CN111601633A - 穿中隔导丝穿刺系统 - Google Patents

穿中隔导丝穿刺系统 Download PDF

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CN111601633A
CN111601633A CN201880086451.8A CN201880086451A CN111601633A CN 111601633 A CN111601633 A CN 111601633A CN 201880086451 A CN201880086451 A CN 201880086451A CN 111601633 A CN111601633 A CN 111601633A
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transseptal
guidewire
sheath
dilator
needle
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韦斯利·罗伯特·佩德森
保罗·索拉贾
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Boston Scientific Medical Device Ltd
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Bao LuoSuolajia
Wei SiliLuobotePeidesen
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00278—Transorgan operations, e.g. transgastric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00853—Material properties low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22042—Details of the tip of the guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • A61M2025/09141—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque made of shape memory alloys which take a particular shape at a certain temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system
    • A61M2210/122—Pericardium

Abstract

用于将可操纵的护套递送到左心房中的穿心房中隔导管系统包含三个部件。第一部件是三节段式针导丝(10)，其由远端针(12)组成，该针设计成在卵圆窝穿刺和针推进后相对于连接的环形导丝节段(14)突然屈曲。远端导丝环推进到左心房中，从而将成角度的针维持在相对于环的中心位置，以保持无创伤的位置，同时将环稳定在左心房中。细长的近端超刚性导丝节段(16)与环形节段连接，该环形节段穿过卵圆窝并向近端延伸，以对于股静脉外部化。该节段具有超刚性并且是显著细长的以允许导管和装置更换。导丝用作支撑轨道，在该支撑轨道上，扩张器(108)和护套(100)能够被推进到左心房中。这种穿中隔系统具有独特的前瞻性并允许谨慎且反复地将扩张器递送到卵圆窝中，以通过与扩张器相互作用的近端护套致动器“呈帐篷状”。然后将近端外部化的GW推进，以允许穿刺卵圆窝。穿刺卵圆窝的精确位置后，将针和线圈状导丝环进一步推进到左心房中。利用近端致动器(112)，使用单手操控以进行单独的扩张器推进以及通过转动或致动护套手柄来操纵护套，将扩张器推进通过卵圆窝进入左心房中。

Description

穿中隔导丝穿刺系统
技术领域
本发明涉及一种用于进行心脏内穿中隔穿刺并使导丝进入左心脏结构的系统。更具体地，本发明旨在以高效且安全的方式实现穿中隔穿刺，以通过远端针节段、中间的环形或线圈状左心房节段和线性细长的近端节段进入左心房。它用作向心脏中的左心房进行结构或其他装置递送的平台。可以将独特构造的可操纵的护套和扩张器与这种针导丝结合。可替代地，它可以与大多数可商购的扩张器-护套穿中隔导管系统一起使用。
