JP2015535465A - 心臓弁不全の治療器具および治療方法 - Google Patents
心臓弁不全の治療器具および治療方法 Download PDFInfo
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Abstract
Description
12 導管
14 イントロデューサーシース
14’ 遠位開放端
16 コード
16’ 近位部分
16’’ 近位端部
18 アンカー
20 グリップ
22 固定部材
25 ガイド素子
30 心臓
32 左心房
33 心房壁
34 左心室
36 僧帽弁
38 前弁尖
38’ 後弁尖
40 心室壁
42 案内手段
50 固定手段
52 ハウジング
53 端部
54 ヘッド部
56 ベース
57、72’、75 構造体
58 位置決め部材
60 付勢手段
62 保持手段
64 第1の保持セグメント
66 第2の保持セグメント
68、168 固定部材
70 貫通セグメント
72 受容セグメント
74 連結リンク
76 切断部材
78 切断刃
80 捕捉領域
100 弁尖
104 矢印
116 コード
168 固定部材
170 第1のセグメント
172 第2のセグメント
174 ヒンジ部
Claims (61)
- 心臓弁不全の治療装置であって、
少なくとも1本の細長いコードと、少なくとも最初において、前記コードの1本を取り囲んでおり、該1本のコードに沿って、該1本のコードと一緒に変位可能であるイントロデューサーシースとであって、
前記1本のコードと前記イントロデューサーシースとは、同時に心臓壁を通って心臓内に入り、あらかじめ定められた心臓弁尖を貫通して通過するように構成されている、少なくとも1本のコードとイントロデューサーシースと、
前記1本のコードの遠位端に連結されており、前記あらかじめ定められた心臓弁尖に実質的に対向する位置にある対向心臓壁部分にアンカーされるようになっているアンカーと、
前記1本のコードと、前記あらかじめ定められた心臓弁尖との相互接続が行われる相互接続位置において、前記1本のコードの近位端部に接続可能である固定手段とを備えており、
前記アンカーのアンカーされる位置と、前記固定手段の前記相互接続位置との両方によって、前記心臓内における、前記1本のコードの動作長が定められ、前記1本のコードによって、前記あらかじめ定められた心臓弁尖の逸脱を抑えるのに十分である張力が、前記あらかじめ定められた心臓弁尖に印加されるようになっている治療装置。 - 前記固定手段は、前記1本のコードの近位端部を、前記あらかじめ定められた心臓弁尖の、左心房に露出している外面に固定するために、前記相互接続位置に配置される、請求項1に記載の治療装置。
- 前記あらかじめ定められた心臓弁尖に、僧帽弁の前弁尖と後弁尖とのうちの逸脱する弁尖が含まれている、請求項1に記載の治療装置。
- 前記固定手段は、固定部材を変位可能に装着されており、この固定部材は、前記1本のコードに沿って移動して、前記相互接続位置に達することができるようになっている、請求項1に記載の治療装置。
- 前記固定手段は、さらに、前記固定部材に連結されているスリーブを有しており、このスリーブは、前記1本のコードと同心に装着されており、前記固定部材と一緒に、前記1本のコードに沿って移動して、前記相互接続位置に位置することができるようになっている、請求項4に記載の治療装置。
- 前記スリーブは、前記あらかじめ定められた心臓弁尖を貫きながら、前記相互接続位置に配置されており、かつ、前記固定部材は、前記1本のコードの近位端部を前記あらかじめ定められた心臓弁尖に固定するようになっている、請求項5に記載の治療装置。
- 前記アンカーは、前記対向する心臓壁部分内に食い込むのに十分な形状を有する外側端を備えている、請求項1に記載の治療装置。
- 前記外側端は、前記1本のコードが前記対向心臓壁部分に固定される前に、前記あらかじめ定められた心臓弁尖を貫通するように配置可能である、請求項7に記載の治療装置。
- 前記イントロデューサーシースは、前記アンカーが、前記あらかじめ定められた心臓弁尖を貫通し、その後、前記対向心臓壁部分に食い込むことを容易にする寸法を有する遠位開放端を備えている、請求項7に記載の治療装置。
