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TWI875920B - 以具有含向內支架單元之瓣膜支撐件的支架框架改進人工心臟瓣膜裝置之取回的裝置、系統及方法 - Google Patents

以具有含向內支架單元之瓣膜支撐件的支架框架改進人工心臟瓣膜裝置之取回的裝置、系統及方法
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TWI875920B
TWI875920BTW110100731ATW110100731ATWI875920BTW I875920 BTWI875920 BTW I875920BTW 110100731 ATW110100731 ATW 110100731ATW 110100731 ATW110100731 ATW 110100731ATW I875920 BTWI875920 BTW I875920B
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valve
stent
valve support
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heart valve
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強納森 伯恩特
蘇恩塔拉 胡恩布瓦
莎拉凡娜 庫馬爾
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美商4C醫療技術公司
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一種可塌縮且可擴展人工二尖瓣膜支架具備至一遞送鞘之一遠端管腔中之經改進取回。各種實施例包括位於一支架框架之內部內且界定穿過其之一流動通道之一瓣膜支撐件,其中該瓣膜支撐件之頂部或上游包括至少部分地在該流動通道上方徑向向內彎曲之一列或複數個支架單元。某些實施例可包括諸如一打開槳狀物之一取回輔助機構,該取回輔助機構附接至該等向內彎曲支架單元中之一或多者且經調適以接納及/或嚙合一線以幫助在一患者之心腔中定位、擴展、取回及/或植入該裝置。

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以具有含向內支架單元之瓣膜支撐件的支架框架改進人工心臟瓣膜裝置之取回的裝置、系統及方法[關於聯邦政府贊助之研究或開發之聲明]
不適用
本發明係關於用於改進一可塌縮且可擴展人工心臟瓣膜裝置之塌縮及/或取回效率之裝置、系統及特徵。
人類心臟包括輔助血液向前(順行)流動穿過心臟之四個腔及四個心臟瓣膜。該等腔包含:左心房、左心室、右心房及右心室。四個心臟瓣膜包含:二尖瓣膜、三尖瓣膜、主動脈瓣膜及肺動脈瓣膜。大體上參見圖1。
二尖瓣膜位於左心房與左心室之間,且藉由充當一單向瓣膜以防止回流至左心房中而幫助控制自左心房至左心室之血流。類似地,三尖瓣膜位於右心房與右心室之間,而主動脈瓣膜及肺動脈瓣膜係半月瓣膜,位於使血液遠離心臟流動之動脈中。該等瓣膜皆係單向瓣膜,其中小葉(leaflet)打開以允許向前(順行)血流。功能正常的瓣膜小葉在反向血液施加之壓力下關閉,以防止血液回流(逆行)至其剛剛流出之腔中。舉例而言,當正常工作時,二尖瓣膜在左心房與左心室之間提供一單向分瓣,打開以允許自左心房至左心室之順行流動,且關閉以防止自左心室至左心房中之逆行流動。當存在時,此逆行流動稱為二尖瓣回流或二尖瓣膜回流。如所展示,正常血流自左心房前進穿過二尖瓣膜到達左心室,從而撞擊在左心室之後外側(而不是隔側)上。此自然流動利用左心室解剖結構,使得該流在左心室內進一步向下引導,且接著朝向主動脈瓣膜及左心室流出道(LVOT)以及相關聯主動脈根向上引導,且最終進入升主動脈中,如所展示。一般而言,正常患者中之此流係層流的且因此係一高效機制。
圖2圖解說明左心房、環狀體、腱索及左心室相對於二尖瓣膜小葉之關係。如所展示,環狀體之上部表面形成室底之至少一部分或左心房腔之下部表面,使得出於本文中之說明之目的,將環狀體之上部表面界定為標誌著左心房腔之下部邊界。
原生心臟瓣膜可由於多種原因及/或狀況(包含但不限於疾病、創傷、先天畸形及老化)而係或變得功能障礙。此等類型之狀況可導致瓣膜結構無法正常關閉,從而在一個二尖瓣膜衰竭之情形中導致血液自左心室至左心房之回流性逆行流動。圖3圖解說明在具有一例示性功能障礙二尖瓣膜之情形下之回流性血流。
