JP6975504B2 - 医療機器 - Google Patents
医療機器 Download PDFInfo
- Publication number
- JP6975504B2 JP6975504B2 JP2021501582A JP2021501582A JP6975504B2 JP 6975504 B2 JP6975504 B2 JP 6975504B2 JP 2021501582 A JP2021501582 A JP 2021501582A JP 2021501582 A JP2021501582 A JP 2021501582A JP 6975504 B2 JP6975504 B2 JP 6975504B2
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- JP
- Japan
- Prior art keywords
- medical device
- mri
- metal
- stainless steel
- needle
- 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.)
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/02—Inorganic materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
- A61L29/18—Materials at least partially X-ray or laser opaque
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- 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
- A61L31/02—Inorganic materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- 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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/18—Materials at least partially X-ray or laser opaque
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- C—CHEMISTRY; METALLURGY
- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
- C22C—ALLOYS
- C22C38/00—Ferrous alloys, e.g. steel alloys
Description
(1) 金属から成る(consisting essentially of)医療機器、又は金属から成る(consisting essentially of)部品を含む医療機器であって、前記金属が高マンガン含有ステンレス鋼である、医療機器。
(2) 前記医療機器が、磁気共鳴イメージング装置の近傍で使用されることがある医療機器、又は磁気共鳴イメージング装置の部品である、(1)記載の医療機器。
(3) 前記医療機器が、磁気共鳴イメージング保証の医療機器である(1)又は(2)記載の医療機器。
(4) 前記医療機器が、少なくとも一時的にその全部又は一部が生体内に導入される医療機器であり、生体内に導入される部分を構成する前記金属が高マンガン含有ステンレス鋼である、(1)〜(3)のいずれか1項に記載の医療機器。
(5) 前記高マンガン含有ステンレス鋼中のマンガン含有量が13質量%以上22質量%以下である、(1)〜(4)のいずれか1項に記載の医療機器。
(6) 前記高マンガン含有ステンレス鋼が下記表1又は表2に示される組成を有する、(5)記載の医療機器。
(8) 前記医療機器が、針、ステント又はステープルである(7)記載の医療機器。
日本冶金工業株式会社製の高マンガン含有ステンレス鋼NAS NM17(商品名)の板(厚さ0.7mm、エリクセン値:11.5mm、LDR 2.0)を原料とし、冷間加工と圧延を繰り返す常法により穿刺針(外径0.89mm、内腔の内径0.50mm、長さ150mm)を製造した。なお、本実施例で用いた高マンガン含有ステンレス鋼NAS NM17(商品名)の組成は次の通りであった。
実施例1で製造した穿刺針(実施例2)又はSUS304ステンレス鋼から製造された市販の穿刺針(比較例1、サイズは内腔も含め実施例1と同じ)を、市販の豚肉に穿刺し、市販のMRI装置で観察した。なお、観察時の磁束密度は0.3テスラであった。観察結果の写真を図2に、その解説図を図3に示す。図2中、参照番号1は、実施例2で用いた穿刺針、参照番号2は比較例1で用いた穿刺針の断面、参照番号3は、このMRI下で観察された画像アーチファクト、参照番号4は豚肉である。
2 比較例1で用いた穿刺針の断面
3 画像アーチファクト
4 豚肉
Claims (6)
- 前記医療機器が、磁気共鳴イメージング装置の近傍で使用されることがある医療機器、又は磁気共鳴イメージング装置の部品である、請求項1記載の医療機器。
- 前記医療機器が、磁気共鳴イメージング保証の医療機器である請求項1又は2記載の医療機器。
- 前記医療機器が、少なくとも一時的にその全部又は一部が生体内に導入される医療機器であり、生体内に導入される部分を構成する前記金属が高マンガン含有ステンレス鋼である、請求項1〜3のいずれか1項に記載の医療機器。
- 前記医療機器が、針、体内埋込医療機器、カテーテル関連機器、鋼製小物類、組織固定用線類、手術及び検査等ロボット関連機器、内視鏡関連機器、又は歯科材料である請求項1〜4のいずれか1項に記載の医療機器。
- 前記医療機器が、針、ステント又はステープルである請求項5記載の医療機器。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2019047731 | 2019-02-26 | ||
JP2019047731 | 2019-02-26 | ||
JP2019160907 | 2019-09-04 | ||
JP2019160907 | 2019-09-04 | ||
PCT/JP2019/046312 WO2020174791A1 (ja) | 2019-02-26 | 2019-11-27 | 医療機器 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP6975504B2 true JP6975504B2 (ja) | 2021-12-01 |
JPWO2020174791A1 JPWO2020174791A1 (ja) | 2021-12-23 |
Family
ID=72238887
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2021501582A Active JP6975504B2 (ja) | 2019-02-26 | 2019-11-27 | 医療機器 |
Country Status (2)
Country | Link |
---|---|
JP (1) | JP6975504B2 (ja) |
WO (1) | WO2020174791A1 (ja) |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2764307B1 (fr) * | 1997-06-04 | 1999-08-27 | Metallurg Avancee Soc Ind De | Acier inoxydable sans nickel pour applications biomedicales |
JP4851878B2 (ja) * | 2006-07-21 | 2012-01-11 | 日本精線株式会社 | カテーテル補強用の筒状編体、及びそれを用いたカテーテル |
-
2019
- 2019-11-27 JP JP2021501582A patent/JP6975504B2/ja active Active
- 2019-11-27 WO PCT/JP2019/046312 patent/WO2020174791A1/ja active Application Filing
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JPWO2020174791A1 (ja) | 2021-12-23 |
WO2020174791A1 (ja) | 2020-09-03 |
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