JP2013534444A - 経カテーテル式房室弁人工器官 - Google Patents
経カテーテル式房室弁人工器官 Download PDFInfo
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- JP2013534444A JP2013534444A JP2013517591A JP2013517591A JP2013534444A JP 2013534444 A JP2013534444 A JP 2013534444A JP 2013517591 A JP2013517591 A JP 2013517591A JP 2013517591 A JP2013517591 A JP 2013517591A JP 2013534444 A JP2013534444 A JP 2013534444A
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- 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
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- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
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- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
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- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
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- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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Abstract
【解決手段】心臓の心房及び心室の間に環状接続チャンネル壁構造18’を有する、接続チャンネル18における房室弁9の機能的置換のための、経カテーテル式房室弁人工器官1であって、接続チャンネル18の内部に配される内部デバイス19と、接続チャンネル18の外側に配される外部デバイス25を含み、内部デバイス19は、径方向に伸張可能な環状支持構造21を有し、かつ、該環状支持構造21に装着されるバルブ22を有し、外部デバイス25は、内部デバイス19の周囲に、内部デバイス19に対して距離を有しながら少なくとも一部を取り囲むように延伸し、内部及び外部デバイス19、21は、それらの間に環状接続チャンネル壁構造18’をクランプするためのクランプ機構を形成することを特徴とする、経カテーテル式房室弁人工器官1。
【選択図】図1
Description
1.僧帽弁輪は、内部からの径方向の力により崩れる可能性がある。
2.弁輪の形状及びサイズの変動により必ずしも全ての人工器官が適合しない可能性がある。
3.バルブステントと尖部の間のゾーンが密閉されていないと、僧帽弁の周辺逆流が起こることが考えられる。
4.尖頂部による定着は、人工器官を、外科医による使用に限定し、左心室の頭尾サイズを縮める可能性がある。
なお、これらの図において、同じ参照符号は、同じか、同様の部品及び要素を特定するために使用される。