背景技术
穿中隔穿刺通常用于通过心脏的右心房(RA)进入其左心房(LA)。房颤消融通常需要进入LA，并且最近，瓣膜和其他结构性心脏病的治疗也需要进入LA。现有的穿中隔装置必须能够可靠地定位卵圆窝(“FO”)上的特定位置，以安全且准确地穿刺FO中隔来进行给定的手术。无意间地穿刺诸如主动脉、左或右心房游离壁或肺静脉之类的结构会导致心脏穿孔和填塞。此外，现在必须横穿FO上的高度特定的位置，以明确指出特定的左心脏目标来进行装置定位。
现有的穿中隔手术具有特定的挑战，包含：(1)由于例如严重的脊柱后凸、相对于外部界标的心脏取向改变、异常的心脏旋转(继发于多发性心脏病)以及心房内中隔上高度可变的FO位置和构造而难以精确且稳定地接合(engaging)FO的特定位置；(2)通常由于中隔增厚或有疤痕而难以推进针；(3)冗余或动脉瘤中隔在FO上留下了呈帐篷状(tented)的针的顶点，其邻近LA游离壁并因此有穿孔和心包填塞的危险；以及(4)事先放置中隔封堵器，这需要天然中隔上的替代穿刺位置；或直接进行封堵器穿刺。
缩写
除非另有说明，否则以下缩写适用于整个公开内容：
·FO：卵圆窝202
·Fr：French(导管尺寸直径的增量)
·GW：导丝10
·LA：左心房208
·LAA：左心耳210
·MRI：磁共振成像
·MV：二尖瓣212
·RA：右心房206
·TEE：经食道超声心动描记术
·TTE：经胸超声心动描记术
发明内容
本发明涉及一种独特的导管系统，更具体地涉及一种用于心房穿中隔穿刺的新颖的针导丝10，该针导丝10具有独特构造的针12，该针12在远端与分节段的GW 10邻近相接，以进行导管系统装置递送。用于穿刺心脏200中的心房中隔的一般目标是FO 202，即位于右心房206和左心房208之间的壁上的心房内中隔204右侧的凹陷。FO 202是在胎儿发育过程中通常覆盖卵圆窝的薄纤维膜的残留物。
具体地，本发明部分地涉及与穿中隔针12结合的穿中隔GW 10。GW 10节段包括刚性的节段近端部16和中间环形节段14，其中远端部22包括穿中隔针12的结点。至少两个中间节段GW环24、26搁置在LA 208中。中间环形节段14由形状记忆材料形成以形成至少两个环形节段：第二个较远端，通常在外侧的宽线圈24和第一个较近端或内侧的线圈26；其中，中间节段14在近端部25处与最终位于外部以进行更换的细长的线性超刚性GW节段16相接。
本发明进一步涉及横穿FO 202的穿中隔GW穿刺系统，该穿中隔GW穿刺系统包括近端部16、远端部22、中间线圈状节段14、穿中隔扩张器108和护套100。GW穿刺针18的远端部包括穿中隔针12，该穿中隔针12在其远端部22处附接至环形GW节段14，并且继而定位成与线性超刚性GW节段16的远端部17相接。穿中隔针12在与环形GW节段14的附接点处具有形状记忆，其中该形状记忆足以使穿中隔针12相对于环形导丝节段14保持预定的突变角度，以维持环24、26内部和中心的无创伤稳定性。环24、26中的一个或多个通过与LA 208的内表面相邻地搁置而被定位并稳定在LA 208中。中间的环形节段14由形状记忆材料形成以形成两个环形24、26；其中，较近端的线圈24的近端部25与GW 16的近端的细长的超刚性节段相接；以及其中，第二弯曲部29被定位在RA 206中，其过渡到GW 10的细长的线性最近端节段。
穿中隔扩张器108包括细长的导管109，该导管109搁置在护套100内，逐渐变细至狭窄的扩张器远端节段110，其中，导管内腔111始终保持与GW 10相配，该GW 10可以具有范围从0.021英寸到0.035英寸或更大的各种直径。在沿远端节段106的某个点处，不透射线的标记物122定位成与护套100上的不透射线的尖端标记物123重叠，此时，在该点处，穿中隔扩张器108和护套100具有相等的外径。扩张器108向前推进到FO 202的精确位置中，以通过邻近手柄104的远端部的致动器112的一系列向前运动来使FO 202“呈帐篷状”。在近端护套手柄104上的可操纵动作允许顺行和逆行屈曲(antigrade and retrograde flexion)，以及将执行对整个护套100的前部或后部的扭转，以将该护套的远端部124和所保持的扩张器尖端110定位成邻近针对特定手术的特定FO部位。通过使用近端护套100上致动器112与扩张器108的近端部119相互作用，使扩张器远端节段110相对于稳定的护套100推进和缩回运动。
