JP2018508281A - ガイドワイヤ固定 - Google Patents
ガイドワイヤ固定 Download PDFInfo
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- JP2018508281A JP2018508281A JP2017542898A JP2017542898A JP2018508281A JP 2018508281 A JP2018508281 A JP 2018508281A JP 2017542898 A JP2017542898 A JP 2017542898A JP 2017542898 A JP2017542898 A JP 2017542898A JP 2018508281 A JP2018508281 A JP 2018508281A
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Images
Classifications
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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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0169—Exchanging a catheter while keeping the guidewire in place
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- A—HUMAN NECESSITIES
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- 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
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- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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- 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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/0293—Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube
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- 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
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
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- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
Abstract
Description
本特許文書は、医療デバイスに関する。より具体的には、限定ではないが、本特許文書は、種々の障害および疾患の最小侵襲性処置において使用するために好適な経皮的デバイスおよび方法に関する。
カテーテルまたは他の介入性医療デバイスの後続導入および設置を容易にするために、血管または他の中空身体構造の中へのアクセスを得る最小侵襲性医術およびその実践は、1950年代初期のセルディンガー法の確立以降、進化し続けている。
血管介入の複雑性が増すにつれて、全長ガイドワイヤ管腔を具現化する特殊目的OTWカテーテルの数も増加している。しかしながら、医師は、概して、より煩雑なOTW長ガイドワイヤよりも短い迅速交換長ガイドワイヤを使用する便宜性を好む。
多くの場合、カテーテルまたは他の介入性医療デバイスが、患者の中に挿入された後、カテーテルまたはデバイスを抜去し、代替サイズのカテーテルまたはデバイスと置換する必要があり得る。例えば、膨張カテーテルの収縮されたバルーンの外形が、時として、大きすぎて、処置されるべき罹患部位(例えば、狭窄)を通り抜けることができない、またはバルーン外形が、小さすぎて、バルーンの膨張ノ際に、罹患部位が、十分に膨張させられない場合がある。これが生じると、膨張バルーンカテーテルは、罹患部位が、バルーンの膨張に応じて、交差し適切に処置され得るように、異なる(より小さいまたはより大きい)サイズのものに交換される必要がある。カテーテルまたはデバイスは、さらに、または代わりに、乏しい制御性または低可撓性を有し、罹患部位の遠位の解剖学的目印まで追跡不能となり得る。この場合、カテーテルまたはデバイスは、解剖学的目印に到達し得るように、より優れた追跡特性を伴うものと交換されなければならない。これらの置換は、カテーテルまたはデバイス交換の間に完了される。
