WO2022152262A1 - 一种血栓取出装置 - Google Patents

一种血栓取出装置 Download PDF

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Publication number
WO2022152262A1
WO2022152262A1 PCT/CN2022/072103 CN2022072103W WO2022152262A1 WO 2022152262 A1 WO2022152262 A1 WO 2022152262A1 CN 2022072103 W CN2022072103 W CN 2022072103W WO 2022152262 A1 WO2022152262 A1 WO 2022152262A1
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Prior art keywords
distal
proximal
main body
modules
thrombectomy device
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PCT/CN2022/072103
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English (en)
French (fr)
Inventor
康尼夫布伦丹
华新
沈泉
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苏州徕瑞医疗技术有限公司
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Application filed by 苏州徕瑞医疗技术有限公司 filed Critical 苏州徕瑞医疗技术有限公司
Priority to CN202280010152.2A priority Critical patent/CN116801835A/zh
Priority to EP22739137.2A priority patent/EP4279025A1/en
Priority to US18/261,779 priority patent/US20240074773A1/en
Publication of WO2022152262A1 publication Critical patent/WO2022152262A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B17/22032—Gripping instruments, e.g. forceps, for removing or smashing calculi having inflatable gripping elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22034—Gripping instruments, e.g. forceps, for removing or smashing calculi for gripping the obstruction or the tissue part from inside
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22035—Gripping instruments, e.g. forceps, for removing or smashing calculi for retrieving or repositioning foreign objects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end

Definitions

  • the present invention relates to the field of medical devices, and more particularly to a thrombus removal device for capturing and removing thrombi or other obstructions, such as formed or retained in a patient's cranial artery.
  • a thrombus that forms or builds up in a patient's cranial artery may lead to an acute ischemic stroke event.
  • Blood clots can block blood flow in the affected arteries and cause irreparable damage to brain tissue, resulting in morbidity and even death in a large number of patients.
  • Devices designed to remove blood clots and restore blood flow are now available, with varying degrees of success.
  • the thrombus that has formed is known to exist in a variety of textures, which can be challenging for some devices.
  • thrombectomy devices cannot remove the entire thrombus in a single pass, which means that blood perfusion in the affected artery cannot be restored.
  • the thrombus removal device may require multiple passes in order to remove a sufficient amount of thrombus so that blood flow can be restored.
  • the device needs to be pulled proximally back to the inlet of the suction catheter, reinserted into the microcatheter, and passed through the thrombus again, redeployed, and retracted. All of this takes time and effort from the clinician and prolongs the time that parts of the patient's brain are left in a state of low oxygen.
  • All mechanical thrombectomy devices must be crimped through the thrombus through the microcatheter, after which they exit the microcatheter, expand radially to a deployed state and engage the thrombus.
  • the thrombus infiltrates the strut of the thrombectomy device, causing the thrombus retrieval device to grasp the thrombus so that when the clinician pulls the thrombectomy device, the thrombus is sufficiently grasped for removal.
  • the vast majority of commercial thrombectomy devices engage the thrombus by radial expansion upon exiting the microcatheter.
  • Second-generation devices now considered “original” devices (eg Medtronic Solitaire, Stryker Trevo) generate radial force to penetrate the thrombus adequately and obtain a firm grip when it is removed by rolling or dragging to Grab the thrombus. This effectively traps the thrombus between the vessel wall and the stent, and the thrombus can effectively "roll” proximally during stent retraction.
  • the greater the radial force the greater the gripping force on the thrombus, but also the greater the friction between the thrombus and the vessel wall, as the thrombus pushes against the vessel wall with greater force.
  • Third-generation devices eg, Cerenovous Embotrap II, MicroVention ERIC
  • Cerenovous Embotrap II Cerenovous Embotrap II, MicroVention ERIC
  • use more pushing action to remove clots They are designed to have large spaces between the modules of the stent into which the thrombus can penetrate, see Figure 2, so that the force exerted on the thrombus is primarily tangential to the vessel wall (in the proximal axial direction) and not A radially outward force of the same component acts on the thrombus. This serves to limit the wall friction experienced by the thrombus due to stent deployment and is intended to make the thrombus easier to remove.
  • these third-generation devices are formed around a central spine wire, which limits the crimp profile of the structure, or are formed using a large number of connections throughout the device, which can adversely affect the flexural stiffness of the structure, as shown in Fig. 2 shown.
  • the thrombus would be contained inside the distal capture mesh from the inside, as the thrombus would move distally from the space between the inner body and the outer body in this configuration.
