KR910002422B1 - 관상기관 내강의 내경확보용 기구 및 이것을 구비한 카테테르 - Google Patents
관상기관 내강의 내경확보용 기구 및 이것을 구비한 카테테르 Download PDFInfo
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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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- A61F2/00—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
내용 없음.
Description
예컨대 관동맥의 협착부를 혈관 확장 카테테르 확장한 후, 그 부분의 재협착을 방지하는 경우 등, 일반적으로 관상기관의 내강의 내경을 확보하는 것을 목적으로 하여 확장유지구(이하, 스텐트라고도 부른다)가 사용되고 있다.
종래, 이와 같은 목적에 사용되는 스텐트로서 스테인레스 와이어를 망상으로 짠것(Surgery, 1986년 99권 2호, 제199∼205페이지), 혹은 1방향성 형상 기억 합금제의 것(특공소 61-6655), 가 고안되고 있다. 이 스테인레스제 스텐트를 사용하여 예컨대 혈관 확장의 확보를 행할 경우, 혈관의 소정위치에 스텐트를 혈관 확장 카테테르를 개재시켜 도입하고, 이어서 카테테르 선단부에 설치된 벌룬을 확장하여 스텐트를 혈관 지름에 넓힐 수 있다. 또, 1방향성 형상 기억 합금체 스텐트인 경우는 마찬가지로 혈관의 소정개소에 도입 후 온수 등으로 가열하여 스텐트의 확장이 행하여진다.
이와 같이 하여, 일단 확장된 스텐트는 외력을 주지않는 한, 그 형상을 변화시킬 수가 없으며, 유치후 시술부가 회복하여도 재차 꺼낼 수가 없다. 그로 인하여 생체으로의 적합성이 대단히 문제로 되어 있다. 그외, 이와 같은 종래의 스텐트는 유치 위치가 잘못되어 있는 것이 확장 후 발견되었다고 하더라도, 일단 확장된 후는, 그 유치 위치의 변경은 매우 곤란하였다.
본 발명은 상기한 사정을 감안하여, 관상기관내에서 일단 확장시킨 경우라도 재차 자유롭게 원래의 형상으로 축소시킬 수가 있으며, 따라서 유치 위치로 부터의 회수가 가능함과 함께, 확장 후에 있어서의 유치 위치의 변경도 자유롭게 할 수 있는 관상기관용 스텐트 및 이 스텐트를 조작하기 위한 카테테르를 제공하는것을 목적으로 한다.
발명의 개시
본 발명은 상기한 문제점을 해결하기 위하여, 스텐트로서 2방향성 형상 기억 합금을 사용한다고 하는 수단을 강구함과 함께, 이 스텐트를, 측공(惻孔)을 설치한 카테테르 선단에 취착시켜, 이 측공을 거쳐서 냉각수를 스텐트에 적당히 접촉시켜 스텐트의 축소, 확장을 자유롭게 행하는 것을 가능하도록 한 것이다.
즉, 본 발명은 상기한 문제점을 해결하는 수단으로서, 온도 변화에 수반하여 지름 방향으로 확장 또는 수축할 수 있는 2방향성 형상 기억 합금의 실질적으로 통상(筒狀)의 성형체로 된 것을 특징으로 하는 관상기관용 스텐트를 제공하는 것이다.
덧붙여, 이 2방향성 형상 기억 합금 통상체는 체온 또는 체온 근방에서 확장상태를 유지하고, 이것보다 실질적으로 낮은 온도에서는 축소 상태를 유지할만한 것이 바람직하다.
다시금, 본 발명은 기단 또는 양단이 개구하고, 그 선단 근방의 주면에 이 개구부와 연통하는 적어도 1개의 측공을 천설하여서 된 카테테르 튜우브와, 이 카테테르 튜우브 후단에 연통하도록 하여 설치된 허브부와, 온도 변화에 수반하여 지름 방향으로 확장 또는 수축할 수 있는 2방향성 형상 기억 합금 통상체로서 되며, 상기한 카테테르 튜우브의 선단의 측공 천설부의 적어도 일부를 덮도록 하여 장착된 관상기관 내강의 내경확보용 기구를 구비하여 된 것을 특징으로 하는 관상기관용 스텐트를 갖춘 카테테르를 제공하는 것이다.
덧붙여, 상기한 카테테르의 허브부는 2개의 포오토를 구비한 분기 허브이며, 그 한쪽의 포오토에 역지 밸브(逆止弁)를 설치하도록 하여도 좋다.