二尖瓣膜回流係由允許至少某些逆行血流自右心房返回至左心房中之一功能障礙二尖瓣膜引起之一特定問題。在某些情形中,功能障礙由二尖瓣膜小葉脫垂至左心房腔中,亦即,環狀體之上部表面上面,而非連接或接合以阻止逆行流動引起。此血液回流以一容積負荷給左心室增加一負擔,此可導致一系列左心室補償性調適及調整,包含重塑心室腔大小及形狀,該心室腔大小及形狀在二尖瓣回流之延長臨床過程期間變化顯著。
一般而言,回流可為原生心臟瓣膜(包含三尖瓣膜、主動脈瓣膜及肺動脈瓣膜以及二尖瓣膜)之一問題。
因此,一般而言,例如二尖瓣膜之原生心臟瓣膜可需要功能性修復及/或輔助,包含一部分或完全替換。此介入可採取數種形式,包含心臟直視手術及對一替換心臟瓣膜之心臟直視植入。參見(例如)美國專利第4,106,129號(Carpentier)以找到高度侵入性、充滿患者風險並且不僅需要一長期住院治療且亦需要一極其痛苦恢復週期之一程序。
用於替換一功能障礙心臟瓣膜之侵入性較小之方法及裝置亦係已知的且涉及替換瓣膜之經皮進入及導管協助遞送。大多數此等解決方案涉及附接至一結構支撐件(諸如此項技術中公知之一支架)或經設計以在自一遞送導管釋放之後旋即擴展之其他形式之線網狀物之一替換心臟瓣膜。參見(例如)美國專利第3,657,744號(Ersek);美國專利第5,411,552號(Andersen)。支撐支架之自擴展變體輔助定位瓣膜,並將經擴展裝置在受試者心腔或血管內固持就位。當(在常見情況下)裝置在第一次定位嘗試中並未正確定位且因此必須被取回並調整位置時,此自擴展形式亦存在問題。在一完全或甚至部分擴展裝置之情形中,此取回程序需要:將裝置重新塌縮至允許操作者將經塌縮裝置縮回至一遞送鞘或導管中之一點,調整裝置之進入位置,且接著藉由將經位置調整之裝置自遞送鞘或導管向遠端重新部署來重新擴展至適當位置。塌縮已擴展之裝置係困難的,此乃因經擴展支架或線網狀物通常經設計以達成經擴展狀態,該經擴展狀態亦抵抗收縮或塌縮力。
除了上文所論述之心臟直視手術方法之外,進入所關注瓣膜亦經由至少以下已知進入路徑中之一者而經皮達成:經心尖、經股動脈、經心房及經中隔遞送技術。
一般而言,本技術聚焦於使用上文所闡述之已知進入路徑中之一者允許經塌縮瓣膜裝置之一部分遞送之系統及方法,其中裝置之一端自一遞送鞘或導管釋放,並擴展以進行一初始定位,後續接著在達成適當定位時完全釋放並擴展。例如,參見美國專利第8,852,271號(Murray,III)、第8,747,459號(Nguyen)、第8,814,931號(Wang)、第9,402,720號(Richter)、第8,986,372號(Murray,III)及第9,277,991號(Salahieh),以及美國專利公開案第2015/0272731號(Racchini)及第2016/0235531號(Ciobanu)。
此外,所有已知人工心臟瓣膜意欲完全替換原生心臟瓣膜。因此,在二尖瓣膜之情形中,此等替換心臟瓣膜及/或錨定或系結結構實體地延伸出左心房腔,且嚙合內部環狀體及/或瓣膜小葉,在諸多情形中,將原生小葉釘在內部環狀體之壁上,藉此永久地消除原生瓣膜之所有剩餘功能性並使得患者完全依賴於替換瓣膜。在其他情形中,錨定結構延伸至左心室中且可錨定至左心室壁組織及/或左心室頂部處之亞環形表面中。其他可包括存在於一肺動脈中或與一肺動脈嚙合。
顯然,將存在如下情形:原生瓣膜在介入性植入程序之前實際上已喪失全部功能性。在此情形中,較佳解決方案將包括不延伸出(例如)左心房之外且起作用以完全替換原生瓣膜功能之一植入物。然而,在諸多其他情形中,原生瓣膜在一定程度上保持功能,且可或可不在植入程序之後繼續喪失功能性。在此情形中,一較佳解決方案包括遞送及植入一瓣膜裝置,該瓣膜裝置將既用作一補充或增強瓣膜而不損壞原生小葉以便只要存在便保持原生瓣膜小葉功能性,同時亦能夠完全替換一瓣膜之原生功能,在人工瓣膜植入後,該瓣膜緩慢喪失其大部分或全部功能性。
最後,已知人工心瓣膜由兩個或三個小葉組成,該兩個或三個小葉經配置以充當一單向瓣膜,從而准許流體在順行方向上流動穿過其,同時防止逆行流動。原生二尖瓣膜位於胸骨後第四肋軟骨處,由一前小葉及後小葉、腱索、乳頭狀肌、心室壁及連接至心房之環狀體組成。每一原生小葉由附接至乳頭狀肌之腱索支撐,腱索隨著每一心室收縮而變得繃緊,從而保持瓣膜能力。原生瓣膜之前小葉及後小葉兩者經由初級、次級及第三級腱附接至前外側及後內側乳頭狀肌兩者。在心肌損傷之情況下,任一乳頭狀肌之一破壞可導致二尖瓣膜之前小葉或後小葉之功能障礙。其他機制可導致原生二尖瓣小葉中之一者或兩者之衰竭。在一單個二尖瓣膜小葉衰竭之情形中,回流可採取返回至左心房中之一非中心偏心血液噴射之形式。其他小葉衰竭可包括一更集中式回流噴射。已知人工瓣膜替換物通常包括經配置以模仿原生瓣膜結構之小葉,該等小葉可隨時間容易出現類似回流結果。
