CN114652394B - Intravascular thrombus removal device - Google Patents

Intravascular thrombus removal device Download PDF

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Publication number
CN114652394B
CN114652394B CN202210355469.1A CN202210355469A CN114652394B CN 114652394 B CN114652394 B CN 114652394B CN 202210355469 A CN202210355469 A CN 202210355469A CN 114652394 B CN114652394 B CN 114652394B
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mesh
distal
proximal
thrombus
units
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CN114652394A (en
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杨加静
褚江
黄海
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Suzhou Hengrui Hongyuan Medical Technology Co ltd
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Suzhou Hengrui Hongyuan Medical Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212Gripping 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3904Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
    • A61B2090/3912Body cavities

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  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
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Abstract

本发明涉及一种血管内血栓取出装置,包括可自膨胀、且呈网管状结构的支架主体,支架主体包括近端、远端,网管状结构在近端及远端聚拢;支架主体包括若干重复单元,若干重复单元沿轴向依次排布;重复单元包括若干沿网管状结构周向依次排布的闭合网格单元;闭合网格单元包括第一网孔及与第一网孔相邻设置的若干第二网孔。本发明通过将第一网孔及若干第二网孔相邻设置,且第一网孔的面积大于第二网孔的面积,较大尺寸的第一网孔可有利于切除血栓,并可使切除的血栓碎片经第一网孔进入至呈网管状结构的支架主体内;较小尺寸的第二网孔能够有效防止血栓碎片从支架主体内部逃离,第一网孔及若干第二网孔相互配合,能够更好的捕获血栓碎片。

The present invention relates to an intravascular thrombus removal device, comprising a self-expandable stent body in a mesh tube structure, the stent body comprising a proximal end and a distal end, the mesh tube structure gathered at the proximal end and the distal end; the stent body comprising a plurality of repeating units, the plurality of repeating units being arranged in sequence along the axial direction; the repeating unit comprising a plurality of closed grid units arranged in sequence along the circumference of the mesh tube structure; the closed grid unit comprising a first mesh and a plurality of second meshes arranged adjacent to the first mesh. The present invention arranges the first mesh and the plurality of second meshes adjacent to each other, and the area of the first mesh is larger than the area of the second mesh, so that the larger-sized first mesh can facilitate the removal of thrombus, and can allow the removed thrombus fragments to enter the stent body in the mesh tube structure through the first mesh; the smaller-sized second mesh can effectively prevent the thrombus fragments from escaping from the inside of the stent body, and the first mesh and the plurality of second meshes cooperate with each other to better capture the thrombus fragments.

Description

Intravascular thrombus removal device
Technical Field
The invention relates to a medical instrument for interventional therapy, in particular to an intravascular thrombus taking-out device, which belongs to the field of medical instruments.
Background
Acute ischemic stroke refers to the symptoms and signs of focal neurological deficit caused by a brain blood supply artery that is blocked by stenosis or occlusion to cause a brain tissue blood supply disorder, resulting in localized brain tissue necrosis. In all stroke patients, acute ischemic stroke accounts for about 70% -80%. At present, the treatment modes of acute ischemic stroke mainly comprise two main types, namely thrombolysis and mechanical thrombolysis. The arterial and venous medicine thrombolysis is a conventional method for treating acute ischemic stroke, but the method has higher requirements on a treatment time window, venous thrombolysis is carried out within 3 hours of onset, the arterial thrombolysis time window is only 6 hours, secondly, the vascular recanalization time of the medicine thrombolysis is long, and the thrombolysis treatment is only suitable for thrombus with smaller volume, and the vascular recanalization rate of the acute ischemic stroke caused by serious large vascular occlusion is low. Mechanical thrombolysis has become the treatment of choice for pre-circulatory and large vessel occlusive strokes. The mechanical thrombus taking process is to pass through the intracranial blood vessel by the stent main body through a blood vessel way, capture thrombus by using the porous net structure of the stent main body and mechanically remove the thrombus from the body so as to recover the blood flow of the intracranial blood vessel.
