CN104125817A - 用于置换或修复心脏瓣膜的锚定装置和方法 - Google Patents
用于置换或修复心脏瓣膜的锚定装置和方法 Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61F2/02—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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
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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
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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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
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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
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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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
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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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2463—Implants forming part of the valve leaflets
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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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
- A61F2/2457—Chordae tendineae prostheses
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- A—HUMAN NECESSITIES
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- 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
- 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
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
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- A—HUMAN NECESSITIES
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- 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
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- A61F2230/0028—Shapes in the form of latin or greek characters
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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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61F2250/0018—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 elasticity, stiffness or compressibility
Abstract
公开了一种用于在心脏中锚定人工心脏瓣膜或瓣环成形环到瓣膜环的装置和将其植入的方法。该装置可以包括人工瓣膜或瓣环成形环,其中一个或多个锚经配置以便在原生小叶和/或瓣下组织下面穿过或以其他方式通过,以固定该装置在原生环处。
Description
相关申请
本申请要求2011年12月21提交的美国临时申请No.61/578,758的优先权,其全部公开内容通过引用并入本文。
技术领域
本发明一般地涉及心脏瓣膜修复和置换。更具体地,本发明涉及经配置用于迅速植入的人工心脏瓣膜和瓣环成形环的锚定装置和方法,以及用于植入其的方法。
背景技术
心脏是一种略呈锥形的中空的肌肉器官;其位于中纵隔中的肺之间并且包封在心包中。心脏倾斜地靠在胸骨体后并且邻接肋软骨各部分的胸中,并且通常伸入胸腔左半中比伸入胸腔右半中更远,使得约三分之一位于正中平面的右侧上并且三分之二位于正中平面的左侧上。心脏由隔片细分成左右两半,并且结(constriction)将该歧管的每一半细分成两个腔,即称为心房的上腔和称为心室的下腔。因此,心脏由四个腔室组成:右和左心房以及右和左心室,单向流动瓣膜在各个心房和心室之间并且在来自心室的出口处。
房室心脏瓣膜(即三尖瓣和二尖瓣)位于心脏的心房和心室之间的心脏中心中,并且在维持血液的向前流动中起重要作用。房室瓣功能失调通常也称为“反流”并且在全球影响超过一百万人。二尖瓣和三尖瓣由每个都称为环的胶原蛋白的纤维环限定,这形成心脏的纤维骨架的一部分。该环提供用于二尖瓣的两个尖或小叶(称为前和后尖)和三尖瓣的三个尖或小叶的外周附接。小叶的自由边缘从一个以上的乳头肌连接到腱索。在健康的心脏中,这些肌肉及其腱索支持二尖瓣和三尖瓣,允许小叶抵抗在左和右心室的收缩(泵出)过程中产生的高压。
虽然瓣膜反流通常由于瓣膜环的膨胀而发生,但是二尖瓣和三尖瓣功能和能力常常取决于瓣膜的支撑结构——如关联的瓣下结构(subvalvular apparatus)——的精细几何和功能完整性。除其他外,这些心脏瓣膜的瓣下结构包括关联的腱索和乳头肌。
如图1和图2中看到的,二尖瓣(MV)是分离左心房(LA)和左心室(LV)的结缔组织的两小叶(或二尖)结构。二尖瓣作用是维持血液流动在一个方向上,即在心室放松或者舒张过程中从左心房朝向左心室,同时在心室挤压或者收缩过程中防止在相反方向上回流。前叶(AL)和后叶(PL)由前连合处(AC)和后连合处(PC)分离。两个瓣膜小叶的基部被附接到称为二尖瓣环(AN)的心脏的圆形纤维结构,并且小叶自由边缘附接到从左心室的乳头肌产生的腱索。前叶(AL)比较大并且附接到环的前段,而后叶(PL)较小但进一步周向地延伸并且附接到环的后段。该后叶呈现标识为P1、P2、P3的三个扇形,而前叶的相应非扇形部分根据卡彭铁尔的分段法(Carpentier’ssegmentation)标识为A1、A2、A3。
三尖瓣也具有瓣下结构,但是是与二尖瓣的二尖结构相对的三尖(即三个尖或小叶)结构。一些二尖瓣和三尖瓣置换过程包括除去这些瓣下结构。然而,瓣下结构可在维持心室的适当形状中发挥作用,并且因此其保存可以是期望的,这取决于特定情况。
当左心室在填充有来自左心房的血液后收缩时,该心室的壁向内移动并且释放一些来自乳头肌和腱索的张力。贴着二尖瓣小叶的下表面向上推动的血液引起其朝向二尖瓣的环面上升。随着后叶和前叶的前缘朝向所述环前进,后叶和前叶的前缘聚集在一起形成密封并且关闭该瓣膜。在健康的心脏中,小叶接合发生在二尖瓣环的平面附近。血液继续在左心室中被增压,直到其喷入主动脉中。乳头肌的收缩与该心室的收缩是同时发生的,并且用于保持健康的瓣膜小叶在由该心室施加的最高收缩压力下紧闭。
原生心脏瓣膜(如主动脉瓣、肺动脉瓣、三尖瓣和二尖瓣)在确保充足血液供应穿过心血管系统的向前流动中发挥关键作用。这些心脏瓣膜可以由于先天状况、发炎状况、感染状况或其他疾病被呈现效果较差。对瓣膜的这种损害可以导致严重的心血管损害。心脏瓣膜疾病是一种普遍状况,在这种普遍状况中,心脏的一个或多个瓣膜无法正常起作用。患病的心脏瓣膜可归类为狭窄的,其中该瓣膜不充分打开来允许血液穿过瓣膜的充分向前流动,和/或机能不全的,其中当小叶应该接合在一起来防止反流时,该瓣膜不完全关闭,造成穿过该瓣膜的血液的过多向后流动或反流。如果不及时治疗,瓣膜疾病可以严重地使人衰弱,并且甚至致命。多年来,此类病症的确定性治疗是在例如心脏直视手术(open heart surgery)过程中该瓣膜的手术修复或置换。
各种手术技术可用于修复患病或受损瓣膜,这通常用在最小钙化瓣膜上。原生瓣膜的手术修复通常使用所谓的瓣环成形环进行。瓣环成形环的示例,包括用于修复原生瓣膜的使用方法公开于1976年4月9日提交的题为“Support for a Natural Heart Valve”的美国专利号4,055,861;1989年11月30日提交的题为“Flexible Annuloplasty Ringand Holder”的美国专利号5,041,130;2001年3月6日提交的题为“Annuloplasty Ring Delivery Method”的美国专利号6,558,416;和2011年2月2日提交的题为“Devices and Methods for Treating a Heart”的共同未决的美国专利申请序列号13/019,506,其中每一个的全部内容通过引用并入本文。
有时心脏瓣膜的实际置换是优选的选择。当原生心脏瓣膜变窄,通常称为狭窄时,或者当原生瓣膜泄漏或反流时,如当小叶被钙化时,可指示进行心脏瓣膜置换。由于主动脉狭窄和其他心脏瓣膜疾病,数千名患者每年接受手术治疗,其中有缺陷的原生心脏瓣膜由人工生物的或机械的人工瓣膜置换。多年来使用人工心脏瓣膜治疗心脏瓣膜病症。
