JP4617095B2 - 制御された薬剤投与のための薬剤溶出性ステント - Google Patents
制御された薬剤投与のための薬剤溶出性ステント Download PDFInfo
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- A—HUMAN NECESSITIES
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- 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
- A61L31/16—Biologically active materials, e.g. therapeutic substances
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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
- A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
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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
- A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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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
- 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
- A61L31/022—Metals or alloys
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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
- 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
- A61L31/146—Porous materials, e.g. foams or sponges
-
- 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
- A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/91533—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
- A61F2002/91541—Adjacent bands are arranged out of phase
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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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
-
- 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
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
- A61L2300/608—Coatings having two or more layers
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Description
薬剤ポリマーステントの製造方法、薬剤ポリマーステントを用いる血管の病気の治療方法も又本明細書において開示される。
本発明の種々の実施形態は、添付の図面に示されている。
ポリマーバリヤ層は又、薬剤の投与にも使用できる。例えば、抗血栓薬、例えばヒルジン又はペパリンを急性血栓症の予防のために外側ポリマーメンブレンに混ぜ込むことができる。
所望ならば、例えばステントフレーム構造に形成されたリザーバからの2種類以上の薬剤の制御された段階的投与の場合に、第3の薬剤ポリマーを塗布するのがよい。
本発明の範囲は、特許請求の範囲の記載に基づいて定められ、文言上の意味及び均等範囲に属する全ての変更は、本発明に包含されるものである。
120 リザーバ
130 薬剤ポリマー
210 ステントフレーム構造
220 リザーバ
222 第1の開放領域
224 第2の開放領域
810 ステントフレーム構造
820 リザーバ
830 薬剤ポリマー
834 第1の層
836 バリヤ層
838 第2の層
840,842 キャップ層
Claims (31)
- 薬剤を体内血管に投与するステントであって、
複数のリザーバが形成されたステントフレーム構造と、
前記リザーバに位置決めされた薬剤ポリマーと、
該薬剤ポリマー上に配置され医薬物質を含まないキャップ層を有するポリマー層と、を備えている、
ことを特徴とするステント。 - 前記ステントフレーム構造は、金属基材又はポリマー基材のうち一方から成る、請求項1記載のステント。
- 前記ステントフレーム構造の基材は、ステンレス鋼、ニチノール、タンタル、MP35N合金、プラチナ、チタン、適当な生体適合性合金、適当な生体適合性ポリマー及びこれらの組合せから成る群から選択された材料から成る、請求項2記載のステント。
- 前記リザーバは貫通穴から成り、これらの貫通穴は、前記ステントフレーム構造の外面に位置した第1の開放領域及びステントフレーム構造の内面に位置した第2の開放領域を有する、請求項1記載のステント。
- 前記貫通穴は、見掛け上一様な直径のものである、請求項4記載のステント。
- 少なくとも1つの貫通穴はテーパしており、該テーパした貫通穴は、前記ステントフレーム構造の外面のところに大きな直径を有する、請求項4記載のステント。
- 前記貫通穴は、前記ステントフレーム構造の外面のところに第1の直径を有し、前記ステントフレーム構造の内面のところに第2の直径を有し、前記第1の直径は、前記第2の直径よりも大きい、請求項4記載のステント。
