本申请要求于2014年6月18日提交的题目为“用于治疗瓣膜返流的二尖瓣植入物”的美国临时专利申请号62/014060的优先权。之前的优先权申请的全部公开内容通过引用并入本文用于所有目的。This application claims priority to US Provisional Patent Application No. 62/014060, filed June 18, 2014, entitled "Mitral Valve Implant for the Treatment of Valve Regurgitation." The entire disclosure of the prior priority application is incorporated herein by reference for all purposes.
背景background
领域field
本发明总体上提供典型地用于治疗心瓣膜疾病和/或用于改变身体的一个或多个瓣膜的特征的改进的医学装置、系统和方法。本发明的实施方案包括用于治疗二尖瓣返流的植入物。The present invention generally provides improved medical devices, systems and methods typically for treating heart valve disease and/or for altering the characteristics of one or more valves of the body. Embodiments of the invention include implants for the treatment of mitral regurgitation.
人心脏经由静脉自器官和组织接收血液，泵送所述血液通过肺部，在肺中血液变得富含氧，并且推动充氧的血液离开心脏到动脉以使得身体的器官系统可以提取氧以用于适当的功能。脱氧的血液流回心脏，在心脏中其被再次泵送至肺部。The human heart receives blood from organs and tissues via veins, pumps the blood through the lungs, where it becomes enriched with oxygen, and pushes the oxygenated blood away from the heart to the arteries so that the body's organ systems can extract oxygen for for the appropriate function. The deoxygenated blood flows back to the heart where it is pumped again to the lungs.
心脏包括四个腔室：右心房(RA)，右心室(RV)，左心房(LA)和左心室(LV)。心脏左右侧的泵送作用在总的心动周期期间一般同步发生。The heart consists of four chambers: the right atrium (RA), right ventricle (RV), left atrium (LA) and left ventricle (LV). The pumping action of the left and right sides of the heart generally occurs simultaneously during the total cardiac cycle.
心脏具有四个瓣膜，所述瓣膜通常被配置成在心动周期期间选择性地在正确的方向上输送血流。将心房与心室分开的瓣膜被称为心房心室(或AV)瓣膜。左心房和左心室之间的AV瓣膜是二尖瓣。右心房和右心室之间的AV瓣膜是三尖瓣。肺动脉瓣将血流引导至肺动脉并且由此至肺部；血液经由肺静脉回到左心房。主动脉瓣引导血流通过主动脉并且由此至外周。通常在心室之间或在心房之间没有直接连接。The heart has four valves that are generally configured to selectively deliver blood flow in the correct direction during the cardiac cycle. The valve that separates the atria from the ventricles is called the atrioventricular (or AV) valve. The AV valve between the left atrium and left ventricle is the mitral valve. The AV valve between the right atrium and right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and thence to the lungs; blood returns to the left atrium via the pulmonary vein. The aortic valve directs blood flow through the aorta and thence to the periphery. Usually there is no direct connection between the ventricles or between the atria.
机械心脏搏动由在整个心脏组织中传播的电脉冲触发。心瓣膜的开启和关闭可以主要由于腔室间的压差所致而发生，这些压力由被动充填或腔室收缩产生。例如，二尖瓣的开启和关闭可以由于左心房和左心室之间的压差而发生。Mechanical heart beats are triggered by electrical impulses that propagate throughout the heart tissue. The opening and closing of heart valves can occur primarily as a result of pressure differentials between the chambers, generated by passive filling or chamber contraction. For example, the opening and closing of the mitral valve can occur due to a pressure difference between the left atrium and left ventricle.
在心室充填(舒张)开始时，主动脉瓣和肺动脉瓣闭合以防止从动脉回流到心室中。其后即刻，AV瓣膜打开以允许从心房到相应的心室中的不受阻碍的流动。在心室收缩(即，心室排空)开始后即刻，三尖瓣和二尖瓣通常关闭，从而形成密封，所述密封防止从心室流回到相应的心房中。At the onset of ventricular filling (diastole), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricles. Immediately thereafter, the AV valves open to allow unimpeded flow from the atrium into the corresponding ventricle. Immediately after the onset of ventricular contraction (ie, ventricular emptying), the tricuspid and mitral valves normally close, forming a seal that prevents flow from the ventricle back into the corresponding atrium.
不幸地，AV瓣膜可能受损或可能不能适当地发挥功能，从而导致非正常的闭合。AV瓣膜是复杂的结构，通常包括瓣环(annulus)，瓣叶(leaflet)，索(chordae)和支持结构。各个心房经由心房前庭与其瓣膜连接。二尖瓣具有两个瓣叶；三尖瓣的类似结构具有三个瓣叶，并且相应的瓣叶表面朝向彼此的相对或接合帮助提供瓣膜的闭合或密封从而防止血液在错误方向上流动。在心室收缩期期间瓣叶不能密封被称为不良对合，并且可能允许血液通过瓣膜回流(返流)。心瓣膜返流可能对患者造成严重的后果，通常导致心力衰竭，血流减少，低血压，和/或到身体组织的氧流动减少。二尖瓣返流也可能导致血液从左心房回流到肺静脉，导致充血。严重的瓣膜返流，如果不加治疗，可能导致永久性的残疾或死亡。Unfortunately, the AV valve may be damaged or may not function properly, resulting in abnormal closure. The AV valve is a complex structure that generally includes an annulus, leaflets, chordae and support structures. Each atrium is connected to its valves via the atrial vestibule. The mitral valve has two leaflets; a similar structure of the tricuspid valve has three leaflets, and the facing or coaptation of the respective leaflet surfaces towards each other helps to provide closure or sealing of the valve preventing blood from flowing in the wrong direction. Failure of the leaflets to seal during ventricular systole is known as malapposition and may allow blood to flow back through the valve (regurgitation). Heart valve regurgitation can have serious consequences for the patient, often resulting in heart failure, decreased blood flow, hypotension, and/or reduced oxygen flow to body tissues. Mitral regurgitation may also cause blood to back up from the left atrium into the pulmonary veins, causing congestion. Severe valve regurgitation, if left untreated, can lead to permanent disability or death.
相关技术描述Related technical description
多种疗法已被应用于治疗二尖瓣返流，并且其他疗法依然被提出但还未被实际用于治疗患者。虽然已经发现若干已知疗法为至少某些患者提供好处，但是仍然需要进一步的选择。例如，药剂(如利尿剂和血管舒张药)可以用于具有轻度二尖瓣返流的患者以帮助减少回流至左心房中的血液的量。然而，药疗法可能缺少患者的依从。很多患者可能偶尔(或甚至是有规律地)没能进行药疗，尽管存在慢性和/或日益恶化的二尖瓣返流的潜在的严重性。二尖瓣返流的药理学治疗也可能是不方便的，常常是无效的(尤其是随着情况恶化)，并且可能与严重的副作用(如低血压)相关。Various therapies have been applied to treat mitral regurgitation, and others are still proposed but have not actually been used to treat patients. While several known therapies have been found to provide benefit to at least some patients, further options are still needed. For example, medications such as diuretics and vasodilators may be used in patients with mild mitral regurgitation to help reduce the amount of blood flowing back into the left atrium. However, drug regimens may lack patient compliance. Many patients may occasionally (or even regularly) miss medication despite the underlying severity of chronic and/or worsening mitral regurgitation. Pharmacological treatment of mitral regurgitation can also be inconvenient, often ineffective (especially as the condition worsens), and may be associated with serious side effects such as hypotension.
各种手术选项也已经被提出和/或用于治疗二尖瓣返流。例如，心内直视手术(open-heart surgery)可以替换或修复功能障碍的二尖瓣。在瓣膜成形术(annuloplasty)瓣环修复中，后二尖瓣环沿其周长的尺寸可以被减小，任选地使用缝线通过机械手术瓣膜成形术缝合瓣环以提供对合(coaptation)。开放手术也可能设法对瓣叶进行整形和/或对支持结构进行改造。无论如何，开放二尖瓣手术(open mitral valve surgery)通常都是一种非常侵入性的治疗，其在患者处于全身麻醉并且胸腔被切开的情况下在心肺机上进行。并发症可以是常见的，并且考虑到心内直视手术的发病率(以及潜在的死亡率)，时间安排变成难题-病更重的患者可能非常需要手术，但是却较不能经受得住手术。成功的开放二尖瓣手术结果也可能非常依赖于手术技巧和经验。Various surgical options have also been proposed and/or used to treat mitral regurgitation. For example, open-heart surgery can replace or repair a malfunctioning mitral valve. In annuloplasty annulus repair, the posterior mitral annulus may be reduced in size along its circumference, optionally using sutures to provide coaptation by mechanically surgical annuloplasty closing of the annulus . Open surgery may also seek to reshape the valve leaflets and/or remodel support structures. Regardless, open mitral valve surgery is typically a very invasive procedure performed on a heart-lung machine while the patient is under general anesthesia and the chest cavity is cut open. Complications can be common, and given the morbidity (and potential mortality) of open-heart surgery, timing becomes a challenge—more ill patients may be in dire need of surgery, but less able to withstand it . Successful open mitral valve surgery outcomes can also be very dependent on surgical skill and experience.
考虑到心内直视手术的发病率和死亡率，创新者已经探寻较小侵入性的手术疗法。利用机器人或通过内窥镜进行的方法通常仍然是相当侵入性的，并且也可能是耗时的，昂贵的，并且在至少某些情况中，非常依赖于外科医生的技术。给这些有时虚弱的患者加以甚至更少的创伤将是理想的，同样理想的将是提供这样的疗法，所述疗法可以由大量的医生使用相差大的技术成功地实施。为此，已经提出了多种据称侵入性较小的技术和方法。这些包括设法从冠状窦内对二尖瓣环进行整形的装置；试图通过从上到下系紧天然瓣环对瓣环进行整形的装置；融合瓣叶的装置(模仿Alfieri缝合)；对左心室进行整形的装置等。Given the morbidity and mortality associated with open-heart surgery, innovators have sought less invasive surgical approaches. Methods performed robotically or endoscopically are still generally quite invasive, and can also be time-consuming, expensive, and, in at least some cases, very dependent on the skill of the surgeon. Inflicting even less trauma on these sometimes debilitating patients would be ideal, as would it be to provide a therapy that can be successfully administered by a large number of physicians using widely varying techniques. To this end, various supposedly less invasive techniques and methods have been proposed. These include devices that seek to reshape the mitral annulus from within the coronary sinus; devices that attempt to reshape the annulus by tightening the native annulus from above to below; devices that fuse the leaflets (mimicking the Alfieri suture); Devices for shaping, etc.
已经开发出了也许是最为人所知的多种二尖瓣置换植入物，这些植入物通常替换(或顶替)天然瓣叶并且依靠手术植入的结构来控制心脏腔室之间的血液流动路径。虽然这些各种各样的方法和工具满足不同水平的肯定，还没有一种被广泛地认可为用于大多数或所有遭受二尖瓣返流的患者的理想疗法。Perhaps the best-known variety of mitral valve replacement implants has been developed, which typically replace (or replace) the natural valve leaflets and rely on a surgically implanted structure to control blood flow between the heart's chambers flow path. Although these various methods and tools meet varying levels of affirmation, none is widely recognized as an ideal therapy for most or all patients suffering from mitral regurgitation.
由于已知的最小侵入性二尖瓣返流疗法和植入物的难题和缺点，仍然还有备选的治疗被提出。一些备选提议要求植入的结构在整个心搏周期内保持在瓣环内。这些提议中的一组包括圆柱形气球等在通过瓣膜开口在心房和心室之间延伸的绳索或刚性杆上保持植入。另一组依靠弓形环结构等，通常结合延伸穿过瓣膜的拱璧(buttress)或结构横构件，以固定植入物。不幸地，天然瓣叶和气球或其他同轴体的全部周长之间的密封可以证明是有挑战的，同时如果允许拱璧或固定器互连横构件弯曲，则每次心搏期间天然瓣环周围的显著收缩可能导致长期植入期间显著的疲劳失效组织。此外，瓣膜组织的显著移动可能使植入物的准确定位变得困难，而与植入物是刚性的还是挠性的无关。Due to the difficulties and shortcomings of the known minimally invasive mitral regurgitation therapies and implants, alternative treatments have still been proposed. Some alternative proposals require the implanted structure to remain within the annulus throughout the heart cycle. One group of these proposals involves a cylindrical balloon or the like held implanted on a tether or rigid rod extending between the atrium and ventricle through the valve opening. Another group relies on arcuate ring structures and the like, often in conjunction with buttresses or structural cross members extending through the valve, to secure the implant. Unfortunately, the seal between the native valve leaflets and the full circumference of the balloon or other coaxial body can prove challenging, while if the buttresses or anchor interconnecting cross-members are allowed to bend, the native valve annulus can become unstable during each heartbeat. Significant shrinkage of the tissue may result in significant fatigue failure during long-term implantation. In addition, significant movement of valve tissue can make accurate positioning of the implant difficult, regardless of whether the implant is rigid or flexible.
鉴于以上，理想的是提供改进的医学装置、系统和方法。尤其理想的是提供新技术用于治疗二尖瓣返流和其他心瓣膜疾病，和/或用于改变身体的其他瓣膜中的一个或多个的特征。仍然需要这样的装置，其可以经由融合或其他方式直接加强瓣叶对合(而不是间接地经由瓣环或心室整形)并且不破坏瓣叶解剖学，但是可以简单且可靠地配置，并且无需过多的成本或手术时间。将尤其有利的是如果这些新技术能够使用较小侵入方法实施，而不需要为了配置停止心脏或依赖心肺机，并且不需要依赖于外科医生的专业技术，从而提供提高的瓣膜和/或心脏功能。In view of the above, it would be desirable to provide improved medical devices, systems and methods. It would be especially desirable to provide new techniques for treating mitral regurgitation and other heart valve diseases, and/or for altering the characteristics of one or more of the body's other valves. There remains a need for devices that can directly enhance leaflet coaptation via fusion or otherwise (rather than indirectly via annulus or ventricular reshaping) and that do not disrupt leaflet anatomy, yet are simple and reliable to deploy, and do not require excessive extra cost or surgical time. It would be especially advantageous if these new techniques could be implemented using less invasive methods, without the need to stop the heart or rely on a heart-lung machine for deployment, and without relying on the expertise of the surgeon, thereby providing improved valve and/or heart function .
概述overview
在一些实施方案中，本文公开了一种用于治疗心瓣膜关闭不全的植入物。所述植入物可以包括下列中的一种或多种：形状记忆结构，偶接至所述结构的生物相容膜，放置在所述植入物的近侧上并偶接至所述膜的中枢(hub)，沿所述近侧上的所述膜的边缘的一个、两个或多个孔或穿孔，和偶接至锚固装置的心室突出物。所述植入物可以折叠起来用于通过经皮导管递送。形状记忆结构可以包括形状记忆脊(spine)，诸如镍钛诺或例如PEEK。心室突出物的一部分，诸如远侧尖端，可以是不透射线的。锚固装置可以是主动的，或被动的。所述脊可以包括诸如用于连接至所述膜和组织的微细孔和微型钩的部件。In some embodiments, disclosed herein is an implant for treating cardiac valve insufficiency. The implant may comprise one or more of: a shape memory structure, a biocompatible membrane coupled to the structure, placed on the proximal side of the implant and coupled to the membrane One, two or more holes or perforations along the edge of the membrane on the proximal side, and a ventricular protrusion coupled to an anchoring device. The implant can be folded for delivery through a percutaneous catheter. The shape memory structure may comprise shape memory spines such as Nitinol or eg PEEK. A portion of the ventricular protrusion, such as the distal tip, may be radiopaque. Anchoring devices can be active, or passive. The spines may include features such as microscopic holes and microhooks for attachment to the membrane and tissue.
本文还公开了一种可操控导管，其包括可操控轴、可旋转柄部中的一种或多种，所述可旋转柄部偶接至放置在所述轴内的牵引线以根据施加于所述柄部的扭矩量调整所述轴的远侧尖端的弯曲半径。在一些实施方案中，所述导管的所述柄部的直径等于所述可操控轴的直径，或不大于所述可操控轴的直径。本文还公开了一种递送导管，所述递送导管包括下列中的一种或多种：偶接至放置在可扭转(torqueable)轴内的牵引线以调整所述导管的所述轴的远侧尖端的弯曲半径的可旋转柄部，被设计成当所述植入物被折叠时容纳所述植入物的鞘，和远侧尖端，所述远侧尖端进一步包括能够使递送导管连接至植入物的中枢(hub)或连接至锚固件的锁定部件。在一些实施方案中，所述导管还可以包括可撕开的一次性漏斗以辅助所述植入物的折叠。在一些实施方案中，所述远侧尖端进一步包括锁定舌片，所述锁定舌片自然地设置为处于解锁位置。所述递送导管可以偶接至所述植入物的瓣环中枢(annular hub)，所述瓣环中枢具有接纳所述递送导管的锁定舌片的部件。在一些实施方案中，引导丝或其他导管可以在所述轴内插入以将锁定舌片推向所述植入物的中枢上的配对部件使得所述导管和所述中枢被锁定。所述导管还可以包括环，诸如从近侧柄部行进至远侧尖端的金属丝使得环中的张力可以经由柄部上的控制件来控制。递送导管可以偶接至植入物的瓣环中枢，所述瓣环中枢具有十字销。引导丝或其他导管可以在所述轴内被插入，并且将金属丝环抵靠十字销和引导丝拉紧，直至环上的张力得到维持为止，使得所述递送导管锁定到所述植入物的中枢。Also disclosed herein is a steerable catheter comprising one or more of a steerable shaft, a rotatable handle coupled to a pull wire placed within the shaft to The amount of torque of the handle adjusts the bend radius of the distal tip of the shaft. In some embodiments, the diameter of the handle of the catheter is equal to, or not greater than, the diameter of the steerable shaft. Also disclosed herein is a delivery catheter comprising one or more of: a pull wire coupled to a pull wire placed within a torqueable shaft to adjust the distal side of the shaft of the catheter A rotatable handle with a radius of curvature of the tip, a sheath designed to accommodate the implant when the implant is folded, and a distal tip further comprising a delivery catheter that can be connected to the implant. The hub of the entry or the locking member connected to the anchor. In some embodiments, the catheter may also include a tearable disposable funnel to aid in folding of the implant. In some embodiments, the distal tip further includes a locking tab that is naturally disposed in an unlocked position. The delivery catheter may be coupled to an annular hub of the implant having a feature that receives a locking tab of the delivery catheter. In some embodiments, a guide wire or other catheter may be inserted within the shaft to push a locking tab against a mating component on the hub of the implant such that the catheter and hub are locked. The catheter may also include a loop, such as a wire that travels from the proximal handle to the distal tip so that the tension in the loop can be controlled via controls on the handle. The delivery catheter can be coupled to the annulus hub of the implant, which has a cross pin. A guidewire or other catheter can be inserted within the shaft and the wire loop pulled tight against the cross pin and guidewire until tension on the loop is maintained so that the delivery catheter locks to the implant of the center.
植入物可以经由锚固件与递送导管的第一偶接以及锚固件与植入物中枢的第二偶接(其中向递送导管施加扭矩从而将锚固件插入到中枢和组织中)可操作地偶接至组织，诸如心脏组织。第一偶接可以被解偶接以收回所述导管。The implant can be operably coupled via a first coupling of the anchor to the delivery catheter and a second coupling of the anchor to the hub of the implant (where torque is applied to the delivery catheter to insert the anchor into the hub and tissue). Attached to tissue, such as heart tissue. The first coupling can be uncoupled to retrieve the catheter.
在一些实施方案中，连合(commissure)锚固件可以通过下列步骤中的一个或多个来被递送：将锚固件偶接到导管的轴，将所述锚固件和所述导管推进至锚固部位，递送所述锚固件使得其与植入物和组织接合，并且将所述锚固件从所述轴解偶接。所述轴可以是可施加力矩的，并且接合机构可以向所述轴施加扭矩使得所述锚固件与植入物和组织接合。所述锚固件可以由形状记忆材料制成并且可以被压缩至导管的轴中用于递送至锚固部位，其中导管的远侧尖端被成型为使得其刺穿组织。可以在递送导管首先刺穿组织后推进锚固件，并且随后收回导管，留下锚固件就位。In some embodiments, a commissure anchor may be delivered by one or more of the following steps: coupling the anchor to the shaft of the catheter, advancing the anchor and the catheter to the anchor site , delivering the anchor such that it engages the implant and tissue, and uncoupling the anchor from the shaft. The shaft may be torqueable, and the engagement mechanism may apply torque to the shaft to engage the anchor with the implant and tissue. The anchor can be made of a shape memory material and can be compressed into the shaft of a catheter for delivery to the anchoring site, with the distal tip of the catheter shaped so that it penetrates tissue. The anchor may be advanced after the delivery catheter first penetrates the tissue, and the catheter subsequently retracted, leaving the anchor in place.
