CN111956301A

CN111956301A - Thrombus extraction device and manufacturing method thereof

Info

Publication number: CN111956301A
Application number: CN202010931191.9A
Authority: CN
Inventors: 刘升华; 牛兴慧; 白会新; 褚晓莉; 黄丹丹
Original assignee: Beijing Yangli Medical Technology Co ltd
Current assignee: Beijing Yingxing Medical Technology Co.,Ltd.
Priority date: 2020-09-07
Filing date: 2020-09-07
Publication date: 2020-11-20

Abstract

The invention discloses a thrombus extraction device and a manufacturing method thereof, wherein the thrombus extraction device comprises a thrombus extraction bracket (1), a push guide wire (3), a near-end development mark (4) and a far-end development mark (5); a developing wire (104) is arranged on the embolectomy bracket (1) between the near-end developing mark (4) and the far-end developing mark (5); a thrombus arresting arm (111) with a thrombus arresting structure is arranged in the unit grid of the effective working section of the thrombus taking support (1). By applying the invention, the problems of undefined release state of the thrombus stent and thrombus escape caused by the undefined release state of the thrombus in the process of taking out the thrombus can be effectively avoided.

Description

Thrombus extraction device and manufacturing method thereof

Technical Field

The invention relates to the technology of medical instruments, in particular to a thrombus extraction device and a manufacturing method thereof.

Background

Acute Ischemic Stroke (AIS) is a group of clinical syndromes of cerebral tissue blood circulation disorder caused by various reasons, and cerebral tissue Ischemic and hypoxic necrosis including neurons, astrocytes and oligodendrocytes is generated from the cerebral tissue blood circulation disorder, and then neurological dysfunction occurs. Acute ischemic stroke has high morbidity, disability rate and mortality rate, and accounts for about 70% of the whole stroke event.

In recent years, cerebrovascular diseases have leaped to be the first cause of death in China, are the main causes of disability of patients due to diseases, and have become public health problems in China and even globally.

The current etiological treatment methods for acute ischemic stroke mainly comprise thrombolytic therapy and intravascular interventional therapy (such as intravascular mechanical thrombus removal). Wherein:

the intravenous thrombolysis is mainly used for carrying out thrombolysis treatment by utilizing medicines such as recombinant tissue plasminogen activator (rt-PA), Urokinase (UK) and the like, the time window of the thrombolysis treatment is 3-6 hours, but the intravenous thrombolysis treatment has poor effect on acute large vessel occlusion, and the open rate of the venous thrombolysis for the internal carotid artery end occlusion is only 6% according to the report of the literature.

The intravascular mechanical thrombus removal is the most important progress of acute ischemic stroke treatment in recent years, so that the AIS treatment time window is remarkably prolonged, and the prognosis of patients with ischemic stroke caused by acute aortic occlusion can be remarkably improved. An intravascular mechanical thrombus removal method is mainly characterized in that the position of the blood vessel occlusion is determined through Digital Subtraction Angiography (DSA), then a thrombus is taken out of the body after a thrombus removal device (such as a thrombus removal stent) is conveyed to the occlusion position by utilizing a nerve micro-guide wire and a micro-catheter, and therefore the occluded blood vessel is opened rapidly.

Several thrombus taking devices sold in the market at present are influenced by factors such as structures, developing schemes and the like, and have the problems that thrombus escapes in the thrombus taking process and the release state of a thrombus taking support is not clear, the release state of the thrombus taking support is one of the reasons for the thrombus escaping, and the escaped thrombus flows to the far end of a blood vessel to form new embolism under the action of blood flow impact, so that the operation risk is increased.

Disclosure of Invention

In view of the above, the main object of the present invention is to provide a thrombus removal device and a method for manufacturing the same, which can effectively avoid the problems of unclear release state of the thrombus stent during the thrombus removal process and thrombus escape.

In order to achieve the purpose, the technical scheme of the invention is as follows:

a thrombus extraction device comprises a thrombus extraction bracket, a pushing guide wire, a proximal end development mark and a distal end development mark; developing wires are arranged on the thrombus taking support between the near-end developing mark and the far-end developing mark; and a thrombus blocking arm with a thrombus blocking structure is also arranged in the unit grid in the effective working section of the thrombus taking support.

Wherein: the thrombus taking support can reciprocate in the guiding sheath along the axial direction through the pushing guide wire connected with the thrombus taking support, and the thrombus taking support moves to the guiding sheath or the micro catheter to be in a compressed state and is in a released state when being separated from the guiding sheath or the micro catheter.

The effective working section of the embolectomy support comprises a near-end working section, a middle working section and a far-end working section.

The developing wire is arranged on the near-end working section, the middle working section, the far-end working section or the whole thrombus taking support.

The thrombus taking support is integrally in a hollow-out round tubular structure; the near end of the probe is of a fully open structure, and the far end of the probe is of an umbrella-shaped closed structure; or both the near end and the far end of the medical device are open structures.

The proximal end working section of the embolectomy support is a hollow circular tube-shaped inclined-section open structure, and the distal end working section of the embolectomy support is a hollow conical umbrella-shaped closed structure; or the far-end working section consists of a hollow circular tubular structure and a hollow conical umbrella-shaped closed structure.