一旦包含穿中隔针12的扩张器108使FO 202呈帐篷状，针12便会推进，从而穿刺FO中隔202并穿入LA 208中。穿中隔针12在其推进穿过FO 202后在与之连接的线圈状GW节段14上的近端部/铰接点20处根据形状记忆以离散的角度折叠或弯曲。它形成的角度范围可以为约45°至140°。穿中隔GW 10的进一步推进将使GW 10的环形区段14的线圈稳定定位在LA 208腔室内，这也有助于通过保持在环的中心来无创地将针位置保持在中心LA 208中。优选地，GW线圈24、26具有较小的内径线圈26和较大的外径线圈24，从而有助于将针12保持在LA 208的高度中心处。直径较小的内线圈防止过量的针12损坏LA壁中的组织。在另一个实施方案中，线圈24、26可以具有相等的直径。
在另一个实施方案中，线圈24、26可以是偏移的，如图3和4中所示，以进一步有助于保持针12的中心位置，该针12也可以进行三维折叠，这一附加特征使得在折叠的远端穿中隔针12推进并向内侧偏转时，该针12不易使LA 208结构穿孔，从而进一步有助于将针12的中心位置维持在偏移但等距的环14内。线圈24、26可以偏移大约0.75至2英寸。线圈24、26具有中度刚性，从而允许与LA游离壁的较少创伤性交互。右心房GW节段中的第二弯曲部29有助于在FO 202上以及在IVC 215中同轴地保持垂直的轨迹。细长的近端超刚性GW节段16的长度将优选为260cm(但也可以显著更长)以进行导管或装置更换。
该系统中此扩张器和可偏转护套独有的新颖的功能部件包含相对于护套更长的可扩展的扩张器尖端。通过使扩张器的不透射线的标记物122和护套的不透射线的标记物123重叠以在相等的外径处对准而进行的战略定位允许穿中隔扩张器108和护套100在FO202的膜上平稳过渡。
本发明的导管系统的向前定位允许远端护套的精确定位以进行精确的装置定位，从而构建理想的LA 208定位，其最终由给定装置的特定左心脏目标(即LAA 210、MV 212)决定。该系统通过在回声或其他成像引导下使用反复的扩张器推进来直观、简单准确地定位特定FO 202目标。在将线圈推进穿过FO 202并固定在LA 208中之后，接着在线圈状GW 10上将扩张器108推进到LA 208中，从而将重叠的不透射线节段保持在适当的位置，直到护套100穿入LA 208中。扩张器远端部106和护套尖端124上重叠的不透射线的标记物122、123用于确认它们处于相等的直径处，以使扩张器108和护套100平稳同时推进通过FO 202。
护套100的可偏转和可操纵的性质将允许针对各种患者特异性解剖结构中的各种RA 206尺寸和FO 202角度，使用单一尺寸的前瞻性导管系统来使护套100获得方向性、成角度以及延展性(reach)。
总体系统优选地包括针导丝10，其由“一码通用”(one size fits all)的导管系统递送，以将包含缩回的针12的扩张器108反复地推进到FO 202上的呈帐篷状的精确位置中。在护套100上与手柄104相邻的致动器112允许对远端节段110的高度受控的推进，以在针穿刺之前使FO膜“呈帐篷状”。致动器112可以用操作员的拇指推进或缩回而无需从可旋转的手柄104上移开操作员的手。扩张器108可以具有更柔性的远端节段，以允许在LA 208中在线圈状GW节段上进行平稳的跟踪。可偏转护套尖端124可以具有单极或双极的方向性。优选地，可操纵的护套100将在RA 206内具有远端固定的2°弯曲部，其可以在2°至20°的范围内，以更容易地建立与FO202的垂直性。标准的可商购的护套扩张器导管也可以与上述新颖的针导丝组合使用。
有利地，该装置满足以下条件：(1)改进的易用性；(2)直观的操控，以进行精确的远端控制；(3)改进的装置和手术效果；(4)在广泛的操作员技能范围内提高装置安全性；(5)增强工作流程并减少手术时间；以及(6)减少组合式针导丝带来的手术成本。
结合附图，在下面对本发明的优选实施方案的描述中，将更加详细地强调本发明的目的和优点。
附图说明
图1是正面描绘的本发明的组合式穿中隔针和GW的第一实施方案的侧面平面图。
图2是正面描绘的本发明的组合式穿中隔针和GW的第二实施方案的侧面平面图。
图3是本发明的组合式穿中隔针和GW的第三实施方案的侧面平面图，从正面角度观察，其带有偏移的环。
图4是已旋转90度的图3的穿中隔针的前视平面图。
图5是示出与本发明的针导丝一起使用的代表性的单极可偏转护套的侧视平面图。