已知可植入人工瓣膜可藉由採用可幫助將裝置取回至一遞送鞘之管腔中之結構來改進。
除非另有指示,否則本文中闡述之某些發明性實施例可容易地應用於單腔或兩腔解決方案。而且,本文中論述之某些實施例可一般而言以改進的原生小葉接合及/或脫垂來應用於保持及/或替換原生瓣膜功能性,且因此不限於二尖瓣膜並且可擴展為包含用於治療三尖瓣膜、主動脈瓣膜及/或肺動脈瓣膜之裝置及方法。
本文中所揭示之數個發明之各種實施例尤其解決此等問題。
一種可塌縮且可擴展人工二尖瓣膜支架具備至一遞送鞘之一遠端管腔中之經改進取回。各種實施例包括位於一支架框架之內部內且界定穿過其之一流動通道之一瓣膜支撐件,其中該瓣膜支撐件之頂部或上游包括至少部分地在該流動通道上方徑向向內彎曲之一列或複數個支架單元。某些實施例可包括諸如一打開槳狀物之一取回輔助機構,該取回輔助機構附接至該等向內彎曲支架單元中之一或多者且經調適以接納及/或嚙合一線以幫助在一患者之心腔中定位、擴展、取回及/或植入該裝置。
100:可擴展且可塌縮人工心臟瓣膜支架/人工瓣膜支架裝置
101:最頂部(或上游)支架單元/最頂部(上游)支架單元
102:外部區段/外部框架元件
104:內部瓣膜支撐件區段/內部瓣膜支撐件/瓣膜支撐件/瓣膜支撐件區段
106:人工瓣膜小葉/人工小葉
108:過渡區段
200:人工心臟瓣膜裝置/經修改且經改進心臟瓣膜裝置/經修改且經改進人工心臟瓣膜裝置/可塌縮且可擴展支架裝置/部分經擴展人工心臟瓣膜裝置/裝置/支架裝置/經植入支架裝置/可塌縮且可擴展支架裝置/至少部分經擴展裝置/人工瓣膜支架裝置
201:向內彎曲支架單元
202:支柱
204:連接器
210:取回輔助機構/槳狀物/狹槽/機構/遞送輔助機構
220:孔/狹槽
I:流入端
O:流出端
S:裙部
W:推線/拉線
圖1以剖面圖解說明心臟之某些特徵。
圖2圖解說明心臟之左側之一剖面透視圖。
圖3圖解說明心臟之一剖面圖,其展示與正常血流相比由二尖瓣膜回流引起之逆行血流。
圖4圖解說明一人工心臟瓣膜裝置之一透視圖。
圖5圖解說明一人工心臟瓣膜裝置之側視及部分剖視圖。
圖6圖解說明本發明之一人工心臟瓣膜裝置之一項實施例之一透視圖。
圖7圖解說明本發明之一人工心臟瓣膜裝置之一項實施例之一剖視圖。
圖8圖解說明本發明之一人工心臟瓣膜裝置之一項實施例之一透視圖。
圖9A圖解說明本發明之一人工心臟瓣膜裝置之一項實施例之一剖視圖。
圖9B圖解說明本發明之一人工心臟瓣膜裝置之一項實施例。
圖10圖解說明本發明之一人工心臟瓣膜裝置之一項實施例之一剖視圖。
圖11圖解說明本發明之一人工心臟瓣膜裝置之一項實施例之一剖視圖。
圖12圖解說明本發明之一人工心臟瓣膜裝置之一側視及部分剖視圖。
圖13圖解說明本發明之一人工心臟瓣膜裝置之一項實施例之一剖視圖。
相關申請案交叉參考
本申請案主張以下申請案之權益:2020年12月4日提出申請且標題為「DEVICES,SYSTEMS AND METHODS FOR IMPROVING RECAPTURE OF PROSTHETIC HEART VALVE DEVICE WITH STENT FRAME HAVING VALVE SUPPORT WITH INWARDLY STENT CELLS」之美國專利申請案第17/111736號,及2020年3月6日提出申請且標題為「DEVICES,SYSTEMS AND METHODS FOR IMPROVING RECAPTURE OF PROSTHETIC HEART VALVE DEVICE WITH STENT FRAME HAVING VALVE SUPPORT WITH INWARDLY STENT CELLS」之美國臨時申請案第62/986,151號、2020年3月10日提出申請且標題為「DEVICES,SYSTEMS AND METHODS FOR IMPROVING RECAPTURE OF PROSTHETIC HEART VALVE DEVICE WITH STENT FRAME HAVING VALVE SUPPORT WITH ELONGATED SECTION」之美國臨時申請案第62/987413號、2020年3月12日提出申請且標題為「DEVICES,SYSTEMS AND METHODS FOR IMPROVING RECAPTURE OF PROSTHETIC HEART VALVE DEVICE WITH STENT FRAME HAVING VALVE SUPPORT WITH INWARDLY BENT STRUTS」之美國臨時申請案第62/988421號,以及2020年3月13日提出申請且標題為「DEVICES,SYSTEMS AND METHODS FOR IMPROVING RECAPTURE OF PROSTHETIC HEART VALVE DEVICE WITH STENT FRAME HAVING VALVE SUPPORT WITH ATTACHMENT TO THE OUTER STENT」之美國臨時申請案第62/989209號,該等申請案之全文特此以引用方式併入。
