Source: https://patents.google.com/patent/CN101484093B/en
Timestamp: 2019-09-19 09:35:12
Document Index: 604518576

Matched Legal Cases: ['Application No. 60', 'art 4', 'art 26', 'art 17', 'Application No. 11', 'Application No. 11']

CN101484093B - Prosthetic insert for improving heart valve function - Google Patents
CN101484093B
CN101484093B CN2007800202603A CN200780020260A CN101484093B CN 101484093 B CN101484093 B CN 101484093B CN 2007800202603 A CN2007800202603 A CN 2007800202603A CN 200780020260 A CN200780020260 A CN 200780020260A CN 101484093 B CN101484093 B CN 101484093B
CN2007800202603A
CN101484093A (en
D·L·豪泽
D·埃伦
J·O·索里姆
2006-06-01 Priority to US60/810,085 priority
2007-05-31 Application filed by 爱德华兹生命科学公司 filed Critical 爱德华兹生命科学公司
2007-05-31 Priority to PCT/US2007/070141 priority patent/WO2007140470A2/en
2009-07-15 Publication of CN101484093A publication Critical patent/CN101484093A/en
2011-09-07 Publication of CN101484093B publication Critical patent/CN101484093B/en
用于改善心瓣膜功能的人工插入物 For improving the function of an artificial heart valve insert
[0002] 本申请要求2006年6月1日提交的美国临时专利申请号60/810，085的权益，在此以其整体并入作为参考。 [0002] This application claims the benefit of US Provisional Patent Application No. 60 / 810,085, 2006 June 1 submitted in its entirety is incorporated herein by reference.
[0003] 本公开涉及可植入心脏修复学（implantable cardiacprosthetics)领域,具体而言，涉及心脏人工插入物，用于减少通过心瓣膜如主动脉瓣的反流，以及涉及植入心脏人工插入物的方法。 [0003] The present disclosure relates to an implantable cardiac prosthetics (implantable cardiacprosthetics), and in particular, to insert an artificial heart, a heart valve such as by reducing the aortic valve regurgitation, and to insert an artificial implantable cardiac Methods.
[0004] 心瓣膜反流，或从心瓣膜流出侧到流入侧的泄漏，是当心瓣膜无法正常关闭时发生的状况。 [0004] Heart valve regurgitation, or leakage from the outflow side of the heart valve to the inflow side, is happening at the time the valve careful not close properly. 心瓣膜反流降低心脏的效率，减少血液循环，并增加对心脏的压力。 Heart valve regurgitation reduced efficiency of the heart, reducing blood circulation and increase the pressure on the heart. 在早期，心瓣膜反流使人感到疲劳和呼吸急促。 Fatigue and shortness of breath early on, heart valve regurgitation people. 如果任其发展，这一问题可导致充血性心力衰竭、心律失常或死亡。 If left unchecked, this problem can lead to congestive heart failure, arrhythmias or death.
[0005] 通过主动脉瓣的反流，有时也被称为主动脉瓣关闭不全（aortic insufficiency)，是影响到数百万成年人健康的严重问题。 [0005] By aortic valve regurgitation, sometimes also known as aortic regurgitation (aortic insufficiency), it is a serious problem affecting the health of millions of adults. 主动脉瓣位于心脏左侧，在左心室与主动脉之间。 The aortic valve is on the left side of the heart, between the left ventricle and the aorta. 心室收缩期间，健康的主动脉瓣打开，以允许血液从左心室流进主动脉； 然后在心室舒张期间关闭，以防止血液从主动脉回流进入左心室。 During ventricular systole, the aortic valve healthy open to allow blood to flow from the left ventricle into the aorta; then closed during ventricular diastole, to prevent blood reflux into the left ventricle from the aorta. 但是，随着时间推移，主动脉环的几何构造发生变化，或其它原因，如钙化、感染和损伤，可能会影响到主动脉瓣的功能性。 However, over time, the geometry of the aortic annulus changes, or other reasons, such as calcification, infections and injuries, may affect the function of the aortic valve. 结果是，主动脉瓣可能无法在心室舒张时完全关闭，从而导致反流。 As a result, the aortic valve may not fully close during ventricular diastole, resulting in reflux.
[0006] 主动脉瓣关闭不全典型地通过在心内直视手术过程中用人工瓣膜替换有缺陷的天然瓣膜来治疗。 [0006] aortic regurgitation typically treated by artificial cardiac valve replacement within a defective native valve direct vision during surgery. 但是，心内直视手术具有高度创伤性，因此对于许多高危患者来说并非一种选择。 But heart surgery is highly invasive, and therefore for many high-risk patients is not an option. 因此，近年来，微创方法（less invasive method)，如经皮瓣膜置换术(percutaneous valver印lacement)，已经发展用于替换主动脉瓣。 Thus, in recent years, minimally invasive method (less invasive method), such as percutaneous valve replacement (percutaneous valver printing lacement), have been developed to replace the aortic valve. 在一个实例中，包括支架和瓣膜的人工修复物（prosthesis)被卷曲成较小外形，然后通过经皮途径被递送到心脏中。 In one example, the artificial valve includes a stent and restoration (prosthesis) is crimped to a smaller profile, then delivered to the heart via transdermal routes. 一旦定位于治疗部位，人工修复物被扩张用以代替天然主动脉瓣的功能。 Once positioned at the treatment site, the endoprosthesis is expanded was used in place of the native aortic valve function. 虽然经皮瓣膜置换术已显示出大有前景，但是在递送技术、瓣周漏（perivalvular leakage)和瓣膜耐用性方面仍然存在挑战。 Although percutaneous valve replacement surgery has shown great prospects, but there are still challenges in the delivery of technology, PVL (perivalvular leakage) and valve durability. 此外，如果可能，修复而不是替换天然瓣膜是期望的。 Also, if possible, repair rather than replace the natural valve is desired.
[0008] 因此，在此处公开的是用于治疗心瓣膜疾病的装置和方法，其包括示例性实施方式，一种不需要体外循环的微创方法。 [0008] Accordingly, disclosed herein is a method and apparatus for treating cardiac valve disease, which includes an exemplary embodiment, a minimally invasive approach that does not require cardiopulmonary bypass. 这种装置和方法的某些实施方式期望能够减少或消除通过心瓣膜的反流。 Certain embodiments of the method and apparatus of this embodiment can be reduced or eliminated by a desired heart valve regurgitation. 还期望的是，这种装置和方法的实施方式非常适合用于在经皮或微创方法中递送。 It is also desirable that the apparatus and method of this embodiment is very suitable for delivering in a minimally invasive or percutaneous method. 还期望的是，这种装置和方法的实施方式非常适合用于修复主动脉瓣。 It is also desirable that the apparatus and method of this embodiment is very suitable for repairing an aortic valve. 还期望的是，这种装置的递送是安全、可靠和容易的。 It is also desirable, delivery of such devices is safe, reliable and easy. 还期望的是，这种装置和方法的实施方式适用于针对广泛多样化的心瓣膜缺损而改善心瓣膜功能。 It is also desirable that the apparatus and method of this embodiment is applicable to heart valves for a wide variety of defects and improve heart valve function. 还期望的是，这种装置和方法的实施方式能够不用替换天然瓣膜就可改善瓣膜功能。 It is also desirable that the apparatus and method of this embodiment is capable of replacing the native valve can not improve valve function. [0009] 本公开的各种实施方式提供了用于改善有缺陷的心瓣膜功能的改进的装置和方法。 [0009] Various embodiments of the present disclosure is provided for improving the function of a defective heart valve of the improved apparatus and method. 具体实施方式可被配置为采用经皮或微创的方法植入心脏，其中体外循环不是必需的。 DETAILED DESCRIPTION embodiments may be configured to employ a percutaneous or minimally invasive implantable cardiac wherein the bypass is not necessary.
[0010] 在本公开一个代表性实施方式中，人工装置包括锚定部件和插入部件，所述插入部件被配置用于在天然瓣膜如主动脉瓣的小叶之间展开。 [0010] discloses a representative embodiment, the present artificial means comprises a deployed anchoring member and the insert member, the insert member is configured as native valve leaflets between the aortic valve. 插入部件期望被成形为填补小叶之间的间隙（一个或多个），以在心室舒张期间产生紧密密封，从而最大限度地减少或防止通过主动脉瓣的反流。 Insertion member is desired to be formed (one or more) to the ventricles during diastole tight seal between the leaflets to fill the gap, thereby minimizing or preventing regurgitation through the aortic valve. 插入部件期望被制造成使得天然小叶与插入部件表面啮合的尺寸。 Insert member desired to be manufactured so that the size of the native leaflets engage a surface of the insertion member. 当被配置用于典型的主动脉瓣时，插入部件期望包括三个臂状物，它们从中心区域径向向外延伸。 When configured for typical aortic valve, the insertion member comprises a desired three arms which extend radially outwardly from the central region. 每个臂状物被成形为放置在主动脉瓣的邻近小叶之间。 Each arm is shaped to be placed between adjacent leaflets of the aortic valve. 锚定部件被提供用于将插入部件稳固在其展开的位置。 The anchoring member is provided for the position of the insertion member securely deployed thereof. 在示例性实施方式中，锚定部件采用支架的形式，所述支架被配置用于在升主动脉（ascending aorta)内的展开。 In an exemplary embodiment, the anchoring member in the form of the stent, the stent is configured to expand within the ascending aorta (ascending aorta) in. 在一种变体中，插入部件可以被配置(例如，具有两个臂状物）用于只有两个小叶的主动脉瓣。 In one variant, the insertion member may be configured (e.g., having two arms) for only two aortic valve leaflets. 在另一种变体中，插入部件可以被配置在肺动脉瓣中使用，用于治疗肺动脉瓣闭锁不全。 In another variant, the insertion member may be disposed in the pulmonary valve, for the treatment of pulmonary insufficiency.
[0011] 在本公开另一代表性实施方式中，人工装置包括由支架形成的锚定部件，和插入部件一其被配置用于在天然主动脉瓣的小叶之间展开。 [0011] In another representative embodiment of the present disclosure, a prosthetic device comprising an anchoring member is formed by the holder, and an insertion member that is configured for deployment between the leaflets of the native aortic valve. 锚定部件期望包括用于提供单向流动的瓣膜部件。 Anchoring means comprises a valve member to provide a desired flow in one direction. 锚定部件期望被配置用于递送至升主动脉。 Desired anchoring member is configured to deliver to the ascending aorta. 支架通过自扩张或球囊扩张进行扩张，使得支架被锚定在主动脉中。 Stents expanded by balloon expandable or self-expanding, such that the stent is anchored in the aorta. 展开之后，在支架里的瓣膜部件防止或最大程度地减少通过主动脉的血液回流。 After deployment, the valve member inside the stent to prevent or minimize backflow of blood through the aorta. 插入部件被递送到天然主动脉瓣中，以改善天然瓣膜的功能。 Insertion member is delivered to the native aortic valve in order to improve the function of the native valve. 因此，两个单独的瓣膜（例如支架瓣膜和天然瓣膜）协同工作，以防止通过主动脉环的反流。 Thus, two separate valves (e.g., the native valve and stent-valve) work together to prevent reflux by the aortic rings. 通过在天然瓣膜内展开插入部件，使天然瓣膜发挥它应有的功能，并且血液以基本自然方式进入冠状动脉。 By expanding member is inserted within the native valve, so that the native valve play its proper function, and the blood into the coronary artery in a substantially natural manner. 该支架瓣膜补充了天然瓣膜的功能。 The stent-valve complements the natural valve function. 如果期望，该支架瓣膜可建造成在天然瓣膜之前或之后（期望的是之后）关闭，以进一步影响和改善天然瓣膜的功能，并改善血液动力学。 If desired, the stent-valve may be constructed before or after the native valve (after the desired) closed, and to further improve the impact function of the native valve, and to improve hemodynamics.