Because of the adherence of the stent main body with blood vessels, the radial supporting force of the stent main body is too large to cause irreversible damage to the blood vessel walls, and other complications such as vascular rupture can be caused when serious, the stent main body in the prior art is unfavorable for capturing thrombus fragments and dragging thrombus, and in the process of capturing thrombus and dragging thrombus, fine thrombus fragments possibly fall off from the stent main body, and the fallen thrombus fragments flow to the far ends of the blood vessels under the action of blood flow impact to form new embolism, so that stroke risks are caused.
Disclosure of Invention
Accordingly, it is necessary to provide an intravascular thrombus removal device that is advantageous in removing thrombus and capturing thrombus fragments, and that can avoid escape of thrombus fragments.
An intravascular thrombus taking-out device comprises a bracket main body which is in a net tubular structure along the axial direction, wherein the bracket main body is in a self-expansion state and a compression state after being stressed;
The bracket main body comprises a proximal end part, a middle part and a distal end part which are arranged along the axial direction, wherein the middle part comprises a plurality of repeating units, and the repeating units are sequentially arranged along the axial direction;
the repeating units comprise a plurality of closed grid units which are sequentially arranged along the circumferential direction of the network management structure, each closed grid unit comprises a first mesh and a plurality of second meshes which are arranged adjacent to the first mesh, and the area of the first mesh is larger than that of the second mesh.
The first meshes and the second meshes are adjacently arranged, the area of the first meshes is larger than that of the second meshes, the first meshes with larger sizes can be favorable for cutting thrombus, cut thrombus fragments can enter the stent body with the net tubular structure through the first meshes, the second meshes with smaller sizes can effectively prevent the thrombus fragments from escaping from the inside of the stent body, and the first meshes and the second meshes are mutually matched, so that the thrombus fragments can be better captured.
In one embodiment, the proximal portion, the plurality of repeating units, and the distal portion are helically distributed along the axial direction.
In one embodiment, two adjacent repeating units are connected by an angle alpha rotated in the axial direction.
In one embodiment, the proximal portion, the distal portion and the plurality of repeating units are each provided with a plurality of developing units, the plurality of developing units on the proximal portion and the distal portion are arranged at intervals, and the developing units on two adjacent repeating units are spirally distributed along the axial direction.
In one embodiment, the developing units on the distal end portion form a plurality of groups of developing structures arranged at intervals along the circumferential direction of the mesh-like structure, two adjacent developing units in the same group are arranged in parallel in the axial direction, and the mesh-like structure is provided with intervals in the circumferential direction.
In one embodiment, each of the repeating units includes two developing units, and the two developing units in the same repeating unit are symmetrically arranged with respect to the axial direction.
In one embodiment, the proximal portion is gathered at an end distal from the distal portion and forms a proximal tubular structure, the intravascular thrombus retrieval device further comprising:
The first developing spring comprises a proximal end connecting part and a distal end connecting part, and the proximal end connecting part is connected with the proximal end tubular structure;
The pushing device comprises a pushing rod, wherein a connecting clamping head is formed at one end, close to the proximal end, of the pushing rod, one end, close to the proximal end, of the pushing rod penetrates through the proximal connecting portion and the proximal tubular structure, the distal connecting portion is arranged between the connecting clamping head and the proximal tubular structure, and the connecting clamping head is in butt joint with the distal connecting portion.
In one embodiment, the distal portion is gathered at an end distal from the proximal portion and forms a distal tubular structure, and the intravascular thrombus retrieval device further includes a second visualization spring coupled to the distal tubular structure.
In one embodiment, the area of the first mesh is 1.5-2.5 times that of the second mesh, the distal end part comprises a plurality of closed meshes, the closed meshes are arranged in a preset mode so that one end of the distal end part far away from the proximal end part is in a closed structure, and the area of the closed meshes is less than or equal to that of the second mesh.
