JP4971163B2 - コーティングされたステント―バルーンアセンブリの製造方法 - Google Patents
コーティングされたステント―バルーンアセンブリの製造方法 Download PDFInfo
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- JP4971163B2 JP4971163B2 JP2007530249A JP2007530249A JP4971163B2 JP 4971163 B2 JP4971163 B2 JP 4971163B2 JP 2007530249 A JP2007530249 A JP 2007530249A JP 2007530249 A JP2007530249 A JP 2007530249A JP 4971163 B2 JP4971163 B2 JP 4971163B2
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- stent
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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
- A61L31/08—Materials for coatings
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
- A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
-
- 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
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S606/00—Surgery
- Y10S606/907—Composed of particular material or coated
- Y10S606/908—Bioabsorbable material
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Epidemiology (AREA)
- Surgery (AREA)
- Materials For Medical Uses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Description
その後、前記ステントのギャップ領域によって露出されたバルーンの領域を残して前記ステント上にステントコーティングを形成する工程と、
を有するコーティングされたステント―バルーンアセンブリの製造方法が提供される。
その後、ギャップによって分けられた支柱を含む前記ステントをバルーン上に取り付ける工程と、
その後、前記ステント上にステントコーティングを形成する工程と、
その後、前記犠牲層の全部または一部を除去する工程と、
を備える、コーティングされたステント―バルーンアセンブリの製造方法が提供される。
その後、前記ステントの支柱の間の前記ギャップの領域において、前記バルーン上に、犠牲層を形成する工程と、
その後、前記ステント上にコーティングを形成する工程と、
その後、前記コーティングが前記ステントの外側表面上に残るように前記犠牲層を除去する工程と、
を備える、コーティングされたステント―バルーンアセンブリの製造方法。
δ=(ΔE/V)1/2
ただし、δは溶解度パラメータ、(cal/cm3)1/2;ΔEは気化エネルギー、cal/mole;Vはモル容積、cm3/モルである。「親水性」とは、ヒルデブラント溶解度パラメータが8.5、9、9.5、10、10.5、11または11.5(cal/cm3)1/2以上である物質のことを言う。
k={Ln(I0/If)}/h
ここでk=吸光度(cm−1)
I0=初期強度
If=最終強度
h=最終強度の場所の距離(cm)
図は一律の縮尺に従わずに描かれており、特に、図3A―3Eと図4A―4Eは図示するために過分または不足に強調されている。
Claims (20)
- カテーテルアセンブリのバルーン上に、ギャップ領域によって分けられた支柱を有するステントを取り付ける工程と、
その後、前記ステントのギャップ領域によって露出されたバルーンの領域を残して前記ステント上にステントコーティングを形成する工程と、
を有するコーティングされたステント―バルーンアセンブリの製造方法。 - 前記バルーン上に前記ステントを取り付ける工程は、前記バルーン上に前記ステントを圧着して、前記バルーンに前記ステントを係合させる工程、を備える、請求項1に記載の方法。
- 前記バルーン上に前記ステントを取り付ける工程に先立って、前記バルーン上に犠牲層を形成する工程をさらに備え、
前記ステントコーティングを形成する工程は、
前記ステント上にコーティング材を付着する工程と、
前記コーティング材が前記ステントの外側表面上に残るように前記バルーンから前記犠牲層を取り除く工程と、を備える請求項1に記載の方法。 - 前記犠牲層が、前記バルーンを流体にさらすことによって除去される、請求項3に記載の方法。
- 前記犠牲層には、オリゴ糖、多糖類、D型グルコース、グルコース、ヘパリン、イオン性塩、塩化カリウム、硫酸銅、重炭酸ナトリウム、ヨウ素塩、アミノ酸、ポリマー、活性物質、薬剤または二薬効結合薬剤(コドラッグ)からなる群から選択された材料を含む、 請求項3に記載の方法。
- 前記犠牲層は、低分子量材を含む請求項3に記載の方法。
- 前記犠牲層は、ヒルデブラント溶解度パラメータが8.5(cal/cm3)1/2以上である材料を含む、請求項3に記載の方法。
- 前記犠牲層は、ヒドロゲルを含む請求項3に記載の方法。
