JP2008503270A - 医療用ステント - Google Patents
医療用ステント Download PDFInfo
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- JP2008503270A JP2008503270A JP2007516792A JP2007516792A JP2008503270A JP 2008503270 A JP2008503270 A JP 2008503270A JP 2007516792 A JP2007516792 A JP 2007516792A JP 2007516792 A JP2007516792 A JP 2007516792A JP 2008503270 A JP2008503270 A JP 2008503270A
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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
- A61F2/82—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
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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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
-
- 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
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
- A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
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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
- 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
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
ほぼ管状の部材は、管状のステント壁により画定される一定のパターンの空隙を含み、かつ放射線不透過性材料は、複数の空隙内に浮遊している。放射線不透過性材料(例えば、放射線不透過性マーカ)は、ステント本体の一方の端部又は両方の端部に近接している。医療用ステントは複数の放射線不透過性マーカを含み、各放射線不透過性マーカは、空隙内に浮遊し、かつにステント本体の端部に近接して配置されている。ポリマーはステント本体の円周の約50パーセント以上にわたって延びる連続した要素を含み得る。ポリマーはリングの形状であり得る。リングはステント本体の厚みの約125パーセント又はそれ以下の厚み、及びステント本体の長さの約25パーセント又はそれ以下の幅、のうちの少なくとも一方を備えている。リングは、少なくとも二つのポリマー材料の層を含み得る。ポリマーはステント本体の縁部に合うように形状化され得る。ポリマーはフルオロポリマー(例えば、延伸ポリテトラフルオロエチレン)であり得る。ポリマーは放射線不透過性材料を封入する。放射線不透過性材料はポリマーに分散され得る。放射線不透過性材料は、放射線不透過性金属体を含み得る。放射線不透過性金属体(例えば、放射線不透過性マーカ)はステント本体の厚みの約110パーセント以下であり、かつステント本体の厚みの約75パーセント以上である厚みを有する。放射線不透過性金属体は、約0.0254mm(0.001インチ)乃至約0.254mm(0.01インチ)(例えば、約0.127mm(0.005インチ)乃至約0.2032mm(0.008インチ))の厚みを有する。放射線不透過性材料は、金属(例えば、タングステン、タンタル、白金、パラジウム、鉛、金、チタン、銀)、金属合金、金属酸化物、次炭酸ビスマス又は硫酸バリウムであり得る。放射線不透過性材料は、約10g/cm3以上の密度を有する。医療用ステントは更に治療剤を含み得る。ほぼ管状の部材及びポリマーのうちの少なくとも一方は治療剤を含み得る。
幾らかの実施形態において、放射線不透過性材料を含むポリマー本体を備えた内部人工器官の位置は容易に確認できる(例えば、X線透視法を用いて)。ある実施形態(例えば、内部人工器官の両方の端部がT字型の放射線不透過性マーカを備えたポリマーリングを含む実施形態)において、内部人工器官の位置と方向の両方が容易に確認できる。
その一方の端部又は両方の端部に(例えば、延伸ポリテトラフルオロエチレンから形成された)ポリマー本体を備えた内部人工器官は、その一方の端部又は両方の端部にポリマー本体を備えていない内部人工器官と比較して、ステント端部が影響を与える可能性(例えば、ステントの一方又は両方の端部との接触により身体の組織が傷つけられるというような体腔に対する害)がより少ない。ポリマー本体は、例えば尖形のステント端部を被覆し、周囲の組織に損傷を与える可能性が低減される。幾らかの実施形態において、ポリマー本体を含む内部人工器官は、そのようなポリマー本体を含んでいない内部人工器官よりも良好に疲労に耐え得る。