그리고, 본 발명에 있어서 형상 기억 합금이란 변태 온도를 가지며, 이 온도 이상으로 되면 미리 기억시킨 형상으로 변화하는 것을 말하며, 1방향성 형상 기억 합금이란 변태 온도 이하일때에는 자유롭게 변형할수 있으며, 변태 온도 이상으로 되어 형상 변화하면 그후 변태 온도 이하가 되더라도 기억한 형상을 유지하는 것을 말하며, 2방향성 형상 기억 합금이란 변태 온도 이하에서의 형상도 기억하고 있으며, 변태 온도를 경계로 해서 두개의 형상을 가역적으로 발현하는 것을 말한다. 또, 본 명세서 중에 있어서, "실질적으로 통상의 성형체"란 통상의 통상체 외에, 횡단면 소용돌이상의 통체, 코일상의 통체 등 여러가지의 형태의 통상체를 포함하는 것으로서 이해되어야만 할 것이다.
발명을 실시하기 위한 최량의 형태
이하, 본 발명을 도시한 실시예를 참조하여 설명하겠다,
제1도(a), (b)는 본 발명의 일실시예에 관계되는 관상기관용 스텐트(10)를 나타낸 것으로써, 편평한 2방향성 형상 기억 합금 선조체(線條體)(예컨대, Ni-Ti계, Cu-Al-Ni계, Cu-Zn-Al계 합금으로 된다)를 나선상으로 성형한 것으로서 이루어진다. 이 스텐트(10)는 체온 또는 체온 가까이의 온도(예컨대,35∼37℃)에서는 제1도(b)와 같이 지름 방향으로 확장한 형상을 유지하며, 그것보다 실질적으로 낮은 온도(예컨대,15∼20℃)에서는 제1도(a)에 나타낸 바와같이 지름 방향으로 수축한 형상을 유지한다. 예컨대, 살 두께 0.04mm, 폭 1mm의 Ni-Ti계 2방향성 형상 기억 합금(Ni를 약 51원자량% 함유함)을 나선상으로 성형한 스텐트에 있어서는 체온으로 약 2mm의 내경의 것이 온도 15℃ 이하에서 내경 약 1.4mm로 수축시킬 수 있었다. 이 스텐트(10)의 내경, 길이 등은 목적으로 하는 유치 부위의 기관에 내부의 크기에 따라서 적당하게 선택된다. 요는 확장시에 유치해야할 혈관등의 관상기관의 개소의 내경과 대략 일치시킬 수가 있으며, 수축시에는 그 개소까지 삽입하는데 충분히 가늘게 할수가 있다면 좋다.
여기서 관상기관 내강의 내경확보용 기구의 형상으로서 상기한 나선상 외에 실질적인 통상의 것이 있지만, 실질적으로 통상과는 외면을 연속시켰을 때에 통상으로 되는 것을 말하며, 다음에 나타낸 실시예에 한하지 않고, 임의의 형태를 채용할 수 있다. 예컨대 제2도(a)에 나타낸 것처럼 수축시에 있어서는 횡단면 소용돌이상을 이루고, 확장시에는 제2도(b)와 같이 원통을 이루도록 한 것, 다시 2방향성 형상 기억합금 선조체를 편조(編租)한 통상체로서 되며, 수축시에는 제3더(a)와 같이 그물눈이 수축된 구조의 가늘고 긴형상으로 되며, 확장시에는 제3도(b)에 나타낸 것처럼 그물눈이 넓어져서 내경이 확대하는 것이더라도 좋다. 다시금, 제4도(a)와 같은 수축시에 가늘다란 파이프상을 이루고, 확장시에 제4도(b)에 나타낸 바와같이 굵은 파이프상으로 되는 것이더라도 좋다.
상술한 스텐트(10)를 체내 관상기관의 목적으로 하는 유치위치에 도입할 경우는 예컨대 제5도에 나타낸바와 같은 카테테르(12)가 사용된다.