  • a thrombus removal device comprising a main body part and a distal end part, the main body part and the distal end part are both self-expanding members, and the most distal end of the main body part is connected to the The most proximal ends of the distal parts are connected, and it is characterized in that the main body part includes a plurality of modules; each of the modules includes several quadrilateral structures formed by struts along the circumferential direction, and adjacent Two quadrilateral structures are connected at a quadrilateral structure connecting node; The most proximal vertices are connected by respective connecting struts to one of the distal vertices of the proximal most adjacent modules of the body portion, such that the adjacent modules are connected by one or two connecting nodes.
  • the quadrilateral structure is a rhombus structure.
  • the module comprises four quadrilateral structures along the circumference.
  • the nearest vertices of each quadrilateral structure of the other modules are connected to the main body through the respective connecting struts.
  • the nearest vertices of the two adjacent quadrilateral structures of the remaining modules are connected to each other through respective connecting struts.
  • One of the distal vertices of the proximal-most adjacent modules closer to the body portion, and the proximal-most vertices of the other adjacent quadrilateral structures are connected to the other one of the proximal-most adjacent modules closer to the body portion through respective connecting struts far end vertex.
  • the number of the modules is 3 or 4.
  • the body portion and the distal portion are constructed of shape memory material.
  • the body portion is made by laser cutting a nitinol tube and expanding it to a desired diameter on a forming mandrel, and then shaping it at that diameter.
  • the distal portion has a spherical structure.
  • the distal portion has a football shape.
  • the distal portion is composed of a plurality of distal longitudinal struts having the same geometric shape, one end of all the distal longitudinal struts is connected together at the proximal-most end of the distal portion, and all the distal longitudinal struts are connected together at one end at the most proximal end of the distal portion.
  • the other ends of the end longitudinal struts are connected together at the most distal end of the distal portion, and the distal longitudinal struts are distributed circumferentially.
  • the distal longitudinal struts are evenly arranged along the circumference.
  • the projection of any distal longitudinal strut on a plane passing through the axis of the distal portion is sinusoidal, such that radial expansion of the distal portion is accompanied by rotation of the distal longitudinal strut sports.
  • the mesh density of the distal portion is greater than the mesh density of the main body portion.
  • the distal portion consists of six distal longitudinal struts of the same geometry.
  • the main body is basically of modular design, and a plurality of repeated modules are used to construct the entire stent structure.
  • the space between adjacent modules of the body portion is maximized as much as possible to allow the thrombus to penetrate the structure most easily.
  • the present invention has a minimal number of connecting nodes, one or two, between adjacent modules, providing an incompatibility with other mechanical thrombus. Designs with superior flexural stiffness properties compared to removal instruments.
  • This mode of connection provides superior flexibility to the entire structure, enhancing the ability of each individual module to function alone during bending, while improving its ability to deliver it to more distal arteries, as well as by pulling it proximally. Back into the suction catheter for the ability to withdraw.
  • Figure 1 shows the forces acting on an intra-arterial thrombus
  • Figure 2 shows a schematic structural diagram of a thrombus removal device in the prior art
  • FIG. 3 is a schematic structural diagram of a thrombus removal device according to an embodiment of the present invention.
  • Fig. 4 is the structure development view of the main body part in Fig. 3;
  • Fig. 5 is the structural representation of the distal part in Fig. 3;
  • FIG. 6 is a schematic structural diagram of a main body part according to another embodiment of the present invention.
  • FIG. 7 is an expanded view of the main body part according to FIG. 6 .
  • the present invention discloses a thrombus removal device, comprising a main body part 1 and a distal end part 2, the main body part 1 and the distal end part 2 are both self-expanding components, so The most distal end 12 of the main body part is connected to the most proximal end 21 of the distal end part, the main body part 1 has a stent structure comprising a plurality of repeating modules 13, the modules 13 being along a circumferential direction
  • There are several quadrilateral structures 14 formed by struts 16 two adjacent quadrilateral structures 14 along the circumferential direction have a quadrilateral structure connecting node 15, and the most proximal vertices 18 of each quadrilateral structure of the nearest module 17 pass through the respective
  • the connecting struts 19 are connected to the proximal-most end 11 of the main body portion, and the proximal-most vertices 18 of each quadrilateral structure of the remaining modules are connected by
  • the quadrilateral structure is a rhombus structure.
  • the device of the present invention is delivered to the desired location of the thrombus in the cranial artery via a microcatheter, the main body portion 1 and distal portion 2 being self-expanding members, where the device is drawn into the microcatheter
  • the main body part 1 and the distal part 2 are in a compressed crimped state, at the desired location of the cranial artery, the main body part 1 and the distal part 2 of the structure are pushed out of the microcatheter and due to shape memory such as Nitinol Due to the superelastic nature of the material, both the body portion 1 and the distal portion 2 try to recover the deformations they undergo during crimping.
  • the device of the present invention is attached in such a way that the structure can be fully drawn into the microcatheter.