図1A及び1Bを参照すると、ステント10はストランド材料14から形成されるほぼ管状のステント本体12を含む。ストランド材料14は、ステント本体12の壁部に所定のパターンの空隙16を画定する。空隙16はステント10の拡張及び収縮を容易にし、同ステント10の可撓性を高める。ステント10は、その端部の各々に、ステント本体12に取り付けられたリング形状のポリマー本体18を含む。固体金属塊の形状である放射線不透過性マーカ20がポリマー本体18に埋め込まれている。複数のマーカがステント端部の円周方向に広がっている。
図2A乃至2Gを参照すると、放射線不透過性マーカを備えたステントの製造方法が図示されている。図2Aを参照すると、放射線不透過性マーカ20が予め成形されたポリマー(例えば、延伸ポリテトラフルオロエチレン)ストリップ52の一方の側50に取り付けられている。マーカ20は、噴霧すること及び低粘度分散体(例えば、TFE、FEP)中にマーカ20を浸漬することのうちの少なくとも一方を実施し、次いでマーカ20をポリマーストリップ52に配置することにより、同ポリマーストリップ52に接着される。ストリップ52は例えばオーブン内にて加熱され、それにより、分散体は硬化し、かつポリマーストリップ52と焼結又は部分的に焼結するであろう。実施形態において、加熱時の温度はポリマーストリップ52の融点未満である。従って、加熱によりポリマーストリップ52が軟化され、同ポリマーストリップ52が溶融されることなくマーカ20に接着される。実施形態において、低粘度分散体中のポリマーに、架橋、及びポリマーストリップ52との焼結若しくは部分的な焼結、のうちの少なくとも一方が施され、それによりマーカ20がポリマーストリップ52に固定される。効率的な製造のために、マーカ20が取り付けられるポリマーストリップはステントの円周より長くすることができる。その後、ストリップは所望のサイズのステントに収容されるべく所望の長さに切断される。
図4A乃至4Cは自己拡張型ステント200の送達を示す。ステント200はカテーテル202上に配置され、シース204により覆われている。標的部位に到達すると、シース204が後退され、かつステント200が体腔と接するように自己拡張する。ステント200の各端部にあるポリマー本体208に埋め込まれた放射線不透過性マーカ206はステント200の位置を決定する(例えば、X線試験により)。
図6A及び6Bを参照すると、ステント100のステント本体の端部102は、放射線不透過性マーカを収容するためのより大きな空隙容積を形成するために変更され得る。図6Aにおいて、応力(矢印Fにより示される)が点104に対して加えられ、より大きな放射線不透過性マーカ106(図6Bに示される)を収容するための空隙領域を増大するためにステントを変形する。代替的又は付随的に、ステントを形成するために使用されるストランド材料は、例えば、ステント端部にて、放射線不透過性マーカのための更なる空間を含むように、ステント形成工程時(例えば、製織時、編みこみ時、クローシェ編み時)に操作され得る。
Claims (26)
- 医療用ステントにおいて、
ほぼ管状の部材からなるステント本体であって、前記ほぼ管状の部材が少なくとも一つの空隙を画定する壁を含むステント本体と、
ポリマーによって前記ステント本体に結合された放射線不透過性材料と、
を含み、前記ポリマーは前記少なくとも一つの空隙にわたって広がっており、かつ前記放射線不透過性材料は前記少なくとも一つの空隙内に浮遊している、医療用ステント。 - 前記ほぼ管状の部材は管状のステント壁により画定された一定のパターンの空隙を含み、かつ前記放射線不透過性材料は複数の空隙内に浮遊している、請求項1に記載の医療用ステント。
- 前記放射線不透過性材料は前記ステント本体の端部に近接している、請求項1に記載の医療用ステント。
- 前記ポリマーは、前記ステント本体の円周の約50パーセント以上にわたって延びる連続した要素を含む、請求項1に記載の医療用ステント。
- 前記ポリマーはリングの形状である、請求項1に記載のステント。
- 前記リングは前記ステント本体の厚みの約125パーセント以下である厚みを有する、請求項5に記載の医療用ステント。
- 前記リングは前記ステント本体の長さの約25パーセント以下である幅を有する、請求項5に記載の医療用ステント。
- 前記ポリマーはフルオロポリマーである、請求項1に記載の医療用ステント。
- 前記ポリマーは延伸ポリテトラフルオロエチレンである、請求項1に記載の医療用ステント。
- 前記ポリマーは前記放射線不透過性材料を封入する、請求項1に記載の医療用ステント。
- 前記放射線不透過性材料は放射線不透過性金属体を含む、請求項1に記載の医療用ステント。
- 前記放射線不透過性金属体は前記ステント本体の厚みの約110パーセント以下であり、かつ同ステント本体の厚みの約75パーセント以上である厚みを有する、請求項11に記載の医療用ステント。
- 前記放射線不透過性金属体は、約0.0254mm(0.001インチ)乃至約0.254mm(0.01インチ)の厚みを有する、請求項11に記載の医療用ステント。
- 治療剤を更に含む、請求項1に記載の医療用ステント。
- 医療用ステントにおいて、
ほぼ管状の部材を画定するとともに、管状のステント壁により画定される一定のパターンの空隙を含むステント本体であって、同空隙の幾何学的形状及び位置のうちの少なくとも一方はステントの拡張及び収縮の少なくとも一方を容易にするように選択されるステント本体と、
前記空隙の一つに浮遊している放射線不透過性マーカと、
を含み、前記放射線不透過性マーカは、前記ステント本体とは関係なく同医療用ステントを放射線不透過性にする、医療用ステント。 - 前記放射線不透過性マーカは前記ステント本体の端部に近接して配置される、請求項15に記載の医療用ステント。
- ステントを形成する方法であって、前記方法は、
放射線不透過性材料を第一のポリマーと結合する工程と、
前記第一のポリマーを、ほぼ管状の部材を画定するステント本体の端部に取り付ける工程と、からなり、
