JP5586147B2 - 壁内空間を活用するための脈管内デバイス - Google Patents
壁内空間を活用するための脈管内デバイス Download PDFInfo
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- JP5586147B2 JP5586147B2 JP2008530010A JP2008530010A JP5586147B2 JP 5586147 B2 JP5586147 B2 JP 5586147B2 JP 2008530010 A JP2008530010 A JP 2008530010A JP 2008530010 A JP2008530010 A JP 2008530010A JP 5586147 B2 JP5586147 B2 JP 5586147B2
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- subintimal
- tip
- lumen
- shaft
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
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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
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0152—Tip steering devices with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
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Description
図1Bからわかるように、完全閉塞120のため、放射線不透過性コントラスト媒体注入X線撮影法を使用して、完全閉塞120及び動脈セグメント114を可視化することはできない。場合によっては、完全閉塞120の周囲の側副動脈に十分な量のコントラスト媒体を入れて先端セグメント114を視覚化してもよいが、先端セグメント114の視覚化は、多くの場合、不鮮明であり、それでも、閉塞セグメント120は視覚化されない。稀ではあるが、十分な放射線不透過性コントラスト媒体を、静脈系を通して逆方向に注入し、先端セグメント114のX線撮影画像を得ることができるが、こうした画像は、多くの場合、不明瞭であり、閉塞セグメント120を明らかにしない。
以上の実施例は、脈管境界を形成するため及び/又は穴が形成されないように保護するため、全体として、血管内膜層を穿通する工程と、内膜下デバイスを内膜下空間内に配置する工程と、閉塞セグメントを横切る工程とを含む。以下のバイパス実施例もまた、血管内膜層を穿通する工程と、内膜下デバイスを内膜下空間内に配置する工程と、閉塞セグメントを横切る工程とを含む最初の工程を含む。この目的のため、境界を形成する実施例及び穴が形成されないように保護する実施例を参照して説明したデバイス及び方法は、以下のバイパス実施例に適用される。
以下の実施例において、上文中に概略に説明した、完全閉塞の視覚化、穿孔保護、及び/又はバイパスに含まれる工程のうちの一つ又はそれ以上を行うデバイスの詳細な例を説明する。これらのデバイスは、例えば、(i)内膜下空間に進入し、脈管内層を周囲組織層から剥離し、内膜下空間を通って完全閉塞を越えて横切るのに十分な軸線方向力及び半径方向トルクを伝達することによって、内膜下デバイスのトラッキングを行い、(ii)内膜下デバイスを内膜下空間内で完全閉塞の先端側の真の内腔に再進入する上で好都合な配向で整合し、(iii)内膜下デバイスの整合及び配向を利用して再進入エレメントを前進し、内膜下デバイスを真の内腔内に向かって差し向け、(iv)完全閉塞の先端側で真の内腔に再びアクセスするため、血管内膜層を穿通し、(v)真の内腔の再進入が行われたことを確認する。
図17及び図18を参照して説明する例は、内膜下空間に進入してこの空間内で前進するため、押し力(push force)及び捩じり力を伝達する内膜下デバイスの特徴を例示する。図17は、チューブ状シャフト1702の中央内腔1701内に摺動自在に配置された内部スタイレット1703によって押し力及び捩じり力を提供する、内膜下デバイス1700の一実施例を示す。スタイレット1703を取り外した状態で、中央内腔はガイドワイヤ(図示せず)を受け入れることもできる。
