WO2023131311A2 - Thrombectomy stent, thrombectomy apparatus, and thrombectomy system - Google Patents

Thrombectomy stent, thrombectomy apparatus, and thrombectomy system Download PDF

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Publication number
WO2023131311A2
WO2023131311A2 PCT/CN2023/071080 CN2023071080W WO2023131311A2 WO 2023131311 A2 WO2023131311 A2 WO 2023131311A2 CN 2023071080 W CN2023071080 W CN 2023071080W WO 2023131311 A2 WO2023131311 A2 WO 2023131311A2
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WO
WIPO (PCT)
Prior art keywords
thrombectomy
pipe diameter
proximal end
diameter section
bracket
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PCT/CN2023/071080
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French (fr)
Chinese (zh)
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WO2023131311A3 (en
Inventor
王永胜
于鹏
郭亚萍
Original Assignee
杭州德诺脑神经医疗科技有限公司
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Publication of WO2023131311A2 publication Critical patent/WO2023131311A2/en
Publication of WO2023131311A3 publication Critical patent/WO2023131311A3/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping 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, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping 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

Definitions

  • the invention relates to the technical field of medical devices, in particular to a thrombectomy bracket, a thrombectomy device and a thrombus retrieval system.
  • Thrombus is a blood clot formed by the abnormal aggregation of platelets and other formed components in the blood in the circulating blood.
  • the blood clot may occur on the inner wall of the heart or on the wall of the blood vessel, causing blood vessel blockage or embolism, and secondary serious physical injury.
  • Thrombosis spreads throughout the entire cardiovascular system can occur in blood vessels anywhere in the body, and affects tissues and organs throughout the body, not limited to myocardial infarction, deep venous thrombosis, or cerebrovascular thrombosis.
  • venous thrombosis causes vascular occlusion and blockage of blood flow, leading to ischemia, hypoxia and even necrosis of related vascular innervated tissues, resulting in symptoms of corresponding tissue and organ dysfunction.
  • Anticoagulant drugs and thrombolytic drugs are often used clinically for treatment, but the therapeutic effect is very insignificant.
  • thrombus provides a new and efficient treatment method for blood vessel recanalization for patients with thrombosis.
  • Mechanical thrombectomy has a short operation time and fewer related complications, and is currently a research hotspot in the field of thrombosis treatment; according to the current mainstream
  • the shape and function of interventional thrombectomy devices can be divided into: spiral, screen type, brush type, suction type, and bracket type.
  • the common defect of these mainstream products is that when passing through a curved blood vessel, the structure is easily deformed and collapsed. When withdrawing, the thrombus is easy to fall off at the curved blood vessel, and the thrombus escapes, causing varying degrees of damage to the blood vessel.
  • the internal carotid artery, middle cerebral artery, vertebral artery, and basilar artery are the most common sites of nerve thrombus.
  • the state of acute thrombus is mostly greasy and slippery. It is difficult to capture it completely with the existing metal thrombectomy stent.
  • An object of the present invention is to provide a thrombus retrieval bracket, a thrombus retrieval device and a thrombus retrieval system with improved thrombus capture performance.
  • the present invention provides a thrombectomy bracket, which includes a first bracket body and a second bracket body; the second bracket body is arranged at the distal end of the first bracket body;
  • the second stent body includes a plurality of first diameter sections and a plurality of transition sections; the first diameter sections and the transition sections are arranged alternately along the axial direction of the thrombectomy stent, and two adjacent The first pipe diameter section is connected through the transition section; when the proximal end and the distal end of the thrombectomy bracket are relatively far apart in the axial direction, at least part of the first pipe diameter section shrinks radially, and axially The radial contraction regions of the two adjacent first pipe diameter sections are arranged at an angle.
  • the present invention also provides a thrombectomy device, which includes the above-mentioned thrombus retrieval bracket and a traction guide wire connected with the thrombus retrieval bracket; The proximal end of the thrombus support is connected to push and pull the thrombus retrieval support.