在一些实施方案中，公开了一种用于治疗心瓣膜关闭不全的植入物。所述植入物可以包括下列中的一个或多个：可移除的形状记忆结构，偶接至所述结构的生物相容膜，放置在所述植入物的近侧上并偶接至所述膜的中枢，沿所述近侧上的所述膜的边缘的一个、两个或多个孔或穿孔，和偶接至锚固装置的心室突出物。所述植入物还可以包括至少一个通路，诸如围绕瓣环边缘放置和/或沿心室突出物的通路。在一些实施方案中，递送多个，诸如2个、3个、4个、5个或更多个锚固件从而将植入物偶接到心脏组织。递送装置可以具有远侧段，所述远侧段包括可旋转地偶接到中央旋转轴的1个、2个或多个锚固件。弹簧支承机构可以施加推力以便导致锚固件离开远端。在一些实施方案中，锚固件可以容纳在内径上带有凹槽的外壳中，使得当中央旋转轴旋转时，锚固件可以离开远端。所述装置可以包括下列的一种或多种，例如：空心轴，在所述空心轴的端部处的尖头，放置在空心轴内的被金属线穿过的一个、两个或多个空心桶，和在近端处的推杆，使得当向推杆施加力时，所述桶一个接一个地离开空心轴。In some embodiments, an implant for treating cardiac valve insufficiency is disclosed. The implant may include one or more of the following: a removable shape memory structure, a biocompatible membrane coupled to the structure, placed on the proximal side of the implant and coupled to A hub of the membrane, one, two or more holes or perforations along the edge of the membrane on the proximal side, and a ventricular protrusion coupled to an anchoring device. The implant may also include at least one pathway, such as a pathway placed around the annulus rim and/or along a ventricle protrusion. In some embodiments, multiple, such as 2, 3, 4, 5 or more anchors are delivered to couple the implant to cardiac tissue. The delivery device may have a distal section comprising 1, 2 or more anchors rotatably coupled to a central axis of rotation. The spring support mechanism can apply a pushing force to cause the anchor to disengage from the distal end. In some embodiments, the anchor can be received in a housing with grooves on the inner diameter such that when the central axis of rotation is rotated, the anchor can be moved away from the distal end. The device may comprise one or more of the following, for example: a hollow shaft, a prong at the end of the hollow shaft, one, two or more hollow barrels, and a pushrod at the proximal end, such that the barrels leave the hollow shaft one by one when force is applied to the pushrod.
在一些实施方案中，本文公开了一种可操控引导丝，包括细长的挠性体部，其具有纵轴、近端和远侧偏转区；在所述近端上的控制件，其用于所述偏转区的可控偏转；和从所述控制件向所述偏转区延伸的可移动偏转元件。在一些实施方案中，所述引导丝没有任何部分的外径大于约10弗伦奇、8弗伦奇、6弗伦奇或4弗伦奇。所述控制件可以具有不大于所述体部的外径的外径。所述控制件围绕所述轴的旋转可以导致所述偏转区的横向移动。所述控制件围绕所述轴在第一方向上的旋转可以导致所述偏转元件的近侧回缩。In some embodiments, disclosed herein is a steerable guide wire comprising an elongate flexible body having a longitudinal axis, a proximal end and a distal deflection zone; a control on the proximal end for use with controllable deflection in said deflection zone; and a movable deflection element extending from said control member to said deflection zone. In some embodiments, no portion of the guide wire has an outer diameter greater than about 10 French, 8 French, 6 French, or 4 French. The control member may have an outer diameter no greater than that of the body. Rotation of the control about the axis may result in lateral movement of the deflection zone. Rotation of the control about the shaft in a first direction may cause proximal retraction of the deflection element.
本文还公开了一种可植入对合辅助装置，包括挠性体部；所述体部上的第一凹表面，所述第一凹表面被构造成限制后瓣叶；所述体部上的第二凹表面，所述第二凹表面被构造成接触前瓣叶；所述体部上的弧形外周上缘，所述弧形外周上缘限定朝向背离所述第一表面的开口；和心室突出物，所述心室突出物背离所述体部延伸并且被构造成锚固在心室中。所述装置还可以包括心室突出物上的锚固件。所述锚固件可以是主动的或被动的。所述装置还可以包括用于支撑所述弧形外周边缘的挠性脊。在一些情况下所述脊可以是可移除的。Also disclosed herein is an implantable coaptation aid comprising a flexible body; a first concave surface on the body configured to constrain a posterior leaflet; a second concave surface configured to contact the anterior leaflet; an arcuate peripheral upper edge on the body defining an opening facing away from the first surface; and a ventricular protrusion extending away from the body and configured to be anchored in a ventricle. The device may also include an anchor on the ventricular protrusion. The anchors can be active or passive. The device may also include a flexible ridge for supporting the arcuate peripheral edge. The ridges may be removable in some cases.
本文还公开了一种用于附接可植入对合装置的心室突出物的锚固系统。所述系统可以包括：肩部，所述肩部具有延伸穿过所述肩部的孔；螺旋状组织锚固件，所述螺旋状组织锚固件从中枢向远侧延伸；所述锚固件上的第一接合结构，所述第一接合结构用于可释放地接合扭矩轴；所述扭矩轴上的第二接合结构，所述第二接合结构用于接合所述锚固件；和植入物，所述植入物具有中枢，所述中枢的尺寸被制成为接收所述螺旋状锚固件穿过；其中所述扭矩轴被构造成用于旋转以驱动所述螺旋状锚固件进入组织中并且将所述植入物固定到组织上。所述第一接合结构可以是孔，且所述第二接合结构可以是突出物。所述突出物可以可横向地移动进出所述孔，诸如响应于所述扭矩轴内的细长元件的轴向移动。Also disclosed herein is an anchoring system for attaching a ventricular protrusion of an implantable apposition device. The system may include: a shoulder having a hole extending through the shoulder; a helical tissue anchor extending distally from a hub; a first engagement structure for releasably engaging a torque shaft; a second engagement structure on the torque shaft for engaging the anchor; and an implant, The implant has a hub sized to receive the helical anchor therethrough; wherein the torque shaft is configured for rotation to drive the helical anchor into the tissue and The implant is secured to tissue. The first engagement structure may be a hole and the second engagement structure may be a protrusion. The protrusion may be movable laterally into and out of the bore, such as in response to axial movement of an elongate member within the torque shaft.
在一些实施方案中，提供了可操控引导丝。所述可操控引导丝可以包括细长的挠性体部，其具有纵轴、近端和远侧偏转区。所述可操控引导丝可以包括在所述近端上的控制件，其用于所述偏转区的可控偏转。所述可操控引导丝可以包括从所述控制件向所述偏转区延伸的可移动偏转元件。在一些实施方案中，所述引导丝没有任何部分的外径大于约10弗伦奇。在一些实施方案中，所述引导丝没有任何部分的外径大于约6弗伦奇。在一些实施方案中，所述引导丝没有任何部分的外径大于约4弗伦奇。在一些实施方案中，所述控制件的外径不大于所述体部的外径。在一些实施方案中，所述控制件围绕所述轴的旋转导致所述偏转区的横向移动。在一些实施方案中，所述控制件围绕所述轴在第一方向上的旋转导致所述偏转元件的近侧回缩。In some embodiments, a steerable guidewire is provided. The steerable guidewire can include an elongated flexible body having a longitudinal axis, a proximal end, and a distal deflection zone. The steerable guidewire may include a control on the proximal end for controllable deflection of the deflection zone. The steerable guidewire may include a movable deflection element extending from the control member toward the deflection zone. In some embodiments, no portion of the guidewire has an outer diameter greater than about 10 French. In some embodiments, no portion of the guidewire has an outer diameter greater than about 6 French. In some embodiments, no portion of the guidewire has an outer diameter greater than about 4 French. In some embodiments, the outer diameter of the control is no greater than the outer diameter of the body. In some embodiments, rotation of the control about the axis results in lateral movement of the deflection zone. In some embodiments, rotation of the control about the shaft in a first direction results in proximal retraction of the deflection element.
在一些实施方案中，提供了可植入对合辅助装置。所述可植入对合辅助装置可以包括挠性体部。所述可植入对合辅助装置可以包括所述体部上的第一凹表面，所述第一凹表面被构造成限制后瓣叶。所述可植入对合辅助装置可以包括所述体部上的第二凹表面，所述第二凹表面被构造成接触前瓣叶。所述可植入对合辅助装置可以包括所述体部上的弧形外周上缘，所述弧形外周上缘限定朝向背离所述第一表面的开口。所述可植入对合辅助装置可以包括心室突出物，所述心室突出物背离所述体部延伸并且被构造成锚固在所述心室中。In some embodiments, implantable alignment assist devices are provided. The implantable coaptation aid may comprise a flexible body. The implantable coaptation aid may include a first concave surface on the body configured to confine a posterior leaflet. The implantable coaptation aid may include a second concave surface on the body configured to contact the anterior leaflet. The implantable coaptation aid may include an arcuate peripheral upper edge on the body defining an opening facing away from the first surface. The implantable coaptation assist device may include a ventricular protrusion extending away from the body and configured to be anchored in the ventricle.
在一些实施方案中，所述可植入对合辅助装置可以包括所述心室突出物上的锚固件。在一些实施方案中，所述可植入对合辅助装置可以包括主动锚固件。在一些实施方案中，所述可植入对合辅助装置可以包括被动锚固件。在一些实施方案中，所述可植入对合辅助装置可以包括用于支撑所述弧形外周边缘的挠性脊。在一些实施方案中，所述脊是可移除的。In some embodiments, the implantable coaptation assist device can include an anchor on the ventricular protrusion. In some embodiments, the implantable coaptation assist device can include an active anchor. In some embodiments, the implantable coaptation assist device can include a passive anchor. In some embodiments, the implantable alignment aid can include flexible ridges for supporting the arcuate peripheral edge. In some embodiments, the ridges are removable.
在一些实施方案中，提供了用于附接可植入对合装置的心室突出物的锚固系统。所述锚固系统可以包括肩部，所述肩部具有延伸穿过所述肩部的孔。所述锚固系统可以包括螺旋状组织锚固件，所述螺旋状组织锚固件从中枢向远侧延伸。所述锚固系统可以包括所述锚固件上的第一接合结构，所述第一接合结构用于可释放地接合扭矩轴。所述锚固系统可以包括所述扭矩轴上的第二接合结构，所述第二接合结构用于接合所述锚固件。所述锚固系统可以包括植入物，所述植入物具有中枢，所述中枢的尺寸被制成为接收所述螺旋状锚固件穿过。在一些实施方案中，所述扭矩轴被构造成用于旋转以驱动所述螺旋状锚固件进入组织中并且将所述植入物固定到组织上。在一些实施方案中，所述第一接合结构是孔，且所述第二接合结构是突出物。在一些实施方案中，所述突出物可横向地移动进出所述孔。在一些实施方案中，所述突出物可响应于所述扭矩轴内的细长元件的轴向移动而横向地移动进出所述孔。In some embodiments, an anchoring system for attaching a ventricular protrusion of an implantable apposition device is provided. The anchoring system may include a shoulder having an aperture extending therethrough. The anchoring system may include a helical tissue anchor extending distally from the hub. The anchoring system may include a first engagement structure on the anchor for releasably engaging a torque shaft. The anchoring system may include a second engagement formation on the torque shaft for engaging the anchor. The anchoring system may include an implant having a hub sized to receive the helical anchor therethrough. In some embodiments, the torque shaft is configured for rotation to drive the helical anchor into tissue and secure the implant to tissue. In some implementations, the first engagement structure is a hole and the second engagement structure is a protrusion. In some embodiments, the protrusion is movable laterally into and out of the aperture. In some embodiments, the protrusion is movable laterally into and out of the aperture in response to axial movement of an elongate member within the torque shaft.
在一些实施方案中，提供了可植入对合辅助装置。所述可植入对合辅助装置可以包括对合辅助体部，所述对合辅助体部包括第一对合表面、相反的第二对合表面，每个表面由第一侧缘、第二侧缘、下缘和上缘限定边界。所述可植入对合辅助装置可以包括从所述下缘延伸的心室突出物。所述可植入对合辅助装置可以包括第一支撑体，所述第一支撑体在所述上缘和所述心室突出物之间延伸穿过所述对合辅助装置的至少一部分。所述可植入对合辅助装置可以包括第二支撑体，所述第二支撑体在所述第一侧缘和所述第二侧缘之间延伸穿过所述对合辅助体部的至少一部分。所述可植入对合辅助装置可以包括通路，所述通路延伸穿过所述对合辅助装置的至少一部分，所述通路的尺寸被制成为接纳可操控导管穿过其中。在一些实施方案中，所述第一支撑体具有其中所述第一支撑体大体上是直线的第一构型和其中所述第一支撑体是弯曲的第二构型。在一些实施方案中，所述第一和第二支撑体被构造成允许所述可植入对合辅助装置的经皮插入。In some embodiments, implantable alignment assist devices are provided. The implantable coaptation aid may comprise an coaptation aid body comprising a first coaptation surface, an opposite second coaptation surface, each surface defined by a first side edge, a second Side, lower, and upper edges define the boundary. The implantable coaptation assist device may include a ventricular protrusion extending from the inferior rim. The implantable coaptation assist device may include a first support extending through at least a portion of the coaptation assist device between the superior rim and the ventricular protrusion. The implantable coaptation aid may include a second support extending through at least one of the coaptation aid body portions between the first side edge and the second side edge. part. The implantable coaptation aid may include a passageway extending through at least a portion of the coaptation aid, the passageway being sized to receive a steerable catheter therethrough. In some embodiments, the first support has a first configuration wherein the first support is substantially straight and a second configuration wherein the first support is curved. In some embodiments, the first and second supports are configured to allow percutaneous insertion of the implantable alignment aid.
在一些实施方案中，所述通路在所述上缘和所述心室突出物之间延伸穿过所述对合辅助装置的至少一部分。在一些实施方案中，所述可操控导管包括被构造成能弯曲的远侧尖端。在一些实施方案中，旋转所述可操控导管的柄部导致所述远侧尖端弯曲。在一些实施方案中，所述第一支撑体包括形状记忆材料。在一些实施方案中，所述第一支撑体结合到所述对合辅助体部。在一些实施方案中，所述对合辅助体部包括内腔，所述内腔的尺寸被制成为接纳所述第一支撑体的至少一部分。在一些实施方案中，所述第一支撑体是可移除的。在一些实施方案中，所述第一支撑体从所述上缘延伸至所述心室突出物。在一些实施方案中，所述通路在所述第一侧缘和所述第二侧缘之间延伸穿过所述对合辅助体部的至少一部分。在一些实施方案中，所述第二支撑体包括形状记忆材料。在一些实施方案中，所述第二支撑体结合到所述对合辅助体部。在一些实施方案中，所述对合辅助体部包括内腔，所述内腔的尺寸被制成为接纳所述第二支撑体的至少一部分。在一些实施方案中，所述第二支撑体是可移除的。在一些实施方案中，所述第二支撑体从所述第一侧缘延伸至所述第二侧缘。在一些实施方案中，所述第一支撑体偶接至所述第二支撑体。在一些实施方案中，所述第一支撑体和所述第二支撑体偶接至可移除的中枢，所述可移除的中枢从所述对合辅助体部的表面突出。In some embodiments, the pathway extends through at least a portion of the coaptation assist device between the superior rim and the ventricular protrusion. In some embodiments, the steerable catheter includes a distal tip configured to bend. In some embodiments, rotating the handle of the steerable catheter causes the distal tip to bend. In some embodiments, the first support includes a shape memory material. In some embodiments, the first support is bonded to the coaptation assistant body. In some embodiments, the coaptation assist body includes a lumen sized to receive at least a portion of the first support. In some embodiments, the first support is removable. In some embodiments, the first support extends from the superior rim to the ventricular protrusion. In some embodiments, the passage extends through at least a portion of the coaptation assist body between the first side edge and the second side edge. In some embodiments, the second support includes a shape memory material. In some embodiments, the second support is bonded to the coaptation assisting body. In some embodiments, the coaptation assist body includes a lumen sized to receive at least a portion of the second support. In some embodiments, the second support is removable. In some embodiments, the second support extends from the first side edge to the second side edge. In some embodiments, the first support is coupled to the second support. In some embodiments, the first support and the second support are coupled to a removable hub that protrudes from a surface of the coaptation assist body.
在一些实施方案中，提供了成套用具。所述成套用具可以包括可植入对合辅助装置。所述可植入对合辅助装置可以包括对合辅助体部，所述对合辅助体部包括第一对合表面、相反的第二对合表面，每个表面由第一侧缘、第二侧缘、下缘和上缘限定边界。所述可植入对合辅助装置可以包括从所述下缘延伸的心室突出物。所述可植入对合辅助装置可以包括通路，所述通路延伸穿过所述对合辅助装置的至少一部分，所述通路的尺寸被制成为接纳可操控导管穿过所述通路。所述成套用具可以包括可操控导管。在一些实施方案中，所述可操控导管被构造成通过二尖瓣并且朝向心室组织弯曲，其中所述可植入对合辅助装置被构造成被朝向所述心室组织传递经过所述可操控导管。In some embodiments, kits are provided. The kit may include an implantable coaptation aid. The implantable coaptation aid may comprise an coaptation aid body comprising a first coaptation surface, an opposite second coaptation surface, each surface defined by a first side edge, a second Side, lower, and upper edges define the boundary. The implantable coaptation assist device may include a ventricular protrusion extending from the inferior rim. The implantable coaptation aid may include a passageway extending through at least a portion of the coaptation aid, the passageway being sized to receive a steerable catheter therethrough. The kit may include a steerable catheter. In some embodiments, the steerable catheter is configured to pass through the mitral valve and bend toward ventricular tissue, wherein the implantable apposition assist device is configured to be passed through the steerable catheter toward the ventricular tissue .
在一些实施方案中，所述通路在所述上缘和所述心室突出物之间延伸穿过所述对合辅助装置的至少一部分。在一些实施方案中，所述可操控导管包括被构造成能弯曲的远侧尖端。在一些实施方案中，旋转可操控导管的柄部导致所述远侧尖端弯曲。在一些实施方案中，所述通路在所述第一侧缘和所述第二侧缘之间延伸穿过所述对合辅助体部的至少一部分。In some embodiments, the pathway extends through at least a portion of the coaptation assist device between the superior rim and the ventricular protrusion. In some embodiments, the steerable catheter includes a distal tip configured to bend. In some embodiments, rotating the handle of the steerable catheter causes the distal tip to bend. In some embodiments, the passage extends through at least a portion of the coaptation assist body between the first side edge and the second side edge.
在一些实施方案中，提供了使用可植入对合辅助装置的方法。所述方法可以包括将对合辅助体部朝向心瓣膜插入的步骤。在一些实施方案中，所述对合辅助体部包括第一对合表面，相反的第二对合表面，每个表面由第一侧缘、第二侧缘、下缘和上缘限定边界，从所述下缘延伸的心室突出物。所述方法可以包括操纵第一支撑体导致所述对合辅助体部呈现弯曲构型的步骤。在一些实施方案中，所述第一支撑体在所述上缘和所述心室突出物之间延伸穿过所述对合辅助装置的至少一部分。所述方法可以包括操纵第二支撑体导致所述对合辅助体部呈现弯曲构型的步骤。在一些实施方案中，所述第二支撑体在所述第一侧缘和所述第二侧缘之间延伸穿过所述对合辅助体部的至少一部分。In some embodiments, methods of using an implantable alignment assist device are provided. The method may include the step of inserting the coaptation assist body towards the heart valve. In some embodiments, the apposition assisting body comprises a first apposition surface, an opposite second apposition surface, each surface bounded by a first side edge, a second side edge, a lower edge, and an upper edge, Ventricular protrusions extending from the inferior border. The method may include the step of manipulating the first support body to cause the coaptation assist body to assume a curved configuration. In some embodiments, the first support extends across at least a portion of the coaptation assist device between the superior edge and the ventricular protrusion. The method may include the step of manipulating the second support body to cause the coaptation assist body to assume a curved configuration. In some embodiments, the second support extends across at least a portion of the alignment assisting body between the first side edge and the second side edge.
