JP2017176850A - 張力を用いた三尖弁の修復 - Google Patents
張力を用いた三尖弁の修復 Download PDFInfo
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- JP2017176850A JP2017176850A JP2017098926A JP2017098926A JP2017176850A JP 2017176850 A JP2017176850 A JP 2017176850A JP 2017098926 A JP2017098926 A JP 2017098926A JP 2017098926 A JP2017098926 A JP 2017098926A JP 2017176850 A JP2017176850 A JP 2017176850A
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Abstract
Description
本出願は、本出願の譲受人に譲渡された、「Tricuspid valve repair using tension」を発明の名称とする、2010年1月22日に出願された、米国出願第12/692,061号を基に優先権を主張し、かつ、その一部継続出願であり、その出願は参照することにより本書に組み込まれる。
本発明の幾つかの応用例は、概して、弁の修復に関する。特に、本発明の幾つかの応用例は、患者の三尖弁の修復に関する。
三尖弁輪の拡張、弁輪形状、肺高血圧、左心室不全または右心室不全、右心室形状、および、弁尖拘束など、幾つかの病態生理学的な異常に、機能性三尖弁逆流(FTR)は支配される。FTRの治療の選択肢は主に外科手術である。中度から重度の三尖弁逆流の現在の患者数は、米国内で160万人と推定されている。このうち、年間8千人のみが三尖弁手術をうけているが、それらのほとんどは、左の心臓弁の手術を伴うものである。
本発明の幾つかの応用例において、張力を利用して患者の三尖弁を修復するための装置および方法が提供される。典型的には、この三尖弁を修復するための装置および方法は、患者の心臓の、三尖弁の形状を改めること、および/または、右心房の壁の形状を改めることによって三尖弁の逆流の減少を容易にするものである。本発明の幾つかの応用例において、第1の組織係合要素が患者の三尖弁の上流にある組織の第1の部分にインプラントされる。それから第2の組織係合要素が患者の三尖弁の上流にある組織の第2の部分にインプラントされる。典型的には、第1および第2の組織係合要素の両方をインプラントした後、その第1および第2の組織係合要素を接続している長手部材を引くことにより、または、組織係合要素のうちのいずれか一方を引くことにより、三尖弁の弁尖間の距離が調整される。代替的または付加的に、長手部材は、第2の組織係合要素をインプラントする前に調整される。幾つかの応用例では、長手部材は調整機構に少なくとも一部が連結され、調整機構の動作に応答して長手部材が引っ張られまたは緩められる。
患者の心臓弁近傍にある組織の第1の部分に少なくとも第1の組織係合要素をインプラントする工程、
前記患者の心臓の心房と接している血管の部分に少なくとも第2の組織係合要素をインプラントする工程、および
前記血管の部分と前記患者の心臓弁近傍にある組織の前記第1の部分との間の距離を調整することにより、前記弁の少なくとも第1の弁尖を前記弁の少なくとも第2の弁尖へ向けて引き寄せる工程
を備える。
前記弁輪の組織の第2の部分に、長手第二部材により第4の組織係合要素と接続された第3の組織係合要素をインプラントする工程、および
前記長手第二部材が前記長手部材と両者の接合点で係合するように、前記弁輪の組織の第3の部分に、前記第4の組織係合要素をインプラントする工程
を備える。
前記第2の組織係合要素をインプラントする工程は、前記リングによって前記ステントが前記血管の壁に固定されるように前記リングを広げる工程を含む。
前記心臓の組織の第2の部分に、長手部材の遠位端にその近位端が接続された第3の組織係合要素をインプラントする工程、および
前記長手部材の近位端部を前記ステントに係合させる工程
を備える。
前記心臓弁近傍にある組織の前記第1の部分は、前記患者の前記血管の部分の反対にある組織の部分を含み、
組織の前記第1の部分に係合させる工程は、前記患者の前記血管の部分の反対にある前記組織の部分に係合させる工程を含み、かつ
前記弁の第1の弁尖を前記弁の第2の弁尖に向けて引き寄せる工程は、前記患者の前記血管の部分と前記患者の前記血管の部分の反対にある前記組織の部分との間の距離を調整する工程を含む。
患者の三尖弁の上流にある組織の第1の部分に少なくとも第1の組織係合要素をインプラントする工程、
前記患者の前記三尖弁の上流にある組織の第2の部分に少なくとも第2の組織係合要素をインプラントする工程、および