図19A及び図19B、図20A及び図20B、図21A及び図21B、及び図22A乃至図22Cを参照して説明する実施例は、真の内腔に向かう配向を容易にする内膜下デバイスの特徴を示す。一般的には、内膜下デバイスを周囲の少なくとも一部に亘って展開する(半径方向に湾曲させるとも呼ぶ)ことによって、真の内腔の方向を湾曲の中心(凹状側)に向かわせる。長さ方向に位置決めした内膜下デバイスから半径方向に湾曲するため、先ず最初に、内膜下デバイスを軸線方向で曲げ即ち湾曲させ、移行形状として作用するのが必要であるか或いは望ましい。従って、本明細書中に説明した内膜下デバイスの幾つかの実施例では、内膜下空間で展開したとき、軸線方向屈曲部(例えば図19A参照)及び半径方向屈曲部(例えば図19B参照)の両方を有する。半径方向屈曲部の凹状の側部が一貫して内腔に向かうため、再進入デバイスは、このデバイスを内膜下デバイスの半径方向湾曲に関して整合することによって、真の内腔に向かって予想通りに差し向けられる(複雑な視覚化技術を使用せずに)。かくして以下の実施例において、半径方向屈曲部(及び軸線方向屈曲部)を吸収し、半径方向屈曲部の凹状の側部に向かう真の内腔の方向を確立する内膜下デバイスの様々な設計を例示する。
上文中に説明したように、所定の半径方向屈曲部を持つ、内膜下デバイスの凹状の側部は、一貫して真の内腔に向かう。かくして、再進入デバイスを、内膜下デバイスの半径方向湾曲部の凹状の側部と整合することによって、真の内腔に向かって予測可能に(複雑な可視化技術を使用せずに)差し向けることができる。従って、以下の実施例において、内膜下デバイスの半径方向湾曲部の凹状の側部に対して整合させ、真の内腔内に予測可能に再進入させた(複雑な可視化技術を使用せずに)様々な再進入デバイスを例示する。
以上、様々な目的のため、内膜下空間内で展開できる様々なデバイスを本明細書中に説明した。以下の実施例は、同じ方法で又は同様に使用できるこのような展開可能なデバイスの追加の例である。例えば、以下の実施例は、完全閉塞の長さに沿って及び完全閉塞の周囲に亘って内膜下空間内で解放されたとき、(i)X線撮影中の動脈壁の確認を補助する可視化補助エレメント、(ii)真の動脈内腔内の完全閉塞を通過するデバイスから一つ又はそれ以上の脈管外層を保護する保護エレメント、及び/又は(iii)真の動脈内腔内の完全閉塞を通過したデバイスと保護エレメントとの間の接近又は接触の表示を提供する保護エレメントとして役立つ展開可能なエレメントを提供する。展開可能なエレメントは、外部包含シースから解放したりこのシース内に再捕捉したりすることを容易に行うことができる。更に、展開可能なエレメントを患者の体内で解放し、永久的インプラントとして展開状態のままにしておいてもよい。この永久的インプラントは、ステントとして役立ち、及び/又は薬剤を溶出することもできる。
本明細書中上文中に説明したデバイスの幾つかは、完全閉塞を完全に又は部分的に除去するために使用してもよい。場合によっては、動脈壁の内部分が除去される。図30A乃至図30Dは、この用途の一例を示し、送出デバイス400を使用して、内膜下デバイス300を、図4、図4A、図4B、及び図5に図示し且つこれらの図を参照して説明したのと同様に、完全閉塞120の周囲に送出する。次いで、以下に更に詳細に説明するように閉塞を除去する。
図32A乃至図32Eは、完全閉塞をバイパスするための変形例のシステムを示す。図32Aを参照すると、この図には内膜下デバイス3200が展開形体で示してある。内膜下デバイス3200は、弾性ワイヤ3210を含む。この弾性ワイヤの先端形態は、正弦波状巻回部が少ないことを除き、図28を参照して説明した弾性ワイヤ形態2800と同様である。内膜下デバイスは、更に、三日月形又は半円形の送出シャフト3220及び引き込み式拘束シース3230を含む。図32AのA−A線に沿った断面である図32Bでわかるように、ワイヤ3210は、半円形送出シャフト3220の凹所に載っており、このシャフトにシース3230が被せてある。