WO2023087476A1 - 血栓清除装置 - Google Patents

血栓清除装置 Download PDF

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Publication number
WO2023087476A1
WO2023087476A1 PCT/CN2021/139691 CN2021139691W WO2023087476A1 WO 2023087476 A1 WO2023087476 A1 WO 2023087476A1 CN 2021139691 W CN2021139691 W CN 2021139691W WO 2023087476 A1 WO2023087476 A1 WO 2023087476A1
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Prior art keywords
shaped
distal end
rods
thrombus
proximal end
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PCT/CN2021/139691
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English (en)
French (fr)
Inventor
刘载淳
黄定国
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上海腾复医疗科技有限公司
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Priority claimed from CN202122818552.1U external-priority patent/CN217338719U/zh
Priority claimed from CN202111361638.4A external-priority patent/CN113951978A/zh
Application filed by 上海腾复医疗科技有限公司 filed Critical 上海腾复医疗科技有限公司
Publication of WO2023087476A1 publication Critical patent/WO2023087476A1/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

Definitions

  • the present application relates to the technical field of medical devices, in particular to a thrombus removal device.
  • vascular disease has become the number one fatal disease in my country, and vascular embolism has become the main pathogenic factor in vascular disease.
  • ischemic stroke pulmonary embolism
  • pulmonary embolism and lower extremity venous embolism have a total of more than 5 million new cases each year.
  • thrombectomy device for interventional thrombectomy has many advantages such as less trauma, short postoperative recovery time, fewer complications after treatment, and good surgical effect, and is more acceptable to patients.
  • Existing interventional thrombectomy programs mainly include catheter-based thrombolysis and thrombus aspiration.
  • Thrombolytic therapy with catheters has the risk of causing cerebral hemorrhage or systemic hemorrhage, and thrombolysis with catheters for a long time also has the risk of infection.
  • Suction thrombus removal involves a large amount of blood loss, and the effect of thrombectomy is limited, so anticoagulant therapy is still required after surgery. Therefore, it is still necessary to develop an interventional thrombectomy program that does not require the assistance of thrombolytic drugs during and after the operation, has less blood loss, shortens the operation time, and has a good thrombectomy effect.
  • the purpose of some embodiments of the present application is to provide a thrombus removal device to solve the problems of existing thrombus removal devices requiring drug assistance, large blood loss, long operation time and poor thrombus removal effect.
  • an embodiment of the present application provides a thrombus removal device, including: a thrombectomy bracket, an inner tube, and a pushing tube;
  • the inner tube is passed through the thrombus-retrieving bracket and the pushing tube, the distal end of the inner tube is connected to the distal end of the thrombus-retrieving bracket, and the inner tube can move axially relative to the pushing tube;
  • the proximal end of the thrombus retrieval bracket is connected to the distal end of the push tube;
  • the thrombectomy stent is an expandable and contractible stent structure and is integrally braided by a plurality of braided wires; the thrombectomy stent includes: a collecting part and a cutting part; the distal end of the collecting part and the proximal end of the cutting part
  • the collection part is in a tubular structure with a closed distal end, the peripheral wall of the cutting part has a mesh and its proximal end has an opening.
  • the multiple braided wires are made of the following materials: shape memory alloy or shape memory polymer material.
  • the multiple braided wires include multiple developing wires; the multiple developed wires are braided together with other braided wires to form the thrombus retrieval bracket.
  • the cutting portion includes a plurality of first V-shaped bars and a plurality of second V-shaped bars; the plurality of second V-shaped bars are smaller than the plurality of first V-shaped bars;
  • the plurality of first V-shaped rods are connected circumferentially and axially to form a cylindrical structure, and the plurality of first V-shaped rods form a plurality of first diamond-shaped meshes;
  • the plurality of first V-shaped rods includes a plurality of distal openings adjacent to the proximal end of the collection portion with nodes facing the proximal end adjoining the first V-shaped rods, and the nodes of the plurality of second V-shaped rods face the distal end and are respectively connected to the proximal ends of the collecting parts, and the two vertices of the opening ends of the plurality of second V-shaped rods are respectively connected to the first V-shaped rods adjacent to the far openings of the plurality of said second V-shaped rods;
  • the V-shaped bar divides the peripheral wall of the cutting part between the distal opening adjoining the first V-shaped bar and the proximal end of the collecting part into two triangular meshes and a second diamond-shaped mesh.
  • the cutting part also includes two first arc-shaped connecting rods and two second arc-shaped connecting rods;
  • a node at the proximal end of the cutting portion is connected to the first V-shaped rod at the distal end and two nodes axially connected to the first V-shaped rod at the proximal end are connected to form a third V-shaped rod.
  • Rods, the distal ends of the two first arc-shaped connecting rods respectively connect with the proximal ends of the third V-shaped rods to form a first opening;
  • a node at the proximal end of the cutting portion is connected to the distal ends of the two second arc-shaped connecting rods respectively to form a second opening.