一般而言,本發明之各種實施例係關於用於在擴展及植入程序期間取回至一遞送鞘之一遠端管腔中之裝置及方法。各種實施例包括位於一支架框架之內部內且界定穿過其之一流動通道之一瓣膜支撐件,其中該瓣膜支撐件之頂部或上游包括至少部分地在該流動通道上方徑向向內彎曲之一列支架單元。某些實施例可包括諸如一打開槳狀物之一取回輔助機構,該取回輔助機構附接至該等向內彎曲支架單元中之一或多者且經調適以接納及/或嚙合一線以幫助在一患者之心腔中定位、擴展、取回及/或植入該裝置。
現在轉至圖4及圖5,圖解說明一可擴展且可塌縮人工心臟瓣膜支架100之一例示性實施例,該可擴展且可塌縮人工心臟瓣膜支架可包括:一外部區段102,其在未變形且完全擴展時可通常看起來像一球;及一內部瓣膜支撐件區段104,其經調適以將人工瓣膜小葉106支撐且保持在內部瓣膜支撐件區段104內、最佳地在位於原生環狀體上面之一點處,且如所展示與原生小葉間隔開或在原生小葉上面,但人工小葉106之其他附接點在本發明之範疇內。內部瓣膜支撐件104可為圓柱形的,但在一較佳實施例中亦可為至少部分錐形的,其中在一流出端O處之一直徑比跨越一流入端I之至少部分之直徑大,其中流入端I徑向安置在外部框架區段內部,且其中流出端可界定瓣膜支撐件104之一下部端或邊緣。因此,在一純粹錐形配置中,瓣膜支撐件區段104可包括跨越其之一平滑減小之直徑,且此平滑直徑減小可自流出端O延伸至流入端I。在其他實施例中,流入端I可包括徑向向外延伸且中斷平滑錐形輪廓之一或多個凸角。就此而言,一較佳實施例為附接在內部瓣膜支撐件104內之每一人工小葉106提供一個凸角,以允許更充分移動自由度及經改進接合。
一較佳構造包括:當植入人工瓣膜支架裝置100時,人工小葉106安置或間隔在原生小葉上面,其中人工小葉106經附接且遠離原生小葉(在原生小葉上面)充分間隔開,以便不實體地干擾原生小葉及所得血流或不與其相互作用。
自支架之外部區段過渡至內部區段之支架單元之層稱為過渡單元,該等過渡單元形成大體上如圖4及圖5中所圖解說明之一過渡區段108。
支架之外部及內部區段可由一個連續結構構造而成,或可組合兩個或更多個結構以達成既定設計目標。如此項技術中已知,可使用形狀互補之心軸來將支架結構(包含支架之外部區段102、過渡區段108及內部瓣膜支撐件104-在某些實施例中,包含上文所論述之凸角L)形成為一單個整體式結構。
在某些實施例中,外部支撐結構可大體上經定位使得其與組織嚙合且起作用以防止瓣膜旁滲漏(PVL)。舉例而言,脫垂預防結構之外部支撐結構可與上文所闡述之過渡區段嚙合或整合在一起以提供抵抗PVL之一屏障。
進一步就此而言,圖中所展示之裝置之一較佳實施例包括一裙部S,該裙部S包括織物或組織,沿著外部框架元件102之外部表面之一部分安置,且沿著過渡區段108之外部表面並沿著內部瓣膜支撐件104之內部表面或面向內表面延伸,使得裙部S面向在該內部瓣膜支撐件中界定的自流入端I至流出端O之流動通道。
圖4之實施例及圖5之某些實施例包括位於瓣膜支撐件104中通常在上游方向上引導之一組最頂部(或上游)支架單元101。換言之,瓣膜支撐件104之一組最頂部支架單元界定瓣膜支撐件104之頂部。
現在轉至圖6,一經修改且經改進人工心臟瓣膜裝置200具備與上文結合圖4及圖5所闡述相同之元件,惟瓣膜支撐件104之最頂部(上游)支架單元101現在在201處且在瓣膜支撐件104之流入端及穿過該瓣膜支撐件之經界定血流通道上方徑向向內彎曲除外。
圖7圖解說明一取回輔助機構,例如,安置於向內彎曲支架單元201中之一或多者上或由該一或多者界定的在210處之一槳狀物或狹槽。展示一單個取回輔助機構210,但亦可提供多於一個取回輔助機構。取回輔助機構210可用於接納一線(例如,如此項技術中眾所周知之一推線及/或拉線W),該線可成環或以其他方式嚙合取回輔助機構210以在遞送及擴展期間、在取回/重新入鞘期間幫助進行定向定位,或在取回/重新入鞘之後幫助進行定向定位及經擴展植入。