- 貫通穴は、ステントフレーム構造の内面に位置した小さな開口部及びステントフレーム構造の外面に位置した大きな細長い開口部を有していることを特徴とする請求項4記載のステント。
- ステントフレーム構造は、ステントを拡張したときに応力を減少させるよう貫通穴の付近に拡大部を有していることを特徴とする請求項4記載のステント。
- ステントフレーム構造の内面に被着されたキャップ層を更に有し、キャップ層は、貫通穴の少なくとも一部を被覆すると共にステントフレーム構造の内面からの薬剤ポリマー中の薬剤の溶出速度を制御するバリヤ特性を発揮することを特徴とする請求項4記載のステント。
- リザーバは、ステントフレーム構造の外面に沿って設けられたチャネルから成ることを特徴とする請求項1記載のステント。
- 薬剤ポリマーは、治療用製剤を含むことを特徴とする請求項1記載のステント。
- 治療用製剤は、アンチセンス薬、抗腫瘍薬、抗増殖薬、抗血栓薬、抗凝固薬、抗血小板物質、抗生物質、抗炎症薬、治療用ペプチド、遺伝子治療薬、治療物質、有機薬剤、医薬物質、組換えDNA生成物、組換えRNA生成物、コラーゲン、膠原性誘導体、タンパク質、タンパク質類似体、サッカリド、サッカリド誘導体及びこれらの組合せから成る群から選択されていることを特徴とする請求項12記載のステント。
- 薬剤ポリマーとポリマー層との間に位置したバリヤ層を更に有していることを特徴とする請求項1記載のステント。
- バリヤ層は、シリコーン−ウレタンコポリマー、ポリウレタン、フェノキシ、エチレンビニルアセテート、ポリカプロラクトン、ポリ(ラクチド−コ−グリコリド)、ポリラクチド、ポリスルホン、エラスチン、フィブリン、コラーゲン、コンドロイチン硫酸、生体適合性ポリマー、生安定性ポリマー、生分解性ポリマー及びこれらの混合物から成る群から選択されたポリマーで構成されていることを特徴とする請求項14のステント。
- 薬剤ポリマーは、抗増殖薬を含む第1の薬剤ポリマー層と、抗炎症薬を含む第2の薬剤ポリマー層と、アンチセンス薬を含む第3の薬剤ポリマー層とから成り、アンチセンス薬、抗炎症薬及び抗増殖薬は、ステントを配備すると、段階的に溶出することを特徴とする請求項1記載のステント。
- キャップ層は、薬剤ポリマー及びステントフレーム構造の内面又は外面の少なくとも一部に被着されていることを特徴とする請求項1記載のステント。
- キャップ層は、シリコーン−ウレタンコポリマー、ポリウレタン、フェノキシ、エチレンビニルアセテート、ポリカプロラクトン、ポリ(ラクチド−コ−グリコリド)、ポリラクチド、ポリスルホン、エラスチン、フィブリン、コラーゲン、コンドロイチン硫酸、生体適合性ポリマー、生安定性ポリマー、生分解性ポリマー及びこれらの混合物から成る群から選択されたポリマーで構成されていることを特徴とする請求項1記載のステント。
- ステントフレーム構造と薬剤ポリマーとの間に位置した接着層を更に有していることを特徴とする請求項1記載のステント。
- 接着層は、ポリウレタン、フェノキシ、ポリ(ラクチド−コ−グリコリド)、ポリラクチド、ポリスルホン、ポリカプロラクトン、接着促進剤及びこれらの混合物から成る群から選択されていることを特徴とする請求項19記載のステント。
- ステントフレーム構造に結合されたカテーテルを更に有していることを特徴とする請求項1記載のステント。
- カテーテルは、ステントを拡張させるために用いられるバルーンを有していることを特徴とする請求項21記載のステント。
- カテーテルは、ステントの拡張を可能にするよう引っ込むシースを有していることを特徴とする請求項21記載のステント。
- 薬剤ポリマーステントを製造する方法であって、
ステントフレーム構造を用意し、
複数のリザーバを前記ステントフレーム構造に切断形成し、
薬剤ポリマーを少なくとも1つの前記リザーバに塗布し、
前記薬剤ポリマーを乾燥させ、
乾燥した薬剤ポリマー上に医薬物質を含まないキャップ層を有するポリマー層を配置し、
前記ポリマー層を乾燥させる
ことを含む方法。 - 前記複数のリザーバは、レーザで切断形成される、請求項24記載の方法。
- 前記薬剤ポリマーは、吹付け、浸漬、塗装、はけ塗り及び計量分配から成る群から選択された方法を用いて塗布される、請求項24記載の方法。
- 薬剤ポリマーは、マスクを用いて少なくとも1つのリザーバに塗布される、請求項24記載の方法。
- ポリマー層は、薬剤ポリマー、バリヤ層又はキャップ層のうち1つを有する、請求項24記載の方法。
- ポリマー層は、吹付け、浸漬、塗装、はけ塗り及び計量分配から成る群から選択された方法を用いて被着される、請求項24記載の方法。
- ポリマー層は、マスクを用いてステントフレーム構造の内面又は外面の少なくとも一部に被着される、請求項24記載の方法。
- 接着層を薬剤ポリマーの塗布に先だって少なくとも1つのリザーバに被着させる工程を更に有する、請求項24記載の方法。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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US10/408,920 US7163555B2 (en) | 2003-04-08 | 2003-04-08 | Drug-eluting stent for controlled drug delivery |
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Publication Number | Publication Date |
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JP2004305753A JP2004305753A (ja) | 2004-11-04 |
JP4617095B2 true JP4617095B2 (ja) | 2011-01-19 |
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JP2004113103A Expired - Fee Related JP4617095B2 (ja) | 2003-04-08 | 2004-04-07 | 制御された薬剤投与のための薬剤溶出性ステント |