  • the thrombectomy bracket also includes a marking ring, which is located at the proximal ends of the two first arc-shaped connecting rods and the two second arc-shaped connecting rods and is fixedly sleeved on the distal end of the pushing tube. .
  • the collection part includes a cylindrical collection section and a tapered collection section that are axially and smoothly connected from the proximal end to the distal end.
  • first V-shaped rod, the second V-shaped rod, the two first arc-shaped connecting rods and the two second arc-shaped connecting rods are all rod-shaped structures woven or twisted by a plurality of braiding wires.
  • the collection part includes a dense mesh weaving section and an open mesh weaving section; the dense mesh weaving section and the open mesh weaving section are arranged alternately along the axial direction or the dense mesh weaving section is located far from the open mesh weaving section end.
  • the number of braided wires in each strand of the open mesh weaving segment is greater than the number of braided wires in the dense mesh collecting segment.
  • the thrombus removal device also includes a tapered head connected to the distal end of the collection part; the diameter of the proximal end of the collection part is greater than or equal to the diameter of the distal end of the cutting part; the plurality of braided wires adopts the following Made of material: shape memory alloy and/or shape memory polymer material.
  • the thrombus removal stent is released to the position of the thrombus, and the peripheral wall of the thrombus removal stent is expanded and attached to the inner wall of the blood vessel, and its proximal opening is opened and facing the thrombus.
  • the thrombus can enter the collection part through the opening at the proximal end and the mesh on the peripheral wall of the cutting part, so that the thrombus can be completely stripped and collected out of the body; in addition, the length of the thrombus retrieval bracket can be adjusted through the inner tube and the push tube, thereby adjusting the thrombus retrieval.
  • the released state of the stent makes it suitable for thrombus clearance in a larger vessel size range.
  • the braided structure adopted as a whole for the thrombectomy support can also simplify the manufacturing process.
  • FIG. 1 is a schematic structural view of a thrombus removal device provided in Embodiment 1 of the present application in an expanded state;
  • Figures 2a and 2b are a front view and a side view of the thrombus removal device shown in Figure 1, respectively;
  • Figures 3a to 3d are schematic structural views of the thrombectomy bracket of the thrombus removal device provided in the embodiment of the present application;
  • Fig. 4a and Fig. 4b are schematic diagrams of the braided structure of the collecting part of the thrombectomy bracket of the thrombus removal device provided by the embodiment of the present application;
  • Figures 5a to 5d are schematic diagrams of the interlaced weaving structure of the rod-shaped structure in the thrombus removal device provided by the embodiment of the present application;
  • 6a to 6d are respectively schematic diagrams of the braided structure of the rod-shaped structure in the thrombus removal device provided by the embodiment of the present application.
  • proximal end and the distal end mentioned in this application have the same meaning in terms of orientation, that is, in the state of use, the distal end is the end away from the operator, the proximal end is the end close to the operator, and the operator is at the proximal end.
  • Control thrombectomy device Unless otherwise specified, the proximal end and the distal end mentioned in this application have the same meaning in terms of orientation, that is, in the state of use, the distal end is the end away from the operator, the proximal end is the end close to the operator, and the operator is at the proximal end. Control thrombectomy device.
  • a thrombus removal device provided in the embodiment of the present application can cooperate with a delivery component to realize rapid removal of intravascular blocking materials such as plaque and thrombus.
  • the thrombus removal device of the embodiment of the present application includes: a thrombectomy support 1 , an inner tube 3 and a pushing tube 4 .
  • the inner tube 3 is installed in the thrombectomy bracket 1 and the push tube 4, the distal end of the inner tube 3 is connected with the distal end of the thrombectomy bracket 1, the inner tube 3 can move relative to the push tube 4 in the axial direction, and the proximal end of the thrombectomy bracket 1 is connected to the push tube 4.
  • the push tube 4 is connected at the far end.
  • the thrombectomy stent 1 is an expandable and contractible stent structure and is integrally braided from a plurality of braided wires.
  • the thrombectomy bracket 1 includes: a collection part 11 and a cutting part 12 .
  • the distal end of the collecting part 11 is in smooth contact with the proximal end of the cutting part 12.
  • the collecting part 11 has a tubular structure with a closed distal end.
  • the peripheral wall of the cutting part 12 has mesh holes and an opening at its proximal end.
  • the thrombus retrieval stent 1 when the thrombus retrieval stent 1 passes through the thrombus in the blood vessel, after the thrombus retrieval stent 1 is released at the distal end of the thrombus, the thrombus retrieval stent 1 can expand, and the inner tube 3 drives the thrombus retrieval stent 1 to extend axially. Or shortening can fine-tune the expansion form of the thrombectomy stent 1 to adapt to different vessel sizes.
  • the peripheral wall of the expanded thrombectomy stent 1 can support and adhere to the inner wall of the blood vessel, and the proximal opening of the cutting portion 12 of the thrombus retrieval stent 1 is open and facing the thrombus.
  • the whole 1 of the bolt-taking support adopts a braided structure, which can simplify the manufacturing process.
