JP2009542359A - 選択的被覆部を備えた医療装置 - Google Patents

選択的被覆部を備えた医療装置 Download PDF

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JP2009542359A
JP2009542359A JP2009518446A JP2009518446A JP2009542359A JP 2009542359 A JP2009542359 A JP 2009542359A JP 2009518446 A JP2009518446 A JP 2009518446A JP 2009518446 A JP2009518446 A JP 2009518446A JP 2009542359 A JP2009542359 A JP 2009542359A
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medical device
wall surface
lumen
coating
covering portion
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ウェーバー、ヤン
アタナソスカ、リリアナ
リー ザ サード シッピー、ジェームズ
イー． パーソネージ、エドワード
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Boston Scientific Limited
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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
    • 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
    • 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
    • A61L31/08—Materials for coatings
    • A61L31/082—Inorganic materials
    • A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
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    • 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
    • A61L31/08—Materials for coatings
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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
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
    • A61F2002/30322—The prosthesis having different structural features at different locations within the same prosthesis differing in surface 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
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0026—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in surface 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
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0056—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in wettability, e.g. in hydrophilic or hydrophobic behaviours
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00598—Coating or prosthesis-covering structure made of compounds based on metal oxides or hydroxides
    • A61F2310/00616—Coating made of titanium oxide or hydroxides
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/0097—Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D1/00—Processes for applying liquids or other fluent materials
    • B05D1/32—Processes for applying liquids or other fluent materials using means for protecting parts of a surface not to be coated, e.g. using stencils, resists

Abstract

内部人工器官のような医療装置及び同医療装置を製造する方法が開示されている。幾らかの実施形態において、同医療装置は、管腔内壁面と管腔外壁面とを有するとともに中央に管腔若しくは通路を定義する長尺管状構造体を形成する、相互に連結されたバンドとコネクタとからなる本体を含む。長尺管状構造体を貫通する横断方向の通路を形成するバンド及びコネクタの管腔内壁面と側壁面とは親水性材料の被覆部を備えており、管状構造体の管腔外壁面は疎水性材料の被覆部を備える。

Description

本発明は、内部人工器官（例えば、ステント）のような医療装置に関する。
本願は、２００６年６月２９日出願の米国仮特許出願第６０／８１８１０１号の優先権を主張する。米国仮特許出願第６０／８１８１０１号の内容は参照により本願の一部として組込まれる。