前記患者の前記三尖弁の上流にある組織の前記第1の部分と前記患者の前記三尖弁の上流にある組織の前記第2の部分との間の距離を調整することにより、前記患者の心臓の右心房の壁の形状を改める工程
を備える。
前記右心房の壁の形状を改める工程は、前記三尖弁の上流にある組織の、前記第1の部分、前記第2の部分および前記第3の部分の間のそれぞれの距離を調整することにより、前記壁の形状を改める工程を含む。
前記患者の前記三尖弁の上流にある組織の前記第1の部分に前記第1の組織係合部をインプラントする工程は、前記右心房の壁の前記第1の部分に前記第1の組織係合要素をインプラントする工程を含む。
前記患者の前記三尖弁の上流にある組織の前記第2の部分に前記第2の組織係合要素をインプラントする工程は、前記右心房の壁の前記第2の部分に前記第2の組織係合要素をインプラントする工程を含む。
前記右心房の壁の形状を改める工程は、前記右心房の壁の、前記第1の部分、前記第2の部分および前記第3の部分の間のそれぞれの距離を調整することにより、前記壁の形状を改める工程を含む。
前記第1の組織係合要素をインプラントする工程は、長手部材が連結された前記第1の組織係合要素をインプラントする工程を含み、
前記第2の組織係合要素には通路が形成されており、かつ前記第2の組織係合要素をインプラントする工程は、前記長手部材を前記通路に通した状態で前記第2の組織係合要素をインプラントする工程を含み、かつ
前記距離を調整する工程は、前記長手部材を近位方向に引っ張り、前記第1組織係合要素と第2組織係合要素とを接近させる工程を含む。
患者の下大静脈の壁の組織の部分に少なくとも第1の組織係合要素の少なくとも一部を係合させる工程、
前記患者の上大静脈の壁の組織の部分に少なくとも第2の組織係合要素の少なくとも一部を係合させる工程、
前記患者の下大静脈の壁の前記組織の部分および前記患者の上大静脈の壁の前記組織の部分からなる群から選択される組織の1以上の部分に張力を付加することにより、心臓弁の少なくとも第1の弁尖を前記弁の少なくとも第2の弁尖に向けて引き寄せる工程、および
前記張力を付加するのと併せて、前記患者の心臓弁の逆流の程度を監視する工程
を備える。
ステント、
遠位端を有する長手部材であって、該遠位端に、該長手部材から横に伸びる環状ループを備える長手部材、および
前記環状ループ、前記長手部材、および前記ステントに対して回転し得るように、前記環状ループに連結された組織アンカー
を備える。
(a)ステント、(b)遠位端を有する長手部材であって、該遠位端に、該長手部材から横に伸びる環状ループを備える長手部材、および(c)前記環状ループに連結された組織アンカーを提供する工程、
前記ステントを患者の血管内に置く工程、
前記環状ループ、前記長手部材、および前記ステントに対して前記組織アンカーを回転させて、前記患者の心臓弁近傍の組織に前記組織アンカーを連結する工程、および
前記組織に前記組織アンカーを連結した後、前記ステントが拡張してインプラント部位の前記血管内にインプラントされるように前記ステントを配置する工程
を備える。
圧縮状態および拡張状態をとるように構成されたステントであって、
1以上の細長部材と、
該1以上の細長部材によって互いに連結されており、該ステントの他の部材では互いに連結されていない2以上のリングであって、該ステントが拡張状態にあるとき、前記細長部材に対して略垂直な各々の平面を画定する2以上のリング
を備えたステント、
遠位端と、前記ステントに連結された近位端を有する長手部材、および
前記長手部材の前記遠位端に連結された組織アンカー
を備える。
(a)(i)1以上の細長部材と、(ii)該1以上の細長部材によって互いに連結されており、該ステントの他の部材では互いに連結されていない2以上のリングを含むステント、(b)遠位端と、前記ステントに連結された近位端を有する長手部材、および(c)前記長手部材の前記遠位端に連結された組織アンカーを提供する工程、
前記ステントを圧縮状態で患者の血管内に置く工程、
前記組織アンカーを前記患者の心臓弁近傍の組織に連結する工程、および
前記リングのそれぞれが前記細長部材に対して略垂直な平面を画定し、前記ステントを前記血管の壁に固定するように、前記ステントを拡張状態に移す工程
を備える。
開口を画定する、径方向に拡張可能なアンカー、
遠位端と近位端を有し、前記径方向に拡張可能なアンカーの前記開口を貫通して前記径方向に拡張可能なアンカーとスライド可能に連結された長手部材、および
前記長手部材の前記遠位端に連結された組織アンカー
を備え、前記径方向に拡張可能なアンカーおよび前記長手部材は、前記径方向に拡張可能なアンカーが前記長手部材にロック可能であるように構成されており、それにより、前記径方向に拡張可能なアンカーが前記長手部材に対して、前記長手部材の近位端に向かう少なくとも近位方向に移動するのが防止される。