Thrombus arresting arms obliquely embedded from the tube wall to the axis direction of the tubular structure are distributed on the middle working section of the thrombus taking support.

The unit grids of the embolectomy support comprise a first unit grid, a second unit grid and a third unit grid which have different structures; the hollow structure of the embolectomy support is formed by combining the first unit grid, the second unit grid and the third unit grid in pairs or three parts.

The first unit grid is a quadrangle formed by a first straight rod and a first curved rod; the second unit grid is a hexagon-like grid formed by the first curved bars; the third unit grid consists of the second unit grid and a thrombus blocking arm obliquely embedded into the axial center direction of the thrombus removal support.

The thrombus arresting arm is of at least one group of V-shaped structures formed by a second curved rod or a first straight rod; the open end of the V-shaped structure, namely the root of the thrombus arresting arm, is fixedly connected with the second unit grid.

The thrombus blocking arm is obliquely embedded into the axis direction of the thrombus taking support, and the embedded angle range is 25-70 degrees; the V-shaped closed end is bent along the axial direction of the embolectomy support, the bending length range is 1 mm-4 mm, and the bending angle range is 25-70 degrees.

The thrombus arresting arms are arranged in any plurality of adjacent or non-adjacent second unit grids.

The hollow conical umbrella-shaped structure of the distal working section of the thrombus taking support extends and converges towards the distal direction of the thrombus taking support to form a cone top and an extension rod, and the cone angle range of the hollow conical umbrella-shaped structure of the distal working section is 30-70 degrees.

The distal visualization marker comprises a first distal visualization marker and a second distal visualization marker; the first far-end development mark is fixedly connected to the starting position of the far-end working section of the embolectomy support, and the second far-end development mark is fixedly connected to an extension rod of a hollow conical umbrella-shaped structure of the far-end working section 103, extends towards the far-end direction and converges to form a conical top.

The first far-end development mark is arranged on a first curved rod at the starting position of the oblique extension of the middle working section of the embolectomy bracket.

The number of the developing wires is 3-5, and the developing wires are fixedly connected with the first far-end developing mark between the middle working section and the far-end working section respectively.

A method for manufacturing a thrombus removal device, comprising the steps of:

manufacturing a hollowed-out thrombus taking support and a thrombus blocking arm with a thrombus blocking structure by adopting a mode of cutting a metal round pipe by laser and then carrying out heat treatment setting;

fixedly connecting a pushing guide wire with the embolectomy support, and welding a near-end development mark on the pushing guide wire and a far-end development mark on the embolectomy support.

Wherein: the thrombus arresting arm is of one to more approximate V-shaped structures consisting of second bent rods, and the opening end of the V-shaped structure, namely the root of the thrombus arresting arm, is connected with the second unit grid; the thrombus arresting arm and the second unit grid are cut integrally.

Further comprising: the method comprises the following steps of setting a developing wire in an effective working section of the embolectomy support, and specifically comprises the following steps:

spirally winding the developing wire along the axial direction of the bolt taking support to the far end direction of the bolt taking support through the first straight rod and the first curved rod; and arranging the developing wire on the near-end working section, the middle working section, the far-end working section or the whole thrombus removal support.

The widths of the first straight rod, the first curved rod and the second curved rod are all smaller than the wall thickness of the bolt taking support, so that the circumferential dimension of the first straight rod and the first curved rod which form the bolt taking support in the bolt taking support is smaller than the radial dimension of the first straight rod and the first curved rod in the bolt taking support.

Compared with the prior art, the thrombus extraction device and the manufacturing method thereof have the following beneficial effects:

1) according to the invention, the development wire is arranged on the thrombus removal support and matched with the near-end development mark, the first far-end development mark and the second far-end development mark, so that the working states, namely the compression state and the release state, of the thrombus removal support in the thrombus removal process in a blood vessel can be clearly displayed, the specific position of the effective working section of the thrombus removal support in the far-end direction can be displayed, and the placement accuracy of the thrombus removal support is improved.

2) According to the invention, the thrombus blocking arm is arranged in the unit grid in the effective working section of the thrombus taking support, so that the problem of thrombus escape in the thrombus taking process can be effectively avoided.

3) The invention also can effectively block micro thrombus which is impacted and dropped by blood flow after the forward blood flow is recovered by designing the effective working section of the thrombus taking support, such as the design of the cone angle of the hollow conical umbrella-shaped structure of the distal working section, and prevent new embolism from being formed at the distal end of the blood vessel, so that the blood flow in the blood vessel can be recovered and re-communicated as soon as possible.

