TW202142196A - 人工心臟瓣膜輸送系統：球滑動附接 - Google Patents

人工心臟瓣膜輸送系統：球滑動附接 Download PDF

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TW202142196A
TW202142196A TW110103583A TW110103583A TW202142196A TW 202142196 A TW202142196 A TW 202142196A TW 110103583 A TW110103583 A TW 110103583A TW 110103583 A TW110103583 A TW 110103583A TW 202142196 A TW202142196 A TW 202142196A
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valve
expandable
stent
delivery system
artificial heart
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傑森 Ｓ 戴德林
托馬斯 班森
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美商４Ｃ醫療技術公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439—Expansion controlled by filaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • 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
    • A61F2230/0071—Three-dimensional shapes spherical

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Mechanical Engineering (AREA)
  • Prostheses (AREA)

Abstract

本發明揭示用於將一操作者可操縱之(若干)繫鏈附接至支架之系統、裝置及方法，其等用於：將可擴展支架裝載及/或摺疊至一輸送導管或鞘中；沿該輸送導管或鞘平移該摺疊支架；將該可擴展支架輸送至該主體心腔中；視需要，將該可擴展支架重新定位於該主體心腔內；若需要，則在該輸送導管或鞘內重新獲取或重新入鞘該可擴展支架；及將該可擴展支架部署至及部署於該主體心腔內。

Description

人工心臟瓣膜輸送系統：球滑動附接
本發明係關於用於將裝置植入於一心腔內之裝置及方法。
一般而言，支架，且明確言之，人工心臟瓣膜及左心耳閉塞裝置在本領域中已為吾人所熟知。天然心臟瓣膜(例如主動脈瓣、肺動脈瓣、三尖瓣及二尖瓣)在確保透過心血管系統之一充足血液供應僅向前流動方面至關重要。此等心臟瓣膜可能由於先天性、炎症性、傳染病及其他疾病或條件而導致功能喪失。心臟直視手術期間早期干預可修復或替換(若干)功能異常瓣膜。近來，除上文所討論之心臟直視手術入路之外，可經由至少以下已知進入路徑之一者經皮進入所關注之瓣膜：經心尖；經股；經右室；及經中隔輸送技術，統稱為經導管技術。
一般而言，在一經導管技術中，人工瓣膜安裝於能够達成摺疊及擴展狀態之一支架框架內。裝置被摺疊且透過位於患者之一血管中之一鞘或輸送導管推進裝置直至到達植入部位。支架框架一般自導管或鞘中釋放，且由各種方式，隨著瓣膜擴展至心臟內之擴展功能大小及方向。關鍵問題之一係易於輸送人工瓣膜，其包含在所有進入路徑中輸送支架框架及瓣膜，包含(但不限於)經心尖輸送。更明確言之，具有一改良輸送系統將係有利的，該輸送系統用於將一可擴展支架附接、裝載、平移、輸送、重新定位及重新入鞘及部署至主體心腔中及至主體心腔內。本發明尤其解決此等問題。
人類心臟由四個腔及四個心臟瓣膜構成，其等幫助血液向前(順行)流過心臟。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、三尖瓣、主動脈瓣及肺動脈瓣。一般參閱圖1。