当置换瓣膜时,人工瓣膜的手术植入通常要求开胸手术,在开胸手术过程中,心脏停止并且将患者放置在心肺旁路(所谓的“心脏-肺机器”)上。在一个普通的外科手术过程中,切除患病的原生瓣膜小叶,并且缝合人工瓣膜到瓣膜环处的周围组织。由于与该过程相关联的创伤和伴随的体外血液循环的持续时间,一些患者未渡过该手术过程或在手术后不久死亡。众所周知的是,患者的风险随对体外循环要求的时间量增加。由于这些风险,相当数量的带有缺陷瓣膜的患者被视为是不能手术的,因为他们的状况太脆弱而不能承受该手术过程。通过一些估计,遭受主动脉狭窄的约30%至50%的80岁以上对象不可以进行主动脉瓣膜置换手术。
由于与常规心脏直视手术相关联的缺点,经皮和微创手术方法正引起强烈关注。在一种技术中,人工瓣膜配置为通过导管插入术的方式在更少侵入性手术过程中被植入。例如,安德森(Andersen)等人的美国专利号5,411,552描述了一种可折叠瓣膜,该可折叠瓣膜穿过导管在压缩状态下经皮引入并且通过球囊膨胀在期望位置膨胀。虽然这些远程植入技术已经示出对于治疗某些患者的很大承诺,但是经由手术介入置换瓣膜仍然是优选的治疗方法。接受远程植入的一个障碍是来自医生的抵抗,这些医生可理解地对从有效——如有疏漏——方法转换成有望有很好的结果但比较外来的新颖方法存在担忧。连同由外科医生在切换到新的心脏瓣膜置换技术时具有的可理解的谨慎,世界各地的监管机构也动作缓慢。许多成功临床试验和后续研究正在进行之中,但是在其被完全接受之前需要关于这些新技术的更多经验。
在一些情况下,原生心脏瓣膜与人工心脏瓣膜的置换可以是期望的治疗。每年有大约60,000次二尖瓣置换(MVR),并且据估计由于增加的手术的风险和年龄,另外60,000名患者应该接受MVR。大部分的这些置换是通过心脏直视手术完成的,其中人工心脏瓣膜通过手术在肺旁路上与患者进行植入。此类手术植入的人工瓣膜有一个长期的和可靠的记录,具有在此类瓣膜置换之后记下的高成功率和临床改善。然而,保持患者花费在肺旁路上的时间为最小可以是可取的。
外科医生叙述到,当在心脏直视手术或微创心脏瓣膜植入(例如,穿过小切口)中尝试瓣膜修复或置换时的最困难任务之一是系保持该瓣膜或修复环在适当位置的缝线结。典型的人工二尖瓣植入物利用均匀分布在缝合环周围且在该缝合环一侧上手动打结的12-24条缝线(通常约15条)。当瓣膜坐落(parachute)到位置上时,由于许多对需要精确放置在环中的缝线以及通常用于固定缝线的结,植入过程可以非常耗时并且难以执行,特别是穿过最小尺寸切口。类似地,在瓣膜修复过程中,许多对缝线必须精确地放置在原生环周围,以附接修复装置。最小化或者甚至消除使用缝线(和/或系缝线结)用于人工瓣膜或修复装置附接的需要将极大地减少该手术过程的时间和/或促进使用较小切口,从而降低感染风险,减少输血的需要,减少在旁路上花费的时间,并且允许更快速的恢复。
因此,需要一种改进的装置和相关使用方法,其中人工瓣膜或瓣膜修复装置可以以在减少体外循环和/或导管插入上所需时间的更有效手术过程中植入。此类装置和方法能够帮助被视为不可手术的有缺陷瓣膜的患者是可取的,因为它们的状况太脆弱而不能承受长时间的常规手术过程。本发明解决了这些需要以及其他需要。
发明内容
公开了用于在原生瓣膜环处植入的瓣膜修复或置换装置以及植入其的方法。该装置可以是人工瓣膜、瓣环成形环或用于在原生瓣膜环处植入的其他装置。该装置具有中央部分,一个或多个锚从固定到该中央部分的固定端从其延伸,锚在自由端处终止。锚以弯曲的方式基本上平行于中央部分的周缘定位(run),在锚和中央部分之间形成小叶接收槽。该装置配置为布置在原生瓣膜环处,并且然后被旋转(扭转)以便放置锚在原有瓣膜小叶下面,原有瓣膜小叶滑入小叶接收槽中,直到装置完全就位。然后将小叶保持在槽内,这可包括来自在锚臂和装置的中央部分之间按压小叶的锚臂的向内压力。
锚可以从中央部分延伸,并且可包括横截面,该横截面配置为具有与平面外刚性不同的平面内刚性。可以存在从中央部分延伸的一个、两个、三个、四个或更多锚。锚可以在围绕其周缘的不同位置处从中央部分延伸,并且可以大体上等距地围绕周缘布置。锚可以由金属或聚合物或其他合适的材料形成,并且装置可包括布覆盖物。该装置可包括不透射线标记(radiopaque marker)和其他结构,以增强在植入过程中的可视性。例如,锚构件可具有一个或多个布置在其上的不透射线标记,如在自由端的尖端处和/或在固定端处。
组件可形成由支撑架和瓣膜小叶形成的人工瓣膜,支撑架具有中央部分和一个或多个从其延伸的弯曲锚,以在锚(一个或多个)和中央部分之间形成至少一个槽,其中至少一个槽具有合适尺寸,以滑动地在其中接收心脏瓣膜小叶的近端部分。锚和槽可优选地具有合适尺寸并且配置为接合原有小叶。例如,至少一个槽可具有的宽度尺寸与原生瓣膜小叶的厚度类似。
根据本发明实施方式的用于治疗心脏的装置包括人工瓣膜,其具有支撑架和瓣膜部分。瓣膜部分可包括多个小叶,该多个小叶固定到支撑架并且配置为接合以允许血液以第一方向流经瓣膜部分并且防止血液以第二方向流经瓣膜部分,其中第一方向与第二方向相反,其中支撑架包括一个或多个附接结构,其配置为附接到处于或邻近原生心脏瓣膜的环的组织,和/或以其他方式促进该装置附接到处于或邻近原生心脏瓣膜的环的组织。