  • the proximal-most vertices 18 of all quadrilateral structures on the module 13 are connected in some way to one of the distal-most vertices 20 of the proximal-most adjacent module that is closer to the body portion.
  • the main body part 1 is basically of a modular design, and a plurality of repeating modules 13 are used to construct the entire support structure.
  • the significance of the geometry of the main body portion 1 is that it is intended to optimize the thrombus propelling capability of the structure by maximizing the space between adjacent struts, while providing a device that is superior to other mechanical thrombus removal devices.
  • the minimal metal-to-arterial nature of the structure allows for a low (or small) crimp profile and enables delivery of the structure into extremely distant cranial arteries, such as the M3 and M4 branches. Additionally, published literature suggests that this minimal metal-to-arterial ratio improves clinical performance due to reduced vascular damage during retrieval.
  • the structure of the present invention maximizes the space between adjacent modules 13 to maximize the penetration of the thrombus into the stent structure.
  • the modules can be connected together by a minimum number of connection nodes, such as by one or two connection nodes 3, depending on the specific rack configuration, as shown in Figures 4, 6 and 7.
  • the module 13 includes four quadrilateral structures 14 along the circumference.
  • connection node 3 between two adjacent modules 13 , except for the nearest module 17 , the most proximal apex 18 of each quadrilateral structure of the remaining said modules 13 is connected by respective connecting struts 19 to the same distal apex 20 of the adjacent module closer to the proximal most end of said body portion.
  • the radial force of each module 13 (and the entire structure) depends on the geometry and material properties of these quadrilateral structures 14 .
  • This mode of connection provides excellent flexibility to the overall structure, as it enhances the ability of each individual module 13 to function on its own during the bending process.
  • the structure is not shaped along a central ridge, unlike traditional thrombectomy devices, it minimizes the amount of metal in the structure, thus resulting in a very low-profile crimped configuration, meaning the structure can be used up to 0.020 inches Compatible with ID microcatheters.
  • the module 13 includes four quadrilateral structures 14 along the circumference.
  • the most proximal vertices 18 of the two adjacent quadrilateral structures of the remaining said modules are connected to one of the distal vertices 20 of the most proximal adjacent modules closer to the main body portion through the respective connecting struts 19, and the other two
  • the most proximal vertex 18 of each adjacent quadrilateral structure is connected by respective connecting struts 19 to the other distal vertex 20 of the adjacent module closer to the proximal most end of the body portion.
  • there are two connection nodes 3 between adjacent modules 13 there are two connection nodes 3 between adjacent modules 13 .
  • Other connection methods between two adjacent modules are also feasible.
  • the present invention enables delivery to more distant distal arteries and also facilitates withdrawal by pulling proximally back into the aspiration catheter.
  • the present invention has the least number of connection nodes, such as one or two, between adjacent modules 13, and this modular structure can realize the following functions:
  • connection mode i.e. one or two connection nodes
  • Its connection mode provides enhanced flexibility and allows for better traceability (during movement towards the thrombus site) as well as better retraction capability (proximal during deployment during movement).
  • the number of modules 13 can be varied to form devices of different lengths.
  • the length of the main body part is 40mm, it can include 4 modules, and when the length of the main body part is 30mm, it can include 3 modules, or other suitable lengths and numbers.
  • the main body portion 1 and the distal end portion 2 are constructed of a shape memory material, such as Nitinol.
  • the body portion 1 can be prepared by laser cutting a nitinol tube and expanding it on a forming mandrel to the appropriate "free diameter", ie the desired one, and then shaping it at that diameter.
  • the distal part 2 is of spherical configuration, preferably a football-shaped configuration, said distal part 2 may be an additional discrete component as a strut that does not form part of the main body part 1 of the thrombectomy device 16 "Omni-directional capture structure" of properly engaged thrombus material. That is, the distal portion 2 serves to collect any thrombus material that is not engaged with the struts 16 of the body portion 1 . In effect, it performs in a similar manner to a thrombus protection device by collecting any loose thrombus that has not been captured by the body portion of the thrombectomy device.
  • the spherical structure of the distal portion 2 consists of several distal longitudinal struts 23 of the same geometry, all of which are connected together at one end at the proximal-most end 21 of the distal portion , the other ends of all the distal longitudinal struts 23 are connected together at the most distal end 22 of the distal portion, and the distal longitudinal struts 23 are only connected at the most proximal end 21 of the distal portion and all
  • the two nodes of the most distal end 22 of the distal end portion are fixedly connected together, and the distal longitudinal struts 23 are dispersedly arranged along the circumference, preferably evenly arranged.
  • any distal longitudinal strut 23 on the plane may be in the shape of a sine, which enables the radial expansion of the distal portion 2 to accompany the rotational movement of the distal longitudinal strut 23, as can be seen, for example, in Fig. 5. This radial expansion with rotational motion allows the thrombus to be captured more easily without causing greater pressure on the vessel wall.