二尖瓣位於左心房與左心室之間且藉由充當一單向閥防止血液回流至左心房來幫助控制血液自左心房流至左心室。類似地，三尖瓣位於右心房與右心室之間，而主動脈瓣及肺動脈瓣係位於血液自心臟流出之動脈中之半月瓣。瓣膜全部係單向瓣膜，具有打開以允許血液向前(順行)流動之小葉。功能正常之瓣膜小葉在反向血液施加之壓力下閉合以防止血液回流(逆行)至其剛流出之腔。例如，二尖瓣在正常工作時在左心房與左心室之間提供一單向閥，其打開以允許自左心房順流至左心室且閉合以防止自左心室逆流至左心房。當出現此逆流時，其被稱為二尖瓣回流或二尖瓣反流。
由於包含(但不限於)疾病、創傷、先天畸形及老化之各種原因及/或條件，天然心臟瓣膜可能會或變得功能異常。在二尖瓣失效之情況中，此等類型之條件可引起瓣膜結構無法適當閉合而導致血液自左心室逆流至左心房。
二尖瓣反流係一特殊問題，其由允許至少一些血液自右心房反流回至左心房之一功能異常之二尖瓣導致。在一些情況中，功能異常起因於(若干)二尖瓣小葉下垂至左心房腔中(即，在環之上表面上方)而非連接或合攏以阻斷反流。此血液回流給左心室帶來一容量負荷，其會導致一系列的左心室代償性適應及調整(包含重塑心室腔大小及形狀)，其在二尖瓣反流之長期臨床期間顯著變動。
反流可為具有先天性心臟瓣膜(一般包含三尖瓣、主動脈瓣及肺動脈瓣及二尖瓣)之一問題。
因此，先天性心臟瓣膜(一般例如二尖瓣)可能需要功能性修復及/或協助，其包含一部分或完全替換。此干預可採取包含心臟直視手術及一心臟瓣膜替換之心臟直視植入術之多個形式。參閱(例如)美國專利第4,106,129號(Carpentier)，用於高侵入性、充滿患者風險及不僅需要延長住院期且需要非常痛苦恢復週期之一手術。
用於替換一功能異常心臟瓣膜之微創方法及裝置亦係已知的且涉及經皮進入及替換瓣膜之導管促進輸送。此等解決方案之大多數涉及附接至一結構支撐(諸如本領域中公知之一支架)之一替換心臟瓣膜，或經設計以在自一輸送導管釋放之後擴展之其他形式之線網。參閱(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有助於在主體心腔或血管內定位瓣膜且將擴展裝置保持於位置中。當裝置在第一次定位嘗試中未正確定位時(如通常情況)，此自擴展形式亦呈現問題，因此必須重新獲取且調整定位。在一完全或甚至部分擴展裝置之情況中，此重新獲取程序需要將裝置重新摺疊至允許操作者將摺疊裝置縮回至一輸送鞘或導管之一點、調整裝置之進入位置且接著藉由將位置調整之裝置自輸送鞘或導管之遠端重新部署來重新擴展至適當位置。摺疊已擴展裝置係困難的，因為擴展支架或線網一般經設計以達成擴展狀態，其亦抵抗收縮力或摺疊力。
除上文所討論之心臟直視手術入路之外，經由至少以下已知進入路徑之一者經皮進入所關注之瓣膜：經心尖；經股；經右室；經主動脈及經中隔輸送技術。
一般而言，本技術聚焦於使用上述已知進入路徑之一者允許輸送摺疊瓣膜裝置之一部分之系統及方法，其中裝置之一端自一輸送鞘或導管釋放且擴展以進行一初始定位，隨後在達成適當定位時完全釋放及擴展。參閱(例如)美國專利第8,852,271號(Murray, III)；美國專利第8,747,459號(Nguyen);美國專利第8,814,931號(Wang)；美國專利第9,402,720號(Richter)；美國專利第8,986,372號(Murray, III)及美國專利第9,277,991號(Salahieh)；及美國專利公開案第2015/0272731號(Racchini)及美國專利公開案及第2016/0235531號(Ciobanu)。
另外，已知「替換」人工心臟瓣膜意欲用於完全替換天然心臟瓣膜。因此，此等替換心臟瓣膜實際上與環形喉內(即，環形平面及上環形表面及/或瓣膜小葉下方)之組織接合，藉此消除天然瓣膜之所有剩餘功能且使患者完全依賴於替換瓣膜。一般而言，維持及/或保留一心臟瓣膜之固有功能係一較佳解決方案，因此增補瓣膜係較佳的，而非完全替換。明顯地，將存在此情況：天然瓣膜在介入性植入術之前幾乎完全喪失功能，或天然瓣膜在植入術之後繼續喪失功能。較佳解決方案係輸送及植入一瓣膜裝置，該裝置將作為一附屬及/或補充功能性瓣膜及完全能够替換已喪失或將喪失其大部分或全部功能之一瓣膜之固有功能。然而，下文所描述之本發明解決方案一般將適用於所有類型及形式之心臟瓣膜裝置，除非另有指定。如熟習技術者將認識到，本發明一般亦適用於支架。