图6是示出与图5的可偏转护套一起使用的扩张器的侧视平面图。
图7是包含心脏和静脉系统(该系统中存在可操纵的护套)的人中心静脉循环系统的前视示意图。
图8是人心脏的横截面的前视示意图，其中可偏转护套定位成穿过中隔并定位在LA中，其中远端针导丝环在LA中。
发明详述
参考附图中的附图标记，本发明的穿中隔穿刺系统优选地是“一码通用”系统，由此，单一尺寸的系统可以在各种解剖构造和心房尺寸中使用。该新标准的一个例外涉及使用约0.021英寸到大于0.035英寸的多个丝径。该系统包括专用部件，其包含GW更换件，该GW更换件具有远端穿中隔针和用于将GW固定在LA 206中的相邻线圈或环。此外，导管部件可以包含新颖的扩张器，该扩张器与近端护套手柄上的致动器相互作用，以通过可操纵的护套受控地定位在FO上。
针导丝
参考示出针导丝10的图1至图4。穿中隔针导丝10应该是单个部件，并且不再需要针对各种解剖结构的单独的穿中隔针、多种更换件以及多种长度和曲线。单个丝具有至少三个限定的节段：(1)远端的穿中隔针12；(2)中间或环形的LA节段14；以及(3)近端细长的线性超刚性GW节段16。
穿中隔针12
穿中隔针12定位成与GW环形节段14的远端部22相接。穿中隔针12优选地相对短，长度在约0.75至约2.0cm之间。针12还应当优选地具有超低轮廓的尖端18。当在推进之前保持在扩张器尖端的中心内腔111中时，与相邻的远端环形节段14相接的针12的近端部20是线性的。
穿中隔针12具有用以使阻力最小化的润滑涂层，以及用以穿刺并轻松过渡到包含那些可能有密集的疤痕或动脉瘤的FO 202中的突然变细(sharply tapered)的尖端18(如图8中所示)。针尖端18上的超细点，前瞻性变细的穿中隔扩张器108向FO 202的缓慢反复递送以进行稳定的定位，以及通过扩张器尖端18使膜“呈帐篷状”而该扩张器尖端18继而由可操纵的穿中隔的护套100支撑，这些均避免了针突然无意穿过FO膜而错失优选的穿刺部位。通过这种前瞻性系统，导致在FO 202上滑动的意外的前部或后部扭矩应该得以最小化。
穿中隔针12优选地由具有形状记忆的诸如不锈钢或包含镍钛诺的合金之类的金属材料构成，并且附接到GW环形节段14，例如通过焊接或可能相互交叉的缝隙附接，所述缝隙相互作用以形成更稳定且灵活的结合，从而允许针自身折叠，由此避免刺穿LA游离壁、肺静脉等。还可以设想到和利用其他的在针12与环形节段14之间形成预成形角度的手段。
穿中隔针12在其与环形GW节段14的远端部22连接的近端部/铰接点20处突然成角度，该远端部22已保持了与LA环形节段14中心的预定角度，从而在中心LA环形节段14处维持了无创伤稳定性，因此避免了包含肺静脉、LA游离壁和LAA 210的LA 208结构的接触和可能的穿孔。
在导丝推进和穿中隔穿刺之后，针12在中心突然屈曲，与邻接的环形GW节段14优选成锐角，如图1至图4所示。针12在进入LA 208后保持线性，但优选相对于远端环形GW节段14成约45°至140°的角度地，向内屈曲。穿中隔针尖端18的直径可以研磨至超低轮廓并逐渐变粗(tapered back)以连接远端环形节段14，最有可能过渡到范围从0.021英寸到0.035英寸或更大的轮廓。
导丝环形节段14
环形GW节段14被设计成无创伤地使GW 10位置稳定在LA 208中，此外，有助于保护左心房游离壁免于不必要的针穿刺。两个或更多个环形节段24、26通常可以具有范围介于约2.5cm和4.0cm之间的直径，并且当其从穿中隔扩张器108进入LA 208时通过形状记忆形成。在一个实施方案中，远端GW环形节段14通过在尺寸上大致相同的两个圆形或可能非圆形的环形成，所述环潜在地具有多种形状，这些形状在展开于LA腔室中时再次形成，如图3至图4所示。
线圈至少提供四个有用的功能：
1.线圈可以通过呈现LA 208内不受约束的已知形状来确认正确的LA腔室定位。
2.线圈14在LA 208中维持稳定的定位，以避免GW 10无意地撤回到RA 206中或者避免针尖端12有力地推进到LA游离壁或肺静脉中。
3.外部宽线圈24提供了较长的GW支撑斜面，在该斜面上，扩张器108和护套100可以围绕曲线以较小的阻力推进到LA 208中，以便于导管支撑。
4.线圈形成外部保护罩，其中，中心定位的针12与穿透的LA 208结构保持安全距离。
