JP2006501033A - 心臓弁輪を再成形するためのデバイス、システムおよび方法 - Google Patents
心臓弁輪を再成形するためのデバイス、システムおよび方法 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
Description
本願は、2000年9月20日に出願された、発明の名称「Heart Valve Annulus Devices and Methods of Using Same」の、同時係属中の米国特許出願番号09/666,617(これは、本明細書中に参考として援用される)の利益を主張する。本願はまた、2002年10月1日に出願された、発明の名称「Systems and Devices for Heart Valve Treatments」の特許協力条約出願番号PCT/US 02/31376の利益を主張し、この出願は、2001年10月1日に出願された米国仮特許出願番号60/326,590の利益を主張し、これらは、本明細書中に参考として援用される。本願はまた、2002年11月26日に出願された、発明の名称「Heart Valve Remodeling Device」の米国仮特許出願番号60/429,444;2002年11月26日に出願された、発明の名称「Neo−Leaflet Medical Devices」の米国仮特許出願番号60/429,709;および2002年11月26日に出願された、発明の名称「Heart Valve Leaflet Retaining Devices」の米国仮特許出願番号60/429,462の利益を主張し、これらは各々、本明細書中に参考として援用される。
本発明は、心臓弁の機能を改善するため、例えば、僧帽弁吐出の処置における、デバイス、システムおよび方法に関する。
(I.健常な心臓の解剖学)
心臓(図1を参照のこと)は、握りしめた拳よりわずかに大きい。心臓は、二重(左側および右側)の、自己調節型の筋肉ポンプであり、これの部分は、一緒に働いて、血液を身体の全ての部分に推進する。心臓の右側は、身体からの乏しく酸素化された血液(「静脈血」)を、上大静脈および下大静脈から受け取り、そしてこの血液を、酸素化のために、肺動脈を通して肺へとポンピングする。左側は、肺からの十分に酸素化された血液(「動脈血」)を、肺静脈を通して受け取り、そしてこの血液を、身体への分配のために大動脈中にポンピングする。
健常な心臓(図4を参照のこと)において、僧帽弁輪の寸法は、中隔(S)から外側(L)まで、および後交連CPから前交連CAまで測定される場合、ピーク収縮圧力において、リーフレットが接合し、しっかりした連接を形成するような解剖学的形状および張力を生じる。輪の対向する内側の面および外側の面において、リーフレットが接合する位置は、リーフレット交連と称され、図4および他の図において、CP(後交連を表す)およびCA(前交連を表す)として示されている。
僧帽弁の逆流の処置において、利尿薬および/または血管拡張薬が、左心室内に逆流する血液の量を減少させることを補助するために使用され得る。その状態が投薬で安定化されない場合は、大動脈内バルーンカウンターパルセイションデバイスが、使用される。慢性または急性の僧帽弁逆流については、僧帽弁を修復または交換するための手術が、しばしば必要とされる。
本発明は、弁輪を再成形するデバイス、システムおよび方法を提供する。これらのデバイス、システム、および方法は、心臓弁輪のリーフレット交連の近くまたは内部に設置するような大きさおよび構成にされた、移植物を備える。使用の際に、この移植物は、組織に接触し、そしてこの組織を外向きに移動させて、心臓弁輪を再成形する。この移植物は、使用の際に、心臓弁輪およびリーフレットに、より効果的な解剖学的形状および張力を回復させ得る。より正常な解剖学的形状および張力は、リーフレットの接合を導き、これが次に、逆行性の流れすなわち逆流を減少させる。この移植物は、拡張した輪の大部分を適所に外科的に巻き付けること、切除すること、および/または固定することなく、そしてリング様構造体の外科的固定なしで、弁の機能を回復する。
本明細書の開示は、当業者が本発明を実施することを可能にするために、詳細かつ正確であるが、本明細書中に開示される実際の実施形態は、本発明を単に例示するのみであり、本発明は、他の特定の構造で実施され得る。好ましい実施形態が記載されるが、細部は、特許請求の範囲によって規定される本発明から逸脱することなく、変更され得る。
(A.概説)