- 前記アンカーは、前記アンカーの前記外側端から横方向に外向きに配置されているグリップを有しており、このグリップは、前記アンカーを前記対向心臓壁部分に確実に係止するようになっている、請求項7に記載の治療装置。
- 前記グリップは、前記アンカーの外側端から半径方向に外向きに展開可能である、請求項10に記載の治療装置。
- 前記アンカーは、前記アンカーの外側端から横方向に外向きに配置されているグリップを有しており、このグリップは、前記アンカーを前記対向心臓壁部分に確実に係止するように構成されている、請求項1に記載の治療装置。
- 請求項1に記載の治療装置を用いて、僧帽弁閉鎖不全を治療する方法であって、
イントロデューサーシースおよび少なくとも1本のコードを、心房壁を通して心臓内に案内するステップと、
前記イントロデューサーシースおよび前記コードの1本を、実質的に同時に、逸脱症を起こしている、少なくとも1つの僧帽弁尖を通過させて、前記心臓の左心室内に通すステップと、
前記イントロデューサーシースおよび前記1本のコードを、左心室を横断するように延ばし、前記僧帽弁尖の1つに実質的に対向する位置にある心室壁部分にアンカーをアンカーして固定するステップと、
前記イントロデューサーシースを、前記アンカーされているコードに沿って、前記1つの僧帽弁尖を通過させて、前記心室壁部分から引き戻すステップと、
前記1本のコードに沿う固定手段を、前記1本のコードの近位端部と前記1つの僧帽弁尖との間の相互接続が行われる相互接続位置に固定するステップとを含む方法。 - 前記1本のコードに沿う前記固定手段を、前記1つの僧帽弁尖の、左心房に露出している外表面とともに、前記相互接続位置に配置するステップを含む、請求項13に記載の方法。
- 前記イントロデューサーシースおよび前記1本のコードを、実質的に同時に、僧帽弁の、逸脱症を起こしている前弁尖を通して、前記心臓の左心室内に入れるステップを含む、請求項13に記載の方法。
- 前記イントロデューサーシースおよび前記1本のコードを、実質的に同時に、僧帽弁の、逸脱症を起こしている後弁尖を通して、前記心臓の左心室内に入れるステップを含む、請求項13に記載の方法。
- 前記相互接続位置への前記固定手段の固定に続いて、前記固定手段と前記心房壁との間に延びている、前記1本のコードの、近位端部以外の近位部分を切り離すステップを含む、請求項13に記載の方法。
- 心臓弁不全を治療する方法であって、
器具を、逸脱症を起こしている、あらかじめ定められた弁尖を貫通させるために心臓内に入れるステップと、
前記器具に、前記あらかじめ定められた弁尖を通過させるステップと、
前記器具における少なくとも1本のコードを、前記あらかじめ定められた弁尖から、前記心臓を横断するように延ばして、前記あらかじめ定められた弁尖に実質的に対向している、心臓壁の対向部分にアンカーするステップと、
前記器具における1本のシースを、アンカーされている1本のコードに沿って、前記あらかじめ定められた弁尖を通過させて、前記心臓壁の対向部分から引き戻すステップと、
前記1本のコードの近位端部を、前記あらかじめ定められた弁尖に固定するステップとを含む方法。 - 前記器具のアンカーを、前記心臓壁の対向部分にアンカーする際に、該アンカーに、グリップ姿勢をとらせるステップを含む、請求項18に記載の方法。
- 前記心臓壁の対向部分をグリップする姿勢に、前記アンカーを展開させるステップをさらに含む、請求項19に記載の方法。
- 前記アンカーを心室壁の内側部分に食い込ませるときに、前記アンカーに、グリップ姿勢をとらせるステップをさらに含む、請求項19に記載の方法。
- 前記1本のコードの近位端部を、前記あらかじめ定められた弁尖の外表面に固定することによって、前記心室壁と前記あらかじめ定められた弁尖との間で、前記1本のコードに張力をかけるステップをさらに含む、請求項21に記載の方法。