前記ほぼ管状の部材は少なくとも一つの空隙を画定する壁を含み、前記第一のポリマーは前記少なくとも一つの間隙にわたって広がっており、かつ前記放射線不透過性材料は前記少なくとも一つの空隙内に浮遊している、方法。 - 前記第一のポリマーの第一のストリップを提供する工程と、
前記第一のポリマーの第一のストリップに複数の放射線不透過性マーカを配置する工程と、
前記第一のストリップをステント本体に取り付ける工程と、
を含む請求項17に記載の方法。 - 前記第一のストリップ上であって、前記ステント本体により画定される空隙に対応する位置に放射線不透過性マーカを配置する工程を含む、請求項18に記載の方法。
- 前記第一のストリップを取り付ける工程は、前記ステント本体と接触して前記第一のストリップを組み立てる工程と、前記第一のストリップを前記ステント本体に結合する工程と、を含む、請求項18に記載の方法。
- 前記第一のストリップを第二のストリップと結合する工程を更に含み、前記第二のストリップは第二のポリマーを含む、請求項20に記載の方法。
- 前記第一のストリップを前記第二のストリップに、接着結合する、溶融結合する、焼結する、又は部分的に焼結する工程を含む、請求項21に記載の方法。
- 前記第二のストリップを少なくとも一つの放射線マーカに適用して、同少なくとも一つの放射線マーカを封入する工程を更に含む、請求項21に記載の方法。
- 前記第一のストリップは、同第一のストリップを、焼結する若しくは部分的に焼結することにより、溶融することにより、又は接着剤により、前記ステント本体に取り付けられる、請求項18に記載の方法。
- 前記ステント本体により画定される空隙に少なくとも一つの放射線不透過性マーカを配置する工程を含む、請求項17に記載の方法。
- 前記第一のポリマーをステント本体の端部に取り付ける工程は、同第一のポリマーを同ステント本体の端部に部分的に焼結する工程を含む、請求項17に記載の方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/872,164 US20050283226A1 (en) | 2004-06-18 | 2004-06-18 | Medical devices |
PCT/US2005/021521 WO2006009867A1 (en) | 2004-06-18 | 2005-06-16 | Medical stents |
Publications (1)
Publication Number | Publication Date |
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JP2008503270A true JP2008503270A (ja) | 2008-02-07 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2007516792A Pending JP2008503270A (ja) | 2004-06-18 | 2005-06-16 | 医療用ステント |
Country Status (5)
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US (1) | US20050283226A1 (ja) |
EP (1) | EP1778129A1 (ja) |
JP (1) | JP2008503270A (ja) |
CA (1) | CA2570914A1 (ja) |
WO (1) | WO2006009867A1 (ja) |
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JP2014171893A (ja) * | 2013-03-11 | 2014-09-22 | Depuy Synthes Products Llc | 脈管装置のための改善された放射線不透過性マーカー |
JP2016527058A (ja) * | 2013-08-09 | 2016-09-08 | ボストン サイエンティフィック サイムド,インコーポレイテッドBoston Scientific Scimed,Inc. | 放射線不透過性コネクタを備えた非外傷性ステントおよび方法 |
KR101761713B1 (ko) * | 2016-03-28 | 2017-07-26 | 주식회사 시브이바이오 | 마커를 구비한 혈관용 생분해성 고분자 스텐트 |
KR20220065505A (ko) * | 2020-11-13 | 2022-05-20 | 주식회사 시브이바이오 | 혈관의 굴곡에 대비하여 위치별 다른 외피길이를 갖는 인조혈관 스텐트 |
KR20220065496A (ko) * | 2020-11-13 | 2022-05-20 | 주식회사 시브이바이오 | 혈관의 굴곡에 대비한 환상부재 주기를 달리하는 인조혈관 스텐트 |
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Also Published As
Publication number | Publication date |
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US20050283226A1 (en) | 2005-12-22 |
CA2570914A1 (en) | 2006-01-26 |
WO2006009867A1 (en) | 2006-01-26 |
EP1778129A1 (en) | 2007-05-02 |
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