在另一个实施方案中，存在至少两个圆形线圈，内部线圈26的直径小于外部线圈24的直径，如图1至图4所示，内部线圈因此位于外部线圈24的中心。在该实施方案中，较大的外部线圈24可以在没有内部线圈26的任何构造变化的情况下由LA 208结构压缩，因此进一步保护了远端针12的变形并保持了其中心位置。
作为示例，GW 10的内部线圈26可以具有在约1.5cm和3.0cm之间的直径，优选约2.5cm的直径。外部线圈24可以具有在约3.0cm和4.0cm之间的直径，优选约3.5cm的直径。
在第三实施方案中，两个线圈24、26是平行的并且直径相等，但是可以偏移约0.75cm至约2.0cm，这与在远端穿中隔针12和GW环形节段14的结点(junction)处的第二预成形的弯曲部相结合，该第二预成形的弯曲部在三维上处于两个偏移的丝线圈24、26的中心，如图5所示。其目的是通过利用该实施方案允许针12在屈曲时不仅在两个维度上周向居中，而且使针12在两个偏移的环24、26的宽度之间在第三维度上居中定向而进一步有助于防止LA 208的针穿孔。线圈24、26之间的距离将优选为约1cm，并且可以在约0.75cm至约2.0cm的范围内。
近端导丝节段16
近端GW节段16在节段16的远端部17处与相邻的线圈节段14相接。近端GW节段16包含近端自由端部28，该近端自由端部28被置于外部，具有足够的长度以在将远端GW环形节段14维持定位于LA中的同时允许导管或装置更换。该节段的远端部17线性地穿过心房中隔过渡到LA 208中。然后优选存在大致位于RA 206中间的固定的第二度浅弯曲部29，其保持优选的2°至20°的角度。细长的近端超刚性GW节段16从长的近端节段17的最远端部延伸到直径优选为0.021英寸至0.035英寸的最近端部28。长的近端超刚性GW节段16的长度可以从240cm延伸至300cm，优选为260cm。这种长的超刚性GW节段16将用作支撑轨，用于更换一系列导管和装置以递送至左心脏目标。
导丝引入护套100
参考图5，穿中隔递送护套(或护套)100优选为单极的可偏转护套，但也可以是双极的可偏转护套，其利用可旋转的近端人体工程学手柄104致动以进行上/下(superior/inferior)屈曲，以及一对一的护套扭矩控制，以进行最佳的前部/后部定位，推进或缩回穿中隔护套100允许上下定位，以在所有平面中进行受控的无创伤引导。护套100具有邻近致动器112放置的近端部102，以及远端节段107。设计成用于商业用途的现有穿中隔系统通常使用来自股静脉进入角度(femoral vein access sight)的护套/扩张器系统的顺时针扭矩进入FO 202，如果过度延展(over-reaching)的扩张器108瞬间向远端“卡”在心房中隔突出脊上，则该顺时针扭矩可能过量(长度过长)，这进而可能产生无意“存储的”扭矩。将扩张器远端节段110定位在FO 202内的进一步努力可能导致RA 206游离壁或心耳的穿孔。相反地，扩张器108的长度或“延展”不足以及不能穿过FO 202而接合膜则导致无法穿刺FO202。
每个系统必须有多个可用的护套尺寸，以适应这些现有市售系统中可变的RA尺寸和构造。护套100具有人体工程学的双向可旋转的手柄104，以进行上下远端护套屈曲，如箭头125所示，以及延展到护套100的护套尖端124。此外，在从前部到后部的位置中向远端的1：1扭矩传递通过护套100的金属丝编织加强件(未示出)来完成，该金属丝编织加强件也改进了对增强的装置递送的后备支撑(back up support)。使用荧光检查和TEE引导，并且在可能的情况下，使用可能实时的MRI和计算机断层摄影术，最初将护套100定位成邻近但不接合心房中隔。
如很快将说明的，一旦在成像引导下将护套100准确地定位在距RA206中的FO 202合适的短距离处(很可能约0.5至约2.0cm)，就在保持护套100固定的同时推进扩张器108。用于扩张器的护套手柄104和相邻的致动器112将允许操作员将一只手保持在适当的位置而无需使用对侧手来操控整个系统(护套和扩张器)。用于扩张器108的致动器112可以通过操作员的拇指或其他手指来操控，以通过与扩张器108上的摩擦元件121相互作用而进行反复的向前推进或缩回。金属丝编织的增强护套100提供了牢固的后备、抗扭结支撑，以将扩张器108的扩张器远端节段110推进，随后将扩张器108推进到FO 202的精确受控的特定位置中，以使膜“呈帐篷状”。