- 前記1本のコードによって、前記あらかじめ定められた弁尖にかけられる張力を、前記あらかじめ定められた弁尖の逸脱を抑えることができるほどに十分に大きく定めるために、前記あらかじめ定められた弁尖と、前記心臓壁の対向部分との間の、前記1本のコードの動作長を特定するステップをさらに含む、請求項18に記載の方法。
- 前記器具を、心房壁に通して左心房内に入れ、前記1本のコードの遠位部分で、逸脱症を起こしている、あらかじめ定められた僧帽弁尖を貫通させ、前記1本のコードに、前記あらかじめ定められた僧帽弁尖を通過させて、左心室を横断させ、前記1本のコードの遠位端に固定されているアンカーを、前記あらかじめ定められた僧帽弁尖に対向している、左心室の対向部分にアンカーすることによって、僧帽弁閉鎖不全を治療するステップを含む、請求項18に記載の方法。
- 前記アンカーを前記心室壁の内側部分に食い込ませることによって、前記アンカーに、前記心臓の内側部分上でグリップ姿勢をとらせるステップを含む、請求項24に記載の方法。
- 前記心室壁の乳頭筋の内側部分に食い込ませた前記アンカーの展開によって、前記アンカーにグリップ姿勢をとらせるステップをさらに含む、請求項25に記載の方法。
- 前記1本のコードの近位端部を、前記あらかじめ定められた僧帽弁尖に固定することによって、前記心室壁の、前記アンカーによって食い込まれている内側部分と、前記あらかじめ定められた僧帽弁尖との間で、前記1本のコードに張力をかけるステップをさらに含む、請求項24に記載の方法。
- 前記1本のコードによって、前記あらかじめ定められた僧帽弁尖にかけられる張力を、前記あらかじめ定められた僧帽弁尖の逸脱を抑えることができるほどに十分に大きく定めるために、前記あらかじめ定められた僧帽弁尖と、前記心室壁の、前記アンカーによって食い込まれる内側部分との間の、前記1本のコードの動作長を特定するステップをさらに含む、請求項27に記載の方法。
- 心臓弁の弁尖の逸脱を抑えることができるほどに十分な張力をかけて、該弁尖にコードを固定することによって、心臓弁不全を治療するための器具であって、
前記コードの近位部分と前記弁尖との間の相互接続を行うように、固定部材を配置する構成になされている固定手段であって、
互いに組み合って、開位置と閉位置との間で相対的に変位可能であり、前記固定部材を動作可能な位置に保持するように構成されているヘッド部およびベースを有している固定手段と、
少なくとも、前記ヘッド部および前記ベースが前記開位置にあるときに、前記ヘッド部と前記ベースとの間に形成される捕捉領域であって、
前記弁尖を受けて、前記固定部材に対する係止姿勢で内部に解除可能に保持することができる寸法を有する捕捉領域とを備えている器具において、
前記ヘッド部および前記ベースを前記閉位置に配置することによって、前記固定部材が前記弁尖を貫通し、前記弁尖を、前記コードとの間の相互接続がなされている状態にするようになっている器具。 - 前記ヘッド部と一緒に、前記開位置と前記閉位置との間で変位可能である位置決め部材をさらに備えている、請求項29に記載の器具。
- 前記位置決め部材は、ハウジングに連結されており、前記開位置から前記閉位置に変位して、前記ヘッド部を駆動するようになっている、請求項30に記載の器具。
- 通常時において、前記ヘッド部を、前記開位置から前記閉位置に付勢するための付勢構造をさらに備えている、請求項30に記載の器具。
- さらに、前記閉位置への前記ヘッド部の配置と並行して、前記コードの近位部分を分離するようになっている分離部材が、前記位置決め部材に変位可能に連結されている、請求項30に記載の器具。
- 前記ヘッド部と前記ベースとの両方上に配置されており、少なくとも、前記固定部材が前記相互接続を行うように配置される前には、前記固定部材を、前記弁尖に対してあらかじめ定められた関係になるように、取り外し可能に保持する構成になされている保持部材をさらに備えている、請求項29に記載の器具。
- 前記保持部材は、前記固定部材を構成している第1の固定セグメントおよび第2の固定セグメントの一方および他方をそれぞれ配置されており、該第1の固定セグメントおよび第2の固定セグメントの一方および他方をそれぞれ取り外し可能に保持し、前記閉位置に配置するように構成されている第1の保持セグメントおよび第2の保持セグメントを有している、請求項34に記載の器具。