在一些实施方案中，操纵第一支撑体包括从递送导管释放所述对合辅助体部。在一些实施方案中，操纵第二支撑体包括从递送导管释放所述对合辅助体部。所述方法可以包括导引所述对合辅助体部经过可操控导管的步骤。所述方法可以包括在将所述对合辅助体部朝向心瓣膜插入之前将可操控导管从所述心室突出物朝向所述上缘传递的步骤。所述方法可以包括使所述可操控导管的远侧部分移动从而围绕后瓣叶弯曲的步骤。所述方法可以将所述对合辅助装置传递经过所述可操控导管的弯曲的步骤。在一些实施方案中，在所述心室突出物与心室组织接合后移除所述可操控导管。在一些实施方案中，当将所述心室突出物朝向所述心室组织推进时所述可操控导管保持就位。所述方法可以包括从所述对合辅助体部移除所述第一支撑体的步骤。所述方法可以包括从所述对合辅助体部移除所述第二支撑体的步骤。所述方法可以包括将所述心室突出物与心室组织接合的步骤。在一些实施方案中，所述方法经皮进行。In some embodiments, manipulating the first support includes releasing the coaptation assist body from the delivery catheter. In some embodiments, manipulating the second support includes releasing the coaptation assist body from the delivery catheter. The method may include the step of directing the coaptation assist body through a steerable catheter. The method may include the step of passing a steerable catheter from the ventricular protrusion towards the superior edge prior to inserting the coaptation assist body towards the heart valve. The method may include the step of moving the distal portion of the steerable catheter to bend around the posterior leaflet. The method may pass the coaptation aid through the bending of the steerable catheter. In some embodiments, the steerable catheter is removed after the ventricular protrusion engages ventricular tissue. In some embodiments, the steerable catheter remains in place when the ventricular protrusion is advanced toward the ventricular tissue. The method may include the step of removing the first support from the coaptation assisting body. The method may include the step of removing the second support from the coaptation assisting body. The method may include the step of engaging the ventricular protrusion with ventricular tissue. In some embodiments, the method is performed transdermally.
附图简述Brief description of the drawings
图1A-1F示意性地图示了心脏和二尖瓣的一些组织，如背景章节和下文所述，并且它们可以与本文所述的植入物和系统相互作用。Figures 1A-1F schematically illustrate some tissues of the heart and mitral valve, as described in the background section and below, and which may interact with the implants and systems described herein.
图2A图示了心脏的简化横截面，示意性显示了心脏舒张期期间的二尖瓣功能。Figure 2A illustrates a simplified cross-section of the heart schematically showing mitral valve function during diastole.
图2B图示了心脏的简化横截面，示意性显示了心脏收缩期期间的二尖瓣功能。Figure 2B illustrates a simplified cross-section of the heart schematically showing mitral valve function during systole.
图3A-3B图示了心脏的简化横截面，示意性显示了在二尖瓣瓣叶关闭不全的情况下心脏收缩期期间的二尖瓣返流。3A-3B illustrate simplified cross-sections of a heart schematically showing mitral regurgitation during systole in the setting of mitral valve leaflet regurgitation.
图4A图示了心脏的程式化横截面，显示了在功能性二尖瓣返流的情况下的二尖瓣关闭不全。Figure 4A illustrates a stylized cross-section of a heart showing mitral regurgitation in the setting of functional mitral regurgitation.
图4B图示了心脏的程式化横截面，显示了在退行性二尖瓣返流的情况下的二尖瓣关闭不全。Figure 4B illustrates a stylized cross-section of a heart showing mitral regurgitation in the setting of degenerative mitral regurgitation.
图5A图示了对合辅助装置的实施方案。Figure 5A illustrates an embodiment of an involution assist device.
图5B图示了沿图5A的剖面A-A支撑结构可以具有的各个横截面。Figure 5B illustrates various cross-sections that the support structure may have along section A-A of Figure 5A.
图5C图示了在心室突出物的远端处锚固件的各种形状。Figure 5C illustrates various shapes of anchors at the distal end of a ventricular protrusion.
图5D图示了对合辅助装置的尺寸范围的非限制性实施例。Figure 5D illustrates a non-limiting example of a range of sizes for an incorporation assist device.
图5E图示了支撑结构的各种变型(材料、尺寸范围)的非限制性实施例的表。Figure 5E illustrates a table of non-limiting examples of various variations (materials, size ranges) of support structures.
图5F图示了心室突出物的远端的实施方案。Figure 5F illustrates an embodiment of the distal end of a ventricular protrusion.
图5G图示了对合辅助装置的位置可以通过利用对合辅助装置的形状来夹住天然后瓣叶来保持。Figure 5G illustrates that the position of the coaptation aid can be maintained by clamping the native posterior leaflet with the shape of the coaptation aid.
图5H图示了对合辅助装置如何可以从心室侧通过后瓣叶固定的实施方案。Fig. 5H illustrates an embodiment of how the coaptation assist device can be secured from the ventricular side through the posterior leaflet.
图6A图示了可操控导管。Figure 6A illustrates a steerable catheter.
图6B图示了图6A的可操控导管在心脏中的位置。Figure 6B illustrates the position of the steerable catheter of Figure 6A in the heart.
图7A图示了递送导管。Figure 7A illustrates a delivery catheter.
图7B图示了锁定机构的实施方案，所述锁定机构将递送导管锁定到瓣环中枢。Figure 7B illustrates an embodiment of a locking mechanism that locks the delivery catheter to the annulus hub.
图7C图示了锁定机构的另一实施方案，所述锁定机构将递送导管锁定到瓣环中枢。Figure 7C illustrates another embodiment of a locking mechanism that locks the delivery catheter to the annulus hub.
图7D图示了对合辅助装置、递送导管和引导丝或可操控导管的偶接。Figure 7D illustrates the coupling of the coaptation aid, delivery catheter, and guide wire or steerable catheter.
图8A-8D图示了对合辅助装置如何折叠以及拉入植入物鞘并且通过股入路递送至心脏。8A-8D illustrate how the coaptation assist device is folded and pulled into the implant sheath and delivered to the heart via the femoral approach.
图8E-8G图示递送导管和植入物鞘如何放置使得对合辅助装置的心室突出物可以被锚固。8E-8G illustrate how the delivery catheter and implant sheath are placed so that the ventricular protrusion of the appropriation assist device can be anchored.
图8H图示了完全打开的对合辅助装置以及定位在瓣环中枢上方的用于将瓣环中枢锚固到瓣环的递送导管。Figure 8H illustrates the coaptation assist device fully open and the delivery catheter positioned over the annulus hub for anchoring the annulus hub to the annulus.
图8I图示了可以用来锚固所述瓣环中枢的锚固件的实施方案。Figure 8I illustrates an embodiment of an anchor that can be used to anchor the annulus center.
图9A图示了经由对合辅助装置的框架中的洞来邻近连合将对合辅助装置锚固的方法。FIG. 9A illustrates a method of anchoring the coaptation aid adjacent the commissures via holes in the frame of the coaptation aid.
图9B图示了图9A的锚固件和横杆的俯视图。Figure 9B illustrates a top view of the anchor and crossbar of Figure 9A.
图10A图示了递送导管的另一实施方案，所述递送导管具有多个内腔和与植入物的连接。Figure 10A illustrates another embodiment of a delivery catheter having multiple lumens and connections to implants.
图10B图示了图10A中所示的递送导管的横截面。Figure 10B illustrates a cross-section of the delivery catheter shown in Figure 10A.
图11A-B图示了锚固件的各个备选实施方案。11A-B illustrate various alternative embodiments of anchors.
图11C图示了递送管，锚固件11A和11B可以通过所述递送管被递送。FIG. 11C illustrates a delivery tube through which anchors 11A and 11B may be delivered.
图11D图示了在锚固过程结束后图11B的锚固件可以看上去如何。FIG. 11D illustrates how the anchor of FIG. 11B may look after the anchoring process is complete.
图12图示了无脊植入物设计(图中用结构1220显示，其以后从植入物中撤出)。Figure 12 illustrates a spineless implant design (shown in the figure with structure 1220, which is later withdrawn from the implant).
图13A-B图示了用于无脊植入物的递送程序的初始阶段。13A-B illustrate the initial stages of a delivery procedure for a spineless implant.
图14A-B图示了用于无脊植入物的各种类型的锚固方法。14A-B illustrate various types of anchoring methods for spineless implants.
图15A图示了锚固导管的实施方案，该实施方案能够实现递送多个锚固件。此图还图示了多个锚固件设计。Figure 15A illustrates an embodiment of an anchor catheter that enables delivery of multiple anchors. This figure also illustrates several anchor designs.
图15B图示了锚固导管的另一实施方案，该实施方案能够实现递送多个锚固件。Figure 15B illustrates another embodiment of an anchor catheter that enables delivery of multiple anchors.
图15C-D图示了15B中的锚固件如何可以偶接到组织。15C-D illustrate how the anchor in 15B can be coupled to tissue.
图16A图示了锚固导管的另一实施方案，该实施方案能够实现递送多个锚固件。Figure 16A illustrates another embodiment of an anchor catheter that enables delivery of multiple anchors.
图16B-C图示了图16A中的工具如何可以用来递送多个锚固件。16B-C illustrate how the tool in FIG. 16A can be used to deliver multiple anchors.
图17A图示了无脊植入物的另一实施方案。Figure 17A illustrates another embodiment of a spineless implant.
图17B-E图示了图17A的实施方案如何可以被锚固。Figures 17B-E illustrate how the embodiment of Figure 17A may be anchored.
详述detail
本公开内所述的装置、系统和方法总体上用于治疗二尖瓣返流(MR)。当在收缩期期间二尖瓣不能阻止血液从左心室回流到左心房时发生二尖瓣返流。二尖瓣由两个瓣叶，前瓣叶和后瓣叶组成，在收缩期期间两个瓣叶对合或会合以阻止回流。通常有两种类型的二尖瓣返流，功能性返流和退行性返流。功能性MR是由包括异常的或受损的左心室(LV)壁运动、左心室扩张和乳头肌病症在内的多种机制引起的。退行性MR是由包括腱索的拉伸或破裂在内的瓣膜瓣叶和瓣膜下组织的结构异常引起的。受损的腱索可以导致瓣叶的脱垂，这意味着瓣叶突出(通常进入心房中)，或者，如果腱索撕裂，则瓣叶成为连枷，导致血液的回流。如下面所述，本公开中的装置、系统和方法在天然后瓣叶上方提供了新的对合表面使得将血液的回流流动最小化或消除。The devices, systems, and methods described within this disclosure are generally useful for treating mitral regurgitation (MR). Mitral regurgitation occurs when the mitral valve is unable to prevent the backflow of blood from the left ventricle into the left atrium during systole. The mitral valve consists of two leaflets, the anterior and posterior leaflets, which coapt, or converge, during systole to prevent backflow. There are generally two types of mitral regurgitation, functional regurgitation and degenerative regurgitation. Functional MR is caused by a variety of mechanisms including abnormal or impaired left ventricular (LV) wall motion, left ventricular dilatation, and papillary muscle disorders. Degenerative MR results from structural abnormalities of the valve leaflets and subvalvular tissues including stretching or rupture of the chordae. Damaged chordae can lead to leaflet prolapse, which means the leaflet protrudes (usually into the atrium), or, if the chordae are torn, the leaflet becomes a flail, causing backflow of blood. As described below, the devices, systems and methods of the present disclosure provide a novel coaptation surface above the native posterior leaflets such that back flow of blood is minimized or eliminated.
参见图1A-1D，显示心脏的四个腔室，左心房10，右心房20，左心室30，和右心室40。二尖瓣60被布置在左心房10和左心室30之间。还示出了三尖瓣50(其将右心房20和右心室40分开)、主动脉瓣80和肺动脉瓣70。二尖瓣60由两个瓣叶(前瓣叶12和后瓣叶14)组成。在健康的心脏中，在收缩期期间在对合区16处两个瓣叶的边缘相对。Referring to FIGS. 1A-1D , the four chambers of the heart, left atrium 10 , right atrium 20 , left ventricle 30 , and right ventricle 40 are shown. The mitral valve 60 is disposed between the left atrium 10 and the left ventricle 30 . Also shown are tricuspid valve 50 (which separates right atrium 20 from right ventricle 40 ), aortic valve 80 and pulmonary valve 70 . The mitral valve 60 is composed of two leaflets (anterior leaflet 12 and posterior leaflet 14). In a healthy heart, the edges of the two leaflets face each other at the coaptation zone 16 during systole.
作为心脏架的部分的纤维瓣环120为被称为前瓣叶12和后瓣叶14的二尖瓣的两个瓣叶提供附接。瓣叶通过附接至腱索32受到轴向支撑。所述索又附接至左心室的乳头肌34、36中的一个或两者。在健康的心脏中，所述索支持结构拴系二尖瓣瓣叶，允许瓣叶在舒张期期间容易地打开，但是耐受心室收缩期期间发展的高压。除了支持结构的拴系作用以外，瓣叶的形状和组织一致性有助于促进有效密封或对合。前瓣叶和后瓣叶的前沿沿对合区16会合，其中三维对合区(CZ)的横截面160示意性地显示在图1E中。The fibrous annulus 120 , which is part of the heart frame, provides attachment for the two leaflets of the mitral valve, referred to as the anterior leaflet 12 and the posterior leaflet 14 . The leaflets are axially supported by attachment to the chordae 32 . The cords in turn attach to one or both of the papillary muscles 34, 36 of the left ventricle. In a healthy heart, the cord support structure tethers the mitral valve leaflets, allowing the leaflets to open easily during diastole, but resisting the high pressures that develop during ventricular systole. In addition to the tethering of supporting structures, the shape and tissue conformity of the leaflets help to promote effective sealing or coaptation. The leading edges of the anterior and posterior leaflets meet along the coaptation zone 16, wherein a cross-section 160 of the three-dimensional coaptation zone (CZ) is schematically shown in Figure IE.
前二尖瓣瓣叶和后二尖瓣瓣叶具有不同的形状。前瓣叶更牢固地附接于覆盖中心纤维体(心脏架)的瓣环，并且比附接于移动性更大的后二尖瓣环的后瓣叶稍硬。约80％的闭合区域是前瓣叶。在二尖瓣环与主动脉的非冠状尖(non-coronary cusp)的基部融合的情况下形成的左(外侧(lateral))124和右(间隔(septal))126纤维三棱的位置邻近连合110、114，在瓣环120之上或之前(图1F)。纤维三棱124、126形成中心纤维体128的间隔延伸和外侧延伸。在一些实施方案中，纤维三棱124、126可以具有优点，如提供牢固的区域用于与一个或多个瓣环锚固件(archor)或心房锚固件的稳定接合。瓣叶12、14之间的对合区CL不是一条简单的线，而是弯曲的漏斗形表面界面。第一110(外侧或左侧的)和第二114(间隔或右侧的)连合是前瓣叶12与后瓣叶14在瓣环120处相会的地方。如在图1C、1D和1F的心房的轴向视图中最清楚可见的，对合区的轴向截面通常显示弯曲的线CL，所述线CL与瓣环CA的形心分开，并且在舒张期CO期间与通过瓣膜的开口分开。此外，瓣叶边缘具有圆齿，相比于前瓣叶，后瓣叶更是如此。关闭不全可能发生在这些A-P(前-后)区段对A1/P1、A2/P2和A3/P3中的一个或多个之间，使得关闭不全特性可能沿对合区CL的曲线而变化。The anterior and posterior mitral leaflets have different shapes. The anterior leaflets are more firmly attached to the annulus covering the central fibrous body (heart frame) and are slightly stiffer than the posterior leaflets, which are attached to the more mobile posterior mitral annulus. About 80% of the closed area is the anterior leaflet. The location of the left (lateral) 124 and right (septal) 126 fibrous triangular ridges that form when the mitral valve annulus fuses with the base of the non-coronary cusp of the aorta Together 110, 114, on or in front of the annulus 120 (Fig. 1F). The fiber triangulations 124 , 126 form the spaced and outer extensions of the central fiber body 128 . In some embodiments, the fibrous triangular ribs 124, 126 may have advantages, such as providing a secure area for stable engagement with one or more annulus or atrial anchors. The coaptation region CL between the leaflets 12, 14 is not a simple line, but a curved funnel-shaped surface interface. The first 110 (lateral or left) and second 114 (septal or right) commissures are where the anterior leaflet 12 meets the posterior leaflet 14 at the annulus 120 . As most clearly seen in the axial views of the atrium in Figures 1C, 1D, and 1F, axial sections of the coaptation zone generally show a curved line CL that separates from the centroid of the annulus CA and that, in diastole, During phase CO, it is separated from the opening through the valve. In addition, the leaflet margins are crenated, more so in the posterior leaflets than in the anterior leaflets. Insufficiency may occur between one or more of these A-P (anterior-posterior) segment pairs A1/P1, A2/P2, and A3/P3 such that the parasuppression properties may vary along the curve of the coaptation zone CL.
现在参看图2A，心脏的正确发挥功能的二尖瓣60在舒张期期间是打开的以允许血液沿从左心房向左心室30的流径FP流动并且由此充填左心室。如在图2B中所示，通过增加心室压力，先是被动地然后是主动地，发挥功能的二尖瓣60在收缩期期间闭合并且有效地将左心室30和左心房10分隔开，由此允许左心室周围的心脏组织收缩从而推动血液通过血管系统。Referring now to FIG. 2A , the heart's properly functioning mitral valve 60 is open during diastole to allow blood to flow along the flow path FP from the left atrium to the left ventricle 30 and thereby fill the left ventricle. As shown in FIG. 2B, by increasing ventricular pressure, first passively and then actively, the functioning mitral valve 60 closes during systole and effectively separates the left ventricle 30 from the left atrium 10, thereby Allows the heart tissue around the left ventricle to contract to push blood through the vascular system.
参见图3A-3B和4A-4B，存在若干病症或疾病状态，其中二尖瓣的瓣叶边缘不能充分相对并且由此允许血液在收缩期中从心室涌回到心房中。不管特定患者的具体病因如何，瓣叶在心室收缩期期间不能密封被称为关闭不全并且造成二尖瓣返流。Referring to Figures 3A-3B and 4A-4B, there are several conditions or disease states in which the leaflet edges of the mitral valve do not adequately oppose and thus allow blood to rush from the ventricle back into the atrium during systole. Regardless of the specific etiology in a particular patient, the failure of the leaflets to seal during ventricular systole is known as regurgitation and causes mitral regurgitation.
通常，关闭不全可以由一个或两个瓣叶的支持结构的过度拴系造成，或可以由支持结构的过度拉伸或撕裂造成。其他较不常见的原因包括心瓣膜感染、先天性异常、以及创伤。瓣膜机能不良可以由以下引起：腱索被拉伸(被称为二尖瓣脱垂)，以及在一些情况中腱索215或乳头肌的撕裂(被称为连枷瓣叶220)，如在图3A中所示。或者，如果瓣叶组织自身是多余的，则瓣膜可能脱垂以致对合发生的水平更高到心房中，在心室收缩期期间的心房230中更高地打开瓣膜。瓣叶中的任一个可能发生脱垂或变成连枷。此病症有时被称为退行性二尖瓣返流。Typically, regurgitation can result from over-tethering of the support structures of one or both leaflets, or can result from overstretching or tearing of the support structures. Other less common causes include heart valve infections, congenital abnormalities, and trauma. Valve dysfunction can be caused by stretching of the chordae (known as mitral valve prolapse), and in some cases tears of the chordae 215 or papillary muscles (known as flail leaflets 220), as in shown in Figure 3A. Alternatively, if the leaflet tissue itself is redundant, the valve may prolapse such that coaptation occurs at a higher level into the atrium, opening the valve higher in the atrium 230 during ventricular systole. Either of the leaflets may prolapse or become flailed. This condition is sometimes called degenerative mitral regurgitation.
