JP6796926B2 - ガイドワイヤーバルブを備える注入カテーテル - Google Patents
ガイドワイヤーバルブを備える注入カテーテル Download PDFInfo
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- 238000001802 infusion Methods 0.000 title claims description 75
- 239000012530 fluid Substances 0.000 claims description 221
- 238000002347 injection Methods 0.000 claims description 204
- 239000007924 injection Substances 0.000 claims description 204
- 238000003780 insertion Methods 0.000 claims description 13
- 230000037431 insertion Effects 0.000 claims description 13
- 210000004204 blood vessel Anatomy 0.000 claims description 11
- 239000003978 infusion fluid Substances 0.000 claims description 6
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- 238000001356 surgical procedure Methods 0.000 description 2
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- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical compound [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 description 1
- 206010016717 Fistula Diseases 0.000 description 1
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Classifications
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
-
- 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
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
-
- 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
- A61M25/0052—Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
-
- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
- A61M25/0075—Valve means
-
- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/008—Strength or flexibility characteristics of the catheter tip
-
- 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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M25/09041—Mechanisms for insertion of guide wires
-
- 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
- A61M25/104—Balloon catheters used for angioplasty
-
- 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
- A61M2025/0018—Catheters; Hollow probes having a plug, e.g. an inflatable plug for closing catheter lumens
-
- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
- A61M25/0075—Valve means
- A61M2025/0076—Unidirectional valves
-
- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
- A61M2025/0079—Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
-
- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/008—Strength or flexibility characteristics of the catheter tip
- A61M2025/0081—Soft tip
-
- 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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/091—Guide wires having a lumen for drug delivery or suction