  • the multiple braided wires of the thrombectomy support 1 can be made of the following materials: shape memory alloy or shape memory polymer material.
  • the thrombectomy support 1 can be braided by memory alloy wire or polymer wire, or jointly braided by memory metal wire and polymer wire.
  • Memory wires include, but are not limited to, nickel-titanium alloys.
  • Materials of polymer filaments include, but are not limited to: polyester, polyethylene, ultra-high molecular weight polyethylene.
  • the multiple braided wires can include multiple developing wires, and the multiple developed wires can be braided together with other braided wires to form the thrombectomy stent 1, so that it is easier to observe the position of the thrombectomy stent 1 in the blood vessel and its expansion form.
  • the material of the developing wire includes but not limited to tantalum wire, platinum-iridium alloy or platinum-tungsten wire.
  • the cutting part 12 includes: a plurality of first V-shaped rods, a plurality of second V-shaped rods, a plurality of connecting rods and a marking ring 13 .
  • the first V-shaped bar is larger than the second V-shaped bar.
  • the shapes and dimensions of the plurality of first V-shaped bars are approximately the same, and the shapes and dimensions of the plurality of second V-shaped bars are approximately the same.
  • the plurality of first V-shaped rods are connected circumferentially and axially to form a cylindrical structure, and the plurality of first V-shaped rods form a plurality of first diamond-shaped meshes C3.
  • the cylindrical structure of the cutting part 12 can support the inner wall of the blood vessel, so that the opening of the proximal end of the cutting part 12 can be opened, so that thrombus can enter the thrombus retrieval stent 1 through the opening.
  • the plurality of first diamond-shaped meshes C3 on the peripheral wall of the cutting part 12 can also cut the thrombus when the thrombus retrieval stent is withdrawn, so that the thrombus can enter the interior of the thrombus retrieval stent 1 .
  • the plurality of first V-shaped rods includes a plurality of first V-shaped rods adjacent to the proximal end of the collection part 11 and the nodes are towards the proximal end.
  • a V-shaped rod also includes a plurality of first V-shaped rods adjacent to the proximal end of the collection part 11 with nodes facing the distal end, referred to as first V-shaped rods 122 adjacent to the opening.
  • the nodes are the intersections of the V-shaped bars.
  • a plurality of first distal openings are adjacent to the first V-shaped rod 121 and the proximal end of the collection part 11 to form a large triangular grid on the peripheral wall of the thrombus retrieval bracket 1 .
  • Nodes of the plurality of second V-shaped rods 123 face the distal end and are respectively connected to the proximal end of the collection part 11, and the two vertices of the opening ends of the plurality of second V-shaped rods 123 are respectively adjacent to the first V with the plurality of far openings.
  • Shaped rod 121 is connected.
  • the second V-shaped bar 123 divides the peripheral wall of the cutting part between the far opening adjacent to the first V-shaped bar 121 and the proximal end of the collection part 11 into two triangular meshes C4 and a second rhombus-shaped mesh C5, that is, the aforementioned large
  • the triangular mesh is divided into two triangular meshes C4 and a second rhombic mesh C5, so that the distal end of the cutting part 12 forms a dense structure, which can provide better radial support force to better adhere to the inner wall of the blood vessel .
  • the triangular mesh C4 and the second diamond-shaped mesh C5 can also cut the thrombus, so that the thrombus can enter the thrombus retrieval bracket 1 easily.
  • the plurality of connecting rods include: two first arc-shaped connecting rods 125 and two second arc-shaped connecting rods 127 .
  • a node at the proximal end of the cutting portion 12 is connected to the first V-shaped rod at the distal end and two nodes axially connected to the first V-shaped rod at the proximal end are connected to form a third V-shaped rod 124 , the distal ends of the two first arc-shaped connecting rods 125 respectively connect with the proximal ends of the third V-shaped rod 124 to form a first opening C2 .
  • the marking ring 13 is located at the proximal ends of the two first arc-shaped connecting rods 125 and the two second arc-shaped connecting rods 127 and is fixedly sleeved on the distal end of the push tube 4 .
  • the proximal ends of the two first arc-shaped connecting rods 125 are converging and connected to the marking ring 13 .
  • the proximal ends of the two first arc-shaped connecting rods 125 are connected to form straight rods and connected to the marking ring 13 .
  • the first opening C2 is a relatively large oblique opening, which facilitates the passage of large thrombi into the thrombus retrieval bracket 1 , and the edge of the first opening C2 can cut the thrombus, facilitating the separation of the thrombus from the vessel wall.
  • a node at the proximal end of the cutting portion 12 is connected to the distal ends of the two second arc-shaped connecting rods 127 to form the second opening C1 .
  • the proximal ends of the two second arc-shaped connecting rods 127 are converging and connected to the marking ring 13 . After the proximal ends of the two second arc-shaped rods 127 converge, they are straight rod-shaped and arranged at intervals, and are connected with the marking ring 13 .
