JP6147382B1 - 塞栓用コイル及び塞栓用コイルの製造方法 - Google Patents
塞栓用コイル及び塞栓用コイルの製造方法 Download PDFInfo
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- 229910001260 Pt alloy Inorganic materials 0.000 claims abstract description 82
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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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- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
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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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Abstract
Description
本実施形態では、Pt濃度30質量%のAu−Pt合金を製造した。純Au及び純Pt(いずれも純度99.99%:田中貴金属工業(株)製)を目的組成になるように秤量し、これを高周波溶解して合金インゴットを鋳造した。合金インゴットは60gを目安に製造した。この溶解鋳造した合金インゴットについて熱間鍛造を行った。この鍛造温度は1000℃で行った。
上記で製造したAu−Pt合金素材を、塞栓用コイルに加工するためのAu−Pt合金線材に加工した。線材への加工は、複数のダイスを用いて冷間引抜き加工してAu−Pt合金からなる線材(線径:38μm)を製造した。加工率は99.97%となった。
次に、上記で製造したAu−Pt合金線材について、2度の巻回加工を行い、2次コイル形状の塞栓用コイルを製造した。まず、Au−Pt合金線材(線径:38μm)を極細の芯線(外径1mm、SUS304製)に巻き付ける1次加工を行い、外径0.25mm、内径0.18mmの螺旋状の線材(1次コイル)に加工した。この螺旋状の線材を、芯棒(外径1.2mm、SUS304製)に巻き付け固定した。この2次コイル加工では、外径2.0mm、内径1.5mmを基準値(目標値)として2次コイル形状に加工している。
2次コイル加工後のAu−Pt合金線材の短手方向断面についてSIM(走査イオン顕微鏡)像観察を行った。SIM像観察の際には、Au−Pt合金線材をFIB加工(集束イオンビーム加工:装置名FB−2000A)にて精密切断して観察面を形成した。SIM像により断面組織を観察し、そのSIM像を基に平均結晶粒径を測定した。本実施例においては、平均結晶粒径の測定は、約16000倍の拡大倍率で、一辺が8μmの視野のSIM像を基に行った。
(ii)写真に任意の位置で線を引く。線は複数引く。
(iii)(ii)の線と粒界とが交差する点(交点)の数(nc)をカウントする。
(iv)(ii)の線の長さを観察領域のスケールと対比し、実際の長さ(L)に補正する。
(v)下記式により、平均結晶粒径(RA)を算出する。
Au−Pt合金線材の体積磁化率を測定した。磁化率測定は、高感度小型磁気天秤MSB−AUTO(Sherwood Scientific社製)にて行った(測定温度:27℃)。各種温度で形態安定化処理した線材と、コイル加工前(形態安定化処理なし)の線材の磁化率を測定している。
形態安定性の評価については、形態安定化処理と共に行った2次コイル加工後の塞栓用コイルについての内径戻り率を測定した。2次コイル化交互の塞栓用コイルを芯棒から取り外し、製造した2次コイルの内径をデジタルスコープ((株)キーエンス社製、VHX−900)で測定した。この測定値と下記式から、芯棒から取外した際の除荷による内径戻り率(KD)を算出した。
Claims (8)
- Au−Pt合金からなる線材で構成された塞栓用コイルであって、
前記塞栓用コイルを構成する前記線材は、Pt濃度24質量%以上34質量%未満、残部Auの組成を有し、α相マトリックスに、α相のPt濃度に対して1.2〜3.8倍のPt濃度のAu−Pt合金からなるPtリッチ相が分布した材料組織を有しており、
前記線材は、その体積磁化率が−13ppm以上−5ppm以下であり、
更に、前記線材は、その短手方向断面の材料組織において、線分法により測定された2以上の平均結晶粒径の平均値が0.20μm以上0.35μm以下となる、塞栓用コイル。 - 線材の短手方向断面の材料組織において、線分法により測定された2以上の平均結晶粒径の標準偏差が、0.025以上0.085以下である請求項1記載の塞栓用コイル。
- 線材の引張強度が800MPa以上である請求項1又は請求項2記載の塞栓用コイル。
- 2次コイル形状を有する請求項1〜請求項3のいずれかに記載の塞栓用コイル。
- Au−Pt合金からなる線材の線径は、10μm以上100μm以下である請求項1〜請求項4のいずれかに記載の塞栓用コイル。
- 請求項1〜請求項5のいずれかに記載の塞栓用コイルの製造方法であって、