  • the distal longitudinal strut 23 does not have any other connecting nodes except for the two nodes, the proximal-most end 21 of the distal portion and the distal-most end 22 of the distal portion.
  • the distal portion 2 consists of six distal longitudinal struts 23 having the same geometry.
  • the mesh density of the distal part 2 is greater than that of the main body part 1, so that the captured thrombus is always contained outside the distal part, that is, contained between the main body part 1 and the proximal end of the football structure. space (see Figure 3). Due to the greater density of the struts forming the football structure, it will be difficult for the thrombus material to pass through the "mesh" formed by the struts (see “Axial View” in Figure 5). This means that the vast majority of thrombus material is likely to be trapped proximal to the football structure and therefore be pushed in front of the football structure upon extraction.
  • the distal portion 2 of the present invention acts as an embolic protection structure, unlike the conventional embolic protection device structure in which the thrombus material is trapped inside the basket structure, in the present invention, the thrombus is always contained outside the spherical structure itself for trapping the thrombus that has been Any embolism that has dislodged from the initial thrombus structure and may have attempted to move distally to other vessels. If the thrombus passes distally, it will be captured by the most proximal distal longitudinal strut 23 on the spherical structure, contained outside the spherical structure itself, and pushed in front of the spherical structure as it is withdrawn proximally into the suction catheter.
  • the distal portion 3 acts as an "all-around capture structure" for the thrombus removal process, ensuring that all thrombus material proximal to the distal portion 2 is pushed proximally when the structure is pulled back towards the aspiration catheter.
  • the spherical structure of the distal portion 2 may perform its function as a separate component, but when the body portion 1 cooperates with the spherical structure, the overall efficiency of the combined body-spherical structure as a thrombectomy device is greatly improved.

