KR101730777B1 - 특별히 고안된 마그네슘-알루미늄 합금 및 혈류역학적 환경에서의 그의 의학적 용도 - Google Patents
특별히 고안된 마그네슘-알루미늄 합금 및 혈류역학적 환경에서의 그의 의학적 용도 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
- A61F2/02—Prostheses implantable into the body
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- A—HUMAN NECESSITIES
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A—HUMAN NECESSITIES
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- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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Abstract
Description
도 1은 비록 명백히 통일되지 않는 결과이지만 생물학적-활성화된 환경에서 Mg 용식 속도가 Al 첨가에 의해 영향받는 것으로 나타난 것을 보여주는 그래프 예시이다.
도 2는 배치-후 동맥절개부 밀봉 위치 및 구성에서의 본 발명의 구체예의 특별히 고안된 Mg-Al 합금으로 제조될 수 있는 폐쇄 장치 구체예의 투시도이다.
도 3(a)-(b)는 15-일 외식편(explant)의 결과, 양 대동맥 (후복막 접근) vs. 용식되지 않은 시편의 사진을 나타낸다.
도 4는 본 발명의 구체예에 따라, 양 대퇴 동맥에 이식하기 전의 이식편 시편 중 하나의 사진을 나타낸다.
도 5는 본 발명의 구체예에 따라, 양 대퇴 동맥에 이식한 후에, 전측 노출의 사진을 나타낸다.
도 6(a)-(d)는 (a) 이식 4시간 후의 좌측 대퇴 동맥, (b) 이식 8시간 후의 좌측 대퇴 동맥, (c) 이식 4시간 후의 우측 대퇴 동맥, 및 (d) 이식 8시간 후의 우측 대퇴 동맥의 생체 밖(ex vivo) 육안 조직학을 나타낸다.
도 7 (a)-(d)는 본 발명의 구체예에 따라, 염증 반응이 거의 없거나 아예 없음을 보이는 양 (동물 G3918) 대퇴 동맥의 부분의 조직병리학을 나타낸다.
도 8은 본 발명의 구체예에 따라, 질량 손실에 의해 시험한 Mg-Al-Fe 합금에 대한 Al 함량 대비 생체내(in vivo) 용식 속도를 나타내는 그래프 예시이다.
도 9는 구성하는 실험 합금 전체에 균일하게 분산된 전이 금속-농축 금속간 입자 (Mg 바탕을 갖는 Al 및 미량의 Fe)를 나타내는 SEM 영상이다.
도 10(a)-(b)는 본 발명의 구체예에 따라, 기존 문헌 vs. 혈류역학적 노출에서 생체-환경 활성화제에서 용식 속도의 비교를 나타낸다.
도 11은 본 발명의 구체예에 따라, 용식의 정도를 나타내는 외식된 Mg 합금 샘플의 광학 현미경 사진이다. 8시간 후 AZ31 (맨위에 나타남), 4시간 노출 후 Mg-8.25A1 (중간에 나타남), 및 8시간 노출 후 Mg-8.25A1 (맨밑에 나타남).
