 상기 적어도 1종의 중합체 재료는 제1 방향을 증가시키는 방식으로 신장되는, 튜브. - 튜브이며,
적어도 1종의 결정화가능한 생분해성 중합체 재료, 및 튜브의 길이에 수직인 법선을 갖는 외부 표면을 포함하고,
튜브는 제1 압축 사이클에 기반하여 측정 시 약 20 MPa 이상의 최대 응력 값을 나타내고,
튜브는 제1 압축 사이클 후 적어도 제1 치수가 17% 이하 변형되는, 튜브. - 제30항에 있어서, 제1 압축 사이클은,
그 사이에 튜브가 배치되어 있는 2개의 평행한 플레이트들 사이의 초기 거리를 수득하는 단계로서, 상기 2개의 평행한 플레이트는 2개의 평행한 플레이트가 튜브에 실질적으로 부하를 제공하지 않는 방식으로 튜브의 외부 표면과 접촉하는, 단계;
플레이트들을, 분당 2개의 평행한 플레이트의 초기 거리의 50%의 속도로 초기 거리의 50%인 거리까지 압축하는 단계로서, 플레이트들의 압축은 튜브를 제1 방향으로 변형하고, 상기 제1 방향은 플레이트들이 압축되는 방향인, 단계; 및
튜브 상의 플레이트들의 압축을 분당 2개의 평행한 플레이트의 초기 거리의 50%의 속도로 해제하는 단계
를 포함하는, 튜브. - 제30항에 있어서, 제1 압축 후 튜브에 상응하는 엔지니어링 응력-스트레인 곡선 하의 총 에너지 값이 적어도 138 kgf·mm/cm인, 튜브.
- 제30항에 있어서, 튜브는 그 상부에 적용된 치료제, 피복물 및 코팅 중 1종 이상을 갖는, 튜브.
- 튜브이며,
적어도 1종의 결정화가능한 생분해성 중합체 재료, 및 튜브의 길이에 수직인 법선을 갖는 외부 표면을 포함하고,
튜브는 제1 압축 사이클에 기반하여 측정 시 약 20 MPa 이상의 최대 응력 값을 나타내고,
제1 압축 후 튜브에 상응하는 엔지니어링 응력-스트레인 곡선 하의 총 에너지 값이 적어도 138 kgf·mm/cm인, 튜브.
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WO2019049115A3 (en) | 2019-05-31 |
US11077604B2 (en) | 2021-08-03 |
CN113165255A (zh) | 2021-07-23 |
WO2019049115A2 (en) | 2019-03-14 |
EP3860825A4 (en) | 2022-06-15 |
US20220040905A1 (en) | 2022-02-10 |
CN113165255B (zh) | 2023-04-28 |
US20240286373A1 (en) | 2024-08-29 |
IL281944B2 (en) | 2024-12-01 |
US11999130B2 (en) | 2024-06-04 |
CN116474179A (zh) | 2023-07-25 |
US20190077067A1 (en) | 2019-03-14 |
EP3860825A2 (en) | 2021-08-11 |
KR102520102B1 (ko) | 2023-04-10 |
IL281944A (en) | 2021-05-31 |
IL281944B1 (en) | 2024-08-01 |
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