(a)長手部材、(b)該長手部材にスライド可能に連結された、径方向に拡張されるアンカー、および(c)前記長手部材の遠位端に連結された組織アンカー、を含む張力装置を、最初に配置チューブ内に収納して提供する工程、
前記配置チューブを患者の左心房内に進入させる工程、
心房中隔に孔を設ける工程、
該孔を通して左心房から前記配置チューブを進入させ、前記配置チューブの遠位端を右心房内に配置させる工程、
前記配置チューブの遠位端から前記組織アンカーを配置して、該組織アンカーを三尖弁近傍にある心臓組織の部分に固定する工程、
前記配置チューブを前記左心房内へ引き抜き、それによって前記径方向に拡張可能なアンカーを左心房内の前記中隔の近くで解放する工程、および
前記径方向に拡張可能なアンカーを前記中隔の左心房側に保持しつつ、前記長手部材を近位方向に引っ張り、前記径方向に拡張可能なアンカーが前記長手部材に対して少なくとも近位方向に移動しないように前記径方向に拡張可能なアンカーを前記長手部材にロックする工程
を備える。
遠位組織穿孔先端具を有し、その最大外径が1.8mm以下である支柱、
前記支柱と関節をなすことができるように、前記遠位先端具近くで前記組織アンカーに連結された複数のリブ、
前記支柱に沿ってスライド可能なように、前記支柱に連結されたランナー、および
前記ランナーおよび前記リブの各一つと関節をなすことができるように、前記ランナーおよび前記リブの各一つに連結された複数のストレッチャ
を含む。
図1A−Gを参照する。図1A−Gは、本発明の幾つかの応用例に従う、患者の心臓2の三尖弁4を修復するための、第1の組織係合要素60aと第2の組織係合要素60bを備えるシステム20の概略図である。第1の組織係合要素60aは、心臓組織の少なくとも一部である第1のインプラント部位30にインプラントされるように設計された組織アンカー40を含む。注意すべきは、組織アンカー40は、限定ではなく例示のために、螺旋形の組織アンカーを含んでおり、組織アンカー40は、以下に限定されないが、図13A−Eを参照して後述する組織アンカーを含め、心臓組織を穿刺または把持するあらゆる組織アンカーを含みうるということである。第2の組織係合要素60bは、血管(例えば上大静脈10(図1E−Gに示されるようなもの)または下大静脈8(図1A−Dに示されるようなもの))の部分において第2のインプラント部位52にインプラントされるように設計されたステント50を含む。第1と第2の組織係合要素60a、60bは可撓性のある長手部材42によって互いに連結されている。通常、第1のインプラント部位30と第2のインプラント部位52との間の距離は、長手部材42を引いて張力を付加しまたは緩めること、および/または、第1および第2の組織係合要素60a、60bの少なくとも一方に張力を付加することによって調整される。これに応答して、三尖弁4の弁尖間の距離が調整されて弁4を通る逆流が減少または除去され、それによって、弁4は修復される。幾つかの応用例では、長手部材42は、後述のように、第2の組織係合要素60bを操作することによって引っ張られ、または緩められる。
・カテーテル22は、患者の大腿静脈に導入され、下大静脈8を通り、右心房6内に入ってもよい。
・カテーテル22は、尺側皮静脈に導入され、鎖骨下静脈を通り、上大静脈10を通り、右心房6内に入ってもよい。
・カテーテル22は、外頸静脈に導入され、鎖骨下静脈を通り、上大静脈10を通り、右心房6内に入ってもよい。
Claims (88)
- 患者の心臓弁近傍にある組織の第1の部分に少なくとも第1の組織係合要素をインプラントする工程、
前記患者の心臓の心房と接している血管の部分に少なくとも第2の組織係合要素をインプラントする工程、および
前記血管の部分と前記患者の心臓弁近傍にある組織の前記第1の部分との間の距離を調整することにより、前記弁の少なくとも第1の弁尖を前記弁の少なくとも第2の弁尖へ向けて引き寄せる工程
を備える方法。 - 前記血管の部分と前記患者の心臓弁近傍にある組織の前記第1の部分との間の距離を調整する工程が、前記第1と第2の組織係合要素を接続する長手部材を引っ張る工程を含む、請求項1に記載の方法。
- 前記第1の組織係合要素をインプラントする工程が、前記弁の弁輪の組織の前記第1の部分に前記第1の組織係合要素をインプラントする工程を含み、前記方法がさらに、
前記弁輪の組織の第2の部分に、長手第二部材により第4の組織係合要素と接続された第3の組織係合要素をインプラントする工程、および
前記長手第二部材が前記長手部材と両者の接合点で係合するように、前記弁輪の組織の第3の部分に、前記第4の組織係合要素をインプラントする工程
