JP5089382B2 - 塞栓フィルタ搬出システム - Google Patents
塞栓フィルタ搬出システム Download PDFInfo
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- JP5089382B2 JP5089382B2 JP2007515291A JP2007515291A JP5089382B2 JP 5089382 B2 JP5089382 B2 JP 5089382B2 JP 2007515291 A JP2007515291 A JP 2007515291A JP 2007515291 A JP2007515291 A JP 2007515291A JP 5089382 B2 JP5089382 B2 JP 5089382B2
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- suction
- catheter
- embolism prevention
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- prevention device
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
- A61B2017/22034—Gripping instruments, e.g. forceps, for removing or smashing calculi for gripping the obstruction or the tissue part from inside
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
- A61B2017/22035—Gripping instruments, e.g. forceps, for removing or smashing calculi for retrieving or repositioning foreign objects
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22079—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with suction of debris
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2217/00—General characteristics of surgical instruments
- A61B2217/002—Auxiliary appliance
- A61B2217/005—Auxiliary appliance with suction drainage system
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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
- A61F2/01—Filters implantable into blood vessels
Description
本発明は、塞栓トラップ、すなわち塞栓症予防装置を除去するためのカテーテルに関する。特に、本発明は、3次元フィルタマトリクスを有し得る塞栓症予防装置を、塞栓の放出を低減又は解消して患者の導管から除去しやすくする吸引カテーテルに関する。本発明は、さらに、迅速な交換が可能であり、患者から除去する間、3次元フィルタマトリクス用の保護ルーメンを形成することができる改良型吸引カテーテルに関する。
体内の脈管系又はその他の導管に入り、血流の閉塞を引き起こす可能性のある異質材料及び/又は固有材料を含むどのような粒子も、塞栓となり得る。塞栓は、フィブリン、血球若しくはその断片、コラーゲン、コレステロール、プラーク、脂肪、石灰化プラーク、気泡、動脈組織の凝固塊、及び/又はその他の多種多様な断片、或いはそれらの組合せから形成され得る。塞栓は、主要な器官に血液を送る中程度の寸法の血管の、狭くなった領域に留まり得る。周囲組織への血流が途絶えると、局所的な細胞死又は微小梗塞が生じる。微小脳梗塞によって脳卒中が引き起こされることがあり、その結果、意識障害、言語障害、麻痺、視覚障害、平衡障害が生じ、ひいては死に至ることもある。心臓では、塞栓は、心筋梗塞、すなわち心臓発作を引き起こす恐れがある。心筋梗塞症は、心筋層区画、すなわち心臓筋の中間層の壊死を指す。心筋梗塞は、冠状動脈又はその支脈の少なくとも部分的な閉塞から起こり得る。冠状動脈に関連する毛細管の閉塞に対応して、微小梗塞症(microinfarction)/微小梗塞(microinfarc)が発症し得る。結果として生じる障害は、しばしば短期的であるが、恒久的になることもある。
血流中の異物によって、乱流又は低流が生じ得る。かかる血流状態によって、感染率が増大することが示されてきている。血栓によって、塞栓が生じるだけでなく、感染の危険が増す。(9)
第1の態様では、本発明は、患者の導管から塞栓症予防装置を除去する方法に関する。この方法は、吸引カテーテルを介して吸引を加えながら、塞栓症予防装置を吸引カテーテル内に引き込むことを含む。この塞栓症予防装置は、3次元フィルタマトリクスを有する。