[0012] 在一个代表性实施方式中，提供了用于治疗有缺陷的心瓣膜的系统和方法。 [0012] In a representative embodiment, a system and a method for treating a defective heart valve. 所述系统包括人工装置，其包括锚定部件和插入部件。 The system comprises an artificial device, comprising an anchor member and the insertion member. 所述系统进一步包括递送导管，用于通过经皮途径将人工装置递送至心脏中。 The system further comprises a delivery catheter, for artificial heart device is delivered via transdermal routes. 递送导管期望包括具有腔的伸长护套（外壳， sheath)，该腔的大小适于容纳人工装置。 Desirable to include an elongated delivery catheter sheath (shell, sheath) having a cavity, the size of the cavity is adapted to receive an artificial means. 在示例性实施方式中，在通过对象脉管系统推进的过程中，人工装置以收缩的构造被容纳在护套内。 In an exemplary embodiment, in the process of advancing through the subject vasculature, the artificial device is housed in a collapsed configuration within the sheath. 在一种变体中，外壳被配置用于逆行推进，并可以配置有可偏转的末端部分，用于促进在主动脉弓周围的导向（navigation)。 In one variant, the housing is configured for retrograde propulsion, and may be configured with a deflectable tip portion for promoting aortic arch around the guide (navigation). 达到治疗部位后，护套被移动至相对人工装置近端，以便从外壳弹出该装置。 After reaching the treatment site, the sheath is moved relative to the proximal end of an artificial means, to eject the device from the housing. 该装置随后被允许扩张，使得插入与主动脉瓣中的间隙相符，锚定部件与主动脉内壁啮合。 The apparatus is then allowed to expand such that the gap in the aortic valve insert match anchor engaging member and the inner wall of the aorta.
[0013] 在本公开另一个代表性实施方式中，人工装置包括锚定部件和具有三个可扩张臂状物的插入部件，所述插入部件被配置用于在闭锁不全的主动脉瓣中的间隙之间展开。 [0013] In another exemplary embodiment of the present disclosure, a prosthetic device comprising an anchoring member having three expandable arms of the insertion member, the insertion member is configured to insufficiency of the aortic valve expand the gap between. 每个臂状物期望包括可扩张区域，其以有些类似降落伞的方式打开，以防止反流。 Each arm comprises an expandable region is desirable, which is somewhat similar to the parachute opens way to prevent reflux. 在心室收缩期间，每个可扩张区域会收缩以使通过主动脉瓣的血液流动不受阻碍。 During ventricular systole, each expandable region shrinks to allow blood to flow unimpeded through the aortic valve.
[0014] 在本公开某个代表性实施方式中，人工装置包括：插入部件，其被配置用于在主动脉瓣内展开：和锚定部件，其被配置用于固定在左心室内。 [0014] In certain representative embodiments of the present disclosure, a prosthetic device comprising: an insertion member, which is configured to be deployed in the aortic valve: and the anchoring member, which is configured for secured within the left ventricle. 伸长的主体部分被提供用于连接插入部件与锚定部件。 An elongated body portion of the insertion member is provided for connection with the anchoring member. 在一种变体中，人工装置可以以多个阶段被递送。 In one variant, artificial means can be delivered in a plurality of stages. 在第一阶段，锚定部件被递送，然后使其生长至心脏壁中。 In the first stage, the anchoring element is delivered, and then allowed to grow to the heart wall. 在第二阶段，在充分的向内生长发生后，插入部件被附着至锚定部件。 In the second stage, after full ingrowth occurs, the insertion member is attached to the anchor member. [0015] 在本公开另一代表性实施方式中，人工装置包括锚定部件和插入部件，所述插入部件被配置用于在二尖瓣的前叶和后叶之间展开。 [0015] In another representative embodiment of the present disclosure, a prosthetic device comprising an anchoring member and the insert member, the insert member is configured to expand the mitral valve between the anterior and posterior lobe. 插入部件期望被成形为填补天然小叶之间的间隙，以防止通过二尖瓣的反流。 Insertion member is desired to be shaped to fill the gap between the native leaflets to prevent regurgitation through the mitral valve. 插入部件的大小使得在心室收缩期间二尖瓣小叶与插入部件表面啮合以产生紧密密封。 Insertion member such that the size of the mitral valve leaflets during ventricular systole the engaging surface of the insertion member to create a tight seal. 作为本实施方式的变体，提供一个或多个通过插入部件的通道以允许血液在一个方向通过装置流动，而进一步改善瓣膜功能。 As a variant of the embodiment according to the present embodiment, there is provided one or more passages through the insertion member to allow blood flow through the device in one direction, and to further improve the valve function.
[0016] 上述和其它特征根据以下对几个实施方式的详细描述将变得更加明显，所述描述参考附图来进行。 [0016] The above and other features of the following detailed description of several embodiments will become more apparent from the description with reference to the accompanying drawings.
[0017] 图1显示了心脏的横截面图。 [0017] Figure 1 shows a cross-sectional view of the heart.
[0018] 图2是人工装置的透视图，其包括锚定部件和插入部件，所述插入部件被配置用于在天然主动脉瓣的小叶之间展开。 [0018] FIG. 2 is a perspective view of an artificial device, comprising an anchor member and the insert member, said insert member being configured for deployment between the leaflets of the native aortic valve.
[0019] 图3是插入部件的横截面图，其带有生物相容性材料的外涂层。 [0019] FIG. 3 is a cross-sectional view of the insert member with an outer coating which is biocompatible material.
[0020] 图4是放置在主动脉瓣内的图2插入部件的横截面图。 [0020] FIG. 4 is a cross-sectional view of the insert member 2 is placed in the aortic valve of FIG.
[0021] 图5是主动脉的部分剖视图，图解在治疗主动脉瓣关闭不全的对象内展开的图2 的人工装置。 [0021] FIG. 5 is a partial cross-sectional view of the aorta, the artificial device illustrated deployed within the object treating aortic regurgitation Fig.
[0022] 图6是透视图，其图解人工装置的一种实施方式，其中插入部件被直接附着到锚定部件。 [0022] FIG. 6 is a perspective view illustrating one embodiment of an artificial device, wherein the insertion member is directly attached to the anchor member.
[0023] 图7是收缩状态下包含在外壳内的图6插入部件的横截面图，用于递送至治疗部位。 [0023] FIG. 7 is a cross-sectional view of the insert member 6 in a contracted state of FIG contained within the housing, for delivery to the treatment site.
[0024] 图8图解从护套弹出并扩张成扩张状态后的图6的插入部件。 [0024] FIG. 8 illustrates a pop-up from the sheath and expand into an expanded state after insertion member of FIG.
[0025] 图9A是人工装置的透视图，该人工装置包括用于在主动脉瓣里展开的插入部件和带有用于稳固到左心室的啮合部件的锚定部件。 [0025] FIG. 9A is a perspective view of an artificial device, comprising means for the artificial aortic valve member in the insertion and deployment of the anchoring member with a member secured to the engagement of the left ventricle.
[0026] 图9B是以扩张状态显示的多个啮合部件的示例性实施方式的分解图。 [0026] FIG 9B is an exploded view of an exemplary embodiment of a plurality of engaging members expanded state display.
[0027] 图9C是以压缩状态显示的图9B的多个啮合部件的透视图，用于递送到心脏。 [0027] FIG. 9C is a perspective view of a plurality of engaging members. 9B shows a compressed state for delivery to the heart.
[0028] 图10是图9A所示的实施方式的变体，其中提供可选的锚定部件。 [0028] FIG. 10 is a variant of the embodiment shown in FIG. 9A, where the optional anchoring member.
[0029] 图11是类似于图2所示的实施方式的人工装置的透视图，其中所述锚定部件包括支架和用于在升主动脉里展开的瓣膜部件。 [0029] FIG. 11 is a perspective view of an artificial device similar to the embodiment shown in FIG. 2, wherein the anchoring member comprises a stent and a valve member in the ascending aorta deployed.
[0030] 图12是类似于图2所示的实施方式的人工装置的透视图，其中插入部件以两个臂状物形成。 [0030] FIG. 12 is a perspective view of an artificial device similar to the embodiment shown in FIG. 2, wherein the insertion member is formed in two arms.
[0031] 图13是人工装置的透视图，该人工装置包括锚定部件和在心脏中展开的插入部件，用于治疗闭合不全的二尖瓣。 [0031] FIG. 13 is a perspective view of an artificial device, the device comprising an artificial anchor member and the insert member deployed in the heart, for the treatment of mitral valve insufficiency closed.
[0032] 图14是图13插入部件的横截面图。 [0032] FIG. 14 is a cross-sectional view of the member 13 is inserted.
[0033] 图15是横截面图，图解说明带有通道和瓣膜部件的插入部件，以允许血液在一个方向通过插入部件流动。 [0033] FIG. 15 is a cross-sectional view illustrating the insertion member and the valve member with a passage to allow blood flow in one direction through the insert member.
[0034] 具体实施方式详述 [0034] DETAILED DESCRIPTION OF EMBODIMENTS
[0035] I.术语解释 [0035] I. Terminology
[0036] 除非另有说明，此处使用的所有技术和科学术语，具有与本公开所属领域普通技术人员通常理解的相同含义。 [0036] Unless otherwise indicated, all technical and scientific terms used herein have the same meaning as disclosed in the art as commonly understood by those of ordinary skill in the art. 为了便于查阅本公开各种实施方式，提供下列术语解释：[0037] 单数术语“一（a)”、“一（an)”和“所述（the) ”包括复数指称，除非上下文另有明确表示。 For ease of reference the present disclosure to various embodiments, the following explanation the term: [0037] The singular terms "a (A)", "a (AN)" and "the (The)" include plural referents unless the context clearly dictates otherwise representation. 术语“或（or)”指所陈述的可选要素的单个要素或两个或更多要素的组合，除非上下文另有明确表示。 The term "or (or)" means the individual elements optional elements stated or combination of two or more elements, unless the context clearly indicates otherwise.
[0038] 术语“包括”（“include”）是指“包含”（“comprises”）。 [0038] The term "comprising" ( "the include") means "including" ( "comprises"). 举例来说，包括或包含A和B的装置含有A和B，但可以任选地含有C或除A和B之外的其它组分。 For example, including or comprising means A and B comprising A and B, but may optionally contain other components in addition to C, or A and B. 另外，包含或包括A或B的装置可以含有A或B或者A和B，并任选地含有一个或多个其它组分，如C。 Additionally, comprising means including A or B, or may contain A or B or A and B, and optionally containing one or more other components, such as C.
[0039] 术语“近端（proximal)，，是指更靠近操作者的设备部分，而“远端”（distal)是指远离操作者的设备部分。 [0039] The term "proximal end (proximal) ,, refers to the portion of the device closer to the operator, while" distal "(distal) portion refers to the device from the operator.
[0040] 术语“对象”是指人和其它动物对象。 [0040] The term "subject" refers to humans and other animal subjects. 在某些实施方式中，对象是人或其它哺乳动物，如灵长类动物、猫、狗、牛、马、啮齿类动物、绵羊、山羊或猪。 In certain embodiments, the subject is a human or other mammals, such as primates, cats, dogs, cows, horses, rodents, sheep, goats or pigs. 在具体实例中，所述的对象是人类患者。 In particular examples, the subject is a human patient.