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Abstract

一种血栓取出装置，包括主体部分（1）以及远端部分（2）,均为自膨胀构件，主体部分（1）包括多个模块（13）；每个模块（13）沿着圆周方向包含数个由支杆（16）形成的四边形结构（14）,沿着圆周方向相邻的两个四边形结构（14）在一个四边形结构连接节点（15）处相连接；最近端模块（17）的每个四边形结构（14）的最近端顶点（18）通过各自的连接支杆（19）连接到主体部分（1）的最近端（11）,其余模块（13）的每个四边形结构（14）的最近端顶点（18）通过各自的支杆（16）连接到更靠近主体部分（1）的最近端的邻近模块（13）的其中一个远端顶点（20），使得相邻的模块（13）通过一个或两个连接节点（3）相连接。血栓取出装置的连接方式可以将装置输送到远端动脉，相邻模块（13）之间具有较大的空间，提高了血栓捕获和取出的效率。

Description

一种血栓取出装置
相关申请的交叉援引
本申请要求2021年1月15日提交的中国专利申请CN202110053305.9的优先权，在此通过援引将其全部内容并入本文。
技术领域
本发明涉及医疗器械领域，尤其涉及一种用于捕获和取出诸如患者的颅动脉中形成或存留的血栓或其他阻塞物的血栓取出装置。
背景技术
在患者的颅动脉中形成或堆积的血栓可能导致急性缺血性中风事件。血栓会阻塞受影响的动脉中的血液流动，并导致对脑组织的不可修复的损害，从而导致大量患者发病甚至死亡。现在已有旨在取出血栓和恢复血流的装置，它们获得了不同程度的成功。已知已经形成的血栓存在多种质地，这对于某些装置可能具有挑战性。通常，血栓取出装置无法单次取出整个血栓，这就意味着受影响的动脉中的血液灌注无法恢复。为了取出足够量的血栓，使血流得以恢复，血栓取出装置可能需要多次通过。其中，装置需要先向近侧拉回到抽吸导管的入口，重新套入微导管，并再次穿过血栓、重新部署和缩回。这一切需要临床医生花费时间和精力，并且会延长患者部分大脑处于低氧状态的时间。
所有机械血栓取出器械都必须通过微导管以卷曲(crimped)的方式穿过血栓，然后它们离开微导管，径向扩展至展开状态并与血栓接合。血栓渗入(infiltration)血栓取出装置的支杆(strut)，从而使血栓取出装置抓取到血栓，以便当临床医生拉动血栓取出装置时，血栓被充分抓紧使其取出。绝大 多数商用血栓取出装置在退出微导管时通过径向膨胀与血栓接合。它们在渗透和抓取血栓方面的有效性主要取决于支架(stent)结构的每个单元面积大小(即相邻支杆之间的开放空间的大小)以及该结构产生的径向向外的力。只要血栓取出装置施加在血栓上的力大于血管作用在血栓上的力，血栓将被取回，参见图1：
F retrieval>F resistant
从图中可知，血管作用在血栓上的力有两个要素，即F resistant＝F friction+F impaction。其中F friction是血栓对血管壁的“粘性”所产生的力，F impaction是穿过血栓的血压差(近端至远端)所产生的力。
对于当前的商用器械，有两种截然不同的方法来进行血栓的整合和取出。现在被视为“原始”器械的第二代器械(例如Medtronic Solitaire，Stryker Trevo)产生径向力以充分穿透血栓，并在通过滚动或拖动将其移除时获得牢固的夹持力以抓取住血栓。这有效地将血栓捕获在血管壁和支架之间，并且在支架收回期间血栓可以有效地向近侧“滚动”。径向力越大，血栓上的夹持力就越大，但血栓与血管壁之间的摩擦力也越大，因为血栓用更大的力推向血管壁。如果结构的径向力固有地过高，则这种用于血栓取出的机制将可能适得其反。第三代器械(例如Cerenovous Embotrap II，MicroVention ERIC)通过更多的推动动作来取出血块。它们设计成在支架的各个模块之间有较大的空间，血栓会渗入其中，参见图2所示，这样施加在血栓上的力主要与血管壁相切(沿近端轴向)，而没有相同分量的径向向外的力作用在血栓上。这用于限制由于支架展开而使血栓经历的壁摩擦力，并且旨在使血栓更容易取出。
通常，这些第三代器械围绕中央脊柱金属丝(spine wire)形成，这会限制结构的卷曲轮廓；或者在整个器械中使用大量连接形成，这会对结构的抗弯刚度产生不利影响，如图2所示。
此外，现有技术中，对于远端有捕获网的结构，血栓将从内部包含在远端捕获网的内部，因为该结构下血栓将从内部主体和外部主体之间的空间内向远 端移动。
发明内容
本发明的目的在于提供一种取出已经在患者的颅动脉中形成或沉积的血栓的装置，旨在优化结构的能力，使其穿透尽可能多的血栓。
为达到上述目的，本发明提供的方案是：一种血栓取出装置，包括主体部分以及远端部分，所述主体部分以及远端部分均为自膨胀构件，所述主体部分的最远端与所述远端部分的最近端相连接，其特征在于，所述主体部分包括多个模块；每个所述模块沿着圆周方向包含数个由支杆形成的四边形结构，沿着圆周方向相邻的两个四边形结构在一个四边形结构连接节点处相连接；最近端的模块的每个四边形结构的最近端顶点通过各自的连接支杆连接到所述主体部分的最近端，其余模块的每个四边形结构的最近端顶点通过各自的连接支杆连接到更靠近所述主体部分的最近端的邻近模块的其中一个远端顶点，使得相邻的模块通过一个或两个连接节点相连接。