患者から塞栓を捕捉し除去するための改良型システムは、吸引カテーテルを使用するものであり、いくつかの実施態様では、この吸引カテーテルは、カテーテルの遠位端に吸引を伝達し、カテーテル中に液体を吸引すると共に、患者から塞栓症予防装置を除去する際にその中でこの装置を引き抜く保護ルーメンともなる。したがって、塞栓症予防装置を除去するには、吸引を加えながらカテーテル内でこの装置を引き抜くことができる。次いで、この吸引カテーテルは、塞栓症予防装置を除去するための搬送手段(vehicle)として働く。吸引を外筒カテーテルシステムと共に使用することによって、塞栓症予防装置を除去する間のどのような塞栓の放出も大幅に低減、又は解消することができる。いくつかの実施態様では、吸引カテーテルは、その中に塞栓症予防装置が回収形状で引き込まれる拡張区画を含む。いくつかの実施態様では、塞栓症予防装置は、フィルタリング中、塞栓が詰まりにくく、且つ展開中、又は回収時の吸引中に流動をほとんど遮断しない流動網となる3次元フィルタマトリクスを含む。特に対象となるいくつかの実施態様では、3次元フィルタマトリクスは、表面毛細繊維等の繊維を含む。こうした繊維を、ガイドワイヤの遠位端に取り付けることができる。吸引カテーテルは、ワイヤ被覆構造又は迅速交換設計とすることができる。特に、迅速交換吸引カテーテルは、単一ルーメン設計とすることができる。多くの装置は、塞栓症予防システム内に組み込むのに特に適しているが、いくつかの装置は、追加の様々な医療用途にも適している。
一般に、塞栓症予防システムは、塞栓症予防装置、任意の治療システム、適当な送達構成要素、及び適当な回収構成要素を含むことができ、これらは、共通の要素を有しても有しなくてもよい。送達構成要素は、一般に、ガイドワイヤ等と、塞栓症予防装置を送達位置に搬送する適当な装置とを含む。同様に、回収構成要素も、ガイドワイヤ等と、塞栓症予防装置を回収する適当な装置とを含むことができるが、1つ以上の構成要素は、この装置を送達するのに使用するのと同じ要素でもよい。具体的には、独立させる塞栓症予防装置では、いくつかの送達構成要素が、装置回収用に使用するいくつかの構成要素と同じであってもなくてもよい。塞栓症予防装置を取り付けておく実施態様では、送達構成要素は、一般に、装置回収用に使用する構成要素と共通の要素を有する。一般に、回収構成要素は、吸引カテーテルを含む。塞栓症予防装置の特定の設計を、以下の見出しの節でさらに説明する。また、繊維ベースの塞栓症予防装置を展開し回収するための特定の一体型システムについても以下で説明する。
塞栓症予防装置は、展開前後の有効な外側表面に関して、また、構造の断面全体にわたる材料の配置に関して、様々な寸法及び形状を取ることができる。例えば、薄膜ベースフィルタ塞栓症予防装置がいくつか市販されている。しかし、3次元フィルタマトリクスを備えた塞栓症予防装置は、望ましいフィルタリング特性及び除去特性を実現することができる。3次元フィルタマトリクスでは、複数の流路を備えた流動網が形成され、したがって、より小型の塞栓が捕捉されるにつれて、マトリクスを通る流動が遮断されてしまうことにはならない。いくつかの実施態様では、3次元フィルタマトリクスを備えた塞栓症予防装置は、ヒドロゲル及び/又は形状記憶繊維等の材料を組み込んだ拡張構造を有する。他の実施態様では、塞栓症予防装置は、展開時に患者の導管内腔全体にわたって繊維が拡張して、3次元フィルタマトリクスを形成することができる、表面毛細繊維等の繊維を組み込む。展開及び回収を可能とする一体型の構造内に、適当な塞栓症予防装置を組み込むことができ、その特定の一実施態様を以下で説明する。
一般に、本明細書に記載の吸引カテーテルは、様々な手技に使用することができる。しかし、こうした吸引カテーテルは、患者の導管から塞栓症予防装置を除去するのに特に有用である。特に、吸引によって、塞栓症予防装置を展開配置から除去に適した配置に変形させる間に放出されるどのような塞栓も捕捉されるという効果が得られる。回収工程を安定させるために、塞栓症予防装置を外筒内の、一般には吸引カテーテルの遠位区画内に引き込むことができる。塞栓症予防装置が吸引カテーテルの遠位区画内に具合良く収まった後は、塞栓が放出される危険は十分に低減し、したがって、吸引を停止し、塞栓症予防装置を安全に引き抜くことができる。したがって、塞栓症予防装置をカテーテルの遠位区画に引き込むことによって、吸引による流動の乱れは、流動させるための分路を使用せずにすむ程度に維持することができる。この工程の様々な段階で、位置決めのために放射線不透過性マーカーを使用することができる。
本明細書に記載の医療装置は、一般に、滅菌容器に梱包されて、医療専門家が使用するように配送される。こうした物品は、電子ビーム照射法、ガンマ線照射法、紫外線照射法、化学的滅菌法等の様々な手法を用いて、且つ/又は、滅菌製造及び滅菌梱包処理を用いて、滅菌することができる。こうした物品には、例えば、その物品が十分機能する状態にあると考えられる適当な期日をラベル表示することができる。
Claims (10)