人工瓣膜可通过传统心脏直视技术或微创技术、和/或通过导管插入被配置用于外科手术植入。支撑架可具有补充附接结构(即,除锚以外),用于固定人工瓣膜在原生心脏瓣膜环处的期望位置处。例如,支撑架可包括配置为缝合到原生心脏瓣膜的环的组织的缝合环,和/或可包括配置为不使用(或使用最少)缝线固定支撑架在瓣膜环处的其他附接结构,比如可膨胀支架结构、夹具、裙部或其他配置为接合原生环的组织或邻近原生环的组织以便固定人工瓣膜在期望位置处的元件。无缝合固定装置的示例和与本发明一起使用的方法公开在2010年6月23日提交的题为“Unitary Quick-Connect Prosthetic Heart Valve andDeployment System and Methods”的美国专利申请序列号12/821,628中,并且还公开在2011年6月23日提交的题为“Systems and Methods forRapidly Deploying Surgical Heart Valves”的美国专利申请序列号13/167,639中,其中每一个的全部内容通过引用明确地并入本文。
本发明的实施方式是用于置换原有心脏瓣膜的人工心脏瓣膜组件,其包括人工瓣膜和从其延伸的锚。人工瓣膜可具有支撑架和瓣膜部分。瓣膜部分是单向瓣膜,其可具有多个小叶,该多个小叶绕人工瓣膜到内部流动腔的中心轴固定到支撑架,并且配置为接合以允许血液以第一方向流经内部流动腔并且防止血液以第二方向流经内部流动腔。人工瓣膜具有外表面,其可配置为接合心脏的组织。至少一个锚构件从支撑架延伸,锚构件包括固定到支撑架的近端固定端以及远端自由端。锚构件至少部分地围绕人工瓣膜的周缘(绕其中心轴径向地)延伸,并且基本上平行于人工瓣膜外部,以限定小叶接收槽,该小叶接收槽配置为滑动地接收心脏瓣膜的小叶。小叶接收槽以连续的不间断的方式从锚构件的近端固定端延伸到锚构件的远端自由端。该槽具有合适尺寸并且配置为滑动地接收并且保持原有瓣膜的期望瓣膜小叶,其中原有瓣膜是原生心脏瓣膜或者先前植入的人工瓣膜。根据特定应用,槽可具有0.25至3.5英寸的长度和0.005至0.25英寸的宽度。
人工瓣膜可以基本上是管状的,外表面绕其周缘形成基本上连续的弯曲表面,锚构件形成曲线,该曲线平行于瓣膜的外表面的弯曲表面。
根据本发明的瓣膜组件可形成具有第一和第二锚构件的人工二尖瓣组件,该第一和第二锚构件限定第一和第二小叶接收槽并且分别具有第一和第二固定端以及第一和第二自由端。每个槽以连续的不间断的方式从锚固定端延伸到锚自由端。锚可以具有合适尺寸并且被布置以接合原生二尖瓣的前叶和后叶,使得槽具有合适尺寸以接收这些小叶。第一和第二锚可具有固定端,其绕装置的周缘被间隔开至少90度,并且更具体地约100度至140度并且更具体地120度,其中锚绕装置的周缘以相同的旋转方向(例如,顺时针方向)延伸。第一锚构件可围绕人工瓣膜的周缘穿过至少90度的角度,第二锚围绕人工瓣膜的周缘穿过至少120度的角度。
根据本发明的组件可形成瓣环成形环,其具有带有周缘的支撑环并且包括中心开口、围绕支撑环的覆盖物和第一锚构件,所述中心开口限定流体可流经其的流动轴,所述覆盖物包括外表面,所述第一锚构件从支撑架延伸。第一锚可具有固定到支撑环的第一近端固定端以及第一远端自由端,其中第一锚构件至少部分地围绕支撑环的周缘延伸并且基本上平行于覆盖物的外表面,以限定第一小叶接收槽,其配置为接收心脏瓣膜的小叶。第一小叶接收槽可优选地以连续的不间断的方式从第一近端固定端延伸到第一远端自由端。第一锚构件可围绕人工瓣膜的周缘延伸穿过至少90度的角度。
瓣环成形环可进一步包括额外的锚构件。例如,其可包括具有固定到支撑环的第二近端固定端和第二远端自由端的第二锚构件,其中第二锚构件至少部分地围绕瓣环成形环的周缘延伸并且基本上平行于其外部以限定第二小叶接收槽,其配置为接收心脏瓣膜的第二小叶。第二小叶接收槽可以以连续的不间断的方式从第二近端固定端延伸到第二远端自由端。第二近端固定端可以周向地从第一锚近端固定端位移至少90度的角度、100和140度之间的角度或约120度的角度。第一锚可围绕瓣环成形环的周缘延伸穿过90和120度之间的角度,并且第二锚可围绕瓣环成形环的周缘延伸穿过150和240度之间的角度。支撑环可以基本上是圆形的、基本上是D形的和/或基本上是鞍形的。
在原生瓣膜环处植入装置(例如,瓣环成形环、人工瓣膜等)的方法可以包括提供包括中央部分、第一弯曲锚、第二弯曲锚的装置,所述第一弯曲锚从固定到中央部分的第一固定端延伸并且大体上平行于其外表面穿过到第一弯曲锚的第一自由端,以形成第一小叶接收槽,所述第二弯曲锚从固定到中央部分的第二固定端延伸并且大体上平行于其外表面穿过到第二自由端,以形成第二小叶接收槽,其中中央部分限定流动轴穿过其中的流动孔口。方法可包括:用第一弯曲锚和第二弯曲锚布置装置邻近原生瓣膜环,装置的流体流动轴大体上平行于穿过原生瓣膜环的流体流动路径,并且将第一自由端布置邻近原生瓣膜环处的原有瓣膜的第一连合处;放置第一自由端在第一原有瓣膜小叶下面;基本上绕其流体流动轴旋转装置以推进第一自由端在第一原有瓣膜小叶下面并且从而滑动地推进第一原有瓣膜小叶进入第一小叶接收槽中;监视第二自由端相对于原有瓣膜的第二连合处的位置;以及一旦第二自由端邻近原有瓣膜的第二连合处,停止装置绕流体流动轴的旋转。一旦第二自由端邻近第二连合处,外科医生或其他使用者可以放置第二自由端在第二原有瓣膜小叶下面;重新开始基本上绕其流体流动轴旋转装置,以推进第二自由端在第二原有瓣膜小叶下面并且从而滑动地推进第二原有瓣膜小叶进入第二小叶接收槽中,同时也进一步推进第一自由端在第一原有瓣膜小叶下面并且进一步滑动地推进第一原有瓣膜小叶进入第一小叶接收槽中;以及当第一原有瓣膜小叶在邻近第一固定端的位置处滑动地推进进入第一小叶接收槽中时,停止旋转装置,由此完成装置的部署。