身体は、動脈、その他の血管及びその他の体腔のような種々の通路を定義する。これらの通路は時として閉塞したり、弱くなったりする。例えば、同通路は腫瘍により閉塞したり、プラークにより狭小化されたり、或いは動脈瘤により脆弱化したりする。このような状態が起こった場合、同通路は、医療用内部人工器官を用いて、再開口されたり、補強されたり、更には同医療用内部人工器官と置き換えられたりする。内部人工器官は典型的には身体の管腔に配置される管状部材である。内部人工器官の例としては、ステント、被覆されたステント及びステント移植体が含まれる。
内部人工器官はカテーテルによって身体の内部に送達され、同カテーテルは、同内部人工器官を所望の部位に輸送する際に、同内部人工器官を圧縮された、又はサイズが低減された形態にて支持する。所望の部位に送達されると、同内部人工器官は、体腔の壁部と接触するように、例えば拡張されるか、又は拡張可能となる。
内部人工器官は、活性を有する薬剤を含む、生体適合性材料及び生体分子の少なくともいずれかにて被覆され得る。
本明細書の開示は、内部人工器官のような医療装置に関する。本発明は特に、ステントのような内部人工器官上に複雑な生体分子被覆パターンを形成することを可能にする、親水性材料及び疎水性材料のうちの少なくとも一方を用いて同内部人工器官を被覆する発見に基づくものである。
一態様において、開示は、内側の管腔内壁面と外側の管腔外壁面とを有するとともに中央に管腔若しくは通路を定義する長尺管状構造体を形成する、相互に連結されたバンドとコネクタとからなる本体を有する医療装置であって、長尺管状構造体を貫通する横断方向の通路を形成するバンド及びコネクタの内側管腔内壁面と側壁面とは親水性材料の被覆部を備えており、同管状構造体の外側管腔外壁面は疎水性材料の被覆部を備える、医療装置を特徴とする。
実施形態は以下の特徴の一つ以上を含み得る。
同医療装置の管腔内壁面及び側壁面の少なくとも一つ以上の選択された領域は、親水性材料、例えば超親水性材料の被覆部を備え得るか、或いは医療装置の管腔内壁面及び側壁面の全体が、親水性材料、例えば超親水性材料の被覆部を備え得る。医療装置の管腔の外側面の少なくとも一つ以上の選択された領域は疎水性材料の被覆部を備え得るか、或いは同医療装置の管腔外壁面全体が疎水性材料の被覆部を備え得る。
内壁面、側壁面及び外壁面の被覆部は、チタン（＋ｙ）酸化物（−ｘ）（ＴｉｘＯｙ）、例えば二酸化チタンを含み得る。チタン（＋ｙ）酸化物（−ｘ）は、結晶構造を有し、例えば、アナターゼ相又はルチル相の状態であり得る。チタン（＋ｙ）酸化物（−ｘ）は非晶相であり得る。チタン（＋ｙ）酸化物（−ｘ）は、以下の相：ルチル、ブルッカイト、単斜晶系、非晶質系、チタン（＋ｙ）酸化物（−ｘ）（ＩＩ）、及びチタン（＋ｙ）酸化物（−ｘ）（Ｈ）のうちの少なくとも一つと組み合わせられたアナターゼ相の状態であり得る。チタン（＋ｙ）酸化物（−ｘ）は、ナノ多孔性、例えば、メソ多孔性、又はマイクロ多孔性であり得る。チタン（＋ｙ）酸化物（−ｘ）は一般的には滑らかで、即ち、ナノ多孔性ではない場合もある。チタン（＋ｙ）酸化物（−ｘ）に加え、被覆部は、リン、例えば５質量％までのリンを含み得る。チタン（＋ｙ）酸化物（−ｘ）及び／またはリンに加え、被覆部は酸化イリジウム若しくは酸化ルテニウム、或いはそれらの両方を含み得る。チタン（＋ｙ）酸化物（−ｘ）は以下の元素：即ち、鉄、炭素、窒素、ビスマス及びバナジウムのうちの少なくとも一つでドープされており、例えば、ビスマス及びバナジウムの両者でドープされ得る。有機化合物の層、例えば、アルキルシラン、アリールシラン及び／又はフルオロアルキルシランの層を、チタン（＋ｙ）酸化物（−ｘ）被覆部上に堆積することもできる。被覆部上に堆積され得る有機化合物の特殊な例は、オクタデシルシラン及びリン酸オクタデシルを含む。
管腔外壁面上の被覆部はまた、例えばパクリタキセルのような生体分子、及び例えばポリ（スチレン−ｂ−イソブチレン−ｂ−スチレン）のようなポリマーを含み得る。管腔外壁面の被覆部はまた、有機溶媒又は疎水性の脂質カプセルを含み得る。管腔外壁面の被覆部、例えば、生体分子を備えたチタン（＋ｙ）酸化物（−ｘ）の被覆部、例えば生体分子を備えた二酸化チタン被覆部は、例えば二酸化チタンのようなチタン（＋ｙ）酸化物（−ｘ）の第二の層を含み得る。
管腔内壁面及び側壁面上の被覆部はまた、例えばヘパリンのような生体分子を含み得る。
管腔外壁面、管腔内壁面及び側壁面上の被覆部は生体分子を含み得る。管腔外壁面被覆部の生体分子は、管腔内壁面及び側壁面の被覆部の生体分子と異なるタイプのものであり得る。
別の態様において、開示は、内側管腔内壁面と外側管腔外壁面とを有するとともに中央に管腔若しくは通路を定義する長尺管状構造体を形成する、相互に連結されたバンドとコネクタとからなる本体を有する医療装置であって、長尺管状構造体を貫通する横断方向の通路を形成するバンド及びコネクタの内側管腔内壁面と側壁面とは疎水性材料の被覆部を備えており、同管状構造体の外側管腔外壁面は親水性材料の被覆部を備える、医療装置を特徴とする。
実施形態は以下の特徴の一つ以上を含み得る。
同医療装置の管腔内壁面及び側壁面の少なくとも一つ以上の選択された領域は、疎水性材料の被覆部を備え得るか、或いは医療装置の管腔内壁面及び側壁面の全体が、疎水性材料の被覆部を備え得る。医療装置の管腔外側面の少なくとも一つ以上の選択された領域は親水性材料、例えば超親水性材料の被覆部を備え得るか、或いは同医療装置の外壁面全体が親水性材料、例えば超親水性材料の被覆部を備え得る。
内壁面、側壁面及び外壁面の被覆部は、チタン（＋ｙ）酸化物（−ｘ）、例えば二酸化チタンを含み得る。チタン（＋ｙ）酸化物（−ｘ）は、結晶構造を有し、例えば、アナターゼ相又はルチル相の状態であり得る。チタン（＋ｙ）酸化物（−ｘ）は非晶相であり得る。チタン（＋ｙ）酸化物（−ｘ）は、以下の相：ルチル、ブルッカイト、単斜晶系、非晶質系、チタン（＋ｙ）酸化物（−ｘ）（ＩＩ）、及びチタン（＋ｙ）酸化物（−ｘ）（Ｈ）のうちの少なくとも一つと組み合わせられたアナターゼ相の状態であり得る。チタン（＋ｙ）酸化物（−ｘ）は、ナノ多孔性、例えば、メソ多孔性、又はマイクロ多孔性であり得る。チタン（＋ｙ）酸化物（−ｘ）は一般的には滑らかで、即ち、ナノ多孔性ではない場合もある。チタン（＋ｙ）酸化物（−ｘ）に加え、被覆部は、リン、例えば５質量％までのリンを含み得る。チタン（＋ｙ）酸化物（−ｘ）及び／またはリンに加え、被覆部は酸化イリジウム若しくは酸化ルテニウム、或いはそれらの両方を含み得る。チタン（＋ｙ）酸化物（−ｘ）は以下の元素：即ち、鉄、炭素、窒素、ビスマス及びバナジウムのうちの少なくとも一つでドープされており、例えば、ビスマス及びバナジウムの両者でドープされ得る。有機化合物の層、例えば、アルキルシラン、アリールシラン及び／又はフルオロアルキルシランの層を、チタン（＋ｙ）酸化物（−ｘ）被覆部上に堆積することもできる。被覆部上に堆積され得る有機化合物の特殊な例は、オクタデシルシラン及びリン酸オクタデシルを含む。