In one embodiment, the material of the bracket main body is nickel-titanium alloy tubular material, and the pipe diameter of the nickel-titanium alloy tubular material is less than or equal to 0.4mm.
According to the scheme, the first mesh openings and the plurality of second mesh openings are adjacently arranged, the area of the first mesh openings is larger than that of the second mesh openings, the first mesh openings with larger sizes can be favorable for cutting thrombus, cut thrombus fragments can enter the stent body with the net tubular structure through the first mesh openings, the second mesh openings with smaller sizes can effectively prevent the thrombus fragments from escaping from the inside of the stent body, and the first mesh openings and the plurality of second mesh openings are matched with each other, so that the thrombus fragments can be better captured.
Drawings
FIG. 1 is a schematic view showing the structure of an intravascular thrombus removal device according to an embodiment of the present invention;
FIG. 2 is a schematic view of a structure of a bracket body according to an embodiment of the present invention;
FIG. 3 is a schematic plan view of a stent body according to an embodiment of the present invention;
Fig. 4 is a schematic diagram of a connection structure of a bracket main body, a push rod and a first developing spring according to an embodiment of the present invention.
Description of the reference numerals
10. Intravascular thrombus extraction device 100, stent body 110, proximal end 120, repeating unit 121, closed mesh unit 1211, first mesh 1212, second mesh 130, distal end 131, closed mesh 200, developing unit 300, first developing spring 310, proximal end connection 320, distal end connection 400, second developing spring 500, push rod 600, connecting clip 700, proximal end tubular structure 800, distal end tubular structure.
Detailed Description
In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The present invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the invention, whereby the invention is not limited to the specific embodiments disclosed below.
In the description of the present invention, it is to be understood that the term "axial" is to be understood as the direction in which the device of the present invention is advanced, i.e. the longitudinal axis of the device of the present invention, also coincides with the longitudinal axis of the vessel along which the device of the present invention is advanced. The term "circumferential" is to be understood as a circumferential direction of the device according to the invention, i.e. around the axis of the device according to the invention, which is perpendicular to the longitudinal axis of the device according to the invention, and coincides with the circumference of the vessel along which the device according to the invention is moved forward. The term "radial" is to be understood as a radial direction of the inventive device, i.e. a straight direction perpendicular to the longitudinal axis of the inventive device, also coinciding with the radial direction of the vessel along which the inventive device is moved forward.
For ease of description and understanding, the terms "distal" and "proximal" should be understood to refer to the direction of the hand-held end of the attending physician or medical intervention physician. The distal end is the side distal from the hand-held end of the attending physician or medical intervention physician, while the proximal end represents the side toward the hand-held end of the attending physician or medical intervention physician. If the phrase "axial" is used in this document, it is understood to mean the direction in which the device of the invention is advanced, i.e. the longitudinal axis of the device also coincides with the longitudinal axis of the vessel along which the device is advanced.
Referring to fig. 1, an intravascular thrombus removal device 10 is provided according to an embodiment of the present invention, comprising a stent body 100 having a mesh-like structure in an axial direction, wherein the stent body 100 has a self-expanded state and a compressed state after being subjected to a force, and in the compressed state, delivery in a blood vessel is facilitated to deliver the stent body 100 to a thrombus site. Under the self-expansion state, the thrombus at the thrombus position can be cut and captured, and finally the captured thrombus is retracted, so that the dredging of the blocked blood vessel is realized, and the arterial blood flow of the blood vessel is recovered.
