相关申请的交叉引用CROSS-REFERENCE TO RELATED APPLICATIONS
本申请要求35U.S.C.§119(e)下2017年1月10日提交的共同未决美国临时专利申请No.62/444584和2017年12月19日提交的共同未决美国临时专利申请No.62/607510的优先权的权益。以引证的方式将临时申请的公开全文并入。This application claims the benefit of priority under 35 U.S.C. §119(e) to co-pending U.S. Provisional Patent Application No. 62/444,584, filed on January 10, 2017, and co-pending U.S. Provisional Patent Application No. 62/607,510, filed on December 19, 2017. The disclosures of the provisional applications are incorporated by reference in their entireties.
技术领域Technical Field
本技术总体涉及医疗装置和方法，更具体地，涉及抽吸导管系统及其使用方法。The present technology relates generally to medical devices and methods, and more particularly, to aspiration catheter systems and methods of using the same.
背景技术Background Art
当到大脑的动脉闭塞(这阻止新鲜氧合血从心脏和肺输送到大脑)时，通常发生急性缺血性中风(AIS)。这些闭塞通常由在动脉中卡住并阻塞为脑组织区域供给的动脉的血栓或栓子引起。如果动脉被阻塞，则缺血后损伤随后发生，并且脑细胞可能停止工作。此外，如果动脉保持阻塞超过几分钟，则脑细胞可能死亡，这导致永久性神经缺损或死亡。因此，立即治疗至关重要。Acute ischemic stroke (AIS) typically occurs when an artery to the brain becomes blocked, preventing fresh oxygenated blood from being delivered to the brain from the heart and lungs. These blockages are usually caused by a blood clot or embolus that becomes lodged in an artery and blocks the artery supplying an area of brain tissue. If an artery is blocked, post-ischemic damage ensues, and brain cells may stop functioning. Furthermore, if the artery remains blocked for more than a few minutes, brain cells may die, leading to permanent neurological deficits or death. Therefore, immediate treatment is crucial.
采用两种主要疗法来治疗缺血性中风：溶栓疗法和血管内治疗。用于重建流动或重新灌注中风区域的最常见治疗是使用静脉内(IV)溶栓疗法。进行溶栓疗法的时间段对于IV输注是在症状发作的3小时内(所选患者为4.5小时)或对于定点动脉内输注是在6小时内。在之后实行疗法没有证明是有益的，并且可能由于溶栓效应而使患者暴露到更大的出血风险。血管内治疗最常使用一套工具来机械地移除栓子，我们不使用溶栓疗法。There are two main therapies used to treat ischemic stroke: thrombolytic therapy and endovascular therapy. The most common treatment used to restore flow or reperfuse the stroke area is the use of intravenous (IV) thrombolytic therapy. The time period for administering thrombolytic therapy is within 3 hours of symptom onset for IV infusion (4.5 hours for selected patients) or within 6 hours for fixed-point intra-arterial infusion. Administering therapy after this time has not been shown to be beneficial and may expose the patient to a greater risk of bleeding due to the thrombolytic effect. Endovascular therapy most often uses a set of tools to mechanically remove the embolus; we do not use thrombolytic therapy.
血管内治疗的整个范围包括机械栓子切除术，该机械栓子切除术使用可收回结构，例如，线圈尖端可收回支架(还称为“支架取回器”或STENTRIEVER)、铁丝网支架或具有撑杆的激光切割支架，这些撑杆可以在大脑解剖结构中的凝块内打开，以使凝块与支架撑杆啮合，在栓子中产生通道以恢复一定量的血流，随后通过将其从解剖结构中拉出连同抽吸技术来收回可收回结构。机械去除AIS关联栓子的其他血管内技术包括手动抽吸血栓切除术(MAT)(还称为“ADAPT”技术)。ADAPT/MAT是血管内手术，在该手术中，将大口径导管插入穿过经股动脉，并且将其操纵穿过复杂的解剖结构至栓子水平，栓子可能位于颅外颈动脉、椎动脉或颅内动脉中。抽吸技术可以用于借助大口径导管去除栓子。另一种血管内手术是Stentriever介导的手动抽吸血栓切除术(SMAT)(类似于Stentriever辅助的“Solumbra”技术)。与MAT一样，SMAT涉及借助经股动脉进入栓子。然而，在实现进入后，使用可收回结构来将栓子拉回到大口径导管中。The entire spectrum of endovascular treatments includes mechanical embolectomy, which uses a retractable structure, such as a coil tip retractable stent (also known as a "stent retriever" or STENTRIEVER), a wire mesh stent, or a laser cut stent with struts that can be opened within a clot in the brain anatomy to allow the clot to engage with the stent struts, create a channel in the embolus to restore a certain amount of blood flow, and then retract the retractable structure by pulling it out of the anatomy along with aspiration techniques. Other endovascular techniques for mechanically removing AIS-associated emboli include manual aspiration thrombectomy (MAT) (also known as the "ADAPT" technique). ADAPT/MAT is an endovascular procedure in which a large bore catheter is inserted through the transfemoral artery and manipulated through the complex anatomy to the level of the embolus, which may be located in the extracranial carotid, vertebral, or intracranial arteries. Aspiration techniques can be used to remove the embolus with the aid of a large bore catheter. Another endovascular procedure is Stentriever-mediated manual aspiration thrombectomy (SMAT) (similar to the Stentriever-assisted "Solumbra" technique). Like MAT, SMAT involves accessing the embolus via the femoral artery. However, after access is achieved, a retractable structure is used to pull the embolus back into the large-bore catheter.
为了进入大脑解剖结构，使用引导导管或导鞘来将介入装置从动脉进入部位(通常是股动脉)引导至目标解剖结构。引导件的长度由进入部位与引导远尖端的期望位置之间的距离确定。用于亚选择性引导和抽吸的诸如导丝、微导管以及中间导管的介入装置借助引导件插入并前进到目标部位。通常，装置以同轴样式使用，即，在中间导管内部的微导管内部的导丝作为组件以逐步样式前进到目标部位，内部最无创伤的元件首先向远端前进并为其他元件的前进提供支撑。同轴装配的各元件的长度将引导件的长度、导管上的近端连接器的长度以及从远端延伸所需的长度考虑在内。In order to enter the brain anatomical structure, a guide catheter or guide sheath is used to guide the interventional device from the arterial entry site (usually the femoral artery) to the target anatomical structure. The length of the guide is determined by the distance between the entry site and the desired position of the guide distal tip. Interventional devices such as guidewires, microcatheters, and intermediate catheters used for subselective guidance and aspiration are inserted and advanced to the target site with the help of guides. Typically, the device is used in a coaxial manner, that is, a guidewire inside a microcatheter inside an intermediate catheter is advanced to the target site as an assembly in a step-by-step manner, with the most non-invasive element inside first advancing to the distal end and providing support for the advancement of other elements. The length of each element of the coaxial assembly takes into account the length of the guide, the length of the proximal connector on the catheter, and the length required to extend from the distal end.
典型的三轴系统(例如用于支架收回器和其他介入装置的抽吸或输送)需要重叠的一系列导管，各导管在近端上具有它们自己的旋转止血阀(RHV)。例如，导丝可以借助具有第一近端RHV的Penumbra Velocity微导管插入，该微导管可以借助具有第二近端RHV的Penumbra ACE68插入，该ACE 68可以借助Penumbra NeuronMAX 088进入导管插入，该进入导管具有经由股引入器定位在高颈动脉中的第三近端RHV。维持这些导管之间的同轴关系在技术上可能具有挑战性。必须用两只手或更常见地为四只手(即，两个操作者)不断地调节三个RHV。进一步地，用于抽吸和/或颅内装置输送的典型三轴系统的工作区域可能需要手术台底座处的3-5英尺的工作区域。A typical triaxial system (e.g., for aspiration or delivery of stent retrievers and other interventional devices) requires an overlapping series of catheters, each with its own rotary hemostasis valve (RHV) on the proximal end. For example, a guidewire can be inserted with the aid of a Penumbra Velocity microcatheter having a first proximal RHV, which can be inserted with the aid of a Penumbra ACE68 having a second proximal RHV, which can be inserted with the aid of a Penumbra NeuronMAX 088 access catheter having a third proximal RHV positioned in the high carotid artery via a femoral introducer. Maintaining a coaxial relationship between these catheters can be technically challenging. The three RHVs must be constantly adjusted with two hands, or more commonly, four hands (i.e., two operators). Further, the working area of a typical triaxial system for aspiration and/or intracranial device delivery may require a working area of 3-5 feet at the base of the operating table.
进入闭塞部位甚至部分恢复到血管的流动所需的时间在确定这种手术的成功结果方面至关重要。类似地，手术期间的远端栓子的发生以及潜在负面的神经学效应和手术并发症(诸如穿孔和脑内出血)是手术成功的限制。需要一种装置和方法的系统，这些装置和方法允许快速进入、优化的导管抽吸以及治疗，以完全恢复到阻塞的脑血管的流动。The time required to access the occlusion site and even partially restore flow to the vessel is crucial in determining the successful outcome of such surgery. Similarly, the occurrence of distal emboli during surgery and the potential negative neurological effects and surgical complications (such as perforation and intracerebral hemorrhage) are limitations to surgical success. A system of devices and methods is needed that allows for rapid access, optimized catheter aspiration, and treatment to fully restore flow to an obstructed cerebral vessel.
发明内容Summary of the Invention
在方面中，描述了一种用于促进神经血管内的管腔内医疗手术的血管内导管前进装置。导管前进装置包括：挠性细长主体，该挠性细长主体具有近端区域、外径、锥形远尖端部、远端开口以及纵向延伸穿过挠性细长主体到远端开口的单个管腔；和近端部，该近端部耦接到挠性细长主体的近端区域。近端部向近端延伸到导管前进元件的最近端。挠性细长主体的硬度向近端朝向越来越硬的材料过渡直到近端部，形成第一多个材料过渡。挠性细长主体的至少一部分由包括增强层的多个层形成。挠性细长主体的外径被定尺为同轴地定位在导管的管腔内，使得挠性细长主体的远尖端部向远端延伸超过导管的远端，以辅助导管到颅内血管的输送。In aspect, an intravascular catheter advancement device for facilitating intraluminal medical procedures within a neurovascular vessel is described. The catheter advancement device includes: a flexible, elongated body having a proximal region, an outer diameter, a tapered distal tip, a distal opening, and a single lumen extending longitudinally through the flexible, elongated body to the distal opening; and a proximal portion coupled to the proximal region of the flexible, elongated body. The proximal portion extends proximally to a proximal-most end of a catheter advancement element. The hardness of the flexible, elongated body transitions proximally toward increasingly harder materials until the proximal end, forming a first plurality of material transitions. At least a portion of the flexible, elongated body is formed from a plurality of layers including a reinforcement layer. The outer diameter of the flexible, elongated body is sized to be coaxially positioned within the lumen of the catheter such that the distal tip of the flexible, elongated body extends distally beyond the distal end of the catheter to assist in delivery of the catheter to the intracranial vessel.
增强层可以是织带。织带可以从挠性细长主体的近端区域延伸，并且在远尖端部的近端的点处终止。点可以位于离挠性细长主体的最远终点4cm和15cm之间。多个层可以还包括第一聚合物材料层和第二聚合物材料层。织带可以定位在第一聚合物材料层与第二聚合物材料层之间。近端部可以是具有耦接到挠性细长主体的远端的海波管。织带可以定位在第一聚合物材料层与第二聚合物材料层之间并定位在海波管的远端上方。The reinforcement layer may be a webbing. The webbing may extend from a proximal region of the flexible, elongated body and terminate at a point proximal to the distal tip. The point may be located between 4 cm and 15 cm from the furthest endpoint of the flexible, elongated body. The plurality of layers may further include a first layer of polymeric material and a second layer of polymeric material. The webbing may be positioned between the first layer of polymeric material and the second layer of polymeric material. The proximal portion may be a hypotube having a distal end coupled to the flexible, elongated body. The webbing may be positioned between the first layer of polymeric material and the second layer of polymeric material and above the distal end of the hypotube.
远尖端部可以包括具有不超过35D的材料硬度的材料。细长主体的近端区域可以包括具有在55D至72D之间的材料硬度的材料。细长主体可以包括第一段，该第一段包括具有不超过35D的硬度的远尖端部。细长主体可以包括第二段，该第二段位于具有不超过55D的硬度的第一段的近端。细长主体可以包括第三段，该第三段位于具有不超过72D的硬度的第二段的近端。近端部可以在第三段内耦接到细长主体。第一段可以未增强，并且第三段可以增强。第二段可以至少部分增强。增强织带可以延伸穿过至少第三段。第一段、第二段以及第三段可以组合，以形成细长主体的插入长度。第一段可以具有大约4cm到大约12.5cm的长度。第二段可以具有大约5cm到大约8cm的长度。第三段可以具有大约25cm到大约35cm的长度。The distal tip portion may comprise a material having a material hardness of no more than 35D. The proximal region of the elongated body may comprise a material having a material hardness between 55D and 72D. The elongated body may comprise a first section comprising a distal tip portion having a hardness of no more than 35D. The elongated body may comprise a second section located proximal to the first section having a hardness of no more than 55D. The elongated body may comprise a third section located proximal to the second section having a hardness of no more than 72D. The proximal portion may be coupled to the elongated body within the third section. The first section may be unreinforced, and the third section may be reinforced. The second section may be at least partially reinforced. The reinforcing webbing may extend through at least the third section. The first, second, and third sections may combine to form the insertion length of the elongated body. The first section may have a length of approximately 4 cm to approximately 12.5 cm. The second section may have a length of approximately 5 cm to approximately 8 cm. The third section may have a length of approximately 25 cm to approximately 35 cm.
系统可以还包括具有管腔和远端的导管。导管可以包括挠性远端管腔部，该挠性远端管腔部具有近端、近端区域以及近端开口。管腔可以在近端与远端之间延伸。导管可以还包括近端延伸部，该近端延伸部从与近端开口相邻的附接点向近端延伸。近端延伸部可以不如挠性远端管腔部挠性，并且可以被构造为控制导管的移动。近端延伸部可以在附接点处具有比远端管腔部在附接点处的外径小的外径。挠性远端管腔部的材料硬度可以向近端朝向越来越硬的材料过渡直到近端延伸部。挠性远端管腔部可以包括第二多个材料过渡。挠性细长主体可以同轴地定位在导管的管腔内，使得挠性细长主体的远尖端部向远端延伸超过导管的远端，使得挠性细长主体的第一多个材料过渡相对于挠性远端管腔部的第二多个材料过渡交错，并且不与该第二多个材料过渡重叠。The system may also include a catheter having a lumen and a distal end. The catheter may include a flexible distal lumen portion having a proximal end, a proximal region, and a proximal opening. The lumen may extend between the proximal end and the distal end. The catheter may also include a proximal extension extending proximally from an attachment point adjacent to the proximal opening. The proximal extension may be less flexible than the flexible distal lumen portion and may be configured to control movement of the catheter. The proximal extension may have an outer diameter at the attachment point that is smaller than the outer diameter of the distal lumen portion at the attachment point. The material hardness of the flexible distal lumen portion may transition toward an increasingly harder material toward the proximal end until the proximal extension. The flexible distal lumen portion may include a second plurality of material transitions. The flexible, slender body can be coaxially positioned within the lumen of the catheter such that the distal tip portion of the flexible, slender body extends distally beyond the distal end of the catheter such that the first plurality of material transitions of the flexible, slender body are staggered relative to and do not overlap with the second plurality of material transitions of the flexible distal lumen portion.
导管可以用同轴地定位在导管的管腔内的装置包裹，使得挠性细长主体的近端部用导管的近端延伸部锁定。导管的近端延伸部的至少一部分可以为颜色编码的。The catheter may be wrapped with a device coaxially positioned within the lumen of the catheter such that the proximal end of the flexible elongate body is locked with the proximal extension of the catheter.At least a portion of the proximal extension of the catheter may be color coded.
挠性细长主体的单个管腔可以被定尺为容纳导丝。挠性细长主体可以包括被定尺为容纳导丝的近端开口。近端开口可以位于挠性细长主体的近端区域中。近端开口可以穿过挠性细长主体的侧壁，并且位于向耦接到近端区域的近端部的远端的一距离。距离可以为离远尖端部大约10cm至离远尖端部大约20cm。近端部可以具有比挠性细长主体的外径小的外径。近端部可以是海波管。装置可以被构造为在导管的远端在颈内动脉的岩部的远端之后，连同导管一起前进。The single lumen of the flexible, slender body can be sized to accommodate a guidewire. The flexible, slender body can include a proximal opening sized to accommodate a guidewire. The proximal opening can be located in the proximal region of the flexible, slender body. The proximal opening can pass through the sidewall of the flexible, slender body and be located at a distance distal to the proximal portion coupled to the proximal region. The distance can be approximately 10 cm from the distal tip to approximately 20 cm from the distal tip. The proximal portion can have an outer diameter that is smaller than the outer diameter of the flexible, slender body. The proximal portion can be a hypotube. The device can be configured to advance along with the catheter after the distal end of the catheter is distal to the petrous portion of the internal carotid artery.
在相关方面中，公开了一种在患者的脑血管中执行医疗过程的方法，方法包括以下步骤：将已组装同轴导管系统插入到患者的血管中。已组装同轴导管系统包括导管和导管前进元件。导管包括：挠性远端管腔部，该挠性远端管腔部具有近端、近端区域、近端开口、远端、以及在近端与远端之间延伸的管腔；和近端延伸部，该近端延伸部从与近端开口相邻的附接点向近端延伸。近端延伸部不如挠性远端管腔部挠性，并且被构造为控制导管的移动。近端延伸部在附接点处具有比远端管腔部在附接点处的外径小的外径。导管前进元件包括：挠性细长主体，该挠性细长主体具有近端区域、外径、锥形远尖端部、远端开口以及纵向延伸穿过挠性细长主体到远端开口的单个管腔；和近端部，该近端部从近端区域向近端延伸到导管前进元件的最近端。在组装时，导管前进元件延伸穿过导管管腔，并且锥形远尖端部向远端管腔部的远端的远端延伸。方法还包括以下步骤：使已组装导管系统前进，直到远端管腔部的远端到达脑血管内的目标部位，并且远端管腔部与近端延伸部之间的附接点定位在主动脉弓中的头臂动脉引出点的近端。方法还包括以下步骤：从导管的管腔去除导管前进元件；以及在向导管的管腔施加负压的同时去除闭塞材料。In a related aspect, a method for performing a medical procedure in a cerebral blood vessel of a patient is disclosed, the method comprising the steps of inserting an assembled coaxial catheter system into the patient's blood vessel. The assembled coaxial catheter system includes a catheter and a catheter advancement element. The catheter includes: a flexible distal lumen portion having a proximal end, a proximal region, a proximal opening, a distal end, and a lumen extending between the proximal end and the distal end; and a proximal extension portion extending proximally from an attachment point adjacent to the proximal opening. The proximal extension portion is less flexible than the flexible distal lumen portion and is configured to control movement of the catheter. The proximal extension portion has an outer diameter at the attachment point that is smaller than an outer diameter of the distal lumen portion at the attachment point. The catheter advancing element comprises: a flexible, elongated body having a proximal region, an outer diameter, a tapered distal tip, a distal opening, and a single lumen extending longitudinally through the flexible, elongated body to the distal opening; and a proximal portion extending proximally from the proximal region to a proximal-most end of the catheter advancing element. When assembled, the catheter advancing element extends through the catheter lumen and the tapered distal tip extends distal to the distal end of the distal lumen portion. The method further comprises the steps of advancing the assembled catheter system until the distal end of the distal lumen portion reaches a target site within a cerebral vessel and the point of attachment between the distal lumen portion and the proximal extension is positioned proximal to a brachiocephalic artery exit point in the aortic arch. The method further comprises the steps of removing the catheter advancing element from the lumen of the catheter; and removing the occlusive material while applying negative pressure to the lumen of the catheter.
在附接点定位在主动脉弓内的头臂动脉引出点的近端时，远端管腔部的远端可以定位在颈动脉虹吸部的远端。远端管腔部可以具有在35cm和60cm之间的长度。导管前进元件的近端部可以在附接点处耦接到挠性细长主体的近端区域，近端部从附接点向近端延伸到导管前进元件的最近端。近端部可以具有延伸穿过近端部的整个长度的单个管腔，该近端部与细长主体的单个管腔连通。细长主体可以具有长度，该长度足以允许细长主体与近端部之间的附接点在与导管组装时保持在主动脉弓内或主动脉弓的近端。导管的远端可以被定位在脑血管内的目标部位附近。When the attachment point is positioned proximal to the brachiocephalic artery exit point within the aortic arch, the distal end of the distal lumen portion can be positioned distal to the carotid siphon portion. The distal lumen portion can have a length between 35 cm and 60 cm. The proximal portion of the catheter advancing element can be coupled to the proximal region of the flexible, slender body at the attachment point, with the proximal portion extending proximally from the attachment point to the most proximal end of the catheter advancing element. The proximal portion can have a single lumen extending through the entire length of the proximal portion, which is connected to the single lumen of the slender body. The slender body can have a length sufficient to allow the attachment point between the slender body and the proximal portion to remain within the aortic arch or proximal to the aortic arch when assembled with the catheter. The distal end of the catheter can be positioned near the target site within the cerebral blood vessels.
已组装导管系统可以用导管前进元件预包裹，该导管前进元件同轴地定位在远端管腔部的管腔内，使得挠性细长主体的近端部用导管的近端延伸部锁定。导管的近端延伸部的至少一部分可以为颜色编码的。挠性细长主体的单个管腔可以被定尺为容纳导丝。挠性细长主体可以包括被定尺为容纳导丝的近端开口。近端开口可以位于挠性细长主体的近端区域中。近端开口可以穿过挠性细长主体的侧壁，并且可以位于向耦接到近端区域的近端部的远端的一距离。距离可以为离远尖端部大约10cm至离远尖端部大约20cm。挠性细长主体的硬度可以向近端朝向越来越硬的材料过渡直到近端部，形成第一多个材料过渡。挠性细长主体的至少一部分可以由包括增强层的多个层形成。增强层可以是织带。织带可以从挠性细长主体的近端区域延伸，并且在远尖端部的近端的点处终止。点可以位于离挠性细长主体的最远终点4cm和15cm之间。多个层可以还包括第一聚合物材料层和第二聚合物材料层。织带可以定位在第一聚合物材料层与第二聚合物材料层之间。近端部可以是具有耦接到挠性细长主体的远端的海波管。定位在第一聚合物材料层与第二聚合物材料层之间的织带定位在海波管的远端上方。The assembled catheter system can be pre-wrapped with a catheter advancing element coaxially positioned within the lumen of the distal lumen portion, locking the proximal end of the flexible, slender body with the proximal extension of the catheter. At least a portion of the proximal extension of the catheter can be color-coded. The single lumen of the flexible, slender body can be sized to accommodate a guidewire. The flexible, slender body can include a proximal opening sized to accommodate a guidewire. The proximal opening can be located in the proximal region of the flexible, slender body. The proximal opening can pass through a sidewall of the flexible, slender body and can be located a distance distal to the proximal end coupled to the proximal region. The distance can be approximately 10 cm from the distal tip to approximately 20 cm from the distal tip. The hardness of the flexible, slender body can transition toward increasingly harder materials proximally until the proximal end, forming a first plurality of material transitions. At least a portion of the flexible, slender body can be formed from multiple layers, including a reinforcement layer. The reinforcement layer can be a webbing. The webbing can extend from the proximal region of the flexible, slender body and terminate at a point proximal to the distal end of the distal tip. The point may be located between 4 cm and 15 cm from the farthest end of the flexible elongated body. The plurality of layers may further include a first polymer material layer and a second polymer material layer. The webbing may be positioned between the first polymer material layer and the second polymer material layer. The proximal end may be a hypotube having a distal end coupled to the flexible elongated body. The webbing positioned between the first polymer material layer and the second polymer material layer is positioned above the distal end of the hypotube.
远尖端部可以包括具有不超过35D的材料硬度的材料。细长主体的近端区域可以包括具有在55D至72D之间的材料硬度的材料。细长主体可以包括第一段，该第一段包括具有不超过35D的硬度的远尖端部。细长主体可以包括第二段，该第二段位于具有不超过55D的硬度的第一段的近端。细长主体可以包括第三段，该第三段位于具有不超过72D的硬度的第二段的近端。近端部可以在第三段内耦接到细长主体。第一段可以未增强，并且第三段可以增强。第二段可以至少部分增强。增强织带可以延伸穿过至少第三段。第一段、第二段以及第三段可以组合，以形成细长主体的插入长度。第一段可以具有大约4cm到大约12.5cm的长度。第二段可以具有大约5cm到大约8cm的长度。第三段可以具有大约25cm到大约35cm的长度。挠性远端管腔部的材料硬度可以向近端朝向越来越硬的材料过渡直到近端延伸部。挠性远端管腔部可以包括第二多个材料过渡。挠性细长主体可以同轴地定位在导管的管腔内，使得挠性细长主体的远尖端部向远端延伸超过导管的远端，使得挠性细长主体的第一多个材料过渡相对于挠性远端管腔部的第二多个材料过渡交错，并且不与该第二多个材料过渡重叠。The distal tip portion may be comprised of a material having a hardness no greater than 35D. The proximal region of the elongated body may be comprised of a material having a hardness between 55D and 72D. The elongated body may include a first section comprising a distal tip portion having a hardness no greater than 35D. The elongated body may include a second section located proximal to the first section having a hardness no greater than 55D. The elongated body may include a third section located proximal to the second section having a hardness no greater than 72D. The proximal portion may be coupled to the elongated body within the third section. The first section may be unreinforced, and the third section may be reinforced. The second section may be at least partially reinforced. A reinforcing webbing may extend through at least the third section. The first, second, and third sections may be combined to form the insertion length of the elongated body. The first section may have a length of approximately 4 cm to approximately 12.5 cm. The second section may have a length of approximately 5 cm to approximately 8 cm. The third section may have a length of approximately 25 cm to approximately 35 cm. The hardness of the material of the flexible distal lumen portion may transition toward increasingly harder material toward the proximal extension. The flexible distal lumen portion may include a second plurality of material transitions. The flexible elongated body may be coaxially positioned within the lumen of the catheter such that the distal tip portion of the flexible elongated body extends distally beyond the distal end of the catheter, such that the first plurality of material transitions of the flexible elongated body are staggered relative to and do not overlap with the second plurality of material transitions of the flexible distal lumen portion.
在相关方面中，描述了一种在患者的脑血管中执行医疗过程的方法，方法包括以下步骤：将导鞘插入到血管中。导鞘包括在导鞘的近端区域与远端区域之间延伸的管腔，导鞘的远端区域具有与导鞘的管腔连通的开口。方法包括以下步骤：定位导鞘，使得导鞘的远端区域定位到至少颈总动脉的层面内。方法包括以下步骤：将中间导管插入穿过导鞘的管腔。中间导管包括管腔和在中间导管的远端处的远端开口。方法包括以下步骤：使中间导管前进，使得中间导管的远端前进穿过导鞘的开口并超过导鞘的远端区域。方法包括以下步骤：将远端进入导管插入穿过中间导管的管腔。远端进入导管包括：挠性远端管腔部，该挠性远端管腔部具有近端、近端区域、近端开口、远端、以及在近端与远端之间延伸的管腔；和近端延伸部，该近端延伸部从与近端开口相邻的附接点向近端延伸。近端延伸部不如挠性远端管腔部挠性，并且被构造为控制导管的移动。近端延伸部在附接点处具有比挠性远端管腔部在附接点处的外径小的外径。方法还包括以下步骤：使远端进入导管前进，使得挠性远端管腔部的远端前进穿过中间导管的远端开口并超过中间导管的远端。In a related aspect, a method for performing a medical procedure in a cerebral blood vessel of a patient is described, the method comprising the steps of inserting a guide sheath into the blood vessel. The guide sheath includes a lumen extending between a proximal region and a distal region of the guide sheath, the distal region of the guide sheath having an opening in communication with the lumen of the guide sheath. The method comprises the steps of positioning the guide sheath so that the distal region of the guide sheath is positioned within the plane of at least the common carotid artery. The method comprises the steps of inserting an intermediate catheter through the lumen of the guide sheath. The intermediate catheter includes a lumen and a distal opening at a distal end of the intermediate catheter. The method comprises the steps of advancing the intermediate catheter so that the distal end of the intermediate catheter advances through the opening of the guide sheath and beyond the distal region of the guide sheath. The method comprises the steps of inserting a distal access catheter through the lumen of the intermediate catheter. The distal access catheter comprises: a flexible distal lumen portion having a proximal end, a proximal region, a proximal opening, a distal end, and a lumen extending between the proximal and distal ends; and a proximal extension extending proximally from an attachment point adjacent to the proximal opening. The proximal extension is less flexible than the flexible distal lumen portion and is configured to control movement of the catheter. The proximal extension has an outer diameter at the attachment point that is smaller than the outer diameter of the flexible distal lumen portion at the attachment point. The method further comprises the steps of advancing the distal access catheter so that the distal end of the flexible distal lumen portion advances through the distal opening of the intermediate catheter and beyond the distal end of the intermediate catheter.
导鞘的远端区域可以包括可膨胀闭塞球囊。方法可以还包括以下步骤：使闭塞球囊膨胀，以闭塞穿过颈总动脉的顺行流动。导鞘的远端区域可以具有无衬里的、未增强区域，该区域被构造为密封到中间导管的外表面上。在前进步骤之前，远端进入导管可以与导管前进元件组装，形成已组装同轴导管系统。导管前进元件包括：挠性细长主体，该挠性细长主体具有近端区域、外径、锥形远尖端部、远端开口以及纵向延伸穿过挠性细长主体到远端开口的单个管腔；和近端部，该近端部从近端区域向近端延伸到导管前进元件的最近端。The distal region of the guide sheath may include an inflatable occlusion balloon. The method may further include the steps of inflating the occlusion balloon to occlude antegrade flow through the common carotid artery. The distal region of the guide sheath may have an unlined, unreinforced region that is configured to seal to the outer surface of the intermediate catheter. Prior to the advancing step, the distal access catheter may be assembled with a catheter advancing element to form an assembled coaxial catheter system. The catheter advancing element includes: a flexible, elongated body having a proximal region, an outer diameter, a tapered distal tip, a distal opening, and a single lumen extending longitudinally through the flexible, elongated body to the distal opening; and a proximal portion extending proximally from the proximal region to a proximal-most end of the catheter advancing element.
在组装时，导管前进元件可以延伸穿过远端管腔部的管腔，并且锥形远尖端部可以向远端管腔部的远端的远端延伸。方法可以还包括以下步骤：使已组装同轴导管系统前进，直到远端管腔部的远端到达脑血管内的目标部位，并且远端管腔部与近端延伸部之间的附接点定位在主动脉弓中的头臂动脉引出点的近端。方法可以还包括以下步骤：从导管的管腔去除导管前进元件；以及在向导管的管腔施加负压的同时去除闭塞材料。When assembled, the catheter advancing element can extend through the lumen of the distal lumen portion and the tapered distal tip can extend distal to the distal end of the distal lumen portion. The method can further include the steps of advancing the assembled coaxial catheter system until the distal end of the distal lumen portion reaches the target site within the cerebral blood vessel and the attachment point between the distal lumen portion and the proximal extension portion is positioned proximal to the brachiocephalic artery exit point in the aortic arch. The method can further include the steps of removing the catheter advancing element from the lumen of the catheter; and removing the occlusive material while applying negative pressure to the lumen of the catheter.
已组装导管系统可以用导管前进元件预包裹，该导管前进元件同轴地定位在远端管腔部的管腔内，使得挠性细长主体的近端部用导管的近端延伸部锁定。中间导管和远端进入导管中的至少一个可以还包括突片，以防止导管相对于所述导管延伸穿过的管腔的过度插入。中间导管和远端进入导管中的至少一个可以还包括可区分颜色编码的元件。挠性细长主体的单个管腔可以被定尺为容纳导丝。挠性细长主体可以包括被定尺为容纳导丝的近端开口。近端开口可以位于挠性细长主体的近端区域中。近端开口可以穿过挠性细长主体的侧壁，并且可以位于向耦接到近端区域的近端部的远端的一距离。距离可以为离远尖端部大约10cm至离远尖端部大约20cm。The assembled catheter system can be pre-wrapped with a catheter advancing element that is coaxially positioned within the lumen of the distal lumen portion so that the proximal portion of the flexible, slender body is locked with the proximal extension of the catheter. At least one of the intermediate catheter and the distal entry catheter may also include a tab to prevent excessive insertion of the catheter relative to the lumen through which the catheter extends. At least one of the intermediate catheter and the distal entry catheter may also include elements with distinguishable color coding. The single lumen of the flexible, slender body can be sized to accommodate a guidewire. The flexible, slender body can include a proximal opening sized to accommodate a guidewire. The proximal opening can be located in the proximal region of the flexible, slender body. The proximal opening can pass through the sidewall of the flexible, slender body and can be located at a distance to the distal end of the proximal portion coupled to the proximal region. The distance can be approximately 10 cm from the distal tip to approximately 20 cm from the distal tip.
在前进步骤之前，中间导管可以与导管前进元件组装，形成已组装同轴导管系统。导管前进元件可以包括：挠性细长主体，该挠性细长主体具有近端区域、外径、锥形远尖端部、远端开口以及纵向延伸穿过挠性细长主体到远端开口的单个管腔；和近端部，该近端部从近端区域向近端延伸到导管前进元件的最近端。在组装时，导管前进元件可以延伸穿过中间导管的管腔，并且锥形远尖端部可以向中间导管的远端的远端延伸。中间导管可以包括挠性远端管腔部和近端延伸部，该近端延伸部从与挠性远端管腔部中的近端开口相邻的附接点向近端延伸。近端延伸部可以不如中间导管的挠性远端管腔部挠性，并且具有比近端细长主体的外径小的外径。Prior to the advancement step, the intermediate catheter can be assembled with the catheter advancement element to form an assembled coaxial catheter system. The catheter advancement element may include: a flexible, slender body having a proximal region, an outer diameter, a tapered distal tip, a distal opening, and a single lumen extending longitudinally through the flexible, slender body to the distal opening; and a proximal portion extending proximally from the proximal region to the nearest end of the catheter advancement element. When assembled, the catheter advancement element can extend through the lumen of the intermediate catheter, and the tapered distal tip can extend distally of the distal end of the intermediate catheter. The intermediate catheter may include a flexible distal lumen portion and a proximal extension portion extending proximally from an attachment point adjacent to the proximal opening in the flexible distal lumen portion. The proximal extension portion may be less flexible than the flexible distal lumen portion of the intermediate catheter and have an outer diameter that is smaller than the outer diameter of the proximal elongated body.