管腔外壁面の被覆部は生体分子も含み得る。管腔外壁面の被覆部、例えば、生体分子を備えたチタン（＋ｙ）酸化物（−ｘ）の被覆部、例えば、生体分子を備えた二酸化チタン被覆部は、例えば二酸化チタンのようなチタン（＋ｙ）酸化物（−ｘ）の第二の層を含み得る。
管腔内壁面及び側壁面上の被覆部もまた生体分子を含み得る。同生体分子を含み得る被覆部はまた、例えばポリ（スチレン−ｂ−イソブチレン−ｂ−スチレン）のようなポリマーを含み得る。管腔内壁面及び側壁面の被覆部はまた、有機溶媒又は疎水性の脂質カプセルを含み得る。管腔内壁面及び側壁面の被覆部、例えば、生体分子を備えたチタン（＋ｙ）酸化物（−ｘ）の被覆部、例えば、生体分子備えた二酸化チタン被覆部は、例えば二酸化チタンのようなチタン（＋ｙ）酸化物（−ｘ）の第二の層を含み得る。
管腔外壁面、管腔内壁面及び側壁面上のコーティングは生体分子を含み得る。管腔外壁面被覆部の生体分子は、管腔内壁面及び側壁面の被覆部の生体分子と異なるタイプのものであり得る。
別の態様において、開示は、医療装置を製造する方法を特徴とし、同方法は：
（ｉ）内側管腔内壁面と外側管腔外壁面とを有するとともに中央に管腔若しくは通路を定義する長尺管状構造体を形成する相互に連結されたバンドとコネクタとからなる本体を有する医療装置であって、同バンド及びコネクタの内側管腔内壁面と側壁面が長尺管状構造体を貫通する横断方向の通路を形成する医療装置を、親水性のチタン（＋ｙ）酸化物（−ｘ）、例えば二酸化チタンで被覆する工程と；
（ｉｉ）同医療装置を、同チタン（＋ｙ）酸化物（−ｘ）の被覆部が疎水性となり得るのに十分な条件下にさらす工程と；
（ｉｉｉ）同医療装置の選択された表面を、同チタン（＋ｙ）酸化物（−ｘ）の被覆部が超親水性となり得るのに十分な条件下にさらす工程と；
（ｉｖ）同医療装置を所望の生体分子と適合性を有する第一の溶液内にて被覆する工程と；
を含み得る。
実施形態は以下の特徴の一つ以上を含み得る。
第一の溶液は、非極性又は極性であり得る。第一の溶液は、例えばパクリタキセル又はヘパリンのような所望の生体分子を含み得る。第一の溶液はまた、例えばポリ（スチレン−ｂ−イソブチレン−ｂ−スチレン）のようなポリマーを含み得る。第一の溶液は疎水性脂質カプセルを含み得る。
第一の溶液は、医療装置の親水性表面に接着されるように構成された少なくとも一つの極性溶媒と、医療装置の疎水性表面に接着するように構成された少なくとも一つの非極性溶媒とを含み得る。同溶液は、少なくとも一つの溶媒と適合性である少なくとも一つの生体分子、例えば、極性溶媒と適合性の第一の生体分子と、非極性溶媒と適合性の第二の生体分子と、を備え得る。第一の生体分子はヘパリンであり、第二の生体分子はパクリタキセルであり得る。第一の溶液は更に、例えばポリ（スチレン−ｂ−イソブチレン−ｂ−スチレン）のようなポリマーを含み得る。第一の溶液は、生体分子を含有する疎水性脂質カプセル並びに親水基を含み得る。
同方法は更に、所望の生体分子と適合性の第二の溶液中にて医療装置を被覆する工程を備え得る。第二の溶液は、非極性又は極性であり得る。第二の溶液は、例えばパクリタキセル又はヘパリンのような生体分子を含み得る。第二の溶液はまた、ポリマーを含み得る。第二の溶液は疎水性脂質カプセルを含み得る。
同方法は、工程（ｉ）の医療装置を、例えば、アルキルシラン、アリールシラン及び／またはフルオロアルキルシラン、特に、オクタデシルシラン又はリン酸オクタデシルのような有機化合物の層で被覆する更なる工程を含み得る。
工程（ｉｉ）の条件は、医療装置を暗所に配置する工程及び／または水研ぎ（ｗｅｔ−ｒｕｂｂｉｎｇ）する工程を含み得る。工程（ｉｉｉ）の条件は、被覆部を備えた医療装置の表面を紫外線で照射する工程を含み得る。被覆部を備えた管腔内壁面及び側壁面の少なくとも一つの領域が照射され得る。被覆部を備えた管腔外壁面の少なくとも一つの領域が照射され得る。工程（ｉｉｉ）はまた、超親水性となった表面の少なくとも一つの領域を、例えば、水研ぎによるような、又は同医療装置を暗所に配置することによるような、疎水性とするのに十分な条件、にさらす工程を含む。
工程（ｉｖ）の被覆工程は、浸漬コーティング、ガスアシスト噴霧、静電塗装、エレクトロスピニング及び／またはロールコーティングであり得る。
チタン（＋ｙ）酸化物（−ｘ）被覆部は、二酸化チタン被覆部であり得る。被覆部は、例えば、ルチル相又はアナターゼ相の状態のような、結晶構造を備え得る。チタン（＋ｙ）酸化物（−ｘ）は、非晶質であり得る。チタン（＋ｙ）酸化物（−ｘ）は、以下の相：ルチル、ブルッカイト、単斜晶系、非晶質系、チタン（＋ｙ）酸化物（−ｘ）（ＩＩ）、及びチタン（＋ｙ）酸化物（−ｘ）（Ｈ）のうちの少なくとも一つと組み合わせられたアナターゼ相の状態であり得る。チタン（＋ｙ）酸化物（−ｘ）は、ナノ多孔性、例えば、メソ多孔性、又はマイクロ多孔性であり得る。チタン（＋ｙ）酸化物（−ｘ）は一般的には滑らかで、即ち、ナノ多孔性ではない場合もある。チタン（＋ｙ）酸化物（−ｘ）に加え、被覆部は、リン、例えば５質量％までのリンを含み得る。チタン（＋ｙ）酸化物（−ｘ）及び／またはリンに加え、被覆部は酸化イリジウム若しくは酸化ルテニウム、或いはそれらの両方を含み得る。チタン（＋ｙ）酸化物（−ｘ）は以下の元素：即ち、鉄、炭素、窒素、ビスマス及びバナジウムのうちの少なくとも一つでドープされており、例えば、ビスマス及びバナジウムの両者でドープされ得る。有機化合物の層、例えば、アルキルシラン、アリールシラン及び／又はフルオロアルキルシランの層を、チタン（＋ｙ）酸化物（−ｘ）被覆部上に堆積することもできる。被覆部上に堆積され得る有機化合物の特殊な例は、オクタデシルシラン及びリン酸オクタデシルを含む。
本願の開示は、種々のパターンの疎水性被覆部及び親水性被覆部を備えたステントを提供する。これらの被覆パターンはステントの種々の領域に種々の生体分子を配置することを可能にし、ステント上に複雑な生体分子のパターンを形成し得る。同開示はまた、そのような複雑な被覆部及び／または生体分子パターンを備えたステントを形成する方法を提供する。