Pt濃度24質量%以上34質量%未満、残部Auの組成を有し、α相マトリックスに、α相のPt濃度に対して1.2〜3.8倍のPt濃度のAu−Pt合金からなるPtリッチ相が分布しており、体積磁化率が−13ppm以上−5ppm以下であるAu−Pt合金からなる線材を巻回加工する巻回加工工程を1回以上行い、
前記巻回加工工程中、少なくとも1回、前記線材を巻回した状態で固定しつつ、350℃以上550℃以下の温度で加熱保持する形態安定化処理を行うことを特徴とする塞栓用コイルの製造方法。 - 塞栓用コイルは2次コイル形状を有し、
前記2次コイル形状を形成するための巻回加工工程の際に形態安定化処理を行う請求項6記載の塞栓用コイルの製造方法。 - Au−Pt合金の素材に対して加工率50%以上の加工を施すことにより、塞栓用コイルに加工するための線材を製造する請求項6又は請求項7記載の塞栓用コイルの製造方法。
Priority Applications (7)
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JP2016043010A JP6147382B1 (ja) | 2016-03-07 | 2016-03-07 | 塞栓用コイル及び塞栓用コイルの製造方法 |
TW106105958A TWI616215B (zh) | 2016-03-07 | 2017-02-22 | 栓塞用線圈及栓塞用線圈的製造方法 |
PCT/JP2017/008231 WO2017154717A1 (ja) | 2016-03-07 | 2017-03-02 | 塞栓用コイル及び塞栓用コイルの製造方法 |
EP17763057.1A EP3391833B1 (en) | 2016-03-07 | 2017-03-02 | Embolization coil and method for manufacturing embolization coil |
US16/069,955 US11654215B2 (en) | 2016-03-07 | 2017-03-02 | Embolization coil and method for producing embolization coil |
KR1020187020953A KR20180097683A (ko) | 2016-03-07 | 2017-03-02 | 색전용 코일 및 색전용 코일의 제조 방법 |
CN201780014037.1A CN108697427B (zh) | 2016-03-07 | 2017-03-02 | 栓塞用弹簧圈及栓塞用弹簧圈的制造方法 |
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CN113768608A (zh) * | 2021-09-24 | 2021-12-10 | 深圳市顺美医疗股份有限公司 | 一种球形弹簧圈及其自动化生产工艺 |
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JP6661132B2 (ja) * | 2018-03-02 | 2020-03-11 | 国立大学法人東京工業大学 | 形状記憶合金及び形状記憶合金線材 |
US20200170647A1 (en) * | 2018-12-04 | 2020-06-04 | Stryker Corporation | Vaso-occlusive device |
US20220354615A1 (en) * | 2019-07-10 | 2022-11-10 | Kyoto Prefectural Public University Corporation | Medical image guidance marker |
US11697869B2 (en) | 2020-01-22 | 2023-07-11 | Heraeus Deutschland GmbH & Co. KG | Method for manufacturing a biocompatible wire |
KR20230003926A (ko) * | 2021-06-30 | 2023-01-06 | 삼성전자주식회사 | 플럭스 도팅 툴 |
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EP3391833A4 (en) | 2019-01-16 |
EP3391833B1 (en) | 2020-12-16 |
TWI616215B (zh) | 2018-03-01 |
JP2017158608A (ja) | 2017-09-14 |
KR20180097683A (ko) | 2018-08-31 |
TW201740985A (zh) | 2017-12-01 |
WO2017154717A1 (ja) | 2017-09-14 |
CN108697427A (zh) | 2018-10-23 |
EP3391833A1 (en) | 2018-10-24 |
CN108697427B (zh) | 2021-06-15 |
US11654215B2 (en) | 2023-05-23 |
US20190030215A1 (en) | 2019-01-31 |
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