[0041] 虽然与此处所述类似或等同的方法和材料可用于本公开的实践或测试中，但是合适的方法和材料描述如下。 [0041] Although here the similar or equivalent methods and materials may be used in the practice or testing of the present disclosure, suitable methods and materials are described below. 在冲突的情况下，遵循包括术语在内的本说明书。 In case of conflict, the present specification includes the term follow including. 此外，材料、 方法和实施例仅仅是说明性的，而不意图是限定性的。 In addition, the materials, methods and examples are merely illustrative and are not intended to be limiting.
[0042] II.人类心脏的解剖学概述 [0042] II. Overview anatomy of the human heart
[0043] 参考图1，提供了心脏1的横截面图。 [0043] Referring to FIG 1, a cross-section of the heart of FIG. 血液流经上腔静脉2和下腔静脉4进入心脏1的右心房6。 Blood flow through the superior vena cava 2 and the inferior vena cava into the right atrium of the heart 4 1 6. 三尖瓣8控制右心房6和右心室15之间的血液流动。 Tricuspid valve 8 controls blood flow between the right atrium 6 and right ventricle 15. 当血液从右心室15泵出至肺部时，三尖瓣8关闭。 When the blood pumped from the right ventricle 15 to the lungs, the tricuspid valve 8 is closed. 此后，三尖瓣8开放，将来自右心房6的血液再填充右心室15。 Thereafter, the tricuspid valve 8 open, the blood from the right atrium 6 and right ventricle 15 of the refill. 三尖瓣8小叶的游离缘通过腱索10连接至右心室15内的乳头肌12，用于控制三尖瓣8的运动。 The free edge of the leaflets of the tricuspid valve 8 is connected via chordae 10 to 15 within the right ventricle of the papillary muscles 12 for controlling the movement of the tricuspid valve 8. 血液从右心室15被泵送通过肺动脉瓣20到达肺动脉22，其分支进入伸向肺部的动脉。 Blood is pumped from the right ventricle 15 through the pulmonary valve 20 reaches the pulmonary artery 22 which branches into the artery toward the lungs.
[0044] 离开肺后，充氧的血液流经肺静脉观，进入心脏1的左心房26。 [0044] After leaving the lungs, oxygenated blood flow through the pulmonary veins concept, into the left atrium of the heart 26 1. 二尖瓣30控制血液在左心房沈和左心室17之间的流动。 Mitral valve 30 to control blood flow between the left atrium and the left ventricle sink 17. 二尖瓣30在心室收缩期关闭，此时血液从左心室17流出进入主动脉34。 Mitral valve 30 closed during ventricular systole, when blood flows from the left ventricle 17 into the aorta 34. 此后，二尖瓣30开放，将来自左心房沈的血液再填充左心室17。 Since then, the mitral valve 30 open, the blood from the left atrium Shen refill the left ventricle 17. 二尖瓣30小叶的游离缘通过腱索11连接至左心室的乳头肌13，用于控制二尖瓣30的运动。 The free edge of the leaflets of the mitral valve 30 is connected to the left ventricle of the papillary muscles 11 by chordae 13, 30 for controlling the motion of the mitral valve. 来自左心室17的血液经主动脉瓣32被泵送至主动脉34，其分支进入通向身体各个部位的动脉。 Blood from the left ventricle through the aortic valve 17, 32 is pumped to the aorta 34 branches into the artery leading to the respective parts of the body. 主动脉瓣32包括三个小叶（也称为皮瓣或尖），其被统称为36。 Aortic valve 32 comprises three leaflets (also referred to as a flap or tip), which is referred to as 36. 当心脏跳动时，小叶36开启和关闭来控制血液从心脏的左心室17流至主动脉34中。 As the heart beats, the leaflets 36 open and close to control the flow of blood from the left ventricle of the heart 17 to the aorta 34.
[0045] III.用于减少通过心瓣膜的反流的人工装置 [0045] III. Regurgitation by means of artificial heart valve for reducing
[0046] 如果心瓣膜的任何部分不能正常发挥功能，心脏的效率可能会受到严重损害。 [0046] If any part of a heart valve does not function properly, the efficiency of the heart may be severely compromised. 例如，心瓣膜可能会失去正常关闭的能力，原因在于瓣膜周围的环面或松弛下垂的小叶的扩张。 For example, heart valve may lose the ability to shut down properly, because the expandable annulus or valve leaflets sagging around. 小叶还可由于疾病如风湿性疾病而收缩，从而在瓣膜内小叶之间留下间隙。 The leaflets may also be due to disease and rheumatic diseases contracted, thereby leaving a gap between the valve leaflets. 心瓣膜关闭能力的丧失导致血液回漏（与正常血液流动相反），通常被称为反流，其通过主动脉瓣进入左心室。 Loss of valvular heart causes blood to leak back capability (with normal blood flow in the opposite), commonly referred to as reflux, which is into the left ventricle through the aortic valve. 反流可严重损害心脏功能，因为更多的血液不得不通过反流瓣膜被泵出，以保持足够的循环。 Reflux can severely damage the heart function, because more blood has to be pumped out by reflux valve, in order to maintain adequate circulation.
[0047] 本公开的实施方式提供用于改善有缺陷的心瓣膜如主动脉瓣的功能的装置和方法。 [0047] The present disclosure provides embodiments for improving a defective heart valve as functions of the apparatus and method of the aortic valve. 此处公开的装置和方法期望采用经皮或微创手术方法被递送到对象的心脏中。 Devices and methods disclosed herein, the desired percutaneous or minimally invasive surgical methods to be delivered to the subject heart. 因此，此处所述的期望递送方法不需要体外循环（例如，来自对象的循环血液被发送至机体以外的路线，以对其进行处理，然后返回至对象的循环）。 Accordingly, it is desired delivery method described herein does not require extracorporeal circulation (e.g., circulating blood from a subject other than the route is transmitted to the body to be treated, and then returned to the circulation of the object). 例如，在一个实施方式中，递送导管（或类似的递送装置）通过胸壁切口插入，然后通过心脏组织（例如，通过心尖）进入患者跳动心脏的腔体。 For example, in one embodiment, the delivery catheter (or a similar delivery device) is inserted through the chest wall incision, then (e.g., through the apex) into the cavity of the patient through the cardiac tissue of the beating heart. 递送导管可允许人工装置以收缩的结构被递送到心脏中，然后在心脏内扩张用于治疗有缺陷的心瓣膜。 It can allow the delivery catheter in a contracted configuration artificial means is delivered to the heart, and then expanded within the heart for the treatment of a defective heart valve. 因为期望传送方式不需要体外循环，所以与传统的心内直视手术相比，并发症大大减少。 Since the desired transmission method does not require cardiopulmonary bypass, and so in a traditional open-heart surgery when compared complications is greatly reduced.
[0048] 图2图解了人工装置100的实施例，其可被用于减少或消除通过心瓣膜如主动脉瓣的反流。 [0048] FIG 2 illustrates an embodiment of an artificial device 100, which may be used to reduce or eliminate such heart valve regurgitation through the aortic valve. 人工装置100包括插入部件102和锚定部件110。 Artificial apparatus 100 includes an insertion member 102 and the anchor member 110. 插入部件102期望包括用于接触天然瓣膜小叶如天然主动脉瓣小叶的实体外表面。 Insert member 102 includes for contacting a desired native valve leaflets entity such as an outer surface of the natural aortic valve leaflets. 在此处使用，“实体（实心，无孔， solid)”表面是指非穿孔表面，其不包含血液可以通过的任何开口。 Used herein, "solid (solid, non-porous, Solid)" surface refers to a non-perforated surface, which does not contain any blood through the openings. 如图2所示，插入部件102包含第一延伸部分或臂状物104，第二延伸部分或臂状物106，和第三延伸部分或臂状物108。 2, the insert member 102 comprises a first extending portion or arm 104, a second extension or arm 106, and a third extension portion 108 or the arm. 延伸部分104、106、108期望在插入部件102的中心部分112周围，以相同角度间隔，并从此处向外径向延伸。 106, 108 in a desired extended portion 102 of the insertion member around the center portion 112, at the same angular intervals and extending radially outwardly from here. 人工装置100可包括多个间隔物（spacer)或连接部件120，用于在与锚定部件110隔开的位置安装插入部件102。 Artificial apparatus 100 may include a plurality of spacers (spacer) or a connecting member 120 for mounting the insert member 102 in a spaced position with the anchor member 110. 如图2所示，三个这样的间隔物或连接部件在图解的实施方式中被提供，用于将插入部件102连接至锚定部件110。 2, three such spacers or connecting member is provided in the embodiment illustrated embodiment, the insert member 102 for connecting to the anchor member 110.
[0049] 在图解的实施方式中，锚定部件110采取自扩张或球囊扩张支架的形式，其具有开放式框架结构，如图2所描绘。 [0049] In the illustrated embodiment, the anchoring member 110 in the form of a self-expanding or balloon-expandable stent having an open frame structure, as depicted in FIG. 所述锚定部件可用各种合适的扩张材料和/或弹性材料制造，如不锈钢、钛、形状记忆合金或其它生物相容性金属。 The anchoring member expanded by various suitable materials and / or elastic material, such as stainless steel, titanium, shape memory alloys, or other biocompatible metal. 在一个实施例中，锚定部件110 是自扩张式的，并用形状记忆合金制造，如镍钛（nickel titanium,NiTi)形状记忆合金，例如如以商品名称Nitinol销售。 In one embodiment, the anchoring member 110 is self-expanding and manufacturing, such as nitinol (nickel titanium, NiTi) shape memory alloys, for example as sold under the trade name Nitinol shape memory alloy. 在另一个实施例中，锚定部件110是球囊扩张式的，并用不锈钢或其它合适的材料制造。 In another embodiment, the anchoring member 110 is a balloon expandable type, and stainless steel or other suitable material.
[0050] 在具体实施方式中，所述的锚定部件110包括支架，该支架具有多个成角度间隔的轴向支柱，或支撑部件，其沿部件轴向（纵向）延伸。 [0050] In a specific embodiment, the anchoring member 110 comprises a bracket having a plurality of angularly spaced axial struts or support members along member axial direction (longitudinal direction) extends. 锚定部件110也可包括多个轴向间隔的圆周带或支柱，其附着至轴向支柱。 Anchor member 110 may also include a circumferential band or a plurality of axially spaced struts, which are attached to the axial struts. 圆周形支柱形成有多个弯曲，这些弯曲允许锚定部件110被压缩到较小的直径以便递送到植入部位，并扩张至其发挥功能的大小，以便将插入部件102锚定至心脏。 Formed with a plurality of circumferential struts bent, the bent member 110 to allow the anchor is compressed to a smaller diameter for delivery to the implantation site, and expanded to the size of its functions, the insert member 102 so as to anchor the heart. 圆周形支柱可包括多个以Z字形（zig-zag)或锯齿（saw-tooth) 构造排列的线型支柱部件，其形成确定相邻支柱部件之间的弯曲。 May include a plurality of circumferential strut members in a Z-shaped strut linear (zig-zag) or zigzag (saw-tooth) arranged structure, which is formed between the curved determined adjacent strut members. 在其它实施例中，一个或一个以上的圆周带可具有弯曲或蜿蜒的形状，而不是Z字形形状。 In other embodiments, one or more circumferential bands may have a curved or serpentine shape, rather than a Z-like shape. 在变体中，锚定部件110可进一步包括固定或附着部件，如倒钩、钉、凸缘、吊钩等等，其沿锚定部件110的外部分布，用于提高锚定部件110在主动脉内锚定插入部件的能力。 In a variant, the anchor member 110 may further include a fixed or attachment means, such as barbs, pins, flanges, hooks, etc., distributed along the outer anchor member 110, for improving the anchoring member 110 in the main the ability to insert intra-arterial anchor member. 对可以在此处公开的实施方式中使用的示例性支架的进一步详述，在美国专利号6730118、美国专利号6767362和美国专利号6908481中公开，在此处每篇专利都以其全部并入作为参考。 Further detailed description of the exemplary stent embodiment may be used in embodiments disclosed herein, in U.S. 6,730,118, U.S. Pat. No. 6,767,362 and U.S. Patent No. 6,908,481 Patent Publication No., each patent are herein incorporated in its entirety Reference.