本明細書にて使用されるように、「生体分子」なる用語は、生物学的な影響を与える化合物、治療剤、薬物、製薬組成物及び類似の物質を参照する。
特に明記しない限り、本明細書中で使用するすべての技術用語及び科学用語は、本発明が属する分野の当業者によって一般に理解されている意味を有する。本明細書に記載したものと類似または同等の方法および材料を、本発明の実施または試験において用いることができるが、適切な方法および材料については以下に記載する。本明細書中で述べたすべての出版物、特許出願、特許、および他の引例は、その全体が引用により本願に組み込まれる。抵触の場合には、定義を含めた本明細書が支配することになる。さらに、材料、方法および実施例は説明のためのものにすぎず、限定することを意図していない。
本開示のその他の特徴及び利点は、以下の詳細な説明及び特許請求の範囲から明らかとなるであろう。
図１Ａを参照すると、長尺管状構造体を形成する相互に連結されたバンド１２とコネクタ１１とからなる本体を備えたステント１０が示されている。図１Ｂを参照すると、ステント１０本体の断面が、内側の管腔内面（ｉｎｎｅｒ ｌｕｍｉｎａｌ ｓｕｒｆａｃｅ）１３と、側壁面１４と、外側の管腔外面（ｏｕｔｅｒ ａｂｌｕｍｉｎａｌ ｓｕｒｆａｃｅ）１５とを有することが示されている。表面１３，１４及び１５はチタン（＋ｙ）酸化物（−ｘ）（ｔｉｔａｎｉｕｍ（＋ｙ）ｏｘｉｄｅ（−ｘ））の被覆部１６、例えば、二酸化チタン（ＴｉＯ２）を備えている。管腔内面１３と側壁面１４との被覆部１６は更に生体分子１７を含む。管腔外面１５の被覆部１６は更に生体分子１８を含む。
ステント１０は種々の方法により製造され得る。例えば、図２を参照すると、選択的に被覆された表面を備えたステント１０を製造する方法２０が記載されている。ステント１０が形成される（工程２１）。ステント１０の表面１３，１４及び１５はＴｉｘＯｙ、例えば、親水性のＴｉｘＯｙ、例えば超親水性のＴｉｘＯｙ、例えば超親水性のＴｉＯ２で被覆されて、被覆部１６が得られる（工程２２）。次に、ステント１０は、例えば、同ステント１０を数日間暗環境に置くことによる、又は“水研ぎ”（例えば、カメイ（Ｋａｍｅｉ）らのＳｕｒｆ．Ｓｃｉｅｎｃｅ、４６３：Ｌ６０９−１２，２０００を参照されたい）と称される工程によるような、ＴｉｘＯｙ被覆部１６を疎水性とするのに十分な条件にさらされる（工程２３）。同工程において、超親水性の表面は、表面の水酸基を除去することにより疎水性表面となる。
次に、ステント１０の選択された表面は、例えば紫外線に露出されることによるような、選択された表面の被覆部１６を親水性、例えば超親水性とするのに十分な条件にさらされる（工程２４）。例えば、図３Ａを参照すると、紫外線３０源が、ステント１０の管腔内側、例えば、ステント１０の内部に配置され得る。光源３０は、ＴｉｘＯｙの被覆部１６を備えた管腔内面１３及び側壁面１４を照射する。そのような照射は被覆部１６を超親水性とするであろう。光源３０が表面１３及び１４を照射する間、被覆部１６を備えた管腔外面１５は、例えばマンドレルを用いて露出から遮断される。従って、十分な照射の後、得られたステント１０は管腔内面１３及び側壁面１４が超親水性であり、かつ管腔外面１５が疎水性である被覆部１６を備える。
別の実施形態において、図３Ｂに示されるように、紫外線３０源が、一般的にはステント１０の管腔外側に配置され得る。光源３０は、ＴｉｘＯｙの被覆部１６を備えた管腔外面１５を照射する。光源３０が表面１５を照射する間、表面１３及び１４は遮断される。従って、十分な照射の後、得られたステント１０は管腔外面１５が親水性であり、かつ管腔内面１３及び側面１４が疎水性である被覆部１６を備える。
例えば紫外線にさらされるような光にさらされることと、水研ぎとは、いずれも選択されたマイクロスケールにて実施され得、実現され得るステント１０の親水性及び疎水性領域の範囲を非常に拡大する。上記したパターンに加えて、その他のパターンも実現可能である。例えば、管腔内面１３及び管腔外面１５の両方の被覆部１６を選択的に光にさらすことにより親水性とすることができる。別の例として、表面１３、１４及び／または１５のいずれかの被覆部１６の一部のみを親水性とすることができる。可能なパターンは無限である。
図２を更に参照すると、選択的に親水性及び疎水性である被覆部１６を備えたステント１０は次に、例えば、浸漬コーティング、ガスアシスト噴霧、静電塗装、エレクトロスピニングまたはロールコーティングにより、所望の生体分子１７及び１８と適合性を有する所望の物質中にて被覆される（工程２５）。例えば、ステント１０は、例えば、キシレン中にパクリタキセル（例えば、１重量％までのパクリタキセル）のような生体分子を含有し、選択的にポリマー（例えば、ポリ（スチレン−ｂ−イソブチレン−ｂ−スチレン）（ＳＩＢＳ））を含む非極性溶液中に浸漬する等により被覆される。非極性溶液及び生体分子は、疎水性の被覆部１６を備える照射されていない表面に接着する。ステントは乾燥され、かつこの工程が繰り返され、疎水性表面に層を構築することができる。別の実施形態において、ステント１０は、別の生体分子（例えば、ヘパリン）を含有する極性溶液中に浸漬する等により被覆される。極性溶液は、親水性被覆部１６を備える照射された表面に接着するであろう。更に別の実施形態において、ステント１０は、極性溶媒と非極性溶媒との組み合わせられたものであり、各々の溶媒に溶解された生体分子と選択的にポリマーとを含む溶媒の組み合わせを含む溶液中にて、浸漬コーティング、ガスアシスト噴霧、静電塗装、エレクトロスピニングまたはロールコーティングにより被覆され得る。この実施形態において、極性溶媒は、ステント１０の親水性領域に接着する一方、非極性溶媒はステント１０の疎水性領域に接着するであろう。得られたステント１０は複数の生体分子で選択的に被覆された表面を有するであろう。
従って、一実施形態において、ステント１０は親水性のＴｉｘＯｙの被覆部１６を備える。ステント１０は、被覆部１６を疎水性とするのに十分な時間、暗所に放置される。次に、管腔内面１３と側壁面１４とが紫外線源３０により照射され、超親水性とされる。親水性被覆部１６を備えたそのような管腔内面１３と側壁面１４とは、極性溶液及びヘパリンのような生体分子で被覆される。一方、疎水性被覆部１６を備えた管腔外面１５は、非極性溶液と、例えばパクリタキセル、例えばパクリタキセルとＳＩＢＳのような結合剤ポリマーとのような生体分子、で被覆される。一実施形態において、ステント１０は、極性溶媒と非極性溶媒との組み合わせられたものであり、各々の溶媒に溶解された生体分子と選択的にポリマーとを含む溶媒の組み合わせを含む溶液で被覆され得る。