Drawings

FIG. 1 is a schematic structural view of a thrombus removal device according to an embodiment of the present invention;

FIG. 2 is a schematic view showing a compressed state of a thrombus removal device according to an embodiment of the present invention;

FIG. 3 is a schematic view showing the construction of a thrombus removal device according to an embodiment of the present invention;

FIG. 4 is a schematic structural view of a proximal working section of a thrombus removal device according to an embodiment of the present invention;

FIG. 5 is a schematic structural view of another embodiment of a thrombus removal device according to an embodiment of the present invention;

FIG. 6 is a schematic view of another embodiment of the distal structure of the thrombectomy stent of the thrombectomy device according to the embodiment of the invention;

FIG. 7 is a schematic view showing a lattice structure of a thrombus removal support unit and a thrombus blocking arm of the thrombus removal device according to the embodiment of the present invention;

FIG. 8 is a schematic axial sectional view of a middle working section of a thrombus removal device according to an embodiment of the present invention;

FIG. 9 is a schematic cross-sectional view of a thrombus removal device according to an embodiment of the present invention;

FIG. 10 is a schematic structural view of another embodiment of a thrombus-arresting arm of a thrombectomy stent of the thrombus removal device in accordance with the present invention;

FIGS. 11a, 11b and 11c are schematic diagrams of a row, a column and a spiral of a stent deployment of a thrombus removal device according to an embodiment of the present invention;

FIGS. 12a and 12b are schematic views showing positions of thrombus-arresting arms of a thrombus removal device according to an embodiment of the present invention;

FIG. 13a is a schematic view of the distal end of a thrombectomy stent of the thrombectomy device in accordance with the embodiment of the present invention;

FIG. 13b is a schematic view of another embodiment of the distal structure of the thrombectomy stent of the thrombectomy device according to the embodiment of the present invention;

FIG. 14 is a right-side view of the distal end of an thrombectomy stent of the thrombectomy device in accordance with the embodiment of the present invention;

FIG. 15a is a schematic structural view of a development wire in a released state of a thrombus removal device according to an embodiment of the present invention;

FIG. 15b is a perspective view of a visualization wire of a thrombus removal device in an intravascular compressed state in accordance with an embodiment of the present invention;

FIG. 15c is a perspective view of a visualization wire of the thrombus removal device in a released state within a blood vessel in accordance with an embodiment of the present invention;

FIG. 15d is a schematic perspective view of a development wire in a state where the thrombus removal device according to the embodiment of the present invention is released in a tortuous section of a blood vessel;

FIGS. 16a, 16b, and 16c are schematic views illustrating the delivery process of a thrombus removal device according to an embodiment of the present invention;

FIG. 16d is a schematic view of the thrombectomy stent of the thrombectomy device in accordance with the embodiment of the present invention released from the lesion site;

FIG. 16e is a schematic view showing a blood recanalization after the thrombus has been removed by the thrombus removal device according to the embodiment of the present invention;

FIG. 17 is a schematic view showing a thrombus-arresting arm of the thrombus removal device according to the embodiment of the present invention arresting a thrombus;

FIG. 18 is a schematic view of the distal working section of the thrombus removal device of an embodiment of the present invention obstructing escaped thrombus;

FIGS. 19a and 19b are schematic longitudinal sectional views showing the release of a thrombectomy stent at a lesion site in a blood vessel according to an embodiment of the present invention.

[ description of main symbols ]

1-thrombus taking support; 101-a proximal working section; 1011-hollowed out circular tube-shaped oblique section; 102-an intermediate working section; 103-a distal working section; 104-developing silk; 105-an extension bar; 106-a first grid of cells; 107-a second grid of cells; 108-a third grid of cells; 109-a first straight bar; 110-a first curved bar; 111-a thrombus-arresting arm; 112-a second knee lever;

2-introducing a sheath; 3, pushing a guide wire; 4-proximal visualization marker;

5-distal visualization of the mark; 501-first distal visualization marker; 502-a second distal visualization marker;

6-blood vessel; 7-thrombosis; 8-blood; 9-microthrombus.

Detailed Description

The present invention will be described in further detail below with reference to the accompanying drawings and embodiments thereof.

For purposes of illustrating and describing embodiments of the present invention more clearly, reference is made to one or more of the drawings, but the additional details or examples used to describe the drawings are not intended to limit the scope of any of the inventive concepts of the present application, the presently described embodiments, or the preferred versions. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

The proximal and distal ends described in the present specification have the same meaning in the direction of the thrombus removal device of the present invention, and specifically: the "proximal end" refers to the end closer to the operator (heart) in the use state, and the "distal end" refers to the end farther from the operator (heart) in use.

FIG. 1 is a schematic structural view of a thrombus removal device according to an embodiment of the present invention.

As shown in FIG. 1, the thrombus removal device is used to mechanically remove a thrombus occluding an intracranial blood vessel by an interventional method, thereby achieving the purpose of recanalization of the blood vessel and restoration of blood flow.

The thrombus extraction device comprises a thrombus extraction bracket 1, an introduction sheath 2, a pushing guide wire 3, a proximal development mark 4 and a distal development mark 5. Wherein:

the two ends of the thrombus removal support 1 are respectively fixed with a near-end development mark 4 and a far-end development mark 5. The proximal developing mark 4 is connected with the pushing guide wire 3; the push guide wire 3 passes through the introducing sheath 2, and the introducing sheath 2 can move freely. The method specifically comprises the following steps: the thrombus taking bracket 1 is fixedly connected with the near-end developing mark 4; the near-end developing mark 4 is fixedly connected with the pushing guide wire 3; the far end of the embolectomy support 1 is fixedly connected with the far-end development mark 5; the distal end development mark 5 includes a first distal end development mark 501 and a second distal end development mark 502 of the middle working section 102 (refer to fig. 3). The thrombectomy stent 1 can be moved back and forth in the axial direction of the introducer sheath 2 by the pushing guide wire 3.