を備える、請求項2に記載の方法。 - 前記血管の部分と前記患者の心臓弁近傍にある組織の前記第1の部分との間の距離を調整する工程が、前記第1の組織係合要素および前記第2の組織係合要素からなる群から選択される1以上の係合要素に張力を付加する工程を含む、請求項1に記載の方法。
- 前記血管の部分と前記患者の心臓弁近傍にある組織の前記第1の部分との間の距離を調整するのと併せて、前記心臓弁の逆流の程度を監視する工程をさらに備える、請求項1に記載の方法。
- 前記血管の部分と前記患者の心臓弁近傍にある組織の前記第1の部分との間の距離を調整する工程が、前記第1の組織係合要素を前記血管の部分へ向けて引っ張る工程を含む、請求項1に記載の方法。
- 前記心臓弁が三尖弁を含み、かつ前記血管の部分と前記患者の心臓弁近傍にある組織の前記第1の部分との間の距離を調整する工程が、前記心臓の三尖弁の二尖弁化を達成する工程を含む、請求項1に記載の方法。
- 前記血管の部分と前記患者の心臓弁近傍にある組織の前記第1の部分との間の距離を調整する工程が、前記第1と第2の組織係合要素を接続する長手部材の部分に連結された調整機構を作動させる工程を含む、請求項1に記載の方法。
- 前記血管の部分に前記第2の組織係合要素をインプラントする工程が、前記血管の部分においてステントを広げる工程を含む、請求項1に記載の方法。
- 前記ステントが、1以上の細長部材で互いに連結され、該ステントの他の部材では互いに連結されない、2以上のリングを含み、かつ
前記第2の組織係合要素をインプラントする工程が、前記リングによって前記ステントが前記血管の壁に固定されるように前記リングを広げる工程を含む、
請求項9に記載の方法。 - 前記方法がさらに、
前記心臓の組織の第2の部分に、長手部材の遠位端にその近位端が接続された第3の組織係合要素をインプラントする工程、および
前記長手部材の近位端部を前記ステントに係合させる工程
を備える、
請求項9に記載の方法。 - 前記第3の組織係合要素に張力を付加する工程をさらに備える、請求項11に記載の方法。
- 前記血管が、上大静脈および下大静脈からなる血管の群から選択される、請求項1に記載の方法。
- 前記患者の心臓弁近傍にある組織の前記第1の部分に前記第1の組織係合要素をインプラントする工程が、組織の前記第1の部分を穿刺することおよび圧搾すること、ならびに、組織の前記第1の部分内に前記第1の組織係合要素の少なくとも一部を進めることからなる群から選択される1以上の行為を実行することによって組織の前記第1の部分に係合させる工程を含む、請求項1に記載の方法。
- 前記心臓弁近傍にある組織の前記第1の部分が、前記患者の前記血管の部分の反対にある組織の部分を含み、
組織の前記第1の部分に係合させる工程が、前記患者の前記血管の部分の反対にある前記組織の部分に係合させる工程を含み、かつ
前記弁の第1の弁尖を前記弁の第2の弁尖に向けて引き寄せる工程が、前記患者の前記血管の部分と前記患者の前記血管の部分の反対にある前記組織の部分との間の距離を調整する工程を含む、
請求項14に記載の方法。 - 前記心臓弁近傍にある組織の前記第1の部分が、前記弁の弁輪の上方の前記心臓の前記心房の壁の組織の部分を含み、かつ前記組織の前記第1の部分に係合させる工程が、前記心房の壁の前記組織の部分に係合させる工程を含む、請求項14に記載の方法。
- 前記心臓弁近傍にある組織の前記第1の部分が、前記弁の弁輪の組織の部分を含み、かつ前記組織の前記第1の部分に係合させる工程が、前記弁の弁輪の前記組織の部分に係合させる工程を含む、請求項14に記載の方法。
- 前記弁の弁輪の前記組織の部分が、弁の前尖の中央部と弁の後尖の中央部の間にある組織の部分を含む、請求項17に記載の方法。
- 患者の三尖弁の上流にある組織の第1の部分に少なくとも第1の組織係合要素をインプラントする工程、
前記患者の前記三尖弁の上流にある組織の第2の部分に少なくとも第2の組織係合要素をインプラントする工程、および
前記患者の前記三尖弁の上流にある組織の前記第1の部分と前記患者の前記三尖弁の上流にある組織の前記第2の部分との間の距離を調整することにより、前記患者の心臓の右心房の壁の形状を改める工程
を備える方法。 - 前記方法が、前記患者の前記三尖弁の上流にある組織の第3の部分に少なくとも第3の組織係合要素をインプラントする工程をさらに備え、かつ
前記右心房の壁の形状を改める工程が、前記三尖弁の上流にある組織の、前記第1の部分、前記第2の部分および前記第3の部分の間のそれぞれの距離を調整することにより、前記壁の形状を改める工程を含む、
請求項19に記載の方法。 - 前記患者の前記三尖弁の上流にある組織の前記第1の部分と前記患者の前記三尖弁の上流にある組織の前記第2の部分との間の距離を調整する工程が、前記第1の組織係合要素と前記第2の組織係合要素との間の距離を調整する工程を含む、請求項19に記載の方法。
- 組織の前記第1の部分が、前記右心房の壁の第1の部分を含み、かつ