図2Aから2Cにおいて見て取れるように、先ず、カテーテル27は、大動脈及び大動脈弁29を通じて左心室5に進められ、次いで、僧帽弁9の自然弁輪13に近い自然弁尖部11のレベル(高さ)において、接続チャンネル18の環状接続チャンネル壁構造18’の周囲に誘導され、巻き付けられる。即ち、カテーテル27は、導かれて、接続チャンネル18の環状接続チャンネル壁構造18’の周囲に巻き付けられるが、腱索の周囲には巻き付けられない。もしもそうでないと、リング状の外部デバイス25は、腱索の間に捕捉されるか又は設置されるという不都合な結果を招くことが考えられる。外部デバイス25のリング26を形成することになる、屈曲性・非弾性ワイヤー25’は、カテーテル27の中を送り出され、そのため、環状接続チャンネル壁構造18’の外周に、自然弁尖部13の対応レベルにおいて巻き付けられる。次に、カテーテル27を僅かに後退させると、ワイヤー25’は、環状伸張接続チャンネル壁構造18’の(断面)外径よりも大きく、外部デバイス25の最終リング26の直径よりも大きな直径を有する、収縮可能ループ31(投げ輪型)として出現する。このようにして、ループ31は、接続チャンネル18の周囲に、それに対し一定の径方向の距離を有して、即ち、接続チャンネル壁構造18’に対し一定の径方向の距離を有して巻き付き、内部デバイス19が、接続チャンネル18の内側及び/又は内部に適切に挿入されることを可能とする。
図12A及び12Bから見て取れるように、互いに別々であり、従って、単一内部ではなく、個別内部を創出する、第1搬送カテーテル100及び第2搬送カテーテル102(個別カテーテル)は、心臓7の心室5(ここでは左心室)に向かって、例えば大動脈(ここでは)、又は、例えば上又は下大静脈(右心室の場合)を通じて送り込まれる。この第1及び第2搬送カテーテルは、大動脈又は大静脈を通じる主要接近通路を提供する、(同じ)一次搬送カテーテル104を通じて推進されてもよい。
Claims (28)
- 心臓(7)の心房(3)及び心室(5)の間に環状接続チャンネル壁構造(18’)を有する、接続チャンネル(18)における房室弁(9)の機能的置換のための、経カテーテル式房室弁人工器官(1)であって、
前記接続チャンネル(18)の内部に配されるように構成される内部デバイス(19)と、
前記接続チャンネル(18)の外側に配されるように構成される外部デバイス(25)を含み、
前記内部デバイス(19)は、径方向に伸張可能な環状支持構造(21)を有し、かつ、環状支持構造(21)に装着されるバルブ(22)を有し、
前記内部デバイス(19)の環状支持構造(21)は、二つの軸端(21’,21’’)を有し、軸に沿って延伸した管状のものであり、
前記外部デバイスは、前記内部デバイス(19)に対して径方向の距離を有して、前記内部デバイス(19)の少なくとも一部を取り囲むように延伸したものであり、
前記内部及び外部デバイス(19,25)は、それらの間に前記環状接続チャンネル壁構造(18’)をクランプするためのクランプ機構を形成するように構成され、
前記外部デバイス(25)は、前記内部デバイス(19)の二つの軸端間で該軸端に対して距離を有しながら、前記環状接続チャンネル壁構造(18’)を周方向に取り囲むように延伸するためのリング(26)を形成するように構成され、
前記内部デバイス(19)の前記環状支持構造(21)は、外周溝(35)を含み、
前記外部デバイス(25)のリング(26)は、前記外周溝(35)に対応する位置に形成される、
ことを特徴とする、経カテーテル式房室弁人工器官(1)。 - 前記外周溝(35)が、断面において、前記リングの断面寸法に一致するか、又はそれよりもやや大きい幅を有し、それにより、前記環状接続チャンネル壁構造(18’)を、前記リングによって外周溝(35)の対向側壁に対してクランプすることが可能となることを特徴とする、請求項1に記載の経カテーテル式房室弁人工器官(1)。
- 前記外部デバイス(25)はさらに、前記リング(26)の位置又はその近傍位置において、前記環状接続チャンネル壁構造(18’)中に侵入する、一つ以上のアンカー部分(151)を有するアンカー部材(150)を含み、該アンカー部材(150)は、前記リング(26)が、その位置で又はその近傍で、前記環状接続チャンネル壁構造(18’)に対し前記アンカー部材(150)によって定着されるよう、挿通される目穴(154)を含むことを特徴とする、請求項1又は請求項2に記載の経カテーテル式房室弁人工器官(1)。
- 前記環状支持構造(21)がメッシュ状構造から構成されることを特徴とする、請求項1から請求項3のいずれか1項に記載の経カテーテル式房室弁人工器官(1)。
- 前記環状支持構造(21)は、該環状支持構造(21)の外周上及び外周まわりに圧縮可能材料が設けられたものであることを特徴とする、請求項1から請求項4のいずれか1項に記載の経カテーテル式房室弁人工器官(1)。
