JP2015071064A - 人工心臓弁 - Google Patents
人工心臓弁 Download PDFInfo
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Abstract
【解決手段】近位端706と、遠位端702と、拡張状態および折畳み状態と、を有しているステント700であって、前記近位端における一連の近位セルと、前記遠位端における一連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一連の遠位セルと、複数の支持ストラット704であって、各支持ストラットが、前記一連の近位セルに接続された第1の端と、前記一連の遠位セルに接続された第2の端とを有している、複数の支持ストラットと、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708であって、前記多数の近位セルは、前記支持ポストの長さに沿って離間した3つの位置において前記支持ポストに接続されている、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。
【選択図】図8B
Description
は、もし同様の設計が最適な柔軟性を有していたならどんな結果になるかを検証している。ポスト頂部の応力は、弁尖の腹部の応力よりも5倍大きいことを明らかにしている。従って、設計を最適化するために、弁尖の応力が弁尖腹部の応力と同等になるまで、ステントは、より柔軟にされている。応力を著しく軽減させるには、0.2−0.3mmの撓みが必要であるが、略1.1mmの撓みであっても、80%に至る応力を軽減させることが分かっている。さらに、1.1mmを超える撓みは、市販の材料および設計によって達成
することが困難であるのみならず、さらなる応力軽減をもたらさないことが明らかにされている。
過程中に生じるような)10%の拡張によって、鋭利な曲げ応力(例えば、「フッキング(hooking)」が40%まで軽減することを明らかにしている。これは、おそらく、患者
の大動脈根、換言すれば、心収縮中に外方に動く生体弁の交連部と調和して機能するステントによって、得られている。
された少なくとも1つの支持ポストと、少なくとも1つの支持ポストに固定された補強体と、を備えている。弁構造体が、少なくとも1つの支持ポストに接続されており、補強体が、弁の弁尖を固定するように構成されている。
患、および弁置換後の大動脈根の幾何学的形状」:バイオメカニクス学会誌、23巻、2
号、181−91ページ、1990年から引用したものである)。大動脈根は、心臓に付属している大動脈の一部である。大動脈は、体内の最大動脈であり、心臓の左心室から下向きに腹部に延びており、腹部において、2つの小さい動脈に分岐している。大動脈は、酸素含有血液を体の全ての部分に供給している。大動脈根は、大動脈弁を含んでおり、冠状動脈、すなわち、血液を心筋に供給する動脈をもたらしている。図1に示されているように、大動脈根10は、いくつかの特徴部、すなわち、左心室流出路(LVOT)1、弁輪2、洞3、洞−上行大動脈接合部(STJ)4、および上行大動脈5を有している。図1は、大動脈根10のいくつかの幾何学的パラメータ、すなわち、DO=開口直径;DA=洞3の遠位側直径;DB=最大突出洞径;LA=洞3の長さ;およびLB=DOとDBとの間の距離をさらに示している。
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。
ポスト108は、第1のセル列124、第2のセル列128、または両方のセル列に隣接して長手方向に延在しているとよい。同様に、支持ポスト108は、第1のセル列124、第2のセル列128、または両方のセル列内において、近位セルに接続されているとよい。
接続されている。各二股区域207dの枝部207e,207fは、収束点207mにおいて単一の支持部材207kに収束している。支持ストラット207の単一の支持部材207kは、支持ポスト208に隣接する単一の近位セル206の遠位端206aに接続されているとよい。
6の長手方向長さの少なくとも一部を横断している。各細長の支持ポスト308は、遠位端308aと、近位端308bと、中間部分308cと、を有している。加えて、各細長の支持ポスト308は、ステント300を弁尖に縫合するための複数の小孔または開口332を備えている。開口332は、異なる形状および大きさを有していてもよい。少なくとも1つの細長の支持ポスト308は、図4に示されているように、全ての近位セル306によって共同で画定されている第1の端338をいくらか超えて延在しているとよい。
08の長さに沿った3つの特定位置に、該支持ポスト508を隣接するセル502に接合するポスト接続部510を備えている。第1のポスト接続部510は、細長の支持ポスト508の近位端508bの近くの両側を第2の列528内に位置する隣接するセル502に接合している。第2のポスト接続部510は、各細長の支持ポスト508の中間部分508cの両側を第1の列524および第2の列528内の隣接するセル502に共通のセグメントに接合している。第3のポスト接続部510は、細長の支持ポスト508の遠位端508aの両側を第1の列524内に位置する隣接するセル502に接合している。これらの最後のポスト接続部510は、支持ポスト508の末端に配置されているとよい。
