JP4407946B2 - 放射線不透過性延伸ポリテトラフルオロエチレン製医療デバイス - Google Patents
放射線不透過性延伸ポリテトラフルオロエチレン製医療デバイス Download PDFInfo
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- JP4407946B2 JP4407946B2 JP2004564690A JP2004564690A JP4407946B2 JP 4407946 B2 JP4407946 B2 JP 4407946B2 JP 2004564690 A JP2004564690 A JP 2004564690A JP 2004564690 A JP2004564690 A JP 2004564690A JP 4407946 B2 JP4407946 B2 JP 4407946B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Animal Behavior & Ethology (AREA)
- Cardiology (AREA)
- Pulmonology (AREA)
- Gastroenterology & Hepatology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Description
組合せデバイスを、放射線的手段によって検出可能なものとすることができる。構成上の変形例も、また、本発明の範囲内である。したがって、また、2つのグラフトの間にステントを介装することができる。あるいは、ステントを、従来技術によるグラフトによってカバーし、さらに、このグラフトを、放射線不透過性ePTFE製リボンによって巻回することができる。あるいは、これらを組み合わせることができる。得られるプロテーゼが放射線不透過性である限りにおいては、本発明による放射線不透過性ePTFEを使用したプロテーゼの構成には、何ら特別の制限はない。
5 放射線不透過性材料
6 ノード
7 フィブリル
8 ステント
10 グラフト
12 放射線不透過性ePTFEリボン
Claims (21)
- 放射線不透過性埋設可能プロテーゼであって、
ノードとフィブリルとからなる構造を有した延伸ポリテトラフルオロエチレン(以下、『ePTFE』と略記する)から形成されたポリマー製プロテーゼと;
前記ノードと前記フィブリルとからなる前記構造の少なくとも一部に対して一体化され、前記構造の少なくとも一部にわたり分散された放射線不透過性フィラーの複数の粒子と;
を具備し、ここで、
前記フィラーは、蛍光測定で検出可能となるに十分であり、血管造影手順への干渉を回避し、かつ、前記プロテーゼの構造的一体性をなお維持する量で存在し、前記量は、約5重量%から約20重量%までの範囲にあることを特徴とするプロテーゼ。 - 請求項1記載のプロテーゼにおいて、
前記プロテーゼが、血管グラフトと、ステントと、ステントカバーと、ステントライナーと、ステントとグラフトとの組合せからなるアセンブリと、カテーテルと、バルーンと、外科用フェルトと、からなるグループの中から選択されたものであることを特徴とするプロテーゼ。 - 請求項1記載のプロテーゼにおいて、
前記放射線不透過性フィラーが、金と、白金と、ステンレススチールと、チタンと、銀と、タンタルと、バリウムと、ビスマスと、イリジウムと、タングステンと、レニウムと、オスミウムと、イリジウムと、パラジウムと、これらの酸化物と、からなるグループの中の少なくとも1つからなる粒子とされていることを特徴とするプロテーゼ。 - 請求項1記載のプロテーゼにおいて、
前記放射線不透過性フィラーが、金粒子とされていることを特徴とするプロテーゼ。 - 請求項1記載のプロテーゼにおいて、
前記放射線不透過性フィラーが、前記プロテーゼ内に一様に分散されていることを特徴とするプロテーゼ。 - 請求項1記載のプロテーゼにおいて、
前記プロテーゼが、放射線に対して半透明であることを特徴とするプロテーゼ。 - 請求項1記載のプロテーゼにおいて、
前記放射線不透過性フィラーが、前記プロテーゼ内において、重量で20%という量でもって存在していることを特徴とするプロテーゼ。 - 請求項3記載のプロテーゼにおいて、
前記粒子が、0.05μm〜2μmという平均直径を有していることを特徴とするプロテーゼ。 - 請求項8記載のプロテーゼにおいて、
前記粒子が、0.05μm〜0.5μmという平均直径を有していることを特徴とするプロテーゼ。 - 請求項9記載のプロテーゼにおいて、
前記粒子が、0.05μm〜0.1μmという平均直径を有していることを特徴とするプロテーゼ。 - 請求項10記載のプロテーゼにおいて、
前記放射線不透過性フィラーが、金粒子とされていることを特徴とするプロテーゼ。 - 請求項1記載のプロテーゼにおいて、
前記プロテーゼが、放射線不透過性ではない第1ePTFE部分と、放射線不透過性とされた第2ePTFE部分と、を備えていることを特徴とするプロテーゼ。 - 請求項12記載のプロテーゼにおいて、
前記第2ePTFE部分が、前記第1ePTFE部分に対して結合されていることを特徴とするプロテーゼ。 - 放射線不透過性血管グラフトであって、
ノードとフィブリルとからなる構造を有した延伸ポリテトラフルオロエチレン(以下、『ePTFE』と略記する)から形成された血管グラフトと;
前記ノードと前記フィブリルとからなる前記構造の少なくとも一部に対して一体化され、前記構造の少なくとも一部にわたり分散された放射線不透過性フィラーの複数の粒子と;
を具備し、ここで、
前記フィラーは、蛍光測定で検出可能となるに十分であり、血管造影手順への干渉を回避し、かつ、前記プロテーゼの構造的一体性をなお維持する量で存在し、前記量は、約5重量%から約20重量%までの範囲にあることを特徴とする血管グラフト。 - 請求項14記載の血管グラフトにおいて、
前記フィラーが、複数の金粒子とされていることを特徴とする血管グラフト。 - 請求項14記載の血管グラフトにおいて、
さらに、前記グラフトに関連したステントを具備していることを特徴とする血管グラフト。 - 請求項15記載の血管グラフトにおいて、
前記金粒子が、0.05μm〜0.1μmという直径を有していることを特徴とする血管グラフト。 - 放射線不透過性埋設可能プロテーゼの形成方法であって、