在一些变型例中，以下内容中的一个或更多个可以可选地以任意可行的组合包括在上述方法、设备、装置以及系统中。附图和以下描述中阐述了装置、系统以及方法的更多细节。其他特征和优点将从描述和附图清楚。In some variations, one or more of the following may be optionally included in any feasible combination in the above methods, devices, apparatuses, and systems. Further details of the apparatuses, systems, and methods are set forth in the accompanying drawings and the following description. Other features and advantages will be apparent from the description and drawings.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
现在将参照以下附图详细地描述这些和其他方面。一般而言，附图绝对来讲或比较地不是等比例，而是旨在为例示性的。而且，可以为了例示清楚的目的而修改特征和元件的相对放置。These and other aspects will now be described in detail with reference to the following drawings. In general, the drawings are not to scale, absolutely or comparatively, but are intended to be illustrative. Furthermore, the relative placement of features and elements may be modified for purposes of illustration and clarity.
图1A至图1B例示了颈内动脉末端直到脑血管的过程；Figures 1A and 1B illustrate the course of the internal carotid artery from its distal end to the cerebral vessels;
图1C例示了来自主动脉弓的头臂动脉引出点的位置；Figure 1C illustrates the location of the brachiocephalic artery exit point from the aortic arch;
图2A是抽吸导管系统的实施方案的分解图；FIG2A is an exploded view of an embodiment of an aspiration catheter system;
图2B是图2A的系统的组装图；FIG2B is an assembled diagram of the system of FIG2A ;
图2C是在圆C-C处截取的图2A的详细图；FIG2C is a detailed view of FIG2A taken at circle C-C;
图2D例示了具有远端闭塞球囊的动脉进入装置的实施方案；FIG2D illustrates an embodiment of an arterial access device with a distal occlusion balloon;
图3是导管的实施方案的侧视图；FIG3 is a side view of an embodiment of a catheter;
图4A是导管的近端延伸部的第一实施方案的剖面图；FIG4A is a cross-sectional view of a first embodiment of a proximal extension of a catheter;
图4B是导管的近端延伸部的另一个实施方案的剖面图；FIG4B is a cross-sectional view of another embodiment of a proximal extension of a catheter;
图4C是在进入鞘的工作管腔内的图4A的近端延伸部的剖面图；FIG4C is a cross-sectional view of the proximal extension of FIG4A within the working lumen of the access sheath;
图4D是在进入鞘的工作管腔内的图4B的近端延伸部的剖面图，进入鞘具有延伸穿过其的导管前进元件；4D is a cross-sectional view of the proximal extension of FIG. 4B within the working lumen of an access sheath having a catheter advancing element extending therethrough;
图4E是比较在图4D的进入鞘的工作管腔内的图4A的近端延伸部与图4B的近端延伸部的表面积的剖面示意图；4E is a cross-sectional schematic diagram comparing the surface areas of the proximal extension of FIG. 4A and the proximal extension of FIG. 4B within the working lumen of the access sheath of FIG. 4D ;
图4F至图4G是相对于进入鞘的工作管腔分别比较梯形和D形近端延伸部的剖面示意图；4F to 4G are schematic cross-sectional views comparing trapezoidal and D-shaped proximal extensions, respectively, relative to the working lumen of the access sheath;
图5A是导管的实施方案的侧视图；FIG5A is a side view of an embodiment of a catheter;
图5B是图5A的导管的顶部平面图；FIG5B is a top plan view of the catheter of FIG5A;
图5C是沿着图5B的线C-C截取的导管的剖面图；FIG5C is a cross-sectional view of the catheter taken along line C-C of FIG5B ;
图5D是沿着图5B的线D-D截取的导管的剖面图；FIG5D is a cross-sectional view of the catheter taken along line D-D of FIG5B ;
图5E至图5F是图5A的导管的部分立体图；5E to 5F are partial perspective views of the catheter of FIG. 5A ;
图6A是导管的实施方案的侧视图；FIG6A is a side view of an embodiment of a catheter;
图6B是图6A的导管的顶部平面图；FIG6B is a top plan view of the catheter of FIG6A ;
图6C是沿着图6B的线C-C截取的导管的剖面图；FIG6C is a cross-sectional view of the catheter taken along line C-C of FIG6B ;
图6D是沿着图6B的线D-D截取的导管的剖面图；FIG6D is a cross-sectional view of the catheter taken along line D-D of FIG6B ;
图6E至图6F是图6A的导管的部分立体图；6E to 6F are partial perspective views of the catheter of FIG. 6A ;
图7A是导管前进元件的实施方案的侧视图；FIG7A is a side view of an embodiment of a catheter advancement element;
图7B是图7A的导管前进元件的剖面图；FIG7B is a cross-sectional view of the catheter advancement element of FIG7A ;
图7C是沿着圆C-C截取的图7B的详细图；FIG7C is a detailed view of FIG7B taken along the circle C-C;
图7D是导管前进元件的另一个实施方案的侧视图；FIG7D is a side view of another embodiment of a catheter advancement element;
图7E是图7D的导管前进元件的近端部的实施方案的剖面图；FIG7E is a cross-sectional view of an embodiment of the proximal portion of the catheter advancement element of FIG7D ;
图7F至图7J是用于耦接到图7E所示的近端部的近端毂的实施方案的各种视图；7F to 7J are various views of an embodiment of a proximal hub for coupling to the proximal portion shown in FIG. 7E ;
图8A是导管的实施方案的侧视图；FIG8A is a side view of an embodiment of a catheter;
图8B是图8A的导管的远端区域的示意剖视图；FIG8B is a schematic cross-sectional view of the distal region of the catheter of FIG8A ;
图8C是图8A的导管的远端区域的示意性剖面图；FIG8C is a schematic cross-sectional view of the distal region of the catheter of FIG8A ;
图9A至图9C是近端延伸连接器的各种视图；9A to 9C are various views of the proximal extension connector;
图10A是导管前进元件的实施方案的示意剖面图；FIG10A is a schematic cross-sectional view of an embodiment of a catheter advancement element;
图10B是图10A的导管前进元件的远端区域的示意剖面图；FIG10B is a schematic cross-sectional view of the distal end region of the catheter advancement element of FIG10A;
图10C是图10A的导管前进元件的中间区域的示意剖面图；FIG10C is a schematic cross-sectional view of a middle region of the catheter advancement element of FIG10A;
图11是与例示了交错的材料过渡的导管前进元件的实施方案对齐的导管的实施方案的示意图；以及FIG11 is a schematic diagram of an embodiment of a catheter aligned with an embodiment of a catheter advancing element illustrating staggered material transitions; and
图12是撕开式盘耦合器。Figure 12 is a tear-away disc coupler.
应理解，附图仅是示例且不意指等比例。应理解，这里描述的装置可以包括不是必须在各附图中描绘的特征。It should be understood that the drawings are merely illustrations and are not intended to be true to scale. It should be understood that the devices described herein may include features that are not necessarily depicted in each of the drawings.
具体实施方式DETAILED DESCRIPTION
导航颈动脉解剖结构以便治疗脑动脉层面的各种神经血管病理(诸如急性缺血性中风(AIS))需要具有优秀挠性和可输送性的导管系统。颈内动脉(ICA)起源于C3和C4椎骨之间的椎间盘层面的颈总动脉(CCA)的分叉。如图1A所示，ICA的过程分为四个部分—颈部Cr、岩石Pt、海绵状Cv以及脑Cb部分。在前循环中，一致曲折的末端颈动脉被骨元件锁定到其位置中。颈部颈动脉Cr进入岩骨并被锁定到一组包在骨中的转弯中。海绵状颈动脉是通过静脉床(海绵窦)的动脉，并且在挠性的同时随着它由另一个骨元件离开海绵窦时被锁定，该另一个骨元件围绕并固定到颅腔中的入口。由于这些骨固定点，岩石和海绵状颈动脉(Pt和Cv)及上方在其曲折度上相对一致。颈动脉虹吸部CS是末端ICA的S形部分。颈动脉虹吸部CS起始于海绵状ICA的后弯，并在到大脑前动脉ACA和大脑中动脉MCA的ICA分叉处终止。眼动脉起源于脑ICA，其代表在进入前循环时的导管挂起的公共点。导管挂起的这些点可能显著增加恢复到大脑的血液灌注所需的时间量，这在AIS的治疗中是具有严重后果的缺点。Navigating the carotid anatomy to treat various neurovascular pathologies at the cerebral artery level, such as acute ischemic stroke (AIS), requires a catheter system with excellent flexibility and deliverability. The internal carotid artery (ICA) originates from the bifurcation of the common carotid artery (CCA) at the level of the intervertebral disc between the C3 and C4 vertebrae. As shown in Figure 1A, the course of the ICA is divided into four parts—the cervical Cr, the petrous Pt, the cavernous Cv, and the cerebral Cb. In the anterior circulation, the consistently tortuous terminal carotid arteries are locked into position by bone elements. The cervical carotid artery Cr enters the petrous bone and is locked into a set of turns encased in the bone. The cavernous carotid artery is an artery that passes through the venous bed (cavernous sinus) and is locked in while being flexible as it leaves the cavernous sinus by another bone element that surrounds and is fixed to the entrance in the cranial cavity. Due to these bone fixation points, the petrous and cavernous carotid arteries (Pt and Cv) and above are relatively consistent in their tortuosity. The carotid siphon CS is the S-shaped portion of the terminal ICA. The carotid siphon (CS) originates at the posterior bend of the cavernous ICA and terminates at the ICA bifurcation to the anterior cerebral artery (ACA) and the middle cerebral artery (MCA). The ophthalmic artery originates from the cerebral ICA, representing a common point of catheter hookup when entering the anterior circulation. These points of catheter hookup can significantly increase the amount of time required to restore blood perfusion to the brain, a drawback with serious consequences in the treatment of AIS.
随着年龄增长，大血管经常变大和变长。在近端和远端固定，颈内颈动脉经常随着年龄而变得曲折。颈总动脉CCA随着它由锁骨离开到颈部区域中而相对固定在胸腔中。颈外和颈内动脉EC A、ICA相对于颈总动脉CCA不固定，由此随着整个颈动脉系统的延长，它们随着年龄的增长而形成曲折。这可能使得它们伸长并形成扭结和曲折，或者在最坏的情况下，形成完整的环或所谓的“颈环”。如果用于横跨这些扭结或弯曲区域的导管太过刚性或不可弯曲，则这些区域可能经受可能使得血管缠绕的拉直或引起血管的集中扭结和折叠的“理发店杆(barbershop pole)”。这些种类的极端曲折性也可能显著增加恢复到大脑的血液灌注所需的时间量，特别是在老年人口方面。在某些情况下，血管在自身上的扭转或者如果未扭曲的动脉扭结，则正常的顺行流动可能会减少到静止，这产生缺血。管理诸如颈部ICA的血管的去扭结或去环也可能增加执行手术所耗费的时间。As we age, the great blood vessels often become larger and longer. While fixed at the proximal and distal ends, the internal carotid artery often becomes tortuous with age. The common carotid artery (CCA) is relatively fixed in the thoracic cavity as it exits from the clavicle into the neck region. The external and internal carotid arteries (ECA, ICA) are not fixed relative to the common carotid artery (CCA), and thus, as the entire carotid system lengthens, they develop tortuosity with age. This may cause them to stretch and form kinks and tortuosity, or in the worst case, form a complete loop or so-called "neck loop." If the catheter used to cross these kinked or tortuous areas is too rigid or inflexible, these areas may be subjected to straightening that may cause the vessels to become entangled or to form a "barbershop pole" that causes concentrated kinking and folding of the vessels. These types of extreme tortuosity may also significantly increase the amount of time required to restore blood perfusion to the brain, particularly in the elderly population. In some cases, the vessel twists on itself or if an untwisted artery kinks, normal antegrade flow may be reduced to a standstill, which produces ischemia. Managing dekinking or delooping of vessels such as the cervical ICA may also increase the time it takes to perform the procedure.
用于中风干预手术的当前导管系统的一个主要缺点是恢复到大脑的血液灌注所需的时间量，包括进入大脑动脉中的闭塞部位所耗费的时间以及完全去除动脉中的闭塞所耗费的时间。因为经常是以下情况：必须进行多于一次尝试来完全去除闭塞，所以减少尝试次数以及减少为了另外尝试而交换装置所需的时间是最小化总时间的重要因素。另外，由于脆弱脑血管中的装置前进，各尝试与潜在的手术风险关联。另一个限制是需要多个操作者来输送并有效地操纵具有多个RHV的长三轴系统，这些RHV通常与传统引导和远端进入导管一起使用。A major drawback of current catheter systems used for stroke intervention procedures is the amount of time required to restore blood perfusion to the brain, including the time it takes to access the occluded site in the cerebral artery and the time it takes to completely remove the occlusion in the artery. Because it is often the case that more than one attempt must be made to completely remove the occlusion, reducing the number of attempts and reducing the time required to exchange devices for additional attempts are important factors in minimizing the overall time. In addition, each attempt is associated with potential surgical risks due to device advancement in fragile cerebral vessels. Another limitation is the need for multiple operators to deliver and effectively manipulate the long triaxial systems with multiple RHVs that are typically used with traditional guide and distal access catheters.
这里描述了用于治疗各种神经血管病理(诸如急性缺血性中风(AIS))的导管系统。这里描述的系统提供到远端目标解剖结构的快速且简单的单操作者进入，特别是在单个操纵点处的脑血管的曲折解剖结构。这里描述的医疗方法、装置以及系统允许导航复杂的曲折解剖结构，以执行快速且安全的脑闭塞的抽吸和去除，以便治疗急性缺血性中风。这里描述的医疗方法、装置以及系统还可以用于输送颅内医疗装置，它们具有或不具有用于在急性缺血性中风的治疗中去除脑闭塞的抽吸。这里描述的系统对于AIS的治疗可以特别有用，无论用户是打算单独执行支架收回器输送，单独执行抽吸，还是将抽吸和支架收回器输送的组合作为AIS的一线治疗。进一步地，这里描述的远端进入导管系统的极度挠性和可输送性允许导管采取曲折解剖结构的形状，而不是施加产生新的解剖结构的拉直力。这里描述的远端进入导管系统可以穿过曲折环，同时维持内部的解剖结构的自然曲线，这降低血管拉直的风险。从而，这里描述的远端进入导管系统可以产生穿过神经血管的安全管道，这维持解剖结构的自然曲折度，以便其他导管穿过(例如介入装置输送导管)。穿过管道的导管不需要具有相同程度的挠性和可输送性，使得如果它们被直接输送到相同的解剖结构而不是穿过管道，则将导致前循环的拉直、扭结或折叠。Described herein are catheter systems for treating various neurovascular pathologies, such as acute ischemic stroke (AIS). The systems described herein provide rapid and simple single-operator access to distal target anatomical structures, particularly the tortuous anatomy of cerebral vessels at a single manipulation point. The medical methods, devices, and systems described herein allow navigation through complex tortuous anatomy to perform rapid and safe aspiration and removal of brain occlusions for the treatment of acute ischemic stroke. The medical methods, devices, and systems described herein can also be used to deliver intracranial medical devices, with or without aspiration, for the removal of brain occlusions in the treatment of acute ischemic stroke. The systems described herein can be particularly useful for the treatment of AIS, regardless of whether the user intends to perform stent retriever delivery alone, aspiration alone, or a combination of aspiration and stent retriever delivery as a first-line treatment for AIS. Furthermore, the extreme flexibility and deliverability of the distal access catheter systems described herein allow the catheter to assume the shape of tortuous anatomy, rather than applying a straightening force that creates a new anatomy. The distal access catheter systems described herein can traverse tortuous anatomy while maintaining the natural curves of the internal anatomy, which reduces the risk of vessel straightening. Thus, the distal access catheter system described herein can create a secure tract through the neurovascular system that maintains the natural tortuosity of the anatomy for passage of other catheters (e.g., interventional device delivery catheters). The catheters passed through the tract do not need to have the same degree of flexibility and deliverability such that if they were delivered directly to the same anatomical structure rather than through the tract, they would cause straightening, kinking, or folding of the anterior circulation.
应当理解，虽然这里特别是关于进入神经血管解剖结构或治疗装置的输送描述了一些实施方案，但这里描述的系统和方法不应限于此并且还可以适用于其他用途。例如，这里描述的导管系统可以用于将工作装置输送到冠状动脉解剖结构或其他血管解剖结构的目标血管。还应当理解，在这里中使用短语“抽吸导管”的情况下，这种导管还可以用于除了抽吸之外的其他目的，诸如将流体输送到治疗部位或者作为支撑导管或远端进入导管，该导管提供促进并引导其他装置(诸如导丝或介入装置，诸如支架收回器)的输送或交换的管道。备选地，这里描述的进入系统还可以用于进入血管外的身体的其他部分。类似地，在将工作装置描述为可扩张脑治疗装置、支架收回器或自扩张支架的情况下，可以使用这里描述的输送系统来输送其他介入装置。It should be understood that although some embodiments are described herein with particular reference to delivery of access to neurovascular anatomy or therapeutic devices, the systems and methods described herein should not be limited thereto and may also be applicable to other uses. For example, the catheter system described herein can be used to deliver a working device to a target vessel of a coronary anatomy or other vascular anatomy. It should also be understood that where the phrase "suction catheter" is used herein, such a catheter may also be used for purposes other than suction, such as delivering fluid to a treatment site or as a support catheter or distal access catheter that provides a conduit to facilitate and guide the delivery or exchange of other devices (such as guidewires or interventional devices, such as stent retrievers). Alternatively, the access systems described herein may also be used to access other parts of the body outside of a blood vessel. Similarly, where the working device is described as an expandable brain treatment device, a stent retriever, or a self-expanding stent, the delivery system described herein may be used to deliver other interventional devices.
现在参照附图，图2A至图2B例示了系统100，该系统包括用于进入和去除脑闭塞以从进入部位治疗急性缺血性中风的装置。系统100可以是单个操作者系统，使得各个部件和系统可以由一个操作者使用最小的手移动一起输送和使用。如下面将更详细描述的，所有丝和导管操纵可以发生在单个旋转止血阀(RHV)434或在共位于同一装置中的多于单个RHV处或附近。系统100可包括导管200、导管前进元件300以及进入导鞘400中的一个或多个，下面将更详细地描述它们中的每一个。导管200被构造为借助导鞘400接收，并且被设计为具有优越的输送能力。导管200可以是与导鞘400的管腔同轴的旋转远端进入导管，从而在管道内提供内径的步进。导管200可以使用插入穿过导管200的管腔223的导管前进元件300来输送，形成导管输送系统150。系统100可以是远端进入系统，该系统可以产生从经皮动脉切开术(例如，股动脉)的进入点到远端导管的目标控制点的可变长度。用于中风介入的常规远端进入系统通常包括借助较短的“引入器”鞘(例如，长度为11-30cm)放置在腹股沟处的长导鞘或引导导管。长导鞘通常定位在ICA中，以支撑包括中风血栓切除术的神经血管介入。为了增加支持，这些元件可以一直前进到骨末端岩石，并且在可能时很少进入到海绵状或鞍突或床突上段末端d终端ICA。为了到达用于ADAPT/MAT或Solumbra/SMAT方法的M1或M2分布中的目标，借助长引导导管插入另外的导管。这些导管通常是大口径抽吸导管，它们在长度上可以是130cm或更长。如下面将更详细描述的，这里描述的远端进入系统100可以更短，例如，在长度上仅为115cm。另外，单个操作者可以通过将这里描述的系统插入穿过导鞘400上的单个旋转止血阀(RHV)434或者共位于同一装置中的多于一个RHV(诸如双头RHV)来使用这里描述的系统。由此，曾经是双人手术的过程可以是一人手术。Referring now to the accompanying drawings, Figures 2A to 2B illustrate a system 100 comprising a device for accessing and removing a cerebral occlusion to treat acute ischemic stroke from an access site. The system 100 can be a single operator system such that the various components and systems can be transported and used together by one operator using minimal hand movement. As will be described in more detail below, all wire and catheter manipulations can occur at or near a single rotary hemostasis valve (RHV) 434 or at more than a single RHV co-located in the same device. The system 100 can include one or more of a catheter 200, a catheter advancement element 300, and an entry guide sheath 400, each of which will be described in more detail below. The catheter 200 is constructed to be received with the aid of the guide sheath 400 and is designed to have superior delivery capabilities. The catheter 200 can be a rotary distal entry catheter coaxial with the lumen of the guide sheath 400, thereby providing a step-up in the inner diameter within the conduit. The catheter 200 can be delivered using a catheter advancement element 300 inserted through the lumen 223 of the catheter 200, forming a catheter delivery system 150. The system 100 can be a distal access system that can produce variable lengths from the entry point of a percutaneous arteriotomy (e.g., the femoral artery) to the target control point of the distal catheter. Conventional distal access systems for stroke intervention typically include a long guide sheath or guide catheter placed in the groin with the aid of a shorter "introducer" sheath (e.g., 11-30 cm in length). Long guide sheaths are typically positioned in the ICA to support neurovascular interventions including stroke thrombectomy. For added support, these elements can be advanced all the way to the petrous end of the bone and, when possible, rarely into the cavernous or sellar or supraclinoid end of the terminal ICA. To reach targets in the M1 or M2 distribution for the ADAPT/MAT or Solumbra/SMAT approaches, additional catheters are inserted with the aid of long guide catheters. These catheters are typically large-bore aspiration catheters that can be 130 cm or longer in length. As will be described in more detail below, the distal access system 100 described herein can be shorter, for example, only 115 cm in length. In addition, a single operator can use the system described herein by inserting it through a single rotary hemostasis valve (RHV) 434 on an introducer sheath 400 or more than one RHV (such as a dual-ended RHV) co-located in the same device. Thus, a procedure that was once a two-person procedure can now be a one-person procedure.
现在将更详细地描述各种系统的各种部件中的各个。Each of the various components of the various systems will now be described in greater detail.
进入导鞘Entering the introducer sheath
再次参照图2A至图2D，远端进入系统100可以包括具有主体402的进入导鞘400，工作管腔从耦接到主体402的近端区域403的近端止血阀434延伸穿过主体402到远端区域的远端开口408。工作管腔被构造成接收穿过其的导管200，使得导管200的远端可以穿过远端开口408延伸超过鞘400的远端。导鞘400可以用于输送这里描述的导管以及领域中已知的各种工作装置中的任意一种。例如，工作装置可以被构造为提供血栓形成治疗，并且可以包括大口径导管、抽吸血栓切除术、高级导管、丝、球囊、可收回结构(诸如线圈尖端可收回支架“Stentriever”)。导鞘400与导管200组合可以用于施加远端抽吸，如下面将更详细描述的。2A to 2D , the distal access system 100 can include an access guide sheath 400 having a body 402 with a working lumen extending through the body 402 from a proximal hemostasis valve 434 coupled to a proximal region 403 of the body 402 to a distal opening 408 at the distal region. The working lumen is configured to receive a catheter 200 therethrough such that the distal end of the catheter 200 can extend beyond the distal end of the sheath 400 through the distal opening 408. The guide sheath 400 can be used to deliver any of the catheters described herein and various working devices known in the art. For example, the working device can be configured to provide thrombosis treatment and can include a large-bore catheter, a suction thrombectomy, an advanced catheter, a filament, a balloon, a retractable structure (such as a coil-tip retractable stent "Stentriever"). The guide sheath 400 in combination with the catheter 200 can be used to apply distal suction, as will be described in more detail below.
导鞘400可以是各种市售导鞘中的任意一种。例如，导鞘400可以具有0.087”-0.089”之间的ID，诸如Cook SHUTTLE 6F(印第安纳州布卢明顿库克医疗(Cook Medical)有限公司)、Terumo DESTINATION 6F(泰尔茂欧洲公司(Terumo Europe NV))、Cordis VISTABRITE TIP(佛罗里达州海厄利亚强生(Cordis)公司)以及Penumbra NEURON MAX 088(加利福尼亚州阿拉米达皮纳姆布勒(Penumbra)有限公司)、或类似的市售导鞘。通常，这里使用法兰西(F)标度来描述鞘尺寸。例如，在鞘被描述为6法兰西的情况下，应当理解，该鞘的内径能够接收具有6F外径的导管，该外径为大约1.98mm或0.078”。因此，应当理解的是，导管在这里可以被描述为具有法兰西的特定尺寸，以指代其内径接收另一导管的外径的兼容性。导管在这里还可以被描述为具有法兰西的特定尺寸，以指代其外径与具有特定内径的另一个导管兼容。The introducer sheath 400 can be any of a variety of commercially available introducer sheaths. For example, the introducer sheath 400 can have an ID between 0.087" and 0.089", such as the Cook SHUTTLE 6F (Cook Medical, Inc., Bloomington, Indiana), the Terumo DESTINATION 6F (Terumo Europe NV), the Cordis VISTABRITE TIP (Cordis, Inc., Hialeah, Florida), and the Penumbra NEURON MAX 088 (Penumbra, Inc., Alameda, California), or similar commercially available introducer sheaths. Generally, the French (F) scale is used herein to describe sheath size. For example, where a sheath is described as 6 French, it will be understood that the inner diameter of the sheath is capable of receiving a catheter having a 6 French outer diameter, which is approximately 1.98 mm or 0.078". Thus, it will be understood that a catheter may be described herein as having a particular size of French to refer to the compatibility of its inner diameter to receive the outer diameter of another catheter. A catheter may also be described herein as having a particular size of French to refer to its outer diameter being compatible with another catheter having a particular inner diameter.
再次参照图2A至图2D，导管主体402可以从近端区域403处的近侧分叉或旋转止血阀(RHV)434延伸到主体402的远端处的尖端406。近端RHV 434可以包括成型到连接器主体中的一个或多个管腔，以连接到导鞘400的主体402的工作管腔。如上所述，工作管腔可以接收导管200和/或用于输送到目标解剖结构的各种工作装置中的任意一种。RHV 434可由厚壁聚合物管或增强聚合物管构造。RHV 434允许借助导鞘400将装置引入到血管中，同时防止或最小化失血并防止空气引入到导鞘400中。RHV 434可与导鞘400一体，或者导鞘400可以在阴鲁尔接口(Luer)适配器的近端上终止，单独的止血阀部件(诸如被动密封阀、陶西-博斯特(Tuohy-Borst)阀或旋转止血阀)可以附接到该适配器。RHV 434可以具有可调节的开口，该开口开放的足够大，以允许去除在尖端上具有粘附凝块的装置，而不在去除期间使得凝块在RHV 434处位移。备选地，RHV 434可以是可去除的，诸如当从鞘400去除装置以防止RHV 434处的凝块位移的时候。RHV 434可以是双RHV。2A to 2D , the catheter body 402 can extend from a proximal bifurcation or rotary hemostasis valve (RHV) 434 at the proximal region 403 to a tip 406 at the distal end of the body 402. The proximal RHV 434 can include one or more lumens molded into the connector body to connect to the working lumen of the body 402 of the guide sheath 400. As described above, the working lumen can receive any of the various working devices for delivery to the target anatomical structure of the catheter 200 and/or the guide sheath 400. The RHV 434 can be constructed of a thick-walled polymer tube or a reinforced polymer tube. The RHV 434 allows the device to be introduced into the blood vessel with the aid of the guide sheath 400 while preventing or minimizing blood loss and preventing air from being introduced into the guide sheath 400. The RHV 434 can be integral with the introducer sheath 400, or the introducer sheath 400 can terminate on the proximal end of a female Luer adapter to which a separate hemostasis valve component (such as a passive sealing valve, a Tuohy-Borst valve, or a rotary hemostasis valve) can be attached. The RHV 434 can have an adjustable opening that is open sufficiently large to allow removal of a device with an adhered clot on the tip without displacing the clot at the RHV 434 during removal. Alternatively, the RHV 434 can be removable, such as when the device is removed from the sheath 400 to prevent displacement of a clot at the RHV 434. The RHV 434 can be a double RHV.
RHV 434可以在鞘400的近端403上形成Y形连接器，使得RHV 434的第一端口可以用于将工作导管插入到鞘400的工作管腔中，并且到臂412中的第二端口可以用于另一个目的。例如，注射器或其他装置可以经由连接器432连接在臂412处，以穿过主体402朝向尖端406和目标解剖结构中输送向前的滴注、用于对照物的冲洗线或盐水注射。臂412还可以连接到大口径抽吸线和抽吸源(未示出)，诸如注射器或泵，以借助工作管腔汲取抽吸。臂412还可以允许在手术期间用盐水或不透射线的对照物冲洗导鞘400。工作管腔可以从远端延伸到导管主体402的近端区域403的工作近端端口。RHV 434 can form a Y-shaped connector on the proximal end 403 of sheath 400 so that a first port of RHV 434 can be used to insert a working catheter into the working lumen of sheath 400, and a second port to arm 412 can be used for another purpose. For example, a syringe or other device can be connected to arm 412 via connector 432 to deliver a forward instillation, a flushing line for a contrast, or a saline injection through the body 402 toward the tip 406 and the target anatomical structure. Arm 412 can also be connected to a large-bore suction line and a suction source (not shown), such as a syringe or pump, to draw suction with the help of the working lumen. Arm 412 can also allow the guide sheath 400 to be flushed with saline or radiopaque contrast during surgery. The working lumen can extend from the distal end to the working proximal port of the proximal region 403 of the catheter body 402.
导管主体402的长度被构造为允许主体402的远尖端406定位为在颈内动脉(ICA)中例如离经股入路一样远，该经股入路具有在需要时提供调节的另外长度。在一些实施方案中(例如，股或径向经皮进入)，主体402的长度可以在80至90cm的范围内，但是应当理解，主体402的长度可以更长，例如，总共多达约100cm或多达约105cm或多达约117cm。在实施方案中，主体402长度适于到颈动脉分叉的经颈动脉入路，在20-25cm的范围内。在另外的实施方案中，主体402长度适于到CCA或近端ICA的经皮经颈动脉入路，并且在10-15cm的范围内。主体402被构造为假设并导航血管的弯曲，而不扭结、塌陷或引起血管创伤，甚至例如在经受高抽吸力时。The length of the catheter body 402 is configured to allow the distal tip 406 of the body 402 to be positioned in the internal carotid artery (ICA), for example, as far as a transfemoral approach, which has an additional length to provide adjustment when needed. In some embodiments (e.g., femoral or radial percutaneous access), the length of the body 402 can be in the range of 80 to 90 cm, but it should be understood that the length of the body 402 can be longer, for example, up to about 100 cm or up to about 105 cm or up to about 117 cm in total. In an embodiment, the body 402 length is suitable for a transcarotid approach to the carotid bifurcation, in the range of 20-25 cm. In another embodiment, the body 402 length is suitable for a percutaneous transcarotid approach to the CCA or proximal ICA, and in the range of 10-15 cm. The body 402 is configured to assume and navigate the bends of the blood vessel without kinking, collapsing, or causing vascular trauma, even when subjected to high suction forces.
导鞘400的尖端406可以具有与通向远端的主体402的段相同或相似的外径。因此，尖端406可以具有与穿过主体402的纵向轴线正交的远端面，并且远端面可以具有基本上等于主体402的横截面外尺寸的外径。在实施方案中，尖端406包括倒角、圆角或锥形，它使得远端面直径略小于主体402的横截面尺寸。在另外的实施方案中，尖端406可以是细长管状部分，该细长管状部分在具有均匀的外径的主体402的区域的远端延伸，使得细长管状部分与主体402的均匀外径相比具有减小的直径。由此，尖端406可以是细长的或可以更钝地成形。因此，尖端406可以被构造为平滑地跟踪穿过血管和/或随着它跟踪穿过血管而扩张血管限制。工作管腔可具有形成远端开口408的远端。The tip 406 of the guide sheath 400 can have an outer diameter that is the same or similar to the distal section of the body 402. Thus, the tip 406 can have a distal face that is orthogonal to the longitudinal axis passing through the body 402, and the distal face can have an outer diameter that is substantially equal to the outer cross-sectional dimension of the body 402. In an embodiment, the tip 406 includes a chamfer, a rounded corner, or a taper that causes the distal face diameter to be slightly smaller than the cross-sectional dimension of the body 402. In another embodiment, the tip 406 can be an elongated tubular portion that extends distally from a region of the body 402 having a uniform outer diameter, such that the elongated tubular portion has a reduced diameter compared to the uniform outer diameter of the body 402. Thus, the tip 406 can be elongated or can be more bluntly shaped. Thus, the tip 406 can be configured to smoothly track through a blood vessel and/or dilate a vascular restriction as it tracks through the vessel. The working lumen can have a distal end that forms a distal opening 408.
导鞘400可包括尖端406，该尖端406从主体402通往远端的段逐渐变细。即，主体402的外表面可以具有从较大尺寸减小到远端处的较小尺寸的直径。例如，尖端406可以从近似0.114”的外径至约0.035”或从约0.110”至约0.035”或从约0.106”至约0.035”逐渐变细。尖端406的锥形的角度可以取决于锥形尖端406的长度变化。例如，在一些实施方案中，尖端406在近似50mm的长度上从0.110”逐渐变细至0.035”。The guide sheath 400 may include a tip 406 that tapers from the section of the body 402 leading to the distal end. That is, the outer surface of the body 402 may have a diameter that decreases from a larger dimension to a smaller dimension at the distal end. For example, the tip 406 may taper from an outer diameter of approximately 0.114" to about 0.035", or from about 0.110" to about 0.035", or from about 0.106" to about 0.035". The angle of the taper of the tip 406 may vary depending on the length of the tapered tip 406. For example, in some embodiments, the tip 406 tapers from 0.110" to 0.035" over a length of approximately 50 mm.