此外，例如二尖瓣替換系統、裝置及方法之已知解決方案需要雙腔解決方案，即，在左心房及左心室中介入及接合植入替換瓣膜裝置。一般，此等解決方案包含在左心房中徑向擴展支架，使用錨定或栓系(透過固有環或環喉向下安置)自支架裝置透過環喉向下連接，具有左心室內之子環下表面、左心室腱索且甚至進入(若干)左心室壁表面。參閱(例如)由Abbott Group銷售之MitraClip® 及當前唯一美國認可之修復裝置。使用MitraClip® 時，將含有MitraClip® 之一導管插入股靜脈。裝置透過下腔靜脈進入心臟至右心房且經中隔輸送。MitraClip® 穿過環進入左心室且坐落於小葉下方，夾持小葉以減少反流。
此等雙腔及天然環解決方案非必要的笨重，且因此自一嚴格結構角度看，更難輸送及定位/重新獲取/重新定位。此外，雙腔解決方案在保持位置所需之心室錨定及/或栓系連接方面存在困難。此外，此等解決方案干擾如上文所描述之天然瓣膜功能，因為安置於左心室內之裝置部分必須選路通過天然環及/或環喉及天然二尖瓣，藉此破壞天然小葉之任何剩餘共接納能力。此外，雙腔解決方案一般需要侵襲性錨定一些天然組織，導致不必要創傷及潜在併發症。
將進一步認識到，雙腔二尖瓣解決方案需要與錨固件、繫鏈及其類似者之子環及/或心室精確接合，因為裝置之心房部分不能將其自身充分錨定至心房室及/或環之上部。同樣，本文中所描述之一些實施例或其部分易於適用於單室或雙室解決方案，除非另有指示。
最後，已知人工心臟瓣膜係由兩個或三個小葉組成，此等小葉經配置以充當一單向瓣膜，允許液體依順行方向流過，同時防止逆向流動。天然二尖瓣位於第四肋軟骨胸骨後，係由一前後小葉、腱索、乳頭肌、心室壁及與心房連接之環組成。各天然小葉係由附接至乳頭肌之腱索支撐，乳頭肌在各心室收縮時繃緊以保持瓣膜功能。天然瓣膜之前葉及後葉經由一級、二級及三級腱索附接至前外側及後內側乳頭肌。在心肌損傷之情況中，乳頭肌破裂可導致二尖瓣之前葉或後葉功能異常。其他機構可能導致一或兩個天然二尖瓣葉失效。在一單一二尖瓣葉失效之情況中，反流可呈一非中心、偏心之血液形式回流至左心房。其他小葉失效可包括一更集中之反流。已知人工瓣膜替換物一般包括經配置以模仿天然瓣膜結構之小葉，天然瓣膜結構可隨著時間變得受至類似反流結果的影響。
可摺疊及可擴展支架之應用不限於人工心臟瓣膜植入物。血管支架係常用的，且一般係可摺疊以利於透過一輸送導管之管腔輸送至工作位點，其中支架自導管之管腔中移出且由一自擴展構件或透過一擴展機構(諸如，除其他之外，一可擴展球囊)擴展。
如上文所討論，已知輸送方法及裝置包括在經由一輸送導管輸送期間摺疊之可擴展人工瓣膜支架及血管支架。已知系統、裝置及方法的一些效益包含易於將一操作者可操縱之(若干)繫鏈附接至支架以用於：將可擴展支架裝載及/或摺疊至一輸送導管或鞘中；沿該輸送導管或鞘平移該摺疊支架；將該可擴展支架輸送至該主體心腔中；視需要，將該可擴展支架重新定位於該主體心腔內；若需要則在該輸送導管或鞘內重新獲取或重新入鞘該可擴展支架；及將該可擴展支架部署至及部署於主體心腔內。
用於將一操作者可操縱之(若干)繫鏈附接至支架之系統、裝置及方法用於：將可擴展支架裝載及/或摺疊至一輸送導管或鞘中；沿該輸送導管或鞘平移該摺疊支架；將該可擴展支架輸送至該主體心腔中；視需要，將該可擴展支架重新定位於該主體心腔內；若需要，則在該輸送導管或鞘內重新獲取或重新入鞘該可擴展支架；及將該可擴展支架部署至及部署於該主體心腔內。本文中所描述之輸送系統實施例適用於單腔人工心臟瓣膜及需要錨定於一單腔外部之人工心臟瓣膜。
發明者 Jason S. Diedering, Minneapolis, MN, 美國公民 Thomas Benson, Maple Grove, MN, 美國公民