図7Aおよび8は、心臓弁輪の内部または近くに設置するための大きさおよび構成にされた、移植物10を示す。この移植物は、僧帽弁内に示されており、そしてこの配置において、弁輪の上方および/または弁輪に沿った、主軸(すなわち、長手方向軸)に沿って延びる。移植物10は、使用の際に、主軸に沿って機械的な力を付与するような大きさおよび形状にされる。この機械的な力は、組織を外向きに移動させて(すなわち、組織を輪の中心から離れるように移動させて)、輪を再成形するように働く。図示される実施形態において(僧帽弁上)この機械的な力は、輪の長軸を伸長させるように働き、そしてこのようにする際に、短軸(すなわち、最も短い軸)を反作用的に短縮し得、そして対応して、他の周囲の解剖学的構造体を変形させ得る。他の弁構造体に配置される場合に、影響を受ける軸は、周囲の解剖学に起因して、「主」軸および「短」軸ではないかもしれないことが理解されるべきである。治療的であるために、この移植物は、心臓周期の一部の間(例えば、心室収縮の収縮の間)に輪を再成形する必要があるのみであり得ることもまた、理解されるべきである。例えば、この移植物は、組織が弛緩する場合に、心室性拡張期の間に、小さいかまたは無視できる、組織の外向きの移動を生じるが、心室収縮の収縮の間、組織の内向きの移動を制限するような大きさにされ得る。
ちょうど記載されたような特徴を有する弾性移植物10は、種々の形状および構成を採り得る。以下の記載は、種々の例示的な配置を記載する。
図7A〜7Cにおける移植物10は、支柱12の間の距離にまたがる単一のレール14を備える。図7Dおよび10に示されるように、移植物10は、1つより多いレール14を備えて、通常は閉じた環状の形状を、この移植物に与え得る。後により詳細に記載されるように、この型の移植物10は、例えば、カテーテルまたはシース内で、つぶされたまっすぐにされた状態で(レールが並列につぶされた状態で)移植部位に運ばれ得る。カテーテルまたはシースから展開される場合、移植物10はばねの力で開き、そして図7Dおよび10に示される、通常は閉じた環状の形状を呈する。
図15A〜15Eに示される移植物10は、1つ以上のレール14を備え、通常は閉じた管状形状を、この移植物に与える。図10に示される、通常は閉じた環状移植物10とは異なり、図15A〜15Eに示される移植物10のレール14は、尖20を備える。尖20は、この移植物が、その短軸(横断軸)に沿って、尖20が折り畳みを占有するように、移植物を永続的に変形させずに、弾性的に折り畳まれることを可能にする(図15Bを参照のこと)。後により詳細に記載されるように、この型の移植物10は、移植部位に、例えば、カテーテルまたはシースの内部で、折り畳まれてつぶされた状態で運ばれ得、次いで展開されて、図15Cが示すように、図15Aに示される、通常は閉じた環状の形状を呈し得る。先に説明されたように、レール14の形状および構成は、展開される場合に、この移植物が輪を挟むか、または輪の上に載るように、変化され得る。
前述のように、支柱12は、心臓弁輪における移植物の係留および安定化をさらに増強するために、他の構造体または機構16を備え得る。これらの構造体または他の機構16は、例えば、ループ、パッド、棘、垂直レッグ、または円周レッグ、あるいは他の係留構造体を、弁の面の下方、面内、および/または面の上方に備え得る。構造体および機構16は、望ましくは、支柱12と輪に隣接する組織との間の接触の表面積を増加させる。構造体および機構16は、輪内に移植物を係留し、そして輪内での移植物の位置を固定するため、および輪からの移植物の移動を妨害するために、望ましくは、弁および周囲の解剖学的構造体に単独にか、または部分的に依存する。移植物の固定はまた、リーフレットの所望の接合を達成することを補助し、そして心臓周期の間のリーフレットの上方への移動または上昇を妨害し得る。
ちょうど記載されたような種々の移植物は、種々の様式での心臓弁輪への移植に役立つ。これらは、例えば、心臓切開外科手順において移植され得る。あるいは、これらは、末梢静脈のアクセス部位(例えば、大腿静脈もしくは頚静脈)を介して、カテーテルに基づく技術を使用してか、あるいは、胸部を介して胸腔鏡によってか、または右心房を介する他の外科的アクセスによって、移植され得る。
図21は、心臓切開手順において、心臓弁の輪において一般的に記載される型の、弾性移植物10を展開するためのツール40を示す。図22Aから22Fは、移植物10を、図21に示されるツール40を使用して僧帽弁輪内に移植物10を展開するための、心臓切開手順の工程を図式的に示す。
(1.弾性移植物の線形展開)
図23〜25は、図7〜14に示される型の、折り畳まれていない弾性移植物の、経皮カテーテルベースの線形典型の代表的な実施形態を示す。
図26および27Aから27Iは、図7〜14に示される型の折り畳まれた弾性移植物10を、左心房内で展開するために使用され得る、移植物送達カテーテル58の別の実施形態を示す。