It is understood that the compression degree or the self-expansion degree of the stent body 100 is mainly influenced by the thickness of a blood vessel at a position, the thinner the blood vessel is, the larger the compression degree is, the smaller the self-expansion degree of the stent body 100 is, the expansion degree of the stent body 100 is also influenced by the thrombus texture at the position, the softer the thrombus texture is, the more loose the expansion degree of the stent body 100 is, the harder the thrombus texture is, the denser the expansion degree of the stent body 100 is, and the smaller the expansion degree of the stent body 100 is, normally, the stent body 100 stays for 3-5 min after being released, so that the stent body 100 is expanded as much as possible, and is further embedded into thrombus tissues to be fully combined with the stent body 100.
Referring to fig. 1,2 and 3, the stent body 100 includes a proximal portion 110, an intermediate portion and a distal portion 130 disposed in an axial direction. The middle part comprises a plurality of repeating units 120, and the repeating units 120 are sequentially arranged along the axial direction. The repeating unit 120 includes a plurality of closed mesh units 121 sequentially arranged in the circumferential direction of the mesh-like structure. Each of the closed mesh units 121 includes a first mesh 1211 and a plurality of second mesh 1212 disposed adjacent to the first mesh 1211, the area of the first mesh 1211 being larger than the area of the second mesh 1212. In the present embodiment, the first mesh 1211 and the first mesh 1211 in the same repeating unit 120 are disposed adjacent to each other in the circumferential direction of the mesh tubular structure.
The area of the first mesh 1211 is 1.5-2.5 times the area of the second mesh 1212. In the present embodiment, the middle portion includes three repeating units 120, and the repeating units 120 include two closed mesh units 121 sequentially arranged in the circumferential direction of the mesh-like structure. In other embodiments, the number of the repeating units 120 and the closed grid units 121 may be single or plural, and may be adjusted according to specific needs without limitation.
When thrombus is cleaned, the first mesh 1211 and the plurality of second meshes 1212 are adjacently arranged, the area of the first mesh 1211 is larger than that of the second mesh 1212, the first mesh 1211 with larger size is beneficial to cutting thrombus, cut thrombus fragments can enter the stent main body 100 with a net tubular structure through the first mesh 1211, the second mesh 1212 with smaller size can effectively prevent the thrombus fragments from escaping from the inside of the stent main body 100, and the first mesh 1211 and the plurality of second meshes 1212 are mutually matched, so that the thrombus fragments can be better captured.
The first mesh 1211 generates weak radial supporting force when catching thrombus, which can reduce excessive stimulation to the vessel wall, and at the same time, the second mesh 1212 generates large radial supporting force when catching thrombus, which can be quickly embedded into thrombus, increase the stability of thrombus catching, and can effectively prevent thrombus fragments from escaping from the inside of the stent body 100. It should be understood that the radial supporting force is a force generated by the stent body 100 to the vessel wall in the self-expanding state, and when the first mesh 1211 of a larger size receives the same force, the first mesh 1211 of a larger size receives a larger pressure and is more easily deformed due to a smaller coverage per unit area, so that the radial supporting force generated when the first mesh 1211 of a larger size catches thrombus is weaker. The smaller size second mesh 1212 receives less pressure when subjected to the same force due to the greater coverage per unit area, and therefore the radial support force generated by the second mesh 1212 when capturing thrombus is greater.
Referring to fig. 1,2 and 3, the proximal portion is gathered at an end distal from the distal portion, and the distal portion is gathered at an end distal from the proximal portion. That is, the proximal end and the distal end of the stent body 100 are in a closed state, so that the thrombus fragments can be effectively prevented from escaping from the proximal end and the distal end of the stent body, and the thrombus fragments can be captured more easily.
