JP5699186B2 - インプレース形成支持部を有する経腔的に移植可能な心臓弁 - Google Patents
インプレース形成支持部を有する経腔的に移植可能な心臓弁 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- 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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- 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
- A61F2/2418—Scaffolds therefor, e.g. support stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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Description
通常の運動は、過度の疲労、動悸、呼吸困難、または狭心痛を生じない。
(i)心臓10の左心室32から上行する上行大動脈38、
(ii)上行大動脈38から弓形に曲がる大動脈弓10、および
(iii)大動脈弓40から腹大動脈(図示されない)に向かって下行する下行大動脈42を備える。
大動脈14の主な枝も示されており、それには直近で右頸動脈(図示されない)および右鎖骨下動脈(図示されない)に分岐する無名動脈44、左頸動脈46、および鎖骨下動脈48が含まれる。
(i)インプラント100によって除外された組織へ支持を提供すること、(ii)インプラント100に軸方向および径方向の強度および剛性を提供すること、および/または、(iii)弁104に支持を提供すること。膨張式構造107の具体的な設計上の特性または向きは各機能をより良く果たすように最適化可能である。たとえば、膨張式チャネル120がデバイスの関連区域に軸方向強度を加えるように設計される場合、チャネル120は実質的に軸方向に向けられていることが理想的である。膨張式チャネル120が主にデバイスの関連区域に径方向強度を加えるように設計される場合、チャネルは全体的に円周方向に向けられることが理想的である。膨張式チャネルの間に組織が延出するのを防止するために、チャネル120は、十分な足場を提供するように互いに十分に近接した間隔になる必要がある。
バルーン111の全長は約18cmである。バルーン111は、カフに適合する形状に膨らませることができ、または、バルーンは、二次的なステップでカフに適合するように形作られてもよい。その代わりに、ライナが織地のカフとは異なる形状であってもよく、この場合、ライナは織地のカフよりも大きく、これによりこのアセンブリは織地によって決定された大きさに膨張することが可能となる。
インプラント170は、全体的にステント様構造172を備えており、この構造172は、自己拡張式ステントを形成するために近位および遠位の曲げを備える環状のジグザグ模様に配置された1つまたは複数の細長い部材を備える。弁174はこの構造172に接続されている。インプラント170は、上記に説明したような様式で構成された、1つ(図16A)または複数(図16B)の膨張式カフ176を含むことができる。膨張式カフ176は、弁周囲漏出を最小限に抑えまたは無くすように構成されている。たとえば、膨張式カフ176は、それが膨張されると弁174の各弁尖の固定された縁部の周りの流体流れを防止または制限するように、インプラント170に配置することができる。図16Aの実施形態では、弁170は単一の円形のカフ174を備えており、このカフは、弁174の弁尖の固定された縁がステント172に取り付けられる位置で、ステント172の外表面に取り付けられている。ステント172が拡張された後に、膨張式カフ176が膨張媒体で満たされる。カフ176は、インプラント170の外表面を生来の解剖学的構造に対してシーリングするのに適切な圧力に膨張される。膨張式の通路は備えていないが血管壁と弁174の間にシーリングを形成するように機能する、Oリングなどの受動的構造も提供することができる。そのような実施形態では、シーリング構造は、好ましくはそれが解剖学的構造に容易に適合することができるように、低デュロメータ材料または発泡体から作製される。シリコーン、またはシリコーン発泡体も、適切なシーリング部材を生成するために使用することができる。