相關申請案之交叉參考 本申請案主張2020年1月31日申請之名稱為「PROSTHETIC HEART VALVE DELIVERY SYSTEM: BALL SLIDE ATTACHMENT」之美國臨時申請案第62/968,216號的權利，該案之全文係以引用的方式併入本文中。
關於聯邦資助的研究或發展 不適用
一般而言，本發明之各種實施例係針對用於將一操作者可操縱之(若干)繫鏈附接至支架之系統、裝置及方法，其等用於：將可擴展支架裝載及/或摺疊至一輸送導管或鞘中；沿該輸送導管或鞘平移該摺疊支架；將該可擴展支架輸送至該主體心腔中；視需要，將該可擴展支架重新定位於該主體心腔內；若需要則在該輸送導管或鞘內重新獲取或重新入鞘該可擴展支架；及將該可擴展支架部署至及部署於主體心腔內。
支撐結構或支架具有多種功能以輔助治療心臟瓣膜反流(二尖瓣或三尖瓣)。此等功能包含其作為功能性人工瓣膜之一支架、心房解剖並置、符合心房擴展之最佳化徑向力、能夠自一微創輸送系統裝載及部署及支撐緩解對瓣膜旁洩漏(PVL)之幾何結構。支架之設計特徵適於滿足以上識別之一或多個功能。以下詳細討論例示性支架之具體設計特徵及屬性以幫助理解漏斗式裝載裝置及相關方法之功用。熟習技術者將認識到，本發明不限於包括支架支撐結構之人工心臟瓣膜，亦可應用於諸如通常用於血管內手術之可摺疊及可擴展支架。另外，熟習技術者將認識到本發明用於植入某些例示性實施例支架設計概念之功用，此等例示性實施例支架設計概念意欲支持用於治療至少二尖瓣、三尖瓣及主動脈瓣之瓣膜反流或其他功能異常之微創手術。
支架可為自擴展的(例如鎳鈦合金或類似材料)或球囊可擴展的(例如鈷鉻合金或類似材料)。支架通常由小區製成，此等小區可為開孔菱形狀結構或具有一工作小區元件之連續結構。支架亦可使用管、線、編織物或類似結構來構造。下文描述例示性支架過渡區段。
現參考圖2至圖3C，與本發明一起使用之一例示性可擴展支架100之一實施例包括一外部區段102 (當完全及/或部分擴展時，其一般可為圓形但不必為完美圓形結構)及一內部瓣膜支撐區段104 (其可為圓柱形但不必為一固定直徑圓筒)，且可擴展支架100經調適以支撐及保持內部瓣膜支撐區段104內之人工瓣膜小葉(圖2中未展示)，最佳地位於天然環(例如二尖瓣環)上方之一點處，儘管用於人工小葉之其他附接點在本發明之範疇內。此外，如上文所討論，支架100可經組態以增補及/或替換三尖瓣之功能。一較佳構造包括安置於天然小葉上方之人工小葉，其中人工小葉與天然小葉附接且與天然小葉間隔足够遠(在天然小葉上方)以實際上不干擾天然小葉或不與其等相互作用。然而，某些實施例考慮與天然小葉之一些相互作用。
形成支架100之外部區段102之個別小區CO 在圖2中可見為由用於形成例示性可擴展支架100之材料界定之開口小區區域。
形成內部瓣膜支撐區段104之個別小區CI 亦被繪示為在由外部區段102界定之一內部區域R內形成之開口小區區域，其中內部瓣膜支撐區段徑向向上延伸至內部區域R中。如圖所展示，個別小區CI 具有不同於個別小區CO 之一大小，且可包括不同於個別小區CO 之一形狀。
促進支架100自外部區段102徑向向內過渡至支架100之內部區段104之支架100之區域係過渡區段或小區區域106。過渡小區區域106可包括小區CT ，其可包括與外部區段小區CO 及/或內部區段小區CI 不同之一大小及/或形狀。支架100之外部區域102及/或內部區域104及/或過渡小區區域106可由一連續結構建構或可組合兩個或更多個結構以達成所欲設計目標。如圖2中所展示，過渡小區區域106一般包括一徑向向上轉向以允許內部瓣膜支撐區段104駐留於內部區域102內。在一些實施例中，內部瓣膜支撐區段104之下部，即，與過渡小區區域106之小區CT 連接之內部瓣膜支撐區段104之部分，亦可包括利於及/或完成徑向向上轉向至內部區域102中之一彎曲形狀。
過渡小區CT 之幾何及/或形狀當如下文圖3A中般擴展時實質上可為直段，或如圖3B中所展示，當擴展時可在支架小區圖案中併入一偏移或一扭曲以允許支架之一受控壓縮。在圖3A及圖3B中示意性地表示自支架100之底部觀察之過渡小區區域106之例示性橫截面幾何形狀。