另一選擇係,如圖8及圖9A至圖9B中所展示,一經修改且經改進心臟瓣膜裝置200具備與上文結合圖4至圖6所闡述相同之元件,惟瓣膜支撐件104之最頂部(上游)支架單元101現在包括徑向向內且在瓣膜支撐件104之流入端及穿過該瓣膜支撐件之經界定血流通道上方彎曲之單個支柱202除外。
圖9B進一步圖解說明取回輔助機構,例如,如上文所闡述安置於單個支柱202中之一或多者之端(上游及自由)部分上之一槳狀物或狹槽210。展示一單個取回輔助機構210,但可提供多於一個取回輔助機構。取回輔助機構210可用於接納一線,該線可圍繞或穿過取回輔助機構210成環或者以其他方式嚙合取回輔助機構210以在遞送及擴展期間、在取回及/或重新入鞘期間幫助進行定向定位,或在取回及/或重新入鞘之後幫助進行定向定位及經擴展植入。
現在轉至圖10,一經修改且經改進人工心臟瓣膜裝置200具備與上文結合圖4及圖5所闡述相同之元件,惟瓣膜支撐件104現在包括安置在瓣膜支撐基座之上游之一伸長瓣膜支撐件區段除外。
伸長瓣膜支撐件區段可藉由一支架帽蓋連接器(諸如一線或支柱或者其他等效連接機構或結構)連接至支架帽蓋。支架帽蓋包括一孔或狹槽,該孔或狹槽用於嚙合諸如一推線及/或拉線之一遞送線以幫助遞送及取回及/或重新定位可塌縮且可擴展支架裝置200。
除了如圖10中所展示之伸長瓣膜支撐件與支架帽蓋之間的一選用連接之外,圖11亦圖解說明如本文中所闡述之在210處之選用取回輔助及/或遞送輔助機構,該選用取回輔助及/或遞送輔助機構可為一環狀物或一打開槳狀物且經調適以接納及/或嚙合延伸穿過遞送導管之管腔之一線以幫助操縱伸長瓣膜支撐件區段。機構210可附接或形成於沿著伸長瓣膜支撐件區段之長度(或在最頂部或上游端處)之任何點處。
裙部S(圖10或圖11中未展示)可覆蓋瓣膜支撐件104之內部部分(藉此形成在其中界定之血流通道之至少一部分)。在某些實施例中,瓣膜支撐件104之伸長區段可包括位於內部區段上之裙部S或可不包括裙部S。
在某些實施例中,伸長瓣膜支撐件區段與瓣膜支撐件基座進行流體連通,且可容許血液進入瓣膜支撐件中。在此情形中,經界定血流通道可包括與瓣膜支撐件基座結合之伸長瓣膜支撐件區段之至少一部分。
圖11圖解說明將部分經擴展人工心臟瓣膜裝置200自一遞送導管之一管腔遞送出並遞送至一受試者心腔(例如,左心房)中。如所展示,一經中隔遞送技術可包括:擴展且完全部署裝置200之外部區段102,同時伸長瓣膜支撐件區段之至少一部分以及外部區段102之上部部分(包含支架帽蓋)可保持在遞送導管之管腔內。所展示實施例並未提供支架帽蓋與伸長瓣膜支撐件區段之間的一連接,但確實提供了與支架帽蓋及位於近端之操作者之一線連接,以及取回及/或遞送輔助機構210連接或嚙合的線,該線亦延伸穿過遞送導管之管腔到達一位於近端之操作者。
因此,若需要進行取回或重新入鞘,則可高效地取回整個裝置200,此乃因伸長瓣膜支撐件區段並不與遞送導管嚙合。
現在轉至圖12,圖解說明一可擴展且可塌縮人工心臟瓣膜支架100之一例示性實施例,該可擴展且可塌縮人工心臟瓣膜支架可包括:一外部區段102,其在未變形且完全擴展時可通常看起來像一球;及一內部瓣膜支撐件區段104,其經調適以將人工瓣膜小葉106支撐且保持在內部瓣膜支撐件區段104內、最佳地在位於原生環狀體上面之一點處,且如所展示與原生小葉間隔開或在原生小葉上面,但人工小葉106之其他附接點在本發明之範疇內。內部瓣膜支撐件104可為圓柱形的,但在一較佳實施例中亦可為至少部分錐形的,其中在一流出端O處之一直徑比跨越一流入端I之至少部分之直徑大,其中流入端I徑向安置在外部框架區段內部,且其中流出端可界定瓣膜支撐件104之一下部端或邊緣。因此,在一純粹錐形配置中,瓣膜支撐件區段104可包括跨越其之一平滑減小之直徑,且此平滑直徑減小可自流出端O延伸至流入端I。在其他實施例中,流入端I可包括徑向向外延伸且中斷平滑錐形輪廓之一或多個凸角。就此而言,一較佳實施例為附接在內部瓣膜支撐件104內之每一人工小葉106提供一個凸角,以允許更充分移動自由度及經改進接合。
一較佳構造包括:當植入人工瓣膜支架裝置100時,人工小葉106安置或間隔在原生小葉上方,其中人工小葉106經附接且遠離原生小葉(在原生小葉上面)充分間隔開,以便不實體地干擾原生小葉及所得血流或不與其相互作用。
自支架之外部區段過渡至內部區段之支架單元之層稱為過渡單元,該等過渡單元形成大體上如圖12中所圖解說明之一過渡區段108。
支架之外部及內部區段可由一個連續結構構造而成,或可組合兩個或更多個結構以達成既定設計目標。如此項技術中已知,可使用形狀互補之心軸來將支架結構(包含支架之外部區段102、過渡區段108及內部瓣膜支撐件104一在某些實施例中,包含上文所論述之凸角L)形成為一單個整體式結構。