膨張式構造107は、所望の性能に依存して、任意の様々な膨張媒体122を使用して膨張できる。一般に、膨張媒体は、水などの液体、もしくは水溶液、CO2などの気体、または硬化可能な媒体(第1の比較的低い粘度でカフ102に導入し、第2の比較的高い粘度に変換することができるもの)を含むことができる。任意の様々な既知のUV開始、もしくは触媒開始の重合反応、または当分野で知られたその他の化学作用システムによって、粘度の向上を行うことができる。粘度向上プロセスの終点は、所望の性能および耐性に依存して、ゲルから堅固な構造までのどの程度の硬度をも生じることができる。
(2)約22〜約27重量パーセントの範囲、特に約24重量パーセントの割合で存在するペンタエリスリトールテトラ3(メルカプトプロピオネート)(pentaerthyritol tetra 3(mercaptopropionate))(QT)と、
(3)約22〜約27重量パーセントの範囲、特に約24重量パーセントの割合で存在するグリシルグリシン緩衝液。
一実施形態では、中間の膨張媒体は気体であり、予め膨張させる媒体は液体である。別の実施形態では、中間の膨張媒体または予め膨張させる媒体は、永久的な膨張媒体が膨張チャネルの内面に接着するのを補助するためのプライマーとして機能する。別の実施形態では、予め膨張させる媒体または中間の膨張媒体は、永久的な膨張媒体が膨張チャネルの内面に接着するのを防止するための離型剤として機能する。
アンカー機構220は、多くの様式でカフ102に取り付けることができ、たとえば組織に係合するように意図されないアンカー機構220の端部は、カフに縫合、糊付け、または圧着することができる。この場合、アンカー機構220の縫合された端部は、縫合から係脱するのを防止する形状を有することができる。アンカー機構220は、それを貫通する穴を有することができ、それを縫合が通過し、またはアンカー機構はワイヤから作製され、縫合が係脱できないようにする構成の形状にすることができる。1つの適切なパターンは、全体的に円形または卵形の形状である。その他のものは当業者には明らかである。図29は、アンカー機構が膨張可能なストラットに配置された修正された実施形態を示す。別の実施形態では、アンカー220が、各アンカーに堅固な係合をもたらし、各アンカーの係合を個々に試験するために、展開制御ワイヤ230の装着点、またはその付近でデバイスに固定できる。
チューブ260が超弾性の場合、力が解放されたときに、フック266を元に戻すことが可能となる。ステンレス鋼などから作製される場合、アンカー240は塑性変形することができ、そしてフック266の露出が固定される。このアンカー240を作動させるには、全体的に、チューブ260を折り曲げるために長手方向の力を必要とし、また、プルワイヤ230における張力を保持するためにロックを必要とすることがある。この固定は、ネジおよびナットなどのインターフェアレンスフィットによって維持することができる。
拡大された遠位部分309は、カテーテル300の近位部分310よりも高いデュロメータによって材料から作製できる。一実施形態では、拡大された遠位部分309の材料は生体適合性材料である。別の実施形態では、材料は、ステンレス鋼などの金属材料である。別の実施形態では、材料は、FEP、PEEK、またはポリイミドなどのポリマーである。別の実施形態では、インプラント100を覆うデバイスの拡大された遠位部分309は、可視スペクトラムで光を伝達することが可能である。これによって、インプラント100の向きがカテーテル300内で視覚化できるようになる。遠位端304は、カテーテル300を蛍光透視法の下で位置決めするために、X線不透過性マーカ(図示されない)を有することができる。
ハンドル機構は、カテーテルの遠位部分に液圧を伝達するためのポートを含んでいてもよく、また、ハンドルによって液圧の力を直接的に生成できるようになっていてもよい。これらの力には、デバイスまたはカテーテルに伝達される押しまたは引きが含まれ、また、移植を可能にしたりデバイスをカテーテルから送出可能にしたりするためのデバイスの露出が含まれる。別の力は、移植し、または移植の位置の大きさを測定するための、デバイスまたはカテーテルの径方向または長手方向の拡張を含むことができる。ハンドルは、圧力、流量、温度、およびドップラ情報などの情報を監視するための電気信号への接続も含むことができる。