支架100之過渡小區區域106可為一支桿、完整小區區段或一部分小區區段。過渡小區區域106可具有一般所需之任何數目個支桿(最少3個)或小區區段以滿足設計需要。如圖3A中所展示，過渡小區CT 或支桿可均勻間隔開且由實質上筆直及間隔相等之支桿108形成，其延伸遠離相對於其相交點或與外部支撐區段102整合之具有支桿108之兩側上之相等角度α及支桿108之兩側上之相等角度β之內部瓣膜支撐區段104。
在一實施例中，過渡區段106之支桿108可如圖3A中般為直的，但相對於內部瓣膜支撐區段104及外部支撐區段102之角度不相等，如圖3C中所展示。此處，筆直支桿108傾斜使得相對於內部瓣膜支撐區段104提供一較小角度α及一較大角度α’。類似地，相對於外部支撐區段102提供一較小角度β’及一較大角度β。此允許過渡區段106之傾斜支桿108之一壓縮嵌套。
在另一較佳實施例中，過渡小區區域106可包括過渡小區支桿108’，該過渡小區支桿108’包括過渡小區CT ，該過渡小區CT 由具有一偏移(即，不直，係扭曲及/或彎曲的)之支桿108’形成。支桿108’之偏移及/或扭曲及/或彎曲程度及因此所得擴展小區CT 之大小及/或形狀可取決於過渡小區區域106中之小區/支桿之數目、當支架摺疊時之堆積密度及過渡小區區域106之應力/應變分佈限制而變動。
現轉至圖4，如上文圖2至圖3B中所討論，沿支桿108之一者，較佳地在可擴展支架102之過渡小區區域106內界定一附接構件402。然而，熟習技術者將認識到，附接構件402亦可沿不在過渡小區區域106內之(若干)支桿界定。另外，附接構件402經展示為圓形，但其他形狀必然可行且在本發明之範疇內。此外，附接構件402可界定於一支架框架之一支桿上，支桿在植入時之支架框架之一下游(人工心臟瓣膜內之正常血流之一下游)側上。替代地，附接構件402可界定於人工心臟瓣膜框架之最下部下游支桿上。
圖5A繪示沿一支架支桿安置及界定之一例示性圓形附接構件402，且圖5B繪示三(3)個附接構件402之例示性可擴展支架102之過渡小區區域106周圍的位置。如所展示，在沿及/或圍繞過渡小區區域106之相鄰附接構件402之間存在一實質上相等間隔或離距。熟習技術者將認識到，亦可採用附接構件402之位置之間的非相等間隔或離距。另外，可使用至少一附接構件402。較佳具有至少兩個且更佳具有至少三個如本文中所描述般界定之附接構件402。
現轉至圖6A至圖7A，繪示在一近端處經可操作地連接至一操作把手之一繫鏈總成410之一實施例，如將進一步討論。繫鏈總成410進一步包括一外管404、一切口管406及具有遠端擴大元件408之一導線，其中繫鏈總成包括能够與把手H近端連接之一長度及自一輸送導管或鞘之遠端充足延伸長度，其特別有利於平移及部署如本文中將進一步討論之人工心臟瓣膜。導線遠端擴大元件408不限於一導線且亦可包含等效物結構，諸如(但不限於)一管、可為中空或實心之一桿，及其類似者。
外管404經提供具有穿過其之一管腔L1。如所展示，切口管406經設定大小以在管腔L1內被滑動地接收，且包括遠離切口管管腔L2延伸之遠端撓性片407。
具有遠端擴大元件408之導線(其中擴大遠端元件409經展示為一球)經調適以在管腔L2內被滑動地接收，為繫鏈總成410創建如圖6D中所展示之一嵌套配置。
圖7A至圖7C繪示在植入程序期間，人工心臟瓣膜裝載、平移、重新定位、重新獲取、部署及釋放之特定步驟期間之繫鏈總成410之組件的操作及關係。
圖7A展示導線之遠端擴大元件409，其中遠端擴大元件408向近側拉回至切口管406之遠端撓性片407中，使片407變形以在其中創建一壓縮或摩擦配合。另外，當如所展示之變形時，片407之間的距離大於當球409未插入片407之間時片407之間的距離。此配置使得擴大遠端元件409 (如所展示之一球)能够具有小於附接構件402之一最小直徑之一直徑，且遠端撓性片407亦具有片407之間之一最大非變形長度，其小於附接構件402之一最小直徑，擴大遠端元件409及遠端撓性片407透過附接構件插入。插入位置如圖6D中所展示，其中遠端擴大元件409 (展示為一球)位於遠端撓性片407之遠側。當遠端擴大元件409及遠端撓性片407透過附接構件402插入時，操作者接著可將如圖7A中所展示之具有擴大遠端元件408之導線向近端縮回，以使遠端撓性片407與遠端擴大元件409接合及變形，引起片407之間的距離增大至現大於附接構件之直徑之一長度，藉此將繫鏈總成410附接至支架102，較佳地在如上文所討論之過渡區段處。重複此程序步驟用於至少一繫鏈總成410之各者，以將(若干)繫鏈總成410附接至支架102。