造を形成している。各第1の支持部材662は、セル接続部630を介して、近位セル606の遠位端ピーク部606aに接続されているとよい。各第2の支持部材664は、直線接続部631に接続されているとよい。図7Bに示されている実施形態では、接続部631は、近位セル606または細長の支持ポスト608に接続されていず、各セル構造部材660の第1の支持部材664にのみ連結されている。図7Bに示されているように、接続部631および支持部材664とストラット605との間の接続部分は、新しい弁を適所に係止するために、既存の外科的または折畳み可能な生体人工弁Vの上に装着されるようになっているとよい。細長の支持ポスト608に代わって、ステント600Aまたはステント600Bは、弁尖の交連部が取り付けられる領域において中断するようになっている連続的な近位セル606を備えていてもよい。
実施形態では、ステント700は、実質的に互いに平行に配向された第1の列724および第2の列726を備えているとよい。各近位セル706は、拡張状態において、1つのステント区域における2つの谷部706b,706c間の遠位端またはピーク部706aと、他のステント区域における2つの谷部706b,706c間の他のピーク706aと、ステント区域を互いに接続する1対のバー750と、によって画定された矢印形状を特徴として備えるようになっているとよい。
Bに示されている実施形態では、ステント800は、1つの列814のみしか有していない。
手方向列に配置されているとよい。いくつかの実施形態では、ステント800は、第1の列824および第2の列826内の近位セル806を備えている。セル接続部830が、同じ列内に位置する互いに隣接する近位セル806を相互接続している。各セル接続部830は、同じ列内に位置する2つの互いに隣接する近位セル805によって共有されているピーク部806aに配置されているとよい。また、第2の列824内のセルの近位端における谷部806bは、第1の列826内の隣接するセルの遠位端における谷部806bを形成しているとよい。
している。ステント1000Aおよびステント1000Bは、実質的に同様である。ステント1000A,1000Bは、互いに異なる位置における連結特徴部1080および互いに異なる種類の支持ポストを有している。
06aに位置するセル接続部1030が、同じ列内に位置する互いに隣接する近位セル1006を相互接続している。
部1080および各スペーサ1070から遠位側に突出している他の連結特徴部を備えている。図10Fを参照すると、ステント1000Eは、図10Eに示されているステント1000Dと実質的に同様であるが、ステント1000Aにおいてすでに示されているような遠位セルの付加的な列を備えている。従って、ステント1000Eは、適切なステント長さLEおよび上行大動脈内に係留されるための裾広がり形態を有していることになる。
08の遠位端1508aの両側に連結している。他のポスト接続部1510が、短縮された支持ポスト1508の近位端1508bの単一の中心点を2つの近位セル1506に接合している。短縮されたポスト1508の近位端1508bにおいて、ポスト接続部1510の近位側には、どのようなステント材料も存在していない。実際、ステント1500は、短縮された支持ポスト1508の近位端1508bの近位側に位置する近位セル1506間に画定された間隙1590を有している。従って、ステント1500は、剛性の低い片持ちのポスト1508を有することになり、ポスト1508の遠位端1508aおよびその近位端1508bの両方が近位セル1506に接続されていても、柔軟性を有することができる。
長孔1666と、長孔1666に摺動可能に係合するように構成されたフィンガー部1670を備えている。フィンガー部1670は、細長の支持ポスト1608の近位側に位置するクロス部材1672に固定して接続されている。長手方向長孔1666の両側の1対の凹状の刻み目1668を用いて、リング、縫合糸、クリップ、またはガイドとして用いられる他の構造体を固定することができる。ステント1600の拡張時に、フィンガー部1670は、長孔1666内に摺動することができ、これによって、細長の支持ポスト1608を短縮することができる。その結果、細長の支持ポスト1608にすぐ隣接するセル1602は、支持ポストから離れる方に拡張することができる。また、摺動機構1660は、人工弁におけるステント1600の使用中にポストの撓みを異ならせることができる。図13Bに示されているように、弁尖Vの取付けおよび輪郭によって、弁尖に悪影響をもたらさない領域において、細長の支持ポスト1609を運動させることができる。