第3の実施形態では、ガイドワイヤ内腔320は0.039インチ〜0.080インチの直径であり、これにより、標準より大きなガイドワイヤの上に、またはピッグテイルカテーテルなどの診断カテーテルの上に、デバイスを送ることができるようになる。これにより、石灰化した弁を通ってより容易に送るのを促進するためにより剛性のある支持の利点がもたらされる。診断カテーテルがガイドワイヤとして使用される場合、それは造影剤注入用のポートとしても機能することができる。
デバイスのハンドル付近の内腔の近位端は、パワーインジェクタツールを使用して造影媒体の注入を可能にするためにフィッチングに取り付けられる。内腔の内径は0.014インチ〜0.100インチの範囲にあってもよい。内腔の直径はカテーテルの長手方向に沿って変わることができる。たとえば、十分な流れおよび適切な大きさのガイドワイヤの使用の両方を可能にすることができるように、人工弁を通過する内腔の部分は、可能な限り最小の直径のものであることが好ましい。この部分は、好ましくは、0.014〜0.080の直径の範囲にある。インプラントの近位のカテーテルの長手方向に沿って延出する内腔の部分は、より大きな直径のものであってもよく、このより大きな直径は、より低い圧力勾配において造影媒体の流れを可能にし、対応するより大きな外径は、デバイス全体の外形を増加しない。内腔のこの部分は、好ましくは、0.035インチ〜0.100インチの内径の範囲にある。内腔の遠位部分は、内腔を通って十分な体積の造影媒体を注入するのに必要な圧力を最小限に抑えるために、より大きな直径へのディフューザまたは移行部を含むことができる。ノーズコーンの周りに配置された複数の出口ポートも造影媒体の流れを促進する。
デバイスの固定、またはアンカー展開用のこのバルーン312aに装着されたステントまたは他の構造もありうる。バルーン312aは、Pederson Jr.等の米国特許第6,280,412号で確認されるような、Boston Scientificによって市販されている「SOX」デバイスと同様の薄膜材料によっても覆うことができる。この覆いにより、デバイスが送り中に隠され、膨張された場合に露出できるようになる。別の実施形態では、保護のためにバルーン312aを覆うティアアウェイシース(tear−away sheath)が使用できる。
好ましくは、膜またはシェアバリア340が、外側シース301の先端から延出し、図28Aに示されるように、外側シース301の上を裏返しに引かれる。次いで、膜またはシェアバリア340は、外側シース301の先端の付近でその外表面342の上で外側シース301に接着される。修正された実施形態では、外側シース301の内面346に可撓性のシェアバリア340が接着される。シェアバリア340は、好ましくは、ポリマーから作製され、約0.0002インチ〜0.0020インチの厚さを有する。一実施形態では、ポリマーのナイロンである。シェアバリア340は、押出し工程によって製造でき、またはポリマーチューブが熱および圧力を使用して鋳型の内側で膨張されるバルーン膨張工程(balloon blowing process)によって製造できる。
0.026インチの外径および0.005インチの厚さの単一の壁を有するポリイミドシース470が適切であることが証明され、0.030インチの外径および0.007インチの厚さの単一の壁を有するグリルアミドナイロンシースも適切であることが証明された。好ましくは、ポリマーシース470は、外径が約0.018インチ〜0.040インチの範囲にあり、壁厚が約0.003インチ〜約0.010インチの範囲にある。さらに、ステンレス鋼、ニチノール、または他の金属シースが利用できる。この場合には、より小さな直径およびより薄い壁厚が一般的に望ましい。一実施形態では、ステンレス鋼シース470が0.014の外径、約0.011インチの内径を有し、ワイヤ230が0.009インチの外径を有する。金属シース470では、好ましい壁は、約0.0005インチ〜約0.0050インチの厚さであり、好ましい外径は約0.007インチ〜約0.025インチである。シース470の内径は、ワイヤ230の上を自由に移動するための間隙を提供する必要がある。0.00〜約0.007インチの間隙が適切な自由な動きをもたらす。潤滑剤または親水性被覆がシース470の内径、またはワイヤ230の外径に適用される。より滑らかでないポリマーでは、異なる間隙が必要になる可能性がある。