在如图3B中所示的过度拴系中，结构正常的瓣膜的瓣叶可能由于瓣环增大或形状改变(所谓的瓣环扩大240)而不能适当地发挥功能。此种功能性二尖瓣返流通常由心肌衰竭和伴发性心室扩大引起。并且由功能性二尖瓣返流引起的过大的容量负荷自身可能加重心力衰竭、心室和瓣环扩张，并且由此使二尖瓣返流恶化。In over-tethering as shown in Figure 3B, the leaflets of a structurally normal valve may not function properly due to an enlarged or altered shape of the annulus (so-called annulus enlargement 240). This functional mitral regurgitation is usually caused by myocardial failure and concomitant ventricular enlargement. And the excessive volume overload caused by functional mitral regurgitation may itself aggravate heart failure, ventricular and annulus dilatation, and thereby worsen mitral regurgitation.
图4A-4B图示在收缩期期间在功能性二尖瓣返流(图4A)和退行性二尖瓣返流(图4B)中血液的回流BF。图4A中瓣环的增加的尺寸，加上由于心室320和乳头肌330的肥大所致的增加的拴系，阻止前瓣叶312和后瓣叶314相对，由此阻止对合。在图4B中，腱索215的撕裂导致后瓣叶344脱垂向上进入左心房中，这阻止了与前瓣叶342的相对。在任一种情况中，结果都是血液回流到心房中，这降低左心室压缩的有效性。Figures 4A-4B illustrate the backflow BF of blood in functional mitral regurgitation (Figure 4A) and degenerative mitral regurgitation (Figure 4B) during systole. The increased size of the annulus in FIG. 4A , combined with increased tethering due to hypertrophy of the ventricles 320 and papillary muscles 330, prevents the anterior leaflet 312 and posterior leaflet 314 from opposing, thereby preventing apposition. In FIG. 4B , tearing of the chordae 215 causes the posterior leaflet 344 to prolapse upward into the left atrium, which prevents opposition to the anterior leaflet 342 . In either case, the result is backflow of blood into the atrium, which reduces the effectiveness of left ventricular compression.
图5A图示了对合辅助装置500的实施方案。对合辅助装置500可以包括对合辅助体部515。对合辅助体部515可以包括第一对合表面535。第一对合表面535可以朝向关闭不全的天然瓣叶布置，在二尖瓣的情况下，当植入时朝向后瓣叶布置。对合辅助体部515可以包括第二对合表面540。第二对合表面540可以与第一对合表面535相反，如图5A中所示。第二对合表面540可以朝向关闭不全的天然瓣叶布置，在二尖瓣的情况下，当植入时朝向前瓣叶布置。第一对合表面535和第二对合表面540可以由第一侧缘和第二侧缘限定边界。第一对合表面535和第二对合表面540可以由下缘和上缘545限定边界。FIG. 5A illustrates an embodiment of an incorporation assist device 500 . The alignment assisting device 500 may include an alignment assisting body 515 . The mating assist body 515 may include a first mating surface 535 . The first coaptation surface 535 may be positioned towards the insufficient native valve leaflet, and in the case of the mitral valve, towards the posterior leaflet when implanted. The apposition assisting body 515 may include a second apposition surface 540 . The second mating surface 540 may be opposite the first mating surface 535, as shown in FIG. 5A. The second coaptation surface 540 may be positioned towards the insufficient native valve leaflet, and in the case of the mitral valve, towards the anterior leaflet when implanted. The first mating surface 535 and the second mating surface 540 may be bounded by a first side edge and a second side edge. The first mating surface 535 and the second mating surface 540 may be bounded by a lower edge and an upper edge 545 .
第一对合表面535和第二对合表面540是形成对合辅助体部515的同一植入物结构的两个侧面。在一些实施方案中，对合辅助体部515的形状可以通常由上缘545的形状、第一对合表面535和第二对合表面540的形状来表征。The first abutment surface 535 and the second abutment surface 540 are two sides of the same implant structure forming the apposition assisting body 515 . In some embodiments, the shape of the coaptation assisting body 515 can be generally characterized by the shape of the upper edge 545 , the shape of the first coaptation surface 535 and the second coaptation surface 540 .
对合辅助装置500可以包括心室突出物525，如图5A中所示。心室突出物525可以从对合辅助体部515的下缘延伸。心室突出物525当植入时可以放置在左心室内。心室突出物525可以提供锚固机构。心室突出物525的远端530通常提供锚固机构。Coaptation assist device 500 may include a ventricular protrusion 525, as shown in FIG. 5A. Ventricular protrusion 525 may extend from the lower edge of coaptation assist body 515 . Ventricular protrusion 525 may be placed within the left ventricle when implanted. Ventricular protrusion 525 may provide an anchoring mechanism. The distal end 530 of the ventricular protrusion 525 generally provides an anchoring mechanism.
心室突出物525的远端530可以具有不同的形状，如图5C中所示。图5C示出了远端530的五个实施方案。要注意有可能有更多的变型，且这些变型不限于图5C中所示的五个实施方案。通常，并且在其他实施方案中，有两种类型的锚固件。被动锚固件的实例显示在图5C中的实施方案555.1至555.4。被动锚固件依赖于在腱索后方的捕获(entrapment)和/或与腱索的干扰。关于被动锚固件，在一些实施方案中，最大尺寸或负责缠绕腱索的尺寸(通常是宽度)可以为10mm-40mm，诸如25mm。The distal end 530 of the ventricular protrusion 525 can have a different shape, as shown in Figure 5C. FIG. 5C shows five embodiments of the distal end 530 . Note that more variations are possible, and these are not limited to the five embodiments shown in Figure 5C. Generally, and in other embodiments, there are two types of anchors. Examples of passive anchors are shown in Figure 5C as embodiments 555.1 to 555.4. Passive anchors rely on entrapment behind the chordae and/or interference with the chordae. With regard to passive anchors, in some embodiments the largest dimension or dimension (typically width) responsible for wrapping the chordae may be 10mm-40mm, such as 25mm.
远端555.1包括一个或多个尖头。尖头可以是细长的杆，如所示的那样其从中央中枢延伸。在图示的实施方案中，四个尖头从中央中枢延伸。在其他实施方案中，一个或多个尖头从中央中枢延伸。尖头可以与中央中枢成一定角度地延伸，从而增加了远端530的表面积。远端555.2可以是大体矩形、矩形、大体正方形、正方形、大体菱形或菱形。远端555.2可以包括一个或多个切口(cut out切口)。切口可以增加抓紧组织的能力。在图示的实施方案中，在远端中形成四个切口。在其他实施方案中，设置一个或多个切口。The distal end 555.1 includes one or more prongs. The prongs may be elongated rods extending from a central hub as shown. In the illustrated embodiment, four prongs extend from the central hub. In other embodiments, one or more prongs extend from the central hub. The prongs may extend at an angle to the central hub, thereby increasing the surface area of the distal end 530 . The distal end 555.2 may be generally rectangular, rectangular, generally square, square, generally rhomboid, or rhomboid. The distal end 555.2 may include one or more cut outs. The incision can increase the ability to grasp the tissue. In the illustrated embodiment, four cuts are made in the distal end. In other embodiments, one or more incisions are provided.
远端555.3包括一个或多个尖头。尖头可以是细长的杆，如所示的那样其从中央中枢延伸。在图示的实施方案中，两个尖头从中央中枢延伸。在其他实施方案中，一个或多个尖头从中央中枢延伸。尖头可以与中央中枢成直角地延伸，从而增加了远端530的表面积。The distal end 555.3 includes one or more prongs. The prongs may be elongated rods extending from a central hub as shown. In the illustrated embodiment, two prongs extend from the central hub. In other embodiments, one or more prongs extend from the central hub. The prongs may extend at right angles to the central hub, thereby increasing the surface area of the distal end 530 .
远端555.4包括一个或多个倒钩。倒钩可以如所示的那样从中央中枢延伸。倒钩可以向中央中枢倒回。在图示的实施方案中，三个或更多个倒钩从中央中枢延伸。在其他实施方案中，在一个或多个方向上设置一个或多个倒钩。Distal end 555.4 includes one or more barbs. The barbs may extend from the central hub as shown. The barb can fall back toward the central hub. In the illustrated embodiment, three or more barbs extend from the central hub. In other embodiments, one or more barbs are provided in one or more directions.
远端555.5包括一个或多个尖头，并且类似于如远端555.1所示的构型。远端555.5是主动锚固件的实例。主动锚固件可以具有可以偶接到心室组织的诸如尖点、倒钩或螺钉的部件。主动锚固件可以需要驱动力，诸如扭矩，从而嵌入组织中。被动或主动锚固件可以由植入物级别的生物相容材料诸如有机硅、PEEK、派伯克斯(pebax)、聚氨酯制成。Distal end 555.5 includes one or more prongs and is similar in configuration to that shown for distal end 555.1. Distal end 555.5 is an example of an active anchor. Active anchors may have features such as points, barbs or screws that can be coupled to ventricular tissue. Active anchors may require a driving force, such as torque, to embed in tissue. Passive or active anchors can be made of implant grade biocompatible materials such as silicone, PEEK, pebax, polyurethane.
对合辅助装置500的尺寸详细描述于图5D中。该图显示了对合辅助装置500的对合辅助体部515的俯视图和正视图。图中所示的三个参数“x”、“y”和“z”表征对合辅助装置500。这些变量x、y和z的范围和大小的非限制性实例显示在图中的“尺寸表”中。The dimensions of the alignment aid 500 are detailed in Figure 5D. This figure shows a top view and a front view of the alignment assisting body 515 of the alignment assisting device 500 . The three parameters "x", "y" and "z" shown in the figure characterize the alignment aid 500 . Non-limiting examples of ranges and sizes for these variables x, y, and z are shown in the "Dimension Table" in the Figures.
对合辅助装置500可以包括支撑结构505。支撑结构505可以称作脊。支撑结构505可以至少部分地限定对合辅助装置500的形状。Coupling aid 500 may include a support structure 505 . Support structure 505 may be referred to as a ridge. The support structure 505 can at least partially define the shape of the alignment aid 500 .
返回至图5A，支撑结构505由虚线显示。在一些实施方案中，支撑结构505由形状记忆材料诸如但不限于镍钛诺(NiTi)、聚醚醚酮(PEEK)或其他刚性聚合物或耐疲劳金属制成。形状记忆材料的使用能够实现本文所述的优势。例如，形状记忆材料的一个优势是其超弹性特性有助于当心脏收缩和扩张并对对合辅助装置500施压时对合辅助装置500保持其形状和作为对合辅助装置的功能性。优势的另一个实例是形状记忆材料适合于将在本文中描述的经皮递送方法。Returning to Figure 5A, the support structure 505 is shown by dashed lines. In some embodiments, support structure 505 is made of a shape memory material such as, but not limited to, Nitinol (NiTi), polyether ether ketone (PEEK), or other rigid polymers or fatigue resistant metals. The use of shape memory materials enables the advantages described herein. For example, one advantage of a shape memory material is that its superelastic properties help the coaptation assist device 500 retain its shape and functionality as a coaptation assist device as the heart contracts and expands and exerts pressure on the coaptation assist device 500 . Another example of advantage is that shape memory materials are suitable for the transdermal delivery methods that will be described herein.
支撑结构505可以包括一个或多个节段。在一些实施方案中，支撑结构505包括一个节段。在一些实施方案中，支撑结构505包括两个节段。在一些实施方案中，支撑结构505包括三个或更多个节段。在一些实施方案中，支撑结构505的一个或多个节段可以包括一个或多个分节段。在图5A中所示的实施方案中，支撑结构505包括两个节段：第一节段505.2和第二节段505.1。Support structure 505 may include one or more segments. In some embodiments, support structure 505 includes one segment. In some embodiments, support structure 505 includes two segments. In some embodiments, support structure 505 includes three or more segments. In some embodiments, one or more segments of support structure 505 may include one or more sub-segments. In the embodiment shown in Figure 5A, the support structure 505 comprises two segments: a first segment 505.2 and a second segment 505.1.
第一节段505.2可以在上缘545和心室突出物525之间延伸经过对合辅助装置500的至少一部分。在一些实施方案中，第一节段505.2可以在上缘545和心室突出物525之间延伸经过对合辅助装置500的整个长度。在一些实施方案中，第一节段505.2从对合辅助体部515的上缘545和下缘之间的位置延伸。在一些实施方案中，第一节段505.2从对合辅助体部515的下缘和心室突出物525之间的位置延伸。在一些实施方案中，第一节段505.2沿对合辅助体部515延伸并继续支撑心室突出物525。The first segment 505.2 can extend across at least a portion of the coaptation assist device 500 between the superior edge 545 and the ventricular protrusion 525. In some embodiments, the first segment 505.2 can extend the entire length of the coaptation assist device 500 between the superior edge 545 and the ventricular protrusion 525. In some embodiments, the first segment 505.2 extends from a location between the upper edge 545 and the lower edge of the coaptation assist body 515. In some embodiments, the first segment 505.2 extends from a location between the inferior edge of the coaptation assist body 515 and the ventricular protrusion 525. In some embodiments, the first segment 505.2 extends along the coaptation assist body 515 and continues to support the ventricular protrusion 525.
第二节段505.1可以在第一侧缘和第二侧缘之间延伸经过对合辅助体部515的至少一部分。在一些实施方案中，第二节段505.1可以延伸经过第一侧缘和第二侧缘之间的整个长度。在一些实施方案中，第二节段505.1从对合辅助体部515的上缘545和下缘之间的位置延伸。在一些实施方案中，第二节段505.1从与对合辅助体部515的下缘相比更靠近上缘545的位置延伸。在一些实施方案中，第二节段505.1从第一侧缘朝向第二侧缘延伸。在一些实施方案中，第二节段505.1从第二侧缘朝向第一侧缘延伸。在一些实施方案中，第二节段505.1沿第一侧缘和第二侧缘之间的节段延伸。在一些实施方案中，第二节段505.1沿对合辅助装置500的边缘延伸。The second segment 505.1 may extend across at least a portion of the coaptation assist body 515 between the first side edge and the second side edge. In some embodiments, the second segment 505.1 can extend the entire length between the first side edge and the second side edge. In some embodiments, the second segment 505.1 extends from a location between the upper edge 545 and the lower edge of the coaptation assist body 515. In some embodiments, the second segment 505 . 1 extends from a location closer to the upper edge 545 than the lower edge of the coaptation assist body 515 . In some embodiments, the second segment 505.1 extends from the first side edge towards the second side edge. In some embodiments, the second segment 505.1 extends from the second side edge towards the first side edge. In some embodiments, the second segment 505.1 extends along the segment between the first side edge and the second side edge. In some embodiments, the second segment 505.1 extends along the edge of the alignment aid 500.
在一些实施方案中，支撑结构505的第一节段505.2和第二节段505.1可以是一个整体件或一体化结构。在一些实施方案中，支撑结构505的第一节段505.2和第二节段505.1是单独的组件。在一些实施方案中，第一节段505.2和第二节段505.1可以是两个单独的节段，两者通过诸如但不限于压接和激光焊接的方法连接在一起。In some embodiments, the first section 505.2 and the second section 505.1 of the support structure 505 can be a single piece or unitary structure. In some embodiments, the first section 505.2 and the second section 505.1 of the support structure 505 are separate components. In some embodiments, the first segment 505.2 and the second segment 505.1 may be two separate segments joined together by methods such as, but not limited to, crimping and laser welding.
在一些实施方案中，第一节段505.2整合在如本文所述的对合辅助体部515内。在一些实施方案中，第一节段505.2整合在如本文所述的心室突出物525内。在一些实施方案中，第一节段505.2是可从如本文所述的对合辅助体部515移除的。在一些实施方案中，第一节段505.2是可从如本文所述的心室突出物525移除的。在一些实施方案中，第二节段505.1整合在如本文所述的对合辅助体部515内。在一些实施方案中，第二节段505.1是可从如本文所述的对合辅助体部515移除的。在一些实施方案中，第一节段505.2可以具有第一区和第二区，所述第一区大体上基本上平行于体部515的纵轴定向，所述第二区大体上基本上垂直于体部515的纵轴定向，如图示的那样。In some embodiments, the first segment 505.2 is integrated within the coaptation assist body 515 as described herein. In some embodiments, the first segment 505.2 is integrated within the ventricular protrusion 525 as described herein. In some embodiments, the first segment 505.2 is removable from the coaptation assist body 515 as described herein. In some embodiments, the first segment 505.2 is removable from the ventricular protrusion 525 as described herein. In some embodiments, the second segment 505.1 is integrated within the coaptation assistant body 515 as described herein. In some embodiments, the second segment 505.1 is removable from the coaptation assist body 515 as described herein. In some embodiments, the first segment 505.2 can have a first region that is generally oriented substantially parallel to the longitudinal axis of the body 515 and a second region that is generally substantially perpendicular Oriented about the longitudinal axis of the body 515, as shown.
支撑心室突出物525的形状的支撑结构505可以具有如图5A中的截面AA所示的各种横截面并且详细地图示在图5B中。在图5B中，显示了横截面的五个实施方案；然而，要注意支撑结构505的横截面的实施方案不限于这五种。横截面550.1是圆形的或大体圆形的。横截面505.2是圆形的或大体圆形的。横截面550.1可以具有比横截面550.2更大的横截面积。横截面550.3包括多个圆形或大体圆形的横截面。在图示的实施方案中，七个圆形的或大体圆形的横截面共同地形成横截面550.3。在其他实施方案中，两个或多个圆形的或大体圆形的横截面共同地形成横截面550.3。横截面550.3可以是线缆的形式。横截面550.4是矩形或大体矩形。横截面550，5是矩形或大体矩形。横截面550.4可以具有比横截面550.5更大的横截面积。The support structure 505 supporting the shape of the ventricular protrusion 525 may have various cross-sections as shown in section AA in FIG. 5A and is illustrated in detail in FIG. 5B. In FIG. 5B, five embodiments of the cross-section are shown; however, it is to be noted that the embodiments of the cross-section of the support structure 505 are not limited to these five. The cross section 550.1 is circular or generally circular. The cross section 505.2 is circular or generally circular. Cross-section 550.1 may have a larger cross-sectional area than cross-section 550.2. Cross-section 550.3 includes a plurality of circular or generally circular cross-sections. In the illustrated embodiment, seven circular or generally circular cross-sections collectively form cross-section 550.3. In other embodiments, two or more circular or generally circular cross-sections collectively form cross-section 550.3. The cross section 550.3 may be in the form of a cable. The cross section 550.4 is rectangular or generally rectangular. The cross section 550,5 is rectangular or generally rectangular. Cross-section 550.4 may have a larger cross-sectional area than cross-section 550.5.
还要注意第一节段505.2和第二节段505.1也可以具有不同的横截面。图5B中所示的每个横截面或实施方案可以具有某些优势，诸如一些横截面可以在一个方向上容易弯曲而在另一个方向上则不容易弯曲。一些其他横截面可以具有比其他横截面更高的可靠特性。对于两种不同的材料镍钛诺和PEEK描述了每种类型的横截面的特征以及图5E中表2中的横截面的范围和非限制性可能尺寸。尽管在表2中呈现了多种构型，但在一些实施方案中，对于两种材料横截面550.4和550.5都可以利用。Note also that the first segment 505.2 and the second segment 505.1 may also have different cross-sections. Each of the cross-sections or embodiments shown in Figure 5B may have certain advantages, such as some cross-sections may bend easily in one direction but not in another. Some other cross-sections may have higher reliability characteristics than others. The characteristics of each type of cross-section and the range and non-limiting possible dimensions of the cross-section in Table 2 in Figure 5E are described for two different materials, Nitinol and PEEK. Although various configurations are presented in Table 2, in some embodiments, both material cross-sections 550.4 and 550.5 may be utilized.
当将对合辅助装置500置于心脏内时，在一些实施方案中，对合辅助装置500使得心室突出物525将大体上被放置在左心室内，如图5G中所示。心室突出物525提供了使用心室的结构锚固对合辅助装置500的机构。将对合辅助装置500定位在后瓣叶上方的实例图示在图5G中。When the alignment assist device 500 is placed within the heart, in some embodiments, the alignment assist device 500 is such that the ventricular protrusion 525 will be placed substantially within the left ventricle, as shown in Figure 5G. Ventricular protrusions 525 provide a mechanism for anchoring the coaptation assist device 500 using the structure of the ventricle. An example of positioning the coaptation assist device 500 above the posterior leaflet is illustrated in Figure 5G.