別の実施形態において、ステント１０は親水性のＴｉｘＯｙの被覆部１６を備える。ステント１０は、同ステントを疎水性とするのに十分な時間、暗所に放置される。次に、被覆部１６を備えた管腔外面１５が紫外線源３０により照射され、超親水性になる。被覆部１６を備えた管腔内面１３と側壁面１４とは、非極性溶液及び生体分子で被覆される。管腔外面１５は、極性溶液と生体分子とで被覆される。一実施形態において、ステント１０は、極性溶媒と非極性溶媒との組み合わせられたものであり、各々の溶媒に溶解された生体分子と選択的にポリマーとを含む溶媒の組み合わせを含む溶液で被覆され得る。
上記に述べたように、別の実施形態において、被覆部１６を備える管腔内面１３及び側壁面１４の全体を照射する、或いは管腔外面１５の全体を照射する（図２の工程２４）よりはむしろ、表面１３、１４及び１５のいずれかの選択された領域が照射され、かつ選択された領域は、所望の極性及び非極性溶液中にて被覆され得る。任意の数の多岐にわたる被覆パターンが可能である。
図４を参照すると、選択的に被覆されるステント１０を製造する別の方法が示されている。ステント１０が形成される（工程４１）。ステント１０の表面１３，１４及び１５はＴｉｘＯｙ、例えば、親水性のＴｉｘＯｙ、例えば超親水性のＴｉｘＯｙ、例えば超親水性のＴｉＯ２で被覆されて、被覆部１６が得られる（工程４２）。次に、ステント１０は、例えば、同ステント１０を数日間暗環境に置くことによるような、ＴｉｘＯｙ被覆部１６を疎水性とするのに十分な条件にさらされる（工程４３）。次に、被覆部１６を備えるステント１０の表面１３、１４及び１５のうちの少なくとも一つ、或いは同ステント１０の表面１３、１４及び１５の選択された部分が、例えばＵＶ照射（例えば、ＸＥランプ、２０分の露出時間）により、同被覆部１６を親水性（例えば、超親水性）とするのに十分な条件にさらされる（工程４４）。ＵＶ照射にさらされる選択された表面は、被覆部１６を備えた全表面１３、１４及び１５を含み得る。ＵＶ照射にさらされた選択された表面は、次に、被覆部１６を疎水性にするのに十分な条件にさらす（工程４５）。同条件は、例えば、管腔内面及び管腔外面のような選択された表面、或いは表面の任意のその他の組み合わせを、ガラス、鉄鋼、又は紙の表面で、水研ぎすることを含む（例えば、カメイらを参照されたい）。ここでも、水研ぎ及びＵＶへの露出のいずれも選択されたマイクロスケールにて実施され得、実現され得る親水性及び疎水性領域のパターンの範囲を非常に拡大する。
更に図４を参照すると、ステント１０は、例えば浸漬コーティング、ガスアシスト噴霧、静電塗装、エレクトロスピニングまたはロールコーティングにより、所望の物質中にて被覆される（工程４６）。水研ぎの一つの興味深い用途は、それが、表面のみを、親水性かつ多孔性のＴｉｘＯｙ被覆部から疎水性の表面に変える一方、埋没している（下側の）多孔性の構造は親水性のままとする点にある。このことは、ステント１０を、異なる溶解薬物及び／またはポリマーを含む極性溶媒と非極性溶媒との種々の組み合わせを用いて被覆することを可能にし、多孔性のＴｉｘＯｙ被覆部内の最上部から底部まで対照的な被覆組成物を作製することを可能にする。一実施形態において、ステント１０は、例えば、パクリタキセル、例えばパクリタキセルとＳＩＢＳのような結合剤ポリマーとのような生体分子、を含む非極性溶液中、及び例えばヘパリン、例えばヘパリン及びポリマーである生体分子、を含有する極性溶液中にて、例えば浸漬コーティング、ガスアシスト噴霧、静電塗装、エレクトロスピニングまたはロールコーティングにより、被覆される。別の実施形態において、ステント１０は、極性溶媒と非極性溶媒とを組み合わせられたものであり、各々の溶媒に溶解された生体分子（例えば、薬物）と選択的にポリマーとを含む溶媒の組み合わせを含む溶液中にて、浸漬コーティング、ガスアシスト噴霧、静電塗装、エレクトロスピニングまたはロールコーティングにより被覆され得る。
別の実施形態において、ステント１０が所望の生体分子及びポリマーのうちの少なくとも一方で被覆されるとすぐに、第二の多孔性ＴｉｘＯｙ被覆が適用される。この実施形態において、ＴｉｘＯｙは高温工程を使用することなく適用される。ＴｉｘＯｙは、例えばマイクロ波支援蒸着を介して適用され得る。この実施形態において、ステント上の生体分子、例えばパクリタキセルは、第二のＴｉｘＯｙ層の孔を介して分散する。
別の実施形態において、親水性の生体分子は、疎水性の脂質カプセル（例えば、リポソーム）中に充填され、疎水性被覆部１６に適用され得る。
更に図４を参照すると、方法４０の工程４２は、例えばメソ多孔性であるナノ多孔性、或いはマイクロ多孔性であるＴｉｘＯｙでステント１０の選択された領域を、及びほぼ滑らかな、即ちナノ多孔性ではないＴｉｘＯｙでその他の選択された領域を、被覆する工程を含む。一実施形態において、ナノ多孔性被覆で被覆された領域は、管腔内面１３及び側壁面１４であり得る一方、滑らかな被覆部を備えた領域は、管腔外面１５であり得る。別の実施形態において、ナノ多孔性被覆で被覆された領域は管腔外面１５であり得る一方、滑らかな被覆部を備えた領域は、管腔内面１３及び側壁面１４であり得る。ナノ多孔性ＴｉｘＯｙ及び滑らかなＴｉｘＯｙで被覆されたステント１０全体は、次に、例えば、ＵＶ照射により、被覆部１６を超親水性とするのに十分な条件にさらされる（工程４４）。ステント１０全体は、次に、例えば、種々の日数若しくは週数のような特定の期間、同ステント１０を暗条件に配置することによるような、被覆部１６の選択された領域を疎水性にするのに十分な条件にさらされる（工程４５）。工程４５において、ナノ多孔性ＴｉｘＯｙで被覆された領域は、超親水性に維持される（例えば、グ（Ｇｕ）の、Ａｐｐ．Ｐｈｙｓ．Ｌｅｔｔ．、８５（２１）：５０６７−６９，２００４を参照されたい）一方、滑らかなＴｉｘＯｙで被覆された領域は疎水性となる。得られたステント１０は、所望の物質中にて、浸漬コーティング、ガスアシスト噴霧、静電塗装、エレクトロスピニングまたはロールコーティングにより被覆され得る（工程４６）。ステント１０は、既に述べたように、極性溶媒、非極性溶媒、或いは、適合性の生体分子及びポリマーの少なくとも一方を含有する極性溶媒及び非極性溶媒の組み合わせを含む溶液、で被覆され得る。