さらに、ワイヤ230に対するシース470の動きを最適化する、チューブ470の内径の表面仕上げを生成するために、押出しパラメータを調整することができる。いくつかのポリマーでは、表面がより粗いことにより摩擦が低下する。上記に示したように、シース470の理想的な壁厚は、選択される特定の材料の強度および剛性に依存するが、同様に、0.002と0.020インチの単一の壁厚の範囲にある。
濾過の大きさは、約25ミクロン〜500ミクロンの寸法の範囲であってもよい。保護デバイス522のフィルタ524は、ニチノール、MP35N、ステンレス鋼、または医療デバイスに使用される任意の許容可能なポリマー材料から作製できる。
代わりに、小さな粒子を除去するために、カテーテル先端に吸引を加えることができる。いずれの方法でも、カルシウムの大きな塊が生来の組織から放出される可能性がある。塊がカテーテルよりも大きい場合は、破壊しなければならず、その後で経皮的に安全に除去することができる。好ましくは、超音波トランスデューサを操作して、これらの大きな塊を破壊して、除去できるのに十分に小さい粒子にすることができる。この技術は、本明細書に参照によって組み込まれる米国特許第4,827,911号、米国特許第4,931,04号、米国特許第5,015,227号、米国特許第4,750,488号、米国特許第4,750,901号、および米国特許第4,922,902号に記載されている。しばしば、これらのデバイスに関する周波数範囲は、約10〜50KHzであるが、約35kHzにおいて最適のようである。
右心室に入った後、デバイスは、大動脈の方法と同様に送ることができ、その場合にカフは、それを遠位に移動しないように保持する直径の差による確実なアンカーのために肺動脈弁の基部を利用する。カフが流体で満たされるときに、受動的または能動的にカフから突出することができるフックまたはバーブも使用することが望ましい可能性がある。バーブは単一のものであってもよく、または複数のバーブまたはフックが使用でき、その場合に長さは組織の構成に応じて1〜5ミリメートルの長さの間であってもよい。組織が柔軟または可撓性である場合に、より長いバーブが必要となる可能性がある。組織がより剛性を有し、より繊維性の構造である場合に、より短い長さを有することが望ましい可能性があり、その場合にバーブがより良く保持することができる。
より短い弁(1〜4センチメートル)が僧帽弁に求められる可能性があるが、大動脈弁は、機能するためのより多くの空間があるより長い弁(1〜8センチメートル)を可能にすることができる。断面積は流出体積を決定するのを助けるので、任意の用途において最大の弁口の大きさが一般に望ましい。大動脈の断面積は、著しく石灰化した弁においてほぼ0.00平方センチメートルから、健康な弁において約5平方センチメートルまで変わる可能性がある。ほとんどの場合、置換において望まれることは、流量を増加させるために断面積を増加させることである。
過去には、マーカワイヤを使用して、直線距離を測定し、この用途で同様の技術を使用して、冠状動脈から大動脈弁の弁輪までの距離などの距離を測定することができた。弁の直径を測定するために、制御されたコンプライアンスを有するバルーンが使用できた。理想的には、バルーンは非常にコンプライアンスを有し、体積制御によって膨張されるが、セミコンプライアントのバルーンを使用し、通常の介入性心臓病学的な膨張デバイスによって膨張させることもできた。その場合は、バルーンのコンプライアンス曲線を使用して、圧力と直径を関連付けることができる。心臓における弁の直径の範囲は、10mm〜50mmの直径の範囲で2mm〜40mmの長さであってもよい。同様の寸法のバルーンが、中隔欠損の大きさを決めるために使用されている。
一時的な弁を配置するステップと、
任意で塞栓保護デバイスを配置するステップと、
狭窄弁の全てまたは一部分を除去、減量、または破壊するステップと、
永久的な人工弁を移植し、次いで一時的な弁および塞栓保護デバイスを除去するステップと、を含む。
当然ではあるが、当業者はこれらのステップの必ずしも全てが必要ではないこと、および/またはいくつかのステップの順が変更できることを理解するであろう。加えて、当業者は、本明細書に記載したステップの様々な修正された実施形態を理解するであろう。
Claims (14)
- 固化媒体を有する膨張式カフと、
前記膨張式カフに連結され、第1の軸方向の流れは許容し前記第1の軸方向とは反対の第2の軸方向の流れは阻止するように構成された弁と、
を備え、
前記膨張式カフは、少なくとも部分的に膨張式構造を形成する膨張式チャネルを少なくとも1つ有しており、
