JP2009061293A - 心臓の人工弁を締着係止するためのデバイス - Google Patents
心臓の人工弁を締着係止するためのデバイス Download PDFInfo
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- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
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Abstract
【課題】心臓の人工弁を締着係止するためのデバイスであって、針金で形づくられ、相互に接続された要素から主に形成されたデバイスに関して、デバイスは十分小さく折り重なることにより、最小の侵襲性で大動脈を通して移植され、大動脈壁についての確実な維持および確実な密封が保証される。
【解決手段】心臓の人工弁を締着係止するためのそれぞれ同一な三対のアーチ型要素3,4,5が固体関節7によって120°の角度をなすように相互に連結される。三つの固体関節7はピボット軸受けの機能を満たす。
【選択図】図1
【解決手段】心臓の人工弁を締着係止するためのそれぞれ同一な三対のアーチ型要素3,4,5が固体関節7によって120°の角度をなすように相互に連結される。三つの固体関節7はピボット軸受けの機能を満たす。
【選択図】図1
Description
本発明は、心臓の人工弁を締着係止するためのデバイスに関し、針金で形作られ相互に連結された要素で本質的に構成されるデバイスに関する。デバイスは折り畳まれた状態で、侵襲性が最も少ない手法により、大動脈を通じて導入可能である。そしてデバイスは展開された後、移植、固定された心臓の人工弁が内生の心臓弁として機能できるように、大動脈壁中に固定される。
従来、確実な大動脈壁への挿入および確実な保持が保証される解決法の提供について、十分満足できる成功例はなかった。このようなデバイスまたは固定するための支持体(ステント)は、後に移植部位で広げられるため、十分小さく折り畳まれなければならない。これまでに知られている解決法では、そのような保持を保証するのに十分な張力およびそれに伴う十分な拡張がなされない。形状記憶合金(メモリー金属)を用いた提案では、転移温度に達するかそれ以上の際に、それぞれこれらの材料の拡張が生じるが、その場合でも必要条件を満たすことができていない。
米国特許5,411,552号公報に記載の解決法も、必要条件を満たさない。なぜなら比較的不安定な物体が用いられているからである。
これまでの方法では解決が不十分なもう一つの問題は、心臓の人工弁または生体弁の確実な取り付けである。概して、それらはステント上に多数箇所でに縫いつけられる。これは時間がかかり、またダメージをさけるために多大な注意を払って行われる必要がある。
移植された心臓の人工弁は長期間機能できなければならないため、構造の設計も基本的な役割を果たす。そうでないと、移植後にダメージや漏出が起こり、結果として、患者の生命を脅かす状態を生じる可能性があるからである。
それゆえ、本発明の目的は、心臓の人工弁を締着係止するデバイスであって、十分小さく折り畳まれ、移植部位での侵襲性が最小の移植となるよう大動脈中で拡張されるデバイスを提供することである。大動脈中では大動脈壁の確実な保持および確実な密封が保証される。
本発明によれば、この目的は請求項1のデバイスによって解決される。
好ましい実施形態および発明の改良は、下位請求項に記載の特徴によって達成される。
好ましい実施形態および発明の改良は、下位請求項に記載の特徴によって達成される。
同一な三対のアーチ型要素はそれぞれ、本発明による解決の実質的要素であって、これらは120°の角度をなすよう相互に連結される。一対をなす二つのアーチ型要素は互いに逆向きにカーブするよう曲げられ、固体関節によって接続される。固体関節は、同時にピボット軸受けの機能を果たし、固体関節を支点として一対の要素はシーソーと同様に旋回することができる。アーチ型要素の一つに、たとえば大動脈の蠕動を通じて、圧縮力がかけられた場合、このアーチ型要素は固体関節の回転軸について力と同じ方向に旋回する。同時に、それぞれの対における他のアーチ型要素はそれに対して反対方向に旋回する。よって、対をなす二つのアーチ型要素のうちの一つはその際大動脈壁に押しつけらることになるため、上記の密着および保持を増している。
一対のアーチ型要素は、可能な限り、ピボット軸受けを形成する固体関節について、等しい長さまたは少なくとも略等しい長さの揺れ腕が形成されるように、てこの関係が同じとなる大きさとすることが好ましい。
アーチ型要素の対同士が120°の角度をなすことにより、固体関節の距離は比較的大きくなる。また、アーチ型要素により覆われる表面積が大きいこともまた利点である。なぜなら、遠位アーチ型要素は人工心臓弁を固定するために用いられるだけでなく、支持する機能も有するからである。
上述の利点は、もう一つのカーブしたアーチ型要素によっても得ることができる。このアーチ型要素は、遠位方向に配置される。
その場合、遠位領域において第二の遠位アーチ型要素が第一の遠位アーチ型要素とほぼ同じようにカーブするよう設計される。ある程度まで、これら二つのアーチ型要素は、それらが互いに近接して伸び、それらの間に谷間が形成されるように設計され、形づくられる。それらは同じ位置で相互に連結される。その位置には、接続部として、近位方向にカーブしたアーチ型要素とのかけはしとして固体関節が設けられる。よって、形成された谷間が遠位方向に開く。そして、心臓の人工弁の一部が谷間の中に導入され、支えられる。
遠位アーチ型要素の少なくとも一部分は近位方向に収縮し、方向転換点に導かれる。転換点では隣接したアーチ型要素が結合されている。遠位に配置された二つのアーチ型要素では、それぞれ遠位外側のアーチ型要素に適用される。