Further, the embolectomy support 1 is formed by laser cutting a metal round tube, such as a nickel-titanium tube, and then performing heat treatment and shaping, and is integrally in a hollow round tubular structure. The thrombus removal support 1 is fixedly connected with the pushing guide wire 3 and the proximal developing mark 4 in a welding mode. The bolt taking bracket 1 is fixedly connected with the far-end development mark 5 in a welding mode. The push guidewire 3 is made of stainless steel or nitinol. The push guide wire 3 is made of a metal wire, and the outer layer of the metal wire is coated with a hydrophilic coating. The introducing sheath 2 is a polymer pipe made of polyamide through an extrusion mode. The proximal end developing marker 4 and the distal end developing marker 5 are both made of a material that does not transmit a ray, for example, the material thereof is any one of platinum-iridium alloy or platinum-tungsten alloy.

The thrombus removal device in this embodiment has two states, i.e., a compressed state and a released state, of the thrombectomy stent 1, and accordingly has two operating states. Fig. 1 shows the release state of the device.

FIG. 2 is a schematic view showing a compressed state of the thrombus removal device according to the embodiment of the present invention.

As shown in fig. 2, when the thrombus removal device is in a compressed state, the thrombus removal stent 1 is preloaded in the introduction sheath 2, the thrombus removal stent 1 is in a compressed state, and is introduced into the microcatheter through an auxiliary instrument when in use, and is pushed to a lesion site of a thrombus to be removed in the microcatheter together with the push guide wire 3 in a compressed state, the position of the thrombus removal stent 1 is kept unchanged, and the microcatheter is withdrawn, so that the thrombus removal stent 1 can be released from the microcatheter again and then is in a released state.

FIG. 3 is a schematic structural view of a thrombus removal device according to an embodiment of the present invention.

As shown in fig. 3, the embolectomy stent 1 has an overall hollowed-out tubular structure, a proximal end of the hollow-out tubular structure is a fully open structure, a distal end of the hollow-out tubular structure is an umbrella-shaped closed structure, the hollow-out tubular structure is made of a metal tubular, such as nitinol, by laser cutting, and an effective working section of the hollow-out tubular structure can be divided into a proximal working section 101, a middle working section 102 and a distal working section 103. Wherein, the near end working section 101 is provided with a developing wire 104, and the extension part of the far end working section 103 along the axial direction is provided with an extension rod 105. The developer wire 104 may also be disposed on the middle working section 102, the distal working section 103, or on straight or curved bars of the unit grid of the entire thrombectomy rack 1.

In another embodiment, as shown in fig. 5, the thrombectomy stent 1 has an overall hollow tubular structure, and both the proximal end and the distal end are open. The embolectomy stent 1 is made of a metal round tube, such as nickel-titanium alloy, through laser cutting, and the working section of the embolectomy stent can be divided into a proximal working section 101, an intermediate working section 102 and a distal working section 103. Wherein, the semi-open structure of near-end working segment 101 specifically is: the lower half part of the cross section of the device is a hollow open structure, and the upper half part of the cross section of the device is a hollow circular tube net structure. The mesh structure of the hollow circular tube at the near-end working section 101 is also provided with a developing wire 104. The distal working segment 103 is also hollow and open, and is formed by extending the middle working segment 102 in the distal direction. The distal working section 103 has distal developing marks 5 fixed to the distal ends of the open-structured claws, as shown in fig. 6. Wherein, the far-end development mark 5 is fixedly connected by welding.

FIG. 4 is a schematic structural view of the proximal working section of the thrombectomy stent of the thrombectomy device according to the embodiment of the invention.

As shown in fig. 4, in the present embodiment, the proximal working section 101 of the embolectomy stent 1 is a hollow circular tube-shaped oblique cross section 1011, and has a hollow open structure, and extends in the distal direction to form a middle working section 102 (not shown), and converges in one position in the proximal direction, and is fixedly connected with the proximal visualization mark 4 and the pushing guide wire 3 by welding.

In addition, referring to fig. 3, the middle working section 102 is a hollow round tubular structure, and is a main body of the thrombus removal stent 1, and is provided with a thrombus blocking arm 111 obliquely embedded from the tube wall to the axis direction of the tubular structure. The intermediate working segments 102 extend in the proximal direction to form proximal working segments 101 and extend in the distal direction to converge to form distal working segments 103.

FIG. 7 is a schematic view showing the lattice structure of the thrombus removal device according to the embodiment of the present invention.

The proximal working section 101 of the thrombectomy stent 1 is taken as an example for the description of the present embodiment, and as shown in the planar development of the proximal working section 101 shown in fig. 7, the thrombectomy stent further comprises a first unit cell 106, a second unit cell 107 and a third unit cell 108 with a thrombi arresting structure. The proximal working section 101, the middle working section 102 and the distal working section 103 of the embolectomy support 1 are 22-49 unit grids in total. The unit cell includes a first unit cell 106, a second unit cell 107, and a third unit cell 108 having different structures.