図15Aから15Eは、尖20の周りで折り畳まれ得る弾性移植物10を示す。図29が示すように、折り畳みは、移植物10が、移植物送達カテーテル58のシース60内で、送達輪郭(これは、送達輪郭の直径を最小にする、側部から側部につぶされた状態を構成するのみでなく、送達輪郭の長さを最小にする、長さ方向につぶされた状態を構成する)で左心房内に運ばれることを可能にする。
広がった弾性移植物の展開を補助するための、1つより多くのガイドループ66またはテザー(tether)の使用は、以前に議論された。1つ以上のガイドループ66またはテザーは、同様に、対称的な型または非対称的な型のいずれかの折り畳まれた弾性移植物の展開を補助するために使用され得る。
上記実施形態は、弾性移植物10の広がり、展開の間、主軸寸法または短軸(隔壁から側方の)寸法のいずれかで、あるいは両方の寸法で、ガイドワイヤによって制御され得ることを実証する。他の形態の拘束機構が、移植物10の広がりを制御するために使用され得る。
先に記載されたように、移植物10は、弾性変形可能な材料から形成され得る(図38を参照のこと)。移植物10は、先に記載されたように、支柱および1つ以上のレールを備える。移植物10は、移植物送達カテーテル58によって、左心房内に、通常はつぶされた状態で展開される。この配置において、移植物送達カテーテル58は、移植物10の弾性変形可能な材料を、輪内でインサイチュで拡張させるための、機械的拡張デバイス(例えば、シザージャッキなど)を備え得る(図39A〜39Cを参照のこと)。あるいは、移植物送達カテーテル58は、移植物10を輪内で拡張させるために、膨張可能体82(例えば、バルーン)を備え得る(図40A〜40Cを参照のこと)。拡張の間、弾性変形可能な移植物10は、輪を伸張させて、所望の主軸方向サイズを達成する。一旦拡張されると、弾性変形可能な移植物10は、所望の距離を維持し、これによって、輪の収縮を制限する。弾性変形可能な移植物10は、移植物を心臓弁輪内出さらに係留し、そして安定化させるための、他の構造体または機構を備え得る。
僧帽弁のような心臓弁および隣接する解剖学的構造体の形状および構造は、一般に、その部位およびその疾患もしくは損傷の知識と共に、ヒト解剖学の教科書を使用して、医療の専門家によって理解される。所定の移植物についての形状および寸法の範囲は、処置されるべき部位によって規定される。所定の患者についての正確な寸法は、移植物の移植の前に、処置されるべき部位のX線、MRI、またはCT走査によって決定され得る。
移植物10の種々の実施形態が、心臓弁の再成形の観点で記載された。この機能に適切な技術的特徴を有する所定の移植物10はまた、他の機能によく適した他の技術的特徴を組み込み得る。
Claims (44)
- 心臓弁輪を再成形するための移植物であって、該移植物は、心臓弁輪の近くまたは内側に載るような大きさおよび構成にされた本体を備え、組織に接触し、そして該組織を外向きに移動させて、該心臓弁輪を再成形する、該本体の部分を備える、移植物。
- 心臓弁輪を再成形するための移植物であって、該移植物は、心臓弁輪の近くまたは内側で、正味の圧縮状態で載るような大きさおよび構成にされた本体を備え、組織に接触し、そして該組織を移動させて、該心臓弁輪を再成形する、該本体の部分を備える、移植物。
- 心臓弁輪を再成形するための移植物であって、以下:
心臓弁輪の近くまたは内側で、正味の圧縮状態で載るような大きさおよび構成にされた本体;および
該本体に付属し、該心臓弁輪の近くまたは内側の組織に接触するための、間隔を空けた支柱であって、該支柱は、正味の圧縮の結果として組織を移動させ、該心臓弁輪を再成形するような大きさおよび構成にされている、支柱、
を備える、移植物。 - 輪およびリーフレット交連を有する心臓弁を再成形するための移植物であって、以下:
心臓弁輪の近くまたは内側で、正味の圧縮状態で載るような大きさおよび構成にされた本体;および
該本体に付属し、該リーフレット交連またはその近くの組織に接触するための、間隔を空けた支柱であって、該支柱は、正味の圧縮の結果として組織を移動させ、該心臓弁輪を再成形するような大きさおよび構成にされている、支柱、
を備える、移植物。 - 心臓弁輪を再成形するための移植物であって、以下:
心臓弁輪の近くまたは内側で、正味の圧縮状態で載るような大きさおよび構成にされた本体;および
該本体に付属し、該心臓弁輪の近くまたは内側の組織に接触するための、間隔を空けた支柱であって、該支柱は、該本体の圧縮の結果として、組織に張力を付与し、該心臓弁輪を再成形するような大きさおよび構成にされている、支柱、
を備える、移植物。 - 輪およびリーフレット交連を有する心臓弁を再成形するための移植物であって、以下:
心臓弁輪の近くまたは内側で、正味の圧縮状態で載るような大きさおよび構成にされた本体;および
該本体に付属し、該リーフレット交連またはその近くの組織に接触するための、間隔を空けた支柱であって、該構造は、該本体の圧縮の結果として、該リーフレット交連またはその近くの組織に張力を付与し、リーフレットの接合のために、該心臓弁輪を成形し、そして引っ張るような大きさおよび構成にされている、支柱、