[0051] 虽然锚定部件主要以支架的形式进行描述，应该可以理解广泛多样的锚定机构都可以使用，同时保留在本公开范围之内。 [0051] While the anchor member is primarily described in the form of the stent, it should be understood that a wide variety of anchoring mechanism may be used, while remaining within the scope of the present disclosure. 例如，锚定部件可以由一个或一个以上固定器形成。 For example, the anchoring member may be formed by one or more holders. 在一个具体实施例中，锚定部件可以是多个间隔分开的固定器，其向外延伸以接触心瓣膜环附近或心瓣膜环内的组织。 In one particular embodiment, the anchoring member may be a plurality of spaced-apart anchor, which extends outwardly to the vicinity of or in contact with the heart valve annulus of the heart valve annulus tissue. 固定器的尺寸和配置适于将主体稳固至心瓣膜环。 Fixture sizes and configurations adapted to secure the body Zhixin valve annulus. 例如，所述一个或多个固定器可以是环形带，其由聚乙烯、聚丙烯、聚碳酸酯、尼龙、聚四氟乙烯、聚氨基甲酸酯、不锈钢、Nitinol、钛、聚酰亚胺、聚酯、形状记忆材料或它们的混合物制成。 For example, the one or more holders may be an endless belt, which is made of polyethylene, polypropylene, polycarbonate, nylon, polytetrafluoroethylene, polyurethane, stainless steel, as Nitinol, titanium, polyimides , polyester, or a shape memory material made of a mixture thereof. 所述一个或多个固定器可包括突起、倒钩、针和吊钩等等啮合部件，用于辅助将人工装置锚定在心瓣膜内。 The one or more fixed projections may include barbs, like needles and hook engaging means, means for anchoring the auxiliary artificial heart within the valve.
[0052] 插入部件102被配置用于插入闭锁不全的主动脉瓣的小叶之间，以填补小叶之间的间隙。 [0052] The insert member 102 is configured for insertion between the leaflets of the aortic valve insufficiency, to fill a gap between the leaflets. 在一个具体实施例中，插入部件102显示出足够的刚性，以基本保持其展开的形状，并具有足够的弹性和/或柔性，以便被压缩到减小的直径，用于在递送护套中递送。 In one particular embodiment, the insert member 102 exhibits sufficient rigidity to substantially maintain its deployed shape, and have sufficient elasticity and / or flexibility, so as to be compressed to a reduced diameter for delivery sheath deliver. 插入部件可由塑料、金属（如形状记忆金属）或适于植入到对象内的其它生物相容性材料制造。 The insertion member may be formed of plastic, metal (e.g. shape memory metal) for implantation or other biocompatible materials of the object. 在具体实施例中，如图3所图解，插入部件102可包括内支撑层127和外层或护套128。 In a particular embodiment, illustrated in Figure 3, the insert member 102 may include an inner support layer 127 and outer layer or jacket 128. 外层1¾可由生物相容性材料制造，如布类或织物材料（天然或合成）或生物材料，如胶原或生物组织材料，以保护天然小叶免受损害（例如，阻止响应小叶接合和解除接合可能发生的磨损）。 1¾ outer layer may be manufactured from a biocompatible, such as cloth or fabric material (natural or synthetic) or biological material such as collagen or biological tissue material to protect against damage to the native leaflets (e.g., prevents leaflet engagement and disengagement in response to wear) may occur. 例如，与天然小叶相容的平滑的动物心包(smooth animal pericardium)，如马、牛、猪或其它动物的心包组织，可以包括在外层128内。 For example, compatible with natural animal pericardial leaflets smooth (smooth animal pericardium), such as horses, cattle, swine or other animal pericardial tissue, may be included in the outer layer 128. 这些组织可以通过适当的鞣革环境来鞣制或固定，或心包可以与通过解毒方法结合的戊二醛和肝素交联。 These tissues may be tanned with appropriate tanning or fixed environment, or pericardium can be crosslinked with glutaraldehyde detoxification by binding and heparin. 在某个实施例中，生物组织材料可以是天然组织产品之一，其显示出改进的生物相容性，并减轻钙化及血栓形成。 In certain embodiments, the biological tissue material may be one of natural tissue products, which exhibit improved biocompatibility and reduce the calcification and thrombosis. 外层1¾可覆盖内层127的整个外表面或经选择的一部分的外表面，如那些接触天然瓣膜的部分。 1¾ inner layer may cover a portion of the outer surface 127 of the outer surface of the entire or selected, such as those portions in contact with the native valve.
[0053] 在某些实施例中，插入部件102的直径与天然主动脉瓣的直径相似，这样，每个延伸部分就延伸进入主动脉瓣小叶之间的尖端中。 [0053] In certain embodiments, the diameter of the diameter of the insertion of the native aortic valve member 102 is similar, so that each extension portion to extend between the tip into the aortic valve leaflets. 因此，装置100的插入部件102在展开后保持在主动脉瓣内居中。 Thus, the insertion member 100 of the apparatus 102 remains centered within the expanded aortic valve. 在某些实施例中，插入部件的直径约18mm至约^mm,其中约22毫米为具体实施例。 In certain embodiments, the diameter of the insertion member is from about 18mm to about ^ mm, wherein about 22 mm to the specific embodiments. 与锚定部件110的直径相比，插入部件102的直径可以略小。 Compared to the diameter of the anchor member 110, the diameter of the insertion member 102 may be slightly smaller. 此构造允许插入部件收缩或折叠成较小直径，用于在递送护套中递送。 This configuration allows the insertion member collapsed or folded into a smaller diameter for delivery within the delivery sheath. 此外，插入部件的长度可以有所变化。 Further, the length of the insertion member may vary. 例如，在一个实施方式中，插入部件的长度与锚定部件长度大致相同。 For example, in one embodiment, the length of the insertion member is substantially the same as the length of the anchoring member. 在其它实施例中，插入部件的长度大于或小于锚定部件的长度。 In other embodiments, the insert member length is greater than or less than the length of the anchoring member. 在某些实施例中，插入部件的长度为约20mm到约30mm，其中约25mm为具体实施例。 In certain embodiments, the length of the insert member is from about 20mm to about 30mm, from about 25mm where the specific embodiments.
[0054] 如图4所示，插入部件102的横截面轮廓可以成形为使得天然小叶36a、36b、36c 能够接触插入部件102的侧面，以在心室舒张期建立紧密密封。 [0054] As shown in FIG. 4, the cross-sectional profile of the insert member 102 may be shaped such that the native leaflets 36a, 36b, 36c can contact the side surface of the insertion member 102, the ventricular diastolic Establishing tight seal. 例如，三个间隔开的延伸或臂状物104、106和108从插入部件102的中心区域112径向向外延伸。 For example, three spaced apart arms 104, 106 and extension 108 or from the central region of the insertion member 102 extends radially outwardly 112. 在某些实施例中， 臂状物在宽度上从中心部分向延伸部分外端逐渐变细。 In certain embodiments, the arm extending in width from the central portion to the outer end of the tapers. 例如，每个臂状物包括第一末端114 和第二末端116。 For example, each arm 114 comprises a first end and a second end 116. 所述的第一末端114比第二末端116宽。 Said first end is wider than a second end 114,116. 每个臂状物都包括第一侧面122 和第二侧面124，每一个侧面被配置为与天然小叶接触。 Each arm 122 includes a first side and a second side 124, each configured to contact a side surface of the native leaflets. 末端114、116和侧面122、1M可被配置为具有平滑边缘，以尽量减少或消除溶血效应。 122,1M end side 114, 116 and may be configured to have a smooth edge to minimize or eliminate hemolysis effect. 此外，每个臂状物被配置为填补主动脉瓣的相邻小叶之间的间隙，从而防止通过主动脉瓣的反流。 In addition, each arm being configured to fill the gap between adjacent leaflets of the aortic valve, thereby preventing regurgitation through the aortic valve. 臂状物的接触表面可以显示出足够的顺应性和/或柔韧性，以允许天然小叶与插入部件102啮合，产生紧密密封而不损坏小叶。 The contact surface of the arm may exhibit sufficient compliance and / or flexibility to allow the insertion member engaging the native leaflets 102, to produce a tight seal without damage to the leaflets. 例如，如上所述，每个臂状物可包括生物相容性材料，如胶原或心包组织，以阻止响应臂状物与天然小叶啮合或接合而可能发生的磨损。 For example, as described above, each arm may include a biocompatible material such as collagen or pericardial tissue to prevent the arm in response to wear and meshing or engaging the native leaflets may occur.
[0055] 当用于治疗主动脉瓣时，插入部件的横截面轮廓可以被最小化，以便当主动脉瓣完全开放时限制从左心室到主动脉的血流阻力。 [0055] When used to treat aortic valve, the cross-sectional profile of the insertion member may be minimized in order to limit the resistance to blood flow from the left ventricle into the aorta when the aortic valve is fully open. 此外，插入部件的一个端部或两个端部可以是锥形或圆形的，这样就不存在垂直面对血液流动的平面。 In addition, one end or both ends of the insertion member may be tapered or rounded, so there is a plane perpendicular to the face of blood flow. 关于图解的实施方式，应当理解人工装置能够最大限度地减少或防止反流，而不利用任何移动部件。 About the illustrated embodiment, it should be appreciated that artificial means can minimize or prevent reflux, without using any moving parts. 因此，与需要利用移动部件的可选心瓣膜修复和更换技术相比，该装置可以获得更大的耐用性。 Thus, the need to use alternative heart valve repair and replacement of the moving parts as compared to techniques, the apparatus can obtain greater durability.
[0056] 插入部件102可被配置以可扩张的结构，如可移动的薄片（flap)，以进一步阻止通过主动脉瓣的反流。 [0056] The insert member 102 may be configured to be expandable structure, such as a movable sheet (FLAP), to further prevent regurgitation through the aortic valve. 每个可扩张的结构可被配置用于填补相邻天然瓣膜小叶之间的空隙。 Each expandable structure may be configured to bridge the gap between the adjacent native valve leaflets. 在一个实施例中，可移动的薄片可以被配置为以类似于降落伞的方式打开，以阻止天然主动脉瓣小叶之间的血液反流。 In one embodiment, the movable sheet may be configured in a manner similar to the parachute opened, to prevent regurgitation of blood between the native aortic valve leaflets. 在心室收缩期，可移动薄片收缩，以使血液以基本无阻碍的方式，从左心室经天然主动脉瓣流进主动脉。 In the ventricular systole, the movable sheet shrink, so that the blood in a substantially unimpeded manner, the flow from the left ventricle into the aorta through the native aortic valve. 关于可扩张插入部件（例如瓣膜部分）的另外详细说明，可以在申请人于2006年4月19日提交的共同未决的美国申请号11/407，582(美国专利公布号2006/0M1745)中找到，其在此以全文并入作为参考。 About expandable insert parts (such as valve portion) is discussed in further detail, co-pending US application number may be on April 19, 2006 submitted by the applicant 11 / 407,582 (US Patent Publication No. 2006 / 0M1745) in find, which is hereby incorporated by reference in its entirety. 在'5¾申请中所述的、被配置用于二尖瓣的可扩张人工装置的原理和特点，也适用于此处所述的在主动脉瓣里使用的装置。 In the '5¾ application, principles and features of the mitral valve may be configured to be expandable artificial means, it is also suitable for use in the apparatus described herein in the aortic valve.
