JP5907354B2 - デポ剤保持機能部を有する埋め込み可能なプロテーゼ - Google Patents
デポ剤保持機能部を有する埋め込み可能なプロテーゼ Download PDFInfo
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- JP5907354B2 JP5907354B2 JP2013502640A JP2013502640A JP5907354B2 JP 5907354 B2 JP5907354 B2 JP 5907354B2 JP 2013502640 A JP2013502640 A JP 2013502640A JP 2013502640 A JP2013502640 A JP 2013502640A JP 5907354 B2 JP5907354 B2 JP 5907354B2
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Images
Classifications
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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
-
- 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
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
-
- 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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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y80/00—Products made by additive manufacturing
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Optics & Photonics (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Physics & Mathematics (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)
Description
Claims (27)
- 管状構造体を形成する複数の相互接続される支柱と、複数の生体吸収性デポ剤とを備える、埋め込み可能な管腔内プロテーゼであって、
前記支柱の各々が、径方向内側に面する管腔内面と、径方向外側に面する管腔外面とを有し、前記支柱のうちの少なくとも一部が、前記管腔外面および前記管腔内面に配置される対向する端部開口を伴う複数の貫通穴を有し、前記貫通穴の各々が、該貫通穴の中間部分に幾何学的保持機能部を伴う内面を有し、前記幾何学的保持機能部が、前記貫通穴の拡張部に対応するあるいは前記貫通穴の狭窄部に対応する所定の形状を有し、
前記生体吸収性デポ剤の各々が前記貫通穴のうちの別個の1つ内で保持され、前記各貫通穴の前記幾何学的保持機能部が、前記生体吸収性デポ剤の分子量、強度、または、質量の減少の後に前記生体吸収性デポ剤を該貫通穴内に保持するように構成され、
前記貫通穴の拡張ボリュームは、一部または全部が生体吸収性デポ剤の第1の層で満たされ或いは占められ、前記貫通穴の狭窄ボリュームは、一部または全部が生体吸収性デポ剤の第2の層で満たされ或いは占められ、前記第1の層は、加水分解劣化に対する耐性が第2の層における生体吸収性高分子よりも高い生体吸収性高分子を含む、埋め込み可能な管腔内プロテーゼ。 - 前記生体吸収性デポ剤が、生体吸収性高分子と混合される治療薬の組成体から成る、請求項1に記載の管腔内プロテーゼ。
- 前記管状構造体の表面上にコーティングを更に備え、前記コーティングが、前記生体吸収性デポ剤の治療薬と同じあるいは異なる治療薬を保持する、請求項2に記載の管腔内プロテーゼ。
- 前記管状構造体の任意の管腔内面上および任意の管腔外面上に薬物コーティングが存在しない、請求項1に記載の管腔内プロテーゼ。
- 前記貫通穴が前記支柱の非微粒子基体材料に形成される、請求項1に記載の管腔内プロテーゼ。
- 前記幾何学的保持機能部が前記貫通穴の狭窄部であり、前記狭窄部が、前記貫通穴の両方の端部開口の交差寸法よりも小さい交差寸法を有する、請求項1に記載の管腔内プロテーゼ。
- 前記幾何学的保持機能部が前記貫通穴の拡張部であり、前記拡張部が、前記貫通穴の両方の端部開口の交差寸法よりも大きい交差寸法を有する、請求項1に記載の管腔内プロテーゼ。
- 前記各貫通穴の内面が前記端部開口のうちの一方から前記端部開口のうちの他方に連続的に延び、前記内面が凸状である、請求項1に記載の管腔内プロテーゼ。
- 前記各貫通穴の内面が前記端部開口のうちの一方から前記端部開口のうちの他方に連続的に延び、前記内面が凹状である、請求項1に記載の管腔内プロテーゼ。
- 前記各貫通穴の前記幾何学的保持機能が、該貫通穴の内面に形成される複数の溝を備える、請求項1に記載の管腔内プロテーゼ。
- 前記幾何学的保持機能が、少なくとも一部が、基体材料の積み重ねられた層によって規定され、前記各層が、直接に隣接する層の穴と位置合わせされる穴を有し、前記層のうちの少なくとも1つの穴が、前記貫通穴の拡張部または狭窄部の交差寸法を規定する、請求項1に記載の管腔内プロテーゼ。
- 前記生体吸収性デポ剤が生体吸収性高分子から成る複数の層を備え、薬物組成体および高分子組成体のうちのいずれか一方または両方が複数の前記層間で異なる、請求項1に記載の管腔内プロテーゼ。
- 前記生体吸収性デポ剤が生体吸収性高分子から成る複数の層を備え、前記生体吸収性デポ剤が、前記生体吸収性高分子の同じ層または異なる層にある薬物を備える、請求項1に記載の管腔内プロテーゼ。
- 相互接続される構造部材から成る管状フレームと、複数の生体吸収性デポ剤とを備える、埋め込み可能な管腔内プロテーゼであって、