前記プロテーゼが、延伸ポリテトラフルオロエチレン(以下、『ePTFE』と略記する)から形成されたポリマー製プロテーゼと;前記ePTFE構造のノードとフィブリルとからなる構造に対して一体化された放射線不透過性フィラーと;を具備してなるものであり、
前記方法においては、
PTFE粉末と潤滑剤と放射線不透過性フィラーの複数の粒子とを混合し、これにより、混合物を形成し;
前記混合物を円筒形ビレット内において加圧下で予成形し、これにより、前記ビレットの全体にわたって前記放射線不透過性フィラーの粒子を分散させ;
前記ビレットを所定形状を有した物品へと押し出し;
前記物品を、膨張させあるいは延伸させあるいは膨張と延伸との双方を行い、これにより、前記ePTFEの前記ノードと前記フィブリルとからなる前記構造に対して前記放射線不透過性フィラーが一体化された延伸された放射線不透過性プロテーゼを形成し、ここで、前記フィラーは、蛍光測定で検出可能となるに十分であり、血管造影手順への干渉を回避し、かつ、前記プロテーゼの構造的一体性をなお維持する量で存在し、前記量は、約5重量%から約20重量%までの範囲にあり;
前記延伸された放射線不透過性プロテーゼを焼結し、これにより、焼結された放射線不透過性プロテーゼを形成する;
ことを特徴とする方法。 - 請求項18記載の方法において、
前記放射線不透過性フィラーを、金粒子とすることを特徴とする方法。 - 請求項19記載の方法において、
さらに、前記プロテーゼに対して少なくとも1つの薬剤を添加することを特徴とする方法。 - さらに、前記放射線不透過性材料が、約5重量%から約30重量%の範囲で前記プロテーゼ中に存在する、請求項1に記載の放射線不透過性埋設可能プロテーゼ。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/324,367 US8088158B2 (en) | 2002-12-20 | 2002-12-20 | Radiopaque ePTFE medical devices |
PCT/US2003/026514 WO2004060210A1 (en) | 2002-12-20 | 2003-08-26 | Radiopaque eptfe medical devices |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2006511283A JP2006511283A (ja) | 2006-04-06 |
JP4407946B2 true JP4407946B2 (ja) | 2010-02-03 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2004564690A Expired - Fee Related JP4407946B2 (ja) | 2002-12-20 | 2003-08-26 | 放射線不透過性延伸ポリテトラフルオロエチレン製医療デバイス |
Country Status (8)
Country | Link |
---|---|
US (1) | US8088158B2 (ja) |
EP (1) | EP1578311B2 (ja) |
JP (1) | JP4407946B2 (ja) |
AT (1) | ATE456939T1 (ja) |
AU (1) | AU2003265641A1 (ja) |
CA (1) | CA2509729A1 (ja) |
DE (1) | DE60331197D1 (ja) |
WO (1) | WO2004060210A1 (ja) |
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-
2002
- 2002-12-20 US US10/324,367 patent/US8088158B2/en not_active Expired - Fee Related
-
2003
- 2003-08-26 AT AT03814585T patent/ATE456939T1/de not_active IP Right Cessation
- 2003-08-26 EP EP03814585.0A patent/EP1578311B2/en not_active Expired - Lifetime
- 2003-08-26 AU AU2003265641A patent/AU2003265641A1/en not_active Abandoned
- 2003-08-26 DE DE60331197T patent/DE60331197D1/de not_active Expired - Lifetime
- 2003-08-26 WO PCT/US2003/026514 patent/WO2004060210A1/en active Application Filing
- 2003-08-26 JP JP2004564690A patent/JP4407946B2/ja not_active Expired - Fee Related
- 2003-08-26 CA CA002509729A patent/CA2509729A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
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JP2006511283A (ja) | 2006-04-06 |
EP1578311B1 (en) | 2010-02-03 |
DE60331197D1 (de) | 2010-03-25 |
AU2003265641A1 (en) | 2004-07-29 |
CA2509729A1 (en) | 2004-07-22 |
ATE456939T1 (de) | 2010-02-15 |
EP1578311A1 (en) | 2005-09-28 |
US8088158B2 (en) | 2012-01-03 |
WO2004060210A1 (en) | 2004-07-22 |
US20040122509A1 (en) | 2004-06-24 |
EP1578311B2 (en) | 2014-01-22 |
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