原生瓣膜环可以是二尖瓣环或三尖瓣环。如果原生环是三尖瓣环,装置可包括三个围绕装置的周长隔开的锚,每个锚配置为滑动地接收原有三尖瓣的三个瓣膜小叶中的一个。在原生瓣膜环是带有完整的原生二尖瓣小叶的二尖瓣环的情况中,第一连合处可以是原生二尖瓣的PC连合处,第一小叶可以是原生二尖瓣的前叶,第二连合处可以是原生二尖瓣的AC连合处,并且第二小叶可以是原生二尖瓣的后叶。
植入装置的方法包括心脏直视手术,包括其中在布置装置邻近原生瓣膜环之前的手术,外科医生或其他使用者暂时地停止心脏的心脏功能并且将患者放置在心肺旁路上。在完成装置的部署之后可以恢复心脏的心脏功能,并且然后从心肺旁路移走患者。
本发明的方法包括提供瓣膜修复或置换装置。装置可包括瓣环成形环,一个或多个锚从其延伸,或者可包括人工瓣膜,其具有支撑架和小叶,小叶固定到支撑架以形成单向瓣膜结构,并且一个或多个锚从支撑架延伸。每个锚具有固定到支撑架的近端和自由远端,槽被限定在支撑架和锚之间。锚邻近原生瓣膜的连合点布置,并且自由端被布置在瓣膜的原生小叶下面(并且在原生心脏瓣膜环下面)。装置(例如,瓣环成形环或人工心脏瓣膜)绕其中心轴旋转以推进锚在原生小叶下面,使得原生小叶被滑动地推进进入槽中。推进和固定可以在心脏直视或微创手术过程中执行。中央部分(例如,环部分或支撑架)可包括缝合环,并且固定支撑架到原生心脏瓣膜环的组织可包括将缝合环缝合到原生心脏瓣膜环的组织。装置可包括支架,在锚(一个或者多个)在原有小叶下面旋转之前、之中或之后,支架被膨胀以便与原生组织接触。原生瓣膜环可以是任何心脏瓣膜的原生瓣膜环,具体应用于二尖瓣和三尖瓣。
在将中央部分固定到原生瓣膜环之后,外科医生或其他使用者可添加一根或多根缝线或者其他固定装置/方法以固定装置到局部组织,以便防止装置向后旋转离开其部署的位置。在这样的部署中,锚保持装置以防止向上运动、向下运动、侧向运动等,而缝线或其他组织连接器用于防止装置旋转,使得小叶旋转地滑动离开槽以从锚释放。
方法可包括暂时地停止心脏的心脏功能和将患者放置在心肺旁路上,执行各种步骤(比如推进和固定人工瓣膜到原生环),并且然后恢复心脏的心脏功能并且从心肺旁路移走患者。装置的部署可以随旁路上的患者进行,或者可以随患者的心脏跳动(例如,在从旁路移走患者之后,随重新开始的心脏功能)进行,并且随外科医生或其他使用者当进行长度调整时监测心脏功能和/或心室形状而进行。
本发明的方法可包括在固定支撑架到原生心脏瓣膜环的组织之前从心脏除去一些原生瓣膜小叶和/或瓣下结构(例如,腱索)。
本发明的前述和其他目的、特征和优点将由下列详细描述变得更显而易见,这参照附图进行。
附图说明
图1是人心脏的左侧的横截面图,其示出通过二尖瓣与左心室分开的左心房;
图2是处于闭合位置的二尖瓣的外科医生的视图或平面图,其图解了附接到环(AN)的前叶(AL)和后叶(PL),并且指示可识别的小叶段;
图3是根据本发明实施方式的装置的实施方式的底视图;
图4和图5是根据本发明实施方式的部署在心脏中的装置的实施方式的透视图(以局部横截面)和顶视图;
图6A-6C是根据本发明的部署在二尖瓣环中的装置的顶视图;
图7A-7D分别是根据本发明实施方式的人工心脏瓣膜的侧视图、底视图、透视图和顶视图;
图8A和图8B是根据本发明实施方式的装置的侧视图;
图9A和图9B是根据本发明实施方式的装置的透视图和特写横截面图;
图10是根据本发明实施方式的装置的透视图;
图11是根据本发明实施方式的装置的顶视图;
图12是根据本发明实施方式的装置的顶视图;
图13是根据本发明实施方式的装置的透视图;
图14A-14B是根据本发明实施方式的装置的透视图;以及
图15是根据本发明实施方式的装置的顶视图。
具体实施方式
本发明是锚定装置,其包括人工心脏瓣膜和瓣环成形环以及使用该锚定装置用于固定在患者体内——比如在人心脏中的原生心脏瓣膜环——中的其他装置。该装置对固定在瓣膜(如二尖瓣和三尖瓣)的环处的装置具有特定适用性,该瓣膜具有瓣下结构比如腱索。二尖瓣及其瓣下结构描绘在图1和图2中。
图3描绘了用于锚定人工心脏瓣膜或修复环到心脏的二尖瓣环的装置10。虽然其他材料(金属或非金属的)可以是合适的,但是装置10可以由金属,比如不锈钢制成。装置10由中心环12组成,该中心环12具有两个半圆形锚,即前锚14a和后锚14p,该两个半圆形锚在围绕环的周缘间隔开大约120度的角度16的位置处附接到中心环12并且从中心环12延伸。该角度和间距将装置10分成大约1/3和2/3部分,从而接近原生二尖瓣的前叶和后叶的比例。锚14a、14p被间隔稍微远离中心环12的外周缘并且基本上平行于中心环12的外周缘定位,并且分别限定前小叶接收槽18a和后小叶接收槽18p。小叶接收槽18a、18p具有大体上相当于二尖瓣的前叶和后叶的厚度的宽度20a、20p,即槽18a、18p具有约0.005至0.25英寸的宽度。这些槽宽度20a、20p足以允许二尖瓣的前叶和后叶滑动地进入槽18a、18p。槽18a、18p具有长度22a、22p,足以接收各自二尖瓣小叶的大部分。前叶接收槽18a的长度22a可以在约0.25至3.5英寸之间,而后叶接收槽18p的长度22p可以在约0.25和3.5英寸之间。中心环12限定具有内径26的内开口24。如果装置10是人工心脏瓣膜的一部分(例如,人工心脏瓣膜的支撑支架的一部分),内径20可以在0.75至1.5英寸之间。如果装置10是瓣膜修复装置诸如瓣环成形环的一部分,内径可以在0.75至1.5英寸之间。