  • the first opening C1 is a small oblique opening, and the edge of the first opening C1 can cut the thrombus, which facilitates the separation of the thrombus from the blood vessel, and facilitates the entry of small thrombus into the thrombus retrieval support 1 through the first opening C1.
  • the marking ring 13 can be made of X-ray-opaque metal, including but not limited to tantalum, platinum-iridium alloy, nickel-titanium alloy, and stainless steel. The marking ring 13 can be used to indicate the position of the thrombectomy stent in the blood vessel. It should be noted that the proximal ends of the two first arc-shaped connecting rods 125 and the two second arc-shaped connecting rods 127 may also be directly connected to the push tube 4 .
  • the weaving structure of the cutting part 12 will be described in detail below.
  • the multiple braided wires woven into the thrombus removal bracket 1 are divided into four bundles, and the four bundles of braided wires are respectively braided into two first arc-shaped connecting rods 125 and two second arc-shaped connecting rods 127 by means of interlaced braiding.
  • the two first arc-shaped connecting rods 125 and the two second arc-shaped connecting rods are respectively dispersed into two bundles and then continue to be braided to the distal end to form four first V-shaped rods.
  • each strut that is adjacent to the first V-shaped rod with each far opening it is dispersed into two bundles at the midpoint position and then continues to be braided into a small V-shaped rod at the distal end, and the circumferentially adjacent
  • the intersecting parts of the small V-shaped rods are interlaced and then dispersed into multiple bundles of braided wires to continue weaving the collection part 11 to the distal end. Therefore, the number of braiding filaments in a bundle of braiding filaments is reduced by half for each dispersal of the braiding filaments from the proximal end to the distal end.
  • the braiding filaments are combined at the position where the aforementioned braiding filaments are dispersed and then braided toward the proximal end.
  • the weaving method of the above-mentioned rod-shaped structure can all be staggered weaving, that is, one up and one down interlaced weaving, please refer to FIGS. 5a-5d.
  • the above-mentioned rod-shaped structure can also be made by combining multiple braided wires
  • the braided wires at the distal end of the cutting part can be uniformly dispersed into multiple braided wires, wherein every two braided wires are gradually intersected with each other in a positive and negative two-way helical structure to form a tubular collecting part 11 .
  • the number of intersecting braiding filaments can be one or two strands.
  • the cross-braiding method can be one and one cross-braiding, see Figure 4b; or two strands and two strands For cross braids, see Figure 4a; alternatively, one and two-strand cross braids are also possible.
  • each strand of braided filaments may contain one or more braided filaments.
  • the collecting part 11 may include a dense mesh weaving section B and an open mesh weaving section A.
  • the dense mesh weaving section B may be located at the far end of the sparse mesh weaving section A, please refer to Fig. 3a.
  • the dense mesh weaving section B and the open mesh weaving section A may be alternately distributed along the axial direction.
  • the root number of each braided wire of the open mesh weaving section is greater than the root number of the braided silk of the dense mesh collection section, for example, the root number of each braided silk of the open mesh weaving section can be the number of the braided silk of the dense mesh collection section 2 times.
  • the thrombus removal device also includes a conical head 2 connected to the distal end of the collection part 11, and the distal end of the inner tube 3 is connected to the proximal end of the conical head 2 after a plurality of metal wires at the distal end of the collection part 11 converge.
  • the distal end of the conical head 2 is a sharp point, which is convenient for pushing the thrombus removal device to the position of the thrombus in the blood vessel.
  • the diameter of the proximal end of the collection part 11 is greater than or equal to the diameter of the distal end of the cutting part 12, which not only facilitates the entry of thrombus into the collection part, but also can well support the inner wall of the blood vessel to prevent the thrombus from missing.
  • the collection part 11 may include a cylindrical collection section and a tapered collection section that are axially connected smoothly from the proximal end to the distal end.
  • the ratio of the axial length of the cylinder structure of the cylindrical collecting section, the tapered collecting section, and the cutting part 12 to the maximum diameter of the thrombus retrieval bracket 1 is greater than 2, so that the thrombus retrieval bracket 1 has a slender tubular structure as a whole, It is convenient to remove a large number of thrombus at one time.
  • the embodiments of the present application at least have the following advantages and positive effects:
  • the thrombus removal stent is released to the position of the thrombus, and the peripheral wall of the thrombus removal stent is expanded and attached to the inner wall of the blood vessel, and its proximal opening is opened and facing the thrombus.
  • the thrombus can enter the collection part through the opening at the proximal end and the mesh on the peripheral wall of the cutting part, so that the thrombus can be completely stripped and collected out of the body; in addition, the length of the thrombus retrieval bracket can be adjusted through the inner tube and the push tube, thereby adjusting the thrombus retrieval.
  • the released state of the stent makes it suitable for thrombus clearance in a larger vessel size range.