に画定されている。図15Aおよび図15Bに示されているように、折畳み可能な部材1862,1864は、柔軟であり、これによって、拡張状態と折畳み状態との間で自在に動くことができる。中心開口1866は、折畳み可能な部材1862,1864が拡張状態と折畳み状態との間で動くのを促進するものである。折畳み可能な部材1862,1864によって、細長の支持ポスト1808は、ステント1800の拡張時に短縮することができる。手術時に、折畳み可能な特徴部1860は、ステント1800が小径に折り畳まれるときに軸方向において延び、ステント1800が大径に拡張されるときに軸方向において短縮することになる。
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。
近位セル2006に取り付けられた近位端2004bと、遠位端と近位端との間の中間部分2004cと、を有している。各支持ストラット2004の中間部分2004cは、図17Aに示されるように、蛇行形状または正弦波形状を有しているとよい。
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。
2104を備えているとよい。好ましくは、ステント2100は、細長の支持ポスト2108と同じ数の支持ストラット2104を有している。
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。
。しかし、これらの2つの実施形態の支持ストラット2304の遠位端2304aは、互いに異なる形状を有している。
(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。
テント2500の上面図である。二次ポスト2510は、ステント2500を作製するニチノールよりも耐疲労性の高いステンレス鋼のような材料から作製されているとよい。支持ポスト2508は、少なくとも2つの小孔または開口2532を有している。各二次ポスト2510は、交差パターンで実質的に互いに直交して配向された2つの小孔2512を有している。二次ポスト2510は、縫合糸Sを用いて支持ポスト2508に取り付けられているとよい。1本の縫合糸Sは、支持ポスト2508の1つの小孔2532および二次ポスト2510の対応する小孔2512を通っており、これによって、該二次ポストを支持ポストに取り付けている。他の縫合糸Sは、支持ポスト2508の他の小孔2532および他の二次ポスト2510の対応する小孔2512を通っており、これによって、該二次ポストを支持ポストに取り付けている。このようにして、両方の二次ポスト2510が、縫合糸Sによって、支持ポスト2508に取り付けられている。
うに適合された補強体または二次ポスト2810,2820を示している。ポスト2810,2820は、中空コアを有しており、滑らかな湾曲形状または円筒形状を特徴として有しているとよい。ポスト2810は、その長さに沿って小孔2812を有している。小孔2812は、卵状または楕円状の形状を有しているとよい。ポスト2828は、2種類の小孔2822,2824を有しているとよい。小孔2822は、交互に並んだ実質的に卵状または楕円状の貫通孔の形態にある。ポスト2820の遠位端2820aの近くに位置する部分小孔2824は、縫合糸を保持するために、実質的に円形の形状を有している。
たらすフラップ3002を備えている。例えば、付加的な縫合糸が、フラップ3002を支持ポストに取り付けるとよい。フラップ3002は、補強体3000を支持ポストに固定するノブから弁尖の運動を保護することにもなる。フラップ3002の縁と折畳み線FLに沿った傾斜側部3014との間の距離は、弁尖がステントに対して開くことを維持するのに十分な大きさであるべきである。補強体3000は、図33Aに示されているように、ステントSTに取り付けられているとよい。図33Bおよび図33Cに示されているように、ステントSTがどのように変形されるかに関わらず、弁尖がステントに対して摩耗する可能性が低くなる。
Claims (18)
- 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一連の近位セルと、
前記遠位端における一連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一連の遠位セルと、
複数の支持ストラットであって、各支持ストラットが、前記一連の近位セルに接続された第1の端と、前記一連の遠位セルに接続された第2の端とを有している、複数の支持ストラットと、
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、前記多数の近位セルは、前記支持ポストの長さに沿って離間した3つの位置において前記支持ポストに接続されている、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3つの離間した位置は、前記支持ポストの近位端と、前記支持ポストの遠位端と、前記支持ポストの前記近位端及び前記遠位端の中間にある位置とを含むことを特徴とする、請求項1に記載の人工心臓弁。
- 前記支持ポストは、第1の長手方向側部と、第2の長手方向側部とを備え、前記複数の近位セルは、前記第1の長手方向側部に沿った3つの離間した位置及び前記第2の長手方向側部に沿った3つの離間した位置において前記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。