护套100优选地包含但不必须有可扩张的轴以容纳高度可变的装置轮廓；另一方面，可以使用一系列固定直径的护套来容纳各种装置轮廓。范围从约8.5Fr到潜在地高达30Fr的理想的可伸展或可扩张的护套可以消除为不同手术保留多个可用的护套直径的需求。因此，一个实施方案是适合于在一定直径范围内可扩张的单个护套尺寸。对于围绕复杂或多个曲线的装置递送，可能优选的是可能需要在距近端手柄两个或更多个距离处进行偏转的穿中隔护套。
多个其他支撑结构可以在护套主体内线性地延伸，以为随后在更大角度的解剖结构上进行装置递送保持足够水平的支撑。2°至20°的第二弯曲部可以定位在较远端的可偏转弯曲部的近端，这将有助于在FO处获得更大的垂直角度，以实现有力的同轴后备支撑。另外，这将允许远端屈曲大于180°，这有时可能是在左心脏的内侧面实现适当的护套定位而需要的。护套毂114上的紧密止血阀将使GW 10(包含直径低至0.021英寸的那些)周围的背部出血最小化。优选地，护套100将是90cm长(70cm可用长度)或更长。可以包含用于将扩张器锁定到护套的毂。
穿中隔扩张器108
穿中隔扩张器108(或“扩张器”)优选地具有超低轮廓的远端节段110，该远端节段110带有倒锥形(如106所示)，其在扩张器108的远端部106处与固定的外径118相连接，以与护套内径相匹配。扩张器108可以以向前的动作推进，直到“呈帐篷状”的FO膜显示在精确的位置上，该精确的位置针对通过TEE或其他针对所执行的手术的实时成像检测器可视的位置。
在一个优选的实施方案中，扩张器108将通过摩擦接触元件121或使用互锁齿轮与邻近护套手柄104的致动器112相互作用，以对扩张器的运动进行精确温和的控制。允许扩张器推进或缩回的致动器112将优选地用同侧拇指来控制，从而保持用一只手操控扩张器108和护套手柄104两者的能力。扩张器108沿其长度具有可变的挠性，带有更具挠性的远端节段118，以防止导管系统在GW环形节段14上推进时过度矫直或运动。
扩张器远端节段106的最大长度应该能够推进超过固定的远端护套100，优选地高达约5cm，尽管它可以改变以延伸超过护套尖端约3.0cm至约8.0cm。这允许在远端GW 10上使扩张器108受控推进穿过FO 202并进入LA 208中。在扩张器108进行中隔穿刺并推进到LA208中，同时保持护套104固定在RA 206中之后，应该有足够的空间，直到不透射线的标记物122、123在中隔的RA 206侧重叠，此后，具有齐平外径的带有穿中隔扩张器108和护套100的复合系统现在能够作为整个单元被推进到LA208中。
扩张器远端节段106终止于低轮廓尖端110，并且在扩张器远端节段106的近端具有不透射线的标记物122，该不透射线的标记物122与护套尖端124上的不透射线的标记物123的轮廓匹配，从而在两者之间提供了平稳的过渡点，以同时推进穿过FO 202，从而防止护套尖端边缘“悬挂”在心房中隔交叉点上。
具体实施方式
参考图7和8，对人类患者201的示例性操作方法如下。如下所述，该技术通常由补充有标准荧光检查法的TEE或TTE引导。应该理解，该手术还可以通过心内回声、实时MRI或与手术前体积渲染的计算机断层摄影图像的图像整合来引导。后面的这种成像方法使用标准的荧光图像，可以将预先获取的计算机断层摄影图像定向并叠加在该荧光图像上以进行引导。参见Nance等人的美国专利8,900,214，该专利被并入本文以对包含心脏200在内的人体解剖结构以及将穿中隔护套100插入心房区域进行总体描述。
使用荧光检查法，将带0.032J-尖端的GW从右股静脉216推进到上腔静脉218中。可操纵的护套100和扩张器108作为整个单元在带J-尖端的GW 10上推进并且定位在RA 206中间。将带J-尖端的GW 10移除并且冲洗扩张器108。然后，在荧光检查下，将GW 10的远端尖端18推进到0.032相配的扩张器108中，以及将GW 10的远端尖端18刚好定位在扩张器远端节段110的近端。
护套100上的人类工程学手柄104被轴向定向，以允许可偏转的尖端124朝着FO202向前屈曲。在朝着FO 202操控护套100之前，通过荧光检查法和超声心动描记术将1到3cm的扩张器108向固定的护套100的远端推进。为了实现这种前部或后部取向，将护套100向前部或向后部扭转。将护套100推进或撤回以获得更高或更低的位置。再次，将近端的护套手柄104转动以使远端末端124屈曲到上(即逆行)或下(即顺行)轨迹。TEE探头最常用于使用正交视图进行FO 202和相邻的扩张器远端尖端110的最佳成像：针对上下取向的双腔视图，以及用以显示前部-后部定位的主动脉水平的短轴视图。使用这些TEE视图，可以获得FO 202上的精确位置以进行手术针对性穿刺。与护套手柄104相邻的致动器112用于缓慢且反复地推进扩张器尖端110，从而在FO 202内创建“帐篷状”，并通过TEE确认正确的位置。如果扩张器远端110定位不正确，则扩张器108可以用致动器112撤回，并在操控护套100之后重新定向。