- 前記第1の保持セグメントは、前記ヘッド部に連結されており、貫通セグメントを有する前記第1の保持セグメントを前記閉位置に配置するように構成されており、前記第2の保持セグメントは、前記ベースに連結されており、受容セグメントを有する前記第2の保持セグメントを前記閉位置に配置するように構成されている、請求項35に記載の器具。
- 前記相互接続において、前記貫通セグメントは、前記捕捉領域内に保持されている前記弁尖を貫通するように配置されている、請求項36に記載の器具。
- 前記相互接続において、さらに、前記貫通セグメントおよび前記受容セグメントは、前記コードおよび前記弁尖と相互接続されるように配置されている、請求項36に記載の器具。
- 前記相互接続において、さらに、前記コードは、実質的に前記貫通セグメントと前記受容セグメントとの間で、前記弁尖に係止されている、請求項36に記載の器具。
- 前記第1および第2の保持セグメントのうちの少なくとも1つは、それぞれ、前記コードを、自身と、前記第1および第2の固定セグメントのうちの対応する1つとに連結されるように受ける構成となっている、請求項35に記載の器具。
- 請求項29に記載の器具を用いて、僧帽弁閉鎖不全を治療する方法であって、
固定手段が開位置にあるときに、コードの近位部分を該固定手段に接続するステップと、
前記固定手段が前記開位置にあるときに、固定部材を、ヘッド部およびベースに取り外し可能に保持されるように配置するステップと、
前記ヘッド部および前記ベースを、少なくとも部分的に閉じた位置に配置し、弁尖を捕捉領域内に、前記固定部材に対する係止姿勢で解除可能に保持するステップと、
前記コード、前記固定部材、および前記弁尖の間の相互接続を成し遂げるために、前記ヘッド部および前記ベースを閉位置に配置するステップとを含む方法。 - 前記ヘッド部および前記ベースが前記開位置にあるときに、前記固定手段から前記弁尖、前記コード、および前記固定部材を取り除くステップを含む、請求項41に記載の方法。
- 前記固定部材で前記弁尖を貫通させて、少なくとも部分的に前記相互接続を確定するステップを含む、請求項41に記載の方法。
- 前記ヘッドおよび前記ベースを前記閉位置に配置したときに、前記コードの近位部を、前記固定部材から分離するステップを含む、請求項41に記載の方法。
- 前記固定部材の貫通セグメントおよび受容セグメントを、前記ヘッド部およびベースにそれぞれ連結されている第1の保持セグメントおよび第2の保持セグメントの一方および他方に配置するステップを含む、請求項41に記載の方法。
- 前記ベースおよび前記ヘッド部を前記閉位置に配置して、前記弁尖を、前記貫通セグメントと前記受容セグメントとの間に、解除可能に係止姿勢に保持するステップを含む、請求項45に記載の方法。
- 前記ベースおよび前記ヘッド部を前記閉位置に配置して、前記貫通セグメントを、前記弁尖を貫通し、前記弁尖および前記コードと相互接続するように配置するステップを含む、請求項46に記載の方法。
- 前記相互接続において、前記貫通セグメントを、前記受容セグメント内に挿入するステップをさらに含む、請求項47に記載の方法。
- 伸張状態のコードを、左心房から、僧帽弁口および両僧帽弁尖の間を通して、左心室に案内するステップと、
前記コードの近位部分を、僧帽弁の、左心房側の外側に保持しながら、前記コードの遠位部分を前記左心室の心室壁にアンカーするステップと、
前記コードの近位端部を、固定部材の受容セグメントに接続するステップと、
前記僧帽弁のあらかじめ定められた弁尖を、固定手段で解除可能に把持して、係止姿勢に保つステップと、
前記固定部材の貫通セグメントを、前記受容セグメントに留められるまで、係止姿勢に保たれている、前記あらかじめ定められた弁尖に通すステップと、
留められた前記貫通セグメントおよび前記受容セグメント、接続された前記コードおよび前記あらかじめ定められた弁尖を、前記固定手段から取り外すステップとを
含む、僧帽弁閉鎖不全を治療する方法。 - 前記コードの近位部分を、前記固定部材に隣接している、前記コードの近位端部から分離するステップを含む、請求項49に記載の方法。