- 前記第1の長手方向側部に沿った前記3つの離間した位置は、前記支持ポストの近位端と、前記支持ポストの遠位端と、前記支持ポストの前記近位端及び前記遠位端の中間にある位置とを含み、前記第2の長手方向側部に沿った前記3つの離間した位置は、前記支持ポストの前記近位端と、前記支持ポストの前記遠位端と、前記支持ポストの前記近位端及び前記遠位端の中間にある前記位置とを含むことを特徴とする、請求項3に記載の人工心臓弁。
- 近位端と遠位端との間で長手方向に延在し、拡張状態および折畳み状態を有しているステントであって、
前記近位端における一連の近位セルであって、前記一連の近位セルは、前記ステントの周囲に延在する第1の環状列のセルと、前記ステントの周囲に延在する第2の環状列のセルとを備え、前記第1の環状列の前記セルの各々は、前記ステントの前記拡張状態における長手方向に対して実質的に平行に配向されている少なくとも1つのバーを備えている、一連の近位セルと、
前記遠位端における一連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一連の遠位セルと、
複数の支持ストラットであって、各支持ストラットが、前記一連の近位セルに接続された第1の端と、前記一連の遠位セルに接続された第2の端とを有している、複数の支持ストラットと、
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。 - 前記第2の環状列の前記セルの各々は、前記ステントの前記遠位端の方を指す第1の端と前記ステントの前記近位端の方を指す第2の端とを備えたダイヤモンド形状を実質的に有するように、複数のストラットによって形成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。
- 前記一連の近位セルは、前記ステントの周囲に延在する第3の環状列のセルをさらに備え、前記第3の環状列の前記セルの各々は、前記長手方向に対して実質的に平行に配向されている少なくとも1つのバーを備えていることを特徴とする、請求項6に記載の人工心臓弁。
- 前記第1の環状列の前記セルの各々は、前記ステントの前記近位端の方を指す第1の接合点を形成するように互いに接合された第1及び第2のストラットと、前記ステントの前記近位端の方を指す第2の接合点を形成するように互いに接合された第3及び第4のストラットとを備えている複数のストラットによって形成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。
- 前記第2の環状列の前記セルの各々は、前記長手方向に対して実質的に平行に配向されている少なくとも1つのバーを備え、前記第1の環状列の前記バーは、前記第2の環状列の前記バーと長手方向において一直線上になっていることを特徴とする、請求項5に記載の人工心臓弁。
- 前記第1の環状列の前記セルの各々は、第1の一連の環状ピーク部と第2の一連の環状ピーク部とを形成するように互いに接合された複数のストラットを備え、前記第1の一連の環状ピーク部は、前記ステントの前記遠位端の方を指すピーク部と交互になっている前記ステントの前記近位端の方を指すピーク部を備え、前記第2の一連の環状ピーク部は、前記ステントの前記遠位端の方を指すピーク部と交互になっている前記ステントの前記近位端の方を指すピーク部を備え、前記第1の一連のピーク環状部は、前記長手方向に対して実質的に平行に配向されている複数のバーによって前記第2の一連の環状部に接続され、各バーは、遠位方向を指しているピーク部を相互接続していることを特徴とする、請求項5に記載の人工心臓弁。
- 近位端と遠位端との間で長手方向に延在し、拡張状態および折畳み状態を有しているステントであって、
前記近位端における一連の近位セルと、
前記遠位端における一連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一連の遠位セルと、
複数の支持ストラットであって、各支持ストラットが、第1の端及び第2の端を有し、前記近位セルの各々が、前記支持ストラットのうちの1つの支持ストラットの前記第1の端に接続され、前記遠位セルの各々が、前記支持ストラットのうちの1つの支持ストラットの前記第2の端に接続されている、複数の支持ストラットと、
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。 - 前記ステントは、近位セルの数よりも多い数の遠位セルを備えていることを特徴とする、請求項11に記載の人工心臓弁。
- 前記支持ストラットの一群が、前記一群の支持ストラットの中の前記支持ストラットの前記第1の端が前記近位セルの1つに接続されるように、且つ前記一群の支持ストラットの中の前記支持ストラットの前記第2の端が複数の遠位セルに接続するように、二股に分かれていることを特徴とする、請求項12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、
