JP2020049275A - 人工心臓弁用の切頂型リーフレット - Google Patents
人工心臓弁用の切頂型リーフレット 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
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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
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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
- A61F2/2415—Manufacturing methods
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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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- 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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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
Description
一実施形態によれば、リーフレットフレーム130は、図2A〜2Dに示すように、概ね管状の部材で、開口部122の一般的な開放パターンを画定する。経カテーテルの実施形態では、リーフレットフレーム130は、異なる直径の間で圧縮と拡張ができるように作用できる。リーフレットフレーム130は、フレーム第1端部121aと、フレーム第1端部121aとは反対側のフレーム第2端部121bとを備える。図2Aに示すように、リーフレットフレーム130は、リーフレットフレーム外面126aと、リーフレットフレーム外面126aとは反対側のリーフレットフレーム内面126bとを備える。リーフレットフレーム130は、リーフレット自由縁142に連結する接合柱136を画定する。
フィルム160は、一般に、生体適合性がある任意のシート状材料であり、実施形態に従ってリーフレットをフレームに連結するように構成される。「フィルム」という語は、特定目的に適した1つ以上の生体適合性材料の総称として使用されるものと理解される。リーフレット140もフィルム160で構成される。
一実施形態によれば、植え込み時に左心室の索枝を覆わないことにより、大動脈弁置換術で起こり得るような心臓伝導系との干渉を防止するように人工弁100を構成できる。例えば、人工弁100の長さを約25mm未満又は約18mm未満にしてよい。また、人工弁100のアスペクト比(人工弁100の長さと拡張時の機能的直径との間の関係を表す比率)を1未満にしてよい。しかしながら、人工弁100は任意の長さで構成してよく、より一般的には所望の寸法で構成してよい。
図4Aを参照すると、一実施形態では、弁送達システム500は、上述のような折り畳み構成と拡張構成を有する人工弁100と、細長い可撓性カテーテル480(例えばバルーンカテーテル)とを備え、カテーテルを介して人工弁100を展開するように構成される。カテーテル480は、人工弁100を拡張させ、且つ/又は必要に応じて人工弁100を微調整して確実に配置させるためのバルーンを備えてよい。脈管構造を通じて送達するために、人工弁100をカテーテル480の遠位部に取り付けてよい。折り畳み構成時の弁をカテーテル480上に保持する目的で、弁送達システムは、経カテーテル人工弁100にぴったりとフィットする取り外し可能シース(図示せず)をさらに備えてよい。
上記実施形態の人工弁100を、経カテーテル手法を用いる代わりに外科的に植え込んでもよいと理解される。外科的に植え込まれる人工弁100の実施形態は、上記実施形態と実質的に同じであり得るが、一実施形態によれば、図4Aに示す通り、リーフレットフレーム外面126aに隣接して縫合カフ170が追加される。縫合カフ170は、当技術分野において周知であり、人工弁100を植え込み部位(例えば組織開口部150)に連結するための縫合糸を受け取る構造を提供するように作用できる。縫合カフ170は、任意の適切な材料(例えばダブルベロアポリエステルが挙げられるが、これに限定されない)を含んでよい。リーフレットフレーム130に応じて、リーフレットフレーム130の外周または弁周囲に縫合カフを配置してよい。
本明細書に記載の実施形態は、本明細書に記載の実施形態の人工弁100を製作する方法にも関連する。円筒形のマンドレル710を使用して各種実施形態を製作できる。図5を参照すると、マンドレル710は、表面にリーフレットフレーム130を受け入れるように作用できる構造形態を含む。
Claims (15)
- リーフレットフレーム基部を有する管状形状のリーフレットフレームと、リーフレットを画定するフィルムと、該リーフレットフレームに連結された複数のリーフレットを備える人工弁であって、
各リーフレットは、リーフレット自由縁と該リーフレット自由縁とは反対側のリーフレット基部とを含み、
取り付け線は、リーフレットフレーム基部がリーフレットフレームに取り付けられた部分の直線であり、該取り付け線が管状形状のリーフレットフレームの軸に対しねじれの関係になるように、リーフレットフレームの軸とは交差しない方向に伸び、かつリーフレットフレームの軸は取り付け線が存在する面に対し垂直である、人工弁。 - 各リーフレットの基部に沿った取り付け線は、2つの隣接する接合柱の頂点をつなぐ線の下側かつ外側に位置する、
ここで、前記下側とは、人工弁の軸方向沿いに、リーフレット自由縁側からリーフレット基部側へ向かう方向を指し、前記外側とは、人工弁の軸から半径方向外側を指す、請求項1に記載の人工弁。 - 各リーフレットは、2つのリーフレット側部と、リーフレット基部と、該リーフレット基部とは反対側のリーフレット自由縁とを有し、該2つのリーフレット側部は、該リーフレット基部から分岐し、該リーフレット基部は直線状で、リーフレットフレームは、リーフレットフレーム基部と複数のリーフレットフレーム側部と有し、各リーフレットは、リーフレットフレーム基部と2つのリーフレットフレーム側部により囲まれ、かつ、リーフレット自由縁側で空いており、前記リーフレット基部は前記リーフレットフレーム基部に連結され、2つのリーフレット側部の各々は2つのリーフレットフレーム側部の1つに連結される、請求項1に記載の人工弁。