[0057] 如上所述，并如图2所示，人工装置100包括多个间隔物或连接部件120。 [0057] As described above and shown in Figure 2, apparatus 100 includes a plurality of artificial spacers or connecting member 120. 每个连接部件通常可以为圆柱形状，尽管可使用任何其它合适的形状。 Each connection member may be generally cylindrical in shape, although any other suitable shape may be used. 在某些实施例中，每个连接部件的长度为约6mm到约14mm，其中约IOmm为具体实施例。 In certain embodiments, the length of each connecting member is from about 6mm to about 14mm, from about IOmm wherein the specific embodiments. 每个连接部件优选地将插入部件102的臂状物结合至锚定部件110。 Preferably each connecting member is inserted into the arm member 102 is bonded to the anchoring member 110. 连接部件120可协助稳定插入部件102。 Connecting member 120 may assist in stabilizing member 102 is inserted. 每个连接部件期望显示出足够的刚性，以基本将插入部件保持在相对于锚定部件的固定位置。 Each connector member desired exhibit sufficient rigidity to substantially the insert member held in a fixed position relative to the anchoring member. 连接部件可由塑料、金属或其它生物相容性材料制成，其适于植入到对象中。 The connecting member may be formed of plastic, metal, or other biocompatible material, which is adapted for implantation into a subject. 连接部件120也最大限度地减少人工装置对流向冠状动脉血流的干扰，这是通过使锚定部件110定位于冠状动脉口之上以及插入部件102定位在天然主动脉瓣内来实施。 Connecting member 120 also minimizes the flow disturbance means of doing coronary flow, which is obtained by the anchor member 110 is positioned above the coronary ostia and the insertion member 102 is positioned within the native aortic valve is implemented.
[0058] 正如图4中最佳图解，主动脉瓣32的天然小叶36a、36b、36c在心室舒张期与插入部件102接触而产生紧密密封。 Native leaflets 36a [0058] As best illustrated in Figure 4, the aortic valve 32, 36b, 36c in contact with ventricular diastolic insertion member 102 and a tight seal is generated. 通过使主动脉瓣32产生紧密密封，可以最大限度地减少或避免从主动脉进入左心室的反流。 By the aortic valve 32 generates a tight seal, can minimize or prevent reflux into the left ventricle from the aorta. 在心室收缩期，天然小叶开放——正如它们自然而为，使血液从左心室被泵至主动脉。 In the ventricular systole, the leaflets naturally open - as to their nature and the blood is pumped from the left ventricle to the aorta. 从图4可以看出，插入部件102的横截面面积与通过主动脉瓣环的流通面积相比，相对较小。 As it can be seen from Figure 4, the cross-sectional area of ​​the insert member 102 as compared to the flow area through the aortic annulus, is relatively small. 因此，在图解的实施方式中，插入部件102基本不会在心室收缩期阻碍血液经主动脉瓣的流动。 Thus, in the illustrated embodiment, the insertion member 102 does not substantially obstruct the ventricular systole the flow of blood through the aortic valve.
[0059] 参考图5，其图解了在对象中展开后的人工装置100。 [0059] Referring to Figure 5, which illustrates the apparatus 100 after the artificial expanded in a subject. 如图5所示，锚定部件110在主动脉瓣上方如冠状动脉口38上方的主动脉中展开，以便不干扰通过冠状动脉的血液流动。 5, the anchor member 110 to expand as the aorta above the coronary ostia 38 above the aortic valve, in order not to interfere with blood flow through the coronary arteries. 插入部件102在天然主动脉瓣中展开，以改善主动脉瓣的功能。 Insert member 102 deployed in the native aortic valve in order to improve the function of the aortic valve. 例如，插入部件102位于天然主动脉瓣内，其每个臂状物104、106和108在两个小叶的相邻边缘之间延伸，这样， 主动脉瓣32的小叶与臂状物104、106和108接合。 For example, the insertion member 102 is located within the native aortic valve, each arm 104, 106 and 108 extending between the edges of two adjacent leaflets so that the leaflets and the aortic valve 32 of the arm 104 and 108 engage. 连接部件120从锚定部件110延伸至插入部件102，以保持插入部件102处于充分固定的位置。 Connecting member 120 extends from the anchor member 110 to the insertion member 102 to maintain the insert member 102 is fully secured position. 在心室舒张期，主动脉瓣32的小叶关闭并挤压插入部件的壁而产生一个紧密密封。 In the diastolic ventricle, the leaflets of the aortic valve 32 closed and pressing wall member insertion generated a tight seal. 虽然闭锁不全或有缺陷的主动脉瓣中的天然小叶可能无法完全关闭，但是插入部件102的臂状物填充间隙，使得很少或没有血液能够从主动脉回流至左心室。 While aortic valve insufficiency or defective in native leaflets may not be completely closed, but the arm member 102 is inserted to fill the gaps, so that little or no blood to flow back from the aorta into the left ventricle.
[0060] 正如所示，天然主动脉瓣不被切除，并继续以基本正常的方式发挥作用。 [0060] As shown, the native aortic valve is not cut, and continues to play a role in normal manner. 因此，随着时间推移，如果天然瓣膜能够自身治愈或如果发现可替代治疗，有可能去除人工装置。 Thus, over time, if the native valve itself can be cured or alternatively the treatment if it is found, it is possible to remove artificial means.
[0061] 参考图6，显示了根据另一实施方式的人工装置200。 [0061] Referring to FIG 6 showing another embodiment of the apparatus according to the embodiment of the artificial 200. 人工装置200包括插入部件102和锚定部件110。 Artificial apparatus 200 includes an insertion member 102 and the anchor member 110. 在图解的实施方式中，插入部件102直接与锚定部件110连接，而不通过连接部件120。 In the illustrated embodiment, the insertion member 102 is connected to the anchor member 110 directly, without passing through the connection member 120. 例如，插入部件可以通过插入部件102的近端118连接到锚定部件110， 例如插入部件102的近端被部分容纳在锚定部件110的末端部分内并被其环绕。 For example, the insertion member 102 by inserting the proximal end of member 118 is connected to anchor member 110, such as the proximal end portion of the insertion member 102 is received within end portion 110 of the anchor member and its surrounding. 在图解的实施方式中，插入部件102的直径小于锚定部件110的直径。 In the illustrated embodiment, the diameter of the insertion member 102 is smaller than the diameter of the anchor member 110. 此结构允许插入部件102在植入过程中收缩或折叠，并随后在瓣膜里展开。 This configuration allows the insertion member 102 is retracted or folded during implantation, and then deployed in the valve.
[0062] 所公开的人工装置可被配置用于以经皮或微创方法递送，其中只需要小的进入切口。 [0062] Artificial disclosed apparatus may be configured for percutaneous or minimally invasive approach to the delivery, which requires only a small entry incision. 在一个实施例中，人工装置可被配置以便其能够被卷曲或以其它方式收缩成较小外形，然后放置在递送护套中，用于推进至治疗部位。 In one embodiment, the artificial device may be configured so that it can be crimped or otherwise contracted into a smaller shape, and then placed in a delivery sheath, advanced to a treatment site. 例如，图7图解了在收缩状况下护套(sheath) 142内的人工装置200。 For example, FIG. 7 illustrates in the collapsed condition the sheath (sheath) inside the artificial means 142,200. 如所示，插入部件102可被配置具有足够的柔韧性，以使臂状物可以折叠，或者使其呈现弯曲外形，以便在递送过程中暂时减小插入外形。 As shown, the insert member 102 may be configured with sufficient flexibility, so that the arm can be folded, or it assumes the bent shape, so as to temporarily reduce the insertion profile during delivery. 从护套142中弹出后，锚定部件110和插入部件102扩张到完全扩张的状态，如图8所示。 After ejected from the sheath 142, expanded to a fully expanded state and the insert member 110 of anchor member 102, as shown in FIG. 当以经皮方法被递送到主动脉瓣后，期望利用可偏转护套，以便于通过病人的血管和在主动脉弓周围的导向。 When a transdermal methods are delivered to the aortic valve, desirable to utilize a deflectable sheath through the patient's blood vessel in order to guide and around the aortic arch. 关于被配置用于将治疗装置递送到主动脉瓣的可偏转护套的各种实施方式的详细说明，可以在申请人于2005年6月13日提交的共同未决的美国申请号11/152，观8中找到，其名称为“心瓣膜递送系统”，其此处以全文引用的方式并入。 For details on the treatment device is configured to deliver to the aortic valve may be various embodiments of the deflection of the sheath can on June 13, 2005, filed in the Applicant's co-pending U.S. Application No. 11/152 watch 8 found the name of "the heart valve delivery system", which is herein incorporated by way of reference in its entirety.
[0063] 图9A显示人工装置300，其可用于减少或消除心瓣膜反流，如主动脉瓣反流。 [0063] Figure 9A shows an artificial device 300, which may be used to reduce or eliminate the heart valve regurgitation, such as aortic regurgitation. 在此实施方式中，人工装置包括插入部件102——其被配置用于插入主动脉瓣中，和锚定部件302——其被配置用于固定至左心室内的肌肉壁。 In this embodiment, a prosthetic device includes an insertion member that is configured for insertion into 102-- aortic valve, and the anchor member 302-- configured for fixing to the muscular wall of the left ventricle. 锚定部件302可以包括多个啮合部件304，如钩或指状物，其沿肌肉壁穿透组织，以将插入部件102固定至心脏。 Anchor member 302 may include a plurality of engaging members 304, such as hooks or fingers which penetrate muscle tissue along the wall to the insertion member 102 is fixed to the heart. 啮合部件304可用任何生物相容性材料制成，如生物相容性的金属或塑料，其能穿透左心室肌肉壁，以将插入部件102固定至心脏，而不会基本损伤该壁。 The engaging member 304 made of any biocompatible material can be used, such as a biocompatible metal or plastic, which can penetrate the muscular wall of the left ventricle, to the insertion member 102 is fixed to the heart, without substantially damaging the wall. 锚定部件302可包括伸长的主体部分或轴306，其连接啮合部件304与插入部件102。 Anchoring member 302 may include an elongated body portion or shaft 306, which is connected to the engaging member 304 and the insertion member 102. 在一个实施例中，伸长主体部分306和啮合部件304可由单块材料制成。 In one embodiment, elongated body portion 306 is made and the engaging member 304 may be a single piece of material. 另一个实施例中，伸长主体部分306和啮合部件304可以各自单独制造，随后通过任何合适的方法如焊接而彼此结合。 In another embodiment, the elongate body portion 306 and the engaging member 304 may be individually manufactured and then bonded to each other by welding such as any suitable method. 伸长主体部分306和啮合部件304 可以由相同或不同的材料制成，这取决于装置300的每一部分所期望的材料特性（弹性、刚性、收缩性等）。 An elongated body portion 306 and the engaging member 304 may be made of the same or different materials, depending on each portion of the device 300 of the desired material properties (elasticity, rigidity, shrinkage, etc.).
[0064] 通过将多个啮合部件304放置在左心室心尖附近的左心室内，人工装置300可放置在心脏内，以最大限度减少主动脉瓣反流。 [0064] By a plurality of engaging members 304 disposed within the left ventricle near the apex of the left ventricle, the artificial device 300 may be placed within the heart, to minimize aortic regurgitation. 在图解的实施方式中，多个指状物或钩沿左心室心尖附近的左心室肌肉壁穿透组织。 In the illustrated embodiment, a plurality of fingers of the left ventricle muscle wall in the vicinity of the left ventricular apex fingers or hooks to penetrate tissue. 插入部件102定位在主动脉瓣环内，以使其上部和下部可在天然主动脉瓣的上面和下面延伸，并且插入部件102的臂状物被调整为与主动脉瓣的三个尖端接合，因此，每个小叶可在插入臂状物之间上下移动。 Insert member 102 is positioned within the aortic annulus to its upper and lower portions may extend above and below the native aortic valve, and the inserted arm member 102 is adjusted to three with the tip engaging the aortic valve, Thus, each leaflet is movable vertically between the insertion arms.