- 前記ヒドロゲルが、ポリ(エチレングリコール)、N―イソプロピルアクリルアミド、ポリオキシエチレン―ポリオキシプロピレンブロック共重合体、プルロニック−ポリ(アクリル酸)グラフト共重合体、プルロニック−キトサングラフト共重合体、エラスチン模倣ポリペプチド、および前記の組み合わせおよび混合物からなる群から選択される、請求項8に記載の方法。
- 前記ステントコーティングを形成する工程は、
前記ステントの支柱の間の前記ギャップ領域によって露出されたバルーンの領域上に犠牲層を形成する工程と、
その後、前記ステント上にコーティングを形成する工程と、
その後、前記コーティングが前記ステントの外側表面上に残るように前記犠牲層を除去する工程と、
を備える、請求項1に記載の方法。 - 前記犠牲層が、前記バルーンを流体にさらすことによって除去される、請求項10に記載の方法。
- 前記犠牲層には、オリゴ糖、多糖類、D型グルコース、グルコース、ヘパリン、イオン性塩、塩化カリウム、硫酸銅、重炭酸ナトリウム、ヨウ素塩、アミノ酸、ポリマー、活性物質、薬剤または二薬効結合薬剤(コドラッグ)からある群から選択された材料を含む、 請求項10に記載の方法。
- 前記犠牲層は、低分子量材を含む、請求項10に記載の方法。
- 前記犠牲層は、ヒルデブラント溶解度パラメータが8.5(cal/cm3)1/2以上である材料を含む、請求項10に記載の方法。
- 前記犠牲層は、ヒドロゲルを含む、請求項10に記載の方法。
- 前記ヒドロゲルが、ポリ(エチレングリコール)、N―イソプロピルアクリルアミド、ポリオキシエチレン―ポリオキシプロピレンブロック共重合体、プルロニック−ポリ(アクリル酸)グラフト共重合体、プルロニック−キトサングラフト共重合体、エラスチン模倣ポリペプチド、および前記の組み合わせおよび混合物からなる群から選択される、請求項15に記載の方法。
- カテーテルアセンブリのバルーン上に犠牲層を形成する工程と、
その後、ギャップによって分けられた支柱を含むステントをバルーン上に取り付ける工程と、
その後、前記ステント上にステントコーティングを形成する工程と、
その後、前記犠牲層の全部または一部を除去する工程と、
を備える、コーティングされたステント―バルーンアセンブリの製造方法。 - 前記犠牲層を除去した後に、前記ステントの前記支柱の下の犠牲層のうちの一部がバルーン上に残る、請求項17に記載の方法。
- 前記犠牲層は、活性物質または治療薬剤を含む、請求項18に記載の方法。
- バルーン上にギャップによって分けられた支柱を含むステントを取り付ける工程と、
その後、前記ステントの支柱の間の前記ギャップの領域において、前記バルーン上に、犠牲層を形成する工程と、
その後、前記ステント上にコーティングを形成する工程と、
その後、前記コーティングが前記ステントの外側表面上に残るように前記犠牲層を除去する工程と、
を備える、コーティングされたステント―バルーンアセンブリの製造方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US10/928,587 | 2004-08-26 | ||
US10/928,587 US7648727B2 (en) | 2004-08-26 | 2004-08-26 | Methods for manufacturing a coated stent-balloon assembly |
PCT/US2005/030759 WO2006026587A2 (en) | 2004-08-26 | 2005-08-25 | Methods for manufacturing a coated stent-balloon assembly |
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JP2008510593A JP2008510593A (ja) | 2008-04-10 |
JP4971163B2 true JP4971163B2 (ja) | 2012-07-11 |
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JP2007530249A Active JP4971163B2 (ja) | 2004-08-26 | 2005-08-25 | コーティングされたステント―バルーンアセンブリの製造方法 |
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US (1) | US7648727B2 (ja) |
EP (1) | EP1781349B1 (ja) |
JP (1) | JP4971163B2 (ja) |
AT (1) | ATE424861T1 (ja) |
DE (1) | DE602005013239D1 (ja) |
ES (1) | ES2322382T3 (ja) |
WO (1) | WO2006026587A2 (ja) |
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US20060043650A1 (en) | 2006-03-02 |
JP2008510593A (ja) | 2008-04-10 |
EP1781349B1 (en) | 2009-03-11 |
WO2006026587A2 (en) | 2006-03-09 |
EP1781349A2 (en) | 2007-05-09 |
WO2006026587A3 (en) | 2006-08-10 |
ATE424861T1 (de) | 2009-03-15 |
ES2322382T3 (es) | 2009-06-19 |
DE602005013239D1 (de) | 2009-04-23 |
US7648727B2 (en) | 2010-01-19 |
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