熟習技術者應瞭解，儘管一較佳實施例包括一球形遠端擴大元件409及一圓形附接構件402，但其他形狀可用於球形遠端擴大元件409及/或附接構件402。一些此等形狀可為互補的，例如，替代遠端球形遠端擴大元件409之一方形元件及一方形附接構件402。然而，只要遠端元件(例如所繪示之球409)適合穿過附接構件402且可向遠處拉動以使可撓性遠端片407變形以達成附接，則無需互補構件。
熟習技術者亦應瞭解，一瓣膜旁洩漏緩解裙或織物可覆蓋可擴展支架102之至少部分，其包含(但不限於)過渡小區區域。在此一情況中，繫鏈總成410可延伸穿過裙或織物以達至且附接至附接構件402，且自附接構件402釋放。
因此，附接至支架框架，(若干)繫鏈總成410可用於將自擴展支架框架102摺疊至一輸送導管或鞘之管腔之近端且幫助將摺疊支架框架102自遠端穿過輸送導管或鞘來平移至預先定位於關注之心腔處之鞘之輸送導管之遠端。此時，摺疊支架框架102自輸送導管或鞘至少部分地釋放且開始自擴展。附接之(若干)繫鏈總成410可用於藉由操縱(若干)繫鏈總成410以將至少部分擴展之支架框架102移動至主體心腔內之適當位置來輔助此程序。在某些情況中，藉由近端拉動(若干)繫鏈總成410之一或多者以依一所要方向移動支架框架102且進入心臟瓣膜內之一所要姿態，相對於解剖標誌重新定位包括一人工心臟瓣膜之至少部分擴展支架框架可為有利的。圖10A至圖10C繪示包括三個繫鏈總成410之一實施例，其中圖10A係一預設位置且支架框架102基本上與輸送鞘之縱軸對稱地對準。圖10B及圖10C展示拉動(或推動)一或多個繫鏈總成410以引起連接支架框架102遠離對稱對準之縱軸以呈現一不對稱姿態以幫助定位及部署支架框架102之能力。
圖11A及圖11B及圖12A及圖12B提供各繫鏈總成410之遠端連接至其之一操作把手H之實施例。如所指示，可藉由在把手H處向近處或遠處移動附接推/拉及釋放機構430來操縱繫鏈總成410遠離輸送鞘之遠端延伸長度。此可作為繫鏈總成之一組合組來完成，或可選擇個別繫鏈總成410相對於其他(若干)繫鏈總成410來選擇性地延長(向遠處推動)或縮短(向近處拉動)，及/或包括外管404、切口管406及具有擴大遠端元件408之導線之各繫鏈總成410之組件可各獨立地向近處推動及/或向遠處拉動。各繫鏈總成410具有其自身長度及附接至把手H之釋放機構430。
各推/拉及釋放機構430進一步包括可鎖定及解鎖之一槓桿且允許操縱繫鏈總成410之個別組件。當鎖定時，如上文所描述，相關聯繫鏈總成410附接至一附接構件402。如圖12A至圖12B，由解鎖一槓桿(如所展示般致動槓桿)達成自附接構件402釋放繫鏈總成410，且接著向遠處拉動總成之解鎖部分(即，向遠處拉動繫鏈總成之相關組件(即，切口管406、具有擴大遠端元件之導線408))來遠離且脫離與附接構件402之附接接合。熟習技術者應瞭解，此相同機構430可用於推進及/或縮回繫鏈總成410之組件以達成與附接構件402之附接及/或自附接構件402釋放。
圖12A至圖12B提供一機構，藉由該機構，繫鏈總成410自支架框架個別釋放且向如圖7B及圖7C中之近處縮回。
在一些情況中，藉由將至少部分擴展之支架102向近處拉動至輸送導管或鞘之管腔中來至少部分地恢復、重新入鞘及/或重新獲取至少部分擴展之支架102，接著重新開始釋放及部署步驟可為有利的。
如圖7B及圖7C中所展示，當包括人工心臟瓣膜之支架框架被適當定位時，具有擴大遠端元件408之導線之擴大遠端元件409被推離遠端撓性片407，使得遠端撓性片407返回至其等未變形之形狀，此允許將切口管406及具有遠端擴大元件408之導線自附接構件402中取出，藉此自支架框架102斷接繫鏈總成410。一旦各提供繫鏈總成410自支架框架102斷接，則(若干)繫鏈總成410可自心腔中取出。
