JP5659168B2 - 折畳み可能な人工心臓弁用ステント特徴部 - Google Patents
折畳み可能な人工心臓弁用ステント特徴部 Download PDFInfo
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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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
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- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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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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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
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Description
本明細書に開示される全ての実施形態において、ステントは、人工心臓弁の一部である。ステントは、拡張状態および折畳み状態を有している。拡張状態では、ステントの少なくとも一部は、実質的に円筒形状を有しているとよい。図2は、菅からレーザ切断されたときに見られるような非拡張状態、すなわち、平坦に展開された状態にあるステント100の展開図を示している。ステント100は、概して、一列または複数列の遠位セル102と、少なくとも1つの支持ストラット104と、一列または複数列の近位セル106と、少なくとも1つの細長の支持ポスト108と、支持ポスト108を少なくともいくつかの近位セル106に連結している少なくとも1つのポスト接続部110と、を備えている。1つまたは複数の支持ストラット104は、遠位セル102を近位セル106に接続している。いくつかの実施形態では、3つの支持ストラット104が、近位セル105および遠位セル102を相互接続しているとよい。しかし、ステント100は、この数よりも多いかまたは少ない数の支持ストラット104を備えていてもよい。支持ストラット104の具体的な数に関わらず、支持ストラット104は、長手方向において、近位セル106を遠位セル102から分離しており、これによって、近位セル106は、遠位セル102に対して近位側に位置することになる。
ステント1700は、ステントの拡張時に支持ポストの長さを短縮させることできる折畳み可能な特徴部1760を有する細長の支持ポスト1708を備えている。前述の実施形態と同様、細長の支持ポスト1708は、遠位端1708aと、近位端1708bと、中間部分1708cと、を有している。加えて、細長の支持ポスト1708は、小孔または開口1732を備えている。図14Bに示されているように、弁Vの弁尖取付けは、細長の支持ポスト1708の遠位端1708aの近くに配置される小孔1732しか必要としていないので、折畳み可能な特徴部1760を細長の支持ポストの中間部分1708cと近位端1708bとの間に配置されているとよい。しかし、折畳み可能な特徴部1760は、細長の支持ポスト1708の長さに沿ったどのような適切な位置に配置されていてもよい。その位置に関わらず、折畳み特徴部1760は、図14Aおよび図14Bに示されるように、ステントの拡張中、細長の支持ポスト1708を軸方向において短縮することができる。
支持ストラットの配置および形式は、支持ポストの柔軟性の程度を変化させることができる他の主要設計パラメータである。支持ストラットが支持ポストからより離れて接続されていると、背圧中の交連領域からの負荷が、ステントに接続された交連部およびストラットに急速に分布される代わりに、ステント本体に沿って徐々に分配されることが可能である。これは、弁尖への動的負荷を減少させるのみならず、ステントの歪も低減させることになる。最大の動的負荷は、支持ストラットが支持ポストに直接接続されている実施形態(図11A〜図11D参照)において、受けることになる。支持ストラット接続部が支持ストラットに隣接している実施形態(例えば、図3および図4)は、いくらか少ない動的負荷を受けてことになり、支持ストラット接続部が支持ポストからはなれて配置されている実施形態(図17Aおよび図17B)は、さらに少ない動的負荷を受けることになる。支持ストラット接続部が2つの互いに隣接する支持ポストの中間に位置している実施形態(例えば、図5Aおよび図5Bと、図18A、図18Bおよび図18C)は、最小の動的負荷を受けることになる。
支持ストラットの形態および接続部は、ステントの弁輪部分(すなわち、近位セル)、従って、弁機能に影響をもたらす可能性がある。例えば、弁輪区域は、もし支持ストラットが図18A、図18Bおよび図18Cに示されているように設計されて、セルに接続されているなら、心臓が拍動中に大動脈に対して捩れたときに、弁輪区域は、捩れ自由度とは実質的に独立して機能することができる。
