JP5701497B2 - ステントの分解を調節し、pHを中性に維持するためのコーティングを有する吸収性ステント - Google Patents
ステントの分解を調節し、pHを中性に維持するためのコーティングを有する吸収性ステント Download PDFInfo
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- JP5701497B2 JP5701497B2 JP2009266016A JP2009266016A JP5701497B2 JP 5701497 B2 JP5701497 B2 JP 5701497B2 JP 2009266016 A JP2009266016 A JP 2009266016A JP 2009266016 A JP2009266016 A JP 2009266016A JP 5701497 B2 JP5701497 B2 JP 5701497B2
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- 238000006386 neutralization reaction Methods 0.000 description 1
- 239000002840 nitric oxide donor Substances 0.000 description 1
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- OSTGTTZJOCZWJG-UHFFFAOYSA-N nitrosourea Chemical compound NC(=O)N=NO OSTGTTZJOCZWJG-UHFFFAOYSA-N 0.000 description 1
- 230000000399 orthopedic effect Effects 0.000 description 1
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- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 1
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- VSAISIQCTGDGPU-UHFFFAOYSA-N tetraphosphorus hexaoxide Chemical compound O1P(O2)OP3OP1OP2O3 VSAISIQCTGDGPU-UHFFFAOYSA-N 0.000 description 1
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- MNRILEROXIRVNJ-UHFFFAOYSA-N tioguanine Chemical compound N1C(N)=NC(=S)C2=NC=N[C]21 MNRILEROXIRVNJ-UHFFFAOYSA-N 0.000 description 1
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- 230000008467 tissue growth Effects 0.000 description 1
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- 229960005294 triamcinolone Drugs 0.000 description 1
- GFNANZIMVAIWHM-OBYCQNJPSA-N triamcinolone Chemical compound O=C1C=C[C@]2(C)[C@@]3(F)[C@@H](O)C[C@](C)([C@@]([C@H](O)C4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 GFNANZIMVAIWHM-OBYCQNJPSA-N 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- 229910000391 tricalcium phosphate Inorganic materials 0.000 description 1
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- YFHICDDUDORKJB-UHFFFAOYSA-N trimethylene carbonate Chemical class O=C1OCCCO1 YFHICDDUDORKJB-UHFFFAOYSA-N 0.000 description 1
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Images
Classifications
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- 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
- A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
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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
- A61L31/02—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
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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
- A61L31/148—Materials at least partially resorbable by the body
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- A61L2420/00—Materials or methods for coatings medical devices
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Description
本発明は移植式の医療機器に関し、より詳細には、ステントの分解時の分解速度を調節し、pHを中性に維持するための薬剤徐放性コーティングを有する吸収性の金属ステントに関する。
(関連技術の説明)
多くのエンドプロテーゼの目的は患者の体内の管腔内部の支持機能を与えることである。したがってエンドプロテーゼは移植可能であり、かつ支持機能を与える支持体/足場を有する設計となっている。金属材料のインプラントは公知のものである。こうした性質を有するインプラントの支持体又は足場構造体用の材料としての金属の選択は特に金属の機械的性質に基づいて行われる。
〔発明が解決しようとする課題〕