前記患者の前記三尖弁の上流にある組織の前記第1の部分に前記第1の組織係合部をインプラントする工程が、前記右心房の壁の前記第1の部分に前記第1の組織係合要素をインプラントする工程を含む、
請求項19に記載の方法。 - 組織の前記第2の部分が、前記右心房の壁の第2の部分を含み、かつ
前記患者の前記三尖弁の上流にある組織の前記第2の部分に前記第2の組織係合要素をインプラントする工程が、前記右心房の壁の前記第2の部分に前記第2の組織係合要素をインプラントする工程を含む、
請求項22に記載の方法。 - 前記方法が、前記右心房の壁の第3の部分に少なくとも第3の組織係合要素をインプラントする工程をさらに備え、かつ
前記右心房の壁の形状を改める工程が、前記右心房の壁の、前記第1の部分、前記第2の部分および前記第3の部分の間のそれぞれの距離を調整することにより、前記壁の形状を改める工程を含む、
請求項23に記載の方法。 - 前記方法が、前記右心房の壁の形状を改めるのと併せて、前記三尖弁の逆流の程度を監視する工程をさらに備える、請求項19に記載の方法。
- 前記患者の前記三尖弁の上流にある組織の前記第1の部分と前記患者の前記三尖弁の上流にある組織の前記第2の部分との間の距離を調整する工程が、前記第1と第2の組織係合要素を接続する長手部材を引っ張る工程を含む、請求項19に記載の方法。
- 前記患者の前記三尖弁の上流にある組織の前記第1の部分と前記患者の前記三尖弁の上流にある組織の前記第2の部分との間の距離を調整する工程が、前記第1と第2の組織係合要素を接続する長手部材の部分に連結された調整機構を作動させる工程を含む、請求項19に記載の方法。
- 前記患者の心臓の右心房の壁の形状を改める工程が、前記患者の前記三尖弁の少なくとも第1の弁尖と前記患者の前記三尖弁の少なくとも第2の弁尖を互いに引き寄せる工程を含む、請求項19に記載の方法。
- 前記第1の組織係合要素をインプラントする工程が、長手部材が連結された前記第1の組織係合要素をインプラントする工程を含み、
前記第2の組織係合要素には通路が形成されており、かつ前記第2の組織係合要素をインプラントする工程が、前記長手部材を前記通路に通した状態で前記第2の組織係合要素をインプラントする工程を含み、かつ
前記距離を調整する工程が、前記長手部材を近位方向に引っ張り、前記第1組織係合要素と第2組織係合要素とを接近させる工程を含む、
請求項19に記載の方法。 - 前記長手部材を引っ張る工程が、前記第1組織係合要素と第2組織係合要素とが合体するまで前記長手部材を引っ張る工程を含む、請求項29に記載の方法。
- 患者の下大静脈の壁の組織の部分に少なくとも第1の組織係合要素の少なくとも一部を係合させる工程、
前記患者の上大静脈の壁の組織の部分に少なくとも第2の組織係合要素の少なくとも一部を係合させる工程、
前記患者の下大静脈の壁の前記組織の部分および前記患者の上大静脈の壁の前記組織の部分からなる群から選択される組織の1以上の部分に張力を付加することにより、心臓弁の少なくとも第1の弁尖を前記弁の少なくとも第2の弁尖に向けて引き寄せる工程、および
前記張力を付加するのと併せて、前記患者の心臓弁の逆流の程度を監視する工程
を備える方法。 - 前記張力を付加する工程が、前記少なくとも第1の組織係合要素の係合と、前記少なくとも第2の組織係合要素の係合の後で前記張力を付加する工程を含む、請求項31に記載の方法。
- 前記張力を付加する工程が、前記患者の下大静脈の壁の前記組織の部分と、前記患者の上大静脈の壁の前記組織の部分との間の距離を調整する工程を含む、請求項31に記載の方法。
- 前記患者の下大静脈の壁の前記組織の部分と前記患者の上大静脈の壁の前記組織の部分との間の距離を調整する工程が、前記張力の付加により、前記第1の組織係合要素と前記第2の組織係合要素の間の距離を調整する工程を含む、請求項33に記載の方法。
- 前記患者の下大静脈の壁の前記組織の部分に前記少なくとも第1の組織係合要素の前記一部を係合させる工程が、前記下大静脈内で第1のステント部材を広げ、該第1のステント部材の少なくとも一部を前記下大静脈の壁の前記部分と接触させる工程を含む、請求項31に記載の方法。
- 前記患者の上大静脈の壁の前記組織の部分に前記少なくとも第2の組織係合要素の前記一部を係合させる工程が、前記下大静脈内で第2のステント部材を広げ、該第1のステント部材の少なくとも一部を前記下大静脈の壁の前記部分と接触させる工程を含む、請求項31に記載の方法。
- 前記張力を付加する工程が、前記患者の心房の壁の形状を改める工程を含む、請求項31に記載の方法。
- 前記張力を付加する工程が、前記少なくとも第1の組織係合要素と前記少なくとも第2の組織係合要素を接続する長手部材を引っ張る工程を含む、請求項31に記載の方法。