を備える、移植物。 - 前記本体が、環状の形状を備える、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、閉じた環状の形状を備える、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、開いた環状の形状を備える、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、少なくとも1つのレールを備える、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、ワイヤ形状の構造体を備える、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、カテーテル内への配置のために折りたたみ可能である、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、少なくとも1つの先端を備え、該先端が、永続的な変形なしで、前記本体をつぶすことを可能にするような大きさおよび構成にされている、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、組織内方成長材料を備える、請求項1、2、3、4、5または6に記載の移植物。
- 少なくとも1つの構造体をさらに備え、該構造体は、前記本体に付属しており、そして前記心臓弁輪、その上方、またはその下方の組織に接触して、該本体を安定化するような大きさおよび構成にされている、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、前記輪の近くに延びるような大きさおよび構成にされている、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、前記輪の上方に延びるような大きさおよび構成にされている、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、前記輪の上方の組織に接触するような大きさおよび構成にされている、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、前記輪の近くに延びる1つの部分、および該輪の上方に延びる別の部分を備えるような大きさおよび構成にされている、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、前記輪の近くに延びる1つの部分、および該輪の上方の組織に接触する別の部分を備えるような大きさおよび構成にされている、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、弾性材料を備える、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、可塑性変形可能な材料を備える、請求項1、2、3、4、5または6に記載の移植物。
- 前記本体が、超弾性材料を備える、請求項1、2、3、4、5または6に記載の移植物。
- 保持要素をさらに備え、該保持要素は、前記本体に付属しており、そしてネイティブな心臓弁リーフレットの少なくとも一部分を越えて延び、制限要素は、該心臓弁リーフレットの逆行性の移動を制限するような形状にされている、請求項1、2、3、4、5または6に記載の移植物。
- 新リーフレット要素をさらに備え、該新リーフレット要素は、前記本体に付属しており、そして少なくとも1つのネイティブな心臓弁リーフレットの空間を占有し、該新リーフレット要素は、一方向弁機能を提供するような形状にされている、請求項1、2、3、4、5または6に記載の移植物。
- 心臓弁機能に影響を与えるように前記本体に付属する、第二の心臓弁処置要素をさらに備える、請求項1、2、3、4、5または6に記載の移植物。
- 前記第二の心臓弁処置要素が、ネイティブな心臓弁リーフレットを補充するか、修復するか、または置換するための手段を備える、請求項26に記載の移植物。
- 前記第二の心臓弁処置要素が、ネイティブな心臓弁リーフレットを保持するための手段を備える、請求項26に記載の移植物。
- 前記支柱のうちの少なくとも1つが、ワイヤ形状の構造体を備える、請求項3、4、5または6に記載の移植物。
- 前記本体および前記支柱の各々が、ワイヤ形状の構造体を備える、請求項3、4、5または6に記載の移植物。
- 前記支柱のうちの少なくとも1つが、前記本体上につぶすことが可能である、請求項3、4、5または6に記載の移植物。
- 前記支柱のうちの少なくとも1つが、組織内方成長材料を備える、請求項3、4、5または6に記載の移植物。