在实施方案中，导鞘400包括一个或多个不透射线标记411。不透射线标记411可以布置在远尖端406附近。例如，一对不透射线的带可以被锻造、涂漆、嵌入或以其他方式布置在主体402中或上。在一些实施方案中，不透射线标记411包括钡聚合物、钨聚合物混合物、填充钨或填充铂的标记，该标记维持装置远端的挠性并改善沿着导鞘400的长度的过渡及其抗扭结性。在一些实施方案中，不透射线标记411是钨负载的PEBAX或聚氨酯，它被热焊接到主体402。标记411在图中被示出为围绕主体402的一个或多个区域的圆周的环。然而，标记411不需要是环，并且可以具有其他形状或者产生各种图案，这些图案为操作者提供与远端开口408在血管内的位置有关的定向。因此，操作者可以在荧光透视下可视化远端开口408的位置，以确认远端开口408指向将导管200要输送到的目标解剖结构。例如，不透射线标记411允许操作者在解剖学进入点(例如，患者的腹股沟)处旋转导鞘400的主体402，使得远端开口由随后的工作装置(例如，前进到ICA的导管和丝)提供到ICA的进入。在一些实施方案中，不透射线标记411包括铂、金、钽、钨或在X射线荧光镜下可见的任意其他物质。应当理解，这里描述的系统的各种部件中的任意一个可以并入如上所述的不透射线标记。In an embodiment, the introducer sheath 400 includes one or more radiopaque markers 411. The radiopaque markers 411 can be positioned near the distal tip 406. For example, a pair of radiopaque bands can be wrought, painted, embedded, or otherwise positioned in or on the body 402. In some embodiments, the radiopaque markers 411 comprise barium polymer, tungsten polymer blend, tungsten-filled, or platinum-filled markers that maintain flexibility at the distal end of the device and improve transition along the length of the introducer sheath 400 and its kink resistance. In some embodiments, the radiopaque markers 411 are tungsten-loaded PEBAX or polyurethane that are heat-welded to the body 402. The markers 411 are illustrated as rings circumferentially surrounding one or more regions of the body 402. However, the markers 411 need not be rings and can have other shapes or create various patterns that provide the operator with orientation regarding the location of the distal opening 408 within the blood vessel. Thus, the operator can visualize the position of the distal opening 408 under fluoroscopy to confirm that the distal opening 408 is pointing to the target anatomical structure to which the catheter 200 is to be delivered. For example, the radiopaque marker 411 allows the operator to rotate the body 402 of the guide sheath 400 at an anatomical entry point (e.g., the patient's groin) so that the distal opening provides access to the ICA by subsequent working devices (e.g., a catheter and wire that advances to the ICA). In some embodiments, the radiopaque marker 411 comprises platinum, gold, tantalum, tungsten, or any other substance visible under an X-ray fluoroscopy. It should be understood that any of the various components of the system described herein can incorporate a radiopaque marker as described above.
在一些实施方案中，导鞘400可以在扭结性、不透射线性、柱强度以及挠性方面具有与在颈动脉进入和AIS手术中使用的其他鞘类似的性能特性。内衬可以由低摩擦聚合物构造，诸如PTFE(聚四氟乙烯)或FEP(氟化乙烯丙烯)，以提供用于借助内管腔使装置前进的光滑表面。外护套材料可以为内衬提供机械完整性，并且可以由诸如PEBAX、热塑性聚氨酯、聚乙烯、尼龙等的材料构造。可以并入第三层，该第三层可以在内衬与外护套之间提供增强。增强层可以防止主体402的内管腔变平或扭结，以允许穿过血管中的弯曲的无阻碍装置导航以及抽吸或逆流。主体402可以圆周地增强。增强层可以由金属(诸如不锈钢、镍钛诺、镍钛诺织带、螺旋带、螺旋丝、切割不锈钢等)或刚性聚合物(诸如PEEK)制成。增强层可以是诸如线圈或织带的结构、或者是激光切割或机器切割以便挠性的管。在另一个实施方案中，增强层可以是切割的海波管，诸如镍钛诺海波管或切割的刚性聚合物等。主体402的外护套可由朝向远端的越来越柔软的材料形成。例如，主体402的近端区域可以由诸如尼龙的材料形成，主体402的在主体402的近端区域的远端的区域可以具有72D的硬度，而更远端的区域可以越来越挠性，并且由朝向远尖端406延伸的硬度为55D、45D、35D的材料形成，该远端406可由硬度不超过35D并且在一些实施方案中软于35D的材料形成。主体402可包括亲水涂层。In some embodiments, the guide sheath 400 can have performance characteristics similar to other sheaths used in carotid artery access and AIS surgery in terms of kink resistance, radiopacity, column strength, and flexibility. The liner can be constructed of a low-friction polymer, such as PTFE (polytetrafluoroethylene) or FEP (fluorinated ethylene propylene), to provide a smooth surface for advancing the device with the aid of the inner lumen. The outer sheath material can provide mechanical integrity for the liner and can be constructed of materials such as PEBAX, thermoplastic polyurethane, polyethylene, nylon, etc. A third layer can be incorporated that can provide reinforcement between the liner and the outer sheath. The reinforcement layer can prevent the inner lumen of the body 402 from flattening or kinking to allow unimpeded device navigation through the bends in the blood vessel and suction or reverse flow. The body 402 can be circumferentially reinforced. The reinforcement layer can be made of metal (such as stainless steel, nitinol, nitinol webbing, spiral ribbon, spiral wire, cut stainless steel, etc.) or a rigid polymer (such as PEEK). The reinforcement layer can be a structure such as a coil or webbing, or a tube that is laser cut or machine cut for flexibility. In another embodiment, the reinforcement layer can be a cut hypotube, such as a nitinol hypotube or a cut rigid polymer, etc. The outer sheath of the body 402 can be formed of a material that becomes increasingly softer towards the distal end. For example, the proximal region of the body 402 can be formed of a material such as nylon, and the area of the body 402 distal to the proximal region of the body 402 can have a hardness of 72D, while the more distal areas can be increasingly flexible and formed of a material with a hardness of 55D, 45D, 35D extending toward the distal tip 406, which can be formed of a material with a hardness not exceeding 35D and, in some embodiments, softer than 35D. The body 402 may include a hydrophilic coating.
主体402的挠性可以在其长度上变化，朝向主体402的远端部分具有增加的挠性。挠性的可变性可以以各种方式来实现。例如，外护套可以在各种段处在硬度和/或材料上变化。与导鞘的其他段相比，较低硬度的外护套材料可以用在导鞘的远端段中。备选地，可以减小护套材料的壁厚，和/或可以改变增强层的密度，以提高挠性。例如，可以伸展线圈或织带的节距，或者可以改变管中的切割图案，以更挠性。备选地，增强结构或材料可以在细长主体402的长度上变化。在另一个实施方案中，在最远端挠性段与近端段之间存在过渡段，变化挠性的一个或多个段在最远端段与细长主体402的其余部分之间。在该实施方案中，最远端段为约2cm至约5cm，过渡段为约2cm至约10cm，并且近端段占据鞘长度的其余部分。The flexibility of the body 402 can vary over its length, with increasing flexibility toward the distal portion of the body 402. This variability in flexibility can be achieved in various ways. For example, the outer sheath can vary in hardness and/or material at various sections. A lower hardness outer sheath material can be used in the distal section of the guide sheath compared to other sections of the guide sheath. Alternatively, the wall thickness of the sheath material can be reduced, and/or the density of the reinforcement layer can be varied to increase flexibility. For example, the pitch of the coils or webbing can be stretched, or the cut pattern in the tube can be altered to provide greater flexibility. Alternatively, the reinforcement structure or material can vary over the length of the elongated body 402. In another embodiment, a transition section exists between the distal-most flexible section and the proximal section, with one or more sections of varying flexibility located between the distal-most section and the remainder of the elongated body 402. In this embodiment, the distal-most section is approximately 2 cm to approximately 5 cm, the transition section is approximately 2 cm to approximately 10 cm, and the proximal section occupies the remainder of the sheath length.
导鞘400的不同内径可用于接收不同外径导管200。在一些实施方案中，第一导鞘400的工作管腔可具有被定尺为接收6F导管的内径，并且第二导鞘400的工作管腔可具有被定尺为接收8F导管的内径。在一些实施方案中，导鞘400的远端区域可具有约0.087”至0.088”的内径。导鞘400可以接收导管，这些导管具有适于这些内径尺寸的外径。应当理解，导鞘400(以及与鞘400组合使用的各种部件中的任意一个)可以是丝上(OTW)或快速交换型装置，将在下面更详细地描述该装置。The different inner diameters of the guide sheaths 400 can be used to receive catheters 200 of different outer diameters. In some embodiments, the working lumen of the first guide sheath 400 can have an inner diameter sized to receive a 6F catheter, and the working lumen of the second guide sheath 400 can have an inner diameter sized to receive an 8F catheter. In some embodiments, the distal region of the guide sheath 400 can have an inner diameter of approximately 0.087" to 0.088". The guide sheath 400 can receive catheters having outer diameters appropriate for these inner diameter sizes. It should be understood that the guide sheath 400 (and any of the various components used in combination with the sheath 400) can be an over-the-wire (OTW) or rapid exchange device, which will be described in more detail below.
如上所述，鞘400可包括由大体三层形成的主体402，这三层包括润滑内衬、增强层以及外护套层。增强层可包括提供良好的可扭转性的织带，该织带可选地由线圈叠加，以提供良好的抗扭结性。在增强层仅为织带的鞘中，外护套层的聚合物通常可以具有较高的硬度且较厚，以避免扭结问题。仅用较厚聚合物编织的这种鞘的壁厚可为约0.011”。这里描述的具有带有线圈叠加的织带的鞘400的壁厚提供了可扭转性和抗扭结性这两者，并且可以具有通常较薄的壁，例如，大约0.0085”的壁厚。从而，近端外径可以减小到约0.107”外径。由此，鞘400是高性能鞘400，该鞘具有良好的扭矩和抗扭结性，较薄的壁为系统提供整体较低的轮廓。较薄的壁和较低的轮廓允许穿过血管的较小插入孔，而不影响总的管腔尺寸。在一些实施方案中，与近端相比，导鞘400的壁厚可以缓慢地步降为朝向鞘的远端更薄。As described above, the sheath 400 may include a body 402 formed from generally three layers, including a lubricious inner liner, a reinforcement layer, and an outer jacket layer. The reinforcement layer may include a webbing that provides good twistability, optionally overlaid with coils to provide good kink resistance. In sheaths where the reinforcement layer is solely webbing, the polymer of the outer jacket layer may typically be of higher durometer and thicker to avoid kinking issues. Such sheaths braided solely with a thicker polymer may have a wall thickness of approximately 0.011". The wall thickness of the sheath 400 described herein with webbing overlaid with coils provides both twistability and kink resistance and may have a generally thinner wall, for example, approximately 0.0085". Thus, the proximal outer diameter can be reduced to approximately 0.107" outer diameter. Thus, the sheath 400 is a high performance sheath 400 having good torque and kink resistance, with thinner walls providing an overall lower profile for the system. The thinner walls and lower profile allow for smaller insertion holes through the vessel without affecting the overall lumen size. In some embodiments, the wall thickness of the introducer sheath 400 can gradually decrease to be thinner towards the distal end of the sheath compared to the proximal end.
导鞘400可以包括远尖端406，该远尖端406被设计为与延伸穿过其工作管腔的导管的外径良好密封。远尖端406可以由软材料形成，该软材料没有衬里和增强层这两者。润滑衬里层以及增强层可以延伸穿过除了远尖端406的长度之外的主体402的大部分(参见图2C)。鞘400的远尖端406的该无衬里的、未增强部分的长度可以变化。在一些实施方案中，长度在鞘400的远端区域的约3mm至约6mm之间。由此，鞘400的衬里409可以终止于离鞘400的最远端终点至少约3mm，留下最后3mm无衬里的软材料形成远尖端406。在一些实施方案中，增强层的线圈和织带可以使它们的端部由不透射线的标记411(诸如被定位在鞘400的最远端终点附近的标记带)保持就位。衬里层409在终止之前可以在标记带411的远端延伸至少一长度，例如，约1mm的长度。壁层的交错终止可以辅助从标记带411到远尖端406的软聚合物材料407的过渡。软聚合物材料407可以延伸超过衬里层409的长度。形成远尖端406的无衬里软材料407可以是PEBAX材料，该材料具有不超过约40D、不超过约35D、不超过约62A或不超过约25D的硬度。材料的柔软度和鞘400的该无衬里远尖端406的长度可以变化。通常，材料足够柔软，以被向下压缩到延伸穿过鞘400的管腔的导管200的外径上，诸如在借助管腔施加负压时。远尖端406的该无衬里未增强区域407的长度足够长，以提供良好的密封，但不长至引起以下问题：具有在相对滑动期间在鞘400与导管200之间的、可能阻塞鞘管腔的风琴褶或折叠，或负面地影响导管200在鞘管腔内的可滑动性。The guide sheath 400 may include a distal tip 406 designed to seal well with the outer diameter of the catheter extending through its working lumen. The distal tip 406 may be formed of a soft material that lacks both a lining and a reinforcement layer. The lubricating lining layer and the reinforcement layer may extend through most of the body 402 except for the length of the distal tip 406 (see FIG. 2C ). The length of this unlined, unreinforced portion of the distal tip 406 of the sheath 400 may vary. In some embodiments, the length is between about 3 mm and about 6 mm at the distal end of the sheath 400. Thus, the lining 409 of the sheath 400 may terminate at least about 3 mm from the most distal end of the sheath 400, leaving the last 3 mm of the soft material without lining to form the distal tip 406. In some embodiments, the coils and webbing of the reinforcement layer may have their ends held in place by radiopaque markers 411 (such as marker bands positioned near the most distal end of the sheath 400). The backing layer 409 can extend at least a length, for example, about 1 mm, distal to the marker band 411 before terminating. The staggered termination of the wall layers can aid in the transition from the marker band 411 to the soft polymer material 407 of the distal tip 406. The soft polymer material 407 can extend beyond the length of the backing layer 409. The unlined soft material 407 forming the distal tip 406 can be a PEBAX material having a durometer of no more than about 40D, no more than about 35D, no more than about 62A, or no more than about 25D. The softness of the material and the length of the unlined distal tip 406 of the sheath 400 can vary. Typically, the material is sufficiently soft to be compressed downwardly against the outer diameter of the catheter 200 extending through the lumen of the sheath 400, such as when negative pressure is applied via the lumen. The length of this unlined, unreinforced region 407 of the distal tip 406 is long enough to provide a good seal, but not so long as to cause problems such as having accordions or folds between the sheath 400 and catheter 200 that could obstruct the sheath lumen during relative sliding, or negatively affect the slidability of the catheter 200 within the sheath lumen.
远尖端406可以具有接近延伸穿过鞘400的导管200的外径的内径。在一些实施方案中，远尖端406的内径可以取决于要使用什么尺寸的导管而变化。例如，当近端附近的导管的外径为大约0.101”时，远尖端406处的鞘的内径可以为约0.106”，使得直径的差为大约0.005”。在施加真空时，柔软的无衬里且未增强的远尖端406可以移动，以消除该0.005”间隙，并且在导管200延伸出其远端开口408时在导管200的近端区域附近向下压缩到导管200的外径上。远尖端406的内径与导管的外径之间的差可以在约0.002”-0.006”之间。远尖端406的内径还可以是锥形的，使得开口408的最远端终点处的内径仅比延伸通过工作管腔的导管200的近端的外径大0.001”至0.002”。在一些实施方案中，远尖端406被成形为使得壁相对于鞘400的中心轴线成一定角度倾斜，诸如大约60度。The distal tip 406 can have an inner diameter that approximates the outer diameter of the catheter 200 extending through the sheath 400. In some embodiments, the inner diameter of the distal tip 406 can vary depending on what size catheter is to be used. For example, when the outer diameter of the catheter near the proximal end is approximately 0.101", the inner diameter of the sheath at the distal tip 406 can be approximately 0.106", making the difference in diameter approximately 0.005". Upon application of a vacuum, the soft, unlined and unreinforced distal tip 406 can move to eliminate this 0.005" gap and compress down onto the outer diameter of the catheter 200 near the proximal region of the catheter 200 as the catheter 200 extends out of its distal opening 408. The difference between the inner diameter of the distal tip 406 and the outer diameter of the catheter can be between approximately 0.002"-0.006". The inner diameter of the distal tip 406 can also be tapered so that the inner diameter at the distal-most terminus of the opening 408 is only 0.001" to 0.002" larger than the outer diameter of the proximal end of the catheter 200 extending through the working lumen. In some embodiments, the distal tip 406 is shaped so that the wall is inclined at a certain angle relative to the central axis of the sheath 400, such as approximately 60 degrees.
在一些情况下，期望鞘主体402也能够闭塞其所位于的动脉，例如，在可能产生远端栓子的手术期间。闭塞动脉停止顺行血流，从而降低远端栓子的风险，远端栓子可能导致诸如TIA或中风的神经症状。图2D示出了动脉进入装置或鞘400，它具有远端闭塞球囊440，该球囊在膨胀时在鞘远尖端406的位置处闭塞动脉。在手术中的任意点，例如，在通过抽吸和/或输送stentriever或其他介入装置去除闭塞期间，可以使闭塞球囊440膨胀，以闭塞血管，以降低脑血管的远端栓子的风险。鞘400除了可以包括鞘400的工作管腔之外，还可以包括膨胀管腔，该膨胀管腔被构造为输送用于使闭塞球囊440膨胀的流体。膨胀管腔可以将球囊440流体地连接到例如近端适配器上的臂412。当期望血管闭塞时，该臂412可以附接到诸如注射器的膨胀装置，以用流体使球囊440膨胀。臂412可以连接到被动或主动抽吸源，以进一步降低远端栓子的风险。In some cases, it may be desirable for the sheath body 402 to also occlude the artery in which it is positioned, for example, during a procedure where distal emboli may be present. Occluding the artery stops antegrade blood flow, thereby reducing the risk of distal emboli, which can lead to neurological symptoms such as a transient ischemic attack (TIA) or stroke. FIG2D illustrates an arterial access device or sheath 400 having a distal occlusion balloon 440 that, when inflated, occludes the artery at the location of the sheath distal tip 406. At any point during the procedure, for example, during removal of the occlusion by aspiration and/or delivery of a stentriever or other interventional device, the occlusion balloon 440 can be inflated to occlude the vessel and reduce the risk of distal emboli in the cerebral vessels. In addition to the working lumen of the sheath 400, the sheath 400 can also include an inflation lumen configured to deliver fluid for inflating the occlusion balloon 440. The inflation lumen can fluidly connect the balloon 440 to, for example, an arm 412 on a proximal adapter. When vessel occlusion is desired, the arm 412 can be attached to an inflation device, such as a syringe, to inflate the balloon 440 with fluid. The arm 412 can be connected to a passive or active suction source to further reduce the risk of distal emboli.
根据一些实施方案，导鞘400的长度足够长到能进入目标解剖结构，并且在额外长度在患者身体外部以便调节的情况下离开动脉进入部位。例如，导鞘400(无论是否具有远端闭塞球囊440)可以足够长，以从股动脉进入岩石ICA，使得额外的长度仍可用于调节。导鞘400可以是各种尺寸，以接受各种工作装置，并且可以适应操作者的偏好。例如，当前MAT和SMAT技术描述了在AIS期间将具有0.054”-0.072”的内径的抽吸导管输送到栓子。因此，导鞘400的工作管腔可以被构造为接收导管200以及领域中已知的其他导管或工作装置。例如，工作管腔可以具有内径，该内径被定尺为容纳至少6法兰西导管(1.98mm或0.078”OD)，或优选地至少6.3法兰西导管(2.079mm或0.082”OD)。然而，导鞘400的内径可以更小或更大，以与其他导管尺寸兼容。在一些实施方案中，工作管腔可具有内径，该内径被定尺为容纳7法兰西(2.31mm或0.091”OD)导管或8法兰西(2.64mm或0.104”OD)或更大的导管。在一些实施方案中，工作管腔可以具有至少约0.054”高到约0.070”、0.071”、0.074”、0.087”、0.088”或0.100”的内径，由此，被构造为接收具有与这些尺寸适贴配合的外径的导管200。不管长度和内径如何，导鞘400在穿过血管的远端前进期间都能抵抗扭结。According to some embodiments, the length of the guide sheath 400 is long enough to access the target anatomy and to exit the arterial access site with the extra length outside the patient's body for adjustment. For example, the guide sheath 400 (with or without the distal occluding balloon 440) can be long enough to access the petrous ICA from the femoral artery, such that the extra length is still available for adjustment. The guide sheath 400 can be of various sizes to accept various working devices and can accommodate operator preferences. For example, current MAT and SMAT techniques describe delivering an aspiration catheter having an inner diameter of 0.054"-0.072" to the embolus during AIS. Therefore, the working lumen of the guide sheath 400 can be configured to receive the catheter 200 as well as other catheters or working devices known in the art. For example, the working lumen can have an inner diameter that is sized to accommodate at least a 6 French catheter (1.98 mm or 0.078" OD), or preferably at least a 6.3 French catheter (2.079 mm or 0.082" OD). However, the inner diameter of the guide sheath 400 can be smaller or larger to be compatible with other catheter sizes. In some embodiments, the working lumen can have an inner diameter that is sized to accommodate a 7 French (2.31 mm or 0.091" OD) catheter or an 8 French (2.64 mm or 0.104" OD) or larger catheter. In some embodiments, the working lumen can have an inner diameter of at least about 0.054" up to about 0.070", 0.071", 0.074", 0.087", 0.088", or 0.100", thereby being constructed to receive a catheter 200 having an outer diameter that fits snugly with these sizes. Regardless of the length and inner diameter, the guide sheath 400 resists kinking during distal advancement through a vessel.
被包括在鞘400中的工作管腔可以被定尺寸为以滑动配合接收其相应的工作装置。工作管腔可以具有比其预期接收的任意导管200的外径大至少0.001英寸的内径，特别是如下面将更详细描述的在导管200将用于抽吸时。如下面更详细描述的，导管200可以包括在管腔部分222中的狭缝236，该狭缝236被构造为在从抽吸源施加抽吸时稍微加宽并且改善导管200和导鞘400之间的密封。另外地或备选地，如上所述，鞘400的远尖端406可以被设计为向下移动到导管200的外径上，以改善密封。所实现的密封的强度允许从导管200的远尖端到导鞘的近端403(在近端403导鞘400连接到抽吸源)的连续抽吸管腔，即使在存在具有最小泄漏或没有泄漏的更低吸力时也是如此。通常，当在导管200与导鞘400之间存在足够的重叠时，基本上没有泄漏。然而，当试图到达远端解剖结构时，导管200可以前进到其极限，并且导管200与导鞘400之间的重叠最小。由此，可能期望另外的密封来防止导管200周围的泄漏到鞘400中。导管200与导鞘400之间的密封可以在导管200相对于鞘400的最大延伸时防止该泄漏。The working lumen included in the sheath 400 can be sized to receive its corresponding working device with a sliding fit. The working lumen can have an inner diameter that is at least 0.001 inches larger than the outer diameter of any catheter 200 it is intended to receive, particularly when the catheter 200 is to be used for suction as will be described in more detail below. As described in more detail below, the catheter 200 can include a slit 236 in the lumen portion 222 that is configured to slightly widen and improve the seal between the catheter 200 and the guide sheath 400 when suction is applied from a suction source. Additionally or alternatively, as described above, the distal tip 406 of the sheath 400 can be designed to move downwardly onto the outer diameter of the catheter 200 to improve the seal. The strength of the seal achieved allows for a continuous suction lumen from the distal tip of the catheter 200 to the proximal end 403 of the guide sheath (where the guide sheath 400 is connected to the suction source) even when there is a lower suction force with minimal or no leakage. Typically, when there is sufficient overlap between the catheter 200 and the introducer sheath 400, there is substantially no leakage. However, when attempting to reach distal anatomical structures, the catheter 200 may be advanced to its limit, and the overlap between the catheter 200 and the introducer sheath 400 may be minimal. Thus, additional sealing may be desired to prevent leakage around the catheter 200 into the sheath 400. The seal between the catheter 200 and the introducer sheath 400 may prevent this leakage at the maximum extension of the catheter 200 relative to the sheath 400.
远端进入导管Distal access catheter
再次参照图2A至图2B以及图3和8A至图8C，远端进入系统100可包括远端进入或支撑导管200，该导管被构造为延伸穿过和离开导鞘400的远端。图3例示了导管200的实施方案的侧视图。导管200可以包括相对挠性的远端管腔部222，该远端管腔部222耦接到更刚性的、抗扭结的近端延伸部230。导管200提供即使穿过脑血管的极度曲折也简单地进入中风位置的快速方式。这里描述的导管具有一定程度的挠性和可输送性，该程度使得它们最佳地适于前进穿过脑血管解剖结构，而不扭结或椭圆化，即使在导航急转弯时也是如此。例如，远端管腔部222可以执行180度转弯(参见图1B所示的靠近颈动脉虹吸部的转弯T)并且维持4.0mm的折叠宽度跨度而没有扭结或椭圆化。进一步地，远端管腔部222具有一定程度的挠性，该程度维持血管的自然曲折度，远端管腔部前进穿过血管而不施加拉直力，使得在使用期间维持解剖结构的自然形状和弯曲。导管200(特别是与将在下面更详细地描述的导管前进元件300组合)提供超出导鞘400的延伸管道，该管道具有穿过旋绕解剖结构的优越输送能力，该输送能力允许将抽吸力传递到目标中风部位以及输送中风介入装置，诸如支架收回器、支架、引流器或其他工作装置。Referring again to Figures 2A-2B and Figures 3 and 8A-8C, the distal access system 100 may include a distal access or support catheter 200 configured to extend through and out of the distal end of the introducer sheath 400. Figure 3 illustrates a side view of an embodiment of the catheter 200. The catheter 200 may include a relatively flexible distal lumen portion 222 coupled to a more rigid, kink-resistant proximal extension portion 230. The catheter 200 provides a rapid means of easily accessing a stroke site, even through the extreme tortuosity of the cerebral vasculature. The catheters described herein have a degree of flexibility and deliverability that makes them optimally suited for advancement through the cerebral vascular anatomy without kinking or elliptical motion, even when navigating sharp turns. For example, the distal lumen portion 222 can perform a 180-degree turn (see Turn T near the carotid siphon shown in Figure 1B) and maintain a folded width span of 4.0 mm without kinking or elliptical motion. Furthermore, the distal lumen portion 222 has a degree of flexibility that maintains the natural tortuosity of the vessel, and the distal lumen portion is advanced through the vessel without applying a straightening force, so that the natural shape and curvature of the anatomy is maintained during use. The catheter 200 (particularly in combination with the catheter advancement element 300 described in more detail below) provides an extended conduit beyond the introducer sheath 400 that has superior delivery capabilities through tortuous anatomy, which allows for the transfer of suction forces to the target stroke site and the delivery of stroke intervention devices, such as stent retrievers, stents, drains, or other working devices.
内管腔223在管腔部222的近端与远端之间延伸穿过管腔部222。导管200的内管腔223可以具有第一内径，并且导鞘400的工作管腔可以具有第二更大的内径。在将导管200插入穿过鞘400的工作管腔时，导管200的管腔223可以被构造为与鞘400的工作管腔流体连接和连续，使得流体流入和/或流出鞘400是可能的，诸如通过从在近端处耦接到系统100的抽吸源施加抽吸。随着导管200的前进和撤回，在近端处在抽吸期间，鞘400和导管200的组合可以与血流连续地连通。10. The inner lumen 223 extends through the lumen portion 222 between the proximal and distal ends of the lumen portion 222. The inner lumen 223 of the catheter 200 can have a first inner diameter, and the working lumen of the introducer sheath 400 can have a second, larger inner diameter. Upon insertion of the catheter 200 through the working lumen of the sheath 400, the lumen 223 of the catheter 200 can be configured to be fluidly connected and continuous with the working lumen of the sheath 400 so that fluid flow into and/or out of the sheath 400 is possible, such as by applying suction from a suction source coupled to the system 100 at the proximal end. As the catheter 200 is advanced and withdrawn, the combination of the sheath 400 and the catheter 200 can be in continuous communication with the blood flow during suction at the proximal end.
旋转导管系统可以产生超过传统导管的、特别是在抽吸方面的远端接入的优势。导管柱内径的阶跃变化在可以由旋转导管200与传统引导导管组合生成的抽吸流动和力方面产生很大的优势。例如，在具有0.070”内径的旋转导管200与标准6F外径/0.088”内径引导导管(例如Penumbra Neuron MAX 088)配对的情况下，可以产生抽吸物理现象，在该物理现象中，0.088”导管直径将占主导地位，并且产生整个系统中的0.080等效流动。The rotary catheter system can produce advantages over conventional catheters for distal access, particularly in aspiration. The step change in catheter column inner diameter produces a significant advantage in the aspiration flow and force that can be generated by the rotary catheter 200 in combination with a conventional guide catheter. For example, where a rotary catheter 200 having a 0.070" inner diameter is paired with a standard 6F OD/0.088" ID guide catheter (e.g., the Penumbra Neuron MAX 088), an aspiration physics phenomenon can be created in which the 0.088" catheter diameter will dominate and produce a 0.080 equivalent flow throughout the system.
除了抽吸手术之外，导管200和远端进入系统100可以用于输送工具和介入工作装置。如下面将更详细描述的，要借助导管200输送的典型支架收回器可以具有180cm的推丝控制元件。具有旋转支撑导管200的远端进入系统100允许使用更短的长度(例如120cm-150cm)到达远端中风部位。总长度可以与借助导管抽吸时的直径和半径一样重要。更短的长度与三轴系统中典型的多个RHV的消除结合，允许单个操作者使用。In addition to aspiration procedures, the catheter 200 and distal access system 100 can be used for delivery tools and interventional work devices. As will be described in more detail below, a typical stent retriever to be delivered with the aid of the catheter 200 may have a 180 cm push wire control element. The distal access system 100 with a rotating support catheter 200 allows for the use of a shorter length (e.g., 120 cm-150 cm) to reach the distal stroke site. The total length can be as important as the diameter and radius when aspiration is performed with the aid of a catheter. The shorter length, combined with the elimination of multiple RHVs typical in a triaxial system, allows for use by a single operator.
应当理解，在导管在这里被描述为抽吸导管的情况下，它不应仅限于抽吸。类似地，在导管在这里被描述为输送支架收回器或其他工作装置的方式的情况下，它不应照此受限。还应当理解，这里描述的系统可以用于执行并入治疗组合的手术。例如，导管200可以用于输送支架收回器输送系统，可选地在存在借助导管200抽吸时。作为另一个示例，用户可以开始使用这里描述的系统执行第一介入手术，诸如抽吸血栓切除术，并且切换到另一种介入手术，诸如输送支架收回器或植入物。It should be understood that where a catheter is described herein as being an aspiration catheter, it should not be limited to only aspiration. Similarly, where a catheter is described herein as being a means of delivering a stent retriever or other working device, it should not be so limited. It should also be understood that the systems described herein can be used to perform procedures that incorporate a combination of treatments. For example, catheter 200 can be used to deliver a stent retriever delivery system, optionally in the presence of aspiration with the aid of catheter 200. As another example, a user can begin performing a first interventional procedure using the system described herein, such as an aspiration thrombectomy, and switch to another interventional procedure, such as delivering a stent retriever or implant.
还应当理解的是，导管200不需要旋转或包括近端延伸部230，而是可以是具有均匀直径的非旋转的传统导管。术语“支撑导管”、“旋转导管”、“远端进入导管”以及“中间导管”在这里可互换使用。It should also be understood that the catheter 200 need not rotate or include a proximal extension 230, but can be a non-rotating conventional catheter having a uniform diameter. The terms "support catheter," "rotating catheter," "distal access catheter," and "intermediate catheter" are used interchangeably herein.
期望具有可以安全地导航到闭塞部位的、具有尽可能大的内径的导管200，以便在抽吸的情况下优化抽吸力和/或提供用于输送工作装置的足够间隙。取决于患者解剖结构以及凝块尺寸和组成，远端管腔部222的内径的合适尺寸可以在0.040”和0.100”之间的范围内，或更优选地为在0.054”和0.088”之间的范围内。远端管腔部222的外径可以被定尺为导航到脑动脉中，例如，在脑血管的M1段或M2段的层面上。外径(OD)应在仍维持导管200的机械完整性的同时尽可能小。在实施方案中，导管200的远端管腔部222的OD与导鞘400的工作管腔的内径之间的差在0.001”和0.002”之间。在另一个实施方案中，差在0.001”和0.004”之间。It is desirable to have a catheter 200 with as large an inner diameter as possible that can be safely navigated to the occlusion site in order to optimize suction force in the event of suction and/or provide sufficient clearance for delivery of working devices. Depending on the patient anatomy and the clot size and composition, a suitable size for the inner diameter of the distal lumen portion 222 can be in the range of between 0.040" and 0.100", or more preferably in the range of between 0.054" and 0.088". The outer diameter of the distal lumen portion 222 can be sized for navigation into a cerebral artery, for example, at the level of the M1 segment or M2 segment of the cerebral vessel. The outer diameter (OD) should be as small as possible while still maintaining the mechanical integrity of the catheter 200. In an embodiment, the difference between the OD of the distal lumen portion 222 of the catheter 200 and the inner diameter of the working lumen of the introducer sheath 400 is between 0.001" and 0.002". In another embodiment, the difference is between 0.001" and 0.004".
