JP2016529007A - 人工弁のための径方向に折り畳み自在のフレーム及び当該フレームを製造するための方法 - Google Patents
人工弁のための径方向に折り畳み自在のフレーム及び当該フレームを製造するための方法 Download PDFInfo
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- 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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- A61F2/2412—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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- A61F2210/0019—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
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- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
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- A61F2230/00—Geometry 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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- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0067—Three-dimensional shapes conical
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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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
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Abstract
Description
2,102,202 流入端領域
3,103,203 流出端領域
10,10’,10” 交連取り付け領域
110,110’,110”
210,210’,210”
11,11’,11” 保持部
111,111’,111”
211,211’,211”
12,12’,12” 交連取り付け部
112,112’,112”
212,212’,212”
20,20’,20” 固定/位置決めアーチ
120,120’,120”
220,220’,220”
20a,20a’,20a” 固定/位置決めアーチの第1のアーム
120a,120a’,120a”
220a,220a’,220a”
20b,20b’,20b” 固定/位置決めアーチの第2のアーム
120b,120b’,120b”
220b,220b’,220b”
21,121,221 位置決めアーチのアイレット
30,130,230 セル構造体
31,31’,31” 第1のセル領域
32,32’,32” 第2のセル領域
40,40’,40” 保持アーチ
40a,40a’,40a” 保持アーチの第1のアーム
40b,40b’,40b” 保持アーチの第2のアーム
41,241 切り欠き
50 環状カラー
51 環状カラーの支柱
113 締結孔
140,140’,140” 更なる支持構造体
240,240’,240”
215a,215a’,215a” 第1の交連取り付けアーム
215b,215b’,215b” 第2の交連取り付けアーム
311 第1のセル領域の支柱
321 第2のセル領域の支柱
Claims (31)
- 人工弁のための径方向に折り畳み自在のフレーム(1,100,200)であって、
− 前記フレーム(1,100,200)の基端にある流出端領域(3,103,203)、及び、前記流出端領域(3,103,203)とは反対側の前記フレーム(1,100,200)の先端にある流入端領域(2,102,202)と、
− 前記フレーム(1,100,200)の前記流出端領域(3,103,203)に位置するとともに、少なくとも2つの人工弁小葉の交連縁部を受けるように構成される少なくとも2つの径方向に離間された交連取り付け領域(10,10’,10”)と、
− 前記フレーム(1,100,200)の流れ軸線の周りで径方向に配置される複数の格子セルから構成されるとともに、前記少なくとも2つの交連取り付け領域(10,10’,10”,110,110’,110”、210,210’,210”)を接続するセル構造体(30,130,230)と、
− 少なくとも1つの固定/位置決めアーチ(20,20’,20”,120,120’,120”,220,220’,220”)であって、前記少なくとも1つの固定/位置決めアーチ(20,20’,20”,120,120’,120”,220,220’,220”)が前記セル構造体(30,130,230)と径方向で少なくとも部分的に重なり合う、少なくとも1つの固定/位置決めアーチ(20,20’,20”,120,120’,120”,220,220’,220”)と、
を備え、