-
- 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
- A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
-
- 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/12—Blood circulatory system
Description
かかるカテーテルは、(t-PAのような)血餅溶解材料のような流体を導入するために、バルーン部材の近位に位置し且つバルーン部材に専用の開口部を通じた治療サイトへ流体を注入するという属性を有する。流体注入は、バルーンの膨張又は収縮、又はバルーンの膨張が維持されているときと同時に実行することができる。かかる装置は、複数の機能を直列的及び/又は並列的に発揮させることができる。かかる機能としては、例えば、バルーン閉塞(おそらく次の拡張)及び血餅溶解流体注入の同時実行、血流の詰まりに対する血栓除去の手術及び造影剤の注入の間における動脈側への血餅の移動のリスクの低減、コントラスト増強剤の使用量の減少、スタッフ及び患者の血管造影の使用の減少及び放射線被曝の減少が挙げられる。
1.管腔血管内にガイドワイヤーを挿入する
2.選択されたターゲットに対して、管腔血管内のカテーテルをガイドワイヤーを超えて提供する
3.膨張部材を膨張させて、ターゲットにおける管腔血管を閉塞する
4.膨張部材の近位に位置する側面注入開口部を通って流体を注入し、流体が膨張部材を超えて通過しないようにする
図1A〜図1Dは、本発明の実施形態に係る例示的なカテーテルであり、組み合わされた注入-ガイドワイヤー内腔と選択的なバルブ機構を有する例示的なカテーテルを示す模式図である。
図2A〜図2Bは、本発明の実施形態に係る例示的なカテーテルの一部の断面及びそこに設けられたシールを示す模式図である。
図3A〜図3Bは、本発明の実施形態に係る他の例示的なバルーンカテーテルの一部の断面及びそこに設けられたシールを示す模式図である。
図4A〜図4Bは、本発明の実施形態に係る他の2つの例示的なカテーテルであって、組み合わされた注入-ガイドワイヤー内腔を有するカテーテルの一部の断面を示す模式図である。
図5A〜図5Hは、本発明の実施形態に係る他の例示的なカテーテルの一部の断面を示す模式図である。
図6A〜図6Bは、本発明の実施形態に係る、第1の例示的なバルブ機構を有する例示的な注入内腔を示す模式図である。
図7A〜図7Bは、本発明の実施形態に係る、例示的なバルーンカテーテルであって、流体出口に対するバルーンの位置により区別可能な例示的なバルブ機構を組み込んだバルーンカテーテルを示す模式図である。
図8A〜図8Bは、本発明の実施形態に係る、追加の例示的な逆流シールを備える例示的なバルブ機構を有する例示的な注入内腔を示す模式図である。
図9A〜図9Bは、本発明の実施形態に係る、追加の例示的な近位シール及び遠位シールのセットを備える例示的なバルブ機構を有する例示的な注入内腔を示す模式図である。
図10A〜図10Iは、本発明の実施形態に係る、ガイドワイヤーベースのバルブ機構を備える例示的な血管形成注入バルーンカテーテルの模式的な側面図及び断面図である。
図11A〜図11Cは、本発明の実施形態に係る、注入内腔の中間部分の他の例示的な断面形状を示す模式図である。
図12A〜図12Cは、本発明の実施形態に係る、他の例示的な流体出口タイプ及び/又は分布を示す模式図である。
図13A〜図13Bは、本発明の実施形態に係る例示的なバルーンカテーテルであって、第1の例示的な強化を備える単一の近位流体出口を有する例示的なバルーンカテーテルの模式的な切断図である。
図14A〜図14Bは、本発明の実施形態に係る例示的なバルーンカテーテルであって、第2の例示的な強化を備える単一の近位流体出口を有する例示的なバルーンカテーテルの模式的な切断図である。
図15A〜図15Bは、本発明の実施形態に係る例示的なバルーンカテーテルであって、第3の例示的な強化を備える単一の近位流体出口を有する例示的なバルーンカテーテルの模式的な切断図である。
1.管腔血管(例えば、静脈又は動脈、必要に応じて冠状動脈、周辺又は透析標的血管)にガイドワイヤー1310を挿入する
2.選択されたターゲットに対して、管腔血管内のバルーンカテーテル1000をガイドワイヤー1310を超えて提供する
3.膨張部材1200を膨張させて、ターゲットにおける管腔血管を少なくとも部分的に閉塞する
4.側面注入開口部1116を通って流体(例液体、懸濁薬剤又はコントラスト増強剤)を注入し、流体が膨張部材1200を超えて通過しないようにする又は通過を最小限に留めるようにする。
Claims (16)
- 軸に沿って延在する注入内腔を囲む注入壁部を有するカテーテルであって、
血管の狭窄部分を拡張するように構成された拡張バルーンと、
前記拡張バルーンに連結された膨張内腔とを備え、
前記注入内腔は、近位壁部セグメント、遠位壁部セグメント及びそれらの間に延在する中間壁部セグメントを有し、
前記近位壁部セグメントは、近位ガイドワイヤー開口部を備え、前記遠位壁部セグメントは、遠位ガイドワイヤー開口部を備え、
少なくとも20mmの長さにわたり、前記遠位壁部セグメントの最小断面積が前記中間壁部セグメントの最小断面積よりも小さくなるように、前記近位壁部セグメントは、広がりつつ前記中間壁部セグメントに隣接し、前記中間壁部セグメントは、狭まりつつ前記遠位壁部セグメントに隣接して設けられ、
前記中間壁部セグメントは、前記近位壁部セグメントと対応する流体入口と、前記遠位壁部セグメントに対応する流体出口と、を備え、