- 前記張力を付加する工程が、前記第1の組織係合要素と第2の組織係合要素を接続する張力部品の一部に連結された調整機構を作動させる工程を含む、請求項31に記載の方法。
- ステント、
遠位端を有する長手部材であって、該遠位端に、該長手部材から横に伸びる環状ループを備える長手部材、および
前記環状ループ、前記長手部材、および前記ステントに対して回転し得るように、前記環状ループに連結された組織アンカー
を備える装置。 - 前記装置が、チューブをさらに備え、該チューブは、前記ステントにより画定される管腔を貫通する大きさを有し、かつ該チューブの回転によって前記組織アンカーが回転するように、前記組織アンカーに取り外し可能に連結されるように構成されている、請求項40に記載の装置。
- 前記組織アンカーには通路が形成されており、かつ、前記チューブは細長の連結要素を備え、該細長の連結要素は最初に前記通路に通してあり、それにより前記チューブが前記組織アンカーに連結されている、請求項41に記載の装置。
- 前記チューブが前記組織アンカーに取り外し可能に連結されている場合、前記チューブの長手部分は前記長手部材と並んで配置され、かつ該チューブのいかなる部分も前記長手部材の周囲に配置されない、請求項41に記載の装置。
- 前記装置が、アダプタホルダをさらに備え、前記アダプタホルダは、前記チューブに連結されており、かつ径方向に広がる性向を有するアームを画定する形状を有し、かつ前記アームが径方向に圧縮されているときに前記チューブを前記アンカーに連結するものである、請求項41に記載の装置。
- 前記装置が、前記ステントにより画定される管腔を貫通する大きさの運搬ツールオーバーチューブをさらに備え、前記チューブが、該運搬ツールオーバーチューブを貫通するように構成されており、かつ該オーバーチューブは、前記アームを包囲する位置に置かれたときに前記アームを径方向に圧縮するように構成されている、請求項44に記載の装置。
- 前記装置がアダプタをさらに備え、前記アダプタは、前記環状ループを貫通する円筒部を画定する形状を有し、かつ前記組織アンカーの近位部に固定的に連結された遠位部を有し、かつ、前記チューブが、前記アームが径方向に圧縮されると、前記アダプタホルダを介して前記アダプタに取り外し可能に連結され、それにより前記組織アンカーに取り外し可能に連結されるように構成されている、請求項44に記載の装置。
- 前記装置がさらにアダプタを備え、前記アダプタは、前記環状ループを貫通する円筒部を画定する形状を有し、かつ前記組織アンカーの近位部に固定的に連結された遠位部を有し、かつ、前記チューブが、前記アダプタに取り外し可能に連結され、それにより前記組織アンカーに取り外し可能に連結されるように構成されている、請求項41に記載の装置。
- 前記装置が、前記ステントにより画定される管腔を貫通する大きさの運搬ツールオーバーチューブをさらに備え、前記チューブは、該運搬ツールオーバーチューブを貫通するように構成されている、請求項41に記載の装置。
- 前記装置が、アダプタをさらに備え、該アダプタは、前記環状ループを貫通する円筒部を画定する形状を有し、かつ前記組織アンカーの近位部に固定的に連結された遠位部を有する、請求項40−48のいずれか1項記載の装置。
- 前記ステントが、複数の互いに接続された超弾性金属製の支材を備える、請求項40−48のいずれか1項記載の装置。
- 前記ステントが、1以上の細長部材と、該1以上の細長部材によって互いに連結され、該ステントのその他の部材によっては互いに連結されていない2以上のリングを備える、請求項40−48のいずれか1項記載の装置。
- (a)ステント、(b)遠位端を有する長手部材であって、該遠位端に、該長手部材から横に伸びる環状ループを備える長手部材、および(c)前記環状ループに連結された組織アンカーを提供する工程、
前記ステントを患者の血管内に置く工程、
前記環状ループ、前記長手部材、および前記ステントに対して前記組織アンカーを回転させて、前記患者の心臓弁近傍の組織に前記組織アンカーを連結する工程、および
前記組織に前記組織アンカーを連結した後、前記ステントが拡張してインプラント部位の前記血管内にインプラントされるように前記ステントを配置する工程
を備える方法。 - 前記方法が、前記組織に前記組織アンカーを連結した後であって、前記ステントを配置する前に、前記組織アンカーをインプラント部位に向けて引っ張る工程をさらに備える、請求項52に記載の方法。
- 前記血管が、上大静脈および下大静脈からなる血管の群から選択される、請求項52に記載の方法。
- 前記回転させる工程が、前記ステントにより画定される管腔を貫通し、かつ前記組織アンカーに取り外し可能に連結されたチューブを用いて前記組織アンカーを回転させる工程を含む、請求項52に記載の方法。