前記管状フレームが径方向に拡張するように構成され、前記構造部材のうちの少なくとも一部には複数の貫通穴が形成され、前記貫通穴の各々が、2つの端部開口と、前記端部開口間で延びる内面とを備え、前記内面が予め選択されたサイズおよび形状の窪みを有し、
前記生体吸収性デポ剤の各々が前記貫通穴のうちの別個の1つに保持され、前記各生体吸収性デポ剤が治療薬と生体吸収性高分子とを備え、前記各生体吸収性デポ剤は、前記各生体吸収性デポ剤が内部に保持される前記貫通穴の前記窪み内に延びる突出部を備え、前記生体吸収性デポ剤が前記端部開口のうちの少なくとも一方から抜け出すのを防止するために、前記突出部と前記窪みとが互いに係合され、
前記突出部は、前記生体吸収性デポ剤の他の部分における生体吸収性高分子より加水分解劣化に対する耐性が高い生体吸収性高分子を含む、埋め込み可能な管腔内プロテーゼ。 - 前記貫通穴の全てが、略直線状でかつ径方向に方向付けられる中心軸線を有し、前記中心軸線が、前記貫通穴の前記端部開口のそれぞれの中心を通って延びる、請求項14に記載の管腔内プロテーゼ。
- 前記管状フレームが中心軸線を有し、前記各貫通穴が、前記中心軸線に対して略垂直な末端間長さを有する、請求項15に記載の管腔内プロテーゼ。
- 前記窪みが前記貫通穴の中間部分にある、請求項14に記載の管腔内プロテーゼ。
- 前記内面が凹状である、請求項17に記載の管腔内プロテーゼ。
- 前記窪みが前記貫通穴の前記端部開口のうちの一方にある、請求項14に記載の管腔内プロテーゼ。
- 前記内面が凸状である、請求項19に記載の管腔内プロテーゼ。
- 前記窪みが前記貫通穴の中心軸線の周りで全周にわたって延び、前記中心軸線が前記貫通穴の前記端部開口のそれぞれの中心を通って延びる、請求項14に記載の管腔内プロテーゼ。
- 前記生体吸収性高分子が患者内への埋め込み時に加水分解劣化を受け、前記生体吸収性高分子が前記生体吸収性デポ剤の中間部分および端部分に配置される、請求項14に記載の管腔内プロテーゼ。
- 埋め込み可能な管腔内プロテーゼを形成する方法であって、
相互接続される構造部材から成る管状フレームを形成するステップと、
前記構造部材に複数の貫通穴を形成するステップと、
前記貫通穴の各々の内面に窪みを形成するステップと、
前記各貫通穴に生体吸収性デポ剤を形成するステップであり、前記生体吸収性デポ剤が内部に保持される前記貫通穴の前記窪みと係合する前記生体吸収性デポ剤の突出部を形成する工程を備え、前記突出部と前記窪みとの係合が前記生体吸収性デポ剤の前記貫通穴の端部開口からの抜け出しを防止するステップと、
を備え、
前記突出部は、前記生体吸収性デポ剤の他の部分における生体吸収性高分子より加水分解劣化に対する耐性が高い生体吸収性高分子を含む、方法。 - 前記貫通穴を形成する前記ステップが、前記管状フレームを形成する前記ステップの後に行なわれ、前記窪みを形成する前記ステップが、前記貫通穴を形成する前記ステップの後に行なわれる、請求項23に記載の方法。
- 前記窪みが、凹面、凸面、および、溝のうちのいずれか1つである、請求項23に記載の方法。
- 前記貫通穴を形成する前記ステップが、前記貫通穴のうちの1つの端部開口を形成するように前記構造部材へ向けてレーザを方向付けた後、前記貫通穴のうちの1つの内部に拡張ボリュームまたはテーパ状の内面を形成するために前記構造部材に対するレーザの方向角度を変化させる工程を備える、請求項23に記載の方法。
- 前記管状フレームおよび前記貫通穴が、基体材料の層を積み重ねることによって形成され、前記層の各々が、直接に隣接する層の複数の穴と位置合わせされる複数の穴を有し、前記層のうちの少なくとも1つの複数の穴が前記貫通穴の内面に前記窪みを形成する、請求項23に記載の方法。
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US12/752,757 | 2010-04-01 | ||
US12/752,757 US8562670B2 (en) | 2010-04-01 | 2010-04-01 | Implantable prosthesis with depot retention feature |
PCT/US2011/029305 WO2011123282A1 (en) | 2010-04-01 | 2011-03-22 | Implantable prosthesis with depot retention feature |
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US7731890B2 (en) | 2006-06-15 | 2010-06-08 | Advanced Cardiovascular Systems, Inc. | Methods of fabricating stents with enhanced fracture toughness |
US8747879B2 (en) | 2006-04-28 | 2014-06-10 | Advanced Cardiovascular Systems, Inc. | Method of fabricating an implantable medical device to reduce chance of late inflammatory response |
US9517149B2 (en) | 2004-07-26 | 2016-12-13 | Abbott Cardiovascular Systems Inc. | Biodegradable stent with enhanced fracture toughness |
US7971333B2 (en) | 2006-05-30 | 2011-07-05 | Advanced Cardiovascular Systems, Inc. | Manufacturing process for polymetric stents |
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US8562670B2 (en) | 2013-10-22 |
US9439792B2 (en) | 2016-09-13 |
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