- 前記支柱のうちの少なくとも1つが、前記輪、その上方、またはその下方の組織との接触の表面積を増加させるような大きさおよび構成にされた構造体を備える、請求項3、4、5または6に記載の移植物。
- 心臓弁輪を再成形するための方法であって、以下の工程:
請求項1、2、3または4に記載の移植物を心臓に導入する工程;および
該請求項1、2、3または4に記載の移植物の本体を心臓弁輪の近くまたは内側に配置することによって、該心臓弁輪を再成形するように、組織を移動させる工程、
を包含する、方法。 - 前記導入する工程が、心臓切開手術手順を使用する工程を包含する、請求項34に記載の方法。
- 前記導入する工程が、前記移植物がカテーテル内を運ばれる手術手順を使用する工程を包含する、請求項34に記載の方法。
- 前記導入する工程が、脈管内手術手順を使用する工程を包含する、請求項34に記載の方法。
- 前記組織を移動させる工程が、前記請求項1、2、3または4に記載の移植物の本体を、少なくとも1つのワイヤに係留し、同時に該本体を、心臓弁輪の近くまたは内側に配置する工程を包含する、請求項34に記載の方法。
- 心臓弁輪を再成形するための方法であって、以下の工程:
請求項5に記載の移植物を心臓に導入する工程、および
該請求項5に記載の移植物の本体を、正味の圧縮状態で、心臓弁輪またはその近くに配置することによって、該心臓弁輪に張力を付与して該心臓弁輪を再成形する工程であって、ここで、前記支柱が、該心臓弁輪の近くまたは内側の組織に接触し、そして張力を付与している、工程、
を包含する、方法。 - 輪およびリーフレット交連を有する心臓弁を再成形するための方法であって、以下の工程:
請求項6に記載の移植物を心臓に導入する工程、および
該請求項6に記載の移植物の本体を、正味の圧縮状態で、該リーフレット交連またはその近くで配置することによって、リーフレットの接合のために、該心臓弁輪を成形し、そして引っ張るように、張力を付与する工程であって、ここで、前記支柱が、該リーフレット交連またはその近くの組織に接触し、そして張力を付与している、工程、
を包含する、方法。 - 前記導入する工程が、心臓切開手術手順を使用する工程を包含する、請求項39または40に記載の方法。
- 前記導入する工程が、前記移植物がカテーテル内を運ばれる手術手順を使用する工程を包含する、請求項39または40に記載の方法。
- 前記導入する工程が、脈管内手術手順を使用する工程を包含する、請求項39または40に記載の方法。
- 前記張力を付与する工程が、前記請求項5または6に記載の移植物の本体を、それぞれ少なくとも1つのワイヤに係留し、同時に該本体を、心臓弁輪またはその近くで圧縮状態で配置する工程を包含する、請求項39または40に記載の方法。
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CN (1) | CN100553590C (ja) |
AT (1) | ATE418938T1 (ja) |
AU (2) | AU2003277116A1 (ja) |
CA (1) | CA2498030A1 (ja) |
DE (1) | DE60325634D1 (ja) |
HK (1) | HK1082175A1 (ja) |
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US20090306622A1 (en) | 2009-12-10 |
US9861475B2 (en) | 2018-01-09 |
WO2004030569A2 (en) | 2004-04-15 |
CA2498030A1 (en) | 2004-04-15 |
DE60325634D1 (de) | 2009-02-12 |
EP1562522A2 (en) | 2005-08-17 |
CN1703176A (zh) | 2005-11-30 |
US20060106456A9 (en) | 2006-05-18 |
ATE418938T1 (de) | 2009-01-15 |
CN100553590C (zh) | 2009-10-28 |
AU2003277116A1 (en) | 2004-04-23 |
WO2004030569A3 (en) | 2004-12-29 |
AU2009208049A1 (en) | 2009-08-27 |
EP1562522B1 (en) | 2008-12-31 |
EP1562522A4 (en) | 2007-02-28 |
HK1082175A1 (en) | 2006-06-02 |
US20040127982A1 (en) | 2004-07-01 |
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