- 前記外部デバイス(25)の前記リング(26)が、開放リング又は閉鎖リングの内の一つであることを特徴とする、請求項1から請求項5のいずれか1項に記載の経カテーテル式房室弁人工器官(1)。
- 前記リング(26)がワイヤー材料から構成され、該ワイヤー材料が弾性ワイヤー材料であることを特徴とする、請求項1から請求項6のいずれか1項に記載の経カテーテル式房室弁人工器官(1)。
- 前記外部デバイス(19)が、開放リングの形を取るクランプとして形成されることを特徴とする、請求項1から請求項7のいずれか1項に記載の経カテーテル式房室弁人工器官(1)。
- 前記内部デバイス(19)が、前記接続チャンネル(18)の漏斗形に全体として一致する漏斗形を有することを特徴とする、請求項1から請求項8のいずれか1項に記載の経カテーテル式房室弁人工器官(1)。
- 前記漏斗形は、前記内部デバイス(19)の環状支持構造(21)の軸末端(21’,21’’)の内の一つに設けられることを特徴とする、請求項9に記載の経カテーテル式房室弁人工器官(1)。
- 前記内部デバイス(19)の環状支持構造(21)の外面が、突起を含まず、前記外周溝(35)が、前記環状支持構造(21)において径方向内側に凹んだ凹みとして形成されることを特徴とする、請求項1から請求項10のいずれか1項に記載の経カテーテル式房室弁人工器官(1)。
- 前記環状支持構造(21)が、前記環状接続チャンネル壁構造(18’)の内周に対し能動的な径方向外向きの力を及ぼすことが可能となるよう径方向に伸張可能であり、及び/又は、前記外部デバイス(25)が、前記環状接続チャンネル壁構造(18’)の外周に対し能動的な径方向内向きの力を及ぼすことが可能となるように収縮可能であることを特徴とする、請求項1から請求項11のいずれか1項に記載の経カテーテル式房室弁人工器官(1)。
- 前記環状支持構造(21)及び/又は外部デバイス(25)が形状記憶材料から形成されることを特徴とする、請求項1から請求項12のいずれか1項に記載の経カテーテル式房室弁人工器官(1)。
- 請求項1から請求項13のいずれか1項に記載の経カテーテル式房室弁人工器官を移植する方法であって、前記心臓(7)の中に前記外部デバイス(25)及び内部デバイス(19)を、該外部デバイス(25)と前記内部デバイス(19)とが互いに物理的に接触しないように設置することを含む移植方法。
- 前記外部デバイス(25)が、前記内部デバイス(19)の周囲に配される複数のステープルを含み、該それぞれのステープルは、基礎部材(41)と挿通脚部(43)を含み、前記基礎部材(41)は、前記内部デバイス(19)の径方向外側の位置で、前記内部デバイス(19)に対して径方向の距離を隔てて延伸し、それによって、前記環状接続チャンネル壁構造(18’)を前記基礎部材(41)と前記内部デバイス(19)の間で径方向にクランプするように構成されるものであり、前記挿通脚部(43)は、前記環状接続チャンネル壁構造(18’)に径方向に挿通し、前記内部デバイス(19)を固定するためのものであることを特徴とする、請求項1から請求項14のいずれか1項に記載の経カテーテル式房室弁人工器官(1)。
- 前記外部デバイス(25)が、前記内部デバイス(19)の周囲に配される複数のクリップを含み、各クリップは、U字基礎部分(51)及び二つのU字脚部分(53,55)を持つU字型であり、前記U字脚部分(53,55)の外方脚部分(55)は、その外側の位置で、前記内部デバイス(19)に沿って、径方向の距離を隔てて延伸するように構成され、前記U字脚部分(53,55)の内方脚部分(53)は、前記内部デバイス(19)に沿ってその内側に接して延伸するように構成され、前記U字脚部分(53,55)は、前記環状接続チャンネル壁構造(18’)及び前記内部デバイス(19)をその間に径方向にクランプするように構成されるものであり、前記クリップは、前記環状支持構造(21)の軸末端に配置され、かつ、請求項10と組み合わせて、前記クリップは、前記環状支持構造(21)の他の軸末端に配置されることを特徴とする、請求項1から請求項15のいずれか1項に記載の経カテーテル式房室弁人工器官(1)。