이 카테테르(12)는 양단이 개구한 카테테르 튜우브(14)(예컨대 에틸렌-초산비닐코폴리머로서 된다)와, 이 카테테르 튜우브(14)의 후단에, 카테테르 튜우브의 루우멘과 연통하도록 하여 설치된 허브부(16)(예컨대 폴리카아보네이트로서 된다)로써 되어 있다. 카테테르 튜우브(14)의 선단 근방의 주면에는 다수의 측공(18)이 천설되어 있어서, 카데테르 튜우브(14)내에 도입된 스텐트 냉각액이 이 측공(18)을 거쳐서 방사상으로 배출되도록 되어 있다. 허브부(16)는 제6도에 확대하여 나타낸 것처럼, 직선상 통상부(16a)와, 이 직선상 통상부(l6a)의 중간에서 분기부(16b)로써 되어 있다. 직선상 통상부(16a)는 가이드 와이어의 도입구로 되는 것으로서, 그 때문에 혈액등의 누설을 방지하기 위한 역지밸브(20)(예컨대 실리콘 고무 등의 유연소재로서 된다)이 그 기단개구부 근방에 조절되어 있다. 그리고, 분기부(16b)는 냉각액등의 도입에 사용되는 것으로서 포오트(16c)를 갖는다.
스탠트(10)를 관상기관의 유치위치에 도입할 때에, 먼저, 스텐트(10)를 카테테르 튜우브(14)의 선단의 측공(18) 부분에 삽입한다. 이어서 예컨대 빙냉 생리식염수를 포오트(16c)에서 도입하고, 측공(18)에서 배출시킴으로서 스텐트(10)를 15∼20℃로 냉각하면 제7도에 나타낸 것처럼 스텐트(10)가 그대로 수축하여 카테테르 튜우브(14)의 측공 천설부분(18)에 밀착한다.
다음에 측공(18)으로 부터 빙냉 생리식염수를 유출시킨채 제8도에 나타낸 것처럼, 관상기관(22)내에 미리 도입되고 있는 가이드 카테테르(24)안을 가이드와이어(26)를 이용하여 목적으로 하는 유치 부위까지 도입한다. 이 유치 부위에 도달했을때, 빙냉 생리식염수의 도입을 정지한다. 이것에 의해, 스텐트(10)가 체온에 의해 차츰 따뜻해지며, 체온 근방으로 따뜻해지면 제9도에 나타낸 것처럼, 스텐트(10)가 확장하고, 관상기관(22) 내벽면에 압접하여, 유지된다. 따라서, 카테테르 튜우브(14)의 선단부를 스텐트(10)에서 용이하게 뽑아낼 수 없으며, 이것에 의해서 스텐트(l0)를 관상기관(22)의 소정위치에 그대로 유치시킬 수 있다.
이 스텐트(10)를 회수할 경우는, 카테테르 튜우브(14)의 선단의 측공(18) 부분을 스텐드(10)내에 삽입하고, 빙냉 생리식염수를 포오트(16c)에서 도입하고, 측공(18)에서 배출시킴으로서, 스텐트(10)를 수축시켜 제7도에 나타낸 바와같이 측공(18) 부분에 밀착시킬 수 없으므로, 그대로 끌어냄으로서 회수할 수 있다. 스텐트(10)의 유치 위치를 변경시키고 싶은 경우도 마찬가지의 조작으로 행할수 있다.
덧붙여, 카테데르 튜우브(14)선단에 천설되는 측공(18)의 수, 범위에 대해서는 스텐트의 크기 등을 고려하여 임의로 선택할 수 있다.
이상 상세히 설명한 바와 같이, 본 발명에 의하면, 관상기관용 스텐트로서 체온을 기준으로 하는 온도 변화에 의해 확장, 수축 자재인 2방향성 기억 합금의 원통체를 사용했으므로, 유치 위치로 부터의 회수가 가능해짐과 함께, 확장 후에 있어서의, 유치 위치의 변경도 용이해지는 등 현저한 효과를 나타낸다. 다시 본 발명에 관계되는 스텐트 조작용 카테테르에 의하면 선단주면에 천설한 측공을 거쳐서 스텐트의 수축을 자유롭게 행할 수가 있으므로, 스텐트의 도입, 회수를 매우 간단 또한 용이하게, 행하는 것이 가능해진다.
산업상의 이용 가능성
본 발명의 내경확보용 기구 및 이를 구비한 카테테르는 사람 또는 동물의 혈관 등의 관상기관에 삽입하고, 그 기관의 내경을 일정한 크기로 유지 확장시켜, 적어도 일정기간, 그 상태로 유지시키는 경우에 이용된다.
본 발명은 관상기관의 내강의 내경을 확보하기 위한 확장 유지구 및 이 확장 유지구를 도입 또는 회수하기 위한 카테테르에 관한다.