変形例として、拘束シース3230が、形成したワイヤ3210を少なくとも部分的に直線状にする上で十分な剛性を備えている場合には、拘束シース3230がワイヤ3210の周囲にだけ配置されていてもよく、送出シャフト3220の凹所内に置かれていてもよい。ワイヤ3210の先端は、シャフト3220の丸みのあるチップ3222に連結されている。ワイヤ3210及び半円形シャフト3220は、ニッケルチタニウム、ステンレス鋼、エルジロイ 、又はMP35N等の弾性金属材料で形成されていてもよく、シース3230は、PTFE(例えばテフロン)でライニングしたポリエーテルブロックアミド(例えばペバックス(ペバックス(Pebax)は登録商標である)等のポリマー材料で形成されていてもよい。
図33A乃至図33Eは、配向デバイス3330を導入するために一つ又はそれ以上の内膜下ガイドカテーテル3310/3320を使用する実施例を概略に示す。これらの図は、例示の目的で脈管壁の外層を切除したウィンドウを示す。幾つかの特徴において変形例のバイパス実施例であるこの実施例では、上文中に説明したように鈍く剥離することにより内膜下空間を安全に横切るため、ガイドワイヤ内腔(図示してある)を備えた又は備えていない、球状チップ310(例えば直径が0.965mm(0.038インチ)のオリーブ状溶接ボール)を持つ内膜下横断デバイス300を使用する。
図34A乃至図34Hは、内膜下横断デバイス又はガイドワイヤを使用して配向デバイス3400を導入する実施例を概略に示す。この実施例では、配向デバイス3400は、内膜下横断デバイス又はガイドワイヤをその内部に収容し、かくして上文中に説明した内膜下ガイドカテーテルに対する必要をなくすように設計されている。特に図34Aを参照すると、配向デバイス3400の先端部分の詳細図が示してある。図34B(1)は、図34AのA−A線に沿った断面図であり、図34B(2)は、図34AのB−B線に沿った断面図である。配向デバイス3400は、先端が配向エレメント3440に連結された細長い外チューブシャフト3410を含む。細長い内チューブシャフト3420が外シャフト3410及び配向エレメント3440を通って延びている。内シャフト3420の先端は、先端非外傷性チューブ状チップ3450と同様に、配向エレメント3440の先端に連結されている。デバイスを滑らかに通過させるため、低摩擦ライナ3430が内シャフト3420の内腔に亘って設けられていてもよい。
上文中に説明した配向デバイス(例えば3330、3340、3400)のうちの幾つかは、再進入デバイスを送出するための側方ポートと関連する実質的に平らな配向エレメントを有する。側方ポートは、全体として、配向エレメントの平面に対して直角に配向されている。この構成では、側方ポートは、脈管の真の内腔に向かって差し向けられているか或いは脈管の真の内腔から逆方向に180°の角度で差し向けられているかのいずれかである。本質的には、配向デバイスは、側方ポートが面する方向の数を、360°の自由度から2°の自由度に減少する。以下、ポートが真の内腔に向かって差し向けられているのか或いは真の内腔から遠ざかる方向に差し向けられているのかを決定し、かくして2°の自由度を1°の自由度に減少する方法を説明する。一般的には、側方ポートが真の内腔から遠ざかる方向に差し向けられている場合には、配向デバイスを引っ込め、180°回転し、再度展開して側方ポートを真の内腔に向かって差し向ける。次いで、本明細書中上文中に説明した再進入デバイスを、側方ポートを通して、脈管壁を通して、及び真の内腔内に前進する。
図36A乃至図36Gを参照すると、これらの図には、変形例の再進入デバイスが概略に示してある。これらの実施例は、上文中に説明した配向デバイスのうちの任意のデバイスで使用できるが、上文中に説明した配向デバイス3330、3340、3400で使用するのに特に適している。一般的には、以上の再進入デバイスの各々は、例えば冠動脈の用途について、直径が0.3556mm(0.014インチ)のプロファイルを持つ従来のガイドワイヤと同様の大きさであってもよい。更に、一般的には、以上の再進入デバイスの各々は、血管内膜層を穿通して脈管の真の内腔に進入するための機構として回転アブレーションを使用する。
112 基端セグメント
114 先端セグメント
115 中間層
116 元来の内腔
117 外膜層