圖8及圖9提供包括三(3)個繫鏈總成(410)之一較佳實施例之額外細節。
如所討論，用於所揭示之輸送系統之一較佳進入路徑包括一經心尖入路，儘管所有其他輸送進入路徑可使用本發明成功導航。
本文中所闡述之本發明及其應用之描述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與本發明考量內之其他實施例組合。本文可揭示實施例之變動及修改，且在研究本專利文件之後，一般技術者將理解實施例之各種元件之實際替代物及等效物。可在不背離本發明之範疇及精神之情況下對本文中所揭示之實施例進行此等及其他變動及修改。
100:支架 102:外部區段/支架框架 104:內部瓣膜支撐區段/內部區段 106:過渡小區區域/過渡區段 108:支桿 108’:過渡小區支桿 402:附接構件 404:外管 406:切口管 407:遠端撓性片 408:遠端擴大元件 409:遠端擴大元件/球 410:繫鏈總成 430:釋放機構 Cl :小區 CO :小區 CT :小區 H:把手 L1:管腔 L2:切口管管腔 R:內部區域 α:角度 α’:角度 β:角度 β’:角度
圖1繪示橫截面中心臟之某些特徵。
圖2繪示一例示性支架之一透視圖。
圖3A繪示圖2之例示性支架之一過渡區段之一實施例之一仰視圖。
圖3B繪示圖2之例示性支架之一過渡區段之一實施例之一仰視圖。
圖3C繪示圖2之例示性支架之一過渡區段之一實施例之一仰視圖。
圖4繪示在一例示性支架中界定之一附接構件之一實施例。
圖5A繪示在圖2之例示性支架之一過渡區段中界定之一附接構件之一實施例。
圖5B繪示包括在圖2之例示性支架之一過渡區段中界定之三個附接構件之一實施例。
圖6A繪示具有遠端球之一線之一實施例。
圖6B繪示用於滑動接收具有圖6A之遠端球之導線之一切口管之一實施例。
圖6C繪示用於接收圖6B之切口管之一外管之一實施例。
圖6D繪示包括圖6A至圖6C之具有遠端球之導線、切口管及外管之一組裝繫鏈之一實施例。
圖7A繪示其中球在一部分縮回位置中之組裝繫鏈之一實施例。
圖7B繪示在一釋放位置中之組裝繫鏈之一實施例。
圖7C繪示在一完全縮回位置中之組裝繫鏈之一實施例。
圖8繪示遠離一輸送導管或鞘延伸之三個間隔繫鏈總成之一實施例。
圖9繪示附接至圖2之例示性支架之一過渡區段中界定之三個附接構件之三個間隔繫鏈總成之一實施例。
圖10A繪示附接至一例示性支架框架之三個附接構件之三個例示性繫鏈總成，其未自一縱軸位移。
圖10B繪示附接至一例示性支架框架之三個附接構件之三個例示性繫鏈總成，其相對於一縱軸在一第一方向上位移。
圖10C繪示附接至一例示性支架框架之三個附接構件之三個例示性繫鏈總成，其相對於一縱軸在一第二方向上位移。
圖11A繪示用於遠離輸送導管或鞘之遠端來調整(減少)各繫鏈總成之延伸之一例示性把手及機構。
圖11B繪示用於遠離輸送導管或鞘之遠端來調整(增加)各繫鏈總成之延伸之一例示性把手及機構。
圖12A繪示用於將繫鏈總成之一者自支架之例示性附接構件之附接處釋放之一例示性把手及機構。
圖12B繪示用於將繫鏈總成之一者自支架之例示性附接構件之附接處釋放之一例示性把手及機構。
100:支架
102:外部區段/支架框架
104:內部瓣膜支撐區段/內部區段
106:過渡小區區域/過渡區段
CO:小區
CI:小區
CT:小區

Claims (26)

  1. 一種可擴展人工心臟瓣膜，其包括： 一支架框架，其形成一外部區段；一過渡區段，其界定該支架框架之一下游邊緣；該外部區段，其界定一內部區域；及一內部瓣膜支撐區段，其係由該支架框架支撐且被安置於該內部區域內，其中該內部瓣膜支撐經構形以支撐該內部瓣膜支撐內之人工瓣膜小葉， 其中該外部區段及過渡區段包括界定該支架框架之小區之支桿；及 一或多個附接構件，其包括一形狀且係在該過渡區段之一或多個徑向向內轉動支桿上或沿該一或多個徑向向內轉動支桿界定，該一或多個附接構件之各者經構形以可釋放地接收一繫鏈元件。
  2. 如請求項1之可擴展人工心臟瓣膜，進一步包括經調適以徑向向內轉動以形成該內部瓣膜支撐之該過渡區段之該等支桿。