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Abstract

本申请实施例提供了一种血栓清除装置。其包括：取栓支架(1)、内管(3)以及推送管(4)；内管(3)穿设于取栓支架(1)以及所述推送管(4)内，内管(3)远端与取栓支架远端相连，内管(3)可沿轴向相对推送管(4)移动；取栓支架(1)近端与推送管远端相连；取栓支架(1)为可膨胀和收缩的支架结构且由多根编织丝一体编织制成；取栓支架(1)包括：收集部(11)以及切割部(12)；收集部(11)远端与切割部(12)近端平滑相接，收集部(11)呈远端封闭的管状结构，切割部(12)周壁具有网孔且其近端具有开口。本申请实施例可提高取栓效率以及取栓效果。

Description

血栓清除装置
交叉引用
本申请引用于2021年11月17日递交的名称为“血栓清除装置”的第202111361638.4号中国专利申请，其通过引用被全部并入本申请。
技术领域
本申请涉及医疗器械技术领域，特别涉及一种血栓清除装置。
背景技术
血管疾病已经成为我国第一大致死性疾病，而血管疾病中血管栓塞已成为主要致病因素。尤其缺血性脑卒中、肺栓塞、下肢静脉栓塞患者每年新发病总和超过500万人。
采用取栓装置介入取栓具有创伤小，术后恢复时间短，治疗后并发症少，手术效果好等诸多优点，也更能被病人接受。现有的介入取栓方案主要包括置管溶栓、血栓抽吸等。置管溶栓治疗方案具有引发脑出血或全身性出血的风险，长时间置管溶栓还有感染风险。抽吸式血栓清除失血量大，取栓效果有限，术后仍需进行抗凝治疗。因此，仍需开发术中、术后无需溶栓药物的辅助、失血量小、手术时间短、取栓效果好的介入取栓方案。
发明内容
本申请部分实施例的目的在于提供一种血栓清除装置，解决现有取栓装置需要药物辅助、失血量大、手术时间长且取栓效果不佳的问题。
为解决上述技术问题，本申请实施例提供一种血栓清除装置，包括：取栓支架、内管以及推送管；
所述内管穿设于所述取栓支架以及所述推送管内，所述内管远端与所述取栓支架远端相连，所述内管可沿轴向相对所述推送管移动；所述取栓支架近端与所述推送管远端相连；
所述取栓支架为可膨胀和收缩的支架结构且由多根编织丝一体编织制成；所述取栓支架包括：收集部以及切割部；所述收集部远端与所述切割部近端平滑相接，所述收集部呈远端封闭的管状结构，所述切割部周壁具有网孔且其近端具有开口。
另外，所述多根编织丝采用以下材料制成：形状记忆合金或形状记忆高分子材料。
另外，所述多根编织丝包括多根显影丝；所述多根显影丝与其他编织丝一起编织成所述取栓支架。
另外，所述切割部包括多个第一V形杆以及多个第二V形杆；所述多个第二V形杆均小于所述多个第一V形杆；
所述多个第一V形杆周向相接和轴向相接形成筒体结构，且所述多个第一V形杆形成多个第一菱形网孔；
所述多个第一V形杆包括邻近所述收集部近端且结点朝向近端的多个远开口邻接第一V形杆，多个所述第二V形杆的结点朝向远端并分别与所述收集部的近端相连，且多个所述第二V形杆的开口端的两个顶点分别与多个所述远 开口邻接第一V形杆相连；其中，所述第二V形杆将所述远开口邻接第一V形杆和收集部近端之间的切割部周壁分割成两个三角形网孔以及一个第二菱形网孔。
另外，所述切割部还包括两个第一弧形连接杆以及两个第二弧形连接杆；
所述切割部近端的一个结点朝向远端的第一V形杆和与其轴向相接的两个结点朝向近端的第一V形杆的支杆相连并形成一个第三V形杆，所述两个第一弧形连接杆的远端分别与所述第三V形杆的近端相接并形成第一开口；
所述切割部近端的一个结点朝向远端的第一V形杆的近端分别与两个所述第二弧形连接杆的远端相连并形成第二开口。
另外，所述取栓支架还包括标记环，所述标记环位于所述两个第一弧形连接杆以及两个第二弧形连接杆的近端并固定套设于所述推送管远端。
另外，所述收集部包括由近端到远端轴向平滑相接的筒状收集段以及锥形收集段。
另外，所述第一V形杆、第二V形杆、两个第一弧形连接杆以及两个第二弧形连接杆均为由多根编织丝交错编织或者拧成的杆状结构。
另外，所述收集部包括密网编织段和疏网编织段；所述密网编织段和所述疏网编织段沿轴向交错分布或者所述密网编织段位于所述疏网编织段远端。
另外，所述疏网编织段的每股编织丝的根数大于所述密网收集段的编织丝的根数。
另外，所述血栓清除装置还包括与所述收集部远端相连的锥形头；所述收集部近端的直径大于或者等于所述切割部远端的直径；所述多根编织丝采用以下材料制成：形状记忆合金和/或形状记忆高分子材料。
由上述技术方案可知，本申请实施例至少具备如下优点和有益效果：