The unit grid 106 is a rhomboid quadrilateral which is formed by a first straight rod 109 and a first curved rod 110 and is similar to a diamond; the second unit cell 107 is formed of a hexagon-like shape formed by the first curved bars 110; the third unit cell 108 is constituted by the second unit cell 107 and the thrombus occlusion arm 111 obliquely inserted into the axial direction of the thrombus support 1. The thrombus arresting arm 111 has one or more substantially V-shaped structures formed by the second curved bars 112, and preferably, the number of the second curved bars 112 is 2. The V-shaped open ends, i.e., the roots of the thrombus-arresting arms 111, are connected to the second unit cells 107. The thrombus block arm 111 is cut integrally with the second unit mesh 107.

The widths of the first straight rod 109, the first curved rod 110 and the second curved rod 112 are all smaller than the wall thickness of the thrombectomy support 1, that is, the circumferential dimension of all the straight rods and curved rods forming the thrombectomy support 1 in the thrombectomy support 1 is smaller than the radial dimension of the thrombectomy support 1, so that the thrombectomy support 1 is easier to embed thrombus, and the probability of thrombus falling off is reduced.

FIG. 8 is a schematic axial cross-sectional view of the middle working section 102 of the thrombectomy stent of the thrombectomy device according to the embodiment of the invention.

As shown in FIG. 8, the left side of the thrombectomy stent 1 is connected with the proximal working section 101, and the right side is connected with the distal working section 103. In the middle working section 102, the thrombus blocking arms 111 arranged in the unit grids are obliquely embedded into the axis direction of the thrombus removal support 1 to block escaping thrombus, and the plurality of thrombus blocking arms 111 reduce the risk of thrombus escaping and forming new embolism at the far end of the blood vessel. Further, the embedded angle range of the thrombus arresting arm 111 is 25-70 degrees, the V-shaped closed end of the thrombus arresting arm 111 is bent along the axial direction of the thrombus extraction support 1, the bending length range is 1-4 mm, the bending angle range is 25-70 degrees, and the bent thrombus arresting arm and the axial direction of the thrombus extraction support 1 can be parallel or not parallel.

FIG. 9 is a cross-sectional view of a thrombus removal device according to an embodiment of the present invention.

As shown in FIG. 9, in the cross section of the thrombectomy stent 1, a plurality of thrombus blocking arms 111 form a channel in the axial direction of the thrombectomy stent 1, so that a part of forward blood flow is restored as soon as possible after the thrombus is spread, and a part of the occluded blood vessel is opened, thereby reducing the volume of brain tissue necrotized by ischemia and hypoxia.

FIG. 10 is a schematic structural view of another embodiment of the thrombus-arresting arm of the thrombectomy stent of the thrombus removal device in accordance with the embodiment of the present invention.

In other embodiments, as shown in FIG. 10, the thrombus-arresting arms 111 are formed from one or two sets of straight or curved rods. In various embodiments, the number of the thrombus barrier arms 111 may be 4 to 28.

FIGS. 11a, 11b and 11c are schematic diagrams of the expanded rows, columns and spiral columns of the thrombectomy stent of the thrombectomy device according to the embodiment of the invention.

In the planar development of the embolectomy stent 1, the pattern formed by the unit grids longitudinally arranged along the black thick line direction is called a column. Starting from the proximal direction, the first column is column 1, the second column is column 2, and so on. Similarly, another case of arranging the unit cells in the vertical direction is called a spiral row, for example, the first row is a spiral row 1, the second row is a spiral row 2, and so on.

Similarly, a pattern formed by a grid of cells arranged laterally along the direction of a black bold line is called a row. Starting from the near end direction, the first row is row 1, the second row is row 2, and so on.

As shown in fig. 11a, the layout of the

rows

1, 2, … … and 4 of the thrombectomy stent 1 is shown; FIG. 11b shows the state of the row 1, row 2, row … … and row 4 of the deployed thrombectomy stent 1; FIG. 11c shows the arrangement of the

spiral rows

1, 2, … …, and 4 of the stent 1. According to different embodiments, the number of the columns, the spiral columns or the rows in the embolectomy support 1 can be 3-8 respectively.

FIGS. 12a and 12b are schematic views showing positions of thrombus-arresting arms of a thrombus removal device according to an embodiment of the present invention.

As shown in fig. 12a and 12b, the thrombus-arresting arms 111 may be disposed in any one of the unit cells of the second, third, fourth, sixth, and seventh rows in the expanded view of the stent 1 as defined in fig. 11a to 11 c. Fig. 12a shows a case where there are at most 4 unit cells per column (as in the second unit cell 107), and fig. 12b shows a case where there are at most 5 unit cells per column.

In addition, in other embodiments, the thrombectomy stent 1 defined in FIGS. 11a, 11b, and 11c is expanded into rows, columns, and helical columns. In another embodiment, the thrombus arresting arms 111 may be further disposed within the cell lattice in which 2 adjacent odd-numbered rows and/or 2 adjacent even-numbered rows and/or 2 adjacent rows in the odd-numbered columns and/or the even-numbered columns of the deployment figure are located; in yet another embodiment, the thrombus arresting arms 111 may also be disposed within a grid of cells in an odd-numbered helical row or an even-numbered helical row of the deployment view; in yet another embodiment, the thrombus arresting arms 111 may also be disposed within a grid of cells in 2 adjacent odd and even helical columns in the expanded view; in a further embodiment, the thrombus-arresting arms 111 may also be disposed within a grid of cells that are spaced apart in one or two columns in the expanded view.