多くの場合、最小侵襲性手技では、ガイドカテーテルまたは解剖学的目印に対してガイドワイヤの留置位置を維持しながら、あるカテーテルまたは他の介入性医療デバイスを別のものと交換する必要がある。解剖学的目印が位置する標的脈管または他の中空構造口に対してガイドカテーテルの位置を維持することもまた、交換の間、有益と成り得る。ガイドワイヤの位置を維持するために、特に、OTWカテーテルの使用が予期されるとき、取扱のために2人のオペレータ(医師およびその助手)が必要とされる、約270cmまたはそれを上回るガイドワイヤ長が、以前は使用された。オペレータの1人が、長ガイドワイヤを操作し、長ガイドワイヤを定位置に保持する一方、もう1人のオペレータが、カテーテルを交換していた。オペレータは、交換の間、相互にやりとりする必要があり、これは、手技時間の延長につながり、ガイドワイヤの先端は、蛍光透視下で監視される必要があり、これは、オペレータおよび患者に増加した放射線被ばくを受けさせた。加えて、ガイドワイヤの長い長さは、取扱が煩わしく、時として、手術室の床に接触する、または別様に汚染され、その廃棄を必要とした。
本発明は、例えば、以下を提供する。
(項目1)
ガイドカテーテルおよびガイドワイヤと併用するための経皮的デバイスであって、
管腔を画定し、前記ガイドカテーテルの管腔より小さい外径を有する、細長い管部材と、
前記管部材を前記ガイドカテーテル内で、または前記ガイドカテーテルの遠位端を部分的に越えて、摺動可能に位置付けるために、前記管部材に取り付けられ、前記管部材から近位に延在する、押動部材と、
前記押動部材の一部上に位置付けられた固定機構であって、前記固定機構は、移動させられまたはサイズが増加すると、前記ガイドワイヤを前記ガイドカテーテルまたは前記管部材の内側表面に対して係合させるように構成されている、固定機構と
を備える、経皮的デバイス。
(項目2)
前記管部材は、前記押動部材より可撓性である、項目1に記載の経皮的デバイス。
(項目3)
前記管部材は、少なくとも6cmの長さを含む、項目1または2のいずれか1項に記載の経皮的デバイス。
(項目4)
前記管部材の前記管腔の直径は、前記ガイドカテーテルの前記管腔の直径より1フレンチサイズ以下だけ小さい、項目1〜3のいずれか1項に記載の経皮的デバイス。
(項目5)
前記管部材は、前記管部材全体が前記ガイドカテーテル内に位置付けられる第1の後退位置と、前記管部材の一部が前記ガイドカテーテルの遠位端を越えて延在する第2の延在位置との間で移動可能である、項目1〜4のいずれか1項に記載の経皮的デバイス。
(項目6)
前記管部材は、内側ポリマー層と、外側ポリマー層と、前記内側ポリマー層と外側ポリマー層との間に配置された補強部材とを含む、項目1〜5のいずれか1項に記載の経皮的デバイス。
(項目7)
前記押動部材は、前記管部材の近位端部分に取り付けられている、項目1〜6のいずれか1項に記載の経皮的デバイス。
(項目8)
前記押動部材は、前記管部材の横断面に対して偏心的に位置付けられている、項目1〜7のいずれか1項に記載の経皮的デバイス。
(項目9)
前記固定機構は、膨張させられると、前記ガイドワイヤを前記ガイドカテーテルまたは前記管部材の前記内側表面に対して係合させるように構成された固定バルーンである、項目1〜8のいずれか1項に記載の経皮的デバイス。
(項目10)
前記押動部材は、管腔を含み、前記管腔は、膨張流体を前記固定バルーンに送達するまたは膨張流体を前記固定バルーンから除去するために前記固定バルーンの内部と流体連通する、項目9に記載の経皮的デバイス。
(項目11)
前記押動部材は、ハイポチューブを含む、項目10に記載の経皮的デバイス。
(項目12)
前記押動部材の近位端部分は、注射器または他の膨張デバイスに結合可能な膨張マニホールドを含む、項目10または11のいずれか1項に記載の経皮的デバイス。
(項目13)
前記固定バルーンは、前記管部材の近位に位置付けられ、前記押動部材の周りに巻着されている、項目9〜12のいずれか1項に記載の経皮的デバイス。
(項目14)
前記固定バルーンは、内側ポリマー層と、外側ポリマー層とを含む、項目9〜13のいずれか1項に記載の経皮的デバイス。
(項目15)
前記押動部材の近位端部分上に位置付けられた膨張インジケータバルブをさらに備え、前記インジケータバルブは、前記固定バルーンの内部と流体連通する、項目9〜14のいずれか1項に記載の経皮的デバイス。
(項目16)
前記固定機構の中心は、前記押動部材の軸方向平面に対してオフセットされている、項目1〜15のいずれか1項に記載の経皮的デバイス。
(項目17)
前記固定機構上または前記固定機構内に位置付けられた放射線不透過性マーカをさらに備える、項目1〜16のいずれか1項に記載の経皮的デバイス。
(項目18)
前記管部材の真円形部分につながる部分的円筒形開口部を画定する凹面トラックをさらに備える、項目1〜17のいずれか1項に記載の経皮的デバイス。
(項目19)
前記凹面トラックの第1の区画は、弧状断面形状を含む、項目18に記載の経皮的デバイス。
(項目20)
前記弧状断面形状は、少なくとも0.5cmの長さに延在する、項目19に記載の経皮的デバイス。
(項目21)
前記弧状断面形状は、前記管部材の断面円周の25%〜40%に半径方向に延在する、項目19または20のいずれか1項に記載の経皮的デバイス。
(項目22)
前記凹面トラックの第2の区画は、半円筒形断面形状を含む、項目19〜21のいずれか1項に記載の経皮的デバイス。
(項目23)
前記半円筒形断面形状は、少なくとも0.5cmの長さに延在する、項目22に記載の経皮的デバイス。
(項目24)
前記半円筒形断面形状は、前記管部材の断面円周の40%〜70%に半径方向に延在する、項目22または23のいずれか1項に記載の経皮的デバイス。
(項目25)
前記凹面トラックの支持構造は、ハイポチューブの形態における前記押動部材から無管腔構造に遷移する、項目18〜24のいずれか1項に記載の経皮的デバイス。
(項目26)
前記ハイポチューブの遠位端および前記無管腔構造の近位端は、ともに溶接される噛合する非垂直切断部を含む、項目25に記載の経皮的デバイス。
Claims (26)
- ガイドカテーテルおよびガイドワイヤと併用するための経皮的デバイスであって、