マグネシウム及びマグネシウム合金製のステントが抱えている潜在的な問題点として、マグネシウム及び/又はマグネシウム合金は生体内で急速に分解してしまい、その組成を調整して分解時間を大きく変化させることが比較的困難である点がある。更に局所的なpHレベルの上昇が腐食速度を更に加速し、周辺組織に対する負荷となる傾向がある。
本発明は上記に大まかに述べたようなマグネシウム合金製のステントに関連した制約を解決するものである。
他の元素、特にアルミニウムは、大幅に大きな速度で分解してステントの近傍にアルカリ性環境を形成する溶性の電解質を滲出させ、これにより主な金属イオンの分解を速め、ステントの機械的強度が早期に失われる可能性がある。
(1) 生体分解性の金属材料から形成された足場構造体と、
前記足場構造体に付着させられた少なくとも1つのコーティングと、を含み、前記少なくとも1つのコーティングが、少なくとも100キロダルトン(1.661×10-19g)の分子量を有するポリラクチドと10キロダルトン(1.661×10-20g)未満の分子量を有するポリラクチドとの混合物を含み、低分子量のポリラクチドに対する高分子量のポリラクチドの重量比が約5:1〜約1:5の範囲である、管腔内医療機器。
(2) 生体分解性の金属材料から形成された足場構造体と、
前記足場構造体に付着させられた少なくとも1つのコーティングと、を含み、前記少なくとも1つのコーティングが、少なくとも100キロダルトン(1.661×10-19g)の分子量を有するポリラクチド−コ−グリコリドと10キロダルトン(1.661×10-20g)未満の分子量を有するポリラクチド−コ−グリコリドとの混合物を含み、前記低分子量のポリラクチド−コ−グリコリドに対する前記高分子量のポリラクチド−コ−グリコリドの重量比が約5:1〜約1:5の範囲である、管腔内医療機器。
(3) 生体分解性の金属材料から形成された足場構造体と、
前記足場構造体に付着させられた少なくとも1つのコーティングと、を含み、前記少なくとも1つのコーティングが、少なくとも100キロダルトン(1.661×10-19g)の分子量を有するポリカプロラクトンと10キロダルトン(1.661×10-20g)未満の分子量を有するポリラクチド−コ−グリコリドとの混合物を含み、ポリラクチド−コ−グリコリドに対するポリカプロラクトンの重量比が約5:1〜約1:5の範囲である、管腔内医療機器。
(4) 生体分解性の金属材料から形成された足場構造体と、
前記足場構造体に付着させられた少なくとも1つのコーティングと、を含み、前記少なくとも1つのコーティングが、少なくとも100キロダルトン(1.661×10-19g)の分子量を有するポリラクチドと10キロダルトン(1.661×10-20g)未満の分子量を有しかつカルボキシル末端基を有するポリラクチドとの混合物を含み、カルボキシル末端基を有する低分子量のポリラクチドに対する高分子量のポリラクチドの重量比が約5:1〜約1:5の範囲である、管腔内医療機器。
(5) 生体分解性の金属材料から形成された足場構造体と、
前記足場構造体に付着させられた少なくとも1つのコーティングと、を含み、前記少なくとも1つのコーティングが、少なくとも100キロダルトン(1.661×10-19g)の分子量を有するポリラクチド−コ−グリコリドと10キロダルトン(1.661×10-20g)未満の分子量を有しかつカルボキシル末端基を有するポリラクチド−コ−グリコリドとの混合物を含み、カルボキシル末端基を有する低分子量のポリラクチド−コ−グリコリドに対する高分子量のポリラクチド−コ−グリコリドの重量比が約5:1〜約1:5の範囲である、管腔内医療機器。
(6) 生体分解性の金属材料から形成された足場構造体と、
前記足場構造体に付着させられた少なくとも1つのコーティングと、を含み、前記少なくとも1つのコーティングは、少なくとも100キロダルトン(1.661×10-19g)の分子量を有するポリカプロラクトンと10キロダルトン(1.661×10-20g)未満の分子量を有しかつカルボキシル末端基を有するポリラクチド−コ−グリコリドとの混合物を含み、カルボキシル末端基を有するポリラクチド−コ−グリコリドに対するポリカプロラクトンの重量比が約5:1〜約1:5の範囲である、管腔内医療機器。
(7) 病理学的状態を治療するために治療上の有効量で局所的に放出される治療薬を更に含む、実施態様1に記載の管腔内機器。
(8) 病理学的状態を治療するために治療上の有効量で局所的に放出される治療薬を更に含む、実施態様2に記載の管腔内機器。
(9) 病理学的状態を治療するために治療上の有効量で局所的に放出される治療薬を更に含む、実施態様3に記載の管腔内機器。
(10) 病理学的状態を治療するために治療上の有効量で局所的に放出される治療薬を更に含む、実施態様4に記載の管腔内機器。
(11) 病理学的状態を治療するために治療上の有効量で局所的に放出される治療薬を更に含む、実施態様5に記載の管腔内機器。
(12) 病理学的状態を治療するために治療上の有効量で局所的に放出される治療薬を更に含む、実施態様6に記載の管腔内機器。
Claims (6)
- 生体分解性の金属材料から形成された足場構造体と、
前記足場構造体に付着させられた少なくとも1つのコーティングと、を含み、前記少なくとも1つのコーティングが、少なくとも100キロダルトン(1.661×10−19g)の分子量を有するポリラクチドと10キロダルトン(1.661×10−20g)未満の分子量を有するポリラクチドとの生体分解性の混合物を含み、前記混合物は、低分子量のポリラクチドに対する高分子量のポリラクチドの重量比が約5:1〜約1:5の範囲であり、分解すると局所pHを低下させるかまたは前記金属材料の分解による局所pHの上昇を抑制するかもしくは遅らせるのに十分な酸性分解物を生成する、管腔内医療機器。 - 前記生体分解性の金属材料がマグネシウムの比率が90%よりも高いマグネシウム合金である、請求項1に記載の管腔内機器。
- 生体分解性の金属材料から形成された足場構造体と、
前記足場構造体に付着させられた少なくとも1つのコーティングと、を含み、前記少なくとも1つのコーティングが、少なくとも100キロダルトン(1.661×10−19g)の分子量を有するポリラクチドと10キロダルトン(1.661×10−20g)未満の分子量を有しかつカルボキシル末端基を有するポリラクチドとの生体分解性の混合物を含み、前記混合物は、カルボキシル末端基を有する低分子量のポリラクチドに対する高分子量のポリラクチドの重量比が約5:1〜約1:5の範囲であり、分解すると局所pHを低下させるかまたは前記金属材料の分解による局所pHの上昇を抑制するかもしくは遅らせるのに十分な酸性分解物を生成する、管腔内医療機器。 - 前記生体分解性の金属材料がマグネシウムの比率が90%よりも高いマグネシウム合金である、請求項3に記載の管腔内機器。
- 病理学的状態を治療するために治療上の有効量で局所的に放出される治療薬を更に含む、請求項1または2に記載の管腔内機器。
- 病理学的状態を治療するために治療上の有効量で局所的に放出される治療薬を更に含む、請求項3または4に記載の管腔内機器。
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