  • the present invention also provides a thrombectomy system, which includes the above-mentioned thrombectomy device, a push rod, a loading sheath, and a microcatheter; The proximal end is connected to push and pull the thrombectomy bracket; the loading sheath is used to accommodate the thrombectomy device in a compressed state; the microcatheter is used to communicate with the loading sheath, and the microcatheter The inner lumen is used to deliver the thrombectomy device.
  • the first diameter section can adapt to blood vessels of different diameters to ensure the wall-attachment performance of the blood vessel.
  • the two axially adjacent first pipe diameter sections are arranged at an angle in the radially contracted area, that is, the two axially adjacent first pipe diameter sections are not the same in the radially contracted part, and the radially contracted
  • the region that has not shrunk in the radial direction is also dislocated, which means that when the thrombus retrieval stent is pulled after capturing the thrombus in the blood vessel, the thrombus retrieval stent can maintain its shape in different directions, and the overall shape of the thrombus retrieval stent There will be no obvious collapse, and the thrombus retrieval stent that can maintain its shape in different directions can increase the resistance of the thrombus to escape, and can
  • Fig. 1 is a schematic structural view of a thrombectomy device according to an embodiment of the present invention
  • Fig. 2 is a structural schematic diagram of the thrombectomy device shown in Fig. 1 after the relative deflection of 90 degrees in the circumferential direction;
  • Fig. 3 is a schematic structural view of the thrombectomy bracket of the thrombectomy device shown in Fig. 1 under axial tension;
  • Fig. 4 is a schematic structural view of the thrombectomy bracket of the thrombectomy device shown in Fig. 2 under axial tension;
  • Fig. 5 is a schematic cross-sectional view along section line II-II in Fig. 1;
  • Fig. 6 is a schematic cross-sectional view along the section line ⁇ - ⁇ in Fig. 1;
  • Fig. 7 is a schematic diagram of an enlarged structure at A in the thrombectomy device shown in Fig. 1;
  • Fig. 8 is a structural schematic diagram of the connection between the traction guide wire shown in Fig. 1 and the proximal end of the thrombectomy bracket;
  • Fig. 9 is a structural schematic diagram of another embodiment in which the traction guide wire is connected to the proximal end of the thrombectomy bracket;
  • Fig. 10 is a structural schematic diagram of another embodiment in which the traction guide wire is connected to the proximal end of the thrombectomy bracket;
  • Fig. 11 is a structural schematic diagram of the connection between the development guide wire shown in Fig. 1 and the distal end of the thrombectomy bracket;
  • Fig. 12 is a schematic structural view of the thrombectomy system including the thrombectomy device of Fig. 1 before assembly;
  • Fig. 13 is a structural schematic view of the bolt removing system of Fig. 12 when assembled and used;
  • Fig. 14 is a schematic diagram of the pushing state of the thrombectomy device in the thrombectomy system shown in Fig. 13;
  • Fig. 15 is a schematic diagram of the first state of the thrombectomy device shown in Fig. 1 during the thrombectomy process;
  • Fig. 16 is a schematic diagram of the second state of the thrombectomy device shown in Fig. 1 during the thrombectomy process;
  • Fig. 17 is a schematic diagram of the third state of the thrombectomy device shown in Fig. 1 during the thrombectomy process;
  • Fig. 18 is a schematic diagram of the fourth state of the thrombectomy device shown in Fig. 1 during the thrombectomy process;
  • Fig. 19 is a schematic diagram of the fifth state of the thrombectomy device shown in Fig. 1 during the thrombectomy process;
  • Fig. 20 is a schematic view from another perspective of the fifth state of the thrombus removing device shown in Fig. 19 .
  • first and second are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features.
  • a feature defined as “first” or “second” may explicitly or implicitly include one or more of said features.