要记住，定位的其他实例是可能的并且在本公开内的其他地方进行讨论，在此特殊实施例中，图示具有曲线形状的心室突出物525的对合辅助装置500。心室突出物525和/或第一支撑体505.2可以由形状记忆材料构成，在此情况下在植入后保持曲线形状。曲线形状可以使得对合辅助装置500能够在与天然后瓣叶14接合后保持就位。Keeping in mind that other examples of positioning are possible and discussed elsewhere within this disclosure, in this particular embodiment, an apposition assist device 500 is shown having a curvilinear shaped ventricular protrusion 525 . The ventricular protrusion 525 and/or the first support body 505.2 may be constructed of a shape memory material, in which case the curvilinear shape is retained after implantation. The curvilinear shape may enable the coaptation aid 500 to remain in place after engagement with the native posterior leaflet 14 .
图5F示出了用于心室突出物525的被动锚固件的实施方案。在此实施方案中，沿心室突出物525的长度行进的管560在对合辅助装置500的远端处终止于两个管565.1和565.2。可以用伸直的金属丝将对合辅助装置500递送到心脏的左侧使得两个管565.1和565.2近似直线，如虚线565.1和565.2所示(位置A)，表明伸直的金属丝处于推进的状态。在一些实施方案中，两个管565.1和565.2可以由形状记忆材料制成，所述形状记忆材料包括但不限于聚氨酯、有机硅、聚乙烯、派伯克斯(pebax)和尼龙。在没有伸直的金属丝的情况下，两个管565.1和565.2可以具有默认的形状，所述默认的形状可以是卷曲的或盘绕的，如图5F中的实线565.1和565.2所示(位置B)。FIG. 5F shows an embodiment of a passive anchor for a ventricular protrusion 525 . In this embodiment, the tube 560 that runs the length of the ventricular protrusion 525 terminates at the distal end of the coaptation assist device 500 in two tubes 565.1 and 565.2. The coaptation assist device 500 can be delivered to the left side of the heart with a straightened wire such that the two tubes 565.1 and 565.2 are approximately straight, as shown by dashed lines 565.1 and 565.2 (position A), indicating that the straightened wire is in an advanced position. state. In some embodiments, the two tubes 565.1 and 565.2 can be made of shape memory materials including, but not limited to, polyurethane, silicone, polyethylene, pebax, and nylon. In the absence of straightened wires, the two tubes 565.1 and 565.2 may have a default shape, which may be crimped or coiled, as shown by solid lines 565.1 and 565.2 in FIG. 5F (position B).
在植入物适当地被递送并放置在心脏中后，伸直的金属丝可以被撤回，从而允许两个管565.1和565.2采取它们默认的形状(位置B)。两个管565.1和565.2因与腱索缠绕而可以提供锚固支撑。这种类型的锚固的优势在于，要是由于放置不满意而导致变得必须将对合辅助装置500重新定位，可以将伸直的金属丝可以推进返回到两个管565.1和565.2中，使两个管565.1和565.2成直线并且导致两个管565.1和565.2脱离腱索结构。尽管上述的实施例描述了两个管565.1和565.2，但要理解可以存在一个、两个或多个管。After the implant is properly delivered and placed in the heart, the straightened wire can be withdrawn, allowing the two tubes 565.1 and 565.2 to assume their default shape (position B). The two tubes 565.1 and 565.2 can provide anchoring support by being wrapped around the chordae. The advantage of this type of anchoring is that if it becomes necessary to reposition the coaptation aid 500 due to unsatisfactory placement, the straightened wire can be advanced back into the two tubes 565.1 and 565.2, allowing both tubes 565.1 and 565.2 to The tubes 565.1 and 565.2 are aligned and cause the two tubes 565.1 and 565.2 to break away from the chordal structure. Although the above embodiments describe two tubes 565.1 and 565.2, it is understood that there may be one, two or more tubes.
在图5H中图示了锚固对合辅助装置500的又另一个实施方案。主动锚固件可以偶接到心室突出物525的远端。在递送植入物后，可以驱动主动锚固件通过后瓣叶从而在如所示的瓣环(心房)节段处偶接到对合辅助装置500。将在本文中讨论将锚固件定位和驱动的方法。Yet another embodiment of an anchoring apposition assist device 500 is illustrated in FIG. 5H . An active anchor can be coupled to the distal end of the ventricular protrusion 525 . Following delivery of the implant, the active anchor can be driven through the posterior leaflet to couple to the coaptation assist device 500 at the annulus (atrial) segment as shown. Methods of positioning and actuating the anchor will be discussed in this article.
在另一个实施方案中，心室突出物525的尖端可以是不透射线的或回声的，从而当经皮放置对合辅助装置500时辅助对合辅助装置500的放置和锚固。在这样的程序中，荧光或超声成像模态可以用来对心脏和对合辅助装置500可视化。In another embodiment, the tip of the ventricular protrusion 525 may be radiopaque or echogenic to aid in the placement and anchoring of the alignment assist device 500 when the device is placed percutaneously. Fluorescence or ultrasound imaging modalities may be used to visualize the heart and the coaptation assist device 500 during such procedures.
返回至图5A，在另一个实施方案中，对合辅助装置500可以包括中枢(hub)510。中枢510可以具有一个或多个目的。一个目的可以是充当如本文所讨论的锚固装置。另一个目的可以是为了如本文所讨论的那样提供经皮递送对合辅助装置500的机构。在一些实施方案中，中枢(未显示)可以在对合辅助装置500的远端处存在。中枢可以位于心室突出物525的末端处。心室中枢可以位于心室突出物525的远端530的最远侧尖端。为了区分两个中枢，在近侧上的中枢510将简单地称作“中枢”、“瓣环中枢”或“近侧中枢”。心室突出物的远侧尖端处的中枢将特别地称为“心室中枢”。Returning to FIG. 5A , in another embodiment, the alignment assist device 500 may include a hub 510 . Hub 510 may have one or more purposes. One purpose may be to act as an anchor as discussed herein. Another purpose may be to provide a mechanism for percutaneous delivery of the alignment assist device 500 as discussed herein. In some embodiments, a hub (not shown) may be present at the distal end of the coaptation assist device 500 . The hub may be located at the end of the ventricular protrusion 525 . The ventricular hub may be located at the most distal tip of the distal end 530 of the ventricular protrusion 525 . To distinguish between the two hubs, the hub 510 on the proximal side will be referred to simply as the "hub", "annular hub", or "proximal hub". The hub at the distal tip of the ventricular protrusion will specifically be referred to as the "ventricular hub".
还参照图5A，对合辅助装置500的对合辅助体部515可以由多种生物相容材料制成，所述生物相容材料诸如膨体聚四氟乙烯(ePTFE)。这种材料提供了对合表面，前瓣叶将抵靠着对合表面关闭。对合辅助装置500的对合辅助体部515可以偶接到支撑结构505使得支撑结构505的形状赋予对合辅助装置500的大体形状。Referring also to FIG. 5A , the coaptation assist body 515 of the coaptation assist device 500 can be made from a variety of biocompatible materials, such as expanded polytetrafluoroethylene (ePTFE). This material provides the coaptation surface against which the anterior leaflet will close. The alignment aid body 515 of the alignment aid device 500 may be coupled to the support structure 505 such that the shape of the support structure 505 imparts the general shape of the alignment aid device 500 .
对合辅助装置500的形状可以进一步得到一个或多个肋状物546(未显示)的支撑。可以存在一个、两个或多个肋状物546。肋状物546可以由多种材料制成，所述多种材料诸如但不限于缝合线、聚丙烯、尼龙、NiTi线缆、NiTi丝和PEEK。本文描述了将对合辅助装置500的对合辅助体部515偶接到支撑结构505和/或肋状物546(如果存在肋状物546的话)的过程。The shape of the alignment aid 500 may be further supported by one or more ribs 546 (not shown). There may be one, two or more ribs 546 . Ribs 546 may be made from a variety of materials such as, but not limited to, suture, polypropylene, nylon, NiTi cable, NiTi wire, and PEEK. Described herein is the process of coupling the alignment aid body 515 of the alignment aid 500 to the support structure 505 and/or the ribs 546 (if the ribs 546 are present).
在一些制造方法中，所述过程可以通过在支撑结构505和/或肋状物546(如果存在肋状物546)上滑动聚乙烯(PE)管开始。该组合放置在两个ePTFE片材之间，之后施加热量和压力。由于ePTFE材料中的小孔，ePTFE与PE管粘合，所述管的聚乙烯材料可以熔融到ePTFE材料中的小孔中，形成机械粘合。类似地，当施加热量和压缩时，PE管材料可以熔融到支撑结构505和/或肋状物546中的微细孔中。可以谨慎地安放支撑结构505和/或肋状物546中的微细孔从而改善粘合。In some fabrication methods, the process may begin by sliding polyethylene (PE) tubing over support structure 505 and/or ribs 546 (if ribs 546 are present). The combination is placed between two ePTFE sheets, after which heat and pressure are applied. The ePTFE is bonded to the PE pipe due to the small pores in the ePTFE material, and the polyethylene material of the pipe can melt into the small pores in the ePTFE material, forming a mechanical bond. Similarly, the PE pipe material may melt into the microscopic pores in the support structure 505 and/or ribs 546 when heat and compression are applied. Microscopic holes in support structure 505 and/or ribs 546 may be carefully placed to improve adhesion.
在上述过程的变型中，可以放置PE片，这时可以不存在PE管。在此变型中，正如上面所述，应用加热和压缩的简单过程，并且可以产生更均一的复合结构。在进一步的实施方案中，支撑结构505和/或肋状物546可以具有诸如微细孔的部件，所述微细孔偶接ePTFE膜。微细孔直径可以在例如0.005”-0.030”的范围。In a variation of the procedure described above, the PE sheet can be placed and the PE pipe may not be present. In this variant, as described above, a simple process of heating and compression is applied and a more uniform composite structure can be produced. In further embodiments, the support structure 505 and/or the ribs 546 may have features such as microscopic pores coupled to the ePTFE membrane. Micropore diameters may range, for example, from 0.005" to 0.030".
在关于可以用来制备对合辅助装置500的对合辅助体部515的材料类型的变型中，可以利用其它材料诸如但不限于海绵材料、聚氨酯、有机硅、牛或猪心包。粘合过程可以包括但不限于热粘合、缝合和胶合。In variations regarding the types of materials that may be used to make the inclination assist body 515 of the inclination assist device 500, other materials such as, but not limited to, sponge material, polyurethane, silicone, bovine or porcine pericardium may be utilized. Bonding processes may include, but are not limited to, thermal bonding, sewing, and gluing.
继续参照图5A，在一些实施方案中，对合辅助装置500具有穿孔或槽520。可以存在一个或多个这样的穿孔或槽520。这些穿孔520可以服务于提供可以放置锚固件的部位的目的，如本文所讨论的那样。With continued reference to FIG. 5A , in some embodiments, the alignment aid 500 has perforations or slots 520 . There may be one or more such perforations or slots 520 . These perforations 520 may serve the purpose of providing sites where anchors may be placed, as discussed herein.
对合辅助装置500的一个优势在于对合辅助装置500可以折叠成较小的结构。对合辅助装置500可以通过递送导管经皮递送。在一些实施方案中，支撑结构505由形状记忆材料制成。当对合辅助装置500在心脏内展开时，重新获得对合辅助装置500的所需形状。现在许多实施方案描述用来将对合辅助装置500递送至心脏中的各种方法、装置和系统。One advantage of the alignment aid 500 is that the alignment aid 500 can be folded into a smaller configuration. Coaptation aid 500 may be delivered percutaneously via a delivery catheter. In some embodiments, support structure 505 is made of a shape memory material. When the alignment assist device 500 is deployed within the heart, the desired shape of the alignment assist device 500 is regained. A number of embodiments now describe various methods, devices, and systems for delivering the coaptation assist device 500 into the heart.
在一些使用方法中，第一支撑体具有其中第一支撑体505.2大体是直线的第一构型，和其中第一支撑体505.2是弯曲的第二构型。在一些使用方法中，第一支撑体505.2和第二支撑体505.1被构造成允许经皮插入对合辅助装置500。In some methods of use, the first support has a first configuration in which the first support 505.2 is generally straight, and a second configuration in which the first support 505.2 is curved. In some methods of use, the first support body 505.2 and the second support body 505.1 are configured to allow percutaneous insertion of the alignment assist device 500 .
在递送操作中的前几个步骤可以类似于本领域中已知的那些。例如在下部躯干/大腿上部区域(腹股沟)中穿刺患者的身体从而得到进入股静脉的入路。通常，将跨间隔鞘(trans-spetal sheath)和针插入到下腔静脉并向上推进至房间隔，在该点处进行跨室间隔穿刺，并且将跨间隔鞘推进到左心房中。移除所述针，跨间隔鞘现在提供至左心房的入路。关于上述步骤的更多细节可以在公共医学文献中发现。The first few steps in the delivery procedure can be similar to those known in the art. Access to the femoral vein is obtained eg by puncturing the patient's body in the lower torso/upper thigh region (groin). Typically, a trans-spetal sheath and needle are inserted into the inferior vena cava and advanced up to the interatrial septum, at which point a trans-spetal puncture is made and the trans-spetal sheath advanced into the left atrium. With the needle removed, the transseptal sheath now provides access to the left atrium. More details on the above steps can be found in the public medical literature.
所述方法可以包括各种步骤包括现在描述的那些。对合辅助装置500的心室突出物525可以大体上放置在左心室内。可以有利的是使用各种导引技术将对合辅助装置500导引至此位置。例如，可以将简单的引导丝放置在跨间隔鞘内并且通过首先进入左心房并且穿过二尖瓣而引导到左心室中。然而，简单的引导丝可能不能在心室突出物525的放置中提供充分的准确度。The method may include various steps including those now described. Ventricular protrusion 525 of coaptation assist device 500 may be placed substantially within the left ventricle. It may be advantageous to guide the alignment aid 500 to this location using various guidance techniques. For example, a simple guide wire can be placed within a transseptal sheath and guided into the left ventricle by first entering the left atrium and passing through the mitral valve. However, a simple guide wire may not provide sufficient accuracy in the placement of the ventricular protrusion 525 .
在一些实施方案中，可以使用在可操控鞘内放置引导丝的方法。带有引导丝的可操控鞘可以通过跨间隔鞘推进并且随后通过二尖瓣推进至左心室中，在左心室中可操控鞘的操控能力将对适当地定位引导丝提供额外的支持。在放置引导丝后，可操控鞘需要在递送对合辅助装置之前被移除。这种方法尽管提供了对引导丝的更准确定位，但涉及了移除可操控鞘的一个额外步骤。为了在减少执行植入所需的步骤的数目方面改进此过程，本文公开了可操控鞘的多个实施方案。In some embodiments, placement of a guide wire within a steerable sheath may be used. The steerable sheath with guide wire can be advanced through the transseptal sheath and then through the mitral valve into the left ventricle where the steerability of the steerable sheath will provide additional support for proper positioning of the guide wire. After placement of the guide wire, the steerable sheath needs to be removed prior to delivery of the coaptation aid. This approach, while providing more accurate positioning of the guide wire, involves an additional step of removing the steerable sheath. To improve this process in terms of reducing the number of steps required to perform implantation, various embodiments of a steerable sheath are disclosed herein.
小直径可操控导管Small Diameter Steerable Catheters
参照图6A，图示了小直径可操控导管600。在一些实施方案中，可操控导管600的柄部610的直径615可以等于或基本上等于可操控导管600的体部605的直径620。可操控导管600内可以具有牵引线625。当旋转柄部610时，例如在箭头632的方向上，可操控导管600的远侧部分沿箭头635从直线位置630移动至弯曲位置640。弯曲位置640可以有益于定位心室突出物625，如本文所讨论的。当旋转柄部610时，例如在箭头632的相反方向上，可操控导管600的远侧部分沿弯曲位置640移动至直线位置630。可操控导管600的直线位置630由虚线显示，不要与也以虚线显示的牵引线625混淆。直线位置630可以有益于根据解剖学插入或撤回可操控导管600。Referring to Figure 6A, a small diameter steerable catheter 600 is illustrated. In some embodiments, the diameter 615 of the handle 610 of the steerable catheter 600 can be equal or substantially equal to the diameter 620 of the body 605 of the steerable catheter 600 . Steerable catheter 600 may have a pull wire 625 within it. When handle 610 is rotated, eg, in the direction of arrow 632 , the distal portion of steerable catheter 600 moves along arrow 635 from straight position 630 to curved position 640 . The curved position 640 may be useful for positioning the ventricular protrusion 625, as discussed herein. When handle 610 is rotated, eg, in the opposite direction of arrow 632 , the distal portion of steerable catheter 600 moves along curved position 640 to straight position 630 . The linear position 630 of the steerable catheter 600 is shown by a dashed line, not to be confused with the pull line 625 also shown by a dashed line. The linear position 630 may be beneficial for anatomically inserting or withdrawing the steerable catheter 600 .
在一些实施方案中，柄部610的直径可以等于体部605的直径。这可以是有利的，因为当可操控导管600放置在心室中后，对合辅助装置500可以滑动经过柄部610和/或体部605。在一些实施方案中，可操控导管600可以包括从柄部610延伸的在近端处的延伸体612。延伸体612可以是金属丝或其他细长结构。延伸体612的目的是辅助加载其他导管或装置，同时允许临床医生或其他操作者保持对可操控导管600的控制。在将其他导管或装置加载到延伸体612上后，利用可操控导管600来导引其他导管或装置。延伸体612的长度可以匹配或超出被加载的导管或装置的长度使得在加载和递送其他导管或装置的过程中，保持对可操控导管600的控制。In some embodiments, the diameter of the handle 610 can be equal to the diameter of the body 605 . This may be advantageous because the coaptation assist device 500 may be slid over the handle 610 and/or body 605 after the steerable catheter 600 is placed in the ventricle. In some embodiments, the steerable catheter 600 can include an extension 612 at the proximal end extending from the handle 610 . Extension 612 may be a wire or other elongated structure. The purpose of the extension 612 is to assist in loading other catheters or devices while allowing the clinician or other operator to maintain control of the steerable catheter 600 . After the other catheter or device is loaded onto the extension body 612, the steerable catheter 600 is used to guide the other catheter or device. The length of extension 612 may match or exceed the length of the catheter or device being loaded such that control of steerable catheter 600 is maintained during loading and delivery of other catheters or devices.
在一些实施方案中，可以仅在必要时向柄部610偶接延伸体612。例如，如果在操作期间，医疗小组决定较长的导管是必需的，则可以向柄部610偶接延伸体612。偶接机构可以包括但不限于螺纹连接、压配合或其他机构。In some embodiments, extension 612 may be coupled to handle 610 only when necessary. For example, extension 612 may be coupled to handle 610 if, during the procedure, the medical team decides that a longer catheter is necessary. Coupling mechanisms may include, but are not limited to, threaded connections, press fits, or other mechanisms.
在一些实施方案中各种子部件(体部605、柄部615、延伸体612)的尺寸的非限制实例可以如下：体部605的直径620的范围可以为2-10Fr，诸如4Fr，约2Fr-约6Fr，约3Fr-约5Fr，或小于10Fr、9Fr、8Fr、7Fr，6Fr，5Fr、4Fr、3Fr或2Fr。在一些情况下柄部610长度可以为约1/2”-约2”，诸如约1”，所述柄部直线行程(用于启动牵引线)的范围在一些情况下可以为约1/8”-约3”，诸如约1/4”。Non-limiting examples of dimensions of the various subcomponents (body 605, handle 615, extension 612) in some embodiments may be as follows: The diameter 620 of the body 605 may range from 2-10 Fr, such as 4 Fr, about 2 Fr - about 6Fr, about 3Fr - about 5Fr, or less than 10Fr, 9Fr, 8Fr, 7Fr, 6Fr, 5Fr, 4Fr, 3Fr or 2Fr. In some cases the length of the handle 610 may be about 1/2" to about 2", such as about 1", and the range of linear travel of the handle (for activating the pull line) may be about 1/8 in some cases "-about 3", such as about 1/4".