在一些实施方案中，导管200的远端管腔部222具有外径(OD)，该外径被构造为嵌合穿过6F引入器鞘(0.070”-0.071”)，并且管腔223具有内径(ID)，该内径被定尺为接收0.054”导管。在一些实施方案中，导管200的远端管腔部222具有OD，该OD被构造为嵌合穿过8F引入器鞘(0.088”)，并且管腔223具有ID，该ID被定尺为接收0.070”或0.071”导管。在一些实施方案中，远端管腔部222的OD为2.1mm，并且管腔223具有0.071”的ID。在一些实施方案中，管腔223具有0.070”至0.073”的ID。导鞘400的外径可以适于插入到至少颈动脉中，工作管腔被合适地定尺为为导管200提供通道，以治疗在朝向大脑的颈动脉的远端的闭塞。在一些实施方案中，工作管腔的ID可以是大约0.074”，并且导鞘400的主体的OD可以是对应于5法兰西鞘尺寸的大约0.090”。在一些实施方案中，工作管腔的ID可以是大约0.087”，并且导鞘400的主体的OD可以是对应于6法兰西鞘尺寸的大约0.104”。在一些实施方案中，工作管腔的ID可以是大约0.100”，并且导鞘400的主体的OD可以是对应于7法兰西鞘尺寸的大约0.117”。在一些实施方案中，导鞘400ID在0.087”和0.088”之间，并且导管200的远端管腔部222的OD为近似0.082”和0.086”，使得直径差在0.001”与0.005”之间。In some embodiments, the distal lumen portion 222 of the catheter 200 has an outer diameter (OD) that is configured to fit through a 6F introducer sheath (0.070"-0.071"), and the lumen 223 has an inner diameter (ID) that is sized to receive a 0.054" catheter. In some embodiments, the distal lumen portion 222 of the catheter 200 has an OD that is configured to fit through an 8F introducer sheath (0.088"), and the lumen 223 has an ID that is sized to receive a 0.070" or 0.071" catheter. In some embodiments, the OD of the distal lumen portion 222 is 2.1 mm and the lumen 223 has an ID of 0.071". In some embodiments, the lumen 223 has an ID of 0.070" to 0.073". The outer diameter of the guide sheath 400 can be suitable for insertion into at least the carotid artery, with the working lumen suitably sized to provide a passage for the catheter 200 to treat an occlusion at the distal end of the carotid artery toward the brain. In some embodiments, the ID of the working lumen can be approximately 0.074", and the OD of the body of the guide sheath 400 can be approximately 0.090", corresponding to a 5 French sheath size. In some embodiments In some embodiments, the ID of the working lumen can be approximately 0.087" and the OD of the body of the guide sheath 400 can be approximately 0.104" corresponding to a 6 French sheath size. In some embodiments, the ID of the working lumen can be approximately 0.100" and the OD of the body of the guide sheath 400 can be approximately 0.117" corresponding to a 7 French sheath size. In some embodiments, the ID of the guide sheath 400 is between 0.087" and 0.088" and the OD of the distal lumen portion 222 of the catheter 200 is approximately 0.082" and 0.086", so that the diameter difference is between 0.001" and 0.005".
在实施方案中，导管200的管腔部222具有从近端到远端的均匀直径。在其他实施方案中，导管200的管腔部222为锥形和/或具有朝向远端管腔部222的远端的步降，使得导管200的最远端具有与导管200的更近端区域相比更小的外径，例如，在该更近端区域附近，远端管腔部222用导鞘400密封。在另一个实施方案中，如将在下面更详细地描述的，导管OD的管腔部222在重叠部分处或附近步进，以更紧密地匹配鞘内径。应当理解，外径的该步进可以是由于改变导管200的壁厚而产生。例如，与远端附近的导管200的壁厚相比，导管200可以具有在近端附近稍微更厚的壁厚，以提供与鞘的更佳密封。该实施方案在具有适于与单个进入鞘尺寸一起使用的多于一个导管的系统中特别有用。应当理解，这里考虑更小或更大的鞘尺寸。In an embodiment, the lumen portion 222 of the catheter 200 has a uniform diameter from the proximal end to the distal end. In other embodiments, the lumen portion 222 of the catheter 200 is tapered and/or has a step-down toward the distal end of the distal lumen portion 222, such that the distal-most end of the catheter 200 has a smaller outer diameter than the more proximal region of the catheter 200, e.g., near this more proximal region, where the distal lumen portion 222 seals with the introducer sheath 400. In another embodiment, as will be described in more detail below, the lumen portion 222 of the catheter OD steps at or near the overlap to more closely match the sheath inner diameter. It should be understood that this stepping in outer diameter can be caused by varying the wall thickness of the catheter 200. For example, the catheter 200 can have a slightly thicker wall thickness near the proximal end compared to the wall thickness of the catheter 200 near the distal end to provide a better seal with the sheath. This embodiment is particularly useful in systems with more than one catheter adapted for use with a single access sheath size. It should be understood that smaller and larger sheath sizes are contemplated herein.
管腔部222的长度可以短于导鞘400的工作管腔的长度，使得在使管腔部222朝向目标位置前进时，导致在管腔部222与工作管腔之间的短重叠区域348仍然存在(参见图2B)。将闭塞部位和可以定位导鞘400远尖端406的部位的变化考虑在内，管腔部222的长度可以在从约10cm至约45cm的范围内。在一些实施方案中，导管200的远端管腔部222可以在20-45cm之间，并且导管200的近端延伸部230可以在约90cm至约100cm之间，使得导管200可以具有近似115cm的总工作长度。导鞘400的主体402可以在80cm至约90cm之间。在其他实施方案中，导管的近端到导管的远端之间的导管200的工作长度可以大于115cm直到大约130cm。在一些实施方案中，导管200可以具有在近端突片234(或近端毂)与远尖端之间的133cm的工作长度，远端管腔部222可以具有约38.7mm的轴长度。The length of the lumen portion 222 can be shorter than the length of the working lumen of the guide sheath 400 so that when the lumen portion 222 is advanced toward the target location, a short overlap region 348 between the lumen portion 222 and the working lumen still exists (see FIG2B ). Taking into account the variation in the occlusion site and the location where the distal tip 406 of the guide sheath 400 can be positioned, the length of the lumen portion 222 can be in the range of from about 10 cm to about 45 cm. In some embodiments, the distal lumen portion 222 of the catheter 200 can be between 20-45 cm, and the proximal extension 230 of the catheter 200 can be between about 90 cm to about 100 cm, so that the catheter 200 can have a total working length of approximately 115 cm. The body 402 of the guide sheath 400 can be between 80 cm and about 90 cm. In other embodiments, the working length of the catheter 200 between the proximal end of the catheter and the distal end of the catheter can be greater than 115 cm up to about 130 cm. In some embodiments, the catheter 200 can have a working length of 133 cm between the proximal tab 234 (or proximal hub) and the distal tip, and the distal lumen 222 can have a shaft length of approximately 38.7 mm.
管腔部222的长度可以小于导鞘400的主体402的长度，使得随着导管200从工作管腔延伸，在导管200的重叠区域348与工作管腔的内径之间保持密封。在一些实施方案中，管腔部222的长度足以到达大脑中动脉(MCA)的M1段的区域和来自颈内动脉区域的其他主要血管，使得导管200的管腔部222的近端区域避免在主动脉弓内延伸。这限制了导管200的管腔部222必须在仍然到达更远端的大脑解剖结构中的目标部位的同时导航的严重异常弯曲形成(angulation)的数量。在导管200到达ICA并且到栓子的距离可以小于20cm的实施方案中，与具有鞘主体402和工作管腔的导鞘400结合使用。The length of the lumen portion 222 can be less than the length of the body 402 of the guide sheath 400 so that as the catheter 200 extends from the working lumen, a seal is maintained between the overlap region 348 of the catheter 200 and the inner diameter of the working lumen. In some embodiments, the length of the lumen portion 222 is sufficient to reach the region of the M1 segment of the middle cerebral artery (MCA) and other major vessels from the internal carotid artery region so that the proximal region of the lumen portion 222 of the catheter 200 avoids extending within the aortic arch. This limits the number of severe abnormal bend formations (angulations) that the lumen portion 222 of the catheter 200 must navigate while still reaching the target site in the more distal brain anatomy. In embodiments where the catheter 200 reaches the ICA and the distance to the embolus can be less than 20 cm, it is used in combination with a guide sheath 400 having a sheath body 402 and a working lumen.
具有小于30cm(例如近似10cm至30cm，诸如25cm)的长度的远端管腔部222可以允许与主体402的重叠区域348产生密封，同时仍然提供到颅内血管的足够可及范围。如上所述，颈动脉虹吸部CS是末端ICA的S形部分，该部分起始于海绵状ICA的后弯，并在到大脑前动脉ACA和大脑中动脉MCA的ICA分叉处终止。在一些实施方案中，如下面将更详细描述的，远端管腔部222的长度可以在约35cm-60cm之间、或者在40cm-60cm之间、或者在40cm-45cm之间，以允许导管200的远端在近端延伸部230保持在颈动脉虹吸部的近端的同时延伸到至少大脑中动脉中。A distal lumen portion 222 having a length of less than 30 cm (e.g., approximately 10 cm to 30 cm, such as 25 cm) can allow a seal to be created with the overlap region 348 of the body 402 while still providing adequate access to the intracranial vessels. As described above, the carotid siphon CS is the S-shaped portion of the terminal ICA that begins at the posterior bend of the cavernous ICA and terminates at the ICA bifurcation to the anterior cerebral artery ACA and the middle cerebral artery MCA. In some embodiments, as will be described in more detail below, the length of the distal lumen portion 222 can be between approximately 35 cm and 60 cm, or between 40 cm and 60 cm, or between 40 cm and 45 cm to allow the distal end of the catheter 200 to extend into at least the middle cerebral artery while the proximal extension 230 remains proximal to the carotid siphon.
远端管腔部222可以具有从其附接点到近端延伸部230测量的长度，该长度足够长，以从在颈动脉虹吸部的近端的颈内动脉(ICA)的区域延伸到在颈动脉虹吸部的远端的ICA的区域(包括大脑的至少M1区域)。在管腔部222延伸到目标解剖结构中时，可以在靠近鞘主体402的远端区域的导鞘400的工作管腔与导管200的管腔部222之间维持重叠区域348。应当理解，在导管200沿着远端管腔部222的至少一部分的OD与导鞘400的内径大致匹配或者差可以在0.001”-0.002”之间的情况下，可以由重叠区域348实现对注入或抽吸的流体的密封。导管OD与导鞘400的内径之间的差可以变化，例如，在千分之一至千分之二英寸之间或在千分之一至千分之四英寸之间或在千分之一至千分之十二英寸之间。在导管与鞘之间对注入或抽吸的流体的密封可以由它们大致类似的尺寸之间的重叠348来实现，而不并入任何单独的密封结构或密封特征。The distal lumen portion 222 can have a length, measured from its attachment point to the proximal extension 230, that is sufficiently long to extend from a region of the internal carotid artery (ICA) proximal to the carotid siphon to a region of the ICA distal to the carotid siphon (including at least the M1 region of the brain). As the lumen portion 222 extends into the target anatomy, an overlap region 348 can be maintained between the working lumen of the introducer sheath 400 proximate the distal region of the sheath body 402 and the lumen portion 222 of the catheter 200. It should be understood that sealing against insufflated or aspirated fluids can be achieved by the overlap region 348 when the OD of the catheter 200 along at least a portion of the distal lumen portion 222 substantially matches the inner diameter of the introducer sheath 400, or the difference can be between 0.001" and 0.002". The difference between the catheter OD and the inner diameter of the introducer sheath 400 can vary, for example, between 1 and 2 thousandths of an inch, or between 1 and 4 thousandths of an inch, or between 1 and 12 thousandths of an inch. Sealing between the catheter and sheath for insufflated or aspirated fluids can be achieved by the overlap 348 between their substantially similar dimensions without incorporating any separate sealing structure or sealing feature.
重叠区域348可以具有几厘米的长度，并且可以取决于从栓子到远端管腔部222的远端的距离(例如，取决于导管200相对于导鞘前进多远)而变化。重叠区域348被定尺并构造为产生密封，该密封允许从导管200的远尖端区域到导鞘400可以连接到抽吸源的、导鞘的近端区域403的连续抽吸管腔。所实现的密封的强度可以是导管200的外径与工作管腔的内径之间的差以及重叠区域348的长度、所施加的抽力以及部件的材料的函数。例如，密封可以通过增加重叠区域348的长度来改善。然而，增加重叠区域348的长度可能产生较大的长度，穿过该长度，抽吸借助较小直径的管腔部222来拉动，而不是借助较大直径的工作管腔来拉动。作为另一个示例，即使在存在较短的重叠区域348时，由抽吸源施加的较高抽吸力也可以在管腔部222与工作管腔之间产生较强的密封。进一步地，即使吸力较小且重叠区域348较短，形成管腔部和/或主体402的相对更软的材料也仍可以提供足够的密封。在实施方案中，重叠区域348被构造为启用针对多达28inHg的真空的密封。在实施方案中，重叠区域348被构造为在最小泄漏或无泄漏的情况下启用针对多达300mmHg或多达600mmHg或多达700mmHg的压力的密封。The overlap region 348 can have a length of several centimeters and can vary depending on the distance from the embolus to the distal end of the distal lumen portion 222 (e.g., depending on how far the catheter 200 is advanced relative to the guide sheath). The overlap region 348 is sized and configured to create a seal that allows for a continuous suction lumen from the distal tip region of the catheter 200 to the proximal region 403 of the guide sheath where the guide sheath 400 can be connected to a suction source. The strength of the seal achieved can be a function of the difference between the outer diameter of the catheter 200 and the inner diameter of the working lumen, as well as the length of the overlap region 348, the suction applied, and the materials of the components. For example, the seal can be improved by increasing the length of the overlap region 348. However, increasing the length of the overlap region 348 may create a larger length through which suction is pulled by the smaller diameter lumen portion 222 rather than by the larger diameter working lumen. As another example, the higher suction force applied by the suction source can produce a stronger seal between the lumen portion 222 and the working lumen even when there is a shorter overlap region 348. Further, even if the suction force is lower and the overlap region 348 is shorter, the relatively softer material forming the lumen portion and/or body 402 can still provide an adequate seal. In an embodiment, the overlap region 348 is configured to enable sealing for a vacuum of up to 28 inHg. In an embodiment, the overlap region 348 is configured to enable sealing for pressures of up to 300 mmHg, or up to 600 mmHg, or up to 700 mmHg with minimal or no leakage.
导管200可以向上伸缩，使得远端管腔部222的远端可以到达例如M1、M2区域内的脑血管目标，而远端管腔部222的近端保持在主动脉内。图2C例示了主动脉弓905。来自股骨进入点的最远端颈动脉是右颈总动脉906，该右颈总动脉从头臂动脉干910引出(或在所谓的“似牛解剖结构”中为左颈总动脉，该左颈总动脉从相同的头臂动脉干910引出)。远端管腔部222被构造为向下延伸到主动脉弓905的侧面，或者在头臂动脉干910的引出点下方延伸。这避免了近端延伸部230进行头臂动脉引出点的转弯，该转弯可能经常是非常严重的。头臂动脉的引出点经常是导管随着它们上升到大脑而可能穿过的第一个严重转弯。导管段的较小挠性部分能够避免在颈内动脉层面处看到的这些增加的曲折区域。远端管腔部222的更近端区域通常被设计为接近较刚性近端延伸部230的挠性，以避免扭结。这些较刚性的近端区域(包括近端延伸部230处的远端管腔部222之间的材料过渡)可以保持低于头臂动脉转弯的曲折水平。The catheter 200 can be telescoped upward so that the distal end of the distal lumen 222 can reach a cerebral vascular target, for example, in the M1, M2 region, while the proximal end of the distal lumen 222 remains within the aorta. Figure 2C illustrates the aortic arch 905. The most distal carotid artery from the femoral entry point is the right common carotid artery 906, which leads out of the brachiocephalic trunk 910 (or the left common carotid artery in the so-called "cow-like anatomy", which leads out of the same brachiocephalic trunk 910). The distal lumen 222 is constructed to extend downward to the side of the aortic arch 905, or to extend below the exit point of the brachiocephalic trunk 910. This avoids the proximal extension 230 from making a turn at the brachiocephalic exit point, which can often be very severe. The brachiocephalic exit point is often the first severe turn that a catheter may traverse as it ascends to the brain. The less flexible portion of the catheter segment can avoid these increased tortuosity areas seen at the level of the internal carotid artery. The more proximal region of the distal lumen 222 is generally designed to approach the flexibility of the more rigid proximal extension 230 to avoid kinking. These more rigid proximal regions (including the material transition between the distal lumen 222 at the proximal extension 230) can remain below the tortuosity of the brachiocephalic artery turns.
在一些实施方案中，远端管腔部222可以具有长度，该长度允许远端管腔部222的远端到达颈动脉虹吸部的远端进入颈内动脉的大脑部分中，同时远端管腔部222的近端(例如，它过渡到近端延伸部230的位置，如下面将更详细描述的)保持在头臂动脉干910的引出点的近端的主动脉内，例如在降主动脉915内(参见图2C)。在该实施方案中，远端管腔部可以在约35cm和60cm之间。In some embodiments, the distal lumen portion 222 can have a length that allows the distal end of the distal lumen portion 222 to reach the distal end of the carotid siphon into the cerebral portion of the internal carotid artery, while the proximal end of the distal lumen portion 222 (e.g., where it transitions into the proximal extension 230, as described in more detail below) remains within the aorta proximal to the point of exit of the brachiocephalic trunk 910, such as within the descending aorta 915 (see FIG2C ). In this embodiment, the distal lumen portion can be between approximately 35 cm and 60 cm.
如上面提及的，近端延伸部230和远端管腔部222之间的附接点产生可能易于扭结的、材料和挠性的过渡。由此，优选地，避免使附接点前进到极度弯曲中。例如，远端管腔部222可以具有长度，该长度允许附接点前进不远于颈动脉虹吸部的第一转弯，或者不远于头臂动脉引出点610或主动脉弓905。在一些实施方案中，远端管腔部222具有长度，该长度足以允许附接点保持在降主动脉915内，同时仍然进入神经血管的M1或M2区域。当远端管腔部222具有在约35cm至约60cm之间的长度时，通常避免将材料过渡定位在来自主动脉弓905的头臂动脉引出点910的极度转弯内。As mentioned above, the attachment point between the proximal extension 230 and the distal lumen portion 222 creates a transition in material and flexibility that may be prone to kinking. Thus, preferably, advancing the attachment point into an extreme bend is avoided. For example, the distal lumen portion 222 can have a length that allows the attachment point to be advanced no further than the first turn of the carotid siphon, or no further than the brachiocephalic exit point 610 or the aortic arch 905. In some embodiments, the distal lumen portion 222 has a length that is sufficient to allow the attachment point to remain within the descending aorta 915 while still accessing the M1 or M2 region of the neurovasculature. Positioning the material transition within the extreme bend of the brachiocephalic exit point 910 from the aortic arch 905 is generally avoided when the distal lumen portion 222 has a length between about 35 cm and about 60 cm.
如上所述，可以在远端管腔部222与鞘主体402之间的重叠区域348处产生密封。通常可以期望将密封重叠区域348定位在神经血管的极度弯曲之外。在一些实施方案中，远端管腔部222可以具有长度，该长度允许远端管腔部222的远端向颈动脉虹吸部的远端延伸进入颈内动脉的大脑部分中，同时重叠区域348保持在头臂动脉引出点910、主动脉弓905的近端或降主动脉915内。在该实施方案中，长度可以在约35cm至约60cm之间、约40cm至约60cm之间、或大于40cm直到小于鞘主体402的工作长度。As described above, a seal can be created at the overlap region 348 between the distal lumen portion 222 and the sheath body 402. It can generally be desirable to position the sealing overlap region 348 beyond the extreme bends of the neurovascular vessel. In some embodiments, the distal lumen portion 222 can have a length that allows the distal end of the distal lumen portion 222 to extend distally of the carotid siphon into the cerebral portion of the internal carotid artery while the overlap region 348 remains within the brachiocephalic exit point 910, the proximal end of the aortic arch 905, or the descending aorta 915. In this embodiment, the length can be between about 35 cm and about 60 cm, between about 40 cm and about 60 cm, or greater than 40 cm up to less than the working length of the sheath body 402.
如上面关于图2C描述的，鞘400的远尖端406的未增强区域407可以具有长度，该长度允许它在施加负压时向导管200的外表面上提供足够的密封力。与鞘400的该实施方案一起使用的导管200的远端管腔部222可以具有短于60cm、短于50cm、短于40cm、短于35cm、短于30cm至约10cm的长度。例如，当与具有被构造为密封的未增强区域407的鞘400一起使用时的导管200的远端管腔部222可小于约30cm，例如，在10cm和约30cm之间。2C , the unreinforced region 407 of the distal tip 406 of the sheath 400 can have a length that allows it to provide sufficient sealing force against the outer surface of the catheter 200 when negative pressure is applied. The distal lumen portion 222 of the catheter 200 used with this embodiment of the sheath 400 can have a length shorter than 60 cm, shorter than 50 cm, shorter than 40 cm, shorter than 35 cm, shorter than 30 cm, to about 10 cm. For example, the distal lumen portion 222 of the catheter 200 when used with a sheath 400 having an unreinforced region 407 configured to seal can be less than about 30 cm, e.g., between 10 cm and about 30 cm.
应当理解，在重叠区域348处的密封可以是由于内径与外径的小差而产生和/或可以由于位于远端管腔部的外表面或鞘主体的内表面上的另外密封元件而产生。密封元件可以包括在重叠区域中的步进直径或突出特征。密封元件可以包括一个或多个外部脊特征。当管腔部插入到鞘主体的管腔中时，一个或多个脊特征可以可压缩的。脊几何结构可以使得密封元件表现为O形环、方形环或其他活塞密封设计。密封元件可以包括一个或多个倾斜表面，该倾斜表面偏置在鞘主体管腔的内表面上。密封元件可以包括被致动来密封的一个或多个可扩张构件。可膨胀或可扩张构件可以是球囊或覆盖织带结构，它可以在任意时间(包括在导管定位在期望部位之后)膨胀或扩张并且在两个装置之间提供密封。由此，在定位期间不需要在导管上施加密封力，而是在定位导管之后施加或致动密封力来密封。密封元件可以定位在远端管腔部的外表面上，例如，靠近远端管腔部的近端区域，并且可以位于重叠区域内。多于一个密封元件可以定位在导管的长度上。It should be understood that the seal at the overlap region 348 can be due to a small difference between the inner diameter and the outer diameter and/or can be due to additional sealing elements located on the outer surface of the distal lumen or the inner surface of the sheath body. The sealing element can include a stepped diameter or protruding feature in the overlap region. The sealing element can include one or more external ridge features. When the lumen is inserted into the lumen of the sheath body, the one or more ridge features can be compressible. The ridge geometry can make the sealing element behave like an O-ring, a square ring or other piston seal design. The sealing element can include one or more inclined surfaces that are biased on the inner surface of the sheath body lumen. The sealing element can include one or more expandable members that are actuated to seal. The expandable or expandable member can be a balloon or a covered webbing structure that can be expanded or expanded at any time (including after the catheter is positioned at the desired location) and provide a seal between the two devices. Thus, there is no need to apply a sealing force on the catheter during positioning, but rather a sealing force is applied or actuated to seal after the catheter is positioned. The sealing element may be positioned on an outer surface of the distal lumen portion, for example, near a proximal region of the distal lumen portion, and may be located within the overlapping region.More than one sealing element may be positioned along the length of the catheter.
在一些实施方案中，附加的密封元件可以是杯形密封、球囊密封或由软聚合物形成的盘形密封，该软聚合物定位在重叠区域附近的远端管腔部的外部周围，以提供附加的密封。密封元件可以是薄壁管，该薄壁管具有与鞘主体管腔的内径大致匹配的外径。管可以在一端上密封，以产生杯形密封，或者在两端上密封，以形成盘形或球囊密封。球囊密封可以包括产生可塌陷空间的滞留空气。可以穿过壁管形成一个或多个狭缝，使得球囊密封可以是可塌陷的并且更容易穿过RHV。球囊密封不需要包括用于维持滞留空气的较小可塌陷密封元件的狭缝。密封元件可以是可调的，以便实现鞘配合和塌陷。In some embodiments, the additional sealing element can be a cup seal, a balloon seal, or a disc seal formed by a soft polymer positioned around the outside of the distal lumen near the overlap area to provide additional sealing. The sealing element can be a thin-walled tube having an outer diameter that roughly matches the inner diameter of the sheath body lumen. The tube can be sealed on one end to create a cup seal, or sealed on both ends to form a disc or balloon seal. The balloon seal can include trapped air that creates a collapsible space. One or more slits can be formed through the wall tube so that the balloon seal can be collapsible and easier to pass through the RHV. The balloon seal does not need to include a slit for maintaining a smaller collapsible sealing element for trapped air. The sealing element can be adjustable to achieve sheath fit and collapse.
在一些实施方案中，系统可以包括一个或多个特征，该一个或多个特征限制导管200相对于鞘400延伸到特定距离，使得所实现的重叠区域348最佳和/或防止导管200过度插入。例如，突片可以定位在导管200的区域上，使得在将导管200插入穿过鞘400所选距离时，突片具有被构造为抵靠插入导管200所穿过的端口的尺寸，以防止导管200穿过鞘400的进一步远端延伸。突片还可以定位在导管前进元件300的区域上，以确保导管前进元件300相对于导管200的远端的最佳延伸，以辅助导管200前进到颅内血管中。In some embodiments, the system can include one or more features that limit extension of the catheter 200 relative to the sheath 400 to a specific distance so that the overlap region 348 achieved is optimized and/or prevents over-insertion of the catheter 200. For example, a tab can be positioned on a region of the catheter 200 such that, when the catheter 200 is inserted a selected distance through the sheath 400, the tab is sized to abut against a port through which the catheter 200 is inserted to prevent further distal extension of the catheter 200 through the sheath 400. The tab can also be positioned on a region of the catheter advancing element 300 to ensure optimal extension of the catheter advancing element 300 relative to the distal end of the catheter 200 to assist in advancing the catheter 200 into the intracranial vessels.
再次参照图3，近端延伸部230被构造为使远端管腔部222以双向方式移动穿过导鞘400的工作管腔，使得远端管腔部222可以前进离开导鞘400，进入用于目标血管内的治疗的目标位置。在一些实施方案中并且如图3所示，导管200的近端延伸部230可以具有比远端管腔部222的外径小的外径，这形成导管200的近端棘或栓绳。用于近端延伸部230的比远端管腔部222的外径小的外径允许鞘400的较大直径工作管腔维持比将由导管200的较小直径管腔部222另外提供的更大的抽吸力，或者允许以较小的摩擦力穿过管腔输送工作装置。管腔部222的明显更短的长度引起与工作管腔连续的管腔部222之间的管腔直径的步进，这提供显著增加的、用于输送工作装置和/或抽吸凝块的半径和管腔面积，特别是与抽吸管腔沿着抽吸导管的整个内径延伸的其他系统相比。更具体地，导管200的管腔面积和在远端管腔部222近端的工作管腔的管腔面积的组合体积大于沿着系统的整个长度的大口径导管的管腔面积。由此，可以提高在单次抽吸尝试期间去除栓子的可能性。更具体地，沿着近端延伸部230的步进的管腔直径可以使得能够实现更大的抽吸力，这引起栓子的改善抽吸。进一步地，导管200和近端延伸部230的该构造大幅加速使导管200和/或工作装置缩回和重新前进穿过工作管腔离开远端腔408所需的时间。这描述了抽吸闭塞所耗费的时间。导管200的近端延伸部230具有长度和结构，该长度和结构延伸穿过导鞘400的工作管腔到达系统100的近端，使得近端延伸部230可以用于使导管200前进和缩回穿过工作管腔。然而，导管200的近端延伸部230仅占据系统100的管腔空间的一部分，这导致用于抽吸和/或输送工作装置的增大管腔面积。步进的管腔直径还增大了可用于前向冲洗对照物、盐水或其他溶液的环形面积，而诸如微导管或其他装置的装置可以同轴地定位在导管200的管腔部222和/或工作管腔中。这可以提高在装置导航期间执行血管造影的容易和能力。3 , the proximal extension 230 is configured to allow the distal lumen portion 222 to move in a bidirectional manner through the working lumen of the introducer sheath 400, such that the distal lumen portion 222 can be advanced out of the introducer sheath 400 and into a target location for treatment within the target vessel. In some embodiments and as shown in FIG3 , the proximal extension 230 of the catheter 200 can have an outer diameter that is smaller than the outer diameter of the distal lumen portion 222, forming a proximal spine or tether of the catheter 200. The smaller outer diameter for the proximal extension 230 than the outer diameter of the distal lumen portion 222 allows the larger diameter working lumen of the sheath 400 to maintain a greater suction force than would otherwise be provided by the smaller diameter lumen portion 222 of the catheter 200, or allows a working device to be delivered through the lumen with less friction. The significantly shorter length of lumen portion 222 results in a stepped lumen diameter between lumen portions 222 that are continuous with the working lumen, which provides a significantly increased radius and lumen area for delivering a working device and/or aspirating a clot, particularly compared to other systems in which the aspiration lumen extends along the entire inner diameter of the aspiration catheter. More specifically, the combined lumen area of catheter 200 and the lumen area of the working lumen proximal to distal lumen portion 222 is greater than the lumen area of a large-bore catheter along the entire length of the system. This improves the likelihood of removing an embolus during a single aspiration attempt. More specifically, the stepped lumen diameter along proximal extension 230 enables greater aspiration force, resulting in improved aspiration of an embolus. Furthermore, this configuration of catheter 200 and proximal extension 230 significantly accelerates the time required to retract and re-advance the catheter 200 and/or working device through the working lumen and out of distal lumen 408. This represents the time it takes to aspirate an occlusion. The proximal extension 230 of the catheter 200 has a length and structure that extends through the working lumen of the guide sheath 400 to the proximal end of the system 100, so that the proximal extension 230 can be used to advance and retract the catheter 200 through the working lumen. However, the proximal extension 230 of the catheter 200 only occupies a portion of the luminal space of the system 100, which results in an increased luminal area for aspiration and/or delivery of working devices. The stepped luminal diameter also increases the annular area that can be used for forward flushing of contrast, saline or other solutions, while devices such as microcatheters or other devices can be coaxially positioned in the luminal portion 222 and/or working lumen of the catheter 200. This can improve the ease and ability to perform angiography during device navigation.
在实施方案中，导管200的远端管腔部222被构造为挠性且润滑的，以便能够安全地导航到目标位置。远端管腔部222在经受高抽吸力时可以是抗扭结和抗塌陷的，以便能够有效地抽吸凝块。管腔部222可以具有朝向远端的增加的挠性，沿着其长度具有平滑的材料过渡，以防止其结构中的任意扭结、异常弯曲形成或急剧弯曲，例如，在严重异常弯曲形成(诸如具有90°或更大至180°转弯的严重异常弯曲形成)的导航期间，例如就像在颈动脉虹吸部中一样地在主动脉-髂骨接合处、来自主动脉的左锁骨下动脉引出点、来自升主动脉的头臂(无名)动脉的引出点以及许多其他周边位置处。远端管腔部222可以从在其与近端延伸部230的接合处附近更不挠性过渡到在最远端处更挠性。从远端管腔部222的近端到远端的挠性的变化可以由如这里描述的各种方法中的任意一个来实现。例如，远端管腔部222的第一部分可以由沿着第一长度具有硬度72D的材料形成，第二部分可以由沿着第二长度具有硬度55D的材料形成，第三部分可以由沿着第三长度具有硬度40D的材料形成，第四部分可以由沿着第四长度具有硬度35D的材料形成，第五部分可以由沿着第五长度具有硬度25D的材料形成，第六部分可以由沿着第六长度具有硬度85A的诸如Tecoflex的材料形成，并且导管的最终远端部可以由具有硬度80A的诸如Tecoflex的材料形成。在一些实施方案中，导管200的远端管腔部222的最终远端部可以由具有硬度62A的诸如Tecothane的材料形成，该材料在硬度上与导管前进元件300的区域匹配，下面将更详细地描述该导管前进元件。由此，远端管腔部222从在其与近端延伸部230的接合处附近更不挠性过渡到在最远端处更挠性，例如导管前进元件300的远尖端可以从该最远端延伸。应当理解，这里描述的其他手术导管可以具有类似的构造，如这里将在别处描述的，该构造提供从导管的近端向远端过渡的可变相对刚度。In an embodiment, the distal lumen portion 222 of the catheter 200 is constructed to be flexible and lubricated so as to enable safe navigation to the target location. The distal lumen portion 222 can be kink-resistant and anti-collapse when subjected to high suction forces so as to enable effective aspiration of clots. The lumen portion 222 can have increasing flexibility toward the distal end, with a smooth material transition along its length to prevent any kinking, abnormal bend formation or sharp bends in its structure, for example, during navigation of severe abnormal bend formations (such as severe abnormal bend formations with 90° or greater to 180° turns), for example, at the aorta-iliac junction, the left subclavian artery exit point from the aorta, the brachiocephalic (innominate) artery exit point from the ascending aorta, and many other peripheral locations, as in the carotid siphon. The distal lumen portion 222 can transition from being more inflexible near its junction with the proximal extension 230 to being more flexible at the distal end. The variation in flexibility from the proximal end to the distal end of the distal lumen portion 222 can be achieved by any of a variety of methods as described herein. For example, a first portion of the distal lumen portion 222 can be formed from a material having a durometer of 72D along a first length, a second portion can be formed from a material having a durometer of 55D along a second length, a third portion can be formed from a material having a durometer of 40D along a third length, a fourth portion can be formed from a material having a durometer of 35D along a fourth length, a fifth portion can be formed from a material having a durometer of 25D along a fifth length, a sixth portion can be formed from a material such as Tecoflex having a durometer of 85A along a sixth length, and the final distal portion of the catheter can be formed from a material such as Tecoflex having a durometer of 80A. In some embodiments, the final distal portion of the distal lumen portion 222 of the catheter 200 can be formed from a material such as Tecothane having a durometer of 62A, which matches the durometer of a region of the catheter advancing element 300, which will be described in more detail below. Thus, the distal lumen portion 222 transitions from being more inflexible near its junction with the proximal extension 230 to being more flexible at the distal-most end, from which, for example, the distal tip of the catheter advancing element 300 may extend. It should be understood that other surgical catheters described herein may have similar configurations, as will be described elsewhere herein, that provide a variable relative stiffness transitioning from the proximal end to the distal end of the catheter.