[0065] 图9B和9C显示了锚定部件302的下端部分，其具有用伸长尖头物制成的多个啮合部件304。 [0065] Figures 9B and 9C show a lower end portion of the anchor member 302 having a plurality of engagement members 304 formed with elongated sharp-pointed object. 伸长尖头物304期望被配置为，当其被推离递送护套时，从图9C压缩构造自扩张成图9B的“开花的”或扩张的构造。 An elongated prong 304 is configured as desired, when it is pushed away from the delivery sheath, 9C compressed from FIG configured as a self-expanding or expanded configuration of FIG. 9B "blooming." 此开花式构造借助自弯曲区域30½期望实现，其使尖头物304从主体502的中心径向向外并向后朝向主体的第二末端偏转。 This means self-blossom-structure to achieve a desired bending region 30½, which causes the tip thereof toward the body 304 from the body 502 and central radial outward deflection of the second end. 尖头物304期望有尖角或有刺，以促进与心脏肌肉壁渗透和啮合。 Sharp pointed object 304 is desired, or barbed, so as to facilitate the engagement and penetration of the heart muscle wall.
[0066] 锚定部件302可由单管形状记忆材料制成，例如，举例来说，Nitinol。 [0066] The anchor member 302 may be a single tube made of a shape memory material, such as, for example, Nitinol. 在制造过程中，形状记忆材料可以用机械或激光切割工具来切割。 In the manufacturing process, the shape memory material can be mechanically or laser cutting tool to cut. 切割管后，扩张或开花式形状可以采用本领域已知的技术（如热定形形状）被赋予形状记忆材料的记忆。 After the cut tube, or flower-like shape may be expandable using techniques known in the art (e.g., heat setting shape) is given a shape memory material of memory. 制造锚定部件的方法在申请人共同未决的美国申请号11/750，272(以下简称“'272申请”）中详细描述，其在此以引用方式并入。 The method for producing the anchoring member in the Applicant's co-pending U.S. Application No. 11 / 750,272 (hereinafter referred to as " '272 application") described in detail, which is herein incorporated by reference. 在一个优选的实施方式中，锚定部件被制成具有延伸的构造，其符合在锚定部件将被展开的位置处心脏特定表面区域的轮廓，如'272申请所述。 In a preferred embodiment, the anchoring member is made to have a configuration extending conforming to the contour of the heart at the position of the specific surface area of ​​the anchoring member to be expanded, as described in the application 272 '.
[0067] 包括尖头物304在内的锚定部件302的表面，期望被配置用于促进组织在其表面甚至进入其中生长。 [0067] 304 comprises a prong member 302 including the anchor surface is configured to facilitate a desired tissue or even into the surface thereof wherein the growth. 在一个实施例中，通过给锚定部件提供相对粗糙和/或多孔表面来实现这种生长。 In one embodiment, by providing a relatively rough and / or porous surfaces to the anchoring member to achieve such growth. 此外，本领域已知的生物涂层类型可被包括在锚定部件302的表面上，以促进愈合和组织生长。 Furthermore, known in the art of biological type it may be included in the coating on the surface of the anchor member 302 to facilitate healing and tissue growth. [0068] 图10显示了锚定部件402的另一种变体，其中一个或多个锚如图示的板404，位于心脏肌肉壁的相对侧上，用于将人工装置400锚定至心脏。 [0068] Figure 10 shows another variation of the anchor member 402, wherein one or more of the anchor plate 404, as illustrated, positioned on opposite sides of the heart muscle wall, it means 400 for anchoring to the artificial heart . 板404可由任何生物相容性材料制成，如生物相容性金属或塑料。 Plate 404 may be made of any biocompatible material, such as a biocompatible metal or plastic. 锚定部件402包括轴406，其具有被连接到插入部件102的上端部分和延伸通过心脏壁的下端部分。 Anchoring member 402 comprises a shaft 406, which is connected to the insert member having an upper portion and a lower end portion 102 extends through the heart wall. 一块板404被安置于左心室内的轴上，另一块板404被安置于左心室外的轴上，以将轴稳固在适当的位置。 A plate 404 is disposed on the shaft within the left ventricle, the other plate 404 is disposed on the shaft outside the left ventricle in order to secure the shaft in place.
[0069] 如果期望，人工装置可以以多个阶段展开，其中，在第一阶段，插入部件被递送之前，锚定部件附着到主动脉（或心室壁）。 [0069] If desired, artificial means can be expanded to a plurality of stages, wherein, in a first stage, is delivered prior to the insertion member, the anchoring member is attached to the aorta (or ventricular wall). 在第二阶段，该装置的插入部件后来（如几个小时、几天或几周后）被连接到锚定部件。 In the second stage, subsequently the insertion member of the apparatus (such as a few hours, days or weeks later) is connected to the anchor member. 第一阶段和第二阶段之间的时间间隔有利于组织愈合，甚至在锚定部件上生长，从而进一步在心脏内嵌入锚定部件。 Time between the first and second phases spacer facilitate tissue healing, growing or even on the anchor member, thereby further anchoring member embedded within the heart. 在不存在装置的插入部件可赋予组织额外压力的情况下，愈合和过度生长可以更迅速地进行，其具有较小的副作用（例如不必要的疤痕）。 In the case where the insertion member is not present apparatus can impart additional pressure tissue healing and overgrowth can be performed more quickly, with fewer side effects (e.g., unwanted scarring). 关于示例性锚定部件、可扩张插入部件和两阶段展开的附加详细说明可在'272申请中找到。 Additional details on exemplary anchoring member, the expandable member is inserted and expanded in two stages can be found in the '272 application.
[0070] 图11显示了人工装置的另一种可选实施方式，以500表示。 [0070] Figure 11 shows another alternative embodiment of the artificial means, represented at 500. 锚定部件110可以是支架，并且可以包括安装在支架内的瓣膜部件130。 Anchor member 110 may be a stent, and may include a valve member 130 mounted in the bracket. 在图解的实施方式中，瓣膜部件130是有三小叶式生物人工瓣膜。 In the illustrated embodiment, the valve member 130 is three biological prosthetic valve leaflets. 在具体实施例中，锚定部件和瓣膜部件可采取Cribier-Edwards 瓣膜的形式，由加利福尼亚的Edwards Lifesciencea of Irvine制造。 In a particular embodiment, the anchoring member and the valve member may take the form Cribier-Edwards valve, of Irvine, California, manufactured by Edwards Lifesciencea. 关于有支架瓣膜示例性实施方式的附加详细说明可以在美国专利号6，893，460中找到，其在此以全文引用的方式并入。 Additional details regarding stent-valve has an exemplary embodiment can be found in U.S. Patent No. 6,893,460, which is incorporated by reference in its entirety herein.
[0071] 支架中的瓣膜部件130确保通过支架的单向流动。 [0071] The valve member 130 to ensure that the scaffold unidirectional flow through the stent. 支架期望被配置用于递送到升主动脉中。 Desired to be configured to deliver the stent into the ascending aorta. 支架以自扩胀或球囊扩张的方式扩张，以使支架被锚定在主动脉内。 In a self-expanding stent expanding or balloon expandable dilation, the stent to be anchored in the aorta. 展开后，支架内的瓣膜部件防止血液经主动脉回流。 After development, the inner valve member through the aortic stent to prevent blood reflux. 插入部件被递送到天然主动脉瓣中，以改善天然瓣膜的功能。 Insertion member is delivered to the native aortic valve in order to improve the function of the native valve. 因此，两个单独的瓣膜（即支架瓣膜和天然瓣膜）协同运作，以阻止经主动脉环的反流。 Thus, two separate valves (i.e., native valve and stent-valve) cooperative operation to prevent regurgitation through the aortic rings. 通过插入部件在天然瓣膜内的展开，天然瓣膜被允许发挥它应有的功能，血液被允许以基本自然的方式流入冠状动脉。 By expanding member is inserted within the native valve, the native valve is allowed to play its proper function, blood is allowed to flow into the coronary substantially natural way. 该支架瓣膜补充了天然瓣膜的功能。 The stent-valve complements the natural valve function. 如果期望，支架瓣膜可被建造成在天然瓣膜之前或之后闭合，以进一步影响和改善天然瓣膜功能，并改善进入冠状动脉的血流动力学和/或灌注。 If desired, the stent-valve may be constructed before or after the natural valve is closed, in order to further improve the impact and natural valve function, and improve access to the coronary hemodynamics and / or perfusion.
[0072] 参考图12，提供了根据又一种实施方式的人工装置600。 [0072] Referring to Figure 12, there is provided according to a further embodiment of an artificial device 600. 人工装置600被配置用于在只有两个小叶的异常主动脉瓣中使用。 Artificial apparatus 600 is configured for use in only two aortic valve leaflets exception of. 为了治疗这部分人群，插入部件602具有两个臂状物604、606，用于填补小叶之间的间隙。 For the treatment of this population, the insert member 602 having two arms 604, used to fill a gap between the leaflets. 此外，在某些具有三个小叶的主动脉瓣中，可能没有必要填补三个小叶各个之间的间隙。 In addition, in some having three aortic valve leaflets, it may not necessary to fill the gaps between the three leaflets. 因此，使用图12所示类型的插入部件可以是期望的，用于防止或减少在三个小叶瓣膜中的反流。 Thus, the type shown in FIG insertion member 12 may be desirable, for preventing or reducing reflux of the three valve leaflets.
[0073] 为了说明起见，人工装置的期望实施方式已在上文描述，用于用在通常具有三个小叶的瓣膜如主动脉瓣中。 [0073] For purposes of illustration, the artificial device is desirable embodiments have been described above, used in generally has three valve leaflets for aortic valve as. 但是，本领域普通技术人员应该认识到，装置的变体也可以一种类似的方式用于治疗另一种具有三个小叶的瓣膜，如肺动脉瓣。 However, those of ordinary skill in the art will be appreciated, variants of the device may also be used for the treatment in a similar manner with another three valve leaflets, such as the pulmonary valve. 用于治疗肺动脉瓣时，锚定部件（例如支架）可被配置用于在肺动脉干或肺动脉内展开。 For the treatment of pulmonary valve, the anchoring member (e.g., stent) may be configured to expand within the pulmonary artery or pulmonary artery. 可选地，锚定部件可被固定在右心室内。 Alternatively, the anchoring member may be fixed to the right ventricle.