- 前記外部デバイス(25)がさらに、前記内部デバイス(19)の外周に、該内部デバイス(19)に対して径方向の距離を隔てて延伸する複数のアームを含み、前記環状接続チャンネル壁構造(18’)を、前記アームと前記内部デバイス(19)の間で径方向にクランプし、該各アームが、その自由端(61)から出発し、前記内部デバイス(19)と平行に、それに対し径方向の距離を隔てて延伸し、それによって、前記環状接続チャンネル壁構造(18’)を受け、各アームと前記内部デバイス(19)の間で前記環状接続チャンネル壁構造(18’)をクランプするための径方向ギャップ(63)を形成するように構成され、かつ、各アームが、前記内部デバイス(19)に向かって延伸し、前記内部デバイス(19)に、前記内部デバイス(19)の環状支持構造の軸末端に固定して接続されるように構成され、請求項10と組み合わせて、前記アームは、前記環状支持構造(21)の他の軸末端に配置されることを特徴とする、請求項1から請求項16のいずれか1項に記載の経カテーテル式房室弁人工器官(1)。
- 心臓(7)の心房(3)及び心室(5)の間に環状接続チャンネル壁構造(18’)を有する、接続チャンネル(18)における房室弁(9)の機能的置換のための経カテーテル式房室弁人工器官(1)として、
前記接続チャンネル(18)の内部に配される内部デバイス(19)、及び、
前記接続チャンネル(18)の外側に配される外部デバイス(25)を含み、
前記内部デバイス(19)は、径方向に伸張可能な環状支持構造(21)を有し、かつ、該環状支持構造(21)に装着されるバルブ(22)を有し、
前記外部デバイスは、前記デバイス(19)に対して径方向の距離を有して、前記内部デバイス(19)の少なくとも一部を取り囲むように延伸し、
前記内部及び外部デバイス(19,25)は、それらの間に前記環状接続チャンネル壁構造(18’)をクランプするためのクランプ機構を形成する、経カテーテル式房室弁人工器官(1)の移植方法であって、
前記心臓(7)の前記心室(5)にカテーテル(27,104)を進めること、
前記心室(5)に前記カテーテル(27,104)を通じてワイヤー(25’)を進め、前記環状接続チャンネル壁構造(18’)の周囲に前記ワイヤー(25)を導くこと、
捕捉機構を備える捕捉ワイヤーを、前記カテーテル(27,104)を通じて、前記心臓(7)の前記心室(5)に進めること、
該機構によって前記ワイヤー(25’)の自由端(25’’)を捕捉し、該自由端(25’’)を前記カテーテル(27,104)の中に引き込み、そうすることによって、前記ワイヤー(25’)が、前記外部デバイス(25)を前記環状接続チャンネル壁構造(18’)の周囲に設けるための収縮可能なループ(31)を形成することを可能とすること、
前記内部デバイス(19)を前記接続チャンネル(18)の内部に送り込むこと、及び、
前記内部デバイス(19)を径方向に伸張し、前記ループ(31)を径方向に縮小し、それらの間に前記環状接続チャンネル壁構造(18’)をクランプすること、
を含む方法。 - 前記捕捉機構が、捕捉スネア(28)及び捕捉バスケット(108)の内の一つであることを特徴とする、請求項18に記載の方法。
- 前記方法が拍動心臓に対して行われることを特徴とする、請求項19に記載の方法。
- 前記捕捉ワイヤーを進めるための前記カテーテル(27,104)が、大動脈から、又は静脈アクセスを通じて、心房中隔を貫通する穿孔を通じて(経中隔アプローチ)心臓腔に進入する逆行性動脈アプローチによって、又は、心尖を貫通する穿孔を通じて(経心尖アプローチ)、又は、心臓の外から心房壁を貫通する穿孔を通じて、前記心室(5)に送り出されることを特徴とする、請求項18から請求項20のいずれか1項に記載の方法。
- 前記内部デバイス(19)が、大動脈から、又は静脈アクセスを通じて、心房中隔を貫通する穿孔を通じて(経中隔アプローチ)心臓に進入する逆行性動脈アプローチによって、又は、心尖を貫通する穿孔を通じて(経心尖アプローチ)、又は、心臓の外から心房壁を貫通する穿孔を通じて、前記心室(5)に送り出されることを特徴とする、請求項18から請求項21のいずれか1項に記載の方法。