In summary, the location and number of the thrombus blocking arms 111 in a particular unit cell grid is not limited in all embodiments of the present invention.

FIG. 13a is a schematic view of the distal end of the thrombectomy stent of the thrombectomy device in accordance with the embodiment of the present invention.

As shown in fig. 13a, the distal working segment 103 includes a hollow tubular structure and a hollow conical umbrella-shaped closed structure. The hollow circular tubular structure is formed by extending the hollow circular tubular structure of the middle working section 102 and the tail end in the far end direction, the tail end points of the hollow circular tubular structure are 3-4, and the hollow circular tubular structure is fixedly connected with the first far end development mark 501 of the middle working section 102 in a welding mode. The first distal development mark 501 of the middle working section 102 is used for displaying the specific position of the effective working section of the thrombectomy stent 1 in the distal direction, so as to improve the placement accuracy of the thrombectomy stent 1.

The root of the opposite near end (i.e. the conical umbrella-shaped structure) of the hollowed-out conical umbrella-shaped closed structure of the far-end working section 103 is connected with the hollowed-out circular tubular structure, and the hollowed-out conical umbrella-shaped structure extends and converges towards the far-end direction of the embolectomy stent 1 to form a cone top and an extension rod 105, and is fixedly connected with the second far-end development mark 502 at the farthest end in a welding manner, as shown in fig. 13 b. The cone angle of the hollow conical umbrella-shaped structure of the far-end working section 103 is 30-70 degrees, so that thrombus which is knocked off by blood flow after the forward blood flow is recovered can be blocked, and new embolism is prevented from forming at the far end of the blood vessel.

FIG. 13b is a schematic view of another embodiment of the distal structure of the thrombectomy stent of the thrombectomy device according to the embodiment of the invention.

In another embodiment, as shown in fig. 13b and 14, the distal working section 103 is a hollow conical umbrella-shaped closed structure, and is formed by the hollow circular tubular structure of the middle working section 102 extending and converging towards the distal end along the axial direction of the embolectomy stent 1, and an extension rod 105 is formed at the converging position (not shown in fig. 13 b). The extension rod 105 is fixedly connected to the second distal imaging marker 502 by welding. The cone angle of the hollow conical umbrella-shaped structure of the far-end working section 103 is 30-70 degrees. In this embodiment, the first distal development mark 501 of the middle working segment 102 is fixed by welding to the first curved bar 110 at the starting position where the middle working segment 102 extends obliquely.

In another embodiment, referring to fig. 6, the distal working segment 103 is an open structure, and is formed by extending the middle working segment 102 (not shown) in the distal direction, and is fixedly connected to the distal imaging marker 5 by welding.

In addition, referring to fig. 3, the proximal end of the visualization wire 104 is fixedly connected with the proximal visualization mark 4 in a welding manner, and starting from the proximal visualization mark 4, the visualization wire 104 is spirally wound along the axial direction of the thrombectomy stent 1 to the distal end of the thrombectomy stent 1 through the first straight rod 109 and the first curved rod 110, and is fixedly connected with the first distal visualization mark 501 of the middle working section 102 in a welding manner.

In the embodiment of the invention, the width of the first straight rod 109 and the first curved rod 110 ranges from 0.04mm to 0.1mm, the diameter of the developing wire 104 ranges from 0.03mm to 0.08mm, and the diameter of the thrombectomy support 1 ranges from 3mm to 6mm, so that the smaller diameter of the developing wire 104 wound on the straight rod/curved rod of the thrombectomy support 1 does not affect the overall size of the thrombectomy support 1 and the operation in the thrombectomy process. The developing wires 104 are made of a material which does not allow the transmission of rays, the material is any one of platinum-iridium alloy or platinum-tungsten alloy, and the number of the developing wires 104 can be 3-5. In the present embodiment, 3 developing wires 104 are provided, and are fixedly connected to the first distal developing marks 501 (not shown) of the 3 middle working stages 102 by welding.

FIG. 15a is a structural view of a development wire in a released state of the thrombus removal device in accordance with the embodiment of the present invention.

As shown in fig. 15a, the development wire 104 is seen in perspective in a state where the thrombectomy stent 1 is in a released state. Because the visualization wire 104 is wound on the thrombus removal stent 1, and the visualization wire 104 is from the proximal visualization mark 4 to the first distal visualization mark 501 of the middle working section 102, the thrombus removal stent 1 is completely visualized in the blood vessel, and the overall opening form of the thrombus removal stent 1 in the blood vessel can be judged according to the form of the visualization wire 104, so that the imaging support is provided for the thrombus removal process.

FIG. 15b is a perspective view of a development wire of a thrombus removal device according to an embodiment of the present invention in a state of being compressed in a blood vessel, FIG. 15c is a perspective view of a development wire of a thrombus removal device according to an embodiment of the present invention in a state of being released in a blood vessel, and FIG. 15d is a perspective view of a development wire of a thrombus removal device according to an embodiment of the present invention in a state of being released in a tortuous section of the blood vessel.