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US (1) | US7163555B2 (ja) |
EP (1) | EP1466634B1 (ja) |
JP (1) | JP4617095B2 (ja) |
DE (1) | DE602004015182D1 (ja) |
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US7713297B2 (en) | 1998-04-11 | 2010-05-11 | Boston Scientific Scimed, Inc. | Drug-releasing stent with ceramic-containing layer |
US20050283228A1 (en) * | 1998-07-29 | 2005-12-22 | Stanford Ulf H | Expandable stent with relief holes capable of carrying medicines and other materials |
US8382821B2 (en) | 1998-12-03 | 2013-02-26 | Medinol Ltd. | Helical hybrid stent |
US20040267349A1 (en) | 2003-06-27 | 2004-12-30 | Kobi Richter | Amorphous metal alloy medical devices |
EP1132058A1 (en) * | 2000-03-06 | 2001-09-12 | Advanced Laser Applications Holding S.A. | Intravascular prothesis |
US8088060B2 (en) * | 2000-03-15 | 2012-01-03 | Orbusneich Medical, Inc. | Progenitor endothelial cell capturing with a drug eluting implantable medical device |
US20160287708A9 (en) * | 2000-03-15 | 2016-10-06 | Orbusneich Medical, Inc. | Progenitor Endothelial Cell Capturing with a Drug Eluting Implantable Medical Device |
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US7208010B2 (en) * | 2000-10-16 | 2007-04-24 | Conor Medsystems, Inc. | Expandable medical device for delivery of beneficial agent |
DE69926017T2 (de) * | 1998-04-27 | 2005-12-22 | SurModics, Inc., Eden Prairie | Bioaktive Wirkstoffe freisetzende Beschichtungen |
DE60133053T2 (de) | 2000-10-16 | 2009-02-26 | Conor Medsystems, Inc., Menlo Park | Ausdehnbare medizinische Vorrichtung zur Abgabe eines nützlichen Agens |
US6758859B1 (en) * | 2000-10-30 | 2004-07-06 | Kenny L. Dang | Increased drug-loading and reduced stress drug delivery device |
US6517888B1 (en) | 2000-11-28 | 2003-02-11 | Scimed Life Systems, Inc. | Method for manufacturing a medical device having a coated portion by laser ablation |
US7163555B2 (en) | 2003-04-08 | 2007-01-16 | Medtronic Vascular, Inc. | Drug-eluting stent for controlled drug delivery |
-
2003
- 2003-04-08 US US10/408,920 patent/US7163555B2/en not_active Expired - Lifetime
-
2004
- 2004-04-07 JP JP2004113103A patent/JP4617095B2/ja not_active Expired - Fee Related
- 2004-04-08 DE DE602004015182T patent/DE602004015182D1/de not_active Expired - Lifetime
- 2004-04-08 EP EP04008616A patent/EP1466634B1/en not_active Expired - Fee Related
Also Published As
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US20040204750A1 (en) | 2004-10-14 |
US7163555B2 (en) | 2007-01-16 |
EP1466634B1 (en) | 2008-07-23 |
DE602004015182D1 (de) | 2008-09-04 |
JP2004305753A (ja) | 2004-11-04 |
EP1466634A1 (en) | 2004-10-13 |
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