本申请实施例的血栓清除装置，通过将取栓支架释放至血栓位置处，取栓支架扩张后周壁贴附血管内壁，且其近端开口张开并正对血栓，通过向近端回撤取栓支架，血栓可经近端开口以及切割部周壁网孔进入收集部内，从而可以完整剥离血栓并收集带出体外；此外，通过内管和推送管可以调整取栓支架的长度，从而调整取栓支架的释放状态，使之能够适应较大血管尺寸范围的血栓清除。并且取栓支架整体采用编织结构还可以简化制作工艺。
附图说明
一个或多个实施例通过与之对应的附图中的图片进行示例性说明，这些示例性说明并不构成对实施例的限定，附图中具有相同参考数字标号的元件表示为类似的元件，除非有特别申明，附图中的图不构成比例限制。
图1为本申请实施例一提供的血栓清除装置呈扩张状态的结构示意图；
图2a、2b分别为图1所示的血栓清除装置的主视图和侧视图；
图3a～图3d分别为本申请实施例提供的血栓清除装置的取栓支架的结构示意图；
图4a、图4b为本申请实施例提供的血栓清除装置的取栓支架的收集部的编织结构示意图；
图5a～图5d分别为本申请实施例提供的血栓清除装置中的杆状结构的交错编织结构示意图；
图6a～图6d分别为本申请实施例提供的血栓清除装置中的杆状结构的拧的编织结构示意图。
具体实施方式
为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本申请部分实施例进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本申请，并不用于限定本申请。
除非特别说明，本申请中提及的近端、远端在朝向上具有相同含义，即使用状态下，远端为远离操作者的一端，近端为靠近操作者的一端，操作者在近端控制血栓清除装置。
请参阅图1、图2a及图2b所示，本申请实施例提供的一种血栓清除装置，可与输送组件配合，实现血管内堵塞材料如斑块、血栓等的快速清除。本申请实施例的血栓清除装置包括：取栓支架1、内管3以及推送管4。内管3穿设于取栓支架1以及推送管4内，内管3远端与取栓支架1远端相连，内管3可沿轴向相对推送管4移动，取栓支架1近端与推送管4远端相连。取栓支架1为可膨胀和收缩的支架结构且由多根编织丝一体编织制成。取栓支架1包括：收集部11以及切割部12。收集部11远端与切割部12近端平滑相接，收集部11呈远端封闭的管状结构，切割部12周壁具有网孔且其近端具有开口。
如图1所示，当取栓支架1穿过血管内的血栓，使取栓支架1在血栓远端释放后，取栓支架1能够膨胀，通过内管3带动取栓支架1轴向伸长或者缩短可以微调取栓支架1的膨胀形态，以适应不同的血管尺寸。扩张的取栓支架1的周壁能够支撑贴附血管内壁，取栓支架1的切割部12的近端开口张开并对着血栓。将取栓支架1向近端回撤，血栓经切割部12的开口以及切割部12周壁的网孔进入收集部11内，即可剥离、收集血管内的血栓，以便带出体外。取 栓支架整体1采用编织结构，可简化制作工艺。
取栓支架1的多根编织丝可采用以下材料制成：形状记忆合金或形状记忆高分子材料。取栓支架1可由记忆合金丝或者聚合物丝编织制成，或者由记忆金属丝和聚合物丝共同编织制成。记忆金属丝包括但不限于镍钛合金。聚合物丝的材料包括但不限于：涤纶、聚乙烯、超高分子量聚乙烯。值得一提的是，多根编织丝可包括多根显影丝，多根显影丝可与其他编织丝一起编织成取栓支架1，从而更便于观察取栓支架1在血管中的位置及其膨胀形态。显影丝的材料包括但不限于钽丝、铂铱合金或者铂钨丝等。
请参阅图3a～图3d，切割部12包括：多个第一V形杆、多个第二V形杆、多个连接杆以及标记环13。第一V形杆大于第二V形杆。示例性地，多个第一V形杆的形状尺寸大致相同，多个第二V形杆的形状尺寸大致相同。
多个第一V形杆周向相接和轴向相接形成筒体结构，且多个第一V形杆形成多个第一菱形网孔C3。切割部12的筒体结构能够支撑血管内壁，使切割部12近端开口张开，便于血栓通过开口进入取栓支架1内部。切割部12周壁的多个第一菱形网孔C3在取栓支架回撤时也能够切割血栓，便于血栓进入取栓支架1内部。
多个第一V形杆包括邻近收集部11近端且结点朝向近端的多个第一V形杆，为便于区分，将其称为远开口邻接第一V形杆121，多个第一V形杆还包括邻近收集部11近端且结点朝向远端的多个第一V形杆，称为近开口邻接第一V形杆122。结点为V形杆的相交部。其中，多个第一远开口邻接第一V形杆121与收集部11近端在取栓支架1周壁上形成大三角形网格。
多个第二V形杆123的结点朝向远端并分别与收集部11的近端相连， 且多个第二V形杆123的开口端的两个顶点分别与多个远开口邻接第一V形杆121相连。其中，第二V形杆123将远开口邻接第一V形杆121和收集部11近端之间的切割部周壁分割成两个三角形网孔C4以及一个第二菱形网孔C5，即将前述大三角形网格分割成两个三角形网孔C4和一个第二菱形网孔C5，从而使切割部12远端形成密集结构，能够提供更好的径向支撑力，以更好地与血管内壁相贴。同时，三角形网孔C4和第二菱形网孔C5也能够切割血栓，便于血栓进入取栓支架1内部。