使用において、ステント１０は、例えばカテーテル送達システムを使用して送達される等のように使用される。カテーテルシステムは、例えば、ワング（Ｗａｎｇ）の米国特許第５１９５９６９号明細書、ハムリン（Ｈａｍｌｉｎ）の米国特許第５２７００８６号明細書及びラーデル−デヴェンス（Ｒａｅｄｅｒ−Ｄｅｖｅｎｓ）の米国特許第６７２６７１２号明細書に記載されている。ステント及びステント送達はまた、ボストンサイエンティフィックシメッド（ミネソタ州メープルグローブ所在）より入手可能なＲａｄｉｕｓ（登録商標）システム又はＳｙｍｂｉｏｔ（登録商標）システムにより例示される。例えば、生体分子１７及び１８のような一種類以上の生体分子を備えるステント１０は、例えば、血管中に生体分子を送達し得る。生体分子１７及び１８は血管の種々の細胞、例えば、内皮細胞又は平滑筋細胞を標的とし得る。
既に記載されているように、ステント１０の被覆部１６は、ＴｉｘＯｙ、好ましくは二酸化チタンを含み得る。チタン（ＩＶ）オキシド或いはチタニアとしても知られている二酸化チタンはチタンの天然由来の酸化物であり、化学式ＴｉＯ２である。ＴｉＯ２は、種々の形態：ルチル、アナターゼ、ブルッカイト、二酸化チタン（Ｂ）（単斜晶系）、二酸化チタン（ＩＩ）及び二酸化チタン（Ｈ）の形態にて発生する。カープ（Ｃａｒｐ）ら、Ｐｒｏｇ．Ｓｏｌｉｄ Ｓｔａｔｅ Ｃｈｅｍ．、３２：３３−１７７、２００４。ＴｉＯ２被覆部は血液適合性であることが知られている。マイツ（Ｍａｉｔｚ）ら、Ｂｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｃｏｒｐｏｒａｔｉｏｎ所内報告書、２００１；ツシガノフ（Ｔｓｙｇａｎｏｖ）ら、Ｓｕｒｆ．Ｃｏａｔ．Ｔｅｃｈ．、２００：１０４１−４４、２００５。血液適合性物質は血栓形成のほんのわずかな誘導を示す。ルチル相及びアナターゼ相の両方のＴｉＯ２は、血小板粘着の低下を示す。ルチル相の最上面にリンを注入すること（例えば、約２％乃至約５％のイオン密度にて）によりＴｉＯ２への血小板粘着が減少する。マイツら。
ＴｉｘＯｙ被覆部１６の多形、結晶構造及びドーピングは、ステント１０を形成及び使用する際に考慮することが必要な幾らかの要因である。ステント１０のＴｉｘＯｙ被覆部１６は、結晶であり得る（アナターゼ又はルチル構造）。結晶構造は光活性である。結晶構造はまた、生体分子１７及び１８の吸着及び貯蔵を容易にする空隙又は粗度を有し、同生体分子１７及び１８は、単独にて、或いはポリマー及びその他の生体分子の少なくとも一方との組み合わせにて、被覆部１６に配置され得る。被覆部１６はまた、非晶質であり得る（カルプチャミー（Ｋａｒｕｐｐｕｃｈａｍｙ）ら、Ｖａｃｕｕｍ、８０：４９４−９８、２００６）か、又は以下の相：アナターゼ、ルチル、ブルッカイト、非晶質系、単斜晶系、チタン（＋ｙ）酸化物（−ｘ）（ＩＩ）、及びチタン（＋ｙ）酸化物（−ｘ）（Ｈ）、のうちの一つ以上の組み合わせであり得る。
被覆用に純粋なＴｉｘＯｙを使用することに代えて、リンが、低い割合（例えば、約０．５乃至約５％）にてＴｉｘＯｙ層に埋め込まれ（例えば、プラズマ浸漬工程を使用して）、被覆部の血液適合性を増大させる。マイツら。
その他の実施形態において、被覆部１６は、ＴｉｘＯｙと酸化イリジウム（ＩｒＯｘ）の組み合わせ；或いはＴｉｘＯｙと酸化ルテニウム（ＲｕＯｘ）の組み合わせ；或いはＴｉｘＯｙとＩｒＯｘ及びＲｕＯｘの組み合わせであり得る。ＲｕＯｘ及びＩｒＯｘは身体においてステント１０を包囲する細胞にて起こる炎症の可能性を低減する。それは、これらの化合物が、ストレスを受けた細胞の副産物の破壊を触媒し得るからである。
一実施形態において、ＴｉｘＯｙ被覆部１６は、例えば、鉄（Ｆｅ）、炭素（Ｃ）、窒素（Ｎ）、ビスマス（Ｂｉ）、バナジウム（Ｖ）或いはそれらの組み合わせでドープされ得る。Ｆｅ−ドーピングは、光誘導される親水性のＴｉｘＯｙ変換率を高め、親水性の状態から疎水性の状態への変換率を低減する。ユ（Ｙｕ）ら、Ｍａｔ．Ｃｈｅｍ．Ｐｈｙｓ．、９５：１９３−９６、２００６。Ｂｉ−ドーピング及びＶ−ドーピングの少なくともいずれかは、水の接触角を低減する一方、Ｂｉ−Ｖ−ドーピングは暗条件下にて水の低い接触角の維持を促進する。ホン（Ｈｏｎｇ）ら、Ｍａｔ．Ｌｅｔｔ．、６０：１２９６−１３０５、２００６。Ｃ−ドーピングはまた、ＴｉＯ２の親水特性に影響を与えることが報告されている。イリエ（Ｉｒｉｅ）ら、Ｔｈｉｎ Ｓｏｌｉｄ Ｆｉｌｍｓ、５１０：２１−５、２００６。
ステント１０上にＴｉｘＯｙ被覆部１６を堆積させるために種々の技術が使用可能であり、同技術としては、ゾル−ゲル経路、カチオン電着が含まれる。（カルプチャミーら、Ｓｏｌｉｄ Ｓｔａｔｅ Ｉｏｎｉｃｓ、１５１：１９−２７、２００２；カルプチャミーら、Ｍａｔ．Ｃｈｅｍ．Ｐｈｙｓ．、９３：２５１−５４、２００５、ハットリ（Ｈａｔｔｏｒｉ）ら、Ｌａｎｇｕｍｕｉｒ、１５：５４２２−２５、１９９９。多くの堆積技術が高温処理工程にて使用され（例えば、約４００℃に加熱して）、堆積されたフィルムを結晶構造に変化させる。そのような高温工程が望ましくない場合（例えば、ステントが既にある種のポリマー、微小電気機械システム（ＭＥＭｓ）又は生体分子のような熱感受性の構成要素の被覆部を有する場合）、ＴｉｘＯｙのマイクロ波支援蒸着が使用され得る。ヴィギル（Ｖｉｇｉｌ）ら、Ｌａｎｇｕｍｕｉｒ、１７：８９１−９６、２００１、グレッセル−ミカエル（Ｇｒｅｓｓｅｌ−Ｍｉｃｈｅｌ）ら、Ｊ．Ｃｏｌｌ．Ｉｎｔｅｒｆ．Ｓｃｉｅｎｃｅ、２８５：６７４−７９、２００５。マイクロ波支援蒸着の一方法において、アナターゼ粒子が、マイクロ波リアクタを使用して懸濁液中にて直接合成され、（約７０ｎｍの直径である）粒子が室温にて浸漬コーティング工程により堆積される。グレッセル−ミカエルら。化学浴堆積はＴｉｘＯｙ堆積において高温工程を回避する別の方法である。パタン（Ｐａｔｈａｎ）ら、Ａｐｐ．Ｓｕｒｆ．Ｓｃｉｅｎｃｅ、２４６：７２−７６、２００５。
既に述べたように、親水性のＴｉｘＯｙ被覆部１６は、暗所に放置した場合に疎水性となるであろう。ユら、カルプチャミーら、２００５。しかしながら、ＴｉｘＯｙの被覆部は紫外線（ＵＶ）照射にさらした場合に疎水性から超親水性となることが知られている。この効果は、アナターゼ相及びルチル相（ユら）においてのみならず、非晶質相においても存在する（カルプチャミーら、Ｖａｃｕｕｍ、８０：４９４−９８、２００６）。ＴｉｘＯｙはまた、ＵＶ光の下では光触媒であるが、同光触媒効果はアナターゼ相にのみ存在している。超親水性表面は５°未満の角度で水と接触する。ＴｉｘＯｙの超親水性効果は、表面積が拡大することから（ユら、Ｊ．Ｐｈｏｔｏｃｈｅｍ．Ｐｈｏｔｏｂｉｏｌ．Ａ、１４８：３３１−３９、２００２）及びマイクロ多孔性構造であることから、ナノ多孔性構造、例えばメソ多孔性構造（孔の直径が２０乃至５００オングストローム）ではより大きい。従って、疎水性ＴｉｘＯｙ被覆部１６のＵＶ光源３０への露出（例えば、３６５ｎｍ、５ｍＷｃｍ−２）は同材料を超親水性へ戻す。