在某些實施例中,外部支撐結構可大體上經定位使得其與組織嚙合且起作用以防止瓣膜旁滲漏(PVL)。舉例而言,脫垂預防結構之外部支撐結構可與上文所闡述之過渡區段嚙合或整合在一起以提供抵抗PVL之一屏障。
進一步就此而言,圖中所展示之裝置之一較佳實施例包括一裙部S,該裙部S包括織物或組織,沿著外部框架元件102之外部表面之一部分安置,且沿著過渡區段108之外部表面並沿著內部瓣膜支撐件104之內部表面或面向內表面延伸,使得裙部S面向在該內部瓣膜支撐件中界定的自流入端I至流出端O之流動通道。
圖4之實施例及圖5之某些實施例包括位於瓣膜支撐件104中通常在上游方向上引導之一組最頂部(或上游)支架單元101。換言之,瓣膜支撐件104之一組最頂部支架單元界定瓣膜支撐件104之頂部。
現在轉至圖13,一經修改且經改進人工心臟瓣膜裝置200具備與上文結合圖12所闡述相同之元件,惟瓣膜支撐件104現在包括延伸於支架裝置200之瓣膜支撐件104與外部區段102之間的至少一個且較佳地兩個連接器204(但可使用更多個連接器)除外。如所展示,在一第一端處,連接器204在瓣膜支撐件104之最頂部或上游端處連接至該瓣膜支撐件,且在一第二端處,該等連接器連接至裝置200之外部區段102。連接器204可為熱固型的或可使用一形狀記憶或如熟習此項技術者將瞭解之其他材料。當經連接且裝置200完全擴展時,連接器204可通常係筆直的,或該等連接器可稍微彎曲以在支架200上提供額外向外擴展力,該額外向外擴展力可幫助確保經植入支架裝置200抵靠腔壁保持就位。如所展示,連接器204安置在由外部區段102界定之內部內。
連接器204之第一端及第二端可機械地或以其他方式附接至裝置200之瓣膜支撐件104及/或外部區段102,或由該瓣膜支撐件及/或該外部區段形成。熟習此項技術者眾所周知之例示性連接方法包含但未必限於縫合、焊接、鉚接。
圖12及圖13中所展示之支架帽蓋包括一孔或狹槽220,該孔或狹槽用於嚙合諸如一推線及/或拉線之一遞送線以幫助遞送及取回及/或重新定位可塌縮且可擴展支架裝置200。
本文中闡述之各種結構修改允許瓣膜支撐件104在裝置200裝載至一遞送導管之管腔中期間以及在必要時至少部分地取回一至少部分經擴展裝置200期間更高效地向內塌縮,以便重新定位及/或重新擴展及/或重新植入裝置200。
儘管此結構可在一經中隔遞送技術及進入(例如)左心房及二尖瓣膜中係最有利的,但其他遞送進入路徑、技術及心臟瓣膜亦可適合於裝置200之經改進結構及相關優點。
值得注意的係,目前所闡述之人工瓣膜支架裝置200之各種實施例可經由至少以下已知進入及遞送路徑中之一者而經皮遞送:股動脈進入、靜脈進入、經心尖、經主動脈、經中隔及經心房、自主動脈逆行遞送技術。另一選擇係,可使用手術及/或心臟直視技術來遞送及植入人工瓣膜支架裝置200。
本文中所闡述之發明性概念之各種實施例包括:
1.一種人工心臟瓣膜裝置,其經調適以用於擴展及植入至一患者之一心腔中來補充及/或替換原生瓣膜小葉功能性,該裝置包括:一可塌縮且可擴展支架,其具有一外部區段,該外部區段包括一外部表面、一內部表面且界定一內部;一瓣膜支撐件,其操作上連接至該可塌縮且可擴展支架,其中該瓣膜支撐件徑向向上延伸至該外部區段之該內部中且包括一流入端及一流出端,該流入端徑向向上延伸至該外部區段中,其中一血流通道界定於該流入端與該流出端之間,且其中該瓣膜支撐件在該外部區段之該內部內完全倒置,複數個人工瓣膜小葉,其安置在由該瓣膜支撐件區段界定之該血流通道內,其中人工瓣膜小葉經結構設計以允許自該流動通道之該流入端至該流出端之流動且阻止自該流動通道之該流出端至該流動通道之該流入端之流動,其中該瓣膜支撐件包括由複數個單個支柱界定之一頂部區段,該複數個單個支柱在該血流通道上方徑向向內彎曲。
2.如實施例1之裝置,其中該瓣膜支撐件由該可塌縮且可擴展支架界定及形成。
3.如實施例1及2之裝置,其進一步包括使該可塌縮且可擴展支架之該外部區段徑向向內轉動之過渡單元,該等過渡單元安置於該可塌縮且可擴展支架之該外部區段與該瓣膜支撐件之間。
4.如實施例1至3之裝置,其中該瓣膜支撐件與該瓣膜支撐件之外部區段構成一單個整體式支架。
5.如實施例1至4之裝置,其中該複數個單個支柱中之至少一者包括一取回輔助機構。
6.如實施例5之裝置,其中該取回輔助機構包括經調適以用於接納穿過其之一線之一打開槳狀物。