多个连接杆包括：两个第一弧形连接杆125以及两个第二弧形连接杆127。切割部12近端的一个结点朝向远端的第一V形杆和与其轴向相接的两个结点朝向近端的第一V形杆的支杆相连并形成一个第三V形杆124，两个第一弧形连接杆125的远端分别与第三V形杆124的近端相接并形成第一开口C2。标记环13位于两个第一弧形连接杆125以及两个第二弧形连接杆127的近端并固定套设于推送管4远端。可选地，两个第一弧形连接杆125近端汇聚连接于标记环13。其中，两个第一弧形连接杆125近端相连后呈直杆状并与标记环13相连。第一开口C2为较大的斜开口，便于大块血栓通过其进入取栓支架1内部，第一开口C2的边缘可以切割血栓，便于血栓与血管壁分离。
切割部12近端的一个结点朝向远端的第一V形杆126的近端分别与两个第二弧形连接杆127的远端相连并形成第二开口C1。两个第二弧形连接杆127的近端汇聚连接至标记环13。两个第二弧形杆127近端汇聚后呈直杆状且间隔设置并与标记环13相连。第一开口C1为较小的斜开口，第一开口C1的边沿可切割血栓，便于血栓与血管分离，有利于小块血栓通过第一开口C1进入取栓支架1内部。标记环13可由不透X射线的金属制成，包括但不限于钽、 铂铱合金、镍钛合金及不锈钢等，标记环13可以用于指示取栓支架在血管中的位置。需要说明的是，两个第一弧形连接杆125和两个第二弧形连接杆127的近端也可以直接与推送管4相连。
下面对切割部12的编织结构进行详细说明。
将编织成取栓支架1的多根编织丝分成四束，采用交错编织方式将四束编织丝分别编织成两根第一弧形连接杆125以及两根第二弧形连接杆127。两根第一弧形连接杆125以及两根第二弧形连接杆分别分散成两束后继续向远端编织成四根第一V形杆。继续向远端编织时，当周向相邻的两个第一V形杆的支杆的远端相交时，将相交的支杆的编织丝交错编织后再分散成两束继续向远端编织成第一V形杆；当第一V形杆的某个支杆远端不与其他V形杆的支杆相交时，将该支杆分散成两束后继续向远端编织成一个第一V形杆，由此形成第三V形杆。在切割部12的近端，对于每个远开口邻接第一V形杆的每个支杆，分别在其中点位置分散成两束后继续向远端编织成一个小V形杆，周向相邻的小V形杆的支杆相交处交错编织后再分散成多束编织丝继续向远端编织出收集部11。因此，从近端到远端编织丝每分散一次，一束编织丝的编织丝根数减少一半。反之，当从远端向近端编织时，在前述编织丝分散的位置处将编织丝合并后向近端编织。上述杆状结构的编织方式均可采用交错编织方式，即一上一下交错编织的方式，请参阅图5a～图5d。作为一种替换例，上述杆状结构亦可通过将多根编织丝
切割部远端的编织丝可以均匀分散成多股编织丝，其中每两股编织丝分别以正反两向螺旋结构向远端逐步相互交叉编织形成管状收集部11。编织丝相互交叉编织时，相互交叉的编织丝的股数可以为一股或者2股，相应地，交叉 编织方式可以为一股和一股交叉编织，请参阅图4b；或者两股和两股交叉编织，请参阅图4a；或者也可以为一股和两股交叉编织。其中，每股编织丝可以包含一根或者多根编织丝。
收集部11可以包括密网编织段B和疏网编织段A。其中，密网编织段B可以位于疏网编织段A远端，请参阅图3a。或者，密网编织段B和疏网编织段A可以沿轴向交错分布。疏网编织段的每股编织丝的根数大于密网收集段的编织丝的根数，举例而言，疏网编织段的每股编织丝的根数可以为密网收集段的编织丝的2倍。
血栓清除装置还包括与收集部11远端相连的锥形头2，收集部11远端的多根金属丝汇聚后内管3远端以及锥形头2近端相连。锥形头2远端为尖端，便于将血栓清除装置推进至血管内的血栓位置。
收集部11近端的直径大于或者等于切割部12远端的直径，既便于血栓进入收集部内，又可良好支撑血管内壁防止血栓遗漏。
收集部11可以包括由近端到远端轴向平滑相接的筒状收集段以及锥形收集段。筒状收集段、锥形收集段以及切割部12的筒体结构的轴向长度与取栓支架1的最大直径之比均大于2，从而使得取栓支架1整体呈细长的管体结构，便于一次性取出大量血栓。
基于上述技术方案，本申请实施例至少具有以下优点和积极效果：
本申请实施例的血栓清除装置，通过将取栓支架释放至血栓位置处，取栓支架扩张后周壁贴附血管内壁，且其近端开口张开并正对血栓，通过向近端回撤取栓支架，血栓可经近端开口以及切割部周壁网孔进入收集部内，从而可以完整剥离血栓并收集带出体外；此外，通过内管和推送管可以调整取栓支架 的长度，从而调整取栓支架的释放状态，使之能够适应较大血管尺寸范围的血栓清除。