デバイスの硬度を上げ、また心臓の人工弁を留める可能性を高めるため、近位の方向に収縮し、頂点を有するカーブしたアーチ型要素を用いることもできる。そのアーチ型要素のカーブした部位は、それぞれの隣接したアーチ型要素の間に設けられ、それぞれの曲率に沿うように形成されている。遠位端をもつこれらのアーチ型要素は、一つの遠位外側のアーチ型要素またはそれぞれの遠位外側のアーチ型要素に固定される。この連結によっても、それぞれの固体関節が形成される。これらは、一つの対を接続する他の固体関節から、さらに離れて設けられるべきである。
デバイスは移植され、広げられるため、そこで心臓の人工弁のくぼみを押し込み、支え、維持することが可能である。
本発明に係るデバイスのアーチ型要素の構造は、広い表面となる方法で、そしてそれゆえ十分な安全性をもって心臓の人工弁を支える。さらにそれを、実質的により少量で、たとえば裁縫などによって、締着することができる。
このような構成での解決により、確実な維持、大動脈壁上で必要とされる密封、および大動脈壁の密封がそれぞれ可能となる。アーチ型要素による内側からの心臓の人工弁に対する押しつけは、密封や心臓の人工弁への負荷軽減に有利である。
本発明に係るデバイスは、バルーンカテーテルを用いて移植することができる。また、移植部位で展開させることができる。有利には、好適な転移温度を有する形状記憶合金がデバイスに用いられる。こうすることにより、さらなる拡張が得られる。このために、ニッケルとチタンとを含む合金を用いることができる。この合金は二チノールの名前で入手できる。
その上、デバイスの、心臓の人工弁を支持し、保持する部分は、別個に支持体中に移植することができる。この支持体については下記の実施形態に参照され、有利な特性は変わらない。この部分は、心臓の人工弁を伴わせるための三つのセグメントから実質的になり、その移植は、手術により、通常の方法で行うことができる。
以下の本文では、本発明が実施形態によりさらに詳細に説明される。
図1には、本発明に係るデバイスの実施形態の展開図が示されている。デバイスは半径方向に対称な放射状に設計されており、三つの同一な部分が120°の角度をなして用いられるよう設計される。
各部分には、キャリアーとして心臓の人工弁や生体弁を留めるため、アーチ型要素の構成を用いる。
本実施形態においては、二つのアーチ型要素4および5が用いられ、それらは外側の遠位に配置されている。場合によっては、外側のアーチ型要素5は外してもよい。
アーチ型要素4はカーブして内側に曲げられ、逆方向に曲げられたアーチ型要素3に接続される。両側にある二つの接続部は、固体関節7に相当する。固体関節7は同時に、てこに相当する二つのアーチ型要素3、4にとってのピボットとして機能する。これについては、すでに記載の一般的部分で説明されている。
第二のアーチ型要素3は外側に曲げられて遠位に配置される。第二のアーチ型要素3は、安定性を増し、心臓の人工弁を付加的に支え、締着する可能性を与える。その場合、二つの遠位外側のアーチ型要素4および5を、結合部が同じ位置となるようさらに相互に連結し、その位置に固体関節7もまた配置することができる。
二つのアーチ型要素4および5の間には谷間が存在する。谷間は、遠位方向から開かれ、そこに心臓の人工弁が導入され、固定される。
アーチ型要素5は、ここではアーチ型要素4より外側に位置するものであり、さらに近位方向の内部に引かれ、末端がそれぞれの支持リッジ8に接続される。この実施形態では、支持リッジ8は、デバイスの長さ方向に平行となるよう並べられる。そして、鋸歯型、菱形、または曲折型の横断型リッジとともに支持体を形成する。支持体は展開された状態で大動脈壁に密着する。引っかけて動かないようにするために、付加的な突端9を、支持リッジ8および/または大動脈壁中で引っかけて動かないようにする横断型リッジの上に設計することができる。
支持リッジ8の構造および長さ、およびアーチ型要素3、4および5の領域で締着された心臓の人工弁へのそれぞれの距離が長いことにより、それぞれ冠状血管が閉じたまま固まってしまい、血管を完全にふさいでしまわないように、心臓の人工弁を位置させることが可能となる。
ここに示された実施形態において、120°の角をなして用いられた個々の要素の間に、近位に寄せられた付加的なアーチ型要素2が存在し、遠位外側のアーチ型要素5に連結される。ここでさらに、連結部材となるのは固体関節6であるが、固体関節6は固体関節7からできるだけ離れて配置されるべきである。こうすれば、一つのセグメントあたり二つのレバーを用いることができる。そしてデバイスを固定するためのこのような二重反射構造により、2倍の力が実現される。
拡張され、移植された状態で、心臓の人工弁の一部を互いにアーチ型要素5の部位1とアーチ型要素2との間に順に導入することができる。こうすれば、心臓の人工弁は支持され、そこに固定される。
なお、心臓の人工弁の維持を向上させ、負荷を減少させるために、用いるアーチ型要素の数をさらに増加させることができる。
Claims (9)
- 針金状の要素によって形成された、心臓の人工弁を締着係止するためのデバイスであって、心臓の人工弁を締着係止するために、それぞれ同一な三対のアーチ型要素(3、4または5)が、固体関節(7)によって120°の角度をなすように相互に連結され、前記固体関節(7)はピボット軸受けとしての機能を満たすことを特徴とするデバイス。
- 請求項1に記載のデバイスにおいて、二つのアーチ型要素(3、4)が互いに逆向きに曲げられて揺れ腕を形成し、前記揺れ腕は前記固体関節(7)を支点として同じ長さを有することを特徴とするデバイス。
- 請求項1または2に記載のデバイスにおいて、前記心臓の人工弁は第一および/または第二の遠位アーチ型要素(4、5)に固定されてなることを特徴とするデバイス。