118 動脈壁
120 慢性全閉塞
132 進入点
130 内膜下空間
300 放射線不透過性内膜下
400 展開デバイス
402 カテーテルシャフト
404 先端バルーン
406 外チューブ
408 内チューブ
410 膨張内腔
412 ガイドワイヤ内腔
414 送出チューブ
416 送出内腔
600 内膜下デバイス
604 チューブ状シャフト
606 螺旋状相互係止ギヤ
608 螺旋状ワイヤコイル
610 螺旋状内マンドレル
Claims (25)
- 内部に閉塞がある脈管内腔を形成する脈管壁を介して治療を行うシステムにおいて、
長さ方向軸線を画定するとともに、先端側方開口部まで貫通した内腔を有する細長いシャフトを持つ壁内配向デバイスであって、前記長さ方向軸線から横方向に延びるよう構成された一つ以上の延長部を持つ先端配向エレメントを含む、壁内配向デバイスと、
脈管組織を穿通するように形成され、前記配向デバイスの前記内腔に挿入される大きさ及び形体を備えた再進入デバイスと、
を備え、
一つ以上の延長部の各々が、潰れた送出形体と拡張した展開形体とを含み、
各延長部の最も基端側の部分であって、展開形体において前記配向デバイスの前記内腔の外部に位置する基端側の部分は、送出形体においても前記配向デバイスの前記内腔の外部に位置しており、
前記延長部は、ヒンジ連結された少なくとも二つのウィングを含み、これらのウィングは、潰れた送出形体と拡張した展開形体との間で移動するように形成されており、
前記ウィングは、カットした金属チューブによって形成されている、システム。 - 請求項1に記載のシステムにおいて、
前記配向デバイスは、前方に押圧されたデバイスを前記先端側方開口部に向かって差し向け、後方に押圧されたデバイスが前記配向デバイスの前記内腔を通って基端方向に通過できるように前記配向デバイスの前記内腔に配置されたフラップを更に含む、システム。 - 請求項1に記載のシステムにおいて、
前記ウィングは、前記展開形体で、等しく両方向に延びている、システム。 - 請求項1に記載のシステムにおいて、
前記延長部は先端及び基端を有し、前記細長いシャフトの先端は前記延長部の先端に連結されており、外チューブが前記細長いシャフトの基端部分を摺動自在に受け入れ、前記外チューブの先端が前記延長部の基端に連結されており、前記細長いシャフトと前記外チューブとの間の相対的移動により前記延長部の展開を制御する、システム。 - 請求項1に記載のシステムにおいて、
前記先端側方開口部の基端側の前記細長いシャフトの一部には、螺旋状カットが形成されている、システム。 - 請求項2に記載のシステムにおいて、
前記フラップは、押圧されることにより、前方に押圧されたデバイスを前記先端側方開口部に向かって差し向ける傾斜部を前記配向デバイスの前記内腔内に形成する、システム。 - 請求項6に記載のシステムにおいて、
前記細長いシャフトには、前記フラップを受け入れるスロットが設けられている、システム。 - 請求項1に記載のシステムにおいて、
前記再進入デバイスは、
先端テーパ区分を持つ細長い駆動シャフトと、
前記駆動シャフトの前記先端テーパ区分に連結された、外面に沿って研磨コーティングが設けられた研磨用チップと、を備え、
前記先端テーパ区分は、前記再進入デバイスを前記脈管内腔内に穿通した後、反対側の脈管壁が穿通されないように前記チップを撓ませることができる、システム。 - 請求項8に記載のシステムにおいて、
前記コーティングは、グリットダイヤモンドコーティングである、システム。 - 請求項8に記載のシステムにおいて、
前記再進入デバイスは、回転駆動装置によって回転されるように形成されている、システム。 - 請求項1に記載のシステムにおいて、
前記再進入デバイスは、脈管組織を穿通するように形成された螺旋状カット区分によって形成された先端部分を持つ細長いシャフトを備え、
前記螺旋状カット区分の夫々の巻回部間の間隔は、前記再進入デバイスの先端部分の可撓性が基端部分よりも高いように、先端方向で増大し、
前記螺旋状カット区分は、前記再進入デバイスが脈管組織を穿通した後、反対側の脈管壁が穿通されないように、十分な可撓性を有する、システム。 - 請求項11に記載のシステムにおいて、
前記螺旋状カット区分のチップは尖っている、システム。 - 請求項11に記載のシステムにおいて、