优选的，所述四边形结构为菱形结构。
优选的，所述模块沿着圆周包含四个四边形结构。
优选的，当相邻的两个模块之间具有一个连接节点时，除最近端的模块外，其余所述模块的每个四边形结构的最近端顶点通过各自的连接支杆连接到更靠近所述主体部分的最近端的邻近模块的同一个远端顶点。
优选的，当相邻的两个模块之间具有两个连接节点时，除最近端的模块外，其余所述模块的其中两个相邻的四边形结构的最近端顶点通过各自的连接支杆连接到更靠近所述主体部分的最近端的邻近模块的其中一个远端顶点，其他相邻的四边形结构的最近端顶点通过各自的连接支杆连接到更靠近所述主体部分的最近端的邻近模块的另外一个远端顶点。
优选的，所述模块的数量为3个或4个。
优选的，所述主体部分和远端部分由形状记忆材料构成。
优选的，通过对镍钛合金管激光切割，并在成型芯轴上将其扩展至所需的直径，然后在该直径将其定型，制成所述主体部分。
优选的，所述远端部分为球形结构。
优选的，所述远端部分为橄榄球形结构。
优选的，所述远端部分由数个具有相同几何形状的远端纵向支杆组成，所有所述远端纵向支杆的一端在所述远端部分的最近端连接在一起，所有所述远端纵向支杆的另一端在所述远端部分的最远端连接在一起，所述远端纵向支杆沿圆周分散布置。
优选的，所述远端纵向支杆沿圆周均匀布置。
优选的，任一远端纵向支杆在穿过所述远端部分轴线的平面上的投影为正弦形的形状，使得所述远端部分在径向扩张时伴随着远端纵向支杆的旋转运动。
优选的，所述远端部分的网格密度大于所述主体部分的网格密度。
优选的，所述远端部分由六个具有相同几何形状的远端纵向支杆组成。
本发明提供的血栓取出装置，主体部分基本上是模块化设计，使用多个重复模块来构建整个支架结构。所述主体部分的相邻模块之间的空间尽可能最大化，以使血栓最容易地渗入到结构中。与围绕中央脊形成或与大量连接节点连接的其他模块化设计不同，本发明在相邻模块之间具有最少的连接节点，所述连接节点为一个或两个，提供了一种与其他机械血栓移除器械相比具有优异的抗弯刚度特性的设计。这种连接模式为整个结构提供了卓越的灵活性，增强了每个单独模块在弯曲过程中独自起作用的能力，同时提高了将其输送到更远端动脉的能力，以及通过向近端拉回至抽吸导管中以撤回的能力。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例。
图1示出了作用在动脉内血栓上的力；
图2示出了现有技术中血栓取出装置的结构示意图；
图3是根据本发明的一种实施方式的血栓取出装置的结构示意图；
图4是图3中主体部分的结构展开图；
图5是图3中远端部分的结构示意图；
图6是根据本发明又一实施方式的主体部分的结构示意图；
图7是根据图6的主体部分的展开图。
附图标号说明：
Figure PCTCN2022072103-appb-000001
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行描述，显然，所描述的实施例仅仅是本发明的一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员无需付出创造性劳动下可获得的所有其他实施方式，都属于本发明保护的范围。
需要说明的是，当一个元件被称为是“连接”另一个元件，它可以是直接连接另一个元件或者可能同时存在居中元件。在介入医疗器械领域，一般将植入人体或动物体内的医疗器械的距离操作者较近的一端称为“近端”，将距离操作者较远的一端称为“远端”，依此定义医疗器械的任一部件的“近端”和“远 端”。另外，附图均采用简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。另外，各个实施例之间的技术方案或者技术特征可以在合理范围内相互结合。
如图3、图4、图6-7所示，本发明公开一种血栓取出装置，包括主体部分1以及远端部分2，所述主体部分1以及远端部分2均为自膨胀构件，所述主体部分的最远端12与所述远端部分的最近端21相连接，所述主体部分1具有支架结构，所述支架结构包括多个重复的模块13，所述模块13沿着圆周方向包含若干个由支杆16形成的四边形结构14，沿着圆周方向相邻的两个四边形结构14具有一个四边形结构连接节点15，最近端的模块17的每个四边形结构的最近端顶点18都通过各自的连接支杆19连接到所述主体部分的最近端11，其余模块的每个四边形结构的最近端顶点18都通过各自的连接支杆19连接到更靠近所述主体部分的最近端的邻近模块的其中一个远端顶点20，相邻的模块通过一个或两个连接节点3连接在一起。其中，所述最近端的模块17为最靠近操作者的模块。连接节点3与某个远端顶点20重合。
在优选的实施方式中，所述四边形结构为菱形结构。