图4和图5描绘了锚定在二尖瓣环AN中的装置10。前叶AL被布置在前叶槽18a内,使得槽18a保持前叶AL的近端部分(小叶的近端部分邻近环AN,与邻近小叶边缘的远端部分相对)。类似地,后叶PL被布置在后叶槽18p内,使得槽18p接收后叶PL的近端部分(小叶的近端部分邻近环AN,与邻近小叶边缘的远端部分相对)。因此,前锚14a和后锚14p被布置在其各自的小叶AL、PL和心室壁之间,而中心环12被布置在二尖瓣环AN内。因此,锚14a、14p和槽18a、18p防止装置的移动,例如在心脏收缩过程中移动到心房中或者在心脏舒张过程中移动到心室中。小叶槽18a、18p用于夹紧小叶AL、PL,以锚定装置10在环AN中的期望位置。
图6A-6C示意性地描绘了装置10的安装,如从左心房观察的(即穿过二尖瓣向左心室中看)。在图6A中,布置装置10,中心环12大体上居中布置在二尖瓣环AN中,并且后锚自由端28p邻近AC连合处。将后锚自由端28p插在前叶和后叶之间(例如,通过整体地操纵装置10和/或通过弯曲后锚自由端28p远离邻近中心环12的其正常位置/从邻近中心环12的其正常位置向下),这样其布置在后叶PL下面,并且然后逆时针方向旋转装置10,后叶PL滑入后锚槽18p中,到其中前锚自由端28a邻近PC连合处的点,如图6B中所示。然后,将前锚自由端28a插在前叶和后叶之间(例如,通过整体地操纵装置10和/或通过弯曲前锚自由端28a远离邻近中心环12的其正常位置/从邻近中心环12的其正常位置向下),这样其布置在前叶AL下面,并且进一步顺时针方向旋转装置10,前叶AL滑入前锚槽18a中(并且后叶PL进一步滑入后锚槽18p中),直到该装置完全就位。当完全就位时,如图6C中所描绘的,锚14a、14p均在其各自的小叶AL、PL以下,前叶锚14a的附接杆30a被布置在PC连合处,并且后叶锚14p的附接杆30p被布置在AC连合处。
图7A-7D描绘了利用本发明的锚定组件的人工二尖瓣组件40。瓣膜组件40具有固定到支撑结构44的三叶瓣膜部分42。支撑结构44包括锚定装置46,其自身具有带有后锚50a和前锚50p的中心环48,后锚50a和前锚50p限定后槽52a和前槽52p,后槽52a和前槽52p配置为滑动地接收二尖瓣的后叶和前叶。组件40进一步包括上游支架结构54,其配置为被膨胀到与周围组织接合,如与心房壁接合。该支架可以是自膨胀的或球囊膨胀的。支架54优选被卷曲(在球囊膨胀的情况下)或受限制的(在自膨胀的情况下)为相对小的输送直径用于输送,如图8A中所描绘的。一旦锚部分与原生瓣叶完全接合(即被旋转至接合),支架可以被部署到其膨胀状态,如图8B中所描绘的。如果支架部分54是自膨胀的,输送导管将需要护套来限制支架为其压缩输送配置。如果支架是球囊膨胀的,输送导管将需要球囊或类似径向膨胀的装置,以径向膨胀支架。
各种元件的配置可以在组件上的不同位置处变化。例如,锚和/或中心环的横截面形状可以不同于矩形,和/或可以沿其长度改变。例如,如图9A和图9B中所描绘的,锚组件60可以具有中心环62,锚部分64a、64p具有“C”形的通道横截面。横截面形状可以被设计使得锚的平面内刚性基本上小于其平面外刚性,或者反之亦然。这种差异的刚性可以帮助锚在插入过程中贴合原生环,同时仍然提供轴向方向上的高保持力。
图10描绘了该装置的进一步实施方式,其中锚组件70具有后锚72p和前锚72a,但是锚72a、72p被固定至单独的组件环部分74a、74p。这些单独的环部分74a、74p可以相对于彼此旋转,从而允许锚72a、72p相对于彼此单独(独立)旋转。锚72a、72p的这种独立旋转可以使该装置的安装对于外科医生或其他使用者更容易。
可以作出各种修改以促进易用性。例如,锚装置80部分可以具有锚84a、84p,其具有圆端或其他的钝端,比如图11中所描绘的球形尖的端86a、86p,以便当小叶滑入槽88a、88p时降低尖端阻碍或损伤小叶组织、心室壁、索等的可能性。此类结构可以使锚84a、84p更容易在瓣膜小叶之后穿过。圆形结构可以与锚(即,同时,由相同材料形成等)形成为一体化部分,或者可以是在制造过程中附接到锚的单独部件。例如,圆形部分可以由压装和/或粘接到锚的PTFE形成。
根据本发明的锚定装置可以使用各种材料,并且可以包括覆盖物等。例如,锚定装置(例如由金属形成)的结构可以包括布覆盖物。这种覆盖物可以用于多种目的。例如,用促进组织向内生长的生物相容覆盖物,如PTFE布覆盖装置将促进患者的原生组织随时间附接到装置,可能地减少组织刺激和来自金属对组织接触的潜在损害。组织向内生长也可以帮助通过提供机械稳定性改进装置的锚定并且由此降低移动和栓塞的机会。该覆盖物,尤其是布覆盖物也可以为外科医生或其他使用者提供使用缝线来进一步固定装置在适当位置的能力。柔性/弹性覆盖物,如布也可以提供表面,该表面将“让路”(例如,被压缩)以允许小叶滑入槽中,但也将推回(即弹回)到槽中,以便一次接合小叶在适当位置并且帮助保持装置在适当位置。覆盖物也可以用于保持润滑涂层,如甘油,这可以促进锚在小叶和心室之间穿过。