使用呈帐篷状的位置确认正确的定位之后，GW 10近端部和针尖端18穿刺并穿过FO 202膜。随着GW 10进一步推进，针12在铰接点20处突然屈曲，在该铰接点20处，针12附接到GW 10的环形节段14。随着GW10仍进一步推进，其远端的线圈14自动定位在LA 208中，以及针12在线圈24、26的中心保持屈曲。导管始终被抽吸并通过更换进行冲洗。GW环形节段14一进入LA中，患者就接受肝素治疗。GW 10的正确定位是通过验证其预成型的形状来确认的。如在装置描述中所指出的，线圈状或环形的节段14可以采取几种不同的实施方案。扩张器108在线圈状丝上推进，从而将护套100维持在RA 206内的固定位置。
在荧光检查下使适当长度的扩张器108推进时，扩张器108和护套尖端124上的不透射线的标记物122、123在RA 206中重叠，从而确认两个导管的外径相等并准备好作为整个单元被推进到LA 208中。护套尖端124现在搁置在FO 202上和LA 208中。同样，所有扩张器108和护套100的操控均作为单只手工序执行。移除扩张器108，从而将导丝环24、26和护套100保持固定在LA 208中。
GW 10的细长的近端节段加载有主要装置，该主要装置现在被推进到护套尖端124中，并且移除GW 10。然后，可以对护套100进行更精细的操控，以将装置递送至目标并随后展开。在展开之后，将可操纵的护套100拉回到RA 206中，随后将其从患者身上移除。用鱼精蛋白逆转肝素并关闭经皮血管入口。
这种穿中隔手术是用前瞻性的导管系统执行的，在穿刺之前，该导管系统被反复地推进到FO 202的精确位置上。导管系统的该性质使得将仅需要一种装置形状即可到达LA208。这与使用多种导管尺寸将导管扭转到FO202中的现有技术不同，该多种导管尺寸最初可能太小而无法到达FO 202或者太长，从而使患者处于FO膜滑落和潜在地使RA游离壁穿孔的风险。
本发明的任何部件或方法步骤的任何形式都可以与本发明的任何其他部件或方法步骤一起使用。不论是否明确描述，本文描述的元件可以以任何组合使用。
除非另有说明或在引用组合的上下文中明显相反地暗示，否则本文所使用的方法步骤的所有组合可以以任何顺序执行。
如本文所用，除非内容另外明确指出，否则单数形式“一个”、“一种”和“该”包含复数指示物。
无论是否具体公开，本文所使用的数值范围旨在包括该范围内包含的每个数字和数字子集。此外，这些数值范围应被解释为对涉及该范围内的任何数字或数字子集的权利要求提供支持。例如，从1到10的公开内容应解释为支持从2到8、从3到7、从5到6、从1到9、从3.6到4.6、从3.5到9.9等的范围。
本文引用的所有专利、专利出版物和经同行评审的出版物(即，“参考文献”)均通过引用以其整体明确地并入本文，其程度如同每个单独的参考文献均被具体地和单独地指示为通过引用并入。在本公开内容与所并入的参考文献之间发生冲突的情况下，以本公开内容为准。
本发明的装置、方法、化合物和组合物可以包括以下或由或基本上由以下组成：本文所述的基本要素和限制，以及本文所述或以其他方式有用的任何附加或任选的步骤、成分、组分或限制。
尽管本发明可以以多种形式实施，但是本文详细描述的内容是本发明的特定优选的实施方案。本公开内容是本发明原理的示例，并且不旨在将本发明限制于所示的特定实施方案。应当理解，本发明不限于本文公开的特定示例、工艺步骤和材料，因为这样的工艺步骤和材料可能在某种程度上是非常有限的。还应理解，本文中使用的术语仅用于描述特定实施方案的目的，而不旨在进行限制，因为本发明的范围将仅限于所附权利要求及其等同物。
该装置的使用范围可以扩展到对血管和非血管腔器官结构的其他(即，非穿中隔)手术。

Claims (30)

1.一种穿中隔导丝，所述穿中隔导丝包括近端部、远端部和中间节段，
a.其中所述远端部包括穿中隔针，所述穿中隔针附接到所述导丝的远端部并定位成与所述导丝的所述远端部相接；
b.其中所述中间节段由形状记忆材料形成以形成至少一个环形节段；以及
c.其中所述近端部与所述中间节段相接。