제1도 (a),(b)는 본 발명에 관계되는 관상기관용 스텐트의 측면도로서, (a)는 수축시, (b)는 확장시의 상태를 나타내고, 제2도(a),(b) 내지 제4도(a),(b)는 본 발명의 관상기관용 스텐트의 사시도이며, (a)는 수축시, (b)는 확장시의 상태를 나타내고, 제5도는 상기 스텐트의 조작에 사용되는 카테테르의 측면도, 제6도는 제5도의 카테테르의 허브부를 확대하여 나타낸 단면도, 제7도는 제5도의 카테테르에 제1도의 스텐트를 장착한 상태를 나타낸 측면도, 제8도 및 제9도는 제7도에 나타낸 카테테르를 사용하여 관상기관에 스텐트를 유치시키는 경우의 조작을 설명하는 부분 단면도이다.
Claims (9)
- 온도변화에 수반하여 지름 방향으로 확장 또는 수축할 수 있는 2방향성 형상기억합금의 실질적으로 통상의 성형체로서 된것을 특징으로 하는 관상기관 내강의 내경 확보용 기구.
- 제1항에 있어서, 그 통상체가 체온 또는 체온 근방에서 지름 방향으로 확장하고, 체온 또는 체온 근방 보다 실질적으로 낮은 온도에서 지름 방향으로 수축하는 것인 관상기관 내강의 내경 확보용 기구.
- 제1항에 있어서, 그 통상체가 코일상의 것인 관상기관 내강의 내경 확보용 기구.
- 제1항에 있어서, 그 통상체가 단면소용돌이상의 통제인 관상기관 내강의 내경 확보용 기구.
- 제1항에 있어서, 그 통상체가 파이프상의 것인 관상기관 내강의 내경 확보용 기구.
- 제1항에 있어서, 그 통상체가 그물눈 모양의 것인 관상기관 내강의 내경 확보용 기구.
- 제1항에 있어서, 2방향성 형상기억합금이 Ni-Ti계, Cu-Al-Ni계 및 Cu-Zn-Al계 합금에서 선택된 것인 관상기관 내강의 내경 확보용 기구.
- 기단 또는 양단이 개구하고, 그 선단 근방의 주면에 그 기단 개구부와 연통하는 적어도 1개의 측공을 천설하여서된 카테테르 튜브와 이 카테테르 튜브 후단에 연통하도록하여 설치된 허브부와, 온도 변화에 따라 지름 방향으로 확장 또는 수축할 수 있는 2방향성 형상기억합금의 실질적으로 통상의 성형체로서 되며, 상기한 카테테르 튜브의 측공 천설부의 적어도 일부를 덮도록 하여 장착된 관상기관 내강의 내경 확보용 기구를 구비하여 된 것을 특징으로하는 관상 스텐트를 갖춘 카테테르.
- 제8항에 있어서, 허브부가 두개의 포오트를 구비한 분기 허브로서 되며 그 한쪽의 포오트에 역지밸브가 설치되어 있는 카테테르.
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JP62070781A JPS63238872A (ja) | 1987-03-25 | 1987-03-25 | 管状器官内腔の内径確保用器具 |
JP62-70781 | 1987-03-25 | ||
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KR890700373A KR890700373A (ko) | 1989-04-24 |
KR910002422B1 true KR910002422B1 (ko) | 1991-04-22 |
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KR1019880701459A KR910002422B1 (ko) | 1987-03-25 | 1988-03-25 | 관상기관 내강의 내경확보용 기구 및 이것을 구비한 카테테르 |
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US (1) | US5037427A (ko) |
EP (1) | EP0411118B1 (ko) |
JP (1) | JPS63238872A (ko) |
KR (1) | KR910002422B1 (ko) |
AU (1) | AU613027B2 (ko) |
DE (1) | DE3852892T2 (ko) |
WO (1) | WO1988007390A1 (ko) |
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1987
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EP0411118B1 (en) | 1995-01-25 |
WO1988007390A1 (en) | 1988-10-06 |
DE3852892T2 (de) | 1995-05-18 |
AU1490488A (en) | 1988-11-02 |
DE3852892D1 (de) | 1995-03-09 |
JPS63238872A (ja) | 1988-10-04 |
EP0411118A4 (en) | 1991-05-29 |
US5037427A (en) | 1991-08-06 |
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