As shown in FIG. 15b, the visualization wire 104 is in a compressed state within the vessel on the thrombectomy stent 1, which is visible under fluoroscopy.

As shown in FIG. 15c, the visualization wire 104, which is visible in perspective, is in a released state within the vessel on the thrombectomy stent 1.

As shown in FIG. 15d, the visualization wire 104 visible under the fluoroscopy condition is in a state of being released in the tortuous vessel on the thrombectomy stent 1.

FIGS. 16a, 16b and 16c are schematic views showing the delivery process of the thrombus removal device according to the embodiment of the present invention.

As shown in fig. 16a to 16c, the procedure of thrombus removal by the thrombus removal holder 1 is described. In this embodiment, as shown in figure 16a, a segment of intracranial blood vessel 6 is embolized by thrombus 7, and blood 8 cannot pass through the thrombus 7.

In this embodiment, as shown in fig. 16b and 16c, the thrombectomy stent 1 of the thrombectomy device is inserted into the microcatheter in a compressed state by the aid of the device and advanced with the microcatheter through the thrombus 7.

FIG. 16d is a schematic view of the thrombectomy stent of the thrombectomy device according to the embodiment of the present invention after being released from the lesion site, and FIG. 16e is a schematic view of the thrombectomy device according to the embodiment of the present invention after the thrombectomy stent is removed from the thrombectomy stent.

As shown in fig. 16d, the position of the thrombectomy stent 1 is kept unchanged, the microcatheter is slowly withdrawn, the thrombectomy stent 1 is released from the microcatheter, and the thrombectomy stent 7 is anchored during the release process, as shown in fig. 19a and 19b, meanwhile, as the thrombectomy stent 1 and the thrombectomy arms 111 thereof are restored to the release state, a blood flow path is supported inside the thrombectomy stent 7, partial forward blood flow is restored, and then the thrombectomy stent 1 and the microcatheter are withdrawn together, the thrombectomy stent 7 is pulled out of the body from the blood vessel by the thrombectomy stent 1, as shown in fig. 16e, the blood flow in the blood vessel is completely re-passed.

FIG. 17 is a schematic view showing a thrombus-arresting arm of the thrombus removal device according to the embodiment of the present invention arresting a thrombus.

As shown in FIG. 17, due to the embedded structure of the thrombus-arresting arm 111, the thrombus-arresting arm 111 can arrest the small thrombus 9 having a small size, preventing the small thrombus 9 from forming a new embolism in the distal end of the blood vessel with the forward blood flow.

FIG. 18 is a schematic view of the distal working section of a thrombus removal device of an embodiment of the present invention obstructing escaped thrombus.

As shown in fig. 18, if a small thrombus 9 falls off during the intravascular thrombectomy process of the thrombectomy stent 1, the distal working section 103 can block the small thrombus 9, so as to prevent the small thrombus 9 from forming a new embolism at the intravascular distal end along with the forward blood flow.

Technical implementation manners of the different embodiments of the present invention may be arbitrarily combined, and although all possible combinations of all implementation manners are not described in the embodiments of the present invention, the technical implementation manners of the different embodiments of the present invention belong to the embodiments of the present invention as long as the combinations of the technical features in the above schemes are not contradictory.

The above description is only a preferred embodiment of the present invention, and is not intended to limit the scope of the present invention.

Claims

1. A thrombus extraction device comprises a thrombus extraction bracket (1), a push guide wire (3), a proximal development mark (4) and a distal development mark (5); the thrombus removal device is characterized in that a development wire (104) is arranged on the thrombus removal support (1) between the near-end development mark (4) and the far-end development mark (5); the unit grids in the effective working section of the thrombus taking support (1) are also provided with thrombus blocking arms (111) with thrombus blocking structures.

2. The thrombus extraction device according to claim 1, wherein the thrombectomy stent (1) is capable of reciprocating in an axial direction in an introduction sheath (2) by the push wire (3) connected thereto, and the thrombectomy stent (1) is moved into the introduction sheath (2) or a microcatheter in a compressed state and is released when being detached from the introduction sheath (2) or the microcatheter.

3. The thrombus extraction device according to claim 1, wherein the active working section of the thrombectomy stent (1) comprises a proximal working section (101), an intermediate working section (102), and a distal working section (103).

4. The thrombus extraction device according to claim 1 or 3, wherein a visualization wire (104) is provided on the proximal working section (101), the intermediate working section (102), the distal working section (103) or the entire thrombus extraction stent (1) of the thrombus extraction stent (1).

5. The thrombus extraction device according to claim 1, wherein the thrombus extraction stent (1) has an overall hollowed-out circular tubular structure; the near end of the probe is of a fully open structure, and the far end of the probe is of an umbrella-shaped closed structure; or the proximal end and the distal end of the medical device are both open structures.

6. The thrombus extraction device according to claim 5, wherein the proximal working section (101) of the thrombus extraction stent (1) is a hollow round tubular oblique section open structure, and the distal working section (103) is a hollow conical umbrella-shaped closed structure; or the far-end working section (103) is composed of a hollow circular tubular structure and a hollow conical umbrella-shaped closed structure.