前記フレーム(1)は、周方向に配置される複数の保持アーチ(40,40’,40”)を更に備え、前記各保持アーチは、前記保持アーチ(40,40’,40”)の先端で互いに結合される第1及び第2のアーム(40a,40a’,40a”,40b,40b’,40b”)を含み、前記2つのアームが円形構造体によって結合され、
前記セル構造体(30)は、複数の第1のセルから構成される第1のセル領域(31,31’,31”)を備え、前記第1のセルは、前記各保持アーチ(40,40’,40”)の前記第1及び第2のアーム(40a,40a’,40a”,40b,40b’,40b”)間に配置され、前記セル構造体(30)は、複数の第2のセルから構成される第2のセル領域(32,32’,32”)を備え、前記第2のセルは、2つの隣り合う保持アーチ(40,40’,40”)の隣接するアーム間に配置される、
径方向に折り畳み自在のフレーム(1,100,200)。 - 前記少なくとも1つの固定/位置決めアーチ(20,20’,20”,120,120’,120”,220,220’,220”)は、前記少なくとも2つの径方向に離間された交連取り付け領域(10,10’,10”,110,110’,110”、210,210’,210”)に強固に取り付けられる請求項1に記載のフレーム(1,100,200)。
- 前記少なくとも1つの固定/位置決めアーチ(20,20’,20”)は、前記少なくとも2つの径方向に離間された交連取り付け領域(10,10’,10”)と一体に単一品として形成される請求項1に記載のフレーム(1)。
- 前記各保持アーチ(40,40’,40”)の前記2つのアーム(40a,40a’,40a”,40b,40b’,40b”)は、略U形状又は略V形状の構造を有する接続部で互いに結合される請求項1から3のいずれか一項に記載のフレーム(1)。
- 全体で3つの前記固定/位置決めアーチ(20,20’,20”)と全体で3つの前記保持アーチ(40,40’,40”)とが設けられる請求項1から4のいずれか一項に記載のフレーム(1)。
- 2つの隣り合う保持アーチ(40,40’,40”)の隣接するアームは、前記フレーム(1)の前記流出端領域(3)付近において、前記少なくとも2つの交連取り付け領域(10,10’,10”)のうちの1つでつながる請求項1から5のいずれか一項に記載のフレーム(1)。
- 前記第1のセル及び/又は前記第2のセルのそれぞれが複数の支柱(311,321)によって形成される請求項1から6のいずれか一項に記載のフレーム(1)。
- 前記各位置決めアーチ(20,20’,20”)及び前記各保持アーチ(40,40’,40”)が閉端を含み、それぞれの前記固定/位置決めアーチ(20,20’,20”)の前記閉端は、関連する保持アーチ(40,40’,40”)の前記閉端に対して略周方向で位置合わせされる請求項1から7のいずれか一項に記載のフレーム(1)。
- 前記複数の保持アーチ(40,40’,40”)のうちの少なくとも1つに設けられる少なくとも1つの締結部を更に備え、前記少なくとも1つの締結部は、縫合糸を受けるように構成される複数の締結孔を含む請求項1から8のいずれか一項に記載のフレーム(1)。
- 前記少なくとも1つの締結部は、縫合糸を受けるように構成される複数の切り欠きを更に含む請求項9に記載のフレーム(1)。
- 前記フレーム(1)の拡張状態で、前記保持アーチ(40,40’,40”)のそれぞれのアームは、前記フレーム(1)に取り付けられる人工弁の小葉と適合する形状を有する請求項1から10のいずれか一項に記載のフレーム(1)。
- 少なくとも1つの環状カラー(50)がそれぞれの前記保持アーム(40a,40a’,40a”,40b,40b’,40b”)の先端部分で前記円形構造体の一部に接続される請求項1から11のいずれか一項に記載のフレーム(1)。
- 前記少なくとも1つの環状カラー(50)は、前記2つの隣り合う保持アーチ(40,40’,40”)の隣接するアーム(40a,40a’,40a”,40b,40b’,40b”)間に配置される前記第2のセル領域(32,32’,32”)の前記第2のセルを形成する支柱(312)の下端部分のそれぞれ又は一部に接続される請求項12に記載のフレーム(1)。
- 人工弁を前記フレーム(1)に固定するために前記少なくとも環状カラー(50)の下端部分の周囲に均等に分布する複数のアイレットを更に備える請求項12又は請求項13に記載のフレーム(1)。
- 前記フレーム(1)の拡張状態において、前記環状カラー(50)の下端部分は、患者の自然心臓弁の位置での前記フレーム(1)の固定を改善するために、及び、人工弁が取り付けられて成る前記フレーム(1)の順行性移動を防止するために設けられる前記フレーム(1)の少なくとも1つのフレアー部分又はテーパ部分を構成する請求項12から14のいずれか一項に記載のフレーム(1)。
- 前記フレーム(1)の拡張状態において、前記フレーム(1)は、その下端部分に、患者の自然心臓弁の位置での前記フレーム(1,100,200)の固定を改善するために、及び、人工弁が取り付けられて成る前記フレーム(1)の順行性移動を防止するために設けられる少なくとも1つのフレアー部分又はテーパ部分を備える請求項1から15のいずれか一項に記載のフレーム(1)。
- 前記フレーム(1)の前記少なくとも1つのフレアー部分又はテーパ部分が放射形状を有する請求項15又は請求項16に記載のフレーム(1)。
- 前記少なくとも1つのフレアー部分又はテーパ部分が前記保持アーチ(40,40’,40”)が位置する付近にのみ設けられ、前記隣り合う保持アーチ(40,40’,40”)の2つのアーム間の領域付近には前記フレアー部分又はテーパ部分が設けられていない請求項17に記載のフレーム(1)。