ＴｉｘＯｙ被覆部１６を備えたステント１０を照射するためのＵＶ光３０源は、例えば、高出力ダイオードレーザに接続されたファイバであり得る。ファイバは横からの照射を可能にするディフューザが装着されている。ファイバ、プラスチック製ロッド又はシートが切り欠き部分を備えている場合、光は材料の反対側から外へ反射される。光の均一性は、光源からの距離が増大するので、ノッチの深さ及び頻度を増大させることにより達成される。ステント１０内部においてこのファイバを回転させることにより、全ての方向における均一な照射が提供され得る。ファイバを回転させる代わりに、回転を必要としないで全ての方向を照射するように、ネジ切りされた（ｔｈｒｅａｄｅｄ）ノッチが形成され得る。ファイバは例えば、ｐｏｌｙＭｉｃｒｏ（ｗｗｗ．ｐｏｌｙｍｉｃｒｏ．ｃｏｍ）から入手可能である。シリカファイバは良好なＵＶ透過度を与える。ファイバは、例えば、約６００μｍ乃至約２ｍｍの直径であり得る。
既に述べたように、親水性の、例えば超親水性のＴｉｘＯｙ、例えば超親水性のＴｉＯ２で被覆されたステント１０を暗所に配置すると、ＴｉｘＯｙ被覆部１６は疎水性に変わるであろう。しかしながら、幾らかの実施形態において、親水性の、例えば超親水性のＴｉｘＯｙで被覆されたステントを疎水性に変えることなく保存する（例えば、暗所にて、例えば梱包状態にて）ことが望ましい場合もある。超親水性表面から疎水性表面へ戻すことは、ＴｉｘＯｙのナノ多孔性（逆オパール）構造を使用することにより回避され得る。グら、Ａｐｐ．Ｐｈｙ．Ｌｅｔｔ．、８５（２１）：５０６７−６９、２００４。
一実施形態において、例えば、アルキルシラン、アリールシラン及び／又はフルオロアルキルシランのような有機化合物の相が、疎水性ＴｉｘＯｙ上に堆積され得る。例えば、疎水性ＴｉｘＯｙ被覆部１６の上にあるオクタデシルシラン又はリン酸オクタデシルの層は被覆部１６の超疎水性状態及び安定性を高め得る。バラウア（Ｂａｌａｕｒ）ら、Ｅｌｅｃｔｒｏｃｈｅｍ．Ｃｏｍｍｕｎｉｃ．、７：１０６６−７０、２００５。この実施形態における被覆部１６は、所望に応じて、ＵＶ光の照射により、親水性、例えば超親水性に変換され得る。
ステント１０は、ステンレス鋼（例えば、３１６Ｌ、ＢｉｏＤｕｒ（登録商標）１０８（ＵＮＳ Ｓ２９１０８））及び３０４Ｌステンレス鋼のような金属材料、ステンレス鋼と、米国特許出願公開第２００３−００１８３８０Ａ１号、米国特許出願公開第２００２−０１４４７５７Ａ１号及び米国特許出願第２００３−００７７２００Ａ１号に記載されているような５乃至６０重量％の一つ以上の放射線不透過性元素（例えば、Ｐｔ、Ｉｒ、Ａｕ、Ｗ）（ＰＲＥＳＳ（登録商標））との合金、Ｎｉｔｉｎｏｌ（登録商標）（ニッケル−チタン合金）、Ｅｌｇｉｌｏｙのようなコバルト合金、Ｌ６０５合金、ＭＰ３５Ｎ、チタン、チタン合金（例えば、Ｔｉ−６Ａｌ−４Ｖ、Ｔｉ−５０Ｔａ、Ｔｉ−１０Ｉｒ）、白金、白金合金、ニオブ、ニオブ合金（例えばＮｂ−１Ｚｒ）Ｃｏ−２８Ｃｒ−６Ｍｏ、タンタル及びタンタル合金を含み得る。材料のその他の例は、２００３年９月２６日に出願された同一出願人による米国特許出願第１０／０６７２８９１号及び２００５年１月３日に出願された、同一出願人による米国特許出願第１１／０３５３１６号に記載されている。その他の材料は、超弾性金属合金、擬似弾性金属合金のような生体適合性の弾性金属を含み、それらは、例えば、シェトッスキ、Ｌ．マクドナルド（Ｓｃｈｅｔｓｋｙ，Ｌ．ＭａｃＤｏｎａｌｄ）の「Ｓｈａｐｅ Ｍｅｍｏｒｙ Ａｌｌｏｙｓ」、Ｅｎｃｙｃｌｏｐｅｄｉａ ｏｆ Ｃｈｅｍｉｃａｌ Ｔｅｃｈｎｏｇｏｌｙ（第３版）、Ｊｏｈｎ Ｓｉｌｅｙ ＆ Ｓｏｎｓ、１９８２年、第２０巻、第７２６−７３６頁、及び２００３年１月１７日に出願された同一出願人による米国特許出願第１０／３４６４８７号に記載されている。
幾らかの実施形態において、ステント１０を製造するための材料は、ＭＲＩによる視認性を高める一つ以上の材料を含む。ＭＲＩ材料の例としては、非鉄金属（例えば、銅、銀、白金又は金）及び、例えばテルビウム−ジスプロシウム、ジスプロシウム及びガドリニウムのような超常磁性元素（例えば、ジスプロシウム又はガドリニウム）を含む非鉄金属−合金を含む。代替的に、又は付随的に、ステント１０は、撮像時に例えばステントに隣接するか、又は同ステントを包囲するかのいずれかである組織の撮像に影響を与える、磁化率アーチファクトを低減するために、磁化率の低い一つ以上の材料を含み得る。磁化率の低い材料は、上記したもの、例えば、タンタル、白金、チタン、ニオブ、銅及びこれらの元素を含有する合金を含む。
ステント１０は所望の形状及びサイズ（例えば、冠状動脈ステント、大動脈ステント、末梢血管ステント、消化管用ステント、泌尿器科用ステント及び神経科用ステント）であり得る。用途に応じて、ステント１０は例えば、約１ｍｍ乃至約４６ｍｍの直径を有し得る。ある実施形態において、冠状動脈ステントは約２ｍｍ乃至約６ｍｍの拡張状態の直径を有し得る。幾らかの実施形態において、末梢血管ステントは約５ｍｍ乃至約２４ｍｍの拡張状態の直径を有し得る。幾らかの実施形態において、消化管用ステント及び／又は泌尿器科用ステントは約６ｍｍ乃至約３０ｍｍの拡張状態の直径を有し得る。幾らかの実施形態において、神経科用ステントは約１ｍｍ乃至約１２ｍｍの拡張状態の直径を有し得る。腹部大動脈瘤（ＡＡＡ）ステント及び胸部大動脈瘤（ＴＡＡ）ステントは、約２０ｍｍ乃至約４６ｍｍの直径を有し得る。ステント１０は、バルーン拡張可能、自己拡張可能、或いは両者の組み合わせであり得る（例えば、米国特許第５３６６５０４号明細書）。
ステント１０は、例えば、米国特許第５６７４２４２号明細書、２００１年７月２日に出願された米国特許出願第０９／８９５４１５号及び２００２年４月３０日に出願された米国特許出願第１０／２３２２６５号のような、例えば治療剤、薬物又は薬学的に活性を有する化合物のような放出可能な生体分子を含み得る。例えば、治療剤、薬物又は薬学的に活性を有する化合物は、抗増殖剤、抗血栓形成剤、抗酸化剤、抗炎症剤、免疫抑制化合物、麻酔剤、抗血液凝固剤及び抗生物質を含む。そのような生体分子の特定の例は、パクリタキセル、シロリムス、エベロリムス、ゾタロリムス、ピクロリムス及びデキサメタゾンを含む。