远端管腔部222包括两层或更多层。在一些实施方案中，远端管腔部222包括内润滑衬里、增强层以及外护套层，将更详细地描述它们中的每一个。The distal lumen portion 222 includes two or more layers. In some embodiments, the distal lumen portion 222 includes an inner lubricious lining, a reinforcement layer, and an outer jacket layer, each of which will be described in more detail.
润滑内衬可以是PTFE衬里，沿着可变的挠性段具有一个或多个厚度。PTFE衬里可以是通过浸涂或薄膜浇铸可去除心轴(例如如领域中已知的镀银铜丝)形成的管状衬里。可以应用具有不同厚度的各种层。例如，可以形成具有约0.005”厚度的蚀刻PTFE的基层。在基层上方可以形成第二中间层，该第二中间层是具有约0.0004”厚度的Tecoflex SG-80A。在中间层上方可以形成第三顶层，该第三顶层是具有约0.0001”或更小的厚度的TecoflexSG-93A。在由轴向伸长去除心轴之前，可以将增强层和/或增强纤维应用到内衬，然后是外护套层和/或另外的外涂层。The lubricated liner can be a PTFE liner having one or more thicknesses along a variable flexible section. The PTFE liner can be a tubular liner formed by dip coating or film casting a removable mandrel (e.g., silver-plated copper wire as known in the art). Various layers having different thicknesses can be applied. For example, a base layer of etched PTFE having a thickness of approximately 0.005" can be formed. A second intermediate layer can be formed over the base layer, which is Tecoflex SG-80A having a thickness of approximately 0.0004". A third top layer can be formed over the intermediate layer, which is Tecoflex SG-93A having a thickness of approximately 0.0001" or less. Reinforcement layers and/or reinforcing fibers can be applied to the liner, followed by an outer jacket layer and/or additional outer coating, prior to removal of the mandrel by axial elongation.
增强层是例如由缠绕带或线圈或织带形成的大体管状结构。用于增强结构的材料可以是不锈钢，例如304不锈钢、镍钛诺、钴铬合金或提供强度、挠性以及抗压碎性的期望组合的其他金属合金。在一些实施方案中，远端管腔部222具有增强结构，该增强结构是包裹到线圈中的镍钛诺带。例如，线圈增强可以是锥形的镍钛诺带，该镍钛诺带被设置到特定的内径(例如，0.078”至0.085”内径)并且具有节距(例如，在0.012”与0.016”之间)。带可以是304不锈钢(例如，大约0.012”×0.020”)。在将线圈转移到导管上之前，可以对线圈进行热定形。线圈的节距可以从远端管腔部222的近端朝向远端增大。例如，带式线圈可以在它们之间具有间隙，并且间隙的尺寸可以趋向远端管腔部222的远端增大。例如，带式线圈之间的间隙的尺寸在远端管腔部222的近端附近可以是近似0.016”间隙，并且在远端附近的带式线圈之间的间隙的尺寸可以更大，诸如0.036”间隙。节距的该变化提供了远端管腔部222的最远端附近的增加的挠性。增强结构可以包括多种材料和/或设计，再次沿着远端管腔部222的长度改变挠性。The reinforcement layer is a generally tubular structure formed, for example, from a wound tape or coil or braid. The material used for the reinforcement structure can be stainless steel, such as 304 stainless steel, Nitinol, cobalt-chromium alloy, or other metal alloy that provides a desired combination of strength, flexibility, and crush resistance. In some embodiments, the distal lumen portion 222 has a reinforcement structure that is a Nitinol ribbon wrapped around the coil. For example, the coil reinforcement can be a tapered Nitinol ribbon that is set to a specific inner diameter (e.g., 0.078" to 0.085" inner diameter) and has a pitch (e.g., between 0.012" and 0.016"). The ribbon can be 304 stainless steel (e.g., approximately 0.012" x 0.020"). The coil can be heat-set before being transferred to the catheter. The pitch of the coil can increase from the proximal end toward the distal end of the distal lumen portion 222. For example, the ribbon coils can have gaps between them, and the size of the gaps can increase toward the distal end of the distal lumen portion 222. For example, the size of the gaps between the ribbon coils near the proximal end of the distal lumen portion 222 can be approximately a 0.016" gap, and the size of the gaps between the ribbon coils near the distal end can be larger, such as a 0.036" gap. This variation in pitch provides increased flexibility near the distal-most end of the distal lumen portion 222. The reinforcing structure can include a variety of materials and/or designs, again varying the flexibility along the length of the distal lumen portion 222.
外护套层可以由具有不同硬度、组成和/或厚度的聚合物的离散段组成，以如上所述的改变沿着远端管腔部222的长度的挠性。The outer jacket layer may be composed of discrete segments of polymers having varying durometers, compositions, and/or thicknesses to vary flexibility along the length of the distal lumen portion 222 as described above.
导管200的外表面的至少一部分可以涂布有润滑涂层，诸如亲水涂层。在一些实施方案中，涂层可以在内表面和/或外表面上，以减少跟踪期间的摩擦。涂层可以包括如领域中已知的各种材料。近端延伸部230还可以涂布为改善穿过工作管腔的跟踪。领域中公知合适的润滑聚合物，并且它们可以包括硅酮等、亲水聚合物(诸如高密度聚乙烯(HDPE)、聚四氟乙烯(PTFE)、聚亚芳基氧化物、聚乙烯吡咯烷酮、聚乙烯醇、羟烷基纤维素、藻酸、糖、己内酯、HYDAK涂层(例如，B-23K、HydroSleek)等、以及它们的混合物和组合。亲水聚合物可以相互间混合或与规定量的水不溶性化合物(包括一些聚合物)混合，以产生具有合适的润滑性、结合以及溶解性的涂层。At least a portion of the outer surface of the catheter 200 can be coated with a lubricious coating, such as a hydrophilic coating. In some embodiments, the coating can be on the inner surface and/or the outer surface to reduce friction during tracking. The coating can include various materials as known in the art. The proximal extension 230 can also be coated to improve tracking through the working lumen. Suitable lubricating polymers are well known in the art, and they can include silicones, etc., hydrophilic polymers (such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinyl pyrrolidone, polyvinyl alcohol, hydroxyalkyl cellulose, alginic acid, sugars, caprolactone, HYDAK coatings (e.g., B-23K, HydroSleek), etc., and mixtures and combinations thereof. The hydrophilic polymers can be mixed with each other or with a specified amount of water-insoluble compounds (including some polymers) to produce a coating with suitable lubricity, binding, and solubility.
在实施方案中，远端管腔部222的最远端具有在1500至3000N-mm2范围内的抗挠刚度(E*I)，并且远端管腔部222的剩余部分具有更高的抗挠刚度，其中，E是弹性模量，并且I是装置的面积惯性矩。这些单位为N-mm2的抗弯刚度范围可以通过评估在使用特定长度计将装置偏转特定距离时生成的克力来测量。例如，使用3mm长度测力计并使导管的尖端偏转2mm，可以生成30-60克的力，或者可以在1500-3000N-mm2之间的抗弯刚度范围内。远端管腔部222的挠性可以基于偏转测量和相关计算。作为比较，基于类似的偏转测量和计算的导管前进元件300的挠性可以如下。在2mm偏转和3mm的测力计长度时，导管前进元件300在克力上可以在1-5之间的范围内，或者在抗弯刚度上可以在50-200N-mm2之间的范围内。应当理解，这里描述的其他手术导管可以具有类似的挠性范围，如这里将在别处描述的，该挠性范围提供从导管的近端向远端过渡的可变相对刚度。In an embodiment, the farthest end of the distal lumen portion 222 has a flexural rigidity (E*I) in the range of 1500 to 3000N -mm , and the remainder of the distal lumen portion 222 has a higher flexural rigidity, where E is the elastic modulus, and I is the area moment of inertia of the device. These units are N-mm2 and the flexural rigidity range can be measured by assessing the gram force generated when using a specific length gauge to deflect the device a specific distance. For example, using a 3mm length dynamometer and deflecting the tip of the catheter by 2mm, a force of 30-60 grams can be generated, or can be within the flexural rigidity range of 1500-3000 N-mm2. The flexibility of the distal lumen portion 222 can be based on deflection measurements and related calculations. By comparison, the flexibility of the catheter advancing element 300 based on similar deflection measurements and calculations can be as follows. At 2 mm deflection and a dynamometer length of 3 mm, the catheter advancing element 300 can have a gram-force in the range of 1-5, or a bending stiffness in the range of 50-200 N-mm2. It should be understood that other surgical catheters described herein can have a similar range of flexibility, as will be described elsewhere herein, that provides a variable relative stiffness transitioning from the proximal end to the distal end of the catheter.
再次参照图2A至图2B，导管200的远端管腔部222可以在远尖端区域处具有不透射线标记224a，以辅助荧光透视下的导航和尖端的适当定位。另外，导管200的近端区域可以具有一个或多个近端不透射线标记224b，使得重叠区域348可以被可视化为导鞘400上的不透射线标记411与导管200上的不透射线标记224b之间的关系。在实施方案中，两个不透射线标记(远尖端处的标记224a和更近端标记224b)不同，以便使荧光透视图像的混淆最小化，例如，导管近端标记224b可以是单带，并且导鞘400上的标记411可以是双带，并且借助远端进入系统输送的工作装置上的任意标记可以具有另一种类型的带或标记。远端管腔部222的不透射线标记224(特别是导航极度曲折的解剖结构的远尖端区域附近的标记)可以是较挠性的，使得它们不影响远尖端区域222附近的远端管腔部222的整体挠性。不透射线标记224可以是钨负载或铂负载标记，它们与在挠性不是最重要的装置中使用的其他类型的不透射线标记相比是较挠性的。在一些实施方案中，不透射线标记可以为具有35D硬度的钨负载PEBAX的带。2A to 2B , the distal lumen portion 222 of the catheter 200 can have a radiopaque marker 224a at the distal tip region to assist in navigation and proper positioning of the tip under fluoroscopy. Additionally, the proximal region of the catheter 200 can have one or more proximal radiopaque markers 224b such that an overlap region 348 can be visualized as the relationship between the radiopaque marker 411 on the guide sheath 400 and the radiopaque marker 224b on the catheter 200. In an embodiment, the two radiopaque markers (the marker 224a at the distal tip and the more proximal marker 224b) are different to minimize confusion in the fluoroscopic image, e.g., the catheter proximal marker 224b can be a single band, and the marker 411 on the guide sheath 400 can be a double band, and any marker on the working device delivered by the distal access system can have another type of band or marker. The radiopaque markers 224 of the distal lumen 222 (particularly markers near the distal tip region for navigating extremely tortuous anatomical structures) can be relatively flexible so that they do not affect the overall flexibility of the distal lumen 222 near the distal tip region 222. The radiopaque markers 224 can be tungsten-loaded or platinum-loaded markers, which are relatively flexible compared to other types of radiopaque markers used in devices where flexibility is not paramount. In some embodiments, the radiopaque marker can be a band of tungsten-loaded PEBAX having a hardness of 35D.
如图8B至图8C中最佳示出的，至少一根增强纤维801可以并入在远端管腔部222的壁内，以防止卷曲的增强层803伸长。纤维801可以定位在衬里层805与增强层803之间。纤维801可以沿着导管200的纵向轴线A从远端管腔部222的近端区域延伸到部分222的远端区域。纤维801的近端可以耦接到远端管腔部222的区域，在该区域附近远端管腔部222耦接到近端延伸部的位置。纤维801的远端可以在远端管腔部222的远端附近终止。纤维801的远端可以被捕获在远端标记带224a与增强层803的端之间。远端标记带224a可以完全封装在内衬805与外护套807之间。在一些实施方案中，纤维801的远端在增强层803的最后一个线圈的远端延伸，该线圈在标记带224a下方延伸，然后沿近端方向返回环绕在带224a上。从而，纤维801的自由端被捕获在增强层803和标记带224a下方。由此，增强纤维801终止于增强层803终止的位置，从而留下未增强的最远尖端区域的约10cm-12cm之间的长度。导管200可以包括沿着远端管腔部222纵向延伸的多个增强纤维801，诸如围绕部分222的圆周分布并且与彼此且与导管200的纵向轴线A平行地对齐的两根、三根、四根或更多根纤维801。增强纤维801的材料可以变化，包括但不限于各种高韧度聚合物，像聚酯、PEEK以及其他类似材料。As best shown in Figures 8B-8C, at least one reinforcing fiber 801 can be incorporated into the wall of the distal lumen portion 222 to prevent the curled reinforcement layer 803 from stretching. The fiber 801 can be positioned between the lining layer 805 and the reinforcement layer 803. The fiber 801 can extend along the longitudinal axis A of the catheter 200 from a proximal region of the distal lumen portion 222 to a distal region of the portion 222. The proximal end of the fiber 801 can be coupled to a region of the distal lumen portion 222 near where the distal lumen portion 222 couples to the proximal extension. The distal end of the fiber 801 can terminate near the distal end of the distal lumen portion 222. The distal end of the fiber 801 can be captured between the distal marker band 224a and the end of the reinforcement layer 803. The distal marker band 224a can be completely encapsulated between the liner 805 and the outer sheath 807. In some embodiments, the distal end of the fiber 801 extends distal to the last coil of the reinforcement layer 803, which extends beneath the marker band 224a and then loops back around the band 224a in a proximal direction. Thus, the free end of the fiber 801 is captured beneath the reinforcement layer 803 and the marker band 224a. Thus, the reinforcement fiber 801 terminates where the reinforcement layer 803 terminates, leaving a length of between approximately 10 cm and 12 cm of the distal-most tip region unreinforced. The catheter 200 can include a plurality of reinforcement fibers 801 extending longitudinally along the distal lumen portion 222, such as two, three, four, or more fibers 801 distributed around the circumference of the portion 222 and aligned parallel to each other and to the longitudinal axis A of the catheter 200. The material of the reinforcement fibers 801 can vary, including but not limited to various high-toughness polymers such as polyester, PEEK, and other similar materials.
如之前提及的，近端延伸部230被构造为允许导管200穿过导鞘400的工作管腔的远端前进和近端缩回，包括从远端管腔408穿出。在实施方案中，近端延伸部230的长度比导鞘400的整个长度(从远尖端到近端阀)长诸如约5cm至15cm。主体402的长度可以在80至90cm或多达约100cm或多达约105cm的范围内，并且近端延伸部230的长度可以在90至100cm之间。As previously mentioned, the proximal extension 230 is configured to allow the catheter 200 to be advanced distally and retracted proximally through the working lumen of the guide sheath 400, including exiting the distal lumen 408. In an embodiment, the length of the proximal extension 230 is longer than the entire length of the guide sheath 400 (from the distal tip to the proximal valve), such as about 5 cm to 15 cm. The length of the body 402 can be in the range of 80 to 90 cm, or up to about 100 cm, or up to about 105 cm, and the length of the proximal extension 230 can be between 90 and 100 cm.
再次参照图3，近端延伸部230可以包括一个或多个标记232，以指示导管200的远端管腔部222与鞘主体402之间的重叠以及导管200的远端管腔部222与可以延伸穿过远端管腔部222的其他介入装置之间的重叠。至少第一标记232a可以是RHV接近标记，该接近标记被定位为使得当标记232a在将导管200插入穿过导鞘400期间与鞘近端止血阀434对准时，导管200定位在最远端位置，具有在导管200与工作管腔之间产生密封所需的最小重叠长度。至少第二标记232b可以是氟保护标记，该标记可以定位在近端延伸部230上并且位于离远端管腔部222的远尖端一距离。在一些实施方案中，标记232可以定位为离远端管腔部222的远尖端大约100cm。3 , the proximal extension 230 can include one or more markings 232 to indicate overlap between the distal lumen portion 222 of the catheter 200 and the sheath body 402, as well as overlap between the distal lumen portion 222 of the catheter 200 and other interventional devices that may extend through the distal lumen portion 222. At least a first marking 232a can be an RHV proximity marking positioned such that when the marking 232a aligns with the sheath proximal hemostasis valve 434 during insertion of the catheter 200 through the introducer sheath 400, the catheter 200 is positioned in the most distal position, with the minimum overlap length required to create a seal between the catheter 200 and the working lumen. At least a second marking 232b can be a fluorine shield marking positioned on the proximal extension 230 at a distance from the distal tip of the distal lumen portion 222. In some embodiments, the marking 232 can be positioned approximately 100 cm from the distal tip of the distal lumen portion 222.
近端延伸部230可以包括抓握特征，诸如近端上的突片234，该特征使得近端延伸部230易于抓住并前进或缩回。如下面将更详细描述的，突片234可以与系统的一个或多个其他部件耦接。近端突片234可以被设计为可在可以插入鞘近端阀434中的任意其他装置(诸如导丝或可收回的支架装置丝)中容易地识别。近端延伸部230和/或突片234的一部分可以着色为亮色，或者用亮色标记，以使得它可与导丝、可收回支架栓绳等容易地区分。在以嵌套样式一起使用多个导管200来到达大脑内的更远端位置的情况下，可以颜色编码或以其他方式标记各近端延伸部230和/或突片234，以向操作者清楚地示出它耦接到哪个导管200的哪个近端延伸部230。导管前进元件300的近端部366还可以包括将其与导管200的近端延伸部230区分的颜色。The proximal extension 230 may include a gripping feature, such as a tab 234 on the proximal end, that makes it easier to grasp and advance or retract the proximal extension 230. As will be described in more detail below, the tab 234 may be coupled to one or more other components of the system. The proximal tab 234 may be designed to be easily identifiable from any other device (such as a guidewire or retractable stent device wire) that may be inserted into the sheath proximal valve 434. A portion of the proximal extension 230 and/or tab 234 may be colored or marked with a bright color so that it can be easily distinguished from a guidewire, retractable stent tether, etc. In the case of using multiple catheters 200 together in a nested pattern to reach more distal locations within the brain, each proximal extension 230 and/or tab 234 may be color-coded or otherwise marked to clearly indicate to the operator which proximal extension 230 of which catheter 200 it is coupled to. The proximal portion 366 of the catheter advancing element 300 may also include a color that distinguishes it from the proximal extension 230 of the catheter 200 .
突片234可以与近端毂集成或者除了近端毂之外，还集成突片，该近端毂耦接到近端延伸部230的近端。例如，如下面将更详细描述的，近端延伸部230可以是具有管腔的海波管。海波管的管腔可以在近端延伸部230的近端处与近端毂流体连通，使得抽吸力和/或流体可以经由近端毂借助海波管输送。Tab 234 can be integrated with or in addition to a proximal hub that is coupled to the proximal end of proximal extension 230. For example, as will be described in more detail below, proximal extension 230 can be a hypotube having a lumen. The lumen of the hypotube can be in fluid communication with the proximal hub at the proximal end of proximal extension 230, such that suction and/or fluid can be delivered via the proximal hub through the hypotube.
近端延伸部230可以构造有足够的刚度，以允许导管200的远端管腔部222的前进和缩回，然而也是足够挠性，以在不扭结的情况下根据需要导航穿过大脑解剖结构。近端延伸部230的构造可以变化。在一些实施方案中，近端延伸部230可以是管状元件，该元件具有与远端管腔部222的外径大致相同的外径，这类似于典型的导管装置。在其他实施方案中，近端延伸部230的外径如上所述的被定尺为避免占据导鞘400的管腔中的太多管腔面积。The proximal extension 230 can be constructed with sufficient rigidity to allow advancement and retraction of the distal lumen 222 of the catheter 200, yet also flexible enough to navigate through the brain anatomy as needed without kinking. The configuration of the proximal extension 230 can vary. In some embodiments, the proximal extension 230 can be a tubular element having an outer diameter that is approximately the same as the outer diameter of the distal lumen 222, similar to a typical catheter device. In other embodiments, the outer diameter of the proximal extension 230 is sized as described above to avoid occupying too much lumen area in the lumen of the guide sheath 400.
近端延伸部230可以是实心金属丝，该金属丝为圆形、矩形、梯形、D形或椭圆形横截面形状(参见图4A至图4G)。近端延伸部230可以是具有如图4A所示的矩形横截面形状的扁平化的丝带。扁平化的丝带还可以具有正方形、矩形或其他横截面形状。丝带可以弯曲成圆形、椭圆形、c形或四分之一圆形或沿着弧形的其他横截面区域。由此可见，带的面向内的表面可以大致平坦，并且带的面向外的表面(即，被构造为抵靠其延伸穿过的进入鞘的内径的表面)可以是大致弯曲(参见图4F至图4G)。表面的曲率可以大致匹配进入鞘的内表面的曲率。产生的这种带的横截面形状可以大体为梯形。带的整体尺寸可以取决于其横截面形状和远端管腔部的尺寸而变化。0.054”尺寸的导管200可以具有横截面为梯形或D形的近端延伸部230。面向内的平坦表面可以具有近似0.020”宽的宽度，并且在梯形形状实施方案的情况下，面向外的弯曲表面可以沿着近似0.030”长的弧形延伸。0.070”尺寸的导管200可以具有横截面为梯形或D形的近端延伸部，并且面向内的平坦表面的宽度略大，例如，近似0.025”，并且在梯形形状的实施方案的情况下，面向外的弯曲表面可以沿着近似0.040”长的弧形延伸。0.088”尺寸的导管200可以具有横截面为梯形或D形的近端延伸部，并且面向内的平坦表面的宽度为近似0.035”，并且梯形形状的实施方案的面向外的弯曲表面可以沿着近似0.050”长的弧形延伸。The proximal extension 230 can be a solid metal wire having a circular, rectangular, trapezoidal, D-shaped or elliptical cross-sectional shape (see Figures 4A to 4G). The proximal extension 230 can be a flattened ribbon with a rectangular cross-sectional shape as shown in Figure 4A. The flattened ribbon can also have a square, rectangular or other cross-sectional shape. The ribbon can be bent into a circular, elliptical, C-shaped or quarter-circular shape or other cross-sectional areas along an arc. As can be seen, the inwardly facing surface of the band can be roughly flat, and the outwardly facing surface of the band (i.e., the surface of the inner diameter of the entry sheath that is configured to extend against it) can be roughly curved (see Figures 4F to 4G). The curvature of the surface can roughly match the curvature of the inner surface of the entry sheath. The cross-sectional shape of the resulting band can be roughly trapezoidal. The overall size of the band can vary depending on its cross-sectional shape and the size of the distal lumen. A 0.054" size catheter 200 can have a proximal extension 230 that is trapezoidal or D-shaped in cross-section. The inward-facing flat surface can have a width that is approximately 0.020" wide, and in the case of a trapezoidal-shaped embodiment, the outward-facing curved surface can extend along an arc that is approximately 0.030" long. A 0.070" size catheter 200 can have a proximal extension that is trapezoidal or D-shaped in cross-section, and the width of the inward-facing flat surface is slightly larger, for example, approximately 0.025", and in the case of a trapezoidal-shaped embodiment, the outward-facing curved surface can extend along an arc that is approximately 0.040" long. A 0.088" size catheter 200 can have a proximal extension that is trapezoidal or D-shaped in cross-section, and the width of the inward-facing flat surface is approximately 0.035", and in the case of a trapezoidal-shaped embodiment, the outward-facing curved surface can extend along an arc that is approximately 0.050" long.
近端延伸部230可以是中空丝，该中空丝具有延伸穿过它的管腔235，诸如如图4B所示的海波管。海波管可以具有椭圆形或圆形形状。在实施方案中，近端延伸部230是具有约0.012”×0.020”的尺寸的不锈钢带。在实施方案中，近端延伸部230是具有约0.014”×0.020”的尺寸的不锈钢带。在实施方案中，近端延伸部230是具有从0.014”至0.018”的尺寸的圆形丝。在另一个实施方案中，近端延伸部230是带，该带具有在从0.010”至0.015”厚、以及0.015”厚至0.025”厚的范围内的尺寸。在实施方案中，近端延伸部230是由扁平化的刚性材料带形成的海波管，该材料被轧制成管状，以具有管腔235。在一些实施方案中，近端延伸部230可以由扁平化的不锈钢带形成，并且被轧制成海波管，使得在将海波管修改成椭圆形横截面形状之前，近端延伸部230具有约0.007”的壁厚、约0.004”的内径以及约0.018”的外径。椭圆化海波管可以维持沿着至少第一尺寸为至少0.001”的内径和沿着至少第一尺寸为至少0.015”的外径。在实施方案中，近端延伸部230材料是金属(诸如不锈钢或镍钛诺)以及塑料(诸如各种聚合物中的任意一个)。在实施方案中，近端延伸部230是具有椭圆形横截面形状的不锈钢海波管(参见图4B)。椭圆形管状形状可以增加近端延伸部230的柱强度、可推动性以及抗扭结性，以便改善穿过曲折的解剖结构的前进。椭圆形海波管的横截面积使导管200对其他工具穿过鞘400的工作管腔的移动的影响最小化。图4C例示了鞘400的工作管腔的剖面图，该工作管腔具有延伸穿过其的近端部230。近端部230具有矩形横截面形状。图4D例示了工作管腔的剖面图，该工作管腔具有延伸穿过其的椭圆化海波管近端部230和导管前进元件300。图4E例示了矩形带与椭圆形海波管之间的表面积的比较。与矩形带相比，椭圆形海波管具有更小的表面积，这允许例如在施加抽吸力期间穿过工作管腔的更大流速。近端延伸部230的材料、尺寸以及形状可以基于远端管腔部222的材料、尺寸以及形状来选择。例如，近端延伸部230可以是0.012”x0.020”的340不锈钢的矩形带，并且远端管腔部222可以具有约0.054”至约0.072”的内径。在另外的实施方案中，近端延伸部230可以是0.014”x0.020”的340不锈钢的矩形带，并且远端管腔部222可以具有约0.088”的内径。不锈钢带230的额外的重量在使更大内径导管前进而不扭结方面可以是有用的。The proximal extension 230 can be a hollow wire having a lumen 235 extending through it, such as a hypotube as shown in Figure 4B. The hypotube can have an oval or circular shape. In an embodiment, the proximal extension 230 is a stainless steel strip having dimensions of approximately 0.012" x 0.020". In an embodiment, the proximal extension 230 is a stainless steel strip having dimensions of approximately 0.014" x 0.020". In an embodiment, the proximal extension 230 is a round wire having dimensions from 0.014" to 0.018". In another embodiment, the proximal extension 230 is a strip having dimensions ranging from 0.010" to 0.015" thick, and 0.015" thick to 0.025" thick. In an embodiment, the proximal extension 230 is a hypotube formed from a flattened strip of rigid material that is rolled into a tubular shape to have a lumen 235. In some embodiments, the proximal extension 230 can be formed from a flattened stainless steel strip and rolled into a hypotube such that the proximal extension 230 has a wall thickness of approximately 0.007", an inner diameter of approximately 0.004", and an outer diameter of approximately 0.018" prior to modifying the hypotube into an oval cross-sectional shape. The ovalized hypotube can maintain an inner diameter of at least 0.001" along at least a first dimension and an outer diameter of at least 0.015" along at least a first dimension. In embodiments, the proximal extension 230 material is metal (such as stainless steel or nitinol) and plastic (such as any of a variety of polymers). In an embodiment, the proximal extension 230 is a stainless steel hypotube having an elliptical cross-sectional shape (see FIG. 4B ). The elliptical tubular shape can increase the column strength, pushability, and kink resistance of the proximal extension 230 to improve advancement through tortuous anatomical structures. The cross-sectional area of the elliptical hypotube minimizes the effect of the catheter 200 on the movement of other tools through the working lumen of the sheath 400. FIG. 4C illustrates an example of the sheath 400. A cross-sectional view of a working lumen having a proximal portion 230 extending therethrough. The proximal portion 230 has a rectangular cross-sectional shape. FIG4D illustrates a cross-sectional view of a working lumen having an ovalized hypotube proximal portion 230 and a catheter advancement element 300 extending therethrough. FIG4E illustrates a comparison of the surface area between a rectangular band and an oval hypotube. The oval hypotube has a smaller surface area than the rectangular band, which allows for a greater flow rate through the working lumen, for example, during application of a suction force. The material, size, and shape can be selected based on the material, size, and shape of the distal lumen portion 222. For example, the proximal extension 230 can be a 0.012" x 0.020" rectangular strip of 340 stainless steel, and the distal lumen portion 222 can have an inner diameter of approximately 0.054" to approximately 0.072". In other embodiments, the proximal extension 230 can be a 0.014" x 0.020" rectangular strip of 340 stainless steel, and the distal lumen portion 222 can have an inner diameter of approximately 0.088". The additional weight of the stainless steel strip 230 can be useful in enabling larger inner diameter catheters to be advanced without kinking.
现在参照图5A至图5F，导管200的远端管腔部222与近端延伸部230之间的接合可以被构造为允许两个部分之间的挠性的平滑过渡，以便不产生扭结或弱点。远端管腔部222与近端延伸部230之间的接合的平滑过渡还允许装置顺利穿过由导鞘400的工作管腔和导管200的管腔部223的管腔223产生的连续内管腔。在实施方案中，远端管腔部222具有过渡段226，靠近该过渡段，管腔部222耦接到近端延伸部230(参见图5A)。过渡段226可以具有成角度的切口，使得从导鞘400的工作管腔到导管200的内管腔223没有突然的阶梯过渡。成角度的切口可以大体为平面。在另选实施方案中，成角度的切口是弯曲或阶梯式的，以提供更平缓的过渡地带。应当理解，远端管腔部222的近端区域可以相对于导管200的纵向轴线以倾斜方式成角度，使得进入管腔中的近端和近端开口与导管200的纵向轴线成不同于90°的角度，例如在近似0°、5°、10°、15°、20°、25°、30°、35°、40°或45°直到小于90°之间。远端管腔部222的近端区域还可以与导管200的纵向轴线大致垂直地对齐，使得进入管腔中的近端和近端开口与导管200的纵向轴线大致成90°。类似地，远端管腔部222的远端区域可以相对于导管200的纵向轴线以倾斜方式成角度，使得远离管腔223的远端和远端开口与导管200的纵向轴线成不同于90°的角度，例如在近似0°、5°、10°、15°、20°、25°、30°、35°、40°或45°直到小于90°之间。远端管腔部222的远端区域还可以与导管200的纵向轴线大致垂直地对齐，使得进入管腔中的远端和远端开口与导管200的纵向轴线大致成90°。5A to 5F , the engagement between the distal lumen portion 222 and the proximal extension 230 of the catheter 200 can be constructed to allow a smooth transition of flexibility between the two parts so as not to produce kinks or weak points. The smooth transition of the engagement between the distal lumen portion 222 and the proximal extension 230 also allows the device to smoothly pass through the continuous inner lumen produced by the working lumen of the guide sheath 400 and the lumen 223 of the lumen portion 223 of the catheter 200. In an embodiment, the distal lumen portion 222 has a transition section 226, near which the lumen portion 222 is coupled to the proximal extension 230 (see FIG. 5A ). The transition section 226 can have an angled cut so that there is no sudden step transition from the working lumen of the guide sheath 400 to the inner lumen 223 of the catheter 200. The angled cut can be substantially flat. In an alternative embodiment, the angled cut is curved or stepped to provide a smoother transition zone. It should be understood that the proximal region of the distal lumen portion 222 can be angled in an oblique manner relative to the longitudinal axis of the catheter 200 such that the proximal end and the proximal opening into the lumen are at an angle other than 90° to the longitudinal axis of the catheter 200, such as between approximately 0°, 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, or 45°, down to less than 90°. The proximal region of the distal lumen portion 222 can also be aligned substantially perpendicularly to the longitudinal axis of the catheter 200 such that the proximal end and the proximal opening into the lumen are at substantially 90° to the longitudinal axis of the catheter 200. Similarly, the distal region of the distal lumen portion 222 can be angled in an oblique manner relative to the longitudinal axis of the catheter 200 such that the distal end and the distal opening distal to the lumen 223 are at an angle other than 90° to the longitudinal axis of the catheter 200, such as between approximately 0°, 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, or 45°, down to less than 90°. The distal region of the distal lumen portion 222 can also be aligned substantially perpendicularly to the longitudinal axis of the catheter 200 such that the distal end and the distal opening into the lumen are at substantially 90° to the longitudinal axis of the catheter 200.
近端延伸部230可以耦接到导管200的近端区域和/或可以沿着远端管腔部222的至少一部分延伸，使得近端延伸部230耦接到远端管腔部222远离近端一距离。近端延伸部230可以由各种机制耦接到远端管腔部222，这些机制包括结合、焊接、胶合、夹持、串接、拴住或系牢组成近端延伸部230和/或部分222的一个或多个部件。远端管腔部222和近端延伸部230可以由焊接结合、机械结合、粘结结合或其某一组合来接合。在一些实施方案中，近端延伸部230和管腔部222通过将近端延伸部230夹在远端管腔部222的层之间来耦接在一起。例如，近端延伸部230可以是海波管或具有远端的杆，该远端被削薄、研磨或切割，使得远端可以在近端区域附近层压或以其他方式附接到导管部222的层。近端延伸部230的远端与部分222之间的重叠的区域可以是至少约1cm。这种类型的耦接允许从近端延伸部230到管腔部222的平滑且均匀的过渡。The proximal extension 230 can be coupled to the proximal region of the catheter 200 and/or can extend along at least a portion of the distal lumen portion 222 such that the proximal extension 230 is coupled to the distal lumen portion 222 a distance away from the proximal end. The proximal extension 230 can be coupled to the distal lumen portion 222 by various mechanisms, including bonding, welding, gluing, clamping, stringing, tying, or fastening one or more components comprising the proximal extension 230 and/or portion 222. The distal lumen portion 222 and the proximal extension 230 can be joined by a welded bond, a mechanical bond, an adhesive bond, or some combination thereof. In some embodiments, the proximal extension 230 and the lumen portion 222 are coupled together by sandwiching the proximal extension 230 between layers of the distal lumen portion 222. For example, the proximal extension 230 can be a hypotube or a rod having a distal end that is thinned, ground, or cut so that the distal end can be laminated or otherwise attached to a layer of the catheter portion 222 near the proximal region. The area of overlap between the distal end of the proximal extension 230 and the portion 222 can be at least about 1 cm. This type of coupling allows for a smooth and uniform transition from the proximal extension 230 to the lumen portion 222.