  • “plurality” means two or more, that is, two or more, unless otherwise specifically defined.
  • connection should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connected, or integrally connected; it can be mechanically connected or electrically connected; it can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application in specific situations.
  • proximal end is defined herein as the end close to the operator, and “distal end” is defined as the end away from the operator. Specifically, the proximal end refers to an end for operation by a user or a machine, or an end for connecting to other devices. The distal end is the end of the device that can be freely inserted into the animal or human body.
  • the thrombectomy stent and the thrombus retrieval device are used to dredge the blocked blood vessel and catch the thrombus in the blocked blood vessel when the blood vessel is blocked.
  • the thrombectomy device includes a thrombectomy bracket and a traction guide wire, the traction guide wire is connected with the thrombectomy bracket and can be passed through the thrombectomy bracket.
  • the thrombectomy stent has radial stretchability, so that the thrombectomy stent has a collapsed state and a natural expansion state. In the collapsed state, the thrombectomy stent can be easily delivered in the blood vessel through the microcatheter and delivered to the lesion site.
  • the microcatheter When the lesion is reached, the microcatheter is withdrawn to restore the thrombus retrieval stent to its natural expansion state, and then cut and capture the thrombus in the lesion, and finally withdraw the thrombus retrieval stent with the thrombus, thereby removing the thrombus and realizing the occlusion of the blood vessel. dredge.
  • a thrombectomy device 100 in this embodiment includes a thrombectomy support 1 and a traction guide wire 2 .
  • the thrombectomy bracket 1 is roughly in the shape of a hollow tube, and its peripheral wall may be in a grid or mesh structure, and the grid or mesh structure may include regular or irregular hole-like structures.
  • the traction guide wire 2 passes through the proximal end of the thrombectomy support 1 and is connected with the proximal end of the thrombectomy support 1 .
  • the proximal end of the pulling guide wire 2 can be connected to the outside world. After the thrombus is captured, the pulling guide wire 2 is pulled to move toward the proximal end of the blood vessel, which can drive the thrombectomy stent 1 to retreat toward the proximal end of the blood vessel.
  • the thrombectomy support 1 has a collapsed state and a naturally expanded state.
  • the radial dimension of the thrombectomy stent 1 is the smallest, which is convenient for delivery in blood vessels, so as to deliver the thrombectomy stent 1 to the lesion.
  • the thrombectomy stent 1 can be made of metal material with shape memory or elastic polymer material, so that the thrombectomy stent 1 can self-expand after being released into the blood vessel to form a roughly tubular or cage-like structure.
  • the thrombectomy stent can be formed by laser cutting a nickel-titanium tube, or by laser-cutting a nickel-titanium plate and then crimping and heat-setting, or braided, for example, braided by using nickel-titanium wire material, or Can be machined from elastic plastic material.
  • the thrombectomy stent 1 When the thrombectomy stent 1 is released into the blood vessel and there is no radial external pressure, the thrombectomy stent 1 expands by itself, and the radial dimension becomes larger. In the naturally expanded state, the thrombus retrieval stent 1 stretches the thrombus at the lesion, and cuts the thrombus by using the grid or mesh structure on its peripheral wall, so that the thrombus is embedded in the thrombus retrieval stent 1 and is removed. Bracket 1 captures. Subsequently, pulling the pulling guide wire 2 to move toward the proximal end of the blood vessel can control the retraction of the thrombus retrieval stent 1 and the thrombus captured therein, and dredge the blocked blood vessel.
  • the thrombectomy bracket 1 includes a first bracket body 11 and a second bracket body 12 .
  • the proximal end of the first stent body 11 is connected to the distal end of the traction guide wire 2
  • the distal end of the first stent body 11 is connected to the proximal end of the second stent body 12
  • the first stent body 11 and the second stent body 12 are connected together.