種々の実施形態を記載してきた。それにも関わらず、この開示の精神及び範囲から逸脱することなく種々の変更がなされることが理解されるであろう。従って、その他の実施形態は、以下に記載の特許請求の範囲内である。
ステントの斜視図である。 線Ａ１−Ａ１に沿ったステントの壁部の断面図である。 ステントを選択的に被覆する方法の実施形態のフローチャートである。 図１Ａのステントの、線Ａ１−Ａ１に沿った壁部の断面図である。 図１Ａのステントの、線Ａ１−Ａ１に沿った壁部の断面図である。 ステントを選択的に被覆する方法の実施形態のフローチャートである。

Claims (33)

  1. 管腔内壁面と管腔外壁面とを有するとともに中央に管腔若しくは通路を定義する長尺管状構造体を形成する、相互に連結されたバンドとコネクタとからなる本体を有する医療装置であって、前記長尺管状構造体を貫通する横断方向の通路を形成するバンド及びコネクタの前記管腔内壁面と前記側壁面とは親水性材料の被覆部を備えており、前記管状構造体の管腔外壁面は疎水性材料の被覆部を備える、医療装置。
  2. 前記管腔内壁面と前記側壁面の少なくとも一つ以上の選択された領域は親水性材料の被覆部を備える、請求項１に記載の医療装置。
  3. 前記材料は超親水性である、請求項２に記載の医療装置。
  4. 前記管腔外壁面の少なくとも一つ以上の選択された領域は疎水性材料の被覆部を備える、請求項１に記載の医療装置。
  5. 前記管腔内壁面、前記側壁面、及び前記管腔外壁面は、チタン（＋ｙ）酸化物（−ｘ）からなる、請求項１に記載の医療装置。
  6. 前記被覆部は、チタン（＋ｙ）酸化物（−ｘ）の上に有機化合物層を更に含む、請求項５に記載の医療装置。
  7. 前記管腔外壁面上の被覆部は生体分子を更に含む、請求項５に記載の医療装置。
  8. 前記被覆部はポリマーを更に含む、請求項７に記載の医療装置。
  9. 前記管腔内壁面及び側壁面上の被覆部は生体分子を更に含む、請求項５に記載の医療装置。
  10. 管腔内壁面と管腔外壁面とを有するとともに中央に管腔若しくは通路を定義する長尺管状構造体を形成する、相互に連結されたバンドとコネクタとからなる本体を有する医療装置であって、前記長尺管状構造体を貫通する横断方向の通路を形成するバンド及びコネクタの前記管腔内壁面と前記側壁面とは疎水性材料の被覆部を備えており、同管状構造体の前記管腔外壁面は親水性材料の被覆部を備える、医療装置。
  11. 前記管腔内壁面と前記側壁面の少なくとも一つ以上の選択された領域は疎水性材料の被覆部を備える、請求項１０に記載の医療装置。
  12. 前記管腔外壁面の少なくとも一つ以上の選択された領域は親水性材料の被覆部を備える、請求項１０に記載の医療装置。
  13. 前記材料は超親水性である、請求項１２に記載の医療装置。
  14. 前記管腔内壁面、前記側壁面、及び前記管腔外壁面は、チタン（＋ｙ）酸化物（−ｘ）からなる、請求項１０に記載の医療装置。
  15. 前記被覆部は、チタン（＋ｙ）酸化物（−ｘ）の上に有機化合物層を更に含む、請求項１４に記載の医療装置。
  16. 前記管腔外壁面上の被覆部は生体分子を更に含む、請求項１４に記載の医療装置。
  17. 前記管腔内壁面及び側壁面上の被覆部は生体分子を更に含む、請求項１４に記載の医療装置。
  18. 前記被覆部はポリマーを更に含む、請求項１７に記載の医療装置。
  19. 医療装置を製造する方法であって、前記方法は：
    （ｉ）管腔内壁面と管腔外壁面とを有するとともに中央に管腔若しくは通路を定義する長尺管状構造体を形成する相互に連結されたバンドとコネクタとからなる本体を有する医療装置であって、前記バンド及びコネクタの前記管腔内壁面と前記側壁面とが長尺管状構造体を貫通する横断方向の通路を形成する医療装置を、親水性のチタン（＋ｙ）酸化物（−ｘ）、で被覆する工程と；
    （ｉｉ）前記医療装置を、前記チタン（＋ｙ）酸化物（−ｘ）の被覆部が疎水性となり得るのに十分な条件下にさらす工程と；
    （ｉｉｉ）前記医療装置の選択された表面を、前記チタン（＋ｙ）酸化物（−ｘ）の被覆部が超親水性となり得るのに十分な条件下にさらす工程と；
    （ｉｖ）前記医療装置を所望の生体分子と適合性を有する第一の溶液内にて被覆する工程と；
    を含む、方法。
  20. 前記第一の溶液は、前記医療装置の親水性表面に接着されるように構成された少なくとも一つの極性溶媒と、前記医療装置の疎水性表面に接着するように構成された少なくとも一つの非極性溶媒とを含む、請求項１９に記載の方法。
  21. 前記溶液は、少なくとも一つの溶媒と適合性である少なくとも一つの生体分子を更に含む、請求項２０に記載の方法。
  22. 前記溶液はポリマーを更に含む、請求項２１に記載の方法。
  23. 所望の生体分子と適合する第二の溶液中にて前記医療装置を被覆する工程を更に含む、請求項１９に記載の方法。
  24. 前記第二の溶液は非極性である、請求項２３に記載の方法。
  25. 前記第二の溶液は極性である、請求項２３に記載の方法。
  26. 前記第二の溶液は所望の生体分子を含む、請求項２３に記載の方法。
  27. 前記第二の溶液はポリマーを含む、請求項２６に記載の方法。
  28. 前記工程（ｉ）の医療装置を有機化合物の層で被覆する工程を更に含む、請求項１９に記載の方法。
  29. 前記工程（ｉｉ）の条件は、前記医療装置を暗環境に配置することを含む、請求項１９に記載の方法。
  30. 前記工程（ｉｉｉ）の条件は、前記チタン（＋ｙ）酸化物（−ｘ）被覆部を備える前記医療装置の表面を紫外線にて照射することを含む、請求項１９に記載の方法。
  31. 前記被覆部を備える前記管腔内壁面及び側壁面の少なくとも一つの領域が照射される、請求項３０に記載の方法。
  32. 前記被覆部を備える前記管腔外壁面の少なくとも一つの領域が照射される、請求項３０に記載の方法。
  33. 前記工程（ｉｉｉ）は、超親水性となった表面の少なくとも一つの領域を、同領域を疎水性にするのに十分な条件にさらす工程を更に含む、請求項３０に記載の方法。
JP2009518446A 2006-06-29 2007-06-15 選択的被覆部を備えた医療装置 Pending JP2009542359A (ja)

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US8771343B2 (en) 2014-07-08

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