The proximal portion 110 includes a plurality of closed cells 131, the plurality of closed cells 131 being arranged in a predetermined pattern such that the proximal end is in a closed configuration. A plurality of closed cells 131 are interconnected and meet at a proximal end such that the end of the proximal portion distal from the distal portion is in a closed configuration. The distal portion 130 includes a plurality of closed cells 131, the plurality of closed cells 131 being arranged in a predetermined pattern such that an end of the distal portion remote from the proximal portion is in a closed configuration. That is, the distal portions 130 are interconnected by a closed mesh 131, and meet at the distal-most end such that the distal-most end assumes a closed configuration,
The area of the closed mesh 131 is smaller than or equal to the area of the second mesh 1212, and when the stent body 100 is retracted, the distal end portion 130 formed by the interconnection of the smaller closed mesh 131 can block thrombus fragments that have fallen into the stent body 100, and in the retraction process, the thrombus is not easily fallen off, dragging the thrombus is facilitated, and escape of the thrombus fragments can be prevented. ,
The inventor finds that the stent main body which is marketed in China at present can only reach the blood vessel with the diameter of more than 1.5mm, and the thrombus can not be removed from the vascular embolism part with the smaller blood vessel diameter (the blood vessel diameter is less than 1.5 mm) for the thinner distal blood vessel. In order to solve the above problems, the applicant has made the following arrangement:
Referring to FIG. 1, the stent body 100 is made of a nickel-titanium alloy tubular material, and the pipe diameter of the nickel-titanium alloy tubular material is less than or equal to 0.4mm. Specifically, the holder body 100 is integrally manufactured using a machining process of laser engraving or laser cutting. It should be appreciated that nickel titanium alloys have superelasticity and shape memory properties and can be heat treated to set to memorize the set shape. Therefore, the stent body 100 made of nitinol has a sufficient radial supporting force, and also has superelasticity and shape memory, while ensuring good adherence. It should be further understood that the stent body 100 can be maintained in a compressed state all the time under the external circumferential restraining force, and when the external circumferential restraining force is removed, the stent body 100 made of nitinol can be restored to its original shape.
For example, the tube diameter of the nitinol tube is 0.4mm, it being understood that when the tube diameter of the nitinol tube is 0.4mm, the minimum compressed diameter of the stent body 100 in the compressed state is also the tube diameter of the nitinol tube, i.e., 0.4mm. The invention can be delivered in smaller diameter blood vessels, and the minimum can be delivered through 0.43mm blood vessels, so that the far-end blood vessels with more tortuosity and tiny intracranial can be reached.
Referring to fig. 2 and 3, the proximal portion 110, the plurality of repeating units 120, and the distal portion 130 are spirally distributed in the axial direction. Specifically, the plurality of closed cells 131 of the distal end portion 130, the plurality of repeating units 120, and the plurality of closed cells 131 of the proximal end portion 110 are sequentially spirally distributed in the axial direction.
More specifically, the adjacent two repeating units 120 are connected by an angle α of rotation in the axial direction, that is, the second of the two adjacent repeating units 120 is rotated by an angle α of rotation in the circumferential direction with respect to the first. The angle of alpha is in the range of 0 deg. -90 deg.. The preferred angular range of alpha is 45 deg.. For example, the repeating unit 120 includes a first repeating unit, a second repeating unit rotated by an angle α with respect to the first repeating unit, and a third repeating unit rotated by an angle α with respect to the second repeating unit.
By rotating the adjacent two repeating units 120 in the axial direction by an angle of α, so that the first mesh 1211 of the adjacent two repeating units 120 are not on the same connecting line in the axial direction, the first mesh 1211 can be spirally distributed in the axial direction. When thrombus is cleaned, the stent body 100 can be rotated by itself, and the first mesh 1211 is spirally arranged in the axial direction, so that the first mesh 1211 having a larger size in both the axial direction and the circumferential direction is arranged, thereby more advantageously rotating the thrombus.
In the present embodiment, the first cells 1211 of adjacent two repeating units 120 are disposed adjacent. The adjacent two first cells 1211 are connected to each other by an angle α in the axial direction, and the angle α is in the range of 0 ° -90 °. The preferred angular range of alpha is 45 deg..