管腔を画定し、前記ガイドカテーテルの管腔より小さい外径を有する、細長い管部材と、
前記管部材を前記ガイドカテーテル内で、または前記ガイドカテーテルの遠位端を部分的に越えて、摺動可能に位置付けるために、前記管部材に取り付けられ、前記管部材から近位に延在する、押動部材と、
前記押動部材の一部上に位置付けられた固定機構であって、前記固定機構は、移動させられまたはサイズが増加すると、前記ガイドワイヤを前記ガイドカテーテルまたは前記管部材の内側表面に対して係合させるように構成されている、固定機構と
を備える、経皮的デバイス。 - 前記管部材は、前記押動部材より可撓性である、請求項1に記載の経皮的デバイス。
- 前記管部材は、少なくとも6cmの長さを含む、請求項1または2のいずれか1項に記載の経皮的デバイス。
- 前記管部材の前記管腔の直径は、前記ガイドカテーテルの前記管腔の直径より1フレンチサイズ以下だけ小さい、請求項1〜3のいずれか1項に記載の経皮的デバイス。
- 前記管部材は、前記管部材全体が前記ガイドカテーテル内に位置付けられる第1の後退位置と、前記管部材の一部が前記ガイドカテーテルの遠位端を越えて延在する第2の延在位置との間で移動可能である、請求項1〜4のいずれか1項に記載の経皮的デバイス。
- 前記管部材は、内側ポリマー層と、外側ポリマー層と、前記内側ポリマー層と外側ポリマー層との間に配置された補強部材とを含む、請求項1〜5のいずれか1項に記載の経皮的デバイス。
- 前記押動部材は、前記管部材の近位端部分に取り付けられている、請求項1〜6のいずれか1項に記載の経皮的デバイス。
- 前記押動部材は、前記管部材の横断面に対して偏心的に位置付けられている、請求項1〜7のいずれか1項に記載の経皮的デバイス。
- 前記固定機構は、膨張させられると、前記ガイドワイヤを前記ガイドカテーテルまたは前記管部材の前記内側表面に対して係合させるように構成された固定バルーンである、請求項1〜8のいずれか1項に記載の経皮的デバイス。
- 前記押動部材は、管腔を含み、前記管腔は、膨張流体を前記固定バルーンに送達するまたは膨張流体を前記固定バルーンから除去するために前記固定バルーンの内部と流体連通する、請求項9に記載の経皮的デバイス。
- 前記押動部材は、ハイポチューブを含む、請求項10に記載の経皮的デバイス。
- 前記押動部材の近位端部分は、注射器または他の膨張デバイスに結合可能な膨張マニホールドを含む、請求項10または11のいずれか1項に記載の経皮的デバイス。
- 前記固定バルーンは、前記管部材の近位に位置付けられ、前記押動部材の周りに巻着されている、請求項9〜12のいずれか1項に記載の経皮的デバイス。
- 前記固定バルーンは、内側ポリマー層と、外側ポリマー層とを含む、請求項9〜13のいずれか1項に記載の経皮的デバイス。
- 前記押動部材の近位端部分上に位置付けられた膨張インジケータバルブをさらに備え、前記インジケータバルブは、前記固定バルーンの内部と流体連通する、請求項9〜14のいずれか1項に記載の経皮的デバイス。
- 前記固定機構の中心は、前記押動部材の軸方向平面に対してオフセットされている、請求項1〜15のいずれか1項に記載の経皮的デバイス。
- 前記固定機構上または前記固定機構内に位置付けられた放射線不透過性マーカをさらに備える、請求項1〜16のいずれか1項に記載の経皮的デバイス。
- 前記管部材の真円形部分につながる部分的円筒形開口部を画定する凹面トラックをさらに備える、請求項1〜17のいずれか1項に記載の経皮的デバイス。
- 前記凹面トラックの第1の区画は、弧状断面形状を含む、請求項18に記載の経皮的デバイス。
- 前記弧状断面形状は、少なくとも0.5cmの長さに延在する、請求項19に記載の経皮的デバイス。
- 前記弧状断面形状は、前記管部材の断面円周の25%〜40%に半径方向に延在する、請求項19または20のいずれか1項に記載の経皮的デバイス。
- 前記凹面トラックの第2の区画は、半円筒形断面形状を含む、請求項19〜21のいずれか1項に記載の経皮的デバイス。
- 前記半円筒形断面形状は、少なくとも0.5cmの長さに延在する、請求項22に記載の経皮的デバイス。
- 前記半円筒形断面形状は、前記管部材の断面円周の40%〜70%に半径方向に延在する、請求項22または23のいずれか1項に記載の経皮的デバイス。
- 前記凹面トラックの支持構造は、ハイポチューブの形態における前記押動部材から無管腔構造に遷移する、請求項18〜24のいずれか1項に記載の経皮的デバイス。
- 前記ハイポチューブの遠位端および前記無管腔構造の近位端は、ともに溶接される噛合する非垂直切断部を含む、請求項25に記載の経皮的デバイス。
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CA2974544C (en) | 2018-02-27 |
JP6839693B2 (ja) | 2021-03-10 |
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JP6663921B2 (ja) | 2020-03-13 |
WO2016191415A1 (en) | 2016-12-01 |
EP3466476A1 (en) | 2019-04-10 |
US10974028B2 (en) | 2021-04-13 |
JP2019022753A (ja) | 2019-02-14 |
EP3302674B1 (en) | 2019-01-30 |
EP3302674A1 (en) | 2018-04-11 |
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