  • the second stent body 12 includes a plurality of first pipe diameter sections 121 and a plurality of transition sections 122, the first pipe diameter sections 121 and the transition sections 122 are arranged alternately along the axial direction of the thrombectomy stent 1, and the adjacent two first pipe diameter sections
  • the radial sections 121 are connected by a transition section 122 .
  • Fig. 1 and Fig. 2 are schematic diagrams of states of the thrombectomy bracket 1 in two different viewing angles before its proximal end is pulled , can also be understood as a schematic diagram of the state in which the thrombectomy stent 1 is completely freely expanded after being released into the blood vessel.
  • the radial dimensions of each region in the circumferential direction of the first pipe diameter section 121 are approximately equal, that is, in the direction perpendicular to the longitudinal direction.
  • Fig. 3 and Fig. 4 are respectively schematic diagrams of the state of the thrombectomy support 1 shown in Fig. 1 and Fig. 2 in two different viewing angles after its proximal end is pulled, which can also be understood as the retraction to capture the thrombus.
  • each first pipe diameter section 121 has obvious radial contraction, that is, radial collapse.
  • the radial contraction areas of the two axially adjacent first pipe diameter sections 121 form a certain angle, which can be understood as the uncollapsed area or the collapse range of the two axially adjacent first pipe diameter sections 121 Relatively small areas are also angled.
  • the radial contraction areas of the two axially adjacent first tube diameter sections 121 are relatively misaligned in the circumferential direction, for example, they are opposite to each other.
  • the misalignment angle is 90 degrees, which can be understood as a 90-degree misalignment for regions with no significant change in radial size.
  • the above structure of alternating displacement along the axial direction of the thrombectomy support 1 makes it easier for the thrombus retrieval support 1 to capture thrombus.
  • the misalignment angle can also be set at other angles, which is not limited in the present application. For ease of understanding, the present application will take a 90-degree misalignment as an example for illustration.
  • FIG. 5 and FIG. 6 are schematic cross-sectional views of two adjacent first pipe diameter sections 121, respectively, the first pipe diameter section 121 has a first area 12a and a second area diametrically opposite to each other. 12b , and the third area 12c and the fourth area 12d oppositely arranged, the first area 12a , the third area 12c , the second area 12b , and the fourth area 12d are sequentially arranged along the circumferential direction of the second bracket body 12 .
  • the "area” may include at least one of a point, a line, and a plane.
  • the first region 12a and the second region 12b shrink radially, the third region 12c and the fourth region 12d maintain the same radial size, or the third
  • the radially contracted size of the region 12c and the fourth region 12d is smaller than the radially contracted size of the first region 12a, and/or smaller than the radially contracted size of the second region 12b.
  • the first area 12a and the second area 12b can be understood as surfaces
  • the third area 12c and the fourth area 12d can be understood as points or lines, that is, the third area 12c and the fourth area 12d are the first area 12a A point or a line intersecting with the second region 12b. That is, the first area 12a and the second area 12b are respectively diametrically opposite two side surfaces, and the third area 12c and the fourth area 12d are the confluence of the circumferential ends of the two side surfaces.
  • the radial dimension of the radial contraction area of the first pipe diameter section 121 is smaller in the middle and larger at the two ends in the circumferential direction. That is, after the above-mentioned first region 12a and the second region 12b shrink radially, the radial size of the first region 12a and the radial size of the second region 12b gradually increase from the center to both sides until they are aligned with the third region 12c. It is equal to the radial dimension of the fourth region 12d.
  • the contraction law of the above regions can be understood as, in the two axially adjacent first pipe diameter sections 121 (Fig. 5 and Fig. 6), the first area 12a and the second At the same time, the area 12b is misaligned in the circumferential direction, and the angle of the misalignment is equal to the included angle of the misalignment of the radial contraction areas of the two first pipe diameter sections 121 , for example, the misalignment angle is 90 degrees.