- 前記フレーム(1)は、当該フレーム(1)がその拡張状態にあるときに、その下端部分にホタテガイの縁のように波を打った流入縁形態を有する請求項1から18のいずれか一項に記載のフレーム(1)。
- 前記フレーム(1)は、チューブの一部から、特に小さい金属チューブから一体に切り取られる構造を有する請求項1から19のいずれか一項に記載のフレーム(1)。
- 患者の体内へ導入されるときの第1の折り畳み形態と、埋め込まれるときの第2の拡張形態とを更に含む請求項1から20のいずれか一項に記載のフレーム(1)。
- 前記フレーム(1,100,200)は、外的刺激の影響下で前記フレーム(1,100,200)が一時的形状から恒久的形状へと変形できるような形状記憶材料から成り、前記フレーム(1,100,200)の前記一時的形状が前記フレーム(1,100,200)の第1の形態に対応し、前記フレーム(1,100,200)の前記恒久的形状が前記フレーム(1,100,200)の第2の形態に対応する請求項21に記載のフレーム(1)。
- 前記外的刺激が規定可能なスイッチング温度である請求項22に記載のフレーム(1)。
- 前記スイッチング温度は、室温と患者の体温との間の範囲内、好ましくは約22℃である請求項23に記載のフレーム(1)。
- 前記少なくとも1つの固定/位置決めアーチ(20,20’,20”)は、自然心臓弁のポケット内に配置されるとともに複数の自然心臓弁小葉の第1の側に配置されるように構成され、前記複数の保持アーチ(40,40’,40”)は、前記第1の側と反対側にある前記複数の自然心臓弁小葉の第2の側に配置されるように構成される請求項1から24のいずれか一項に記載のフレーム(1)。
- 前記少なくとも1つの固定/位置決めアーチ(20,20’,20”,120,120’,120”,220,220’,220”)が、略U形状又は略V形状の構造を含む請求項1から25のいずれか一項に記載のフレーム(1)。
- 請求項1から26のいずれか一項に記載の径方向に折り畳み自在のフレーム(1,100,200)と、当該フレームの内面に取り付けられる弁プロテーゼとを備える体内プロテーゼ。
- 前記弁プロテーゼが心膜から形成される請求項27に記載の体内プロテーゼ。
- 請求項1から28のいずれか一項に記載の径方向に折り畳み自在のフレーム(1)を製造するための方法であって、
i)形状記憶材料から形成される中空チューブを用意するステップと、
ii)所望のパターンが前記中空チューブに切り込まれるように前記中空チューブの所望の領域にわたってレーザ放射ビームを走査することによってステントパターンを切り出すステップと、
iii)前記ステントパターンに形状設定プロセスを適用することにより、前記径方向に折り畳み自在のフレーム(1)の最終構造を規定するステップと、
を備え、
前記方法ステップii)で形成される前記ステントパターンは、
− 複数のセルから構成されるメッシュを規定する基本フレーム(1)のセル構造体(30)であって、前記各セルが複数の支柱によって形成される、基本フレーム(1)のセル構造体(30)と、
− 前記セル構造体(30)の前記複数のセルから離れるように延びる少なくとも1つの固定/位置決めアーチ(20,20’,20”)と、
を備え、
前記方法ステップiii)における形状設定プロセス中に、前記少なくとも1つの固定/位置決めアーチ(20,20’,20”)が前記セル構造体(30)の前記複数のセルと同じ方向に延びて前記セル構造体(30)と少なくとも部分的に径方向で重なり合うように前記固定/位置決めアーチ(20,20’,20”)が曲げられる、
方法。 - 方法i)の後、方法ii)の前に、以下のステップ、すなわち、
− 前記中空チューブをマンドレル上に配置するステップ
を更に備え、
前記ステントパターンは、前記方法ステップiii)において前記形状設定プロセスを適用する前に前記マンドレルから除去される、
請求項29に記載の方法。 - 前記方法ステップiii)は、
− 前記ステントパターンに対して熱処理プロセスを適用するステップ
を備える請求項29又は請求項30に記載の方法。
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EP3038567A1 (en) | 2016-07-06 |
US9867694B2 (en) | 2018-01-16 |
US10433954B2 (en) | 2019-10-08 |
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US11185405B2 (en) | 2021-11-30 |
US20180333258A1 (en) | 2018-11-22 |
WO2015028209A4 (en) | 2015-04-23 |
WO2015028209A1 (en) | 2015-03-05 |
JP6563394B2 (ja) | 2019-08-21 |
US20160213465A1 (en) | 2016-07-28 |
CN105491978A (zh) | 2016-04-13 |
US20200085572A1 (en) | 2020-03-19 |
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EP4098226A1 (en) | 2022-12-07 |
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