The inventor finds that the poor effect of the radiopaque line of the stent main body can also cause the problems of inaccurate positioning of the stent main body, overlong thrombus taking time, thrombus falling off and the like. In order to solve the above problems, the applicant has made the following arrangement:
Referring to fig. 1 and 3, the developing units 200 are distributed on the proximal end portion 110, the distal end portion 130, and the plurality of repeating units 120. The connection modes of the developing unit 200 and the proximal portion 110, the distal portion 130, and the plurality of repeating units 120 may be mechanical nesting, crimping, metal collar, laser welding, adhesive bonding, or the like, and may be one of them, or a combination of a plurality of connection modes, which are not limited and may be adjusted according to specific needs.
Specifically, the developing units 200 on the adjacent two repeating units 120 are spirally distributed in the axial direction such that the developing units 200 on the adjacent two repeating units 120 are not on the same line. Each of the repeating units 120 includes two developing units 200, and the two developing units 200 in the same repeating unit 120 are symmetrically disposed with respect to the axial direction. By spirally distributing the developing units 200 on the adjacent two repeating units 120 in the axial direction and symmetrically arranging the two developing units 200 of each repeating unit 120 in the axial direction, the spatial resolution and visibility of the developing units 200 can be increased, thereby improving the spatial resolution and visibility of the rack main body 100. More specifically, the developing units 200 on the adjacent two repeating units 120 are arranged at an angle α ranging from 0 ° to 90 °. The preferred angular range of alpha is 45 deg..
The developing units 200 on the proximal end portion 110 and the distal end portion 130 are disposed at intervals. More specifically, the developing units 200 on the distal end portion 130 form a plurality of groups of developing structures arranged at intervals along the circumferential direction of the mesh-like structure, and two adjacent developing units 200 in the same group are arranged in parallel in the axial direction with intervals in the circumferential direction of the mesh-like structure. In the present embodiment, the number of the developing structures is two, each of the developing structures includes two developing units 200, and two developing units 200 are provided on the proximal end portion 110. In other possible embodiments, two adjacent developing units 200 have a spacing in both the axial direction and the circumferential direction of the mesh-like structure. The number of groups of the developing structure and the number of developing units 200 may be plural, and are not limited thereto, and may be adjusted according to specific needs.
The developing unit 200 is made of a metal material impermeable to X-rays, and may be any one of gold, platinum, tungsten gold, tantalum gold, or platinum iridium alloy. The main doctor or the medical intervention doctor can check the position of the developing unit 200 through DSA (digital subtraction angiography), so that the main doctor or the medical intervention doctor can be helped to better observe the state of the stent main body 100, and further judge the catching condition of thrombus by the stent main body 100.
Referring to fig. 1,2 and 3, the intravascular thrombus removal device 10 further includes a first visualization spring 300, a second visualization spring 400, the proximal portions converging at an end distal from the distal portions and forming a proximal tubular structure 700, the first visualization spring 300 being connected to the proximal tubular structure 700. The distal portion gathers at an end distal from the proximal portion and forms a distal tubular structure. The second developer spring 400 is connected to the distal tubular structure 800. The connection modes of the first developing spring 300 and the proximal tubular structure 700 and the connection mode of the second developing spring 400 and the distal tubular structure 800 can be nesting, crimping, metal collar, laser welding, adhesive bonding and the like of mechanical structures, can be one of the connection modes, can be a combination of a plurality of connection modes, are not limited, and can be adjusted according to specific needs.
The first developing spring 300 and the second developing spring 400 are made of a metal material impermeable to X-rays, and may be any one of gold wires, platinum wires, or platinum tungsten wires. The main doctor or medical intervention doctor can view the positions of the first and second visualization springs 300 and 400, which are not transparent to X-rays, through DSA (digital subtraction angiography), and can help the main doctor or medical intervention doctor to better observe the positions of the proximal and distal ends of the stent body 100.