- ガイド構造と、吸引装置と、近位部分と、遠位吸引開口を備える遠位端を有する迅速交換セグメントと、前記近位部分と前記迅速交換セグメントとの間に取り付けられたシャフトとを含む迅速交換吸引カテーテルであって、
前記迅速交換セグメントが、前記シャフトと前記迅速交換セグメントとの間の連結部に隣接する迅速交換ポートを含み、前記迅速交換セグメントが前記シャフトよりも大きな直径を有し、
前記ガイド構造が、前記シャフトの外側を延び、前記迅速交換ポートを通り抜けて前記迅速交換セグメントの内側を延びて、前記迅速交換セグメントを通り前記遠位吸引開口を通り抜けることが可能であり、
前記吸引装置が、前記近位部分に取り付けられて、前記近位部分から前記遠位吸引開口まで延びる単一の連続したルーメンを介して前記遠位吸引開口に吸引をもたらす、前記迅速交換吸引カテーテル。 - 前記迅速交換セグメントの長さが、約2cm〜約30cmである、請求項1記載の迅速交換吸引カテーテル。
- 前記シャフトの直径がほぼ一定である、請求項1記載の迅速交換吸引カテーテル。
- 前記迅速交換セグメントが、前記迅速交換セグメントの遠位端に、拡張区画を備える遠位先端を含み、かつ前記遠位先端がほぼ円筒形で、その平均直径が前記シャフトの平均直径よりも少なくとも約20パーセント大きい、請求項1記載の迅速交換吸引カテーテル。
- 前記シャフトと前記迅速交換セグメントとが異なる材料から構成される、請求項1記載の迅速交換吸引カテーテル。
- さらに、前記カテーテルの遠位端にまたはその付近に、放射線不透過性マーカーを備える、請求項1記載の迅速交換吸引カテーテル。
- さらに、前記ガイド構造の遠位端にまたはその付近に取り付けられたフィルタ装置を備える、請求項1記載の迅速交換吸引カテーテル。
- 前記フィルタ装置は繊維の束を備え、前記ガイド構造はハイポチューブ内を延びるコアワイヤを備え、前記繊維の第一端はコアワイヤと共に移動するように取り付けられ、前記繊維の第二端はハイポチューブと共に移動するように取り付けられ、ハイポチューブのコアワイヤに対する相対運動が、前記繊維の束を拡張し展開した形状と縮径された形状との間で移動させる、請求項7記載の迅速交換吸引カテーテル。
- 前記繊維が表面毛細繊維である、請求項8記載の迅速交換吸引カテーテル。
- 前記迅速交換ポートは、前記ガイド構造がポート径の大部分を占め、したがって、前記遠位吸引開口で吸引を行うことが可能となるように寸法設定される、請求項1記載の迅速交換吸引カテーテル。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US10/854,920 US8409237B2 (en) | 2004-05-27 | 2004-05-27 | Emboli filter export system |
US10/854,920 | 2004-05-27 | ||
PCT/US2005/018334 WO2005118050A2 (en) | 2004-05-27 | 2005-05-24 | Emboli filter export system |
Publications (3)
Publication Number | Publication Date |
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JP2008515463A JP2008515463A (ja) | 2008-05-15 |
JP2008515463A5 JP2008515463A5 (ja) | 2008-07-03 |
JP5089382B2 true JP5089382B2 (ja) | 2012-12-05 |
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Application Number | Title | Priority Date | Filing Date |
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JP2007515291A Expired - Fee Related JP5089382B2 (ja) | 2004-05-27 | 2005-05-24 | 塞栓フィルタ搬出システム |
Country Status (4)
Country | Link |
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US (2) | US8409237B2 (ja) |
EP (1) | EP1761298A4 (ja) |
JP (1) | JP5089382B2 (ja) |
WO (1) | WO2005118050A2 (ja) |
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WO2005118050A2 (en) | 2005-12-15 |
JP2008515463A (ja) | 2008-05-15 |
EP1761298A2 (en) | 2007-03-14 |
US8409237B2 (en) | 2013-04-02 |
EP1761298A4 (en) | 2014-09-17 |
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