- 前記近位部分を、前記僧帽弁口および前記両僧帽弁尖の間を通して、前記左心房内に保つステップを含む、請求項49に記載の方法。
- 前記あらかじめ定められた弁尖を、前記貫通セグメントと前記受容セグメントとの間に把持することによって、前記あらかじめ定められた弁尖を、係止姿勢に保つステップを含む、請求項49に記載の方法。
- 前記コードを前記受容セグメントに通すとともに、前記貫通セグメントを用いて、前記あらかじめ定められた弁尖を貫通させるステップを含む、請求項52に記載の方法。
- 伸張状態のコードの近位部分を、心臓弁の、左心室の外側の面の近傍に保ちながら、前記コードを前記左心室内に案内するステップと、
前記コードの遠位端を、前記左心室の心室壁にアンカーするステップと、
あらかじめ定められた弁尖を、固定手段を用いて、解除可能に係止姿勢に維持するステップと、
固定部材を、前記あらかじめ定められた弁尖および前記コードの近位部分と相互接続するように配置するステップと、
前記あらかじめ定められた弁尖を前記係止姿勢に保ちながら、前記固定部材に前記あらかじめ定められた弁尖を貫通させるステップを含み、かつ、前記相互接続を行うステップとを含む、心臓弁不全を治療する方法。 - 前記相互接続のさらなる強化のために、前記コードの近位部分を、前記固定部材の少なくとも一部分に通すとともに、前記固定部材に前記あらかじめ定められた弁尖を貫通させるステップを含む、請求項54に記載の方法。
- 前記固定手段による、前記あらかじめ定められた弁尖の解除可能な把持によって、前記あらかじめ定められた弁尖を係止姿勢に維持するステップを含む、請求項55に記載の方法。
- 前記あらかじめ定められた弁尖の、前記固定手段内への解除可能な固定によって、前記あらかじめ定められた弁尖を係止姿勢に維持するステップを含む、請求項54に記載の方法。
- 前記あらかじめ定められた弁尖が、係止姿勢に維持されているときに、最初に、貫通セグメントと受容セグメントとが、前記あらかじめ定められた弁尖を挟んで相対して配置されるように、前記固定部材の位置を定めるステップを含む、請求項57に記載の方法。
- 前記貫通セグメントを、前記あらかじめ定められた弁尖を貫通し、前記受容セグメント内に受容されるように配置するステップを含む、請求項58に記載の方法。
- 前記コードを、前記受容セグメントを通るように配置しながら、前記貫通セグメントを、前記あらかじめ定められた弁尖および前記受容セグメントを貫通するように配置するステップを含む、請求項57に記載の方法。
- 前記固定部材および前記あらかじめ定められた弁尖に取り付けられる、前記コードの近位端部の範囲を、前記コードの近位部分の残りの部分を前記固定部材から分離することによって限定するステップを含む、請求項54に記載の方法。
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JP2018061855A (ja) | 2018-04-19 |
US20140142687A1 (en) | 2014-05-22 |
CA2891356A1 (en) | 2014-05-30 |
AU2013348100C1 (en) | 2018-06-07 |
WO2014081809A3 (en) | 2014-07-17 |
IL238933A0 (en) | 2015-07-30 |
EP2922502A2 (en) | 2015-09-30 |
US10159571B2 (en) | 2018-12-25 |
AU2013348100A1 (en) | 2015-05-28 |
US20140142689A1 (en) | 2014-05-22 |
WO2014081809A2 (en) | 2014-05-30 |
EP2922502B1 (en) | 2018-04-25 |
AU2013348100B2 (en) | 2018-05-17 |
EP2922502A4 (en) | 2016-08-03 |
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