2.如权利要求1所述的穿中隔导丝，其中所述穿中隔针的长度在约0.75至2.0cm之间。
3.如权利要求1所述的穿中隔导丝，其中所述穿中隔针和至少一个环形节段具有润滑涂层。
4.如权利要求1所述的穿中隔导丝，其中所述穿中隔针在与所述引导丝的附接点处具有形状记忆，其中所述形状记忆足以使所述穿中隔针相对于所述导丝保持预定角度以维持中心无创伤稳定性。
5.如权利要求4所述的穿中隔导丝，其中所述预定角度相对于所述导丝在约45°至140°之间。
6.如权利要求1所述的穿中隔导丝，其中所述中间节段由形状记忆材料形成以形成至少两个环形节段。
7.如权利要求1所述的穿中隔导丝，其中所述环形节段的直径在约2.5cm至4.0cm之间。
8.如权利要求6所述的穿中隔导丝，其中所述环形节段的直径在约2.5cm至4.0cm之间。
9.如权利要求1所述的穿中隔导丝，其中所述中间节段由形状记忆材料形成。
10.如权利要求9所述的穿中隔导丝，其中所述形状记忆材料是镍钛诺。
11.如权利要求6所述的穿中隔导丝，其形成内环和外环，其中所述内环具有介于约1.5cm和3.0cm之间的直径，以及所述外环具有介于约3.0cm和4.0cm之间的直径。
12.如权利要求6所述的穿中隔导丝，其中所述内环与所述外环偏移约0.75cm至约2.0cm的距离。
13.如权利要求1所述的穿中隔导丝，其中所述近端部具有介于约0.021英寸和0.035英寸之间的直径。
14.如权利要求1所述的穿中隔导丝，其中所述近端部具有介于约240cm至300cm之间的长度。
15.如权利要求1所述的导丝，其还包括用于将所述穿中隔针放置在卵圆窝上的穿中隔扩张器。
16.如权利要求15所述的穿中隔导丝，其中所述中隔扩张器具有直径在约0.021和0.035英寸之间的内腔。
17.如权利要求1所述的穿中隔导丝，其中所述中隔扩张器包括不透射线的标记物。
18.如权利要求1所述的穿中隔导丝，其还包括护套。
19.如权利要求18所述的穿中隔导丝，其中所述护套具有单极或双极的可偏转的远端节段，以及用于操纵和定位所述远端节段的近端手柄。
20.一种穿过卵圆窝的穿中隔导丝穿刺系统，所述穿中隔导丝穿刺系统包括近端部、远端部、中间节段、穿中隔扩张器和护套，
a.其中所述远端部包括穿中隔针，所述穿中隔针附接到导丝的远端部并定位成与所述导丝的所述远端部相接，其中所述穿中隔针在与所述导丝的附接点处具有形状记忆，其中所述形状记忆足以使所述穿中隔针相对于所述导丝保持预定角度，以维持无创伤的中心定位；
b.其中所述中间节段由形状记忆材料形成以形成至少两个环形节段；
c.其中所述近端部与所述中间节段相接；
d.其中所述穿中隔扩张器具有近端部和远端部，其中所述远端部包括用于放置在所述卵圆窝上的低轮廓尖端；以及
e.其中所述护套是具有近端部和远端部的单极的可偏转护套，其中所述近端部包括用于向近端致动所述护套的手柄。
21.如权利要求20所述的穿中隔导丝穿刺系统，其中所述穿中隔针的长度在约0.75和2.0cm之间。
22.如权利要求20所述的穿中隔导丝穿刺系统，其中所述穿中隔导丝具有润滑涂层。
23.如权利要求20所述的穿中隔导丝穿刺系统，其中所述预定角度相对于所述导丝在约45°至140°之间。
24.如权利要求20所述的穿中隔导丝穿刺系统，其形成内环和外环，其中所述内环具有介于约1.5cm和3.0cm之间的直径，以及所述外环具有介于约3.0cm和4.0cm之间的直径。
25.如权利要求20所述的穿中隔导丝穿刺系统，其中所述内环与所述外环偏移约0.75cm至约2.0cm的距离。
26.如权利要求20所述的穿中隔导丝穿刺系统，其中所述近端部具有介于约0.025英寸和0.035英寸之间的直径。
27.如权利要求20所述的穿中隔导丝穿刺系统，其中所述近端部具有介于约240cm至300cm之间的长度。
28.如权利要求20所述的穿中隔导丝穿刺系统，其中所述穿中隔扩张器具有直径在约0.021和0.035英寸之间的内腔。
29.如权利要求20所述的穿中隔导丝穿刺系统，其中所述穿中隔扩张器在所述远端部上具有不透射线的标志物，以及所述护套在所述护套的远端部上具有相应的不透射线的标志物。
30.如权利要求20所述的穿中隔导丝穿刺系统，其中所述护套包括邻近所述手柄的致动器，并且其中所述扩张器的远端部包括摩擦元件，其中所述致动器与摩擦元件相互作用，以启动所述扩张器在所述护套内的运动。
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