前記再進入デバイスは、回転駆動装置によって回転されるように形成されている、システム。 - 請求項1に記載のシステムにおいて、
前記先端側方開口部は、一つ以上の前記延長部の平面に対して直角に差し向けられている、システム。 - 請求項1に記載のシステムにおいて、
前記先端側方開口部は、一つ以上の延長部の平面に対して直角に差し向けられている、システム。 - 請求項1に記載のシステムにおいて、
前記配向デバイスは、拡張した展開形体において、平らになっている、システム。 - 請求項1に記載のシステムにおいて、
前記配向エレメントの先端部は、前記長さ方向軸線を横切って横断する先端に面した開口部を含む、システム。 - 請求項1に記載のシステムにおいて、
一つ以上の前記延長部の各々は、曲げられた曲げ部を含む、システム。 - 請求項1に記載のシステムにおいて、
一つ以上の前記延長部の各々は、直線の端部を含む、システム。 - 内部に閉塞がある脈管内腔を形成する脈管壁を介して治療を行うデバイスにおいて、
長さ方向軸線を画定するとともに先端側方開口部まで貫通した内腔を含む細長いシャフトを持つ壁内デバイスであって、長さ方向軸線から横方向に延びるよう構成された一つ以上の延長部と前記長さ方向軸線を横切る先端に面した開口部とを含む壁内デバイスと、
脈管組織を穿通するように形成された先端チップを持ち、前記配向デバイスの前記内腔に挿入される大きさ及び形体を備えた再進入デバイスと、
を備え、
各延長部の最も基端側の部分であって、展開形体において前記配向デバイスの前記内腔の外部に位置する基端側の部分は、送出形体においても前記配向デバイスの前記内腔の外部に位置しており、
前記延長部は、ヒンジ連結された少なくとも二つのウィングを含み、これらのウィングは、潰れた送出形体と拡張した展開形体との間で移動するように形成されており、
前記ウィングは、カットした金属チューブによって形成されている、デバイス。 - 請求項20に記載のデバイスにおいて、
前記先端側方開口部は、一つ以上の前記延長部の平面に対して直角に差し向けられている、デバイス。 - 請求項20に記載のデバイスにおいて、
前記壁内デバイスは、拡張した展開形体において、平らになっている、デバイス。 - 請求項20に記載のデバイスにおいて、
前記ウィングは、前記展開形体で、等しく両方向に延びている、デバイス。 - 請求項20に記載のデバイスにおいて、
一つ以上の前記延長部の各々は、曲げられた曲げ部を含む、デバイス。 - 請求項20に記載のデバイスにおいて、
一つ以上の前記延長部の各々は、直線の端部を含む、デバイス。
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EP1924315A2 (en) | 2008-05-28 |
JP2014061399A (ja) | 2014-04-10 |
EP3650074B1 (en) | 2023-10-25 |
US20150080928A1 (en) | 2015-03-19 |
EP1924315A4 (en) | 2012-10-31 |
EP4292548A3 (en) | 2024-02-28 |
JP2009507565A (ja) | 2009-02-26 |
US11607245B2 (en) | 2023-03-21 |
WO2007033052A3 (en) | 2009-04-16 |
US8961494B2 (en) | 2015-02-24 |
US20130103070A1 (en) | 2013-04-25 |
US20200405348A1 (en) | 2020-12-31 |
US10806487B2 (en) | 2020-10-20 |
EP3650074A1 (en) | 2020-05-13 |
US20070093781A1 (en) | 2007-04-26 |
JP5826810B2 (ja) | 2015-12-02 |
US20230190331A1 (en) | 2023-06-22 |
EP4292548A2 (en) | 2023-12-20 |
EP1924315B1 (en) | 2019-12-04 |
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