[0074] 参考图13到15，人工装置700被配置用于治疗二尖瓣，如缺陷型二尖瓣。 [0074] with reference to FIGS. 13 through 15, the artificial device 700 is configured for treatment of mitral valve, such as defective mitral valve. 如图13 所示，人工装置700包括插入部件702和锚定部件704。 , The artificial device 700 in FIG. 13 includes an insertion member 702 and the anchor member 704. 插入部件702包括一个主体，其尺寸和形状适于填补闭锁不全的二尖瓣前小叶与后小叶之间的间隙。 Insert member 702 includes a body sized and shaped to fill the gap between the front and the insufficiency of the posterior leaflet of the mitral valve leaflets. [0075] 在一种具体实施方式中，插入部件702显示出足够的刚性，以基本保持其展开的形状，并具有足够的弹性和/或柔性，以便被压缩到减小的直径，用于在递送护套中递送。 [0075] In a specific embodiment, the insert member 702 exhibits sufficient rigidity to substantially maintain its deployed shape, and have sufficient elasticity and / or flexibility, so as to be compressed to a reduced diameter, for a delivery sheath delivery. 插入部件可由塑料、金属或适于植入到对象内的其它生物相容性材料制造。 The insertion member may be formed of plastic, metal or other biocompatible for implantation in the target manufacturing materials. 在具体实施例中，如上所述，插入部件可包括基本由生物相容性材料制成的外层或护套，所述生物相容性材料如布类或织物材料（天然或合成）或生物材料，如胶原或生物组织材料，以保护天然小叶免受损害（例如，阻止响应小叶接合和解除接合可能发生的磨损）。 In a particular embodiment, as described above, the insertion member may comprise an outer layer substantially or sheath made of a biocompatible material, the biocompatible material such as a fabric or cloth material (natural or synthetic) or biological materials, such as collagen or biological tissue material to protect the native leaflets from damage (e.g., in response to stop and leaflet engagement releasing engagement wear may occur). 例如，与天然小叶相容的平滑的动物心包，如马、牛、猪或其它动物的心包组织，可以包括在外层内。 For example, compatible with the native leaflets smooth animal pericardium, such as horses, cattle, swine or other animal pericardial tissue, may be included in the outer layer. 这些组织可以通过适当的鞣革环境来鞣制或固定，或心包可以与通过解毒方法结合的戊二醛和肝素交联。 These tissues may be tanned with appropriate tanning or fixed environment, or pericardium can be crosslinked with glutaraldehyde detoxification by binding and heparin. 在某个实施例中，生物组织材料可以是天然组织产品之一，其显示出改进的生物相容性，并减轻钙化及血栓形成。 In certain embodiments, the biological tissue material may be one of natural tissue products, which exhibit improved biocompatibility and reduce the calcification and thrombosis. 外层可覆盖插入部件102的整个外表面或外表面的选定部分，例如那些接触到天然小叶的部分。 Selected portions of the outer layer may cover the entire outer surface or outer surface of the insertion member 102, for example, come into contact with those portions of the native leaflets. 插入部件702的形状可为锥形和/或平滑边缘，以最大程度地减少或消除溶血作用。 Shape of the insert member 702 may be tapered and / or smooth edge to minimize or eliminate hemolysis.
[0076] 插入部件702的横截面轮廓被成形为使得天然小叶能够接触插入部件702的侧面703a和70北，以产生紧密密封。 [0076] The cross-sectional profile of the insertion member 702 is shaped such that a contact can be inserted into the native leaflets of the side member 703a and 702 North 70 to create a tight seal. 如图13-15所示，插入部件702优选地具有月牙形横截面轮廓，以更好地符合天然小叶的弯曲。 As shown, insert member 702 preferably has a curved crescent-shaped cross-sectional profile, to better conform to the native leaflets 13-15. 插入部件702的表面具有顺应性，其允使得天然小叶能够与插入部件702啮合，以产生紧密密封，而不损坏小叶。 Inserting a surface of the compliant member 702, which allows that the native leaflets can be inserted into the engagement member 702, to produce a tight seal without damage to the leaflets. 例如，如上所述，表面可包括生物相容性材料，如胶原或心包组织，以阻止响应插入部件表面与天然小叶啮合或接合时可能发生的磨损。 For example, as described above, the surface may comprise a biocompatible material such as collagen or pericardial tissue to prevent wear may occur in response to the insertion member and the surface engaging the native leaflets or engaged. 在工作中，二尖瓣的天然小叶在心室收缩期挤压插入部件的壁，以产生紧密密封，并防止血液从左心室到左心房的反流。 In operation, the native mitral valve leaflets ventricular systole pressing member is inserted into the wall, to produce a tight seal and to prevent the reflux of blood from the left ventricle into the left atrium.
[0077] 在图解的实施方式中，人工装置700的锚定部件704包括轴或伸长的主体部分706，其下端部分形成穿透部分708。 [0077] In the illustrated embodiment, the anchoring member 700 includes a body 704 artificial means or elongated shaft portion 706, a lower end portion thereof penetrating portion 708 is formed. 板709可以在心脏壁的相对侧上安置在穿透部分708 之上，以将轴固定在适当的位置。 Plate 709 may be disposed on opposite sides of the heart wall over the penetration portion 708, secured to the shaft in position. 锚定部件704的主体部分706和穿透部件708可以是任何合适的形状和材料，其赋予装置700每个部分所期望的材料特性（弹性、刚性、收缩性等等）。 The anchor body portion 704 of the member 706 and piercing member 708 may be of any suitable shape and material portion 700 of each of the desired material properties (elasticity, rigidity, shrinkage, etc.) which confers apparatus. 例如，穿透部件708可以由任何生物相容性材料制造，如生物相容性的金属或塑料，其能穿透左心室肌壁以将插入部件702固定至心脏，而不会基本损害该壁。 For example, penetration member 708 may be manufactured of any biocompatible material such as a biocompatible metal or plastic, which can penetrate the wall of the left ventricle to the insertion member 702 is fixed to the heart, will not substantially damage the wall .
[0078] 在一个实施例中，锚定部件704可被配置为在左心室内展开。 [0078] In one embodiment, the anchoring member 704 may be configured to expand within the left ventricle. 图14是图13所示插入部件702的横截面图。 FIG 14 is a cross-sectional view shown in FIG. 13 of the insertion member 702. 在此实施方式中，插入部件702具有基本实心的横截面。 In this embodiment, the insert member 702 having a substantially solid cross section. 在一种变体中，如图15所示，插入部件702可以包括沿纵轴延伸的通道。 In one variant, shown in Figure 15, the insert member 702 may include a channel extending along the longitudinal axis. 该通道可适合于使血液在一个方向经插入部件流动。 The passage may be adapted in a direction to cause the blood to flow through the insertion member. 瓣膜部件可被包括在插入内，以确保血液仅在一个方向流动。 The valve member may be included within the insert, to ensure that blood flows only in one direction. 在一个具体实施例中，瓣膜部件可以包括一个或多个薄片部件712，其界定出狭缝或开口710。 In one particular embodiment, the valve member may include one or more of the sheet members 712, which defines a slot or opening 710. 通过使血液仅在一个方向流动，瓣膜部件模仿目标瓣膜的功能。 The blood flows only in one direction, the valve member of the valve to mimic the function of a target. 因此，从一个方向流动进入通道的血液打开薄片，从而流经插入部件，而从相反方向流动进入通道的血液被瓣膜阻止。 Thus, the flow direction from a blood inlet channel open sheet, thereby passing through the insertion member, the opposite direction from the flow into the valve passage is blocked blood.
[0079] IV.用于减少通过心瓣膜反流的系统和方法 [0079] IV. Systems and methods for reducing heart valve regurgitation
[0080] 此处公开的是用于治疗有缺陷的心瓣膜的系统和方法。 It disclosed [0080] herein are systems and methods for treating defective heart valve is used. 在一种实施方式中，所述的系统包括人工装置，其包括锚定部件如自扩张式锚定部件和插入部件。 In one embodiment, the system includes an artificial means, which includes an anchor member such as a self-expanding anchoring member and the insertion member. 该系统可进一步包括递送导管，用于通过经皮方法将人工装置递送至心脏。 The system may further include a delivery conduit for delivering to the heart by means of artificial transdermal means. 例如，该导管可被经皮引入患者的脉管系统中（例如引入外周动脉如股动脉中）并推进至植入部位。 For example, the catheter can be percutaneously introduced into a patient's vasculature (e.g., peripheral arterial introduced as the femoral artery) and advanced to the implantation site. 在某些实施方式中，例如，导管的尺寸适于通过在腹股沟内的小切口插入，并具有至少约80cm通常为90-100cm的长度，以使轴以逆向途径实现从股动脉和髂动脉到升主动脉的经腔定位。 In certain embodiments, e.g., a catheter sized through a small incision in the groin is inserted, and generally having at least about 80cm to the shaft in the reverse way to achieve length 90-100cm from the femoral and iliac arteries to the chamber is located over the ascending aorta. 可选地，导管以具有较短的长度，例如约20-60cm，用于通过其它插入点导入，如，例如髂动脉、肱动脉、颈动脉或锁骨下动脉。 Alternatively, the catheter having a shorter length, e.g., about 20-60cm, through the other insertion points for introduction, such as, for example, the iliac artery, brachial artery, carotid artery or subclavian artery. 在股骨途径中，导管期望具有足够长度和柔韧性，以穿过经股动脉、髂动脉、 降主动脉和主动脉弓的路径。 In the femoral approach, the catheter is desirable to have a sufficient length and flexibility to pass through the femoral artery, iliac artery, descending aorta and aortic arch paths. 与此同时，导管期望具有足够的可推性，以通过在近端的推动使其推进至升主动脉；并具有足够的轴向、弯曲和扭转硬度，以便于即使导管位于曲折的血管结构内，医生也可控制远端的位置。 At the same time, a desired catheter has sufficient pushability to push through the proximal end so as to advance the ascending aorta; and has sufficient axial, bending and torsional stiffness to the inner catheter even tortuous vascular structures located , the doctor can control the position of the distal end. 可选地，导管可经肋骨之间的通道穿过。 Alternatively, the catheter can pass through the passage between the ribs. 在一种技术中，导管以所谓微创的方法通过患者心脏以上的胸腔并穿过主动脉弓内的切口推进。 In one technique, a so-called minimally invasive catheter through the incision and advanced through the aortic arch in the heart of the patient's chest above. 在另一项技术中，导管通过心脏壁中的切口推进，优选地是沿心尖。 In another technique, the catheter through the heart wall cut-propulsion, preferably along the apex. 人工装置被推进至将被治疗的心瓣膜，并且其被定位为跨过瓣膜延伸，其中该装置的臂状物被插入小叶之间，使得瓣膜小叶关闭并挤压插入部件的壁而产生紧密密封。 The device is advanced into the artificial heart valve to be treated, and which is positioned to extend across the valve, wherein the arm means is inserted between the leaflets, so that the valve leaflets to close the wall and pressing the insert member to produce a tight seal .
[0081] 在某些实施方式中，递送导管包括伸长的护套，其具有大小适于容纳人工装置的腔。 [0081] In certain embodiments, the delivery catheter comprising an elongated sheath having a cavity sized to receive an artificial device. 在推进通过对象的脉管系统的过程中，人工装置以收缩的构造被容纳在护套中。 In the propulsion system through the vasculature of the subject process, an artificial device in the collapsed configuration is accommodated in the sheath. 例如， 在推进至左心室的过程中，该装置最初被包含在递送护套中，其中锚定部件保持处于径向压缩状态。 For example, the process proceeds to the left ventricle, the device is initially contained within a delivery sheath, wherein the anchoring member is maintained in a radially compressed state. 在一种变体中，递送护套的远端部分被配置用于逆向推进，并可以被配置有可偏转的末端部分，用于促进主动脉弓周围的导向。 In one variation, the distal portion of the delivery sheath is configured for reverse propulsion, and may be configured with a deflectable tip portion for promoting aortic arch around the guide. 到达治疗部位后，护套被移至相对人工装置近端，以便从护套中弹出该装置。 After reaching the treatment site, the sheath is moved proximally relative to artificial means, to eject the device from the sheath. 随后，该装置被允许扩张，使得其插入与主动脉瓣内的间隙相符，并且锚定部件与主动脉内壁啮合。 Subsequently, the device is allowed to expand such that a gap is inserted in the aortic valve in line, and the anchoring member engaging with the inner wall of the aorta.