与所有机械血栓移除器械一样，本发明的装置通过微导管传送至颅动脉中血栓的所需位置，所述主体部分1和远端部分2为自膨胀构件，在该装置被拉入微导管中所述主体部分1和远端部分2处于压缩卷曲状态，在颅动脉的所需位置，该结构的主体部分1和远端部分2从微导管中被推出，并且由于如镍钛合金等形状记忆材料的超弹性性质，所述主体部分1和远端部分2都试图恢复其在卷曲过程中经历的变形。换句话说，它试图恢复其扩展的无应力形状。本发明的装置的连接方式可以确保该结构可以被完全拉入微导管。其中，模块13上的所有四边形结构的最近端顶点18均以某种方式连接到更靠近所述主体部分的最近端的邻近模块的其中一个远端顶点20。
由上述内容可知，主体部分1基本上是模块化设计，使用多个重复模块13来构建整个支架结构。所述主体部分1的几何结构的意义在于，其旨在通过最 大化相邻支杆之间的空间来优化该结构的血栓推动能力，同时提供一种与其他机械血栓移除器械相比具有优异的抗弯刚度特性的设计。该结构最小量的金属对动脉的特性允许低(或小)的卷曲轮廓，并使该结构能够传送到极远的颅动脉中，例如M3和M4分支。另外，已公开的文献表明，由于减少了取回过程中的血管损伤，因此这种最小的金属对动脉比率提高了临床表现。本发明的结构使得相邻模块13之间的空间尽可能最大化，以使血栓最容易地渗透到支架结构中。这些模块可以通过最少的连接节点连接在一起，如通过一个或两个连接节点3连接在一起，这取决于特定的支架配置，如图4、图6和图7所示。
如图4所示，在本发明的一个实施方式中，所述模块13沿着圆周包含四个四边形结构14，当相邻的两个模块13之间具有一个连接节点3时，除最近端的模块17外，其余所述模块13的每个四边形结构的最近端顶点18通过各自的连接支杆19连接到更靠近所述主体部分的最近端的邻近模块的同一个远端顶点20。每个模块13(以及整个结构)的径向力取决于这些四边形结构14的几何形状和材料特性。这种连接模式为整个结构提供了卓越的灵活性，因为它增强了每个单独模块13在弯曲过程中独自起作用的能力。而且，由于该结构与传统的取栓装置不同，不是沿着中央脊成形，因此它使结构中的金属量最小化，因此导致非常低轮廓的卷曲构造，这意味着该结构至多可以与0.020英寸ID的微导管兼容。
如图7所示，在另一个实施方式中，所述模块13沿着圆周包含四个四边形结构14，当相邻的两个模块13之间具有两个连接节点3时，除最近端的模块17外，其余所述模块的其中两个相邻的四边形结构的最近端顶点18通过各自的连接支杆19连接到更靠近所述主体部分的最近端的邻近模块的其中一个远端顶点20，另外两个相邻的四边形结构的最近端顶点18通过各自的连接支杆19连接到更靠近所述主体部分的最近端的邻近模块的另外一个远端顶点20。在本实施方式中，相邻模块13之间具有两个连接节点3。相邻两个模块之间的其他连接方式也是可行的。
采用本发明的血栓取出装置能够输送到较远的远端动脉，也便于通过向近端拉回到抽吸导管中而撤回。本发明在相邻模块13之间具有最少的连接节点，比如一个或两个，这种模块化结构可以实现以下功能：
1)穿透血栓，与血栓接合并在撤回过程中保留血栓。
2)相邻模块之间具有较大的空间，在取出血栓过程中，血栓可以渗入其中并且容纳在其中。
3)最小化支架结构和血管壁之间的接触面积，以最大程度地减少血管损伤的可能性。
4)其连接模式(即一个或两个连接节点)提供了增强的灵活性，并允许更好的可跟踪性(在向血栓位置移动期间)以及更好的撤回能力(在展开结构向近端移动期间)。
所述模块13的数量可变，以此来形成不同长度的装置。比如，主体部分长度为40mm的时候可包括4个模块，主体部分长度为30mm的时候可包括3个模块，也可以是其他合适的长度和数量。
所述主体部分1和远端部分2由形状记忆材料构成，比如镍钛合金。在制备主体部分1时，可以通过对镍钛合金管激光切割，并在成型芯轴上将其扩展至适当的“自由直径”，即所需的一个直径，然后在该直径将其定型。
如图3和图5所示，远端部分2为球形结构，优选为橄榄球形状结构，所述远端部分2可以是一个额外的分立组件，作为未与组成血栓取出装置主体部分1的支杆16适当地接合的血栓材料的“全方位捕获结构”。即远端部分2用于收集没有与主体部分1的支杆16接合的任何血栓材料。实际上，它通过收集尚未被血栓取出装置主体部分捕获的任何松动的血栓，以类似于血栓保护装置的方式执行。
所述远端部分2的球形结构由若干个具有相同几何形状的远端纵向支杆23组成，所有所述远端纵向支杆23的一端在所述远端部分的最近端21处连接在一起，所有所述远端纵向支杆23的另一端在所述远端部分的最远端22处连接 在一起，所述远端纵向支杆23只在所述远端部分的最近端21和所述远端部分的最远端22这两个节点固定连接在一起，所述远端纵向支杆23沿圆周分散布置，优选地均匀布置。任一远端纵向支杆23在平面上的投影可以为正弦形的形状，该形状使所述远端部分2在径向扩张时伴随着远端纵向支杆23的旋转运动，例如可以参见图5。该伴随着旋转运动的径向扩张使得血栓更容易被捕获，并且不会对血管壁造成较大的压力。除了所述远端部分的最近端21和所述远端部分的最远端22这两个节点，所述远端纵向支杆23没有其它任何连接节点。
在本发明的一个实施方式中，所述远端部分2由六个具有相同几何形状的远端纵向支杆23组成。所述远端部分2的网格密度大于所述主体部分1的网格密度，使捕获的血栓始终容纳在所述远端部分之外，即容纳在主体部分1与橄榄球结构近端之间形成的空间中(见图3)。由于形成橄榄球结构的支杆的密度较大，因此血栓材料将很难穿过由支杆形成的“网”(参见图5中的“轴向视图”)。这意味着绝大多数血栓材料很可能会捕获在橄榄球结构的近端，因此在取出时会在橄榄球结构的前方被推动。