- 前記捕捉ワイヤーを進めるための前記カテーテル(27,104)が、肺動脈から、又は静脈アクセスを通じて心臓腔に進入する逆行性動脈アプローチによって、又は、心尖を貫通する穿孔を通じて(経心尖アプローチ)、又は、心臓の外から心房壁を貫通する穿孔を通じて、前記心室(5)に送り出されることを特徴とする、請求項18から請求項20のいずれか1項に記載の方法。
- 前記内部デバイス(19)が、肺動脈から、又は静脈アクセスを通じて心臓腔に進入する逆行性動脈アプローチによって、又は、心尖を貫通する穿孔を通じて(経心尖アプローチ)、又は、心臓の外から心房壁を貫通する穿孔を通じて、前記心室(5)に送り出されることを特徴とする、請求項18から請求項20のいずれか1項又は請求項23に記載の方法。
- 前記ワイヤー(25’)を、前記カテーテル(27,104)を通じて送り出す前記工程が、前記環状接続チャンネル壁構造(18’)の周囲に前記ワイヤー(25)を、それが、弁輪下の溝の内部で後尖の周囲に配置されるように導くことを含むことを特徴とする、請求項18から請求項24のいずれか1項に記載の方法。
- 前記内部デバイス(19)を伸張し、前記ループ(31)を径方向に縮小することにより、前記内部デバイス(19)を前記環状接続チャンネル壁構造(18’)に定着するアンカー機構を活性化することを特徴とする、請求項18に記載の方法。
- 前記内部デバイス(19)が前記環状接続チャンネル壁構造(18’)にクランプされた後、前記ループ(31)を排除する工程をさらに含むことを特徴とする、請求項26に記載の方法。
- 心臓(7)の心房(3)及び心室(5)の間に環状接続チャンネル壁構造(18’)を有する、接続チャンネル(18)における房室弁(9)の機能的置換のための経カテーテル式房室弁人工器官(1)として、内部デバイス(19)及び外部デバイス(25)を含む経カテーテル式房室弁人工器官(1)の移植方法であって、
前記内部デバイス(19)は、径方向に伸張可能な環状支持構造(21)を有し、かつ、該環状支持構造(21)に装着されるバルブ(22)を有し、前記内部デバイス(19)の環状支持構造(21)はさらに外周溝(35)を有するものであり、
前記外部デバイス(25)は、アンカー機構を有し、かつ、前記内部デバイス(19)に対して径方向の距離を有して、前記内部デバイス(19)を少なくとも一部を取り囲むように延伸したものであり、
前記内部及び外部デバイス(19,25)は、その間に前記環状接続チャンネル壁構造(18’)をクランプするクランプ機構を形成するものであり、
前記内部デバイス(19)を前記接続チャンネル(18)の内部に設置すること、
前記外部デバイス(25)を前記接続チャンネル(18)の外部に設置すること、
を含み、前記外部デバイス(25)の設置が、
前記心臓(7)の前記心室(5)にカテーテル(27,104)を進めること、
前記心室(5)に前記カテーテル(27,104)を通じてワイヤー(25’)を進めること、
前記環状接続チャンネル壁構造(18’)の周囲に前記ワイヤー(25)を導くこと、
捕捉機構を備える捕捉ワイヤーを、前記カテーテル(27,104)を通じて、前記心臓(7)の前記心室(5)に進めること、
前記捕捉機構によって前記ワイヤー(25’)の自由端(25’’)を捕捉し、該自由端(25’’)を前記カテーテル(27,104)の中に引き込み、そうすることによって、前記ワイヤー(25’)が収縮可能なループ(31)を形成して、前記外部デバイス(25)を前記環状接続チャンネル壁構造(18’)の周囲に形成することを可能とすること、
を含み、前記内部デバイス(19)の設置が、
前記内部デバイス(19)を前記接続チャンネル(18)の内部に送り込むこと、
前記内部デバイス(19)を径方向に伸張すること、
前記外周溝(35)において前記ループ(31)を径方向に縮小し、前記内部デバイス(19)と前記ループ(31)の間で前記環状接続チャンネル壁構造(18’)をクランプし、前記アンカー機構を活性化すること、及び、
前記アンカー機構の活性化の後、前記ループ(31)を排除すること、
を含む方法。
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