如果存在,覆盖物可以配置为随时间生物再吸收(bioresorb)或以其他方式降解,或者可以由不会随时间生物降解/生物再吸收的材料(一种或多种)形成。潜在用于本发明的此类材料的示例包括PTFE、聚酯、尼龙和其他。
根据本发明的装置的结构支撑部分可以由金属或非金属形成,包括不锈钢、镍钛诺、钛、CoCr、合金、聚合材料和其他生物相容材料。结构支撑部分(即中心环和锚)可优选地由具有最小弹性的基本上刚性的并且不容易塑性变形的材料形成。根据本发明的装置可包括不透射线标记和其他结构,以在植入过程中增强可视性。例如,锚构件可具有一个或多个布置在其上的不透射线标记,如在自由端的尖端处和/或在固定端处。这样的不透射线标记可由高度不透射线材料(例如,金、铂)形成,该材料安装在装置的结构支撑件和/或其他部分上、嵌入装置的结构支撑件和/或其他部分中、与装置的结构支撑件和/或其他部分一起形成或者以其他方式固定到装置的结构支撑件和/或其他部分。
图12描绘了锚组件90的进一步实施方式,其中中心环92具有三个围绕装置的周长布置的锚94a、94b、94c。在所描绘的具体实施方式中,虽然其他间距在本发明的范围内,但是锚94a、94b、94c以约120度与彼此间隔。三锚设计可以适用于非二尖瓣位置处的部署,如在三尖瓣位置处(即在右心室和右心房之间的瓣膜和环)。可替代地,这种组件可以用于锚定在二尖瓣处,其中臂之一(例如,臂94a)用于固定到前叶,并且其他两个臂(例如,臂94a、94c)用于固定到后叶。为了适当地穿过装置到合适位置,外科医生或其他使用者可能需要在后叶中形成切口,比如在接近小叶/环接合处的连合点AC和PC之间的中间位置处,以便推进“额外的”臂(即,臂94c)在后叶下面。然后,后叶将具有两个锚,一个在AC连合处开始,一个在后叶的中间处(即,在所谓的“P2”部分中)开始。这样的配置可提供改进的部署和锚定能力。
本发明的进一步实施方式描绘在图13中,其中锚组件100具有中央部分102,锚104a、104p布置在中央部分102下面(例如,下游)。该配置提供对于给定原生瓣膜环尺寸在中央部分102上具有较大中心开口106的可能性,因此这可以容纳较大的人工瓣膜孔口(其中锚组件是人工瓣膜组件的一部分)或较大的原生瓣膜孔口(其中锚组件是修复装置,比如瓣环成形环的一部分)。
图14A和图14B描绘了锚组件110的进一步实施方式,其中锚112、112p以支架结构114的形式直接固定到中央部分。因此,支架结构114是代替如图3中所描绘的中心环部分的中央部分。图14B添加有与组件110一起形成或以其他方式附接到组件110的瓣膜支撑组件(即,连合支撑件116)。此类锚组件可用作人工瓣膜组件的一部分,如先前在图7A-7D中所描绘的。图14A-14B的实施方式具有额外的优势,即整个锚组件可以被径向地压缩,使得假体(例如,瓣环成形环和/或人工心脏瓣膜)可以被卷曲或以其他方式径向压缩为较小输送轮廓用于经由导管插入(例如,经皮/MIS)潜在输送到原生环并且部署在原生环处。如图14中所示的装置可以在经皮或微创式介入中或者经由心脏直视被输送通过导管。
虽然上面大体上描绘的实施方式具有基本上圆形的配置,这在一些应用——比如人工心脏瓣膜和瓣环成形环——中可以是优选的,但是本发明并不因此受限制。例如,也可以使用非圆形配置,如在图15中所描绘的大体D形配置。锚组件120具有基本上D形的中央部分122,锚124a、124p从其延伸并且弯曲以便配合中央部分122的基本D形状。这样的非圆形配置可以是特别有用的,其中锚组件120用作瓣环成形环或类似修复装置的一部分,如用于二尖瓣的瓣环成形环。注意根据本发明的锚组件——是否是圆形或非圆形,都不必是平面的。例如,三维形式,如在2004年10月19日授权的题为“Mitral ValveAnnuloplasty Ring for Molding Left Ventricle Geometry”的美国专利号6,805,710(其全部内容通过引用并入本文)中公开的所谓“3D鞍形状”也可以与本发明一起使用,以便形成贴合原生解剖结构或者使原生解剖结构变形/再成形的装置。
鉴于许多其中可以应用公开的发明的原则的可能的实施方式,应该认识到所阐述的实施方式仅是本发明的优选示例并且不应该视为限制本发明的范围。相反,本发明的范围由权利要求限定。
Claims (20)
1.一种设计用于在原生心脏瓣膜环处植入的装置的锚定装置,所述锚定装置包括:
中央部分,其具有一个或多个从其延伸的锚,所述一个或多个锚的每一个都具有固定到所述中央部分的近端固定端并且终止于自由端,所述一个或多个锚被间隔稍微远离以弯曲方式的所述中央部分的周缘并且基本上平行于以弯曲方式的所述中央部分的周缘定位,在所述锚和所述中央部分之间形成瓣膜小叶接收槽。
2.根据权利要求1所述的锚定装置,其中所述锚包括横截面,该横截面配置为具有与平面外刚性不同的平面内刚性。