複数のセルと、
多数の前記セルに接続されている少なくとも1つの支持ポストと、
前記少なくとも1つの支持ポストに固定された補強体であって、前記少なくとも1つの支持ポストに固定された第1及び第2の二次ポストを備えている補強体と、
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、少なくとも1つの弁尖を備えた弁構造体であって、前記第1及び第2の二次ポストは、それらの間に前記少なくとも1つの弁尖を挟むように配置されている、弁構造体と、
を備えていることを特徴とする人工心臓弁。 - 前記第1の二次ポストは、中空コアを有していることを特徴とする、請求項14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14に記載の人工心臓弁。
- 前記第1の二次ポストは、第1の組の小孔および第2の組の小孔を備えており、前記第1の組の小孔は、前記第2の組の小孔と異なる形状を有していることを特徴とする、請求項14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、
複数のセルと、
多数の前記セルに接続されている少なくとも1つの支持ポストと、
前記少なくとも1つの支持ポストに固定された補強体であって、前記補強体は、柔軟材料から形成され、前記セルに取り付けられたカフを備えている、補強体と、
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、少なくとも1つの弁尖を備えた弁構造体であって、前記補強体が前記少なくとも1つ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、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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| JP2008537891A (ja) * | 2004-12-30 | 2008-10-02 | ベンター テクノロジーズ リミティド | 人工液流補綴装置 |
| US20060178740A1 (en) * | 2005-02-10 | 2006-08-10 | Sorin Biomedica Cardio S.R.L. | Cardiac-valve prosthesis |
| US20080154355A1 (en) * | 2006-12-22 | 2008-06-26 | Netanel Benichou | Implantable prosthetic valve assembly and method of making the same |
| WO2008150529A1 (en) * | 2007-06-04 | 2008-12-11 | St. Jude Medical, Inc. | Prosthetic heart valves |
Also Published As
| Publication number | Publication date |
|---|---|
| US11045314B2 (en) | 2021-06-29 |
| JP2012519024A (ja) | 2012-08-23 |
| JP6291526B2 (ja) | 2018-03-14 |
| BRPI1008902A2 (pt) | 2016-03-15 |
| AU2010218384A1 (en) | 2011-09-01 |
| US20190388224A1 (en) | 2019-12-26 |
| JP5659168B2 (ja) | 2015-01-28 |
| US20180133005A1 (en) | 2018-05-17 |
| AU2010218384B2 (en) | 2014-11-20 |
| CR20110451A (es) | 2011-09-21 |
| EP2400924A1 (en) | 2012-01-04 |
| US10441417B2 (en) | 2019-10-15 |
| US9901447B2 (en) | 2018-02-27 |
| EP2400924B1 (en) | 2017-06-28 |
| US9387072B2 (en) | 2016-07-12 |
| US20120078347A1 (en) | 2012-03-29 |
| JP5964396B2 (ja) | 2016-08-03 |
| US20160354204A1 (en) | 2016-12-08 |
| WO2010098857A1 (en) | 2010-09-02 |
| US8808366B2 (en) | 2014-08-19 |
| JP2016193221A (ja) | 2016-11-17 |
| US20140296966A1 (en) | 2014-10-02 |
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