합금 | Al(wt. % ) | Fe(wt. % ) |
1. | 1.06 - Mg1Al 또는 Mg1.06Al | <0.01 |
2. | 2.94 - Mg3Al 또는 Mg2.94Al | 0.07 |
3. | 6.09 - Mg6Al 또는 Mg6.09Al | 0.07 |
4. | 8.25 - Mg8Al 또는 Mg8.25Al | 0.05 |
AZ31 | 3.0 - | (1.0 Zn) |
이식 위치 원위-내지-근위 |
합금 | 우측 대퇴 외식편 중량 최초 중량 (g) | % Wt 손실 | 좌측 대퇴 외식편 중량 최초 중량 (g) | % Wt 손실 |
3 | Mg6Al | .00141 .00358 |
61 | .00256 .00359 |
29 |
4 | Mg3Al | .00256 .00345 |
26 | .00288 .00340 |
15 |
5 | Mg1Al | .00331 .00338 |
2.0 | .00326 .00332 |
1.8 |
6 | Mg8Al | .00050 .00345 |
85.5 | .00191 .00341 |
44 |
이식 위치 원위-내지-근위 |
합금 | 우측 대퇴 외식편 중량 최초 중량 (g) | % Wt 손실 | 좌측 대퇴 외식편 중량 최초 중량 (g) | % Wt 손실 |
1 | Mg6Al | .00288 .00357 |
19 | .00295 .00348 |
15 |
2 | Mg3Al | .00305 .00348 |
12 | .00304 .00342 |
11 |
3 | Mg1Al | .00328 .00333 |
1.5 | .00329 .00333 |
1.2 |
4 | Mg8Al | .00259 .00333 |
22 | .00263 .00337 |
22 |
초기 | 최종 | 변화 | 샘플당 초기 | 샘플당 변화 | 백분율 | |
AZ 31B | 96.4 | 90.3 | 6.1 | 3.9 | 0.24 | 6.3% |
Mg- 1Al | 91.7 | 84.8 | 6.9 | 3.7 | 0.28 | 7.5% |
Mg- 3Al | 89.4 | 85.8 | 3.6 | 3.6 | 0.14 | 4.0% |
Mg- 5Al | 84.5 | 75.7 | 8.8 | 3.4 | 0.35 | 10.4% |
Mg- 8Al | 88.3 | 76.8 | 11.5 | 3.5 | 0.46 | 13.0% |
Claims (20)
- 혈관을 통해 형성된 개방부를 밀봉하기 위한 폐쇄 장치 이식편이되, 상기 폐쇄 장치 이식편은:
근위부 및 원위부를 포함하는 플러그;
상기 플러그를 통하여 상기 플러그의 원위부에 대하여 원위인 위치로부터 연장된 와이어; 및
상기 와이어에 부착되고 상기 플러그의 상기 원위부에 대하여 원위로 배치된 지지판을 포함하고;
상기 와이어, 상기 플러그, 및 상기 지지판 중 적어도 하나는 마그네슘 합금을 포함하는 생체용식성 금속으로 형성되고, 상기 마그네슘 합금은 중량으로 1% 내지 8.25% 알루미늄 및 중량으로 0.01% 내지 0.05% 철을 포함하는 폐쇄 장치 이식편. - 제1항에 있어서, 상기 마그네슘 합금은 중량으로 3% 내지 8.25% 알루미늄을 포함하는 폐쇄 장치 이식편.
- 삭제
- 제2항에 있어서, 상기 지지판, 상기 와이어, 및 상기 플러그 각각은 동일한 백분율의 알루미늄을 포함하는 폐쇄 장치 이식편.
- 제2항에 있어서, 상기 지지판, 상기 와이어, 및 상기 플러그 각각은 상이한 백분율의 알루미늄을 포함하는 폐쇄 장치 이식편.
- 제5항에 있어서, 상기 지지판은 상기 플러그에 비해 더 큰 백분율의 알루미늄을 포함하는 폐쇄 장치 이식편.
- 제5항에 있어서, 상기 지지판은 상기 플러그에 비해 더 작은 백분율의 알루미늄을 포함하는 폐쇄 장치 이식편.
- 제5항에 있어서, 상기 지지판은 상기 와이어에 비해 더 큰 백분율의 알루미늄을 포함하는 폐쇄 장치 이식편.
- 제5항에 있어서, 상기 지지판은 상기 와이어에 비해 더 작은 백분율의 알루미늄을 포함하는 폐쇄 장치 이식편.
- 제5항에 있어서, 상기 플러그는 상기 와이어에 비해 더 큰 백분율의 알루미늄을 포함하는 폐쇄 장치 이식편.
- 제5항에 있어서, 상기 플러그는 상기 와이어에 비해 더 작은 백분율의 알루미늄을 포함하는 폐쇄 장치 이식편.