仍然参照图5A至图5F，远端管腔部222的过渡段226可以向上开口到槽238中，该槽238在过渡段226的近端延伸一长度。在一些实施方案中，槽238具有大致弯曲的横截面几何结构。例如，槽238可以沿着导管200的纵向轴线的弧形延伸大约20至大约90度。在一些实施方案中，槽238弯曲，以产生漏斗形状，并且辅助将导管前进元件300装载和重新装载到导管200的管腔中。在其他实施方案中，槽238的边缘弯曲，使得槽238大致不平坦。弯曲形状可以变化，包括泪滴形状，该形状允许平滑过渡并且更好地将导管前进元件300装载/重新装载到管腔中并避免平坦边缘，该平坦边缘随着插入而可以紧靠并捕捉部件。在其他实施方案中，槽238大致平坦。当装置被迫弯曲时，槽238可以在远端管腔部222与近端延伸部230之间提供平滑过渡。这可以降低扭结的可能性并促进推撞阻力。Still referring to Figures 5A to 5F, the transition section 226 of the distal lumen portion 222 can open upward into a groove 238 that extends a length proximal to the transition section 226. In some embodiments, the groove 238 has a generally curved cross-sectional geometry. For example, the groove 238 can extend approximately 20 to approximately 90 degrees along the arc of the longitudinal axis of the catheter 200. In some embodiments, the groove 238 is curved to create a funnel shape and assist in loading and reloading the catheter advancing element 300 into the lumen of the catheter 200. In other embodiments, the edges of the groove 238 are curved, making the groove 238 generally uneven. The curved shape can vary, including a teardrop shape, which allows for a smooth transition and better loading/reloading of the catheter advancing element 300 into the lumen and avoids flat edges that can abut and catch components as they are inserted. In other embodiments, the groove 238 is generally flat. When the device is forced to bend, the groove 238 can provide a smooth transition between the distal lumen portion 222 and the proximal extension 230. This can reduce the likelihood of kinking and promote push-resistance.
远端管腔部222的近端区域可以包括一个或多个标记，以在导管前进元件300的装载/重新装载期间在氟下提供可视化。例如，近端区域可以包括为了不透射线性而装载有钨(80％)的Pebax(例如，35D)区域。The proximal region of the distal lumen portion 222 may include one or more markers to provide visualization under fluorine during loading/reloading of the catheter advancing element 300. For example, the proximal region may include a region of Pebax (e.g., 35D) loaded with tungsten (80%) for radiopacity.
近端延伸部230和/或远端管腔部222的远端可以具有在焊接期间促进机械接合的特征，例如纹理化表面、突出特征或切断特征。在热焊接过程期间，所述特征将促进聚合物远端管腔部222与近端延伸部230之间的机械结合。例如，如图6A至图6F所示，远端管腔部222的近端可以包括短配套套管240，该套管耦接到远端管腔部222的近端边缘221。套管240可以包括在近端开口242与远端开口241之间延伸的内管腔。近端延伸部230的远端可以插入穿过近端开口242和套管240的内管腔内，以将近端延伸部230耦接到远端管腔部222。在一些实施方案中，近端延伸部230可以与远端管腔部222耦接，使得形成近端延伸部230的海波管的远端开口231例如可以借助套管240的远端开口241与远端管腔部222的管腔223连通。套管240还可以与槽238类似地在远端管腔部222与近端延伸部230之间提供过渡。远端管腔部222不需要包括配套套管240来与近端延伸部230耦接。例如，近端延伸部230的远端可以插入穿过在远端管腔部222的近端处的槽238的壁(参见图5A、图5E至图5F)。近端延伸部230的远端可以沿着槽238的长度并且沿着远端管腔部222的壁的至少一长度延伸。The distal end of the proximal extension 230 and/or the distal lumen portion 222 can have features that facilitate mechanical engagement during welding, such as a textured surface, protruding features, or cut-off features. These features will facilitate mechanical bonding between the polymeric distal lumen portion 222 and the proximal extension 230 during the thermal welding process. For example, as shown in Figures 6A-6F, the proximal end of the distal lumen portion 222 can include a short mating sleeve 240 that couples to the proximal edge 221 of the distal lumen portion 222. The sleeve 240 can include an inner lumen extending between a proximal opening 242 and a distal opening 241. The distal end of the proximal extension 230 can be inserted through the proximal opening 242 and the inner lumen of the sleeve 240 to couple the proximal extension 230 to the distal lumen portion 222. In some embodiments, the proximal extension 230 can be coupled to the distal lumen portion 222 such that the distal opening 231 of the hypotube forming the proximal extension 230 can communicate with the lumen 223 of the distal lumen portion 222, for example, via the distal opening 241 of the sleeve 240. The sleeve 240 can also provide a transition between the distal lumen portion 222 and the proximal extension 230, similar to the slot 238. The distal lumen portion 222 need not include a mating sleeve 240 to couple with the proximal extension 230. For example, the distal end of the proximal extension 230 can be inserted through the wall of the slot 238 at the proximal end of the distal lumen portion 222 (see Figures 5A, 5E-5F). The distal end of the proximal extension 230 can extend along the length of the slot 238 and along at least a length of the wall of the distal lumen portion 222.
如上面提及的，导管200的管腔部222可以具有从近端到远端的均匀直径或壁厚，或者管腔部222沿着其长度可以具有不同的外径或壁厚。例如，与远端管腔部222的较近端区域相比，远端管腔部222的最远端可以具有较小的外径。图5A至图5B、图5E至图5F以及图6A至6B、图6E至图6F和图8A示出了远端管腔部222，该远端管腔部具有外径较小的远端管状区域或远端管245，并且近端管状区域或近端管246具有较大的外径。远端管245经由步进部247过渡到近端管246。如图5A和图6A最佳所示，远端管245和近端管246的内径大致相同，这为管腔223提供了平滑的内壁表面。远端管245的外径小于近端管246的外径。步进部247由远端管246与近端管247之间的壁厚的过渡形成。在一些实施方案中，远端管246的外径可以是约0.080”至约0.084”，并且近端管247的外径可以是约0.087”至约0.088”。As mentioned above, the lumen portion 222 of the catheter 200 can have a uniform diameter or wall thickness from the proximal end to the distal end, or the lumen portion 222 can have varying outer diameters or wall thicknesses along its length. For example, the distal-most end of the distal lumen portion 222 can have a smaller outer diameter than the more proximal region of the distal lumen portion 222. Figures 5A-5B, 5E-5F, and Figures 6A-6B, 6E-6F, and 8A illustrate the distal lumen portion 222 having a distal tubular region or distal tube 245 with a smaller outer diameter and a proximal tubular region or proximal tube 246 with a larger outer diameter. The distal tube 245 transitions to the proximal tube 246 via a step-through portion 247. As best shown in Figures 5A and 6A, the inner diameters of the distal tube 245 and the proximal tube 246 are approximately the same, which provides a smooth inner wall surface for the lumen 223. The outer diameter of the distal tube 245 is smaller than the outer diameter of the proximal tube 246. The step 247 is formed by the transition of the wall thickness between the distal tube 246 and the proximal tube 247. In some embodiments, the outer diameter of the distal tube 246 can be about 0.080" to about 0.084", and the outer diameter of the proximal tube 247 can be about 0.087" to about 0.088".
较大外径近端管246的壁的至少一部分可以是不连续的，使得它包括狭缝236(参见图5A至图5C、图5E至图5F、图6A至图6C以及图6E至图6F)。狭缝236可以沿着近端管246的长度延伸一距离。狭缝236可以从近端管246的边缘221延伸近端管247的长度的至少约2cm。狭缝236可以，但是不需要沿着近端管247的整个长度延伸到步进部247的位置。另外，近端管247可以包括多于一个狭缝236。狭缝236可以在与近端延伸部230的远端与远端管腔部222的壁耦接的位置相对的位置处定位在较大直径的近端管246中。由此可见，嵌入近端管246的壁内的近端延伸部230的远端与狭缝236相对地定位(参见图5C和图6C)。应当理解，狭缝236可以在另一个位置处定位在近端管246周围。At least a portion of the wall of the larger outer diameter proximal tube 246 can be discontinuous such that it includes a slit 236 (see Figures 5A to 5C, 5E to 5F, 6A to 6C, and 6E to 6F). The slit 236 can extend a distance along the length of the proximal tube 246. The slit 236 can extend from the edge 221 of the proximal tube 246 for at least about 2 cm of the length of the proximal tube 247. The slit 236 can, but need not, extend along the entire length of the proximal tube 247 to the location of the stepped portion 247. In addition, the proximal tube 247 can include more than one slit 236. The slit 236 can be located in the larger diameter proximal tube 246 at a location opposite the location where the distal end of the proximal extension 230 couples with the wall of the distal lumen portion 222. As can be seen, the distal end of the proximal extension 230, which is embedded within the wall of the proximal tube 246, is positioned opposite the slit 236 (see Figures 5C and 6C). It should be understood that the slit 236 can be positioned around the proximal tube 246 at another location.
狭缝236可以允许近端管246稍微扩张，使得形成狭缝236的壁的端分开，这在它们之间形成间隙。例如，在将导管200插入穿过鞘400的工作管腔时，外径可以滑动配合地接收，使得至少保留重叠区域348。在例如通过从耦接到导鞘400的近端403的抽吸源施加抽吸借助工作管腔施加抽吸力时，可以通过略微加宽由狭缝236形成的间隙来增强在重叠区域348处提供的密封。这种轻微的扩张提供了近端管246的外径与鞘400的工作管腔的内径之间的更好的密封，因为导管200的壁的外表面可以压在工作管腔的内表面上，这产生导管200与鞘400之间的紧密配合。导管200的外表面与工作管腔的内表面之间的该改进的密封使血液直接穿过远端开口408从血管到工作管腔中的渗漏最小化。由此，近端管246的更大外径与狭缝236组合可以通过适应鞘内径的变化来增强导管200与鞘400之间的密封。狭缝236可以取决于形成狭缝236的壁是否分开一段距离而有效地增加近端管246的外径。形成狭缝236的壁可以彼此分开并增加狭缝的宽度。包括在分开形成狭缝236的壁时的增加宽度的近端管246的外径可以与近端管246插入穿过的鞘的内径相同或更大。这允许单个导管与更大范围的内径兼容。在一些实施方案中，当形成狭缝236的壁彼此紧靠且不存在间隙时，近端管246的外径可以为0.081”。当形成狭缝236的壁彼此分开最大距离时，近端管246的外径可增加至约0.087”。另外，近端管246的增加的壁厚允许在远端管腔部222与导管的近端延伸部230之间产生更鲁棒的接合。The slit 236 can allow the proximal tube 246 to expand slightly, causing the ends of the walls forming the slit 236 to separate, creating a gap therebetween. For example, when the catheter 200 is inserted through the working lumen of the sheath 400, the outer diameter can be received in a sliding fit such that at least the overlap region 348 remains. When suction is applied through the working lumen, for example, by applying suction from a suction source coupled to the proximal end 403 of the introducer sheath 400, the seal provided at the overlap region 348 can be enhanced by slightly widening the gap formed by the slit 236. This slight expansion provides a better seal between the outer diameter of the proximal tube 246 and the inner diameter of the working lumen of the sheath 400 because the outer surface of the wall of the catheter 200 can be pressed against the inner surface of the working lumen, creating a tight fit between the catheter 200 and the sheath 400. This improved seal between the outer surface of the catheter 200 and the inner surface of the working lumen minimizes leakage of blood from the blood vessel directly through the distal opening 408 into the working lumen. Thus, the larger outer diameter of the proximal tube 246, combined with the slit 236, can enhance the seal between the catheter 200 and the sheath 400 by accommodating variations in the inner diameter of the sheath. The slit 236 can effectively increase the outer diameter of the proximal tube 246 depending on whether the walls forming the slit 236 are separated by a distance. The walls forming the slit 236 can separate from each other and increase the width of the slit. The outer diameter of the proximal tube 246, including the increased width when the walls forming the slit 236 are separated, can be the same as or larger than the inner diameter of the sheath through which the proximal tube 246 is inserted. This allows a single catheter to be compatible with a wider range of inner diameters. In some embodiments, when the walls forming the slit 236 are abutted against each other and no gap exists, the outer diameter of the proximal tube 246 can be 0.081". When the walls forming the slit 236 are separated by a maximum distance, the outer diameter of the proximal tube 246 can increase to approximately 0.087". Additionally, the increased wall thickness of the proximal tube 246 allows for a more robust joint between the distal lumen portion 222 and the proximal extension 230 of the catheter.
另外或备选地，鞘400的远尖端406可以包括一个或多个特征，这些特征如这里在别处描述的改善鞘400的工作管腔的内径与导管200的近端区域的外径之间的密封。Additionally or alternatively, the distal tip 406 of the sheath 400 may include one or more features that improve the seal between the inner diameter of the working lumen of the sheath 400 and the outer diameter of the proximal region of the catheter 200 as described elsewhere herein.
导管前进元件Catheter Advancement Element
如上面提及的，远端进入系统100可以但不必包括用于将导管200输送到远端解剖结构的导管前进元件300。应当理解，在这里将导管200描述为与导管前进元件300一起使用或用导管前进元件前进的情况下，导管前进元件300不需要用于将导管200输送到目标位置。例如，这里将考虑其他前进工具，诸如领域中已知的微导管和/或导丝。类似地，导管前进元件300可以一起用于使除了这里描述的导管200之外的其他导管前进。例如，导管前进元件300可以用于输送用于具有急性缺血性中风的患者中的凝块去除的5MAX再灌注导管(Reperfusion Catheter)(加利福尼亚州阿拉米达皮纳姆布勒有限公司)或本领域中已知的其他再灌注导管。尽管这里参照导管200描述了导管前进元件300，但应当理解，导管前进元件可以用于前进其他导管，并且不旨在限制其用途。As mentioned above, the distal access system 100 may, but need not, include a catheter advancement element 300 for delivering the catheter 200 to the distal anatomical structure. It should be understood that while the catheter 200 is described herein as being used with or advanced by the catheter advancement element 300, the catheter advancement element 300 need not be used to deliver the catheter 200 to the target location. For example, other advancement tools, such as microcatheters and/or guidewires known in the art, are contemplated herein. Similarly, the catheter advancement element 300 can be used together to advance other catheters other than the catheter 200 described herein. For example, the catheter advancement element 300 can be used to deliver a 5MAX reperfusion catheter (Reperfusion Catheter) (Pinumbrella, Inc., Alameda, California) for clot removal in patients with acute ischemic stroke, or other reperfusion catheters known in the art. Although the catheter advancement element 300 is described herein with reference to the catheter 200, it should be understood that the catheter advancement element can be used to advance other catheters and is not intended to limit its use.
如上所述，远端进入系统100能够提供到远端目标解剖结构(特别是脑血管的曲折解剖结构)的快速且简单的进入。远端进入导管200的挠性和可输送性允许导管200采取曲折解剖结构的形状并且避免施加产生新的解剖结构的拉直力。即使在存在延伸穿过远端进入导管200的管腔的导管前进元件300时，远端进入导管200也能够实现这一点。由此，导管前进元件300的挠性和可输送性与远端进入导管200的远端管腔部222的挠性和可输送性相等或更好，因为两者都被构造为到达大脑中动脉(MCA)循环而没有沿途清理解剖结构的曲线。As described above, the distal access system 100 is capable of providing rapid and simple access to distal target anatomical structures, particularly the tortuous anatomical structures of the cerebral vessels. The flexibility and deliverability of the distal access catheter 200 allows the catheter 200 to assume the shape of the tortuous anatomical structure and avoid applying straightening forces that create new anatomical structures. The distal access catheter 200 is able to achieve this even in the presence of a catheter advancing element 300 extending through the lumen of the distal access catheter 200. Thus, the flexibility and deliverability of the catheter advancing element 300 are equal to or better than the flexibility and deliverability of the distal lumen portion 222 of the distal access catheter 200 because both are configured to reach the middle cerebral artery (MCA) circulation without clearing the curves of anatomical structures along the way.
导管前进元件300可以包括耦接到近端部366的不可扩张的挠性细长主体360。细长主体360可以接收在导管200的远端管腔部222的内管腔223内并延伸通过该内管腔(参见图2B)。导管前进元件300的远尖端346可以如图2B所示的延伸超过导管200的远端。导管前进元件300的近端部366耦接到细长主体360的近端区域并从其向近端延伸。近端部366可以不如细长主体360挠性，并且被构造为使导管前进元件300的细长主体360在导管200的管腔部222内双向移动以及使导管系统100作为整体移动。细长主体360可以以同轴样式插入穿过管腔部222的内管腔223。细长主体360的至少一个区域的外径可以被定尺为大致填充管腔部222的内管腔223。The catheter advancement element 300 may include a non-expandable flexible elongated body 360 coupled to a proximal portion 366. The elongated body 360 may be received in the inner lumen 223 of the distal end luminal portion 222 of the catheter 200 and extend through this inner lumen (see Figure 2B). The distal tip 346 of the catheter advancement element 300 may extend beyond the distal end of the catheter 200 as shown in Figure 2B. The proximal portion 366 of the catheter advancement element 300 is coupled to the proximal region of the elongated body 360 and extends proximally therefrom. The proximal portion 366 may be less flexible than the elongated body 360 and is configured to make the elongated body 360 of the catheter advancement element 300 move bidirectionally in the luminal portion 222 of the catheter 200 and to move the catheter system 100 as a whole. The elongated body 360 may be inserted through the inner lumen 223 of the luminal portion 222 in a coaxial manner. The outer diameter of at least a region of the elongated body 360 may be sized to substantially fill the inner lumen 223 of the lumen portion 222 .
导管前进元件300的总长度(例如，在近端直到最远尖端之间)可以变化，但通常足够长，以延伸穿过支撑导管200加上至少超过支撑导管200的远端的距离，同时近端部366的至少一长度保持在导鞘400的近端之外。在一些实施方案中，导管前进元件300的总长度为约149cm，并且工作长度为从近端突片或毂到最远尖端的143cm。细长主体360可以具有至少与导管200的管腔部222一样长的长度，但是应当理解，细长主体360可以比管腔部222短，只要至少一长度当细长主体360的远端部在管腔部222的远端延伸时保持在管腔部222内即可。在一些实施方案中，远端管腔部222的轴长度可为约39cm，并且细长主体360的插入长度可以为至少约48.5cm、49cm或约49.5cm。近端部366也可以具有变化的长度。在一些实施方案中，近端部366为约94cm。在管腔部222的远端的远端延伸的远端部可以包括远尖端346，该远尖端346在导管前进元件300的使用期间突出超过管腔部222的远端的一长度。如下面将更详细描述的，被构造为从管腔部222的远端向远端突出的细长主体360的远尖端346辅助导管系统穿过脑血管的曲折解剖结构的导航。耦接到细长主体360并从细长主体360向近端延伸的近端部366可以与导管200的近端延伸部230大体并排对齐。如将在下面更详细地描述的，细长主体360与管腔部222之间的结构可以在导管穿过曲折的解剖结构前进以到达用于远端血管中的治疗的目标位置期间维持，并且辅助防止导管200的远端卡在曲折的分支血管上。The overall length of the catheter advancing element 300 (e.g., from the proximal end to the distal-most tip) can vary, but is generally long enough to extend through the support catheter 200 and at least beyond the distal end of the support catheter 200, while at least a length of the proximal portion 366 remains outside the proximal end of the introducer sheath 400. In some embodiments, the overall length of the catheter advancing element 300 is approximately 149 cm, and the working length is 143 cm from the proximal tab or hub to the distal-most tip. The elongated body 360 can have a length at least as long as the lumen 222 of the catheter 200, but it should be understood that the elongated body 360 can be shorter than the lumen 222, as long as at least a length of the distal portion of the elongated body 360 remains within the lumen 222 when the distal portion of the elongated body 360 extends distally of the lumen 222. In some embodiments, the axial length of the distal lumen 222 can be approximately 39 cm, and the insertion length of the elongated body 360 can be at least approximately 48.5 cm, 49 cm, or approximately 49.5 cm. The proximal portion 366 may also have varying lengths. In some embodiments, the proximal portion 366 is approximately 94 cm. The distal portion, extending distally from the distal end of the lumen portion 222, may include a distal tip 346 that protrudes a certain length beyond the distal end of the lumen portion 222 during use of the catheter advancing element 300. As will be described in greater detail below, the distal tip 346 of the elongated body 360, configured to protrude distally from the distal end of the lumen portion 222, assists in navigating the catheter system through the tortuous anatomy of the cerebral vasculature. The proximal portion 366, coupled to and extending proximally from the elongated body 360, may be generally aligned with the proximal extension 230 of the catheter 200. As will be described in greater detail below, the structure between the elongated body 360 and the lumen portion 222 can be maintained during advancement of the catheter through the tortuous anatomy to reach the target location for treatment in the distal vessel and help prevent the distal end of the catheter 200 from becoming stuck in tortuous branch vessels.
在一些实施方案中，细长主体360可以具有较均匀外径的区域，该区域沿着其长度的至少一部分延伸，并且远尖端346从均匀外径向下逐渐变细。当导管前进元件300插入穿过导管200时，该锥形远尖端346被构造为延伸超过并突出穿过管腔部222的远端，而具有均匀直径的主体360的更近端区域保持在管腔部222内。如所提及的，管腔部222的远端可以是钝的并且在外径的尺寸上没有变化，而远尖端346可以是锥形的，这提供导管系统的整体细长的锥形几何结构。细长主体360的外径还接近管腔部222的内径，使得从细长主体360到管腔部222的外径的步进最小化。使该步进最小化防止当远尖端346沿着在血管解剖结构内折弯并弯曲时，由管腔部222的远端形成的唇部卡在曲折的神经血管上(诸如在眼动脉分支附近的颈动脉虹吸部周围)的问题。在一些实施方案中，管腔部222的内径可以是0.054”，并且细长主体360的外径可以是0.048”，使得它们之间的差是大约0.006”。在一些实施方案中，管腔部222的内径可以是0.070”，并且细长主体360的外径可以是0.062”，使得它们之间的差是大约0.008”。在一些实施方案中，管腔部222的内径可以是0.088”，并且细长主体360的外径可以是0.080”，使得它们之间的差是大约0.008”。在一些实施方案中，管腔部222的内径可以是0.072”，并且细长主体360的外径是0.070”，使得它们之间的差是大约0.002”。在其他实施方案中，细长主体360的外径为0.062”，使得它们之间的差为大约0.010”。尽管细长主体360的外径延伸穿过管腔部222的管腔，但管腔部222和以同轴样式延伸穿过它的细长主体360足够挠性，以导航曲折的解剖结构，这在不扭结且不损坏血管的情况下通向M1或M2动脉的层面。In some embodiments, the elongated body 360 can have a region of relatively uniform outer diameter that extends along at least a portion of its length, and the distal tip 346 tapers downward from the uniform outer diameter. When the catheter advancing element 300 is inserted through the catheter 200, the tapered distal tip 346 is configured to extend beyond and protrude through the distal end of the lumen 222, while the more proximal region of the body 360 having a uniform diameter remains within the lumen 222. As mentioned, the distal end of the lumen 222 can be blunt and have no variation in the size of the outer diameter, while the distal tip 346 can be tapered, which provides the overall elongated tapered geometry of the catheter system. The outer diameter of the elongated body 360 is also close to the inner diameter of the lumen 222, minimizing the step-up in the outer diameter from the elongated body 360 to the lumen 222. Minimizing this step prevents problems with the lip formed by the distal end of the lumen portion 222 catching on tortuous neurovascular vessels (such as around the carotid siphon near the ophthalmic artery bifurcation) as the distal tip 346 bends and curves along the vascular anatomy. In some embodiments, the inner diameter of the lumen portion 222 can be 0.054", and the outer diameter of the elongated body 360 can be 0.048", so that the difference therebetween is approximately 0.006". In some embodiments, the inner diameter of the lumen portion 222 can be 0.070", and the outer diameter of the elongated body 360 can be 0.062", so that the difference therebetween is approximately 0.008". In some embodiments, the inner diameter of the lumen portion 222 can be 0.088", and the outer diameter of the elongated body 360 can be 0.080", such that the difference therebetween is approximately 0.008". In some embodiments, the inner diameter of the lumen portion 222 can be 0.072", and the outer diameter of the elongated body 360 is 0.070", such that the difference therebetween is approximately 0.002". In other embodiments, the outer diameter of the elongated body 360 is 0.062", such that the difference therebetween is approximately 0.010". Although the outer diameter of the elongated body 360 extends through the lumen of the lumen portion 222, the lumen portion 222 and the elongated body 360 extending therethrough in a coaxial fashion are flexible enough to navigate tortuous anatomical structures, which leads to the level of the M1 or M2 artery without kinking and without damaging the vessel.
远尖端346的长度(例如，被构造为在使用期间在导管200的远端的远端延伸的导管前进元件300的区域)可以变化。在一些实施方案中，远尖端346的长度可以在离细长主体360的最远端终点约0.50cm至约3.0cm的范围内。在其他实施方案中，远尖端346的长度为至少约0.8cm。在其他实施方案中，远尖端346的长度在2.0cm至大约2.5cm之间。在一些实施方案中，远尖端236的长度取决于细长主体360的内径变化。例如，远尖端236的长度可以短至0.5cm，并且导管200的内径可以是0.054”。远尖端346可以是从细长主体360的外径向下到最远尖端处的第二更小外径的恒定锥形。在一些实施方案中，远尖端346的恒定锥形可以从约0.048”外径向下到约0.031”外径。在一些实施方案中，远尖端346的恒定锥形可以从0.062”外径到约0.031”外径。在又一些实施方案中，远尖端346的恒定锥形可以从0.080”外径到约0.031”外径。远尖端346的恒定锥形的长度可以变化，例如，在0.8cm至大约2.5cm之间、或者在1cm与3cm之间、或者在2.0cm与2.5cm之间。锥形的角度可以取决于细长主体360的外径变化。例如，锥形相对于水平可以在0.9至1.6度之间。锥形与细长主体360的中心线可以成2-3度角。The length of the distal tip 346 (e.g., the area of the catheter advancing element 300 that is configured to extend distally of the distal end of the catheter 200 during use) can vary. In some embodiments, the length of the distal tip 346 can range from about 0.50 cm to about 3.0 cm from the distal-most end of the elongated body 360. In other embodiments, the length of the distal tip 346 is at least about 0.8 cm. In other embodiments, the length of the distal tip 346 is between 2.0 cm and about 2.5 cm. In some embodiments, the length of the distal tip 236 varies depending on the inner diameter of the elongated body 360. For example, the length of the distal tip 236 can be as short as 0.5 cm, and the inner diameter of the catheter 200 can be 0.054". The distal tip 346 can be a constant taper from the outer diameter of the elongated body 360 downward to a second, smaller outer diameter at the distal-most tip. In some embodiments, the constant taper of the distal tip 346 can be from about 0.048" outer diameter downward to about 0.031" outer diameter. In some embodiments, the constant taper of the distal tip 346 can be from 0.062" outer diameter to about 0.031" outer diameter. In yet other embodiments, In one embodiment, the constant taper of the distal tip 346 can be from a 0.080" outer diameter to approximately a 0.031" outer diameter. The length of the constant taper of the distal tip 346 can vary, for example, between 0.8 cm and approximately 2.5 cm, or between 1 cm and 3 cm, or between 2.0 cm and 2.5 cm. The angle of the taper can vary depending on the outer diameter of the elongated body 360. For example, the taper can be between 0.9 and 1.6 degrees relative to horizontal. The taper can be at an angle of 2-3 degrees to the centerline of the elongated body 360.
应当理解，远尖端346不需要逐渐变细，并且可以由于材料特性而不是由于外尺寸的变化来实现其柔软的、无创伤且挠性的特性，以促进到曲折的解剖结构中的栓子的血管内导航。另外或备选地，细长主体360的远尖端346可以沿着其长度具有挠性过渡。远尖端346的最挠性区域可以是其远端终点。沿着远尖端346的长度从远端终点朝向在远端终点近端的区域移动，挠性可以逐渐接近管腔部222的远端的挠性。例如，远尖端346可以由硬度不超过35D或约62A的材料形成，并且朝向硬度不超过55D和72D的越来越硬的材料向近端过渡直到近端部366，该近端部366可以是不锈钢海波管、或者是材料特性和锥形形状的组合。用于形成细长主体360的区域的材料可以包括具有润滑添加剂化合物(诸如Mobilize(缅因州刘易斯顿复合溶液公司(Compounding Solutions)))的PEBAX(例如PEBAX 25D、35D、55D、72D)。在一些实施方案中，用于形成细长主体360的区域的材料可为Tecothane 62A。将润滑添加剂直接并入到聚合物细长主体中意味着并入单独的润滑衬里(诸如特氟隆衬里)是不必要的。这允许可以导航远端大脑解剖结构且不太可能扭结的更挠性的元件。类似的材料可以用于形成导管200的远端管腔部222，这提供类似的优点。还应当理解，远尖端346的挠性可以由挠性润滑材料和锥形形状的组合来实现。例如，尖端346的长度可以保持短于2cm-3cm，但由于挠性材料从最远尖端朝向离最远尖端一距离的更近端区域的变化而维持最佳输送能力。在实施方案中，细长主体360由PEBAX(聚醚嵌段酰胺)嵌入的硅酮形成，该硅酮被设计为维持最高程度的挠性。应当理解，管腔部222的远端的壁厚还可以制作得足够薄，使得由管腔部222的远端相对于细长主体360形成的唇部被最小化。It should be understood that the distal tip 346 need not taper and can achieve its soft, atraumatic, and flexible properties due to material properties rather than changes in outer dimensions to facilitate intravascular navigation of emboli in tortuous anatomical structures. Additionally or alternatively, the distal tip 346 of the elongated body 360 can have a transition in flexibility along its length. The most flexible region of the distal tip 346 can be its distal terminus. Moving along the length of the distal tip 346 from the distal terminus toward a region proximal to the distal terminus, the flexibility can gradually approach the flexibility of the distal end of the lumen portion 222. For example, the distal tip 346 can be formed from a material having a durometer not exceeding 35D or approximately 62A and transitioning proximally toward increasingly harder materials having a durometer not exceeding 55D and 72D until the proximal portion 366, which can be a stainless steel hypotube, or a combination of material properties and a tapered shape. The material used to form the region of the elongated body 360 can include PEBAX (e.g., PEBAX 25D, 35D, 55D, 72D) with a lubricating additive compound such as Mobilize (Compounding Solutions, Lewiston, Maine). In some embodiments, the material used to form the region of the elongated body 360 can be Tecothane 62A. Incorporating the lubricating additive directly into the polymeric elongated body means that it is unnecessary to incorporate a separate lubricating lining (such as a Teflon lining). This allows for a more flexible element that can navigate distal brain anatomy and is less likely to kink. Similar materials can be used to form the distal lumen portion 222 of the catheter 200, which provides similar advantages. It should also be understood that the flexibility of the distal tip 346 can be achieved by a combination of a flexible lubricating material and a tapered shape. For example, the length of the tip 346 can be kept shorter than 2 cm-3 cm, but maintain optimal delivery capabilities due to the change in flexible material from the distal tip toward a more proximal region a distance from the distal tip. In an embodiment, the elongated body 360 is formed of a PEBAX (polyether block amide) embedded silicone designed to maintain the highest degree of flexibility. It should be understood that the wall thickness of the distal end of the lumen portion 222 can also be made thin enough so that the lip formed by the distal end of the lumen portion 222 relative to the elongated body 360 is minimized.
如上面提及的，细长主体360可以被构造为在细长主体360的远端与近端之间具有可变刚度。细长主体360的挠性在远尖端346的最远端终点处最高，并且可以在挠性上逐渐过渡为接近管腔部222的远端的挠性，该远端通常不如远尖端346的最远端终点挠性。在将导管前进元件300插入穿过导管200时，延伸超过管腔部222的远端的细长主体360的区域可以是最挠性的，并且被构造为在血管中的前进期间与管腔部222的远端对齐的细长主体360的区域可以具有与管腔部222本身的远端大致相同的挠性。由此可见，管腔部222的远端的挠性和就在延伸部(无论是锥形还是没有锥形)的近端的主体360的挠性可以大致相同。这提供了材料特性的平滑过渡，以改善穿过曲折的解剖结构的导管系统的跟踪。进一步地，细长主体360的更近端段可以更不挠性并且越来越刚性。应当理解，细长主体360的挠性变化可以是材料差异、尺寸变化(例如通过逐渐变细)或两者的组合的函数。细长主体360超过微导管的益处在于它可以具有仅比导管200的远端管腔部222的内径小0.003”-0.010”的较大外径，并且仍然为了导航曲折的解剖结构而维持高度挠性。当两个部件之间的间隙太紧(例如，小于约0.003”)时，使导管前进元件300相对于导管200滑动所需的力可能导致对部件中的一个或两个的损坏并增加患者在手术期间的风险。间隙导致配合太紧而不能提供最佳的相对滑动。当两个部件之间的间隙太松(例如，大于约0.010”)时，导管200的远端形成唇部，该唇部在前进穿过曲折的神经血管(诸如在眼动脉分叉的颈动脉虹吸部周围)期间易于卡在分支血管上。As mentioned above, the elongated body 360 can be configured to have variable stiffness between the distal and proximal ends of the elongated body 360. The flexibility of the elongated body 360 is highest at the distal-most terminus of the distal tip 346 and can gradually transition in flexibility to a degree closer to the distal end of the lumen portion 222, which is generally less flexible than the distal-most terminus of the distal tip 346. When the catheter advancing element 300 is inserted through the catheter 200, the region of the elongated body 360 extending beyond the distal end of the lumen portion 222 can be most flexible, and the region of the elongated body 360 configured to align with the distal end of the lumen portion 222 during advancement through the vessel can have approximately the same flexibility as the distal end of the lumen portion 222 itself. Thus, the flexibility of the distal end of the lumen portion 222 and the flexibility of the body 360 immediately proximal to the extension (whether tapered or not) can be approximately the same. This provides a smooth transition in material properties to improve tracking of the catheter system through tortuous anatomies. Further, the more proximal segments of the elongated body 360 can be less flexible and increasingly rigid. It should be understood that the change in flexibility of the elongated body 360 can be a function of material differences, dimensional changes (e.g., by tapering), or a combination of both. The benefit of the elongated body 360 over a microcatheter is that it can have a larger outer diameter that is only 0.003"-0.010" smaller than the inner diameter of the distal lumen portion 222 of the catheter 200 and still maintain a high degree of flexibility for navigating tortuous anatomical structures. When the gap between the two components is too tight (e.g., less than about 0.003"), the force required to slide catheter advancing element 300 relative to catheter 200 may cause damage to one or both of the components and increase risk to the patient during the procedure. The gap results in a fit that is too tight to provide optimal relative sliding. When the gap between the two components is too loose (e.g., greater than about 0.010"), the distal end of catheter 200 forms a lip that is prone to snagging on branch vessels during advancement through tortuous neurovascular vessels, such as around the carotid siphon where the ophthalmic artery bifurcates.