ステントは、弁輪部分(すなわち、近位セル)および大動脈/洞−上行大動脈接合部部分(すなわち、遠位セル)の両方を有しているのみならず、代替的に大動脈根の周囲の種々の解剖学的構造/生理機能に適応するように独立して輪郭付けする支持ストラットを有していてもよい。これは、弁の支持ポスト領域への不要な負荷伝達を最小限に抑えながら、弁を係留することに役立つことになる。
(例えば、支持ポストに沿った多くの接続部によって)、ポストおよび/またはステントフレームの柔軟性が低下するにつれて、交連部におけるより大きい応力を分配させる必要がある。応力は、例えば、支持ポストにおける補強体によって、交連部に分配されるようになっているとよい。また、補強体は、弁尖がステントフレームに当たる可能性を低減させるようになっているとよい。
Claims (28)
- 近位端と、遠位端と、拡張状態および折畳み状態と、を有しているステントであって、
前記近位端における複数の近位セルと、
複数の支持ストラットであって、各支持ストラットが、前記近位セルの1つに接続された第1の端と、第2の端と、を有している、複数の支持ストラットと、
前記遠位端における複数の遠位セルであって、前記近位セルから長手方向に離間されている複数の遠位セルと、
多数の前記近位セルに接続された少なくとも1つの支持ポストであって、前記ステントが前記折畳み状態にあるときの第1の形態と前記ステントが前記拡張状態にあるときの第2の形態とを有している折畳み可能な部分を備え、且つ、前記折畳み可能な部分が前記第1の形態にあるときの第1の長さと、前記折畳み可能な部分が前記第2の形態にあるときの前記第1の長さよりも短い第2の長さと、を有している少なくとも1つの支持ポストと、
を備えているステントと、
前記少なくとも1つの支持ポストに接続された弁構造体と、
を備えていることを特徴とする人工心臓弁。 - 前記支持ストラットの各々は、前記第2の端に隣接する湾曲部分を有していることを特徴とする、請求項1に記載の人工心臓弁。
- 前記多数の近位セルは、前記支持ポストの一端および中間に隣接する箇所でのみ、前記少なくとも1つの支持ポストに接続されていることを特徴とする、請求項1に記載の人工心臓弁。
- 前記複数の支持ストラットの少なくとも1つは、前記少なくとも1つの支持ポストに隣接して位置する近位セルに接続されていることを特徴とする、請求項3に記載の人工心臓弁。
- 前記多数の近位セルは、前記支持ポストの一端に隣接する箇所でのみ、前記少なくとも1つの支持ポストに接続されていることを特徴とする、請求項1に記載の人工心臓弁。
- 前記多数の支持ストラットの少なくとも1つは、前記少なくとも1つの支持ポストに隣接して位置する近位セルに接続されていることを特徴とする、請求項5に記載の人工心臓弁。
- 前記多数の近位セルは、前記支持ポストの第1の端に隣接する箇所、第2の端に隣接する箇所、および中間においてのみ、前記少なくとも1つの支持ポストに接続されていることを特徴とする、請求項1に記載の人工心臓弁。
- 前記少なくとも1つの支持ポストは、前記ステントの他の部分に接続されていない一端を有していることを特徴とする、請求項1に記載の人工心臓弁。
- 前記ステントは、前記少なくとも1つの支持ポストの遠位側に配置されて2つの互いに隣接する近位セルを接合しているセル接続部を備えており、前記セル接続部は、前記少なくとも1つの支持ポストに接続されていないことを特徴とする、請求項1に記載の人工心臓弁。
- 前記ステントは、前記ステントの前記近位端において前記少なくとも1つの支持ポストの端から突出している連結特徴部をさらに備えていることを特徴とする、請求項9に記載の人工心臓弁。
- 前記複数の支持ストラットの各々は、第1の端と、第2の端と、前記第1の端と前記第2の端との間の中間部分と、を備えており、少なくとも1つの支持ストラットの前記中間部分は、湾曲した形態を有していることを特徴とする、請求項1に記載の人工心臓弁。
- 前記複数の支持ストラットの少なくとも1つは、前記少なくとも1つの支持ポストおよび近位セルに直接接続されていることを特徴とする、請求項1に記載の人工心臓弁。
- 前記複数の支持ストラットの各々は、1対の遠位端を有するように二股になっており、各遠位端は、遠位セルに接続されていることを特徴とする、請求項1に記載の人工心臓弁。
- 前記複数の支持ストラットの各々は、第1の端と、第2の端と、前記第1の端と前記第2の端との間の中間部分と、を備えており、少なくとも1つの支持ストラットの前記中間部分は、正弦波の形状を有していることを特徴とする、請求項1に記載の人工心臓弁。
- 前記少なくとも1つの支持ポストは、第1の幅を有しており、前記第1の幅よりも小さい幅を有する部分を有していることを特徴とする、請求項1に記載の人工心臓弁。
- 前記支持ストラットの各々は、前記少なくとも1つの支持ポストに隣接していない近位セルに接続されていることを特徴とする、請求項1に記載の人工心臓弁。
- 前記ステントは、少なくとも2つの支持ポストを備えており、前記支持ストラットは、各々、前記少なくとも2つの支持ポスト間の中間に位置する近位セルに接続されていることを特徴とする、請求項1に記載の人工心臓弁。
- 前記複数の支持ストラットの各々は、第1の端と、第2の端と、前記第1の端と前記第2の端との間の中間部分と、を備えており、少なくとも1つの支持ストラットの前記中間部分は、C字状形状を有していることを特徴とする、請求項1に記載の人工心臓弁。