The inventor finds that most of the bracket main bodies on the market at present are connected with the pushing rod and the developing spring in a simple welding mode, and the welding points are easy to fall off or break due to the technical defects of welding, so that the bracket main bodies are damaged and fall in the blood vessels of a human body, and serious clinical accidents are caused. In order to solve the above problems, the applicant has made the following arrangement:
Referring to fig. 1,3 and 4, the intravascular thrombus removal device 10 further includes a push rod 500, with a connecting clip 600 formed at an end of the push rod 500 near the proximal end. The first developer spring 300 includes a proximal connection portion 310 and a distal connection portion 320, the proximal connection portion 310 being connected to a proximal tubular structure 700. One end of the push rod 500 near the proximal end is penetrated through the proximal connecting portion 310 and the proximal tubular structure 700, the distal connecting portion 320 is disposed between the connecting chuck 600 and the proximal tubular structure 700, and the connecting chuck 600 can be abutted against the distal connecting portion 320.
Specifically, the inner diameter of the proximal tubular structure 700 is larger than the diameter of the connecting chuck 600, the inner diameter of the proximal connecting portion 310 is larger than the diameter of the connecting chuck 600, and the connecting chuck 600 and the push rod 500 can pass through the proximal connecting portion 310 and the proximal tubular structure 700 when assembled. The inner diameter of the distal end connecting portion 320 is smaller than the diameter of the connecting chuck 600 and larger than the inner diameter of the proximal end tubular structure 700, and the distal end connecting portion 320 is arranged between the connecting chuck 600 and the proximal end tubular structure 700, so that the connecting chuck 600 can be effectively prevented from falling off from the proximal end of the stent main body 100, and the problem that the stent main body 100 is damaged and falls off in a human blood vessel can be effectively solved.
The connection manner of the proximal tubular structure 700 and the first developing spring 300 and the pushing rod 500 may be the above-mentioned nested manner, and then be connected by welding, adhesive bonding, etc., which is a combination of various connection manners, and is not limited herein, and may be adjusted according to specific needs. For example, the proximal connector 310 is welded to the proximal tubular structure 700 and the connector clip 600 is welded to the proximal tubular structure 700 via the distal connector 320.
The intravascular thrombus removal device 10 of the present invention is used in conjunction with a microcatheter by first determining the location of the thrombus within the vessel by DSA (digital subtraction angiography) and then delivering the microcatheter to the thrombus location and through the thrombus.
The stent body 100 is pushed to the thrombus position by the pushing action of the push rod 500, and the second developing spring 400 is checked by DSA (digital subtraction angiography) to determine the position of the distal-most end of the stent body 100. After the distal-most end of the stent body 100 is adjusted to the proper position, the microcatheter is withdrawn. With the withdrawal of the microcatheter, the stent body 100 will self-expand and deploy at the thrombus site, the repeating unit 120 of the middle portion of the stent body 100 will embed into the thrombus, and at the same time, the several closed cells 131 of the distal end portion 130 of the stent body 100 will self-expand and deploy.
The first mesh 1211 and the plurality of second mesh 1212 of the repeating unit 120 are disposed adjacent to each other, and the area of the first mesh 1211 is larger than that of the second mesh 1212, the first mesh 1211 with a larger size is beneficial to cutting thrombus, and the cut thrombus fragments can enter the stent body 100 with a mesh-tube structure through the first mesh 1211, the second mesh 1212 with a smaller size can effectively prevent the thrombus fragments from escaping from the stent body 100, and the first mesh 1211 and the plurality of second mesh 1212 are mutually matched, so that the thrombus fragments can be better captured.
The distal outlet of the microcatheter is aligned with the first visualization spring 300 as the microcatheter is withdrawn and the stent body 100 is fully released from the microcatheter. Waiting for 3min to 5min, and fully embedding the stent body 100 and thrombus. Then the microcatheter, the stent body 100 and the pushing rod 500 are synchronously retracted until the stent body 100 and the thrombus are pulled out of the body, thus completing the thrombus taking operation.