在植入过程期间，一些方法涉及引导丝或引导丝和可操控鞘。在一些方法中，可操控导管600可以通过股入路推进。由于柄部610在患者身体的外部，因此其可以旋转使得此可操控导管600的远侧部分被放置在后瓣叶下方的合适位置处。可以向柄部610的近端附接延伸体612，从而允许后续加载对合辅助装置500和递送导管700，之后插入到跨间隔鞘650中，如本文所述。此递送导管700然后可以用作用于引入对合辅助装置500的导引件，如本文要解释的那样。Some methods involve a guide wire or a guide wire and a steerable sheath during the implantation procedure. In some methods, steerable catheter 600 may be advanced through the femoral approach. Since the handle 610 is external to the patient's body, it can be rotated such that the distal portion of the steerable catheter 600 is placed in place below the posterior leaflet. Extension 612 may be attached to the proximal end of handle 610, allowing for subsequent loading of apposition assist device 500 and delivery catheter 700 prior to insertion into transseptal sheath 650, as described herein. This delivery catheter 700 can then serve as a guide for introducing the coaptation aid 500, as will be explained herein.
图6B图示了可操控导管600在心脏中的放置。显示了跨间隔鞘650的实施方案。还显示了左心房655、左心室660、二尖瓣的后瓣叶665和二尖瓣的前瓣叶670。可操控导管600显示通过二尖瓣并且被定位在后瓣叶665下方。现在可以理解如何具有使可操控导管600的远侧部分偏转的能力可以是有利的使得可以获得对合辅助装置500的适宜位置。可操控导管600的远侧部分能够如所示的那样在后瓣叶665下方弯曲。在一些方法中，在放置可操控导管600后的下一通用步骤是将对合辅助装置500递送到心脏。现在关于实现递送的方法和装置描述进一步的实施方案。Figure 6B illustrates placement of a steerable catheter 600 in the heart. An embodiment spanning a spacer sheath 650 is shown. Also shown are the left atrium 655, the left ventricle 660, the posterior leaflet 665 of the mitral valve, and the anterior leaflet 670 of the mitral valve. Steerable catheter 600 is shown passing through the mitral valve and positioned below posterior leaflet 665 . It can now be appreciated how having the ability to deflect the distal portion of the steerable catheter 600 can be advantageous so that a proper position of the coaptation assist device 500 can be obtained. The distal portion of steerable catheter 600 can bend below posterior leaflet 665 as shown. In some methods, the next general step after placement of steerable catheter 600 is delivery of coaptation assist device 500 to the heart. Further embodiments are now described with respect to methods and devices for achieving delivery.
递送导管delivery catheter
参照图7A，现在描述递送导管700。递送导管700的功能是将对合辅助装置500携带到心脏。递送导管700的轴体710可以是可施加力矩的和可偏转的。轴体710由交叉阴影线显示。递送导管700可以包括柄部730。柄部730可以具有旋转机构，例如牵拉线等。旋转机构可以对轴体710偏转和操控。在柄部730的远侧是植入物鞘725，如本文所解释的，其可以携带对合辅助装置500至心脏。在一些实施方案中，并且植入物鞘725的甚至更远侧是撕除漏斗(tear away funnel)720。撕除漏斗720可以有助于对合辅助装置500的折叠。在一些实施方案中，轴体710的最远端具有可以将轴体710锁定到对合辅助装置500的部件使得对合辅助装置500可以被运输到心脏并适当地放置。现在关于图7B、7C和7D描述锁定过程和部件。Referring to Figure 7A, delivery catheter 700 is now described. The function of the delivery catheter 700 is to carry the coaptation assist device 500 to the heart. The shaft 710 of the delivery catheter 700 may be momentable and deflectable. The shaft 710 is shown by cross-hatching. Delivery catheter 700 may include a handle 730 . The handle 730 may have a rotation mechanism, such as a pull wire or the like. The rotation mechanism can deflect and manipulate the shaft body 710 . Distal to the handle 730 is an implant sheath 725 which, as explained herein, can carry the coaptation assist device 500 to the heart. In some embodiments, and even further distal to the implant sheath 725 is a tear away funnel 720 . Tear-off funnel 720 may facilitate folding of alignment aid 500 . In some embodiments, the distal-most end of the shaft 710 has features that can lock the shaft 710 to the alignment assist device 500 so that the alignment assist device 500 can be transported to the heart and placed properly. The locking process and components are now described with respect to Figures 7B, 7C and 7D.
参照图7D，递送导管700和对合辅助装置500可以具有匹配部件(matchingfeature)，所述匹配部件能够使它们暂时锁定。在一些实施方案中，递送导管700包括一个或多个远侧锁定舌片705。对合辅助装置500可以包括如本文所述的瓣环中枢510。递送导管700的远侧锁定舌片705可以与对合辅助装置500的瓣环中枢510中的部件偶接，如本文要解释的那样。Referring to Figure 7D, delivery catheter 700 and coaptation aid 500 may have matching features that enable them to be temporarily locked. In some embodiments, delivery catheter 700 includes one or more distal locking tabs 705 . Coaptation assist device 500 may include annulus hub 510 as described herein. The distal locking tab 705 of the delivery catheter 700 can be coupled with components in the annulus hub 510 of the coaptation assist device 500 as will be explained herein.
在一些方法中，可操控导管600或其他引导丝或导管可以通过心室突出物525和/或锚固机构530推进。在一些实施方案中，锚固机构530可以在中央具有孔洞或通路以允许可操控导管600穿过，如图7D中所示。可操控导管600可以从锚固机构530通到瓣环中枢510。通过对合辅助装置500的其他路径是预期的。可操控导管600可以从锚固机构530通到瓣环中枢510并且进一步通到递送导管700。In some methods, steerable catheter 600 or other guide wire or catheter may be advanced through ventricular protrusion 525 and/or anchoring mechanism 530 . In some embodiments, anchor mechanism 530 may have a hole or passageway in the center to allow steerable catheter 600 to pass through, as shown in Figure 7D. Steerable catheter 600 may pass from anchor mechanism 530 to annulus center 510 . Other paths through the apposition assist device 500 are contemplated. Steerable catheter 600 may pass from anchor mechanism 530 to annulus center 510 and further to delivery catheter 700 .
参照图7B，递送导管700的尖端以放大的视图显示。还显示了对合辅助装置500的瓣环中枢510。远侧锁定舌片705可以由一些形状记忆材料诸如镍钛诺制成。锁定舌片705的天然位置被设置成使得它们向内和朝向彼此弯曲，如图7A中所示。在一些方法中，引导丝或导管诸如可操控导管600可以插入到瓣环中枢510中以及远侧锁定舌片705之间，并且可以将远侧锁定舌片705可以抵靠着瓣环中枢510推出。瓣环中枢510设计具有匹配插槽740使得远侧锁定舌片705刚好放入这些插槽740中。只要存在可操控导管600以迫使远侧锁定舌片705向外进入到插槽740中，则递送导管700的尖端仍然锁定到瓣环中枢510。其他锁定机构是有可能的并且一种这样的可选方案现在描述在图7C中。Referring to Figure 7B, the tip of the delivery catheter 700 is shown in an enlarged view. Also shown is the annulus hub 510 of the coaptation assist device 500 . Distal locking tab 705 may be made of some shape memory material such as Nitinol. The natural position of the locking tongues 705 is such that they bend inwardly and towards each other, as shown in Figure 7A. In some methods, a guide wire or catheter such as steerable catheter 600 can be inserted into the annulus center 510 and between the distal locking tongue 705 and the distal locking tongue 705 can be pushed out against the annulus center 510 . The annulus hub 510 is designed with mating slots 740 such that the distal locking tongue 705 fits into these slots 740 . The tip of delivery catheter 700 remains locked to annulus hub 510 as long as there is steerable catheter 600 to force distal locking tab 705 outward into slot 740 . Other locking mechanisms are possible and one such alternative is now depicted in Figure 7C.
参照图7C，瓣环中枢510可以包括插销745。插销745可以是穿过瓣环中枢510的实心件，该实心件通过本领域中已知的方法固定就位。递送导管700可以包括金属丝或缝合线750的环。缝合线750可以围绕物体诸如瓣环中枢510内的引导丝或可操控导管600成环。缝合线750可以延伸进入递送导管700的柄部730。柄部730可以具有控制缝合线750的张力的机构。通过控制张力，对合辅助装置500可以被牵拉抵靠递送导管700的远端并且可以牢固地固定于该远端。当可操控导管600被撤回经过插销745的水平时，缝合线750的环755可以在插销745的上滑动，从而释放插销745和对合辅助装置500。Referring to FIG. 7C , the annulus hub 510 can include a detent 745 . The pin 745 may be a solid piece that passes through the annulus hub 510 and is held in place by methods known in the art. Delivery catheter 700 may comprise a loop of wire or suture 750 . Suture 750 may be looped around an object such as a guidewire within annulus center 510 or steerable catheter 600 . Suture 750 may extend into handle 730 of delivery catheter 700 . The handle 730 may have a mechanism to control the tension of the suture 750 . By controlling the tension, the coaptation assist device 500 can be drawn against the distal end of the delivery catheter 700 and can be securely secured thereto. When the steerable catheter 600 is withdrawn past the level of the pin 745 , the loop 755 of the suture 750 can slide over the pin 745 , thereby releasing the pin 745 and the coaptation aid 500 .
递送程序delivery procedure
图8A-8D显示了递送方法。在一些方法中，植入物鞘725和漏斗720被推进覆盖对合辅助装置500。可以在递送导管700与对合辅助装置500锁定后，将植入物鞘725和漏斗720推进覆盖对合辅助装置500。漏斗720的形状辅助对合辅助装置500闭合或自身折叠起来。植入物鞘725和漏斗720的前进显示在图8A和8B中。图8A中的箭头760指示对合辅助装置500如何被牵拉到漏斗720中。一旦对合辅助装置500处于植入物鞘725内，就移除漏斗720。在一些实施方案中，通过拉扯舌片715，从而使漏斗720裂开，来移除漏斗720，显示在图8C中。然后可以废弃漏斗720和舌片715。在一些方法中，可以将容纳对合辅助装置500的植入物鞘725推进经过引导丝或可操控导管600。要重申的是，当对合辅助装置500可以在可操控导管上流畅地滑动而不存在由于柄部610和体部605的不同尺寸的直径所造成的任何困难时，可操控导管600的设计的优势变得很明显。植入物鞘725可以插入到跨间隔鞘650中，如图8D所示。Figures 8A-8D show delivery methods. In some methods, implant sheath 725 and funnel 720 are advanced over coaptation aid 500 . The implant sheath 725 and funnel 720 may be advanced over the coaptation aid 500 after the delivery catheter 700 is locked with the coaptation aid 500 . The shape of the funnel 720 assists the alignment aid 500 to close or fold upon itself. The advancement of the implant sheath 725 and funnel 720 is shown in Figures 8A and 8B. Arrow 760 in FIG. 8A indicates how alignment assist device 500 is drawn into funnel 720 . Once the coaptation aid 500 is within the implant sheath 725, the funnel 720 is removed. In some embodiments, funnel 720 is removed by pulling on tab 715, thereby breaking open funnel 720, shown in Figure 8C. The funnel 720 and tongue 715 can then be discarded. In some methods, an implant sheath 725 containing the coaptation aid 500 may be advanced over a guide wire or steerable catheter 600 . It is to be reiterated that the design of the steerable catheter 600 is critical when the coaptation aid 500 can slide smoothly over the steerable catheter without any difficulty due to the differently sized diameters of the handle 610 and body 605. The advantages become apparent. Implant sheath 725 may be inserted into transseptal sheath 650, as shown in Figure 8D.
对合辅助装置500和植入物鞘725的系统被推进直至其离开跨间隔鞘650，如图8E中所示。递送导管700被偏转使得植入物鞘725被定位在二尖瓣的瓣叶之间，这显示在图8E中。植入物鞘725被置于腱索765(“P2”位置)之间。一旦植入物鞘725到达该位置，将递送导管700保持就位并缓慢地撤回植入物鞘725，导致对合辅助装置500开始退出植入物鞘725，如图8F中所示。需注意可操控导管600或等效的引导丝仍然就位于后瓣叶下方，并且仍然可以使用控制件柄部610进行主动地调整或偏转。在一些方法中，当递送导管700推进时，对合辅助装置500被推出，沿可操控导管600的路径直至心室突出物525的远端530偶接到心室组织。这图示在图8G中。在对合辅助装置500被推出的同时，植入物鞘725可以被撤回。在一些方法中，可以对递送导管700进行旋转调整以确保适宜的放置。The system of coaptation aid 500 and implant sheath 725 is advanced until it clears the transspacing sheath 650, as shown in Figure 8E. Delivery catheter 700 is deflected such that implant sheath 725 is positioned between the leaflets of the mitral valve, which is shown in Figure 8E. The implant sheath 725 is placed between the chordae 765 ("P2" position). Once the implant sheath 725 is in place, the delivery catheter 700 is held in place and the implant sheath 725 is slowly withdrawn, causing the apposition assist device 500 to begin exiting the implant sheath 725, as shown in Figure 8F. Note that the steerable catheter 600 or equivalent guide wire is still located just below the posterior leaflet and can still be actively adjusted or deflected using the control handle 610 . In some methods, as the delivery catheter 700 is advanced, the coaptation assist device 500 is pushed out, following the path of the steerable catheter 600 until the distal end 530 of the ventricular protrusion 525 is coupled to the ventricular tissue. This is illustrated in Figure 8G. Implant sheath 725 may be withdrawn while coaptation aid 500 is being pushed out. In some methods, rotational adjustments may be made to the delivery catheter 700 to ensure proper placement.
锚固anchor
一旦对合辅助装置500被打开，所述方法可以包括将对合辅助装置500锚固在二尖瓣的心房方位上，即，在二尖瓣环上。现在几个实施方案描述实现锚固的方法和系统。Once the apposition assist device 500 is opened, the method may include anchoring the apposition assist device 500 in the atrial orientation of the mitral valve, ie, on the mitral valve annulus. Several embodiments now describe methods and systems for achieving anchoring.
由形状记忆材料制成的支撑结构505可以是有利的。当对合辅助装置500打开时，对合辅助装置500所采取的形状意欲由形状记忆材料的作用所产生。如本文所述，对合辅助装置500的形状可以意欲提供新的对合表面使得减少或消除返流流动。返回到对递送和锚固过程的解释，递送导管700(可以仍然偶接到对合辅助装置500的瓣环中枢510)现在可以被操纵(旋转地和轴向地)从而将对合辅助装置500适宜地定位在天然瓣叶的后瓣叶上方。在实施方案中，对合辅助装置500的支撑结构505可以具有可以附接到组织的部件。在一些实施方案中，这些部件是被动钩。在一些方法中，这些部件接合瓣环使得对合辅助装置500可以在开始锚固的同时被保持就位。图8H显示了递送导管700的状态，其中植入物鞘725被撤出且轴体710仍然偶接到瓣环中枢510。A support structure 505 made of a shape memory material may be advantageous. The shape that the alignment aid 500 assumes when the alignment aid 500 is open is intended to be created by the action of the shape memory material. As described herein, the shape of the coaptation aid 500 may be intended to provide a new coaptation surface such that regurgitant flow is reduced or eliminated. Returning to the explanation of the delivery and anchoring process, the delivery catheter 700 (which may still be coupled to the annulus center 510 of the annulus assist device 500) can now be manipulated (rotationally and axially) so that the apposition assist device 500 is positioned above the posterior leaflet of the native leaflet. In an embodiment, the support structure 505 of the coaptation assist device 500 can have components that can be attached to tissue. In some embodiments, these components are passive hooks. In some approaches, these components engage the annulus so that the coaptation assist device 500 can be held in place while anchoring begins. FIG. 8H shows delivery catheter 700 with implant sheath 725 withdrawn and shaft 710 still coupled to annulus hub 510 .
锚固件800的实施方案详细地图示在图8I中。锚固件800可以以多种方式偶接到递送导管700和/或对合辅助装置500。瓣环中枢510可以具有插销512。插销512可以提供这样的部位，锚固件800的螺旋结构815可以围绕所述部位进行缠绕，如所示的那样。锚固件800可以具有肩部805。肩部805可以紧密贴合递送导管700的轴体710。肩部805可以具有诸如窗810的部件，其可以锁定递送导管700的远侧锁定舌片705。递送导管700的远侧锁定舌片705可以在销、引导丝或导管诸如可操控导管600存在于递送导管700的轴体710内时锁定。在一些方法中，锚固件800可以预先加载到对合辅助装置500上并且在将对合辅助装置500安装到递送导管700上的过程期间与递送导管700锁定就位。这可以在对合辅助装置500被牵拉到植入物鞘725中且准备好插入到股静脉中之前发生。返回到图8H，可以对轴体710施加扭矩使得锚固件800被驱动到组织中。为了提供锚固件800是否被适宜地固定的反馈，荧光标记可以存在于锚固件800上。所述标记可以位于近端处。这些标记可以通知医疗小组锚固件800可以朝向瓣环中枢510行进大约多远并且可以通知大约何时锚固件800牢固地固定就位。在一些实施方案中，为了确保施加适宜的扭矩，当锚固件800在瓣环中枢510上到底时，在柄部730处的扭矩水平可以达到顶点(spike)。这种增加的扭矩水平可以在柄部730处被感觉到，从而提供了已经施加了适宜的扭矩的反馈。中央引导丝或可操控导管600可以被撤出。这导致远侧锁定舌片705从锚固件800的窗810回退，由此将递送导管700和锚固件800解锁。这可以导致对合辅助装置500的释放。递送导管700和可操控导管600现在可以完全被撤出。An embodiment of an anchor 800 is illustrated in detail in FIG. 81 . Anchor 800 can be coupled to delivery catheter 700 and/or coaptation aid 500 in a variety of ways. The annulus hub 510 may have a latch 512 . Pin 512 may provide a location around which helical structure 815 of anchor 800 may be wrapped, as shown. The anchor 800 can have a shoulder 805 . The shoulder 805 can fit snugly around the shaft 710 of the delivery catheter 700 . Shoulder 805 may have features such as window 810 that may lock distal locking tab 705 of delivery catheter 700 . The distal locking tab 705 of the delivery catheter 700 may lock when a pin, guide wire or catheter such as the steerable catheter 600 is present within the shaft 710 of the delivery catheter 700 . In some approaches, the anchor 800 may be preloaded onto the coaptation aid 500 and locked in place with the delivery catheter 700 during the process of installing the coaptation aid 500 onto the delivery catheter 700 . This may occur before the coaptation assist device 500 is drawn into the implant sheath 725 and ready for insertion into the femoral vein. Returning to FIG. 8H , torque can be applied to shaft 710 such that anchor 800 is driven into tissue. To provide feedback on whether the anchor 800 is properly secured, fluorescent markers may be present on the anchor 800 . The marker may be located at the proximal end. These markings can inform the medical team approximately how far the anchor 800 can travel toward the annulus center 510 and can inform approximately when the anchor 800 is securely in place. In some embodiments, to ensure proper torque is applied, the torque level at the handle 730 may spike when the anchor 800 is bottomed on the annulus hub 510 . This increased torque level can be felt at the handle 730, providing feedback that the proper torque has been applied. The central guidewire or steerable catheter 600 may be withdrawn. This causes the distal locking tab 705 to retract from the window 810 of the anchor 800 , thereby unlocking the delivery catheter 700 and the anchor 800 . This may result in the release of the incorporation aid 500 . Delivery catheter 700 and steerable catheter 600 can now be fully withdrawn.
连合锚固commissure anchor
几个实施方案图示了连合锚固。一个这样的实施方案显示在图9A中。递送导管700(未显示)已经撤出，并且锚固导管900已经通过股入路前进。锚固导管900是可施加力矩的。可以提供一个或多个锚固导管900。锚固导管900的远侧尖端可以具有一个或多个部件以在递送锚固件期间将所述锚固件锁定就位。在图9A中，远侧尖端具有切口905，其可以接收螺旋锚固件915的一部分。锚固导管900还可以具有中央销920。中央销920可以在远侧尖端上具有尖头。在一些实施方案中，中央销920可以具有被撤出的能力。Several embodiments illustrate commissural anchoring. One such embodiment is shown in Figure 9A. Delivery catheter 700 (not shown) has been withdrawn and anchor catheter 900 has been advanced through the femoral approach. Anchor catheter 900 is torqueable. One or more anchor catheters 900 may be provided. The distal tip of anchor catheter 900 may have one or more features to lock the anchor in place during delivery of the anchor. In FIG. 9A , the distal tip has a cutout 905 that can receive a portion of a helical anchor 915 . Anchor catheter 900 may also have a central pin 920 . Central pin 920 may have a pointed tip on the distal tip. In some embodiments, central pin 920 may have the ability to be withdrawn.