本发明的远端部分2作为栓塞保护结构，与血栓材料被捕获在篮式结构内部的传统的栓塞保护装置结构不同，在本发明中，血栓始终容纳在球形结构本身之外，用于捕获已经从初始血栓结构中脱落并且可能试图向远端移动到其他血管的任何栓塞。如果血栓向远端通过，它将被球形结构上最近端的远端纵向支杆23捕获，并容纳在球形结构本身之外，并在向近端撤回进入抽吸导管时在球形结构前方被推动。所述远端部分3用作血栓取出过程的“全方位捕获结构”，确保当向着抽吸导管拉回该结构时，远端部分2近端的所有血栓材料都向近端推动。
远端部分2的球形结构可以作为一个独立的组件执行其功能，但是当主体部分1与球形结构配合一起工作时，该组合的主体-球形结构作为血栓取出装置的整体效率会大大提高。
以上所述仅为本发明的优选实施例，并非因此限制本发明的专利范围，凡 是在本发明的发明构思下，利用本发明说明书及附图内容所作的等效结构变换，或直接/间接运用在其他相关的技术领域均包括在本发明的专利保护范围内。

Claims (15)

  1. 一种血栓取出装置，包括主体部分(1)以及远端部分(2)，所述主体部分(1)以及远端部分(2)均为自膨胀构件，所述主体部分(1)的最远端(12)与所述远端部分(2)的最近端(21)相连接，其特征在于，所述主体部分(1)包括多个模块(13)；每个所述模块(13)沿着圆周方向包含数个由支杆(16)形成的四边形结构(14)，沿着圆周方向相邻的两个四边形结构(14)在一个四边形结构连接节点(15)处相连接；最近端的模块(17)的每个四边形结构的最近端顶点(18)通过各自的连接支杆(19)连接到所述主体部分的最近端(11)，其余模块的每个四边形结构的最近端顶点(18)通过各自的连接支杆(19)连接到更靠近所述主体部分的最近端的邻近模块的其中一个远端顶点(20)，使得相邻的模块通过一个或两个连接节点(3)相连接。
  2. 如权利要求1所述的血栓取出装置，其特征在于，所述四边形结构为菱形结构。
  3. 如权利要求1或2所述的血栓取出装置，其特征在于，所述模块(13)沿着圆周包含四个四边形结构(14)。
  4. 如权利要求1-3中任一项所述的血栓取出装置，其特征在于，当相邻的两个模块(13)之间具有一个连接节点(3)时，除最近端的模块(17)外，其余所述模块(13)的每个四边形结构的最近端顶点(18)通过各自的连接支杆(19)连接到更靠近所述主体部分的最近端的邻近模块的同一个远端顶点(20)。
  5. 如权利要求1-3中任一项所述的血栓取出装置，其特征在于，当相邻的两个模块(13)之间具有两个连接节点(3)时，除最近端的模块(17)外，其余所述模块的其中两个相邻的四边形结构的最近端顶点(18)通过各自的连接支杆(19)连接到更靠近所述主体部分的最近端的邻近模块的其中一个远端顶点(20)，其他相邻的四边形结构的最近端顶点(18)通过各自的连接支杆(19) 连接到更靠近所述主体部分的最近端的邻近模块的另外一个远端顶点(20)。
  6. 如权利要求1-5中任一项所述的血栓取出装置，其特征在于，所述模块(13)的数量为3个或4个。
  7. 如权利要求1所述的血栓取出装置，其特征在于，所述主体部分(1)和远端部分(2)由形状记忆材料构成。
  8. 如权利要求7所述的血栓取出装置，其特征在于，通过对镍钛合金管激光切割，并在成型芯轴上将其扩展至所需的直径，然后在该直径将其定型，制成所述主体部分(1)。
  9. 如权利要求1所述的血栓取出装置，其特征在于，所述远端部分(2)为球形结构。
  10. 如权利要求9所述的血栓取出装置，其特征在于，所述远端部分(2)为橄榄球形结构。
  11. 如权利要求9或10所述的血栓取出装置，其特征在于，所述远端部分(2)由数个具有相同几何形状的远端纵向支杆(23)组成，所有所述远端纵向支杆(23)的一端在所述远端部分的最近端(21)连接在一起，所有所述远端纵向支杆(23)的另一端在所述远端部分的最远端(22)连接在一起，所述远端纵向支杆(23)沿圆周分散布置。
  12. 如权利要求11所述的血栓取出装置，其特征在于，所述远端纵向支杆(23)沿圆周均匀布置。
  13. 如权利要求12所述的血栓取出装置，其特征在于，任一远端纵向支杆(23)在穿过所述远端部分(2)轴线的平面上的投影为正弦形的形状，使得所述远端部分在径向扩张时伴随着远端纵向支杆(23)的旋转运动。
  14. 如权利要求9-12中任一项所述的血栓取出装置，其特征在于，所述远端部分(2)的网格密度大于所述主体部分(1)的网格密度。
  15. 如权利要求9-12中任一项所述的血栓取出装置，其特征在于，所述远端部分(2)由六个具有相同几何形状的远端纵向支杆(23)组成。
PCT/CN2022/072103 2021-01-15 2022-01-14 一种血栓取出装置 WO2022152262A1 (zh)

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