- 各リーフレットは、中央領域と、該中央領域の両側にある2つの側部領域とを含み、該中央領域は、中央領域両側の2辺と、該リーフレット基部と、該リーフレット自由縁とで画定される等脚台形の形状で画定され、該中央領域両側の2辺は、該リーフレット基部から収束し、側部領域の各々は中央領域の両側の1辺と、リーフレット側部の1辺と、リーフレット自由縁とにより画定され、
人工弁が閉状態かつ加圧されていない状態のとき、前記中央領域、あるいは前記中央領域及び前記2つの側部領域の各々が平面である、請求項3に記載の人工弁。 - 前記リーフレットフレーム側部は、
リーフレットフレーム第1端部と、該リーフレットフレーム第1端部とは反対側のリーフレットフレーム第2端部とを備え、ここで各リーフレットは、二次元の等脚台形のフィルムを管状形状のリーフレットフレームに巻き付けることにより少なくとも部分的に決定される形状(接合柱の部分を除く)を有し、各リーフレットを取り囲むリーフレットフレームは、基部と、該基部から分岐する2つの側部とを有し、2つの隣接するリーフレット窓のリーフレットフレーム側部は、リーフレットフレーム第2端部で接合している;かつ、
前記2つの隣接するリーフレット窓のリーフレットフレーム側部が接合する箇所から延伸する接合柱をさらに備える、請求項3に記載の人工弁。 - 前記フィルムは、前記リーフレットフレームの外面に連結され、該フィルムは、複数のリーフレットを画定し、リーフレットの各々がリーフレットの窓から広がる;かつ/あるいは、
前記フィルムは、前記リーフレットフレームの内面に連結され、該フィルムは、複数のリーフレットを画定し、各々のリーフレットがリーフレットの窓から広がる、請求項3に記載の人工弁。 - 前記リーフレットフレームは3つのリーフレットをそれぞれ取り囲む6つのリーフレットフレーム側部を有する;あるいは、
1つのリーフレットに連結されるリーフレットフレーム側部は、隣接するリーフレットに連結されるリーフレットフレーム側部と接合される、請求項3に記載の人工弁。 - 前記リーフレットフレームは、間隔を空けて配置された複数のリーフレットフレーム側部を備え、
2つの隣接するリーフレットフレーム側部の下側の部分と基部要素は、閉じた二等辺三角形の形状を形成し、2つの隣接するリーフレットフレーム側部の下側の部分と基部要素は、上側が空いている等脚台形の形状を形成し、複数の二等辺三角形と複数の等脚台形が交互に配置される、
ここで、前記下側とは、人工弁の軸方向沿いに、リーフレット自由縁側からリーフレット基部側へ向かう方向を指し、前記上側とは、リーフレット自由縁の側を指す、請求項3に記載の人工弁。 - 経カテーテル送達用に折り畳み構成と拡張構成とを含む、請求項3に記載の人工弁。
- 各リーフレットはポリマー材料を含む、請求項3に記載の人工弁。
- 各リーフレットは積層物を含み、かつ、
前記積層物は、複数層のフルオロポリマー膜を有する、請求項10に記載の人工弁。 - 各リーフレットは、少なくとも1層のフルオロポリマー膜を有するフィルムを含み、上記フルオロポリマー膜は、複数の細孔と、該少なくとも1層のフルオロポリマー膜の全ての細孔に存在するエラストマーとを有する、請求項3に記載の人工弁。
- 前記フィルムは、80重量%未満のフルオロポリマー膜を含み、かつ、
前記エラストマーは(パー)フルオロアルキルビニルエーテルを含む、請求項12に記載の人工弁。 - 前記エラストマーは、テトラフルオロエチレンとパーフルオロメチルビニルエーテルのコポリマーを含み、かつ、
前記フルオロポリマー膜はePTFEを含む、請求項12に記載の人工弁。 - 管状形状を有するリーフレットフレームを設けること、ここで該リーフレットフレームは複数のリーフレットフレーム窓を画定する;
フィルムを設けること;
該フィルムを該リーフレットフレームの周囲に巻き付けて、複数層のフィルムを更なる層のフィルムに接触させて、各リーフレット窓から広がる少なくとも1つのリーフレットを画定すること、ここで、各リーフレットは、2つのリーフレット側部と、リーフレット基部と、該リーフレット基部とは反対側のリーフレット自由縁とを有する等脚台形の形状を有し、各リーフレットのリーフレット基部は平坦な取り付け線に沿って平坦であり、取り付け線は、リーフレットフレーム基部がリーフレットフレームに取り付けられた部分の直線であり、該取り付け線が管状形状のリーフレットフレームの軸に対しねじれの関係になるように、リーフレットフレームの軸とは交差しない方向に伸び、かつリーフレットフレームの軸は取り付け線が存在する面に対し垂直である、2つのリーフレット側部は、リーフレット基部から分岐し、リーフレット基部は平坦であり、リーフレット基部はリーフレットフレーム基部に連結され、環状の支持構造を設けるように2つのリーフレット側部の各々が2つのリーフレットフレーム側部の1つと連結される;
接触させたフィルム層を、そのフィルム層自身とリーフレットフレームに接着させること;並びに、
各リーフレットが中央領域および中央領域の両側に2つの側部領域を有するように前記フィルム層を折ること、ここで、人工弁が非圧縮状態下で閉構成にあるとき、隣接するリーフレットの2つの側部領域のリーフレット自由縁は互いに当接する;
を含む、人工心臓弁の製作方法。
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US13/843,196 | 2013-03-15 | ||
US13/843,196 US9144492B2 (en) | 2012-12-19 | 2013-03-15 | Truncated leaflet for prosthetic heart valves, preformed valve |
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EP (3) | EP3479797B1 (ja) |
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CN (1) | CN105050541B (ja) |
AU (3) | AU2013363172C1 (ja) |
CA (2) | CA2990642C (ja) |
ES (3) | ES2647777T3 (ja) |
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