  3. 如請求項1之可擴展人工心臟瓣膜，進一步包括在該過渡區段之三個支桿上或沿該三個支桿界定之複數個附接構件。
  4. 如請求項3之可擴展人工心臟瓣膜，其中該複數個附接構件之各者係與該過渡區段周圍之其他兩個附接構件等間隔地隔開。
  5. 如請求項3之可擴展人工心臟瓣膜，其中該複數個附接構件之各者係與該過渡區段周圍之其他兩個附接構件非等間隔地隔開。
  6. 如請求項3之可擴展人工心臟瓣膜，進一步包括三個附接構件。
  7. 如請求項1之可擴展人工心臟瓣膜，其中該一或多個附接構件之各者包括一圓形。
  8. 如請求項1之可擴展人工心臟瓣膜，其中該支架框架係自擴展的或球囊可擴展的。
  9. 如請求項1之可擴展人工心臟瓣膜，其中該外部區段係圓形。
  10. 如請求項1之可擴展人工心臟瓣膜，其中該外部區段不為圓形。
  11. 如請求項1之可擴展人工心臟瓣膜，其中該內部瓣膜支撐包括一圓筒。
  12. 如請求項1之可擴展人工心臟瓣膜，其中該內部瓣膜支撐包括沿該內部瓣膜支撐之一長度之一非固定直徑。
  13. 如請求項1之可擴展人工心臟瓣膜，其中該等人工瓣膜小葉係支撐於該過渡區段上游之一位置處之該內部瓣膜支撐內。
  14. 一種用於一可擴展人工心臟瓣膜之輸送系統，用於將一自擴展支架框架之位置輸送及/或操縱至一解剖位置，該輸送系統包括： 至少一繫鏈總成，其在一遠端經可操作地連接至一操作把手之一推/拉及釋放機構，該至少一繫鏈總成之各者包括： 一外管，其包括穿過其之一管腔； 一切口管，其在該外管之該管腔內被滑動地接收，且包括穿過其之一管腔及自該切口管之該管腔之一遠端延伸之兩個撓性片，其中該兩個撓性片可遠離該外管之該管腔延伸；及 一導線，其具有經附接至該導線之一遠端之一擴大遠端元件，且在該切口管之該管腔內被滑動地接收，其中該球可遠離該外管之該管腔及該切口管之該管腔延伸。
  15. 如請求項14之輸送系統，其中該支架框架包括經界定於該支架框架之至少一支桿上的至少一附接構件，且其中具有一擴大遠端元件之該導線之該擴大遠端元件經調適以平移穿過該附接構件且可釋放地與該附接構件接合。
  16. 如請求項15之輸送系統，其中該擴大遠端元件包括一球。
  17. 如請求項15之輸送系統，其中該至少一附接構件係界定於該支架框架之至少一最低之下游支桿上。
  18. 如請求項15之輸送系統，其中該附接構件係形成於該自擴展支架框架之一過渡小區區域上。
  19. 如請求項15之輸送系統，其中該擴大遠端元件及該至少一附接構件包括互補形狀。
  20. 如請求項15之輸送系統，其中該擴大遠端元件及該至少一附接構件不包括互補形狀。
  21. 如請求項15之輸送系統，其中該至少一繫鏈總成之一者經調適以附接至該至少一附接構件之一者及自該至少一附接構件之一者釋放。
  22. 如請求項14之輸送系統，其中該推/拉及釋放機構經調適以相對於一輸送導管之一遠端而近端地及/或遠端地平移該至少一繫鏈總成，穿過該輸送導管平移該至少一繫鏈總成。
  23. 如請求項14之輸送系統，其中該推/拉及釋放機構經調適以相對於彼此、相對於一輸送導管之該遠端及相對於該至少一繫鏈總成之任何其他一者而選擇性地平移該外管、該切口管及/或具有擴大遠端元件之該導線。
  24. 如請求項14之輸送系統，適用於輸送一人工心臟瓣膜以治療一或多個群組，該群組由以下組成：天然二尖瓣、天然三尖瓣，及天然主動脈瓣。
  25. 如請求項14之輸送系統，適用於沿由經心尖、經股、經右室及經中隔輸送技術組成之群組中之該等經導管進入路徑中之一或多者來輸送一人工心臟瓣膜。
  26. 一種用於將一人工心臟瓣膜輸送及部署至一患者之心腔之方法，其包括： 提供如請求項14之輸送系統； 將該可擴展支架裝載及/或摺疊至一輸送導管或鞘中； 沿該輸送導管或鞘平移該摺疊支架； 將該可擴展支架輸送至該患者之心腔中； 視需要，將該可擴展支架重新定位於該主體心腔內； 若需要，則在該輸送導管或鞘內重新獲取或重新入鞘該可擴展支架； 將該可擴展支架部署至及部署於該主體心腔內；及 自該患者身上取出該輸送系統。
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