[0082] 尽管本发明实施方式优选地被配置用于经皮或微创递送方法，但是，在某些情况下，插入部件可通过心脏直视外科手术而展开。 [0082] Although the embodiments of the present invention is preferably configured for percutaneous or minimally invasive delivery methods, however, in some cases, the insertion member may be expanded by cardiac surgery direct vision. 在这些实施方式中，递送导管可能不是必需的，因为有缺陷的天然瓣膜可被直接进入。 In these embodiments, the delivery catheter may not be necessary, because of a defective native valve may be directly entered.
[0083] 尽管本公开已在具体实施方式和应用方面进行描述，但是本领域普通技术人员根据该教导可以创造出另外的实施方式和修改，而不偏离所要求包含的发明的精神或超出其范围。 [0083] While the present disclosure has been described in terms of particular embodiments and applications, those of ordinary skill in the art based on the teachings can create additional embodiments and modifications without departing from the spirit of the claimed invention or contained beyond its . 因此，应当理解，此处附图和描述以实施例的方式提供，以便于对本公开的理解，其不应被理解为限制其范围。 Accordingly, it should be understood that the drawings and described herein by way of example is provided to facilitate understanding of the present disclosure, which should not be construed as limiting the scope thereof.
1.用于改善心瓣膜功能的装置，其包括：插入部件，包括主体，所述插入部件被配置用于插入所述心瓣膜的小叶之间，其中所述主体包括三个成角度间隔的延伸部分，其从所述插入部件的中心部分径向向外延伸，所述延伸部分界定出实体小叶接触表面；和锚定部件，其与所述插入部件连接，所述锚定部件包括支架，其具有开放式框架结构， 被配置为可径向压缩到压缩状态用于递送到所述心瓣膜附近的展开部位，并在展开部位可径向扩张到扩张状态。 Apparatus for improving heart valve function, comprising: insertion means, comprising a main body, said insert member being configured for insertion between the leaflets of the heart valve, wherein said body comprises three angularly spaced extending portion extending from the central portion of said radially outward insert member, said extension portion defines a contact surface entity leaflets; and the anchor member, which is connected with the insertion member, the anchoring member comprises a stent that has an open frame structure configured compressed to a compressed state for delivery to the deployment site close to the heart valve to be radially expanded portion and radially expandable to an expanded state. 其中，每个所述小叶接触表面都被配置为，当所述心瓣膜关闭时接触所述心瓣膜的小叶，以最大限度减少通过所述心瓣膜的反流。 Wherein each of the leaflets contact surface is configured to contact the heart valve leaflets of the heart valve when closed, in order to maximize the heart valve regurgitation by reduction.
2.根据权利要求1所述的装置，其中所述锚定部件被制造成当处于扩张状态时与主动脉内壁相啮合的尺寸。 2. The apparatus according to claim 1, wherein the anchoring member is manufactured to size the inner wall of the aorta when in an expanded state of engagement.
3.根据权利要求1所述的装置，其进一步包括至少一个间隔物，用于将所述插入部件连接至所述锚定部件，所述至少一个间隔物具有足够的长度以允许所述锚定部件在具有插入在主动脉瓣中的插入部件的主动脉内展开，使得所述锚定部件和插入部件位于冠状动脉口的相对侧上。 3. The apparatus according to claim 1, further comprising at least one spacer, for connecting the insertion member to the anchoring member, the at least one spacer having a sufficient length to allow the anchoring member deployed within the aorta with the aortic valve is inserted in the insertion member, such that the anchoring member and the insertion member located on the opposite side of the coronary ostia.
4.根据权利要求3所述的装置，其中所述至少一个间隔物的长度是至少6mm。 4. The apparatus according to claim 3, wherein the length of the at least one spacer is at least 6mm.
5.根据权利要求1所述的装置，其中所述实体小叶接触表面被配置用于当心瓣膜关闭时接触主动脉心瓣膜小叶，以最大限度减少通过主动脉心瓣膜的反流。 5. The apparatus according to claim 1, wherein said contact surface leaflet entity configured for contacting the aortic heart valve leaflets when the valve is closed careful to minimize regurgitation through the aortic heart valve.
6.根据权利要求1所述的装置，其中每一个所述延伸部分在宽度上是逐渐变细的。 6. The apparatus according to claim 1, wherein each of said extension portion in the width is tapered.
7.根据权利要求1所述的装置，其中所述主体被配置以便可径向压缩到压缩状态，用于递送到心瓣膜附近的所述展开部位，并在所述展开部位可径向扩张到扩张状态。 7. The device according to claim 1, wherein said body is configured so as to be radially compressed to a compressed state for delivery to the deployment site in the vicinity of the heart valve, and a radially expandable portion to expand expansion.
8.根据权利要求1所述的装置，其中所述支架是自扩张式的。 8. The apparatus according to claim 1, wherein said stent is a self-expanding type.
9.根据权利要求1所述的装置，其中所述支架是球囊扩张式的。 9. The apparatus according to claim 1, wherein said stent is a balloon expandable type.
10.根据权利要求1所述的装置，其中所述支架支撑人工瓣膜，用于堵塞经所述支架的一个方向的血流。 10. The apparatus according to claim 1, wherein said support bracket prosthetic valve, for clogging the blood flow in one direction through the stent.
11.根据权利要求1所述的装置，其中所述锚定部件由形状记忆合金制造。 11. The apparatus according to claim 1, wherein the anchoring member made from a shape memory alloy.
12.根据权利要求1所述的装置，其中所述主体包括内部支撑和界定所述小叶接触表面的外层，所述外层包括生物材料，用以当所述心瓣膜小叶接触所述插入部件主体上的所述小叶接触表面时，抑制所述心瓣膜小叶的磨损。 12. The apparatus according to claim 1, wherein said body comprises an inner supporting and defining an outer contact surface of the leaflets, the outer layer comprises a biomaterial for heart valve leaflet when the insertion member contacting said the leaflets contact the body surface, to suppress the wear of the heart valve leaflet.
13.根据权利要求12所述的装置，其中所述生物材料包括动物心包组织。 13. The apparatus according to claim 12, wherein the biological material comprises animal pericardial tissue.
14.根据权利要求12所述的装置，其中所述内部支撑包括形状记忆材料。 14. The apparatus according to claim 12, wherein said inner support comprises a shape memory material.
15.根据权利要求1所述的装置，其中所述插入部件的主体部分地延伸进入所述支架。 15. The apparatus according to claim 1, wherein the extension member is inserted into the body portion into the bracket.
16.用于改善主动脉瓣功能的装置，其包括：插入部件，包括主体，所述插入部件被配置用于插入所述主动脉瓣小叶之间，所述主体具有中心部分和三个成角度间隔的臂状物，所述臂状物从所述中心部分径向向外延伸；和锚定部件，其配置用于固定至心室内部的肌肉壁，所述锚定部件包括至少一个啮合部件，被配置用于啮合所述肌肉壁，其中，所述锚定部件包括伸长轴，其具有连接到所述插入部件的第一末端和连接到所述至少一个啮合部件的第二末端。 16. A device for improving the function of the aortic valve, comprising: an insertion member comprising a main body, said insert member being configured for insertion between the aortic valve leaflets, said body having a central portion and three angled spaced arms, said arms extending from said central portion radially outwardly; and an anchor member, which is configured for fixing to the muscular wall of the inside of the ventricle, the anchoring member comprises at least one engagement member, It is configured for engaging the muscle wall, wherein the anchoring member comprises an elongated shaft having a first end coupled to said insertion member and a second end connected to said at least one engagement member.
17.根据权利要求16所述的装置，其中所述心室是左心室。 17. The apparatus according to claim 16, wherein said ventricle is a left ventricle.
18.根据权利要求16所述的装置，其中所述主体具有至少一个逐渐变细的末端区域。 18. The apparatus according to claim 16, wherein said body has at least a tapered end region.
19.根据权利要求16所述的装置，其中所述至少一个啮合部件包括多个可扩张的指状物，其配置用于穿透和啮合心脏肌肉壁。 19. The apparatus according to claim 16, wherein said at least one engagement member comprises a plurality of expandable fingers configured for engaging and penetrating the wall of the heart muscle.
20.根据权利要求16所述的装置，其中所述至少一个啮合部件包括第一板和第二板， 所述第一板和第二板位于心脏肌肉壁的相对侧，其中，所述第一板被安置在心脏腔体内的伸长轴上，所述第二板被安置在心脏腔体外的伸长轴上。 20. The apparatus according to claim 16, wherein said at least one engagement member comprises a first plate and a second plate, said first and second plates located on opposite sides of the heart muscle wall, wherein the first an elongated shaft plate is placed in the cavity of the heart, the second elongated shaft plate is placed in the chamber of the heart in vitro.
21.用于改善主动脉瓣功能的装置，其包括：插入部件，包括主体，所述主体具有三个成角度间隔的臂状物并径向向外延伸，所述插入部件用于在主动脉瓣小叶之间插入，所述三个成角度间隔的臂状物被成形为防止通过主动脉瓣的反流；和可扩张的锚定部件，其与所述插入部件相连，所述锚定部件被配置用于在主动脉内展开。 21. A device for improving the function of the aortic valve, comprising: an insertion member comprising a body having three angularly spaced arms extending radially outwardly and the insert member used in the aorta inserted between the valve leaflets, the three arms are angularly spaced shaped to prevent regurgitation through the aortic valve; and an expandable anchoring member, which is connected with the insertion member, the anchoring member It is configured for deployment within the aorta.
22.根据权利要求21所述的装置，其进一步包括至少一个在所述插入部件和所述锚定部件之间延伸的间隔物。 22. The apparatus according to claim 21, further comprising at least one spacer extending between the insert member and the anchoring member.
23.根据权利要求22所述的装置，其中所述至少一个间隔物具有足够的长度以允许所述锚定部件在主动脉里展开，而所述插入部件在主动脉瓣里展开，使得所述锚定部件和所述插入部件位于冠状动脉口的相对侧上。 23. The apparatus according to claim 22, wherein said at least one spacer having a length sufficient to allow the anchor member deployed in the aorta, while the insert member in the deployed aortic valve, such that the anchoring member and said insertion member is located on the opposite side of the coronary ostia.
24.根据权利要求22所述的装置，其中所述至少一个间隔物是伸长杆。 24. The apparatus according to claim 22, wherein said at least one spacer is a wand.
25.根据权利要求21所述的装置，其中所述锚定部件是可扩张的支架，其具有开放式框架结构。 25. The apparatus according to claim 21, wherein said anchoring member is an expandable stent having an open frame structure.
26.根据权利要求22所述的装置，其中所述间隔物包括多个伸长杆，其在所述锚定部件和所述插入部件之间延伸并被连接至所述锚定部件和所述插入部件。 26. The apparatus according to claim 22, wherein said spacer comprises a plurality of elongated rod extending and attached to the anchor member between said anchoring member and said insertion member and said insert member.
CN2007800202603A 2006-06-01 2007-05-31 Prosthetic insert for improving heart valve function CN101484093B (en)
US60/810,085 2006-06-01
PCT/US2007/070141 WO2007140470A2 (en) 2006-06-01 2007-05-31 Prosthetic insert for improving heart valve function
CN201110206268.7A CN102283721B (en) 2006-06-01 2007-05-31 For improving the function of an artificial heart valve insert
CN101484093A CN101484093A (en) 2009-07-15
CN101484093B true CN101484093B (en) 2011-09-07
CN2007800202603A CN101484093B (en) 2006-06-01 2007-05-31 Prosthetic insert for improving heart valve function
EP (2) EP3241525B1 (en)
2007-05-31 EP EP17000717.3A patent/EP3241525B1/en active Active
US20070282429A1 (en) 2007-12-06
EP3241525B1 (en) 2019-04-24