3.根据权利要求1所述的锚定装置,其中所述锚大体上等距离地围绕所述锚定装置的所述中央部分的周缘布置。
4.根据权利要求1所述的锚定装置,其中所述锚由金属或聚合物形成。
5.根据权利要求1所述的锚定装置,其进一步包括一个或多个布置在其上的不透射线标记。
6.根据权利要求1所述的锚定装置,其中所述装置具有两个锚,并且所述锚的所述固定端被间隔开至少90度。
7.根据权利要求1所述的锚定装置,其中所述装置具有两个锚,并且所述锚的所述固定端被间隔开约120度。
8.根据权利要求1所述的锚定装置,其中所述装置具有两个锚,其中一个锚长于另一个锚。
9.根据权利要求1所述的锚定装置,其中所述装置具有三个锚。
10.根据权利要求1所述的锚定装置,其中所述槽具有约0.25至3.5英寸的长度。
11.根据权利要求1所述的锚定装置,其进一步包括布覆盖物。
12.根据权利要求1所述的锚定装置,其中所述中央部分基本上是圆形的。
13.根据权利要求1所述的锚定装置,其中所述中央部分是大体上D形的。
14.根据权利要求1所述的锚定装置,其进一步包括人工瓣膜,所述人工瓣膜包括支撑架和瓣膜部分,其中所述锚定装置被固定到所述人工瓣膜的所述支撑架。
15.根据权利要求14所述的锚定装置,其中所述人工瓣膜的至少一部分基本上是管状的并且具有形成连续弯曲表面的外表面,并且所述一个或多个锚形成曲线,所述曲线与所述人工瓣膜的外表面的弯曲表面平行。
16.根据权利要求1所述的锚定装置,其进一步包括瓣环成形环,其中所述锚定装置被固定到所述环,使得所述一个或多个锚至少部分地围绕所述环的周缘延伸并且基本上平行于所述环的外表面。
17.一种在原生瓣膜环处植入装置的方法,其包括:
提供包括中央部分、第一弯曲锚、第二弯曲锚的装置,所述第一弯曲锚从固定到所述中央部分的第一固定端延伸并且大体上平行于其外表面穿过到所述第一弯曲锚的第一自由端,以形成第一小叶接收槽,所述第二弯曲锚从固定到所述中央部分的第二固定端延伸并且大体上平行于其外表面穿过到第二自由端,以形成第二小叶接收槽,其中所述中央部分限定具有流体流动轴穿过其中的流动孔口;
用邻近所述原生瓣膜环的所述第一弯曲锚和第二弯曲锚布置所述装置,所述装置的流体流动轴大体上平行于穿过所述原生瓣膜环的流体流动路径,并且所述第一自由端邻近所述原生瓣膜环处的原有心脏瓣膜的第一连合处布置;
放置所述第一自由端在第一原有瓣膜小叶下面;
基本上绕其流体流动轴旋转所述装置,以推进所述第一自由端在所述第一原有瓣膜小叶下面并且由此滑动地推进所述第一原有瓣膜小叶进入所述第一小叶接收槽中;
监视所述第二自由端相对于所述原有心脏瓣膜的第二连合处的位置;
一旦所述第二自由端邻近所述原有心脏瓣膜的所述第二连合处,停止绕所述流体流动轴旋转所述装置;
放置所述第二自由端在第二原有瓣膜小叶下面;
重新开始基本上绕其流体流动轴旋转所述装置,以推进所述第二自由端在所述第二原有瓣膜小叶下面并且由此滑动地推进所述第二原有瓣膜小叶进入所述第二小叶接收槽中,同时也进一步推进所述第一自由端在所述第一原有瓣膜小叶下面并且进一步滑动地推进所述第一原有瓣膜小叶进入所述第一小叶接收槽中;以及
当所述第一原有瓣膜小叶在邻近所述第一固定端的位置处被滑动地推进到所述第一小叶接收槽中时,停止旋转所述装置,由此完成所述装置的部署。
18.根据权利要求17所述的方法,其中所述装置包括人工瓣膜,其中所述人工瓣膜包括支撑架和小叶,所述小叶固定到所述支撑架,以形成控制沿所述流动轴的流体流动的单向瓣膜结构。
19.根据权利要求17所述的方法,其中所述原有瓣膜环是原生二尖瓣环,所述第一连合处是原生二尖瓣的PC连合处,所述第一小叶是所述原生二尖瓣的前叶;所述第二连合处是所述原生二尖瓣的AC连合处,并且所述第二小叶是所述原生二尖瓣的后叶。
20.根据权利要求17所述的方法,其中所述装置包括瓣环成形环,所述中央部分形成所述瓣环成形环的环部分。
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PCT/US2012/065312 WO2013095816A1 (en) | 2011-12-21 | 2012-11-15 | Anchoring device and method for replacing or repairing a heart valve |
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US10849752B2 (en) | 2020-12-01 |
EP2793752A1 (en) | 2014-10-29 |
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EP2793752B1 (en) | 2021-04-21 |
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US20160367365A1 (en) | 2016-12-22 |
EP2793752A4 (en) | 2015-06-03 |
CN104125817B (zh) | 2017-03-22 |
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