前記遠位壁部セグメント内の前記注入内腔の大きさ及び形状は、ガイドワイヤーが前記注入内腔内を前記遠位壁部セグメント及び前記近位壁部セグメント全体にわたって延在する、流体の注入を実行するときに、前記遠位ガイドワイヤー開口部を通る遠位流量が、前記流体出口を通る流体出口流量の20%以下となるように配分する遠位圧力勾配を構築するように構成され、前記近位壁部セグメントの前記注入内腔の大きさ及び形状は、ガイドワイヤーが前記注入内腔内を前記遠位壁部セグメント及び前記近位壁部セグメント全体にわたって延在する、流体の注入を実行するときに、前記近位ガイドワイヤー開口部を通る注入内腔から注入内腔の外への流量が、前記流体出口を通る流体出口流量の20%以下となるように配分する近位圧力勾配を構築するように構成され、前記ガイドワイヤーは前記注入内腔内で一定の外径を有する、
カテーテル。 - 前記ガイドワイヤーは、前記注入内腔内を前記遠位壁部セグメント全体にわたって延在するときに、前記遠位壁部セグメントを部分的又は完全に閉塞する、
請求項1に記載のカテーテル。 - 前記ガイドワイヤーは、外径が0.889mmである、
請求項2に記載のカテーテル。 - (前記流体出口の断面領域)/(前記遠位ガイドワイヤー開口部の断面領域)の値は、少なくとも1.5である、
請求項1に記載のカテーテル。 - 前記遠位壁部セグメントの長さは、少なくとも20mmである、
請求項1に記載のカテーテル。 - 前記遠位圧力勾配は、少なくとも0.65センチポアズの粘度の注入流体に基いて決定される、
請求項1に記載のカテーテル。 - 前記近位圧力勾配は、前記近位ガイドワイヤー開口部を通る近位流量が、前記流体出口を通る近位流量の2%以下となるように配分する、
請求項1に記載のカテーテル。 - 前記近位ガイドワイヤー開口部の断面領域は、前記遠位ガイドワイヤー開口部の断面領域以下である、
請求項1に記載のカテーテル。 - 前記中間壁部セグメントの前記注入内腔の断面領域は三日月形であり、内側境界における弧の2つの対向点の最小距離が少なくとも0.5mmである、
請求項1に記載のカテーテル。 - 前記中間壁部セグメントの前記注入内腔の断面領域は、少なくとも1.5mm2、必要に応じて少なくとも1.75mm2である、
請求項1に記載のカテーテル。 - 前記流体出口は、少なくとも1つの開口部を含む、
請求項1に記載のカテーテル。 - 前記狭まりは、緩やかである、
請求項1に記載のカテーテル。 - 前記拡張バルーンは、前記流体出口と前記遠位ガイドワイヤー開口部の間に延在する、
請求項1に記載のカテーテル。 - 前記流体出口は、単一の開口部を含み、
前記単一の開口部は、総開口領域を備え、
前記総開口領域は、前記流体出口の近位側に位置する注入内腔の前記断面領域から、ガイドワイヤーの最小の規定直径の断面領域を差し引いた領域と等しいか、またはそれ以上である、
請求項1に記載のカテーテル。 - 前記開口部の前記注入壁部に、強化構造が付与される、
請求項14に記載のカテーテル。 - 前記強化は、メッシュパッチ、挿入チューブ又は挿入シートを含む、
請求項15に記載のカテーテル。
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2014
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- 2014-01-08 ES ES14703651T patent/ES2742386T3/es active Active
- 2014-01-08 CA CA2897810A patent/CA2897810A1/en not_active Abandoned
- 2014-01-08 WO PCT/US2014/010752 patent/WO2014113257A2/en active Application Filing
- 2014-01-08 AU AU2014207836A patent/AU2014207836B2/en not_active Ceased
- 2014-01-08 CN CN201811404061.9A patent/CN109432543A/zh active Pending
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US20210402080A1 (en) | 2021-12-30 |
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AU2014207836A1 (en) | 2015-08-06 |
CA2897810A1 (en) | 2014-07-24 |
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ES2742386T3 (es) | 2020-02-14 |
CN105007973A (zh) | 2015-10-28 |
US20170151384A1 (en) | 2017-06-01 |
WO2014113257A2 (en) | 2014-07-24 |
JP2016503696A (ja) | 2016-02-08 |
US10363358B2 (en) | 2019-07-30 |
IL239935A0 (en) | 2015-08-31 |
US20240050642A1 (en) | 2024-02-15 |
US11052188B2 (en) | 2021-07-06 |
CN109432543A (zh) | 2019-03-08 |
JP2019162472A (ja) | 2019-09-26 |
EP3623002A1 (en) | 2020-03-18 |
US20150359998A1 (en) | 2015-12-17 |
WO2014113257A3 (en) | 2014-10-02 |
IL239935B (en) | 2019-07-31 |
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