细长主体360与远端管腔部222之间的ID/OD的间隙沿着它们的大部分长度可以在该尺寸范围内(例如0.003”-0.010”)。例如，细长主体360可以具有较均匀的外径，该外径从近端区域到远端区域直到远尖端346的锥形开始的点在约0.048”到约0.080”之间。类似地，导管200的远端管腔部222可以具有较均匀的内径，该内径从近端区域到远端区域在约0.054”至约0.088”之间。由此可见，它们各自的内径和外径之间沿着其大部分长度的差可以在0.003”至0.010”的这样的间隙尺寸范围内。然而，应当理解，锥形的细长主体360的远尖端346相对于远端管腔部222的内径将具有更大的间隙尺寸。然而，在使用期间，该锥形远尖端346被构造为在导管200的远端的远端延伸，使得具有被定尺为与远端管腔部222的内径匹配的外径的细长主体360的区域定位在导管200的管腔内，使得它可以使导管200的远端处的唇部最小化。The ID/OD clearance between the elongated body 360 and the distal lumen portion 222 can be within this size range (e.g., 0.003"-0.010") along most of their lengths. For example, the elongated body 360 can have a relatively uniform outer diameter ranging from about 0.048" to about 0.080" from the proximal region to the distal region until the point where the taper of the distal tip 346 begins. Similarly, the distal lumen portion 222 of the catheter 200 can have a relatively uniform inner diameter ranging from about 0.054" to about 0.088" from the proximal region to the distal region. As can be seen, the difference between their respective inner and outer diameters along most of their lengths can be within this gap size range of 0.003" to 0.010". However, it should be understood that the distal tip 346 of the tapered elongated body 360 will have a larger gap size relative to the inner diameter of the distal lumen portion 222. However, during use, the tapered distal tip 346 is constructed to extend distal to the distal end of the catheter 200 so that a region of the elongated body 360 having an outer diameter sized to match the inner diameter of the distal lumen portion 222 is positioned within the lumen of the catheter 200 so that it can minimize a lip at the distal end of the catheter 200.
细长主体360可以由提供合适的挠性和润滑性的各种材料形成。示例材料包括高密度聚乙烯、72D PEBAX、90D PEBAX或等同刚度和润滑性材料。细长主体360的至少一部分可以被增强，以改善导航和加扭矩(例如，编织增强层)。细长主体360的挠性可以朝向远尖端346增加，使得细长主体360的远端区域比较近端区域更柔软、更挠性并且更容易铰接和弯曲。例如，细长主体的较近端区域可以具有抗弯刚度，该抗弯刚度足够挠性，以在不扭结的情况下导航曲折的解剖结构，诸如颈动脉虹吸部。如果细长主体360沿着其长度的至少一部分具有编织增强层，则编织增强层可以终止于在远尖端346的近端一距离。例如，从织带的端到远尖端的距离可以是约10cm至约15cm或从约4cm至约10cm或从约4cm至约15cm。The elongated body 360 can be formed of various materials that provide suitable flexibility and lubricity. Example materials include high-density polyethylene, 72D PEBAX, 90D PEBAX or equivalent rigidity and lubricity materials. At least a portion of the elongated body 360 can be enhanced to improve navigation and torque (e.g., braided reinforcement layer). The flexibility of the elongated body 360 can be increased toward the distal tip 346 so that the distal region of the elongated body 360 is softer, more flexible and more easily articulated and bent than the proximal region. For example, the proximal region of the elongated body can have a bending stiffness that is flexible enough to navigate tortuous anatomical structures, such as the carotid siphon, without kinking. If the elongated body 360 has a braided reinforcement layer along at least a portion of its length, the braided reinforcement layer can terminate at a distance proximal to the distal tip 346. For example, the distance from the end of the webbing to the distal tip may be from about 10 cm to about 15 cm or from about 4 cm to about 10 cm or from about 4 cm to about 15 cm.
在一些实施方案中，细长主体360可以沿着其长度的至少一部分为大体管状，使得它具有单个管腔368，该管腔平行于导管前进元件300的纵向轴线延伸(参见图7A至图7C以及图10A至图10C)。在实施方案中，细长主体360的单个管腔368被定尺为容纳导丝，然而应当理解，导管前进元件300的使用通常消除对导丝引线的需要。导丝可以从近端开口向导丝可以延伸穿过的远端开口大体同心地延伸穿过单个管腔368。在一些实施方案中，近端开口处于导管前进元件300的近端处，使得导管前进元件300被构造用于丝上(OTW)方法。在其他实施方案中，近端开口是穿过导管前进元件300的壁的快速交换开口362，使得导管前进元件300被构造用于快速交换，而不是用于OTW或除了OTW之外。在该实施方案中，近端开口362延伸穿过细长主体的侧壁，并且定位为离近端突片364一距离且在近端部366的远端(参见图7A至图7B和图7D)。近端开口362可以定位为离远尖端346大约10cm直到离远尖端346大约20cm的距离处。在一些实施方案中，近端开口362可以位于细长本体360接合到近端部366的区域附近，例如，就在海波管的端的远端(参见图7B)。在其他实施方案中，近端开口362更向远端定位，诸如离细长主体360的最远端约10cm至约18cm(参见图7D)。被定位为更靠近远尖端346的近端开口362允许从导管200更容易地去除导管前进元件300，这将导丝留在适当位置，以便进行”快速交换”类型的手术。快速交换仅依赖单人来执行交换。导管前进元件300可以使用保持在适当位置的相同导丝来容易地替换另一个装置。细长主体360的单个管腔368可以被构造为接收直径在0.014”与0.018”范围内、或在0.014”与0.022”之间范围内的导丝。在该实施方案中，细长主体360的内管腔直径可以在0.020”与0.024”之间。导丝、导管前进元件300以及导管200可以全部同轴组装，以便插入穿过导鞘400的工作管腔。细长主体360的管腔368的内径可以是0.019”至大约0.021”。In some embodiments, the elongated body 360 can be generally tubular along at least a portion of its length so that it has a single lumen 368 that extends parallel to the longitudinal axis of the catheter advancement element 300 (see Figures 7A to 7C and Figures 10A to 10C). In an embodiment, the single lumen 368 of the elongated body 360 is sized to accommodate a guidewire, but it should be understood that the use of the catheter advancement element 300 generally eliminates the need for a guidewire. The guidewire can extend generally concentrically through the single lumen 368 from the proximal opening to the distal opening through which the guidewire can extend. In some embodiments, the proximal opening is at the proximal end of the catheter advancement element 300 so that the catheter advancement element 300 is configured for over-the-wire (OTW) methods. In other embodiments, the proximal opening is a rapid exchange opening 362 through the wall of the catheter advancement element 300 so that the catheter advancement element 300 is configured for rapid exchange, rather than for OTW or in addition to OTW. In this embodiment, the proximal opening 362 extends through the side wall of the elongated body and is positioned at a distance from the proximal tab 364 and at the distal end of the proximal portion 366 (see Figures 7A to 7B and 7D). The proximal opening 362 can be positioned at a distance of approximately 10 cm from the distal tip 346 until approximately 20 cm from the distal tip 346. In some embodiments, the proximal opening 362 can be located near the region where the elongated body 360 is joined to the proximal portion 366, for example, just at the distal end of the end of the hypotube (see Figure 7B). In other embodiments, the proximal opening 362 is positioned more distally, such as approximately 10 cm to approximately 18 cm (see Figure 7D) from the distal end of the elongated body 360. The proximal opening 362 positioned closer to the distal tip 346 allows the catheter advancement element 300 to be more easily removed from the catheter 200, which leaves the guidewire in place for the operation of the "rapid exchange" type. Rapid exchange relies only on a single person to perform the exchange. The catheter advancing element 300 can be easily replaced with another device using the same guidewire held in place. The single lumen 368 of the elongated body 360 can be configured to receive a guidewire having a diameter in the range of 0.014" and 0.018", or in the range of between 0.014" and 0.022". In this embodiment, the inner lumen diameter of the elongated body 360 can be between 0.020" and 0.024". The guidewire, catheter advancing element 300, and catheter 200 can all be coaxially assembled for insertion through the working lumen of the guide sheath 400. The inner diameter of the lumen 368 of the elongated body 360 can be 0.019" to approximately 0.021".
图7D示出了被构造为快速交换的导管前进元件300的另一个实施方案。快速交换构造可以显著缩短装置长度，降低人员配置要求，并且减少荧光透视。与这里描述的其他实施方案相同，导管前进元件300可以包括耦接到近端部366的不可扩张的挠性细长主体360，该近端部366耦接到近端突片364或毂375。如本文中在别处描述的，远尖端346附近的区域可以是锥形，使得外径在约1cm至约3cm的长度上逐渐变细。在一些实施方案中，远端锥形长度为2.5cm。在一些实施方案中，远尖端346从约0.080”至约0.031”逐渐变细。同样如本文中在别处描述的，远尖端346可以由具有硬度(例如，62A和35D)的材料形成，该材料向近端朝向具有(例如，55D和72D)的越来越硬的材料过渡直到近端部366。例如，图7D例示了包括远尖端346的细长主体360的段371可以具有35D的硬度和约10cm至约12.5cm的长度。包括远尖端346的细长主体360的段371可以具有62A的硬度和约10cm至约12.5cm的长度。细长主体360的段372可以具有55D的硬度并且具有约5cm至约8cm的长度。细长主体360的段373可以具有72D的硬度，在长度上可以为约25cm至约35cm。组合的三个段371、372、373可以形成细长主体360的插入长度，近端部366从该插入长度向长度可以是约49cm的远尖端346的终点耦接到细长主体360。7D shows another embodiment of a catheter advancement element 300 configured as a rapid exchange. The rapid exchange configuration can significantly shorten the device length, reduce staffing requirements, and reduce fluoroscopy. Identical to other embodiments described herein, the catheter advancement element 300 can include a non-expandable flexible elongated body 360 coupled to a proximal portion 366, which is coupled to a proximal tab 364 or hub 375. As described elsewhere herein, the area near the distal tip 346 can be tapered so that the outer diameter tapers over a length of about 1 cm to about 3 cm. In some embodiments, the distal taper length is 2.5 cm. In some embodiments, the distal tip 346 tapers from about 0.080 " to about 0.031 ". Also as described elsewhere herein, the distal tip 346 can be formed of a material having a hardness (e.g., 62A and 35D), which transitions toward a harder and harder material having (e.g., 55D and 72D) toward the proximal end until the proximal portion 366. 7D illustrates that the segment 371 of the elongated body 360 including the distal tip 346 can have a hardness of 35D and a length of about 10 cm to about 12.5 cm. The segment 371 of the elongated body 360 including the distal tip 346 can have a hardness of 62A and a length of about 10 cm to about 12.5 cm. The segment 372 of the elongated body 360 can have a hardness of 55D and a length of about 5 cm to about 8 cm. The segment 373 of the elongated body 360 can have a hardness of 72D and can be about 25 cm to about 35 cm in length. The three segments 371, 372, 373 combined can form the insertion length of the elongated body 360, from which the proximal portion 366 is coupled to the elongated body 360 to the end of the distal tip 346, which can be about 49 cm in length.
图10A至图10C例示了并入增强层380的导管前进元件300的实施方案。如上面提及的，增强层380可以是织带或其他类型的增强，以改善导管前进元件300的可扭转性并且帮助桥接具有这种挠性差异的导管前进元件300的部件。增强层380可以桥接从刚性近端部366到挠性细长主体360的过渡。在一些实施方案中，增强层380可以是定位在Pebax 382、384的内层与外层之间的织带(参见图10C)。增强层380可以终止于在远尖端区域346的近端一距离。例如，图10A例示了细长主体360，该细长主体具有段371和位于段371近端的段373。段371可以包括具有最多约35D的硬度的远尖端346。段371是未增强的聚合物，该聚合物具有约4cm直到约12.5cm的长度。位于段371近端的细长主体360的段373可以包括增强层380，并且可以延伸总共约37cm直到未增强的远端段371。增强层380的近端区域可以与近端部366的远端区域重叠，使得海波管与增强的小重叠存在于近端部366与细长主体360之间的过渡附近。10A to 10C illustrate an embodiment of a catheter advancement element 300 incorporating a reinforcement layer 380. As mentioned above, the reinforcement layer 380 can be a webbing or other type of reinforcement to improve the torquability of the catheter advancement element 300 and help bridge components of the catheter advancement element 300 that have such flexibility differences. The reinforcement layer 380 can bridge the transition from the rigid proximal portion 366 to the flexible elongated body 360. In some embodiments, the reinforcement layer 380 can be a webbing positioned between the inner and outer layers of Pebax 382, 384 (see FIG. 10C ). The reinforcement layer 380 can terminate at a distance proximal to the distal tip region 346. For example, FIG. 10A illustrates an elongated body 360 having a segment 371 and a segment 373 located proximal to the segment 371. The segment 371 can include a distal tip 346 having a hardness of up to about 35D. Segment 371 is an unreinforced polymer having a length of about 4 cm up to about 12.5 cm. Segment 373 of the elongated body 360 located proximal to segment 371 may include a reinforcement layer 380 and may extend a total of about 37 cm to the unreinforced distal segment 371. The proximal region of the reinforcement layer 380 may overlap with the distal region of the proximal portion 366, such that a small overlap of the hypotube and reinforcement exists near the transition between the proximal portion 366 and the elongated body 360.
再次参照图7D，用于手术导丝805的进入端口362可以定位为离细长主体360的最远端一距离。在一些实施方案中，进入/离开端口362可以与最远端相距约18cm，这产生快速交换丝进入/离开段370。段370(段371和372)内的细长主体360的外径可以是约0.080”-0.082”，而在该快速交换丝进入/离开段370的近端的段373可以具有外径的步降，诸如约0.062”-0.064”。7D , the entry port 362 for the surgical guide wire 805 can be positioned a distance from the distal-most end of the elongated body 360. In some embodiments, the entry/exit port 362 can be approximately 18 cm from the distal-most end, which creates a rapid exchange wire entry/exit segment 370. The outer diameter of the elongated body 360 within segments 370 (segments 371 and 372) can be approximately 0.080"-0.082", while segment 373 at the proximal end of the rapid exchange wire entry/exit segment 370 can have a step-down in outer diameter, such as approximately 0.062"-0.064".
在其他实施方案中，整个导管前进元件300可以是管状元件，该元件被构造为借助近端部366以及细长主体360接收导丝。例如，近端部366可以是海波管或具有管腔的管状元件，该管腔与延伸穿过细长主体360的管腔368连通(图3示出)。在一些实施方案中，近端部366可以是涂布有外径为0.026”的PTFE的不锈钢的削薄海波管。在其他实施方案中，外径可以在0.024”与0.030”之间。在一些实施方案中，诸如丝上版本，近端部366可以是耦接到近端毂375的削薄海波管。近端部366可以与远端管腔部222偏心或同心地延伸。如图7E中最佳示出的，近端部366可以是如这里在别处描述的不锈钢海波管。近端部366可以是圆形或椭圆形横截面形状的实心金属丝。如这里在别处描述的，近端部366可以是具有矩形横截面形状的扁平化的丝带。丝带可以弯曲成圆形、椭圆形、c形或四分之一圆形或沿着弧形的其他横截面形状。近端部366可以具有各种横截面形状中的任意一种，而无论管腔是否延伸穿过该形状，这些形状包括圆形、椭圆形、C形、D形或其他形状。在一些实施方案中，近端部366是具有D形的海波管，使得面向内侧是平坦的，并且面向外侧是圆形的。近端部366的圆形侧可以成形为与鞘400的对应圆形内表面啮合。海波管可以具有润滑涂层，诸如PTFE。海波管可以具有约0.021”的内径、约0.0275”的外径以及约94cm的总长度，该总长度为导管前进元件300提供约143cm的工作长度。包括近端毂375，导管前进元件300可以具有约149cm的总长度。在一些实施方案中，海波管可以是具有约100mm长度的锥形部分，该部分以0.3mm的厚度在近端开始，并且以0.10mm至0.15mm的厚度结束。在又一些实施方案中，细长主体360可以是耦接到近端部366的实心元件，该实心元件没有导丝管腔。In other embodiments, the entire catheter advancing element 300 can be a tubular element configured to receive a guidewire via the proximal portion 366 and the elongated body 360. For example, the proximal portion 366 can be a hypotube or a tubular element having a lumen that communicates with a lumen 368 extending through the elongated body 360 (shown in FIG. 3 ). In some embodiments, the proximal portion 366 can be a skived hypotube of stainless steel coated with PTFE having an outer diameter of 0.026". In other embodiments, the outer diameter can be between 0.024" and 0.030". In some embodiments, such as over-the-wire versions, the proximal portion 366 can be a skived hypotube coupled to a proximal hub 375. The proximal portion 366 can extend eccentrically or concentrically with the distal lumen portion 222. As best shown in FIG. 7E , the proximal portion 366 can be a stainless steel hypotube as described elsewhere herein. The proximal portion 366 can be a solid wire of circular or elliptical cross-sectional shape. As described elsewhere herein, the proximal portion 366 can be a flattened ribbon having a rectangular cross-sectional shape. The ribbon can be bent into a circular, elliptical, c-shaped, or quarter-circular or other cross-sectional shapes along an arc. The proximal portion 366 can have any of a variety of cross-sectional shapes, whether or not the lumen extends through the shape, including circular, elliptical, or c-shaped. shaped, C-shaped, D-shaped or other shapes. In some embodiments, the proximal portion 366 is a hypotube with a D shape, so that it is flat facing the inside and circular facing the outside. The circular side of the proximal portion 366 can be shaped to engage with the corresponding circular inner surface of the sheath 400. The hypotube can have a lubricating coating, such as PTFE. The hypotube can have an inner diameter of about 0.021", an outer diameter of about 0.0275" and a total length of about 94cm, which provides a working length of about 143cm for the catheter advancing element 300. Including the proximal hub 375, the catheter advancing element 300 can have a total length of about 149cm. In some embodiments, the hypotube can be a tapered portion with a length of about 100mm, which starts at the proximal end with a thickness of 0.3mm and ends with a thickness of 0.10mm to 0.15mm. In some further embodiments, the elongated body 360 can be a solid element coupled to the proximal portion 366, which does not have a guidewire lumen.
如图7F至图7J中最佳示出的，海波管的近端可以耦接到近端毂375。近端毂375可以是在近端毂375的内部上形成有鲁尔接口螺纹377和鲁尔接口锥形378的超模压部件。近端毂375可以并入提供用户的更容易抓握的突片364。近端毂375通过限制插入近端RHV 434中来防止导管前进元件300和导管200前进超过基鞘400或引导导管的远尖端，这为系统10的适当操作提供关键的功能和安全特征。As best shown in Figures 7F to 7J, the proximal end of the hypotube can be coupled to a proximal hub 375. The proximal hub 375 can be an overmolded component with Luer threads 377 and a Luer taper 378 formed on the interior of the proximal hub 375. The proximal hub 375 can incorporate tabs 364 that provide a more comfortable grip for the user. The proximal hub 375 prevents the catheter advancing element 300 and catheter 200 from advancing beyond the distal tip of the base sheath 400 or guide catheter by limiting insertion into the proximal RHV 434, which provides a critical functional and safety feature for proper operation of the system 10.
实心细长主体360的至少一部分(例如细长远尖端346)可以由可锻材料形成或嵌入有或附接到该材料，该材料在远端处向下削薄至更小尺寸。远尖端346可以成形为与可以使用导丝的方式类似的期望角度或形状。细长主体360的可锻长度可以是至少约1cm、3cm、5cm且直到约10cm、15cm或更长。在一些实施方案中，可锻长度可以为细长主体360的总长度的约1％、2％、5％、10％、20％、25％、50％或更多。在一些实施方案中，导管前进元件300可以具有约140cm至约143cm的工作长度，并且细长体360可以具有约49cm的插入长度。插入长度可以是约49.5cm的细长主体360的PEBAX部分。由此可见，细长主体360的可锻长度可以在约0.5cm至约25cm或更大之间。形状变化可以是用户在插入之前手动成形可锻长度的函数，或者尖端可以在制造时预成形为特定角度或曲线。备选地，形状变化可以是可逆且可致动的形状变化，使得尖端在用户致动时形成形状，使得尖端可以以笔直格式使用，直到用户期望形状变化为止。导管前进元件300还可以包括延伸穿过细长主体360的管腔的成形心轴，使得医生在使用时可以将远尖端346成型成期望的形状。由此可见，可成型的远尖端346可以并入到具有导丝管腔的细长主体360上。At least a portion of the solid elongated body 360 (e.g., the elongated distal tip 346) can be formed of a wrought material or embedded with or attached to the material, which is thinned downward to a smaller size at the distal end. The distal tip 346 can be shaped into a desired angle or shape similar to the way a guidewire can be used. The wrought length of the elongated body 360 can be at least about 1 cm, 3 cm, 5 cm and up to about 10 cm, 15 cm or longer. In some embodiments, the wrought length can be about 1%, 2%, 5%, 10%, 20%, 25%, 50% or more of the total length of the elongated body 360. In some embodiments, the catheter advancement element 300 can have a working length of about 140 cm to about 143 cm, and the elongated body 360 can have an insertion length of about 49 cm. The insertion length can be the PEBAX portion of the elongated body 360 of about 49.5 cm. As can be seen, the wrought length of the elongated body 360 can be between about 0.5 cm and about 25 cm or more. The shape change can be a function of the user manually shaping the forgeable length before insertion, or the tip can be preformed to a specific angle or curve when manufactured. Alternatively, the shape change can be a reversible and actuable shape change, so that the tip is shaped when the user actuates, so that the tip can be used in a straight format until the user expects the shape change. The catheter advancing element 300 can also include a forming mandrel extending through the lumen of the elongated body 360 so that the doctor can shape the distal tip 346 into a desired shape when in use. As can be seen here, formable distal tip 346 can be incorporated into the elongated body 360 with the guidewire lumen.
应当理解，如上所述，细长主体360可以沿着导管200的整个长度延伸，该整个长度包括远端管腔部222和近端延伸部230，或者细长主体360可以并入近端部366，该近端部366通常与导管200的近端延伸部230并排对齐。细长主体360的近端部366可以与细长主体360同轴或偏心地定位。细长主体360的近端部366可以具有延伸穿过它的管腔。备选地，部分366可以是没有管腔的实心杆或带。It should be understood that, as described above, the elongated body 360 can extend along the entire length of the catheter 200, including the distal lumen portion 222 and the proximal extension 230, or the elongated body 360 can incorporate a proximal portion 366 that is generally aligned side-by-side with the proximal extension 230 of the catheter 200. The proximal portion 366 of the elongated body 360 can be positioned coaxially or eccentrically with the elongated body 360. The proximal portion 366 of the elongated body 360 can have a lumen extending therethrough. Alternatively, the portion 366 can be a solid rod or ribbon without a lumen.
再次参照图7A至图7D，与导管200的远端管腔部222一样，细长主体360可以沿着其长度具有一个或多个不透射线标记344。一个或多个标记344的尺寸、形状以及位置可以变化。一个或多个标记344可以沿着导管前进元件300的一个或多个部分并入，诸如尖端到尖端标记、尖端到锥形标记、RHV接近标记、氟保护标记、或者提供与导管前进元件300及其部件的相对位置有关的各种信息的其他标记。在一些实施方案中且如图7C中最佳示出的，远端区域可以具有第一不透射线标记344a，并且第二不透射线标记344b可以定位为指示远尖端346的锥形化与具有均匀或最大外径的细长主体360的更近端区域之间的边界。这为用户提供与远尖端346相对于管腔部222的远端的最佳延伸有关的信息，该最佳延伸使管腔部222的该远端处的唇部最小化，以便前进穿过曲折的解剖结构。在例如远尖端346不是必须为锥形的而是沿着其长度具有总体挠性的变化的其他实施方案中，第二不透射线标记344b可以定位为指示细长主体360(或细长主体360的远尖端346)和管腔部222的远端的相对挠性大致相同的区域。标记材料可以是铂/铱带、钨、铂或钽浸渍的聚合物、或不影响远尖端346和细长主体360的挠性的其他不透射线标记。在一些实施方案中，不透射线的标记是装有用于不透射线性的钨的挤出PEBAX。在一些实施方案中，近端标记带可以为约2.0mm宽，并且远端标记带可以为约2.5mm宽，以提供关于远尖端346的可辨别信息。Referring again to Figures 7A to 7D, like the distal lumen portion 222 of the catheter 200, the elongated body 360 can have one or more radiopaque markers 344 along its length. The size, shape, and location of the one or more markers 344 can vary. One or more markers 344 can be incorporated along one or more portions of the catheter advancing element 300, such as a tip-to-tip marker, a tip-to-taper marker, an RHV proximity marker, a fluorine shield marker, or other markers that provide various information regarding the relative positions of the catheter advancing element 300 and its components. In some embodiments, and as best shown in Figure 7C, the distal region can have a first radiopaque marker 344a, and a second radiopaque marker 344b can be positioned to indicate the boundary between the tapered distal tip 346 and the more proximal region of the elongated body 360 having a uniform or maximum outer diameter. This provides the user with information regarding the optimal extension of the distal tip 346 relative to the distal end of the lumen portion 222, which minimizes the lip at this distal end of the lumen portion 222 for advancement through tortuous anatomical structures. In other embodiments where, for example, the distal tip 346 is not necessarily tapered but rather has a change in overall flexibility along its length, a second radiopaque marker 344b can be positioned to indicate an area where the relative flexibility of the elongated body 360 (or the distal tip 346 of the elongated body 360) and the distal end of the lumen portion 222 is approximately the same. The marker material can be a platinum/iridium ribbon, tungsten, a platinum or tantalum impregnated polymer, or other radiopaque marker that does not affect the flexibility of the distal tip 346 and the elongated body 360. In some embodiments, the radiopaque marker is extruded PEBAX with tungsten for radiopacity. In some embodiments, the proximal marker band can be approximately 2.0 mm wide and the distal marker band can be approximately 2.5 mm wide to provide discernible information about the distal tip 346.
如上面提及的，导管200的近端延伸部230可以包括在近端延伸部230的近端上的近端突片234。类似地，耦接到细长主体360的近端部366可以包括突片364。突片234、364可以被构造为可去除且可调节地彼此连接和/或连接到它们对应的近端部。耦接允许导管前进元件300与导管200可逆地连接，以锁定(和解锁)远端管腔部222和细长主体360的相对延伸。这允许导管200和导管前进元件300作为单个单元前进。在锁定构造中，突片364或近端部366可以与导管突片234啮合。在解锁构造中，突片364可以与导管突片234脱离。突片364或近端部366可以以关于维持锁定构造的细长主体360和导管200的对应段的关系的样式来附接到导管突片234，例如，点击或锁定到导管突片234中。应当理解，突片364可以是近端毂375(诸如图7F至图7J所示的毂375)上的特征。As mentioned above, the proximal extension 230 of the catheter 200 may include a proximal tab 234 on the proximal end of the proximal extension 230. Similarly, the proximal portion 366 coupled to the elongated body 360 may include a tab 364. The tabs 234, 364 can be configured to be removably and adjustably connected to each other and/or to their corresponding proximal ends. The coupling allows the catheter advancement element 300 to be reversibly connected to the catheter 200 to lock (and unlock) the relative extension of the distal lumen 222 and the elongated body 360. This allows the catheter 200 and the catheter advancement element 300 to advance as a single unit. In the locked configuration, the tab 364 or the proximal portion 366 can engage with the catheter tab 234. In the unlocked configuration, the tab 364 can be disengaged from the catheter tab 234. The tab 364 or proximal portion 366 can be attached to the catheter tab 234 in a manner that maintains a locked configuration with respect to the relationship of the elongated body 360 and corresponding segments of the catheter 200, e.g., clicks or locks into the catheter tab 234. It should be understood that the tab 364 can be a feature on a proximal hub 375, such as the hub 375 shown in Figures 7F-7J.
这种锁定可以通过例如使用突片364上的棘爪来实现，该棘爪在导管突片234中形成的凹处内卡入到位，反之亦然。例如，导管200的突片234可以形成环，该环具有延伸穿过其的中心开口。主体360的突片364可以具有环形棘爪，该环形棘爪具有中心柱，该中心柱被定尺为插入穿过突片234的中心开口，使得突片234的环被接收在突片364的环形棘爪内，这形成供用户来使导管系统穿过进入鞘前进和/或撤回的单一抓住元件。突片234、364可以固定或可以可滑动，以适应细长主体360与导管200的管腔部222之间的不同相对位置。在一些实施方案中，导管200的近端延伸部230的近端可以包括被构造为接收导管前进元件300的近端部366的耦接特征334，诸如夹子、夹具、c形元件或其他连接器(参见图2A)。耦接特征334可以被构造为借助过盈配合与近端部366卡扣在一起，使得需要第一水平的力，以便将近端部366插入到突片234的夹子中，并且需要第二更大水平的力来从突片234的夹子去除近端部366。然而，在将近端部366插入到耦接特征334中时，导管前进元件300和导管200仍然可以相对于彼此沿着系统的纵向轴线可滑动地调节。可滑动地调节两个部件的相对位置所需的力的量可以使得避免无意的调节，并且可以在使用期间维持相对位置，但该位置可以在有意识的修改时调节。应当理解，导管前进元件300的近端部366与导管200的近端延伸部360之间的耦接的构造可以变化。然而，通常，耦接被构造为可逆且可调节的，同时仍然以相对用户友好(例如，允许单手使用)并组织部件的近端(例如，防止近端延伸部360和近端部366变得彼此扭曲和缠结)的方式来提供两个元件之间的足够保持力。还应当理解，被构造为防止缠结并辅助近端部的组织的耦接特征334可以与突片集成，或者可以是沿着它们的近端区域定位的单独特征。234, 364 can be fixed or slidable to accommodate different relative positions between the elongated body 360 and the lumen 222 of the catheter 200. In some embodiments, the proximal end of the proximal extension 230 of the catheter 200 can include a coupling feature 334, such as a clip, clamp, C-shaped element, or other connector, configured to receive the proximal portion 366 of the catheter advancement element 300 (see FIG2A ). The coupling feature 334 can be configured to snap together with the proximal portion 366 via an interference fit, such that a first level of force is required to insert the proximal portion 366 into the clip of the tab 234, and a second, greater level of force is required to remove the proximal portion 366 from the clip of the tab 234. However, when the proximal portion 366 is inserted into the coupling feature 334, the catheter advancement element 300 and the catheter 200 can still be slidably adjusted relative to each other along the longitudinal axis of the system. The amount of force required to slidably adjust the relative position of the two components can be such that inadvertent adjustment is avoided and the relative position can be maintained during use, but the position can be adjusted upon intentional modification. It should be understood that the configuration of the coupling between the proximal portion 366 of the catheter advancement element 300 and the proximal extension 360 of the catheter 200 can vary. However, in general, the coupling is configured to be reversible and adjustable while still providing sufficient retention between the two elements in a manner that is relatively user-friendly (e.g., allowing one-handed use) and organizes the proximal ends of the components (e.g., preventing the proximal extension 360 and the proximal portion 366 from becoming twisted and tangled with each other). It should also be understood that the coupling feature 334, which is configured to prevent tangling and assist in the organization of the proximal portions, can be integrated with the tabs or can be a separate feature located along their proximal regions.
导管前进元件300可以置于锁定构造，导管200被构造为改善穿过急性缺血性中风中的曲折且经常患病的血管的跟踪。这里考虑其他构造。例如，细长主体360可以在外表面上包括一个或多个棘爪。棘爪可以位于细长主体360的近端区域和/或远端区域附近。棘爪被构造为与管腔部222的内表面上的相应成形的表面特征一起锁定，细长主体360延伸穿过该表面特征。导管前进元件300和导管200可以在它们之间并入多于单个锁定连接点。例如，如这里在别处描述的，耦接特征334(诸如夹子、夹具、c形元件或其他连接器)被构造为将导管前进元件300和导管200的近端延伸部230或突片234保持在一起。The catheter advancing element 300 can be placed in a locking configuration, and the catheter 200 is configured to improve tracking through the tortuous and often diseased blood vessels in acute ischemic stroke. Other configurations are contemplated herein. For example, the elongated body 360 can include one or more detents on the outer surface. The detents can be located near the proximal region and/or distal region of the elongated body 360. The detents are configured to lock together with corresponding shaped surface features on the inner surface of the lumen portion 222, through which the elongated body 360 extends. The catheter advancing element 300 and the catheter 200 can incorporate more than a single locking connection point between them. For example, as described elsewhere herein, a coupling feature 334 (such as a clip, a clamp, a c-shaped element, or other connector) is configured to hold the proximal extension 230 or tab 234 of the catheter advancing element 300 and the catheter 200 together.