图9A显示了环910。环910的端部(未显示)可以行进到锚固导管910的柄部或其间的部分长度使得环910的张力可以被控制。环910盘绕经过横杆917或形成螺旋锚固件915的近侧部的其他部分。带有横杆917的螺旋锚固件915的俯视图显示在图9B中。当在身体外时，在进入跨间隔鞘(未显示)之前，螺旋锚固件915可以邻近中央销920放置。环910可以下面的方式布置，即当向环910施加拉力时，环910保持螺旋锚固件915，和中央销920锁定就位。在图9A中，收起此布置结构使得切口905接收螺旋锚固件915的近侧部分。保持环910处于拉伸状态，将整个结构推进至跨间隔鞘中。Figure 9A shows ring 910. The end (not shown) of the loop 910 can be advanced to the handle of the anchor catheter 910 or a partial length therebetween so that the tension of the loop 910 can be controlled. Loop 910 is coiled through crossbar 917 or other portion forming the proximal portion of helical anchor 915 . A top view of a helical anchor 915 with a crossbar 917 is shown in Figure 9B. When outside the body, helical anchor 915 may be placed adjacent central pin 920 prior to entering a transseptal sheath (not shown). Ring 910 may be arranged in such a way that when tension is applied to ring 910, ring 910 holds helical anchor 915, and central pin 920 locks in place. In FIG. 9A , this arrangement is collapsed such that notch 905 receives a proximal portion of helical anchor 915 . Holding the ring 910 in tension, the entire structure is advanced into the transspacing sheath.
一旦处于身体内的所需位置，调整锚固导管900使得锚固导管900的远端定位在连合孔520的上方。中央销920和螺旋锚固件915被推进使得中央销920在通过连合孔520后首先刺穿组织。向锚固导管900施加扭矩，螺旋锚固件915刺穿组织。螺旋锚固件915将支撑结构505或对合辅助装置500的框架锚固到组织。在螺旋锚固件915就位后，撤出中央销920。中央销920的撤出可以允许环910在螺旋锚固件915的横杆917上方滑动，由此释放锚固件915。此过程可以重复地用于其它连合部位从而锚固对合辅助装置500的两末端突出物。Once in the desired position within the body, anchor catheter 900 is adjusted such that the distal end of anchor catheter 900 is positioned over commissure hole 520 . Central pin 920 and helical anchor 915 are advanced such that central pin 920 pierces tissue first after passing through commissure hole 520 . Torque is applied to anchor catheter 900 and helical anchor 915 pierces the tissue. The helical anchor 915 anchors the support structure 505 or the frame of the coaptation assist device 500 to the tissue. After the helical anchor 915 is in place, the central pin 920 is withdrawn. Withdrawal of central pin 920 may allow ring 910 to slide over crossbar 917 of helical anchor 915 , thereby releasing anchor 915 . This process can be repeated for other commissure sites to anchor the protrusions at both ends of the coaptation aid 500 .
备选的锚固技术Alternative Anchoring Techniques
图10A显示了另一实施方案中的可选锚固技术。在此实施方案中，递送导管1000可以具有多个内腔1040。递送导管1000可以具有如图10B中所示的横截面。内腔1040可以携带单个不同的可扭转驱动轴。每个驱动轴可以锁定到锚固件上(对于轴1020和1030的情况)或锁定到瓣环中枢510上(如对轴1010所示)。每个可扭转轴1010、1020、1030可以具有图9A中所图示的锚固导管900的设计。递送导管1000可以具有中央内腔1050，引导丝或可操控导管600可以穿过中央内腔1050。多个可扭转驱动轴1010、1020、1030、引导丝或可操控导管600以及对合辅助装置500可以在进入到跨间隔鞘之前全部加载到递送导管1000的植入物鞘中和从递送导管1000的植入物鞘中撤出。这样整个布置结构可以被推进并且可以遵循如本文所解释的相同程序来放置对合辅助装置500。此布置结构的有利方面在于可以在不需要多次撤出锚固导管、再加载锚固件和重新进入身体的情况下完成锚固过程。Figure 10A shows an alternative anchoring technique in another embodiment. In this embodiment, delivery catheter 1000 may have multiple lumens 1040 . Delivery catheter 1000 may have a cross-section as shown in Figure 10B. Lumen 1040 may carry a single distinct rotatable drive shaft. Each drive shaft can be locked to an anchor (as in the case of shafts 1020 and 1030) or to the annulus hub 510 (as shown for shaft 1010). Each twistable shaft 1010, 1020, 1030 may have the design of the anchor catheter 900 illustrated in Figure 9A. Delivery catheter 1000 may have a central lumen 1050 through which guide wire or steerable catheter 600 may pass. The plurality of twistable drive shafts 1010, 1020, 1030, guidewire or steerable catheter 600, and apposition assist device 500 can all be loaded into and out of the implant sheath of delivery catheter 1000 prior to entering the transseptal sheath. out of the implant sheath. This way the entire arrangement can be advanced and the same procedure as explained herein can be followed to place the alignment aid 500 . An advantage of this arrangement is that the anchoring procedure can be accomplished without the need for multiple withdrawals of the anchoring catheter, reloading of the anchor, and re-entry into the body.
用于锚固件的备选设计Alternative Designs for Anchors
尽管本文中已经描述了一些锚固件，但预期有其他可选的实施方案。图11A显示了具有爪钩的锚固件。图11B显示了类似雨伞的锚固件。在两个实施方案中，锚固件可以由形状记忆材料制成。在两个实施方案中，锚固件可以加载到递送导管(诸如图11C中图示的递送导管)中。Although some anchors have been described herein, other alternative embodiments are contemplated. Figure 11A shows an anchor with claws. Figure 1 IB shows an umbrella-like anchor. In both embodiments, the anchors may be made of shape memory materials. In both embodiments, the anchor can be loaded into a delivery catheter such as the one illustrated in Figure 11C.
锁定机构(诸如本文所述的那些)可以用来将锚固件锁定到递送导管。递送导管可以具有尖头使得递送导管可以被导引到适宜的位置并且初步地刺穿组织。在递送导管被放置在适宜的位置并且完成初步的穿刺后，一个或多个锚固件可以被推进和安装就位。此步骤之后是解锁和撤出递送导管。Locking mechanisms, such as those described herein, can be used to lock the anchor to the delivery catheter. The delivery catheter can have a pointed tip so that the delivery catheter can be guided to the appropriate location and initially penetrate tissue. After the delivery catheter is placed in place and the initial puncture is completed, one or more anchors can be advanced and installed in place. This step is followed by unlocking and withdrawing the delivery catheter.
图11D是图11B的伞状锚固件已经被安装到组织中以锚固对合辅助装置500之后该伞状锚固件外观如何的图示。由于锚固件的天然无应力形状，当在组织中在对合辅助装置500上展开时，变形的形状将对对合辅助装置500的面具有有效的弹簧弹力，确保良好的立足点。FIG. 11D is an illustration of how the umbrella anchor of FIG. 11B looks after it has been installed into tissue to anchor the apposition assist device 500 . Due to the anchor's naturally stress-free shape, when deployed over the coaptation aid 500 in tissue, the deformed shape will have an effective spring force against the face of the coaptation aid 500, ensuring a good footing.
无脊植入物spineless implant
在图5A-F中所述的对合辅助装置500可以包括支撑结构505。支撑结构506可以由如本文所述的形状记忆材料制成。在对合辅助装置的一些实施方案中，预期有另一构造。此构造可以称作无脊对合辅助装置，以指示在心脏中放置对合辅助装置后移除支撑结构。两种类型的对合辅助装置均可以具有某些优势。无脊对合辅助装置可以因为较少的组件和材料以及不存在金属疲劳而是有利的。The alignment assist device 500 described in FIGS. 5A-F may include a support structure 505 . Support structure 506 may be made from a shape memory material as described herein. In some embodiments of the alignment assist device, another configuration is contemplated. This configuration may be referred to as a spineless coaptation aid to indicate removal of the support structure after placement of the coaptation aid in the heart. Both types of involution aids can have certain advantages. Ridgeless alignment aids may be advantageous due to fewer components and materials and absence of metal fatigue.
图12显示了无脊对合辅助装置1200的实施方案。无脊对合辅助装置1200可以包括管或通路1210。通路1210可以围绕瓣环边缘放置。此通路1210可以称作瓣环管。无脊对合辅助装置1200可以包括沿心室突出物的管或通路1212。此通路1212可以称作心室管。FIG. 12 shows an embodiment of a spineless alignment aid 1200 . The spineless coaptation aid 1200 may include a tube or channel 1210 . Access 1210 may be placed around the annulus rim. This access 1210 may be referred to as the annulus. The spineless apposition assist device 1200 may include a tube or access 1212 along the ventricular protrusion. This pathway 1212 may be referred to as the ventricular canal.
可以朝向瓣环管的端部显示通路1210的剖面。尽管图示了圆形剖面，但管或通路1210、1212可以具有其他剖面包括但不限于卵形的和扁的。A cross-section of the passageway 1210 may be shown towards the end of the annulus. Although a circular cross-section is illustrated, the tubes or passages 1210, 1212 may have other cross-sections including, but not limited to, oval and flattened.
支撑结构1210.1、1210.2、1210.3由虚线显示，例外是在瓣环边缘处，在该处支撑结构1210.1和1210.3突出。支撑结构1210.1、1210.2、1210.3可以具有三个不同的节段，其中1210.1和1210.3置于瓣环管中，且1210.2置于心室管中。支撑结构1210.1、1210.2、1210.3可以在偶接在有脊中枢1220内。在一些实施方案中，支撑结构1210.1、1210.2、1210.3可以是不同的和单独的节段。在一些实施方案中，支撑结构1210.1、1210.2、1210.3可以通过使用多种方法之一连接在一起，所述方法诸如，但不限于，压接和激光焊接。支撑结构1210.1、1210.2、1210.3和对合辅助装置1200的此布置结构允许支撑结构1210.1、1210.2、1210.3从对合辅助装置1200中抽出。在一些方法中，通过对有脊中枢1220施加拉力来抽取支撑结构1210.1、1210.2、1210.3。在本文中将提供关于对合辅助装置1200以及递送和锚固对合辅助装置1200的程序的更多细节。The support structures 1210.1, 1210.2, 1210.3 are shown by dashed lines, with the exception of the annulus margins where the support structures 1210.1 and 1210.3 protrude. The support structure 1210.1, 1210.2, 1210.3 may have three distinct segments, with 1210.1 and 1210.3 placed in the annulus canal and 1210.2 placed in the ventricular canal. The support structures 1210.1, 1210.2, 1210.3 may be coupled within the spine 1220. In some embodiments, the support structures 1210.1, 1210.2, 1210.3 may be distinct and separate segments. In some embodiments, support structures 1210.1, 1210.2, 1210.3 may be joined together using one of a variety of methods such as, but not limited to, crimping and laser welding. This arrangement of the support structures 1210.1 , 1210.2, 1210.3 and the alignment aid 1200 allows the support structures 1210.1 , 1210.2, 1210.3 to be withdrawn from the alignment aid 1200 . In some methods, the support structures 1210.1 , 1210.2, 1210.3 are extracted by applying a pulling force to the spine 1220 . More details regarding the coaptation aid 1200 and the procedures for delivering and anchoring the coaptation aid 1200 will be provided herein.
无脊植入物的递送程序Delivery procedure for spineless implants
图13A和13B图示对合辅助装置1200的递送程序。图13A显示图12的对合辅助装置1200。图13A显示了附加部件，锚固部位1300。此锚固部位1300将在本文中更详细地描述。13A and 13B illustrate the delivery procedure for the alignment assist device 1200 . FIG. 13A shows the alignment assist device 1200 of FIG. 12 . FIG. 13A shows an additional component, anchoring site 1300 . This anchor site 1300 will be described in more detail herein.
可操控导管600可以插入到对合辅助装置1200中。可操控导管600可以从心室突出物1212的远侧尖端插入。可操控导管600可以从出口孔1335离开。可以提供递送导管1320。递送导管1320可以包括可扭转轴1310。递送导管1320可以包括与中枢锚固件1300偶接的中枢锁定部件1330。在图13A中，中枢锁定部件1330显示为螺钉。可以利用本文中所解释的其他锁定机构。Steerable catheter 600 may be inserted into coaptation aid 1200 . Steerable catheter 600 may be inserted from the distal tip of ventricular protrusion 1212 . Steerable catheter 600 may exit from exit port 1335 . A delivery catheter 1320 may be provided. Delivery catheter 1320 may include twistable shaft 1310 . Delivery catheter 1320 may include central locking member 1330 coupled to central anchor 1300 . In Figure 13A, the central locking member 1330 is shown as a screw. Other locking mechanisms explained herein may be utilized.
图13B图示了关于递送导管1320的更多细节。递送导管1320的远侧尖端可以包括漏斗1360。在漏斗1360的近侧，可以存在植入物导入器1340。在最近端处，递送导管1320可以具有柄部1370。FIG. 13B illustrates more details about delivery catheter 1320 . The distal tip of delivery catheter 1320 may include a funnel 1360 . Proximal to the funnel 1360, an implant introducer 1340 may be present. At the most proximal end, delivery catheter 1320 may have a handle 1370 .
可操控导管600可以穿过如本文所述的对合辅助装置1200。漏斗1360可以插入到递送导管1320的远侧尖端上。可以使用锁定部件1330将对合辅助装置1200锁定就位，使得中枢锚固件1300连接到可扭转轴1310。Steerable catheter 600 may be threaded through coaptation aid 1200 as described herein. Funnel 1360 can be inserted onto the distal tip of delivery catheter 1320 . Coaptation aid 1200 may be locked in place using locking member 1330 such that central anchor 1300 is connected to twistable shaft 1310 .
可操控导管600可以穿过植入物引入器1340上的有角度的侧端口1350。对合辅助装置1200和可操控导管600可以通过撤出递送导管1320来牵拉通过漏斗1360。随着继续撤出，对合辅助装置1200在植入物引入器1340内部自己折叠。一旦植入物处于引入器1340中，就移除漏斗1360并丢弃。漏斗1360可以被设计成使得其可以容易被移除。对于漏斗的设计包括但不限于撕开设计(前面显示在图8A-8C中)或蛤壳设计(图13B)。Steerable catheter 600 may be passed through angled side port 1350 on implant introducer 1340 . Coaptation aid 1200 and steerable catheter 600 may be pulled through funnel 1360 by withdrawing delivery catheter 1320 . Coaptation assist device 1200 folds upon itself inside implant introducer 1340 as withdrawal continues. Once the implant is in introducer 1340, funnel 1360 is removed and discarded. Funnel 1360 can be designed such that it can be easily removed. Designs for the funnel include, but are not limited to, a tear-away design (shown previously in Figures 8A-8C) or a clamshell design (Figure 13B).
递送导管1320与植入物引入器1340一起可以在可操控导管600上推进，直至植入物引入器1340与跨间隔鞘650的中枢偶接。在此点处，植入物引入器1340可以不能进一步推进，而对合辅助装置1200本身可以推进到跨间隔鞘中。下面几个步骤类似于图8E至图8G中所示的那些，不同之处在于在此实施例中，不使用植入物鞘。对合辅助装置1200置于后瓣叶上方，心室突出物1212置于左心室中。可操控导管600可以被撤出，使得心室突出物1212在P2下方卷曲或盘绕。一旦心室突出物1212被锚固，中枢锚固件1300可以被旋转或以其他的方式致动。中枢锚固件1300可以将对合辅助装置1200的近侧锚固到瓣环。可扭转轴1310可以被撤出。在额外的锚固后(将在本文中解释)，中枢锁定部件1330被撤出，将支撑结构1210.1、1210.2、1210.3与其一起拉动。对合辅助装置1200现在可以在左心中在没有支撑结构1210.1、1210.2、1210.3的条件下操作。The delivery catheter 1320 together with the implant introducer 1340 can be advanced over the steerable catheter 600 until the implant introducer 1340 is coupled with the hub across the septum sheath 650 . At this point, the implant introducer 1340 may not be advanced further, and the coaptation assist device 1200 itself may be advanced into the transseptal sheath. The next few steps are similar to those shown in Figures 8E-8G, except that in this example, an implant sheath is not used. The coaptation assist device 1200 is placed over the posterior leaflet and the ventricular protrusion 1212 is placed in the left ventricle. Steerable catheter 600 may be withdrawn such that ventricular protrusion 1212 crimps or coils below P2. Once the ventricular protrusion 1212 is anchored, the central anchor 1300 can be rotated or otherwise actuated. Central anchor 1300 may anchor proximally of coaptation assist device 1200 to the annulus. The twistable shaft 1310 can be withdrawn. After additional anchoring (to be explained herein), central locking member 1330 is withdrawn, pulling support structures 1210.1, 1210.2, 1210.3 with it. The alignment aid 1200 can now operate in the left heart without the support structures 1210.1, 1210.2, 1210.3.
用于无脊植入物的锚固程序Anchoring procedure for spineless implants
图14A显示用于锚固对合辅助装置1200的实施方案。由于在植入后可以不存在刚性结构诸如支撑结构1210.1、1210.2、1210.3，对合辅助装置1200可能需要额外的锚固件。在一些实施方案中，对合辅助装置1200可以利用密排的锚固件。在一些实施方案中，对合辅助装置1200可以利用本文所述的类似的具有支撑结构505的对合辅助装置以外的额外的密排的锚固件。图14A显示了锚固件1400的实施方案，该实施方案可以用来将对合辅助装置1200和组织偶接。图14B显示了另一个实施方案。在图14B中，缝合线或带子1410用来将对合辅助装置1200“缝合”至组织。缝合线或带子1410可以由几种材料之一制成，所述几种材料包括但不限于，聚丙烯或尼龙。本文现在解释描述如何放置多个锚固件的几个实施方案。FIG. 14A shows an embodiment of an apposition assist device 1200 for anchoring. Since there may be no rigid structures such as support structures 1210.1, 1210.2, 1210.3 after implantation, the coaptation aid 1200 may require additional anchors. In some embodiments, the alignment assist device 1200 can utilize close-packed anchors. In some embodiments, the alignment aid 1200 may utilize additional close-packed anchors beyond a similar alignment aid with support structure 505 described herein. Figure 14A shows an embodiment of an anchor 1400 that can be used to couple an apposition assist device 1200 to tissue. Figure 14B shows another embodiment. In Fig. 14B, sutures or straps 1410 are used to "sewn" the coaptation assist device 1200 to tissue. The suture or strap 1410 can be made from one of several materials including, but not limited to, polypropylene or nylon. Several embodiments describing how to place multiple anchors are now explained herein.
图15A显示递送多个锚固件的锚固导管1500的实施方案。几个锚固件1510(包括锚固件1510.1和锚固件1510.2)堆叠在锚固导管1500内。尽管图15A显示堆叠在锚固导管1500内的两个锚固件1510.1和1510.2，但可以堆叠更多或更少的锚固件。每个锚固件1510可以包括盘绕段1550。盘绕段1550可以包括尖头1570。锚固件1510可以包括锚固件头部1560。锚固件头部1560可以具有由图15A中的1545.1、1545.2、1545.3和1545.4所示的几个横截面中的一个。其他横截面是可能的。Figure 15A shows an embodiment of an anchor catheter 1500 that delivers multiple anchors. Several anchors 1510, including anchor 1510.1 and anchor 1510.2, are stacked within anchor catheter 1500. Although Figure 15A shows two anchors 1510.1 and 1510.2 stacked within anchor catheter 1500, more or fewer anchors may be stacked. Each anchor 1510 can include a coiled section 1550 . The coiled section 1550 may include a prong 1570 . Anchor 1510 may include anchor head 1560 . Anchor head 1560 may have one of several cross-sections shown by 1545.1, 1545.2, 1545.3, and 1545.4 in Figure 15A. Other cross-sections are possible.