7.一種用於將如實施例1至6之可塌縮且可擴展人工心臟瓣膜裝置遞送、取回及/或定位至一患者之一心腔中之方法,其包括:提供一遞送導管,該遞送導管具有穿過其之一管腔;將該遞送導管放置在該患者內,使得該遞送導管之一遠端在該心腔內,且該遞送導管之一近端在該患者之身體之外;將該人工心臟瓣膜裝置塌縮並裝載至該遞送導管之該管腔之一近端中並向遠端平移該人工心臟瓣膜裝置;將該人工心臟瓣膜裝置自該遞送導管之該管腔之該遠端至少部分地遞送至該心腔中;在該心腔內至少部分地擴展該人工心臟瓣膜裝置;及當經正確定位時,將該人工心臟瓣膜裝置植入於該腔內。
8.如實施例7之方法,其進一步包括:提供至少一個推線及/或拉線,該至少一個推線及/或拉線包括與取回輔助機構中之至少一者操作地嚙合之一遠端。
9.如實施例8之方法,其進一步包括:在該人工心臟瓣膜裝置之擴展、定位、取回及/或植入期間,操縱該(等)推線及/或拉線以修改至少該瓣膜支撐件之位置。
10.如實施例7至9之方法,其中該心腔包括左心房。
11.如實施例10之方法,其中該人工心臟瓣膜裝置經植入且經調適以補充原生二尖瓣膜小葉功能性。
12.如實施例10及11之方法,其中該人工心臟瓣膜裝置經植入且經調適以補充且最終完全替換該原生二尖瓣膜小葉功能性。
13.如實施例7至10之方法,其中使用經中隔遞送進入路徑將該遞送導管放置在該患者內。
14.如實施例7至10之方法,其中使用由以下各項組成之群組中之進入路徑中之一者將該遞送導管放置在該患者內:經心尖、經股動脈、經心房。
本文中所闡述之各種發明性概念之額外實施例進一步包括:
1.一種人工心臟瓣膜裝置,其經調適以用於擴展及植入至一患者之一心腔中來補充及/或替換原生瓣膜小葉功能性,該裝置包括:一可塌縮且可擴展支架,其具有一外部區段,該外部區段包括一外部表面、一內部表面且界定一內部,並且包括安置在該外部區段之一上部部分處之一支架帽蓋,該支架帽蓋經調適以與一遞送線連接;一瓣膜支撐件,其操作上連接至該可塌縮且可擴展支架,其中該瓣膜支撐件徑向向上延伸至該外部區段之該內部中且包括一流入端及一流出端,該流入端徑向向上延伸至該外部區段中,其中一血流通道界定於該流入端與該流出端之間,且其中該瓣膜支撐件在該外部區段之該內部內完全倒置,複數個人工瓣膜小葉,其安置在由該瓣膜支撐件區段界定之該血流通道內,其中人工瓣膜小葉經結構設計以允許自該流動通道之該流入端至該流出端之流動且阻止自該流動通道之該流出端至該流動通道之該流入端之流動,其中該瓣膜支撐件包括在上游方向上延伸於該外部區段之該內部內之一伸長區段。
2.如實施例1之裝置,其中該瓣膜支撐件由該可塌縮且可擴展支架界定及形成。
3.如請求項1及2之實施例,其進一步包括使該可塌縮且可擴展支架之該外部區段徑向向內轉動之過渡單元,該等過渡單元安置於該可塌縮且可擴展支架之該外部區段與該瓣膜支撐件之間。
4.如實施例1至3之裝置,其中該瓣膜支撐件與該瓣膜支撐件之外部區段構成一單個整體式支架。
5.如實施例1至4之裝置,其中該瓣膜支撐件之該伸長區段與該支架帽蓋操作地連接。
6.如實施例1至5之裝置,其中該瓣膜支撐件之該伸長區段包括安置或界定於其上之一取回及/或遞送輔助機構。
7.如實施例6之裝置,其中該取回輔助機構包括經調適以用於接納穿過其之一線之一打開環狀物或打開槳狀物。
8.一種用於將如技術方案1至7之可塌縮且可擴展人工心臟瓣膜裝置遞送、取回及/或定位至一患者之一心腔中之方法,其包括:提供一遞送導管,該遞送導管具有穿過其之一管腔;將該遞送導管放置在該患者內,使得該遞送導管之一遠端在該心腔內,且該遞送導管之一近端在該患者之身體之外;將該人工心臟瓣膜裝置塌縮並裝載至該遞送導管之該管腔之一近端中並向遠端平移該人工心臟瓣膜裝置;將該人工心臟瓣膜裝置自該遞送導管之該管腔之該遠端至少部分地遞送至該心腔中;在該心腔內至少部分地擴展該人工心臟瓣膜裝置,其中伸長瓣膜支撐件區段之一部分保持在該遞送導管之該管腔內;及當經正確定位時,將該人工心臟瓣膜裝置植入於該腔內。
9.如實施例8之方法,其進一步包括:提供至少一個推線及/或拉線,該至少一個推線及/或拉線包括與取回輔助機構中之至少一者操作地嚙合之一遠端;且利用該至少一個推線及/或拉線調整或操縱該伸長瓣膜支撐件區段之位置。
10.如實施例9之例示性方法,其進一步包括:在該人工心臟瓣膜裝置之擴展、定位、取回及/或植入期間,操縱該(等)推線及/或拉線以修改至少該瓣膜支撐件之該位置。
11.如實施例7至10之方法,其中該心腔包括左心房。
12.如實施例11之方法,其中該人工心臟瓣膜裝置經植入且經調適以補充原生二尖瓣膜小葉功能性。
13.如實施例11或12之方法,其中該人工心臟瓣膜裝置經植入且經調適以補充且最終完全替換該原生二尖瓣膜小葉功能性。
14.如實施例7至13之方法,其中使用經中隔遞送進入路徑將該遞送導管放置在該患者內。