- チューブを用いて前記組織アンカーを回転させる工程が、前記チューブの長手部分を前記長手部材と並べて配置し、かつ前記チューブのいかなる部分も前記長手部材の周囲に配置されないようにする工程を含む、請求項55に記載の方法。
- 前記回転させる工程が、前記アダプタホルダに連結されたチューブを用いて前記アンカーを回転させる工程を含み、前記アダプタホルダが、径方向に広がる性向を有するアームを画定する形状を有し、かつ前記アームが径方向に圧縮されると前記組織アンカーに前記チューブを連結するものである、請求項55に記載の方法。
- 前記方法が、前記ステントにより画定される管腔を貫通する大きさの運搬ツールオーバーチューブを提供する工程をさらに備え、前記チューブは、該運搬ツールオーバーチューブを貫通するように構成されており、かつ、該オーバーチューブは、前記アームを包囲する位置に置かれると前記アームを径方向に圧縮するように構成されている、請求項57に記載の方法。
- 前記方法が、前記ステントにより画定される管腔を貫通する大きさの運搬ツールオーバーチューブを提供する工程をさらに備え、かつ、前記チューブが、該運搬ツールオーバーチューブを貫通するように構成されている、請求項55に記載の装置。
- 装置であって、
当該装置は、ステントを有し、該ステントは、圧縮状態および拡張状態をとるように構成され、かつ、該ステントは、
1以上の細長部材を有し、かつ、
2以上のリングを有し、該2以上のリングは、前記1以上の細長部材によって互いに連結されており、かつ、該ステントの他の部材によっては互いに連結されておらず、かつ、該2以上のリングは、該ステントが拡張状態にあるとき、前記細長部材に対して概して垂直な各々の平面を定めており、
当該装置は、長手部材を有し、該長手部材は、近位端と遠位端とを有し、該近位端は、前記ステントに連結されており、かつ、
当該装置は、組織アンカーを有し、該組織アンカーは、前記長手部材の前記遠位端に連結されている、
前記装置。 - 前記ステントが厳密に2個のリングを備える、請求項60に記載の装置。
- 前記ステントが厳密に1つの細長部材を備える、請求項60に記載の装置。
- 前記細長部材が互いに連結された2以上のワイヤを備える、請求項62に記載の装置。
- 前記細長部材のうちの1つが、少なくとも部分的に前記長手部材の延長である、請求項60−63のいずれか1項記載の装置。
- 前記ステントが拡張状態にあるとき、前記リングの各々の外径が10から35mmの間である、請求項60−63のいずれか1項記載の装置。
- (a)(i)1以上の細長部材と、(ii)該1以上の細長部材によって互いに連結されており、該ステントの他の部材では互いに連結されていない2以上のリングを含むステント、(b)遠位端と、前記ステントに連結された近位端を有する長手部材、および(c)前記長手部材の前記遠位端に連結された組織アンカーを提供する工程、
前記ステントを圧縮状態で患者の血管内に置く工程、
前記組織アンカーを前記患者の心臓弁近傍の組織に連結する工程、および
前記リングのそれぞれが前記細長部材に対して略垂直な平面を画定し、前記ステントを前記血管の壁に固定するように、前記ステントを拡張状態に移す工程
を備える方法。 - 前記ステントを提供する工程が、厳密に2個のリングを含む前記ステントを提供する工程を含む、請求項66に記載の方法。
- 前記ステントを提供する工程が、厳密に1つの細長部材を含む前記ステントを提供する工程を含む、請求項66に記載の方法。
- 前記ステントを提供する工程が、前記細長部材のうちの1つが、少なくとも部分的に前記長手部材の延長である前記ステントを提供する工程を含む、請求項66に記載の方法。
- 前記ステントを血管内に置く工程が、上大静脈および下大静脈からなる血管の群から選択される血管に前記ステントを置く工程を含む、請求項66に記載の方法。
- 前記方法が、前記ステントを血管内に置くのと併せて、前記心臓弁の逆流の程度を監視する工程をさらに備える、請求項66に記載の方法。
- 張力装置を備える装置であって、該張力装置は、
開口を画定する、径方向に拡張可能なアンカー、
遠位端と近位端を有し、前記径方向に拡張可能なアンカーの前記開口を貫通して前記径方向に拡張可能なアンカーとスライド可能に連結された長手部材、および
前記長手部材の前記遠位端に連結された組織アンカー
を備え、前記径方向に拡張可能なアンカーおよび前記長手部材は、前記径方向に拡張可能なアンカーが前記長手部材にロック可能であるように構成されており、それにより、前記径方向に拡張可能なアンカーが前記長手部材に対して、前記長手部材の近位端に向かう少なくとも近位方向に移動するのが防止される、装置。 - 前記長手部材の少なくとも一部が、ラチェット歯を画定する形状を有し、該ラチェット歯は、前記径方向に拡張可能なアンカーと係合し、それによって前記径方向に拡張可能なアンカーの前記長手部材に対する近位方向の移動が防止される、請求項72に記載の装置。
