JP6907190B2 - バルーンカテーテルおよびその製造方法 - Google Patents
バルーンカテーテルおよびその製造方法 Download PDFInfo
- Publication number
- JP6907190B2 JP6907190B2 JP2018507393A JP2018507393A JP6907190B2 JP 6907190 B2 JP6907190 B2 JP 6907190B2 JP 2018507393 A JP2018507393 A JP 2018507393A JP 2018507393 A JP2018507393 A JP 2018507393A JP 6907190 B2 JP6907190 B2 JP 6907190B2
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- Prior art keywords
- balloon
- elongated body
- blade
- long
- fixed
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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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
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/06—Coatings containing a mixture of two or more compounds
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- 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
- A61M25/1002—Balloon catheters characterised by balloon shape
- A61M2025/1004—Balloons with folds, e.g. folded or multifolded
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
-
- 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
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
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Description
本発明の第1実施形態に係るバルーンカテーテル10は、図1、2に示すように、バルーン30の外表面に薬剤の結晶が設けられた薬剤溶出型のカテーテルである。なお、本明細書では、バルーンカテーテル10の生体管腔に挿入する側を「先端」若しくは「先端側」、操作する手元側を「基端」若しくは「基端側」と称することとする。
本発明の第2実施形態に係るバルーンカテーテルは、水不溶性薬剤の結晶である複数の長尺体52の構造のみが、第1実施形態と異なる。なお、第1実施形態と同様の機能を有する部位には、同一の符号を付し、説明を省略する。
20 カテーテル本体、
21 外管、
22 内管、
30 バルーン、
32 羽根部、
35 重複部、
40 コート層、
41 基材、
42、52 長尺体、
43 屈曲部、
46、53 固定側長尺体、
47、54 頂部側長尺体、
60 バルーンコーティング装置、
94 ディスペンシングチューブ、
100 バルーン折り畳み装置、
120 プリーティング部、
130 フォールディング部、
θ 折れ曲がり角度。
Claims (6)
- 独立した長軸を有して延在する水不溶性薬剤の結晶である複数の長尺体がバルーンの外表面に設けられるバルーンカテーテルであって、
前記長尺体は、前記バルーンの外表面側に固定されている固定側長尺体と、前記固定側長尺体から折れて連続する頂部側長尺体と、を有し、
前記頂部側長尺体の頂部は、前記バルーンの外表面に接触せずに離れており、
前記長尺体の前記頂部側長尺体の頂部側の端部は、他の長尺体に接触せずに離れているバルーンカテーテル。 - 前記バルーンは、収縮した状態において折り畳まれて前記バルーンの外表面同士が重なる重複部を有し、
前記固定側長尺体および頂部側長尺体を有する長尺体は、前記重複部にて重なる前記バルーンの外表面に設けられる請求項1に記載のバルーンカテーテル。 - 前記頂部側長尺体は、前記固定側長尺体から折れ曲がった屈曲部を挟んで連続する請求項1または2に記載のバルーンカテーテル。
- 前記水不溶性薬剤は、ラパマイシン、パクリタキセル、ドセタキセル、またはエベロリムスである請求項1〜3のいずれか1項に記載のバルーンカテーテル。
- 独立した長軸を有して延在する水不溶性薬剤の結晶である複数の長尺体がバルーンの外表面に設けられるバルーンカテーテルの製造方法であって、
前記バルーンの外表面に前記長尺体を形成するステップと、
前記バルーンに径方向に突出する羽根部を形成するステップと、
前記バルーンに形成された羽根部を周方向に沿って折り畳むステップと、を有し、
前記羽根部を形成するステップおよび折り畳むステップの少なくとも一方において、前記バルーンを変形させるために作用させる力によって前記長尺体を折って前記バルーンの外表面側に固定されている固定側長尺体および前記固定側長尺体から折れて連続する頂部側長尺体を形成し、前記頂部側長尺体の頂部を、前記バルーンの外表面に接触せずに離れた状態とし、
前記長尺体に前記固定側長尺体および前記頂部側長尺体を形成する際に、前記長尺体の前記頂部側長尺体の頂部側の端部を、他の長尺体に接触させずに離れた状態とするバルーンカテーテルの製造方法。 - 前記羽根部を折り畳むステップにおいて、前記バルーンの外表面同士が対向して重なる重複部を形成し、当該重複部の対向する外表面に設けられる前記長尺体を折って前記固定側長尺体および頂部側長尺体を形成する請求項5に記載のバルーンカテーテルの製造方法。
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US7160317B2 (en) * | 2002-01-04 | 2007-01-09 | Boston Scientific Scimed, Inc. | Multiple-wing balloon catheter to reduce damage to coated expandable medical implants |
EP2271379B1 (en) * | 2008-03-28 | 2015-11-25 | SurModics, Inc. | Insertable medical devices having microparticulate-associated elastic substrates and methods for drug delivery |
US9198968B2 (en) | 2008-09-15 | 2015-12-01 | The Spectranetics Corporation | Local delivery of water-soluble or water-insoluble therapeutic agents to the surface of body lumens |
EP2453938B1 (en) * | 2009-07-17 | 2015-08-19 | Boston Scientific Scimed, Inc. | Nucleation of drug delivery balloons to provide improved crystal size and density |
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US9227041B2 (en) * | 2010-04-09 | 2016-01-05 | Boston Scientific Scimed, Inc. | Balloon catheters with fibers for delivery of therapeutic agent and methods of making the same |
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