- 제1항에 있어서, 지지판, 와이어, 및 플러그 각각의 표면적 대 부피 비는 동일한 폐쇄 장치 이식편.
- 제2항에 있어서, 상기 지지판, 상기 와이어, 및 상기 플러그 각각은 상이한 표면적 대 부피 비를 포함하는 폐쇄 장치 이식편.
- 제1항에 있어서, 지지판의 표면적 대 부피 비는 플러그의 표면적 대 부피 비보다 큰 폐쇄 장치 이식편.
- 제1항에 있어서, 지지판의 표면적 대 부피 비는 플러그의 표면적 대 부피 비보다 작은 폐쇄 장치 이식편.
- 제1항에 있어서, 지지판의 표면적 대 부피 비는 와이어의 표면적 대 부피 비보다 큰 폐쇄 장치 이식편.
- 제1항에 있어서, 지지판의 표면적 대 부피 비는 와이어의 표면적 대 부피 비보다 작은 폐쇄 장치 이식편.
- 제1항에 있어서, 플러그의 표면적 대 부피 비는 와이어의 표면적 대 부피 비보다 큰 폐쇄 장치 이식편.
- 제1항에 있어서, 플러그의 표면적 대 부피 비는 와이어의 표면적 대 부피 비보다 작은 폐쇄 장치 이식편.
- 혈관을 통해 형성된 개방부를 밀봉하기 위한 폐쇄 장치 이식편이되, 상기 폐쇄 장치 이식편은:
근위부 및 원위부를 포함하는 플러그;
상기 플러그를 통하여 상기 플러그의 원위부에 대하여 원위인 위치로부터 연장된 와이어; 및
상기 와이어에 부착되고 상기 플러그의 상기 원위부에 대하여 원위로 배치된 지지판을 포함하고;
상기 와이어, 상기 플러그, 및 상기 지지판 중 적어도 하나는 중량으로 0.01% 내지 0.08% 철을 포함하는 용식 활성화제와 배합된 마그네슘 합금을 포함하는 생체용식성 금속으로 형성되고, 상기 지지판의 마그네슘 합금은 중량으로 1% 내지 8.25% 알루미늄을 포함하고, 용식 활성화제와 배합된 상기 마그네슘 합금은 혈류역학적 환경에서 AZ31의 용식 속도보다 더 빠른 용식 속도를 가지도록 배합되는 폐쇄 장치 이식편.
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- 2011-11-09 WO PCT/US2011/060053 patent/WO2012064888A2/en active Application Filing
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Also Published As
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IL226250A (en) | 2016-09-29 |
US20170128630A1 (en) | 2017-05-11 |
CA2817203A1 (en) | 2012-05-18 |
US9155530B2 (en) | 2015-10-13 |
CN103313679B (zh) | 2016-11-02 |
AU2011326525B2 (en) | 2015-06-18 |
WO2012064888A2 (en) | 2012-05-18 |
EP2637603A2 (en) | 2013-09-18 |
US9931441B2 (en) | 2018-04-03 |
JP5981930B2 (ja) | 2016-08-31 |
CA2817203C (en) | 2016-05-17 |
MX2013005265A (es) | 2013-06-13 |
KR20130086629A (ko) | 2013-08-02 |
CN103313679A (zh) | 2013-09-18 |
JP2013543761A (ja) | 2013-12-09 |
EP2637603A4 (en) | 2015-12-16 |
MX356254B (es) | 2018-05-21 |
WO2012064888A3 (en) | 2012-07-26 |
KR20160015393A (ko) | 2016-02-12 |
NZ610368A (en) | 2015-10-30 |
EP2637603B1 (en) | 2017-10-11 |
KR101589564B1 (ko) | 2016-01-28 |
US20120116446A1 (en) | 2012-05-10 |
AU2011326525A1 (en) | 2013-06-06 |
IL226250A0 (en) | 2013-07-31 |
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