- 前記径方向に拡張可能なアンカーが前記長手部材に対して移動しないように、前記径方向に拡張可能なアンカーが前記長手部材に圧着されるように構成されている、請求項72に記載の装置。
- 前記径方向に拡張可能なアンカーが、径方向に拡張すると厳密に1つの平面に概ね収まるように構成されている、請求項72に記載の装置。
- 前記径方向に拡張可能なアンカーが、径方向に拡張すると、花弁および羽からなる群から選択される少なくとも一つの形状を画定するような形状を有する、請求項72に記載の装置。
- 前記装置が、前記径方向に拡張可能なアンカーが径方向に圧縮した状態で前記張力装置を内部に最初に収納する配置チューブをさらに備える、請求項72−76のいずれか1項記載の装置。
- (a)長手部材、(b)該長手部材にスライド可能に連結された、径方向に拡張されるアンカー、および(c)前記長手部材の遠位端に連結された組織アンカー、を含む張力装置を、最初に配置チューブ内に収納して提供する工程、
前記配置チューブを患者の左心房内に進入させる工程、
心房中隔に孔を設ける工程、
該孔を通して左心房から前記配置チューブを進入させ、前記配置チューブの遠位端を右心房内に配置させる工程、
前記配置チューブの遠位端から前記組織アンカーを配置して、該組織アンカーを三尖弁近傍にある心臓組織の部分に固定する工程、
前記配置チューブを前記左心房内へ引き抜き、それによって前記径方向に拡張可能なアンカーを左心房内の前記中隔の近くで解放する工程、および
前記径方向に拡張可能なアンカーを前記中隔の左心房側に保持しつつ、前記長手部材を近位方向に引っ張り、前記径方向に拡張可能なアンカーが前記長手部材に対して少なくとも近位方向に移動しないように前記径方向に拡張可能なアンカーを前記長手部材にロックする工程
を備える方法。 - 前記長手部材の少なくとも一部が、前記径方向に拡張可能なアンカーと係合するラチェット歯を画定するような形状を有し、かつ前記径方向に拡張可能なアンカーを前記長手部材にロックする工程が、前記ラチェット歯を用いて、前記径方向に拡張可能なアンカーが前記長手部材に対して近位方向に移動するのを防ぐ工程を含む、請求項78に記載の装置。
- 前記径方向に拡張可能なアンカーを前記長手部材に対してロックする工程が、前記径方向に拡張可能なアンカーが前記長手部材に対して移動しないように、前記径方向に拡張可能なアンカーを前記長手部材に圧着する工程を含む、請求項78に記載の方法。
- 前記径方向に拡張可能なアンカーが、径方向に拡張すると厳密に1つの平面に概ね収まるように構成されている、請求項78に記載の方法。
- 前記径方向に拡張可能なアンカーが、径方向に拡張すると、花弁および羽からなる群から選択される少なくとも一つの形状を画定するような形状を有するように構成されている、請求項78に記載の装置。
- 前記方法が、前記長手部材を引っ張るのと併せて、前記三尖弁の逆流の程度を監視する工程をさらに備える、請求項78に記載の方法。
- 組織アンカーを備えた装置であって、該組織アンカーは、径方向に縮小された状態および径方向に拡張された状態をとるように構成されており、かつ該組織アンカーは、
遠位組織穿孔先端具を有し、その最大外径が1.8mm以下である支柱、
前記支柱と関節をなすことができるように、前記遠位先端具近くで前記組織アンカーに連結された複数のリブ、
前記支柱に沿ってスライド可能なように、前記支柱に連結されたランナー、および
前記ランナーおよび前記リブの各一つと関節をなすことができるように、前記ランナーおよび前記リブの各一つに連結された複数のストレッチャ
を含む、装置。 - 前記装置が、前記組織アンカーを最初に径方向に縮小された状態で収納するカテーテルをさらに備える、請求項84に記載の装置。
- 前記装置が、前記カテーテル内に収納されたインナーチューブをさらに備え、かつ前記ランナーの近位端が前記インナーチューブに最初は取り外し可能に連結されている、請求項85に記載の装置。
- 前記ランナーの近位端の外面がねじ切り加工されている、請求項84−86のいずれか1項記載の装置。
- 前記組織アンカーが少なくとも部分的に記憶形状合金を備える、請求項84−86のいずれか1項記載の装置。
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CA2787663A1 (en) | 2011-07-28 |
US20130046380A1 (en) | 2013-02-21 |
JP2018198971A (ja) | 2018-12-20 |
US20110184510A1 (en) | 2011-07-28 |
JP2013517830A (ja) | 2013-05-20 |
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