- 請求項1乃至3いずれかに記載のデバイスにおいて、第一および第二の遠位アーチ型要素(4、5)は部分的に同一方向に曲げられ、互いに平行に伸び、それらの間に前記心臓の人工弁の一部を導入するために谷間が形成されたことを特徴とするデバイス。
- 請求項1乃至4いずれかに記載のデバイスにおいて、第二の遠位アーチ型要素上に、近位後退部(1)が存在し、前記後退部には、固体関節(6)を備えたさらなるアーチ型要素(2)が固定されたことを特徴とするデバイス。
- 請求項1乃至5いずれかに記載のデバイスにおいて、固体関節(6)および(7)が互いに隔てられて配置されたことを特徴とするデバイス。
- 請求項1乃至6いずれかに記載のデバイスにおいて、第一のアーチ型要素(4)の近位端または前記第二のアーチ型要素(5)の前記近位後退部(1)が支持リッジ(8)に結合され、前記支持リッジは長さ方向に平行に配置されており、針金により鋸歯形、菱形、または曲折形に成形された線状物と共に、展開可能な支持体を形成することを特徴とするデバイス。
- 請求項1乃至7いずれかに記載のデバイスにおいて、前記支持体上に大動脈壁の内側に固定するための突端(9)が形成されたことを特徴とするデバイス。
- 請求項1乃至8いずれかに記載のデバイスにおいて、すべての要素(1〜9)が形状記憶合金で形成されたことを特徴とするデバイス。
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US8206437B2 (en) | 2001-08-03 | 2012-06-26 | Philipp Bonhoeffer | Implant implantation unit and procedure for implanting the unit |
US10993805B2 (en) | 2008-02-26 | 2021-05-04 | Jenavalve Technology, Inc. | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
US11065138B2 (en) | 2016-05-13 | 2021-07-20 | Jenavalve Technology, Inc. | Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath and loading system |
US11185405B2 (en) | 2013-08-30 | 2021-11-30 | Jenavalve Technology, Inc. | Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame |
US11197754B2 (en) | 2017-01-27 | 2021-12-14 | Jenavalve Technology, Inc. | Heart valve mimicry |
US11337800B2 (en) | 2015-05-01 | 2022-05-24 | Jenavalve Technology, Inc. | Device and method with reduced pacemaker rate in heart valve replacement |
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US11564794B2 (en) | 2008-02-26 | 2023-01-31 | Jenavalve Technology, Inc. | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
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Also Published As
Publication number | Publication date |
---|---|
US7198646B2 (en) | 2007-04-03 |
JP4295460B2 (ja) | 2009-07-15 |
EP1994913A3 (de) | 2008-12-03 |
DK1259195T3 (da) | 2009-02-09 |
EP1994913A2 (de) | 2008-11-26 |
DK1994913T3 (da) | 2013-07-22 |
ES2313954T3 (es) | 2009-03-16 |
US20030149478A1 (en) | 2003-08-07 |
EP1259195B1 (de) | 2008-10-15 |
USRE45130E1 (en) | 2014-09-09 |
PT1259195E (pt) | 2008-12-17 |
ES2421438T3 (es) | 2013-09-02 |
DE50114421D1 (de) | 2008-11-27 |
WO2001062189A1 (de) | 2001-08-30 |
EP1994913B1 (de) | 2013-05-15 |
EP1259195A1 (de) | 2002-11-27 |
PT1994913E (pt) | 2013-08-22 |
ATE410979T1 (de) | 2008-10-15 |
CY1108696T1 (el) | 2014-04-09 |
DE10010074A1 (de) | 2001-10-18 |
JP2003523262A (ja) | 2003-08-05 |
DE10010074B4 (de) | 2005-04-14 |
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