本领域的普通技术人员可以理解，上述各实施例是实现本申请的具体实施例，而在实际应用中，可以在形式上和细节上对其作各种改变，而不偏离本申请的精神和范围。

Claims (10)

  1. 一种血栓清除装置，包括：取栓支架、内管以及推送管；
    所述内管穿设于所述取栓支架以及所述推送管内，所述内管远端与所述取栓支架远端相连，所述内管可沿轴向相对所述推送管移动；所述取栓支架近端与所述推送管远端相连；
    所述取栓支架为可膨胀和收缩的支架结构且由多根编织丝一体编织制成；所述取栓支架包括：收集部以及切割部；所述收集部远端与所述切割部近端平滑相接，所述收集部呈远端封闭的管状结构，所述切割部周壁具有网孔且其近端具有开口。
  2. 根据权利要求1所述的血栓清除装置，其中，所述多根编织丝包括多根显影丝；所述多根显影丝与其他编织丝一起编织成所述取栓支架。
  3. 根据权利要求1所述的血栓清除装置，其中，所述切割部包括多个第一V形杆以及多个第二V形杆；所述多个第二V形杆均小于所述多个第一V形杆；
    所述多个第一V形杆周向相接和轴向相接形成筒体结构，且所述多个第一V形杆形成多个第一菱形网孔；
    所述多个第一V形杆包括邻近所述收集部近端且结点朝向近端的多个远开口邻接第一V形杆，多个所述第二V形杆的结点朝向远端并分别与所述收集部的近端相连，且多个所述第二V形杆的开口端的两个顶点分别与多个所述远开口邻接第一V形杆相连；其中，所述第二V形杆将所述远开口邻接第一V形 杆和收集部近端之间的切割部周壁分割成两个三角形网孔以及一个第二菱形网孔。
  4. 根据权利要求3所述的血栓清除装置，其中，所述切割部还包括两个第一弧形连接杆以及两个第二弧形连接杆；
    所述切割部近端的一个结点朝向远端的第一V形杆和与其轴向相接的两个结点朝向近端的第一V形杆的支杆相连并形成一个第三V形杆，所述两个第一弧形连接杆的远端分别与所述第三V形杆的近端相接并形成第一开口；
    所述切割部近端的一个结点朝向远端的第一V形杆的近端分别与两个所述第二弧形连接杆的远端相连并形成第二开口。
  5. 根据权利要求4所述的血栓清除装置，其中，所述取栓支架还包括标记环，所述标记环位于所述两个第一弧形连接杆以及两个第二弧形连接杆的近端并固定套设于所述推送管远端。
  6. 根据权利要求3所述的血栓清除装置，其中，所述收集部包括由近端到远端轴向平滑相接的筒状收集段以及锥形收集段。
  7. 根据权利要求4所述的血栓清除装置，其中，所述第一V形杆、第二V形杆、两个第一弧形连接杆以及两个第二弧形连接杆均为由多根编织丝交错编织或者拧成的杆状结构。
  8. 根据权利要求2所述的血栓清除装置，其中，所述收集部包括密网编织段和疏网编织段；所述密网编织段和所述疏网编织段沿轴向交错分布或者所述密网编织段位于所述疏网编织段远端。
  9. 根据权利要求8所述的血栓清除装置，其中，所述疏网编织段的每股编织丝的根数大于所述密网收集段的编织丝的根数。
  10. 根据权利要求1所述的血栓清除装置，其中，所述血栓清除装置还包括与所述收集部远端相连的锥形头；所述收集部近端的直径大于或者等于所述切割部远端的直径；所述多根编织丝采用以下材料制成：形状记忆合金和/或形状记忆高分子材料。
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CN208851573U (zh) * 2017-08-28 2019-05-14 北京赛铂医药科技有限公司 一种分段式血栓碎取装置
CN110312481A (zh) * 2016-10-24 2019-10-08 伊纳里医疗有限公司 用于治疗血管闭塞的装置和方法
CN112617966A (zh) * 2020-12-31 2021-04-09 杭州唯强医疗科技有限公司 取栓装置

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CN110312481A (zh) * 2016-10-24 2019-10-08 伊纳里医疗有限公司 用于治疗血管闭塞的装置和方法
CN208851573U (zh) * 2017-08-28 2019-05-14 北京赛铂医药科技有限公司 一种分段式血栓碎取装置
CN112617966A (zh) * 2020-12-31 2021-04-09 杭州唯强医疗科技有限公司 取栓装置

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