15.如實施例7至13之方法,其中使用由以下各項組成之群組中之進入路徑中之一者將該遞送導管放置在該患者內:經心尖、經股動脈及經心房。
本文中所闡述之各種發明性概念之仍進一步額外實施例進一步包括:
1.一種人工心臟瓣膜裝置,其經調適以用於擴展及植入至一患者之一心腔中來補充及/或替換原生瓣膜小葉功能性,該裝置包括:一可塌縮且可擴展支架,其具有一外部區段,該外部區段包括一外部表面、一內部表面且界定一內部,並且包括安置在該外部區段之一上部部分處之一支架帽蓋,該支架帽蓋經調適以與一遞送線連接;一瓣膜支撐件,其操作上連接至該可塌縮且可擴展支架,其中該瓣膜支撐件徑向向上延伸至該外部區段之該內部中且包括一流入端及一流出端,該流入端徑向向上延伸至該外部區段中,其中一血流通道界定於該流入端與該流出端之間,且其中該瓣膜支撐件在該外部區段之該內部內完全倒置,複數個人工瓣膜小葉,其安置在由該瓣膜支撐件區段界定之該血流通道內,其中人工瓣膜小葉經結構設計以允許自該流動通道之該流入端至該流出端之流動且阻止自該流動通道之該流出端至該流動通道之該流入端之流動;及至少一個可塌縮且可擴展連接支柱,其安置於該瓣膜支撐件與該外部區段之間,該至少一個連接支柱位於該外部區段之該內部中,且在一第一端處與該瓣膜支撐件連接並在一第二端處與該外部區段連接。
2.如實施例1之裝置,其中該瓣膜支撐件由該可塌縮且可擴展支架界定及形成。
3.如實施例1及2之裝置,其進一步包括使該可塌縮且可擴展支架之該外部區段徑向向內轉動之過渡單元,該等過渡單元安置於該可塌縮且可擴展支架之該外部區段與該瓣膜支撐件之間。
4.如實施例1至3之裝置,其中該瓣膜支撐件與該可塌縮且可擴展支架之外部區段構成一單個整體式支架。
5.如實施例1至4之裝置,其中該至少一個可塌縮且可擴展連接支柱被熱固型就位。
6.如實施例1至5之裝置,其中該至少一個可塌縮且可擴展支柱由該瓣膜支撐件或該可塌縮且可擴展支架之該外部區段形成。
7.如實施例1至6之裝置,其中該至少一個可塌縮且可擴展支柱之至少一端連接至該瓣膜支撐件及/或該可塌縮且可擴展支架之該外部區段。
8.如實施例1至7之裝置,其中該至少一個連接支柱操作地安置於或接近該瓣膜支撐件之該流入端處。
9.如實施例1至7之裝置,其中該至少一個連接支柱沿著該瓣膜支撐件操作地安置於該瓣膜支撐件之該流入端與該流出端之間的一位置處。
如本文中所陳述之本發明及其申請案之說明係說明性的,且不意欲限制本發明之範疇。各種實施例之特徵可在本發明之考慮內與其他實施例相結合。本文中所揭示之實施例之變化及修改係可能的,且熟習此項技術者在研究本專利文件之後將理解實施例之各種元件之實務替代物及等效物。在不背離本發明之範疇及精神之情形下,可對本文中所揭示之實施例做出此等及其他變化及修改。
100:可擴展且可塌縮人工心臟瓣膜支架/人工瓣膜支架裝置
101:最頂部(或上游)支架單元/最頂部(上游)支架單元
102:外部區段/外部框架元件
104:內部瓣膜支撐件區段/內部瓣膜支撐件/瓣膜支撐件/瓣膜支撐件區段
108:過渡區段

Claims (15)

  1. 一種人工心臟瓣膜裝置,其經調適以用於擴展及植入至一患者之一心腔中,該裝置包括:一可塌縮且可擴展支架,其具有:一外部區段,該外部區段界定一內部;一瓣膜支撐件,其中該瓣膜支撐件徑向向上延伸至該外部區段之該內部中且包括一流入端及一流出端,其中一血流通道界定於該流入端與該流出端之間,且其中該瓣膜支撐件在該外部區段之該內部內完全倒置;及使該外部區段徑向向內轉動之過渡單元,該等過渡單元安置於該外部區段與該瓣膜支撐件之間;及複數個人工瓣膜小葉,其安置在該血流通道內,其中該等人工瓣膜小葉經結構設計以允許自該流入端至該流出端之流動且阻止自該流出端至該流入端之流動,其中該瓣膜支撐件之該流入端包括在該血流通道上方徑向向內彎曲之複數個最頂部支架單元。
  2. 一種用於如請求項1之人工心臟瓣膜裝置至一患者之一心腔中之遞送、取回及/或定位之系統,該系統包括:一遞送導管,該遞送導管具有穿過其之一管腔;其中:該遞送導管經放置在該患者內,使得該遞送導管之一遠端在該心腔內,且該遞送導管之一近端在該患者之身體之外;該人工心臟瓣膜裝置經塌縮並被裝載至該遞送導管之該管腔之一近端中,且該人工心臟瓣膜裝置被向該遞送導管之該管腔之一遠端平移;該人工心臟瓣膜裝置自該遞送導管之該管腔之該遠端至少部分地經遞送至該心腔中;該人工心臟瓣膜裝置至少部分地在該心腔內擴展;及當經正確定位時,該人工心臟瓣膜裝置被植入於該心腔內。
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