在一些实施方案中，导管200的近端延伸部230可以在近端部366的专门通道旁边或内延伸。通道可以沿着近端部366的长度定位并且具有与导管近端延伸部230的横截面形状匹配的横截面形状，使得导管200的近端延伸部230可以被接收在通道内并且沿着通道双向平滑地滑动。一旦导管200和细长主体360被固定，则组合系统(即，导管200-导管前进元件300)可以输送到目标部位，例如穿过本文中在别处描述的导鞘400的工作管腔。In some embodiments, the proximal extension 230 of the catheter 200 can extend alongside or within a dedicated channel in the proximal portion 366. The channel can be positioned along the length of the proximal portion 366 and have a cross-sectional shape that matches the cross-sectional shape of the catheter proximal extension 230, such that the proximal extension 230 of the catheter 200 can be received within the channel and smoothly slide bidirectionally along the channel. Once the catheter 200 and the elongated body 360 are secured, the combined system (i.e., the catheter 200-catheter advancing element 300) can be delivered to the target site, for example, through the working lumen of the introducer sheath 400 described elsewhere herein.
装载在导管200的管腔内的导管前进元件300(不管是否并入增强层)可以用于将导管200前进到大脑的远端区域(例如，MCA的层面)。威利斯(Willis)环的传统方法是使用三轴系统，该系统包括放置在传统微导管内的导丝，该微导管放置在中间导管内。整个同轴系统可以延伸穿过基础导管或鞘。鞘通常被定位为使得鞘的远尖端放置在高颈部颈动脉中。同轴系统经常一致地前进，直到传统的同轴系统，然后必须在分开的投掷中以逐步的方式前进的颈动脉末端周围。这是由于两个连续的180度或更大的转弯(参见图1A至图1C)。第一个转弯处于岩石到海绵状颈内动脉的层面。第二个转弯随着它穿过骨元件并到达到大脑前动脉ACA和大脑中动脉MCA的分叉而处于末端海绵状颈动脉。该S形区域在这里中被称为“虹吸部”或“颈动脉虹吸部”。眼动脉起源于脑ICA，其代表在进入前循环时的导管挂起的公共点。The catheter advancement element 300 (whether or not incorporated into a reinforcement layer) loaded in the lumen of the catheter 200 can be used to advance the catheter 200 to the distal region of the brain (e.g., the level of the MCA). The conventional method of the Circle of Willis is to use a triaxial system, which includes a guidewire placed in a conventional microcatheter, which is placed in an intermediate catheter. The entire coaxial system can extend through a base catheter or sheath. The sheath is typically positioned so that the distal tip of the sheath is placed in the high neck carotid artery. The coaxial system often advances in unison until the conventional coaxial system, which then must be advanced in a step-by-step manner around the carotid artery end in a separate throw. This is due to two continuous 180-degree or larger turns (see Figure 1A to Figure 1C). The first turn is at the level of the petrous to cavernous internal carotid artery. The second turn is at the terminal cavernous carotid artery as it passes through the bone element and reaches the bifurcation of the anterior cerebral artery ACA and the middle cerebral artery MCA. This S-shaped region is referred to as a "siphon" or "carotid siphon" herein. The ophthalmic artery arises from the cerebral ICA, which represents a common point from which the catheter hangs upon entering the anterior circulation.
传统的微导管系统可以通过导丝前进直到前循环。因为传统微导管的内径显著大于它前进所通过的导丝的外径，所以可以在系统的远端区域上形成唇部，该远端区域在穿过虹吸部期间可能卡在这些侧分支上。由此，传统的微导管系统(即，导丝、微导管以及中间导管)从不在单个平滑通过中同时前进穿过颈动脉虹吸部的两个弯曲到达远端目标部位。相反，颈动脉虹吸部的弯曲在逐步前进技术中一次一个地拐过。例如，为了穿过颈动脉虹吸部，将传统的微导管保持固定，同时使导丝单独前进第一距离(即，穿过虹吸部的第一个转弯)。然后，将导丝保持固定，同时通过导丝使传统的微导管单独前进穿过第一个转弯。然后，将传统的微导管和导丝保持固定，同时通过微导管和导丝使中间导管单独前进穿过第一个转弯。该过程重复，以便穿过虹吸部的第二个转弯，该转弯通常被认为是到脑血管中的更具挑战性的转弯。将微导管和中间导管保持固定，同时使导丝单独前进第二距离(即，穿过虹吸部的第二个转弯)。然后，将导丝和介入导管保持固定，同时通过导丝使微导管单独前进穿过该第二个转弯。然后，将导丝和微导管保持固定，同时使介入导管单独前进穿过第二个转弯。该多阶段的逐步过程是需要多人对部件执行多次手动更改的耗时过程。例如，两只手将部件固定并推到彼此上方，这迫使用户举行如上所述的步骤。需要逐步程序，因为这些部件(例如，导丝、微导管以及中间导管)之间的阶梯式过渡使得前进过于具有挑战性。Conventional microcatheter systems can be advanced up to the anterior circulation by means of a guidewire. Because the inner diameter of a conventional microcatheter is significantly larger than the outer diameter of the guidewire through which it is advanced, a lip can be formed on the distal region of the system, which may become stuck on these side branches during passage through the siphon. Thus, conventional microcatheter systems (i.e., guidewire, microcatheter, and intermediate conduit) never advance simultaneously through the two bends of the carotid siphon in a single smooth passage to reach the distal target site. On the contrary, the bends of the carotid siphon are turned around one at a time in a step-by-step advancement technique. For example, in order to pass through the carotid siphon, a conventional microcatheter is held stationary while the guidewire is advanced a first distance (i.e., the first turn through the siphon) alone. Then, the guidewire is held stationary while the conventional microcatheter is advanced through the first turn alone by means of the guidewire. Then, conventional microcatheter and guidewire are held stationary while the intermediate conduit is advanced through the first turn alone by means of the microcatheter and guidewire. This process is repeated to pass through the second turn of the siphon, which is generally considered to be a more challenging turn to the cerebral vessels. The microcatheter and the intermediate catheter are held stationary while the guidewire is advanced alone a second distance (i.e., through the second turn in the siphon). The guidewire and the interventional catheter are then held stationary while the microcatheter is advanced alone through this second turn via the guidewire. The guidewire and the microcatheter are then held stationary while the interventional catheter is advanced alone through the second turn. This multi-stage, step-by-step process is a time-consuming process that requires multiple people to perform multiple manual changes to the components. For example, two hands hold the components in place and push them over each other, forcing the user to follow the steps described above. A step-by-step procedure is required because the stepped transitions between these components (e.g., the guidewire, the microcatheter, and the intermediate catheter) make advancement too challenging.
相比之下，导管200和导管前进元件300消除了跨越虹吸部进入远端部位的该多阶段的逐步部件前进程序。导管200和导管前进元件300可以作为单个单元前进穿过颈动脉虹吸部CS的两个转弯。两个转弯可以在单个平滑通过或投掷中穿过到达脑血管中的目标，而不逐步调节它们的相对延伸且不如上面关于传统微导管描述的依赖于传统的逐步前进技术。具有延伸穿过其的导管前进元件300的导管200允许用户将它们在相同相对位置中从虹吸部的第一弯曲一致地前进穿过第二弯曲，超过末端海绵状颈动脉，进入ACA和MCA中。重要的是，两个部件的前进可以在穿过两个弯曲的单个平滑移动中执行，而没有手的位置的任何改变。In contrast, the catheter 200 and catheter advancing element 300 eliminate this multi-stage, step-by-step component advancement procedure across the siphon into the distal site. The catheter 200 and catheter advancing element 300 can be advanced as a single unit through the two turns of the carotid siphon CS. The two turns can be traversed in a single smooth pass or throw to reach the target in the cerebral vessels without gradually adjusting their relative extensions and without relying on the traditional step-by-step advancement techniques described above with respect to conventional microcatheters. The catheter 200 with the catheter advancing element 300 extending therethrough allows the user to advance them consistently from the first bend in the siphon through the second bend, beyond the terminal cavernous carotid artery, into the ACA and MCA in the same relative position. Importantly, advancement of the two components can be performed in a single smooth movement through the two bends without any change in hand position.
导管前进元件300可以相对于导管200并置，这提供用于单个平滑前进的两个部件之间的最佳相对延伸。导管前进元件300可以被定位为穿过导管200的管腔，使得其远尖端346延伸超过导管200的远端。导管前进元件300的远尖端346消除了内构件与外导管200之间的阶梯式过渡，从而避免了卡在血管区域内的分支血管上的问题，使得导管200可以容易地穿过颈动脉虹吸部CS的多个成角度的转弯。例如，如本文在别处描述的，最佳相对延伸可以是细长主体360的远尖端346在导管200的远端向远端延伸。向远端的远端延伸的远尖端346的长度可以在0.5cm与约3cm之间。该并置可以是与机械元件的锁定啮合，或者简单地通过用户将两个部件保持在一起来进行。The catheter advancing element 300 can be juxtaposed with respect to catheter 200, and this provides the best relative extension between the two parts for single smooth advancement.The catheter advancing element 300 can be positioned to pass the lumen of catheter 200 so that its distal tip 346 extends beyond the distal end of catheter 200.The distal tip 346 of catheter advancing element 300 eliminates the stepped transition between inner member and the outer catheter 200, thereby avoiding the problem on the branch vessel in the vascular region that is stuck, so that catheter 200 can easily pass a plurality of angled turns of carotid siphon CS.For example, as described elsewhere herein, the best relative extension can be that the distal tip 346 of elongated body 360 extends distally at the distal end of catheter 200.The length of the distal tip 346 extending distally to the distal end of distal end can be between 0.5cm and approximately 3cm.This juxtaposition can be the locking engagement with mechanical element, or simply two parts are kept together and carried out by the user.
部件可以与导丝一起前进，通过预先定位的导丝前进，或在根本没有任何导丝的情况下前进。在一些实施方案中，导丝可以与导管前进元件300和导管200预组装，使得导丝延伸穿过导管前进元件300的管腔，该管腔借助导管200的管腔来装载，这都发生在插入到患者中之前。预组装的部件可以同时插入到鞘400中，并且一起向上前进穿过颈动脉虹吸部的转弯。The components can be advanced with the guidewire, over a pre-positioned guidewire, or without any guidewire at all. In some embodiments, the guidewire can be preassembled with the catheter advancing element 300 and the catheter 200 so that the guidewire extends through the lumen of the catheter advancing element 300, which is loaded with the lumen of the catheter 200, all before insertion into the patient. The preassembled components can be inserted into the sheath 400 simultaneously and advanced together up through the bend of the carotid siphon.
导管200和导管前进元件300的最佳相对延伸可以另外基于材料过渡的交错。图11是例示了导管前进元件300中的材料过渡的近似位置和导管200中的材料过渡的近似位置的示意图。例如，导管前进元件300可以包括近端部366，该近端部366可以是具有近似72D的硬度的海波管。近端部366在位置1101a处过渡到材料硬度为约55D的区域，该区域在位置1101b处过渡到材料硬度为约35D的区域，该区域在位置1101c处过渡到材料硬度为35D的区域。类似地，导管200可以包括是不锈钢带的近端延伸部230。近端延伸部230在位置1103a处过渡到硬度为72D的区域，该区域在位置1103b处过渡到硬度为55D的区域，该区域在位置1103c处过渡到材料硬度为约40D的区域，该区域在位置1103d处过渡到材料硬度为约35D的区域，该区域在位置1103e处过渡到材料硬度为25D的区域，该区域在位置1103f处过渡到材料硬度为约85A的区域，该区域在位置1103g处过渡到材料硬度为约80A的区域。导管前进元件300的最远端区域可以由材料硬度为约62A的Tecothane形成。导管前进元件300的位置1101和导管200的位置1103可以交错，使得位置彼此偏移。应当理解，更多或更少的材料过渡可以存在于导管前进元件和导管内。The optimal relative extension of the catheter 200 and the catheter advancing element 300 can also be based on the staggering of material transitions. Figure 11 is a schematic diagram illustrating the approximate locations of material transitions in the catheter advancing element 300 and the approximate locations of material transitions in the catheter 200. For example, the catheter advancing element 300 can include a proximal portion 366, which can be a hypotube having a durometer of approximately 72D. The proximal portion 366 transitions to a region of material durometer of approximately 55D at location 1101a, which transitions to a region of material durometer of approximately 35D at location 1101b, which transitions to a region of material durometer of 35D at location 1101c. Similarly, the catheter 200 can include a proximal extension 230 that is a stainless steel band. The proximal extension 230 transitions to a region of 72D durometer at location 1103a, a region of 55D durometer at location 1103b, a region of approximately 40D durometer at location 1103c, a region of approximately 35D durometer at location 1103d, a region of approximately 25D durometer at location 1103e, a region of approximately 85A durometer at location 1103f, and a region of approximately 80A durometer at location 1103g. The distal-most region of the catheter advancing element 300 can be formed from Tecothane having a material durometer of approximately 62A. Location 1101 of the catheter advancing element 300 and location 1103 of the catheter 200 can be staggered, such that their locations are offset from one another. It should be understood that more or fewer material transitions can exist within the catheter advancing element and the catheter.
导管200和导管前进元件300可以在制造时预组装，使得导管前进元件300的最佳长度在导管200的远端向远端延伸和/或材料过渡交错。最佳延伸长度可以使得导管前进元件300的锥形远尖端的整个长度延伸到导管200的远端外部，使得导管前进元件300的均匀外径与导管200的远端大致对齐。这可以引起细长主体360的最大外径与导管200的远端大致对齐，使得它保持在导管200的管腔内，并且仅远尖端346的锥形区域在导管200的管腔的远端延伸。该相对结构提供了用于前进穿过曲折血管的最佳结构，在该结构中，系统远端处的唇部将造成最大的困难。该最佳预组装结构可以由耦合器来维持，该耦合器被构造为与导管200的近端延伸部230和导管前进元件300的近端部366这两者啮合。耦合器可以在如这里在别处描述的手术期间使用。另选地，耦合器可以在手术之前去除。The catheter 200 and the catheter advancing element 300 can be preassembled during manufacture so that the optimal length of the catheter advancing element 300 extends distally and/or the material transition is staggered at the distal end of the catheter 200. The optimal extension length can extend the entire length of the tapered distal tip of the catheter advancing element 300 to the distal end outside of the catheter 200, so that the uniform outer diameter of the catheter advancing element 300 is roughly aligned with the distal end of the catheter 200. This can cause the maximum outer diameter of the elongated body 360 to be roughly aligned with the distal end of the catheter 200, so that it remains in the lumen of the catheter 200, and only the tapered area of the distal tip 346 extends at the distal end of the lumen of the catheter 200. This relative configuration provides an optimal structure for advancing through tortuous blood vessels, in which the lip at the distal end of the system will cause the greatest difficulty. This optimal preassembled structure can be maintained by a coupler that is configured to engage both the proximal extension 230 of the catheter 200 and the proximal portion 366 of the catheter advancing element 300. The coupler can be used during surgery as described elsewhere herein. Alternatively, the coupler can be removed before surgery.
图12例示了被构造为在手术之前去除的耦合器1201的实施方案。耦合器1201可以是临时耦合器，该临时耦合器被构造为仅在制造时和/或在存储期间啮合导管200和导管前进元件300。在一些实施方案中，耦合器1201可以是在一侧上具有粘合材料层的盘。耦合器1201被构造为捕捉导管200的近端延伸部230和导管前进元件300的近端部366，并且维持最佳的预组装延伸结构。耦合器1201可以容易地且不留下任何残留物地从近端延伸部230和近端部366撕掉。耦合器1201可以是塑料材料(诸如聚酰亚胺)的盘。盘的半球被被设计为折叠到它们自身上方，直到各半球的粘合侧彼此啮合，从而分别将导管200和导管前进元件300的近端延伸部230和近端部366的海波管沿着盘的赤道(equator)将它们捕捉在其间。盘可以包括靠近赤道的一对凹口1203，使得盘的整体形状是双叶的。盘可以包括在该对凹口1203的一侧上的第一圆形叶1202a和在该对凹口1203的相对侧上的第二圆形叶1202b，第一和第二叶1202a、1202b中的每一个具有匹配的形状。可以沿着第一和第二叶1202a、1202b之间的盘的赤道捕捉海波管，该第一和第二叶折叠到彼此上方，使得它们的粘合侧可以捕捉海波管。各凹口1203的顶点与盘的赤道对齐，并且各凹口可以包括朝向盘的中心延伸的切口或凹口延伸部1205。各凹口1203的顶点与凹口延伸部1205协作地辅助在准备使用导管系统时开始撕裂，这产生应力集中撕掉位置。凹口延伸部1205帮助引导撕裂方向。从而，耦合器1201与导管200的海波管近端延伸部230和导管前进元件300的海波管近端主体330这两者啮合，海波管近端主体330插入穿过导管200的管腔。耦接啮合允许彼此啮合的两个部件在维持部件的最佳相对延伸的同时容易地插入到包裹箍中。耦合器1201由于圆形平滑表面以及卡住边缘的缺乏而避免卡在包裹箍上。在使用导管系统100之前，用户可以从包裹箍去除导管200/导管前进元件300。通过用户拉动彼此粘附的折叠在上方的叶1202a、1202b，可以从海波管撕掉耦合器1201。从而，从海波管去除整个耦合器1201，而不在海波管上留下任何残留物。系统立即准备以最佳的预组装相对延伸插入。Figure 12 illustrates an embodiment of a coupler 1201 that is configured to be removed before surgery. Coupler 1201 can be a temporary coupler that is configured to engage catheter 200 and catheter advancing element 300 only during manufacturing and/or storage. In some embodiments, coupler 1201 can be a disc with an adhesive material layer on one side. Coupler 1201 is configured to capture the proximal extension 230 of catheter 200 and the proximal portion 366 of catheter advancing element 300 and maintain an optimal pre-assembled extension structure. Coupler 1201 can be easily torn off from proximal extension 230 and proximal portion 366 without leaving any residue. Coupler 1201 can be a disc of plastic material (such as polyimide). The hemispheres of the disc are designed to fold over themselves until the adhesive sides of each hemisphere engage with each other, thereby capturing the hypotubes of the proximal extension 230 and proximal portion 366 of the catheter 200 and catheter advancing element 300, respectively, between them along the equator of the disc. The disc can include a pair of notches 1203 near the equator, giving the disc an overall bilobed shape. The disc can include a first circular lobe 1202a on one side of the pair of notches 1203 and a second circular lobe 1202b on the opposite side of the pair of notches 1203, each of the first and second lobes 1202a, 1202b having matching shapes. The hypotube can be captured along the equator of the disc between the first and second lobes 1202a, 1202b, which fold over each other so that their adhesive sides can capture the hypotube. The apex of each notch 1203 is aligned with the equator of the disc, and each notch can include a cutout or notch extension 1205 extending toward the center of the disc. The apex of each notch 1203 cooperates with the notch extension 1205 to assist in initiating tearing when preparing the catheter system for use, creating a stress-concentrating tear-off location. The notch extension 1205 helps guide the tearing direction. Thus, the coupler 1201 engages both the hypotube proximal extension 230 of the catheter 200 and the hypotube proximal body 330 of the catheter advancing element 300, which is inserted through the lumen of the catheter 200. This coupled engagement allows the two engaged components to be easily inserted into the wrapping cuff while maintaining optimal relative extension of the components. The coupler 1201's rounded, smooth surface and lack of a catching edge prevent it from getting stuck on the wrapping cuff. Before using the catheter system 100, the user can remove the catheter 200/catheter advancing element 300 from the wrapping cuff. The user can tear the coupler 1201 off the hypotube by pulling on the adhered, folded-over leaves 1202a, 1202b. Thereby, the entire coupler 1201 is removed from the hypotube without leaving any residue on the hypotube.The system is immediately ready for insertion with optimal pre-assembled relative extension.
耦合器1201的尺寸使得它们提供与海波管的充分啮合，从而将它们锁定在一起并将相对延伸维持为并非大到负面地影响包裹箍内的存储。耦合器1201的盘可以具有约0.75”至约1”的直径。盘可以较薄，诸如在约0.0005”至约0.0015”厚的聚酰亚胺之间。在一些实施方案中，聚酰亚胺盘为约0.001”厚。盘的一侧可以包括粘合剂(诸如硅酮粘合剂)的层。粘合剂可以为约0.0015”厚。凹口1203的各侧可以具有在盘的外周长与凹口1203的顶点之间延伸的长度1。长度可以为约0.200”长。侧面可以相对于彼此形成角度θ，该角度在约50与70度之间，优选地为约60度。The dimensions of the couplers 1201 are such that they provide sufficient engagement with the hypotube to lock them together and maintain the relative extension to not be so great as to negatively impact storage within the wrap hoop. The disc of the coupler 1201 can have a diameter of about 0.75" to about 1". The disc can be thin, such as between about 0.0005" to about 0.0015" thick polyimide. In some embodiments, the polyimide disc is about 0.001" thick. One side of the disc can include a layer of adhesive, such as a silicone adhesive. The adhesive can be about 0.0015" thick. Each side of the recess 1203 can have a length 1 extending between the outer perimeter of the disc and the apex of the recess 1203. The length can be about 0.200" long. The sides can form an angle θ relative to each other that is between about 50 and 70 degrees, preferably about 60 degrees.
应当理解，导管和导管前进元件可以根据多种方法中的任意一种(例如，收缩包裹和其他已知方法)可释放地预包裹在锁定位置中。It should be appreciated that the catheter and catheter advancing element may be releasably pre-wrapped in the locked position according to any of a variety of methods (eg, shrink wrap and other known methods).
材料Material
本文描述的导管的一个或多个部件可以包括各种材料或由各种材料制成，这些材料包括以下材料中的一种或多种：金属、金属合金、聚合物、金属-聚合物复合材料、陶瓷、亲水聚合物、聚丙烯酰胺、聚醚、聚酰胺、聚乙烯、聚氨酯、其共聚物、聚氯乙烯(PVC)、PEO、PEO浸渍的聚氨酯(诸如Hydrothane、Tecophilic聚氨酯、Tecothane、与Tecoflex混合的PEO软嵌段聚氨酯、热塑性淀粉、PVP及其组合等)或其他合适的材料。One or more components of the catheters described herein may include or be made of various materials, including one or more of the following: metals, metal alloys, polymers, metal-polymer composites, ceramics, hydrophilic polymers, polyacrylamides, polyethers, polyamides, polyethylene, polyurethanes, their copolymers, polyvinyl chloride (PVC), PEO, PEO-impregnated polyurethanes (such as Hydrothane, Tecophilic polyurethane, Tecothane, PEO soft block polyurethanes mixed with Tecoflex, thermoplastic starch, PVP, and combinations thereof, etc.), or other suitable materials.
合适金属和金属合金的一些示例包括：不锈钢，诸如304V、304L以及316LV不锈钢；软钢；镍钛合金，诸如线弹性和/或超弹性镍钛合金；其他镍合金，诸如镍铬钼合金(例如，UNS：N06625(诸如625)、UNS：N06022(诸如)、UNS：N10276(诸如)、其他合金等)、镍铜合金(例如，UNS：N04400(诸如400、NICKEL400、400等)、镍钴铬钼合金(例如，UNS：R30035(诸如等))、镍钼合金(诸如，UNS：N10665(诸如)、其他镍铬合金、其他镍钼合金、其他镍钴合金、其他镍铁合金、其他镍铜合金、其他镍钨合金或钨合金等；钴铬合金；钴铬合金(例如，UNS：R30003(诸如等)；富铂不锈钢；钛；其组合；等；或者如本文在别处描述的任意其他合适的材料。Some examples of suitable metals and metal alloys include: stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel titanium alloys, such as linear elastic and/or superelastic nickel titanium alloys; other nickel alloys, such as nickel chromium molybdenum alloys (e.g., UNS: N06625 (such as 625), UNS: N06022 (such as), UNS: N10276 (such as), other alloys, etc.), nickel copper alloys (e.g., UNS: N04400 (such as 400, NICKEL 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 (such as, etc.)), nickel-molybdenum alloys (such as, UNS: N10665 (such as), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten alloys or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium alloys (e.g., UNS: R30003 (such as, etc.); platinum-rich stainless steel; titanium; combinations thereof; etc.; or any other suitable material as described elsewhere herein.
本文描述的导管的内衬材料可以包括低摩擦聚合物，诸如PTFE(聚四氟乙烯)或FEP(氟化乙烯丙烯)，PTFE具有聚氨酯层(Tecoflex)。可以包括本文描述的导管的增强层材料来提供用于施加扭矩和/或防止变平或扭结的机械完整性，该增强层材料诸如：金属，包括不锈钢、镍钛诺、镍钛诺织带、螺旋带、螺旋丝、切割不锈钢等；或刚性聚合物，诸如PEEK。这里描述的导管的增强纤维材料可以包括各种高韧度聚合物，像凯夫拉尔(Kevlar)、聚酯、间对芳酰胺、PEEK、单纤维、多纤维束、高拉伸强度聚合物、金属或合金等。这里描述的导管的外护套材料可以提供机械完整性，并且可以收缩各种材料，诸如聚乙烯、聚氨酯、PEBAX、尼龙，Tecothane等。这里描述的导管的其他涂层材料包括对二甲苯、特氟隆、硅酮、聚酰亚胺-聚四氟乙烯等。The inner lining material of the catheter described herein may include a low friction polymer such as PTFE (polytetrafluoroethylene) or FEP (fluorinated ethylene propylene), PTFE having a polyurethane layer (Tecoflex). The reinforcing layer material of the catheter described herein may be included to provide mechanical integrity for applying torque and/or preventing flattening or kinking, the reinforcing layer material such as: metal, including stainless steel, nitinol, nitinol webbing, spiral tape, spiral wire, cut stainless steel, etc.; or a rigid polymer such as PEEK. The reinforcing fiber material of the catheter described herein may include various high-toughness polymers such as Kevlar, polyester, meta-aramid, PEEK, single fibers, multi-fiber bundles, high tensile strength polymers, metals or alloys, etc. The outer sheath material of the catheter described herein may provide mechanical integrity and can shrink various materials such as polyethylene, polyurethane, PEBAX, nylon, Tecothane, etc. Other coating materials for the catheter described herein include paraxylene, Teflon, silicone, polyimide-polytetrafluoroethylene, etc.
实施方案描述了将导管输送到目标解剖结构的导管和输送系统以及方法。然而，虽然特别是关于将导管输送到神经血管解剖结构的目标血管(诸如脑血管)描述了一些实施方案，但实施方案不如此限制，并且特定实施方案也可以适用于其他用途。例如，导管可以适于输送到不同的神经解剖结构，诸如锁骨下动脉、椎骨、颈动脉血管以及冠状动脉解剖结构或外周血管解剖结构，仅举几个可能的应用。还应当理解，虽然这里描述的系统被描述为用于治疗特定病情或病理，但所治疗的病情或病理可以变化且不只在限制。与使用这里描述的装置治疗目标有关的术语“栓子”、“栓子的”、“血栓”、“闭塞”等的使用不旨在限制。术语可以可互换地使用，并且可以包括但不限于血凝块、气泡、小脂肪沉积物或在血流内携带到远处或在血管中的某个位置形成的其他物体。术语在这里中可以可互换地用于指可能引起穿过血管或血管内的血流的部分或完全闭塞的内容。The embodiments describe catheters and delivery systems and methods for delivering a catheter to a target anatomical structure. However, while some embodiments are described with particular reference to delivering a catheter to a target vessel (such as a cerebral vessel) of a neurovascular anatomical structure, the embodiments are not so limited, and specific embodiments may also be applicable to other uses. For example, the catheter may be adapted for delivery to different neuroanatomical structures, such as the subclavian artery, vertebral artery, carotid artery, and coronary artery anatomical structures or peripheral vascular anatomical structures, to name just a few possible applications. It should also be understood that while the systems described herein are described as being used to treat specific conditions or pathologies, the conditions or pathologies treated may vary and are not limited. The use of the terms "embolus," "embolic," "thrombus," "occlusion," etc., in connection with the use of the devices described herein to treat a target is not intended to be limiting. The terms may be used interchangeably and may include, but are not limited to, blood clots, bubbles, small fatty deposits, or other objects carried to a distant location within the bloodstream or formed at a certain location within a blood vessel. The terms may be used interchangeably herein to refer to content that may cause partial or complete occlusion of blood flow through or within a blood vessel.
在各种实施方案中，参照附图进行描述。然而，特定实施方案可以在没有这些具体细节中的一个或多个的情况下或结合其他已知方法和构造来实践。在描述中，为了提供实施方案的彻底理解，阐述了大量具体细节，诸如具体构造、尺寸以及过程。在其他情况下，为了不使描述不必要地模糊，未特别详细地描述公知过程和制造技术。贯穿本说明书对“一个实施方式”、“实施方式”、“一个实施方案”、“实施方案”等的参考意味着在至少一个实施方式或实施方案中包括所述的特定特征、结构、构造或特性。由此，短语“一个实施方式”、“实施方式”、“一个实施方案”、“实施方案”等在贯穿本说明书的各种地方的出现不是必须指相同的实施方式或实施方案。此外，特定特征、结构、构造或特性可以以任何合适的方式组合在一个或多个实施方案中。In various embodiments, description is made with reference to the accompanying drawings. However, a particular embodiment can be practiced without one or more of these specific details or in combination with other known methods and configurations. In the description, a large number of specific details, such as specific configurations, dimensions, and processes, are set forth in order to provide a thorough understanding of the embodiments. In other cases, in order not to make the description unnecessarily vague, well-known processes and manufacturing techniques are not particularly described in detail. References throughout this specification to "one embodiment," "an embodiment," "an embodiment," "an embodiment," etc. mean that the specific features, structures, configurations, or characteristics described are included in at least one embodiment or embodiment. Thus, the appearance of phrases "one embodiment," "an embodiment," "an embodiment," "an embodiment," etc. in various places throughout this specification do not necessarily refer to the same embodiment or embodiment. In addition, specific features, structures, configurations, or characteristics can be combined in one or more embodiments in any suitable manner.
相对术语贯穿描述的使用可以指示相对位置或方向。例如，“远端”可以指示远离参考点的第一方向。类似地，“近端”可以指示与第一方向相反的第二方向上的位置。然而，这种术语被提供为创建相对参照系，并且不旨在将导管和/或输送系统的使用和方位限于在各种实施方案中描述的具体构造。Relative terms used throughout the description may indicate relative positions or directions. For example, "distal" may indicate a first direction away from a reference point. Similarly, "proximal" may indicate a position in a second direction opposite the first direction. However, such terms are provided to create a relative frame of reference and are not intended to limit the use and orientation of the catheter and/or delivery system to the specific configurations described in the various embodiments.
虽然该说明书包含许多细节，但这些细节不应被解释为是对要求保护或可以要求保护的范围的限制，相反应被解释为是专用于特定实施方式的特征的描述。在单独实施方式的背景下在该说明书中描述的特定特征还可以在单个实施方式中组合实施。相反，在单个实施方式的背景下描述的各种特征还可以单独在多个实施方式中或以任意合适的子组合实施。而且，虽然特征在上面可以被描述为以特定组合起作用且甚至初始照此要求保护，但来自所要求保护组合的一个或多个特征在一些情况下可以从组合切除，并且所要求保护的组合可以致力于子组合或子组合的变体。类似地，虽然以特定顺序在附图中描绘操作，但这不应被理解为为了实现期望的结果而需要这种操作以所示出的特定顺序或以相继次序来执行或者执行所有所例示的操作。仅公开了一些示例和实施方案。可以基于所公开的内容进行所述示例和实施方案以及其他实施方案的变更、修改以及增强。Although this specification includes many details, these details should not be interpreted as limitations on the scope of protection or that can be claimed, but rather should be interpreted as descriptions of features that are dedicated to a particular embodiment. The specific features described in this specification under the background of a separate embodiment can also be implemented in combination in a single embodiment. On the contrary, the various features described under the background of a single embodiment can also be implemented separately in multiple embodiments or in any suitable sub-combination. Moreover, although features can be described above as working in a specific combination and even initially claimed as such, one or more features from the claimed combination can be cut out from the combination in some cases, and the claimed combination can be dedicated to a variant of a sub-combination or sub-combination. Similarly, although operations are depicted in the accompanying drawings in a specific order, this should not be understood as requiring such operations to be performed in the specific order shown or in a sequential order in order to achieve the desired result or to perform all illustrated operations. Only some examples and embodiments are disclosed. Changes, modifications and enhancements to the examples and embodiments and other embodiments can be made based on the disclosed content.
在以上描述和权利要求中，诸如“的至少一个”或“的一个或多个”的短语可以出现，后面是元件或特征的连接列表。术语“和/或”也可以出现在两个或更多个元件或特征的列表中。除非另外由使用短语的语境含蓄或明确地否定，否则这种短语旨在意指所列元件或特征中独立的任意一个或与其他所列元件或特征中的任意一个组合的、所列元件或特征的任意一个。例如，短语“A和B中的至少一个”、“A和B中的一个或多个”以及“A和/或B”各旨在意指“A独自、B独自或A和B一起”。类似的解释也旨在用于包括三项或多项的列表。例如，短语“A、B以及C中的至少一个”、“A、B以及C中的一个或多个”以及“A、B和/或C”各旨在意指“A独自、B独自、C独自、A和B一起、A和C一起、B和C一起、或A和B和C一起”。In the above description and claims, phrases such as "at least one of" or "one or more of" may appear, followed by a connected list of elements or features. The term "and/or" may also appear in a list of two or more elements or features. Unless otherwise implied or explicitly negated by the context in which the phrase is used, such a phrase is intended to mean any one of the listed elements or features, either independently or in combination with any one of the other listed elements or features. For example, the phrases "at least one of A and B," "one or more of A and B," and "A and/or B" are each intended to mean "A alone, B alone, or A and B together." A similar interpretation is also intended for lists that include three or more items. For example, the phrases "at least one of A, B, and C," "one or more of A, B, and C," and "A, B, and/or C" are each intended to mean "A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together."
上面和权利要求中的术语“基于”的使用旨在意指“至少部分基于”，使得未列举的特征或元件也是可允许的。Use of the term "based on" above and in the claims is intended to mean "based, at least in part, on" such that unrecited features or elements are also permissible.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US62/444,584 | 2017-01-10 | ||
| US62/607,510 | 2017-12-19 |
| Publication Number | Publication Date |
|---|---|
| HK40015164A HK40015164A (en) | 2020-08-28 |
| HK40015164Btrue HK40015164B (en) | 2022-09-09 |
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