Wherein, the distal portions 130 are interconnected by smaller closed meshes 131 and meet at the distal-most end to make the distal-most end in a closed structure, when the stent body 100 is retracted, the distal portions 130 formed by the interconnection of the smaller closed meshes 131 can block thrombus fragments that have fallen into the stent body 100, and in the retraction process, the thrombus is not easy to fall off, which is more favorable for dragging the thrombus, and can prevent the thrombus fragments from escaping.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims (10)

1. The intravascular thrombus taking-out device is characterized by comprising a bracket main body which is in a net tubular structure along the axial direction, wherein the bracket main body is in a self-expansion state and a compression state after being stressed;
The bracket main body comprises a proximal end part, a middle part and a distal end part which are arranged along the axial direction, wherein the middle part comprises a plurality of repeating units, and the repeating units are sequentially arranged along the axial direction;
The proximal end, the plurality of repeating units and the distal end are spirally distributed along an axial direction;
The proximal end part is gathered at one end far away from the distal end part and forms a proximal tubular structure, the distal end part is gathered at one end far away from the proximal end part and forms a distal tubular structure, and the nearest end of the proximal end part and the farthest end of the distal end part are intersected and converged by a closed mesh structure to form a closed structure;
The middle part of the bracket body is provided with a plurality of repeating units, wherein the repeating units at the middle part are spirally symmetrical relative to the bracket body, and the second of the two adjacent repeating units axially rotates by an angle alpha relative to the first in the circumferential direction;
The first developing spring comprises a proximal end connecting part and a distal end connecting part, and the proximal end connecting part is connected with the proximal end tubular structure;
the pushing device comprises a pushing rod, wherein a connecting clamping head is formed at one end, close to the proximal end, of the pushing rod, one end, close to the proximal end, of the pushing rod penetrates through the proximal connecting portion and the proximal tubular structure, the distal connecting portion is arranged between the connecting clamping head and the proximal tubular structure, and the connecting clamping head is abutted to the proximal tubular structure through the distal connecting portion.
2. The endovascular thrombus removal device as in claim 1, wherein two adjacent said repeat units are connected by an angle of rotation α in said axial direction.
3. The endovascular thrombus removal device of claim 1, wherein a plurality of visualization units are distributed on each of the proximal portion, the distal portion and the plurality of repeat units, wherein the plurality of visualization units on each of the proximal portion and the distal portion are spaced apart, and wherein the visualization units on adjacent two of the repeat units are helically distributed along the axial direction.
4. The endovascular thrombus removal device as in claim 3, wherein said visualization units on said distal portion form a plurality of sets of visualization structures circumferentially spaced apart along said mesh-like structure, adjacent two of said visualization units in a same set being disposed in parallel in said axial direction with a spacing circumferentially spaced apart along said mesh-like structure.
5. An intravascular thrombus removal device as in claim 3 wherein each of said repeating units includes two of said visualization units, said two of said visualization units in the same repeating unit being symmetrically disposed about said axis.
6. The endovascular thrombus removal device as in claim 1, further comprising a second visualization spring connected to the distal tubular structure.
7. The endovascular thrombus removal device of claim 1, wherein the first mesh is helically distributed along the stent body axis facilitating self-rotation atherectomy of the stent body.
8. The endovascular thrombus removal device of claim 1, wherein the first mesh has an area of 1.5-2.5 times the area of the second mesh.
9. The endovascular thrombus removal device as in claim 1, wherein the distal portion comprises a plurality of closed cells arranged in a predetermined pattern such that an end of the distal portion distal from the proximal portion is in a closed configuration, the area of the closed cells being less than or equal to the area of the second cells, the closed cells being configured to block the thrombus from falling into the stent body.
10. The endovascular thrombus removal device as in claim 1, wherein the stent body is a nickel-titanium alloy tubular material having a tube diameter of 0.4mm or less.
CN202210355469.1A 2022-04-06 2022-04-06 Intravascular thrombus removal device Active CN114652394B (en)

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