为了初步加载锚固导管1500，锚固件1510被加载到锚固导管1500的中央轴1520上。中央轴1520和锚固件1510可以具有匹配的横截面使得锚固件1510可以旋转地偶接到中央轴1520。在锚固导管1500的近端处，可以包括弹簧1540。此弹簧1540提供了推力使得中央轴1520旋转，锚固件1510在箭头1550的方向上离开锚固导管1500的远端。当锚固件1510离开时，锚固件1510可以接合对合辅助装置1200和组织从而将对合辅助装置1200偶接到组织。中央轴1520的旋转可以由操作者诸如医生控制。在一些实施方案中，中央轴1520偶接到可施加力矩的金属丝(未显示)，所述可施加力矩的金属丝可以在近端处偶接到柄部(未显示)。在一些实施方案中，可施加力矩的金属丝可以手动控制。在一些实施方案中，可施加力矩的金属丝可以经由电动机控制。用来向中央轴1520施加旋转运动的方法是预期的。在图15A中未显示的特征是对锚固导管1500的远端操控和定位的能力。当递送一个锚固件1510时，远侧尖端可以需要重新定位以递送下一个锚固件1510。可以包括操控机构诸如牵拉线从而对锚固导管1500的远侧尖端操控。To initially load anchor catheter 1500 , anchor 1510 is loaded onto central shaft 1520 of anchor catheter 1500 . Central shaft 1520 and anchor 1510 can have matching cross-sections such that anchor 1510 can be rotationally coupled to central shaft 1520 . At the proximal end of the anchor catheter 1500, a spring 1540 may be included. This spring 1540 provides a thrust to rotate the central shaft 1520 and the anchor 1510 away from the distal end of the anchor catheter 1500 in the direction of arrow 1550 . When the anchors 1510 are out, the anchors 1510 can engage the apposition assist device 1200 and the tissue to couple the apposition assist device 1200 to the tissue. Rotation of central shaft 1520 may be controlled by an operator, such as a physician. In some embodiments, the central shaft 1520 is coupled to a torqueable wire (not shown), which can be coupled at the proximal end to a handle (not shown). In some embodiments, the torqueable wire can be manually controlled. In some embodiments, the torqueable wire can be controlled via a motor. Methods for imparting rotational motion to central shaft 1520 are contemplated. A feature not shown in FIG. 15A is the ability to manipulate and position the distal end of anchor catheter 1500 . When delivering one anchor 1510, the distal tip may need to be repositioned to deliver the next anchor 1510. A steering mechanism, such as a puller wire, may be included to steer the distal tip of anchor catheter 1500 .
图15B显示了递送多个锚固件的锚固导管1600的另一个实施方案。图15B仅显示锚固导管1600的远侧尖端。锚固导管1600可以包括多个锚固件1610诸如1610.1和1610.2。尽管锚固导管1600显示了五个锚固件。但可以在任何一次加载更多或更少的锚固件1610。锚固导管1600可以具有中央轴1630。锚固导管1600可以包括螺纹，诸如在壳体1605的内部上的1620。如所示的那样，这些螺纹1620可以容纳锚固件1610的盘圈。为了初步地加载锚固导管1600，锚固件1610插入到壳体1605。锚固件1610插入到中央轴1630上。如前所述，中央轴1630的横截面可以匹配锚固件1610的横截面使得锚固件1610可以安装到中央轴1630上。中央轴1630的旋转可以由可施加力矩的线缆(未显示)控制，所述可施加力矩的线缆可以将中央轴1630偶接到锚固导管1600的柄部(未显示)。操作者诸如医生可以控制旋转。在一些实施方案中，可施加力矩的金属丝可以手动控制。Figure 15B shows another embodiment of an anchor catheter 1600 for delivering multiple anchors. FIG. 15B shows only the distal tip of anchor catheter 1600 . Anchor catheter 1600 may include a plurality of anchors 1610 such as 1610.1 and 1610.2. Although anchor catheter 1600 shows five anchors. But more or fewer anchors 1610 can be loaded at any one time. Anchor catheter 1600 may have a central shaft 1630 . Anchor catheter 1600 may include threads, such as 1620 on the interior of housing 1605 . These threads 1620 may receive coils of the anchor 1610 as shown. To initially load anchor catheter 1600 , anchor 1610 is inserted into housing 1605 . Anchor 1610 is inserted onto central shaft 1630 . As previously mentioned, the cross-section of the central shaft 1630 can match the cross-section of the anchor 1610 so that the anchor 1610 can be mounted to the central shaft 1630 . The rotation of the central shaft 1630 can be controlled by a torque-imparting cable (not shown) that can couple the central shaft 1630 to a handle (not shown) of the anchor catheter 1600 . An operator such as a doctor can control the rotation. In some embodiments, the torqueable wire can be manually controlled.
在一些实施方案中，可施加力矩的金属丝可以经由电动机控制。当中央轴1630旋转时，螺纹将迫使锚固件1610离开锚固导管1600并接合对合辅助装置1200和组织从而将对合辅助装置1200和组织偶接在一起。锚固导管1600还可以具有牵拉线从而对锚固导管1600的远侧尖端操控使得当递送一个锚固件1610时，锚固导管1600可以被定位以递送下一个锚固件1610。In some embodiments, the torqueable wire can be controlled via a motor. As the central shaft 1630 is rotated, the threads will force the anchor 1610 out of the anchor catheter 1600 and engage the apposition assist device 1200 and the tissue thereby coupling the apposition assist device 1200 and the tissue together. Anchor catheter 1600 may also have a puller wire to manipulate the distal tip of anchor catheter 1600 so that while one anchor 1610 is being delivered, anchor catheter 1600 may be positioned for delivery of the next anchor 1610 .
图15B图示了中央缝合线1635。中央缝合线1635可以包括球1640，球1640偶接到中央缝合线1635的端部。图15C和15D图示可以如何使用中央缝合线1635和球1640。球1640可以安放在第一锚固件1610.1内的插槽中。中央缝合线1635可以将第一锚固件1610.1连接到第二锚固件1610.2和其他锚固件1610(在图中未显示)。这种布置可以提供使用中央缝合线1635作为引导丝以在锚固件1610已经旋入组织1645中后使锚固件1610退回的能力。操作者可以希望退回锚固件1610从而重新定位或调整锚固件1610。另外，如果一个或多个锚固件1610变松，则中央缝合线1635可以提供用于所述松动的锚固件1610的系绳，因此防止了栓塞事件。FIG. 15B illustrates central suture 1635 . Central suture 1635 may include a ball 1640 coupled to an end of central suture 1635 . 15C and 15D illustrate how central suture 1635 and ball 1640 may be used. The ball 1640 may seat in a socket within the first anchor 1610.1. Central suture 1635 may connect first anchor 1610.1 to second anchor 1610.2 and other anchors 1610 (not shown in figure). This arrangement can provide the ability to use central suture 1635 as a guide wire to retract anchor 1610 after anchor 1610 has been threaded into tissue 1645 . The operator may wish to retract the anchor 1610 in order to reposition or adjust the anchor 1610 . Additionally, if one or more anchors 1610 become loose, central suture 1635 can provide a tether for the loose anchors 1610, thus preventing an embolic event.
图16A-C显示了递送多个锚固件的锚固导管1700的另一实施方案。锚固导管1700可以具有空心轴。空心轴可以在远端处变尖，所述远端可以用来刺穿对合辅助装置1200和组织。多个锚固件1710诸如1710.1、1710.2可以布置在锚固导管1700的空心轴内。锚固件1710可以是空心桶。16A-C show another embodiment of an anchor catheter 1700 for delivering multiple anchors. Anchor catheter 1700 may have a hollow shaft. The hollow shaft can be tapered at a distal end that can be used to pierce the coaptation aid 1200 and tissue. A plurality of anchors 1710 such as 1710.1, 1710.2 may be disposed within the hollow shaft of anchor catheter 1700. Anchor 1710 may be a hollow barrel.
缝合线1720可以如所示的穿过锚固件1710。可以通过将缝合线1720布置成离开第二锚固件1710.2并且经过侧孔1740进入第一锚固件1710.1来将缝合线1720固定到第一锚固件1710.1。然后可以借助于绳结(如虚线所绘)将缝合线1720固定在第一锚固件1710.1内。除了第一锚固件1710.1以外，其他锚固件1710中的缝合线1720可以看起来如对于锚固件1710.2所示的。除了第一锚固件1710.1以外的锚固件1710的一部分壁被挖除成为切口。所述切口可以辅助更好地将锚固件嵌入在组织内，类似于系墙螺栓。在锚固导管1700的近端处，可以存在诸如推杆管1750的部件从而使锚固件1710诸如1710.1和1710.2在远端处离开锚固导管1700。推杆1750可以附接到柄部(未显示)以便能够使操作者诸如医生在适当时安置一个或多个锚固件1710。箭头1760指示推动的方向。Suture 1720 may be threaded through anchor 1710 as shown. The suture 1720 can be secured to the first anchor 1710.1 by placing the suture 1720 out of the second anchor 1710.2 and into the first anchor 1710.1 through the side hole 1740. The suture 1720 can then be secured within the first anchor 1710.1 by means of a knot (as depicted in dashed lines). Sutures 1720 in anchors 1710 other than first anchor 1710.1 may appear as shown for anchor 1710.2. A portion of the wall of the anchors 1710 other than the first anchor 1710.1 is cut out as an incision. The incisions can assist in better embedding the anchor within the tissue, similar to a tie bolt. At the proximal end of anchoring catheter 1700, there may be a component such as push rod tube 1750 to allow anchors 1710 such as 1710.1 and 1710.2 to exit anchoring catheter 1700 at the distal end. Push rod 1750 may be attached to a handle (not shown) to enable an operator, such as a physician, to place one or more anchors 1710 as appropriate. Arrow 1760 indicates the direction of push.
图16B-C图示了图16A的锚固导管1700如何可以操作。在图16B中，锚固导管1700通过诸如由图5A中520所述的槽推进经过对合辅助装置1200。然后锚固导管1700刺穿组织1645。操作者将第一锚固件1710.1推出锚固导管1700，将锚固件1710.1安置在组织内。一旦安置了第一锚固件1710.1，如图16C中所示安置锚固件1710的剩余部分。在图16C中在安置第一锚固件1710.1后将锚固导管1700拉出组织以便进入第二位置。在第二位置处，锚固导管1700可以安置第二锚固件1710.2。继续此过程直至需要将对合辅助装置1200固定于组织。在递送最后一个锚固件1710后，切割器(未显示)可以在锚固导管1700内前进以切割缝合线1720，留下锚固件1710。16B-C illustrate how the anchor catheter 1700 of FIG. 16A may operate. In FIG. 16B, anchor catheter 1700 is advanced past coaptation aid 1200 through a slot such as that described by 520 in FIG. 5A. Anchor catheter 1700 then pierces tissue 1645 . The operator pushes the first anchor 1710.1 out of the anchor catheter 1700, placing the anchor 1710.1 within the tissue. Once the first anchor 1710.1 is installed, the remainder of the anchor 1710 is installed as shown in Figure 16C. In Fig. 16C the anchor catheter 1700 is pulled out of the tissue after placement of the first anchor 1710.1 to enter the second position. In the second position, anchor catheter 1700 may seat second anchor 1710.2. This process continues until it is desired to secure the coaptation aid 1200 to tissue. After the last anchor 1710 is delivered, a cutter (not shown) can be advanced within anchor catheter 1700 to cut suture 1720 , leaving anchor 1710 behind.
在一些实施方案中，锚固件1710可以是不透射线的或它们可以被不透射线的标记覆盖。在递送锚固件1710的过程期间，如果使用荧光镜可以看到不透射线的标记。这可以有助于围绕对合辅助装置1200的瓣环隔开锚固件1710。In some embodiments, the anchors 1710 can be radiopaque or they can be covered with radiopaque markers. During the process of delivering the anchor 1710, radiopaque markers can be seen if a fluoroscope is used. This may help to space the anchors 1710 around the annulus of the coaptation assist device 1200 .
在一些实施方案中，在固定对合辅助装置1200的同时评估MR，根据MR的存在与否确定缝合动作的针距(pitch)和/或位置。In some embodiments, the MR is assessed while the apposition assist device 1200 is secured, and the pitch and/or location of the suturing action is determined based on the presence or absence of the MR.
具有套管的无脊植入物spineless implant with sleeve
图17A图示了无脊对合辅助装置1800的另一实施方案。在此实施方案中，支撑结构1810可以仅沿心室突出物1820向下移动。管或通路1830可以围绕对合辅助装置1800的瓣环边缘存在。代替利用支撑结构1810来保持对合辅助装置1800的形状，锚固导管1850可以插入到管1830中，如图17B中所示。在图17B中，锚固导管1850可以是可偏转的锚固导管。FIG. 17A illustrates another embodiment of a spineless alignment aid 1800 . In this embodiment, the support structure 1810 can only move down the ventricular protrusion 1820 . A tube or passageway 1830 may exist around the annulus edge of the coaptation assist device 1800 . Instead of utilizing support structure 1810 to maintain the shape of coaptation aid 1800, anchor catheter 1850 may be inserted into tube 1830, as shown in Figure 17B. In Figure 17B, anchor catheter 1850 may be a deflectable anchor catheter.
图17B还显示了第一部位1860.1，在该处可以递送诸如由图15A中的1560所述的锚固件。在此部位1860.1和所有锚固部位1860处，锚固导管1850的尖端将被位于体外的控制件偏转。可以递送锚固件(未显示)，将对合辅助装置1800固定到组织。锚固导管1850的尖端可以是不透射线的，然后其可以在锚固件递送过程期间被可视化。可以利用对尖端的可视化来将锚固件围绕对合辅助装置1800的瓣环定位。图17B图示了第一锚固位置1860.1，图17C图示了第二锚固位置1860.2。在递送适宜数目的锚固件后，将锚固导管1850完全撤回，如图17D中所示。最后，可以移除支撑结构1810，如图17E中所示。Figure 17B also shows a first site 1860.1 where an anchor such as that described by 1560 in Figure 15A can be delivered. At this site 1860.1 and all anchor sites 1860, the tip of the anchor catheter 1850 will be deflected by a control located outside the body. Anchors (not shown) may be delivered to secure the coaptation assist device 1800 to tissue. The tip of the anchor catheter 1850 can be radiopaque, which can then be visualized during the anchor delivery procedure. Visualization of the tip can be utilized to position the anchor around the annulus of the coaptation assist device 1800 . Figure 17B illustrates a first anchor location 1860.1 and Figure 17C illustrates a second anchor location 1860.2. After the appropriate number of anchors have been delivered, the anchor catheter 1850 is fully withdrawn, as shown in Figure 17D. Finally, the support structure 1810 can be removed, as shown in Figure 17E.
在图17A-17E中所示的实施方案的变型中，支撑结构1810可以不仅限于心室突出物；其还可以通过套管1830插入使得可以保持所需的形状。支撑结构可以是形状记忆材料。利用围绕套管1830的支撑结构可以产生这样的锚固导管，所述锚固导管与用于图17A中所述的对合辅助装置1800的锚固导管1850相比具有相对较简单的控制机构。In a variation of the embodiment shown in Figures 17A-17E, the support structure 1810 may not be limited to ventricular protrusions; it may also be inserted through a cannula 1830 so that the desired shape may be maintained. The support structure may be a shape memory material. Utilizing the support structure surrounding the sleeve 1830 can create an anchor catheter with a relatively simpler control mechanism than the anchor catheter 1850 used for the apposition assist device 1800 described in FIG. 17A .
预期的是，可以做出以上公开的实施方案的具体特征和方面的多个组合或子组合并且所述组合或子组合仍然落在本发明中的一个或多个发明内。此外，任何具体的特征、方面、方法、性质、特性、质量、属性、要素等的本文中的公开内容可以与实施方案一起用于在本文中给出的所有其他实施方案。因此，应理解的是，所公开的实施方案的各种特征和方面可以彼此组合或替换从而形成所公开的发明的不同方式。因此，意欲在本文中公开的本发明的范围不应当受上述具体公开的实施方案限制。此外，尽管本发明可以接受各种修改和备选形式，其具体实例已经在附图中示出并且在本文中详细描述。然而，应当理解的是，本发明不应限于所公开的具体形式或方法，而相反地，本发明意在涵盖落在所描述的各种实施方案和所附权利要求的精神和范围内的所有修改、等价物、和替代方案。在本文中所公开的任何方法不需要按所叙述的顺序进行。在本文中所公开的方法包括由从业人员采取的某些行动；然而，它们也可以明示地或暗示地包括那些行为的任何第三方指示。例如，行动如“在二尖瓣附近插入对合辅助体部”包括“指示在二尖瓣附近插入对合辅助体部”。在本文中所公开的范围还包括任一种或全部重叠、子范围、以及它们的组合。语言如“高达”、“至少”、“大于”、“小于”、“之间”等包括所叙述的数字。如在本文中所使用的前面加了术语如“大约”、“约”、和“基本上”的数字包括所叙述的数字，并且还表示与仍然发挥所需功能或实现所需结果的与所述量接近的量。例如，术语“大约”、“约”、和“基本上”可以指在不超过所述量的小于10％范围内、不超过所述量的小于5％范围内、不超过所述量的小于1％范围内、不超过所述量的小于0.1％范围内、不超过所述量的小于0.01％范围内的量。It is contemplated that various combinations or sub-combinations of specific features and aspects of the above-disclosed embodiments can be made and still fall within one or more of the inventions herein. Furthermore, disclosure herein of any specific feature, aspect, method, property, characteristic, quality, attribute, element, etc. can be used in conjunction with an embodiment to all other embodiments given herein. It is therefore to be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another to form various modes of the disclosed invention. Therefore, it is intended that the scope of the present invention disclosed herein should not be limited by the specific disclosed embodiments described above. Furthermore, while the invention is amenable to various modifications and alternative forms, specific examples thereof have been shown in the drawings and described in detail herein. It should be understood, however, that the invention should not be limited to the particular forms or methods disclosed, but on the contrary, the invention is intended to cover all forms which fall within the spirit and scope of the various embodiments described and the appended claims. Modifications, Equivalents, and Alternatives. Any method disclosed herein does not need to be performed in the order recited. The methods disclosed herein include certain actions taken by the practitioner; however, they may also include any third-party instruction of those actions, either expressly or implicitly. For example, an action such as "insert an apposition assisting body near the mitral valve" includes "instruct to insert an apposition assisting body near the mitral valve". Ranges disclosed herein also include any and all overlaps, subranges, and combinations thereof. Language such as "up to," "at least," "greater than," "less than," "between," and the like includes the numbers recited. As used herein, numbers preceded by terms such as "about," "approximately," and "substantially" include the recited number and also mean the same amount that still performs the desired function or achieves the desired result. The amount close to the stated amount. For example, the terms "about," "approximately," and "substantially" can mean within less than 10% of the stated amount, within less than 5% of the stated amount, within less than An amount in the range of 1%, not exceeding less than 0.1% of the stated amount, and not exceeding less than 0.01% of the stated amount.
| Application Number | Priority Date | Filing Date | Title |
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| CN202110375324.3ACN113081393A (en) | 2014-06-18 | 2015-06-17 | Mitral valve implant for treating valvular regurgitation |
| Application Number | Priority Date | Filing Date | Title |
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| US201461014060P | 2014-06-18 | 2014-06-18 | |
| US61/014,060 | 2014-06-18 | ||
| PCT/US2015/036260WO2015195823A1 (en) | 2014-06-18 | 2015-06-17 | Mitral valve implants for the treatment of valvular regurgitation |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110375324.3ADivisionCN113081393A (en) | 2014-06-18 | 2015-06-17 | Mitral valve implant for treating valvular regurgitation |
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| CN106572910Atrue CN106572910A (en) | 2017-04-19 |
| CN106572910B CN106572910B (en) | 2021-04-27 |
| Application Number | Title | Priority Date | Filing Date |
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| CN202110375324.3APendingCN113081393A (en) | 2014-06-18 | 2015-06-17 | Mitral valve implant for treating valvular regurgitation |
| CN201580044329.0AActiveCN106572910B (en) | 2014-06-18 | 2015-06-17 | Mitral valve implants for the treatment of valve regurgitation |
| Application Number | Title | Priority Date | Filing Date |
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| CN202110375324.3APendingCN113081393A (en) | 2014-06-18 | 2015-06-17 | Mitral valve implant for treating valvular regurgitation |
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| CB02 | Change of applicant information | Address after:California, USA Applicant after:Boraris Medical Co., Ltd Address before:California, USA Applicant before:Middle Peak Medical Inc | |
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