7. The thrombus extraction device according to claim 4, wherein the middle working section (102) of the thrombus extraction stent (1) is distributed with thrombus arresting arms (111) which are obliquely embedded from the tube wall to the axial center direction of the tubular structure.

8. The thrombus extraction device according to claim 1, wherein the unit cells of the thrombectomy stent (1) include a first unit cell (106), a second unit cell (107), and a third unit cell (108) which are different in structure from each other; the hollow structure of the embolectomy support (1) is formed by combining the first unit grid (106), the second unit grid (107) and the third unit grid (108) in pairs or in combination of the first unit grid, the second unit grid and the third unit grid.

9. The thrombus extraction device according to claim 8, wherein the first unit lattice (106) is a quadrangle constituted by a first straight bar (109) and a first curved bar (110); the second unit grid (107) is a hexagon-like grid formed by the first curved bars (110); the third unit grid (108) consists of the second unit grid (107) and a thrombus blocking arm (111) which is obliquely embedded into the axial center direction of the thrombus removal support (1).

10. A thrombus extraction device according to claim 7 or 9, wherein the thrombus arresting arms (111) are at least one set of "V" shaped structures consisting of a second curved bar (112) or a first straight bar (109); the open end of the V-shaped structure, namely the root of the thrombus arresting arm (111), is fixedly connected with the second unit grid (107).

11. The thrombus extraction device according to claim 7 or 9, wherein the thrombus blocking arm (111) is obliquely inserted into the axial direction of the thrombus removal stent (1) at an insertion angle ranging from 25 ° to 70 °; the V-shaped closed end is bent along the axial direction of the bolt taking support (1), the bending length range is 1-4 mm, and the bending angle range is 25-70 degrees.

12. The thrombus extraction device according to claim 7 or 9, wherein the thrombus arresting arms (111) are provided in any plurality of adjacent or non-adjacent second unit cells (107).

13. The thrombus extraction device according to claim 3, wherein the hollow conical umbrella-shaped structure of the distal working section (103) of the thrombus extraction stent (1) extends and converges in the distal direction of the thrombus extraction stent (1) to form a conical top and an extension rod (105), and the conical angle range of the hollow conical umbrella-shaped structure of the distal working section (103) is 30-70 °.

14. The thrombus extraction device according to claim 1, wherein the distal end visualization marker (5) comprises a first distal end visualization marker (501) and a second distal end visualization marker (502); the first far-end development mark (501) is fixedly connected to the starting position of the far-end working section (103) of the embolectomy support (1), and the second far-end development mark (502) is fixedly connected to an extension rod (105) which is formed by extending the hollow conical umbrella-shaped structure of the far-end working section (103) towards the far-end direction and converging the hollow conical umbrella-shaped structure to form a conical top.

15. The thrombus extraction device according to claim 14, wherein the first distal end visualization mark (501) is provided on the first curved bar (110) at a starting position where the middle working section (102) of the thrombus removal stent (1) extends obliquely.

16. The thrombus extraction device according to claim 1, wherein the number of the visualization wires (104) is 3 to 5, and the visualization wires are fixedly connected with the first distal visualization mark (501) between the intermediate working section (102) and the distal working section (103), respectively.

17. A method for manufacturing a thrombus extraction device, comprising the steps of:

manufacturing a hollowed thrombus taking support (1) and a thrombus blocking arm (111) with a thrombus blocking structure by adopting a mode of cutting a metal round pipe by laser and then carrying out heat treatment setting;

fixedly connected with a pushing guide wire (3) and the bolt taking support (1), and welding a near-end developing mark (4) on the pushing guide wire (3) and a far-end developing mark (5) on the bolt taking support (1).

18. The method for manufacturing a thrombus extraction device according to claim 17, wherein the thrombus arresting arm (111) has one or more substantially "V" shaped structures composed of second curved bars (112), and the open end of the "V" shaped structure, i.e., the root of the thrombus arresting arm (111), is connected to the second unit cell (107); the thrombus blocking arm (111) is cut integrally with the second unit mesh (107).

19. The method of manufacturing a thrombus extraction device according to claim 17, further comprising: the method comprises the following steps of arranging a developing wire (104) in an effective working section of the embolectomy support (1), and specifically comprises the following steps:

spirally winding the developing wire (104) to the far end direction of the bolt taking bracket (1) along the axial direction of the bolt taking bracket (1) through a first straight rod (109) and a first curved rod (110); and arranging the developing wire (104) on the proximal working section (101), the middle working section (102), the distal working section (103) or the whole thrombus removal support (1) of the thrombus removal support (1).

20. The manufacturing method of the thrombus extraction device according to claim 19, wherein the widths of the straight rod (109), the curved rod (110) and the curved rod (112) are all smaller than the wall thickness of the thrombus extraction stent (1), so that the sizes of the straight rod (109), the curved rod (110) and the curved rod (112) which form the thrombus extraction stent (1) in the circumferential direction of the thrombus extraction stent (1) are smaller than the sizes of the straight rod, the curved rod and the curved rod in the radial direction of the thrombus extraction stent (1).