- 前記複数の支持ストラットの各々は、第1の端と、第2の端と、前記第1の端と前記第2の端との間の中間部分と、を備えており、少なくとも1つの支持ストラットの前記中間部分は、実質的に矩形状の形態を共同で形成している1対の横断部材および1対の長手方向部材を備えていることを特徴とする、請求項1に記載の人工心臓弁。
- 前記複数の支持ストラットの各々は、第1の端と、第2の端と、前記第1の端と前記第2の端との間の中間部分と、を備えており、少なくとも1つの支持ストラットの前記中間部分は、入れ子式セルを備えていることを特徴とする、請求項1に記載の人工心臓弁。
- 前記複数の支持ストラットの各々は、第1の端と、第2の端と、前記第1の端と前記第2の端との間の中間部分と、を備えており、少なくとも1つの支持ストラットの前記中間部分は、入れ子式コイル状のセルを備えていることを特徴とする、請求項1に記載の人工心臓弁。
- 前記複数の支持ストラットの各々は、第1の端と、第2の端と、前記第1の端と前記第2の端との間の中間部分と、を備えており、少なくとも1つの支持ストラットの前記中間部分は、前記第1の端部分に対して横方向に位置ずれした正弦波の形状を有していることを特徴とする、請求項1に記載の人工心臓弁。
- 前記少なくとも1つの支持ポストに固定された補強体であって、前記弁の弁尖を前記ステントに固定するように適合されている、補強体をさらに備えていることを特徴とする、請求項1に記載の人工心臓弁。
- 前記補強体は、前記少なくとも1つの支持ポストに固定された第1の二次ポストと、前記少なくとも1つの支持ポストに固定された第2の二次ポストと、を備えており、前記第1の二次ポストおよび前記第2の二次ポストは、それらの間に前記弁尖を挟むように配置されていることを特徴とする、請求項23に記載の人工心臓弁。
- 前記第1の二次ポストは、前記第2の二次ポストに固定されていることを特徴とする、請求項24に記載の人工心臓弁。
- 前記第1の二次ポストは、複数の小孔を有していることを特徴とする、請求項24に記載の人工心臓弁。
- 近位端と、遠位端と、拡張状態および折畳み状態と、を有しているステントであって、
前記近位端における複数の近位セルと、
複数の支持ストラットであって、各支持ストラットが、前記近位セルの1つに接続された第1の端と、第2の端と、を有している、複数の支持ストラットと、
前記遠位端における複数の遠位セルであって、前記近位セルから長手方向に離間されている複数の遠位セルと、
2つの互いに隣接する遠位セルを相互接続するスペーサと、
多数の前記近位セルに接続された少なくとも1つの支持ポストと、
を備えているステントと、
前記少なくとも1つの支持ポストに接続された弁構造体と、
を備えていることを特徴とする、人工心臓弁。 - 近位端と、遠位端と、拡張状態および折畳み状態と、を有しているステントであって、
前記近位端における複数の近位セルと、
前記遠位端における複数の遠位セルであって、前記近位セルから長手方向に離間されている複数の遠位セルと、
多数の前記近位セルに接続された少なくとも1つの支持ポストと、
複数の支持ストラットであって、前記複数の支持ストラットの少なくとも1つは、前記少なくとも1つの支持ポストに直接接続されている第1の端と、前記遠位セルの1つに接続された第2の端と、を有している、複数の支持ストラットと、
を備えているステントと、
前記少なくとも1つの支持ポストに接続された弁構造体と、
を備えていることを特徴とする、人工心臓弁。
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JP2012519024A (ja) | 2012-08-23 |
US20120078347A1 (en) | 2012-03-29 |
US9387072B2 (en) | 2016-07-12 |
WO2010098857A1 (en) | 2010-09-02 |
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US9901447B2 (en) | 2018-02-27 |
EP2400924B1 (en) | 2017-06-28 |
EP2400924A1 (en) | 2012-01-04 |
JP2015071064A (ja) | 2015-04-16 |
JP6291526B2 (ja) | 2018-03-14 |
AU2010218384B2 (en) | 2014-11-20 |
BRPI1008902A2 (pt) | 2016-03-15 |
US10441417B2 (en) | 2019-10-15 |
AU2010218384A1 (en) | 2011-09-01 |
US20140296966A1 (en) | 2014-10-02 |
US20180133005A1 (en) | 2018-05-17 |
US20160354204A1 (en) | 2016-12-08 |
US8808366B2 (en) | 2014-08-19 |
US11045314B2 (en) | 2021-06-29 |
JP5964396B2 (ja) | 2016-08-03 |
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