前記膨張式チャネルは、少なくとも2つの弁を有するとともに、その2つの弁の間に配置された方向的な弁を有している、
心臓血管人工弁。 - 前記固化媒体は、膨張媒体を硬化させることによって形成されるものであり、前記膨張媒体は、供給の際に2000cpi未満の粘度を有するものである、請求項1に記載の心臓血管人工弁。
- 前記膨張媒体が、少なくとも1つのモノマーと少なくとも1つのアミンを有する、請求項2に記載の心臓血管人工弁。
- 前記少なくとも1つのモノマーが350から850の間の分子量を有する、請求項3に記載の心臓血管人工弁。
- 前記膨張媒体がさらに放射線不透過性の成分を有している、請求項3または4に記載の心臓血管人工弁。
- 前記放射線不透過性の成分がヨウ素化合物である、請求項5に記載の心臓血管人工弁。
- 前記膨張媒体がエポキシベースである、請求項2〜6のいずれか一項に記載の心臓血管人工弁。
- 前記膨張媒体の粘度が1000cps未満である、請求項2〜7のいずれか一項に記載の心臓血管人工弁。
- 前記膨張媒体は血液の流れの中では固化しない、請求項2〜8のいずれか一項に記載の心臓血管人工弁。
- 前記固化媒体は、生体外で少なくとも10年間実質的に存在し続ける、請求項1〜9のいずれか一項に記載の心臓血管人工弁。
- 前記固化媒体が50〜400psiの弾性率を有する、請求項1〜10のいずれか一項に記載の心臓血管人工弁。
- 前記固化媒体が1700psiの重ねせん断強度を有する、請求項1〜11のいずれか一項に記載の心臓血管人工弁。
- 前記固化媒体が、ショアDスケールで81の硬度を有する、請求項1〜12のいずれか一項に記載の心臓管人工弁。
- 固化媒体を有する膨張式カフと、
前記膨張式カフに連結され、第1の軸方向の流れは許容し前記第1の軸方向とは反対の第2の軸方向の流れは阻止するように構成された弁と、
を備え、
前記膨張式カフは、少なくとも部分的に膨張式構造を形成する膨張式チャネルを少なくとも1つ有しており、
前記膨張式チャネルは、少なくとも2つの弁を有するとともに、その2つの弁の間に配置された方向的な弁を有している、
膨張式人工デバイス。
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2008
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- 2008-08-22 EP EP16171391.2A patent/EP3075355A1/en not_active Withdrawn
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CA2697364A1 (en) | 2009-02-23 |
WO2009026563A2 (en) | 2009-02-26 |
AU2008288796A1 (en) | 2009-02-26 |
EP3075355A1 (en) | 2016-10-05 |
CA2697364C (en) | 2017-10-17 |
AU2008288796B2 (en) | 2014-03-20 |
JP2010536504A (ja) | 2010-12-02 |
CA2978267A1 (en) | 2009-02-23 |
WO2009026563A9 (en) | 2009-07-02 |
WO2009026563A3 (en) | 2009-04-16 |
US10130463B2 (en) | 2018-11-20 |
JP5329542B2 (ja) | 2013-10-30 |
US20190159893A1 (en) | 2019-05-30 |
US20090088836A1 (en) | 2009-04-02 |
EP2190379B1 (en) | 2016-06-15 |
EP2190379A4 (en) | 2014-12-24 |
US9308360B2 (en) | 2016-04-12 |
EP2190379A2 (en) | 2010-06-02 |
US20160317291A1 (en) | 2016-11-03 |
JP2014000417A (ja) | 2014-01-09 |
US20110160846A1 (en) | 2011-06-30 |
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