  • the third area 12c and the fourth area 12d in the two first pipe diameter sections 121 are also misaligned in the circumferential direction, and the angle of the misalignment is equal to the gap between the radial contraction areas of the two first pipe diameter sections 121. Angle, for example, the misalignment angle is 90 degrees.
  • the proximal end of the thrombectomy stent 1 is subjected to a pulling force, and a partial area of the first diameter section 121 shrinks radially, that is, radially collapses.
  • This can be represented by radial collapse of the above-mentioned first region 12a and second region 12b, while the radial dimensions of the third region 12c and fourth region 12d remain substantially unchanged, or vary within a small preset range.
  • the adherence performance of the third region 12c and the fourth region 12d to the blood vessel can always be maintained, and because the two axially adjacent first diameters
  • the third area 12c of the section 121 is set at a 90-degree circumferential misalignment
  • the fourth area 12d is set at a 90-degree circumferential misalignment, so that the thrombus caught by the thrombus retrieval stent 1 has an unsmooth escape channel and increased resistance, making it difficult to escape.
  • the first diameter section 121 can adapt to blood vessels of different diameters and ensure the wall-attachment performance with the blood vessels.
  • the two axially adjacent first pipe diameter sections 121 are arranged at an angle in the radially contracted area, that is, the two axially adjacent first pipe diameter sections 121 are not the same in the radially contracted area , the radial contraction area is dislocated, and it can be understood that the radial contraction area is also dislocated, which means that when the thrombectomy stent 1 is pulled after capturing the thrombus in the blood vessel, the thrombectomy stent 1 can pass through the first tube
  • the undeformed area of the diameter section 121 maintains its shape in different directions and improves the radial support force.
  • the whole thrombectomy stent 1 will not collapse significantly, and the thrombus retrieval stent 1 that can maintain its shape in different directions increases the resistance of the thrombus to escape. , and can also enable the thrombus retrieval stent 1 to still maintain the contact area with the thrombus in blood vessels with different degrees of curvature, thereby effectively capturing thrombus in different directions and reducing the risk of thrombus escape.
  • the transition section 122 includes a first support rod 123 and a second support rod 124 arranged at intervals along the circumference of the second bracket body 12 , and the first support rod 123 and the second support rod 123
  • the two support rods 124 extend along the axial direction of the thrombectomy bracket 1 and are arranged between the proximal and distal ends of two adjacent first tube diameter sections 121 facing each other.
  • the first support rod 123 and the second support rod 124 can not only be used as intermediate connectors between two adjacent first pipe diameter sections 121, but also can be used to drive the first pipe at one end to Radial deformation occurs in at least a partial area of the diameter segment 121 .
  • the two axially adjacent transition sections 122 are relatively misaligned in the circumferential direction, the two axially adjacent first pipe diameter sections 121 are relatively misaligned in the circumferential direction, and the two adjacent first pipe diameter sections 121 are relatively misaligned in the circumferential direction
  • the angle is equal to the relative misalignment angle of two adjacent transition sections 122 in the circumferential direction. This means that the circumferential misalignment angle of two axially adjacent first support rods 123 is equal to the circumferential misalignment angle of two axially adjacent first pipe diameter sections 121 .
  • first support rod 123 and the second support rod 124 are separated by 180 degrees in the circumferential direction, and the axially adjacent two first support rods 123 and the two second support rods 124 are circumferentially misaligned by 90 degrees respectively.
  • the first pipe diameter section 121 includes a plurality of first corrugated parts 1211, and the plurality of first corrugated parts 1211 are sequentially connected end to end along the axial direction of the thrombus retrieval support 1, and two adjacent first corrugated parts 1211 forms a plurality of first meshes 101 arranged in the circumferential direction.
  • the shape of the first meshes 101 is a rhombus structure.
  • the first meshes 101 can also be meshes of other shapes. Structures, such as triangles, rectangles, or polygons, etc., are not limited in this application. For ease of understanding, Fig. 1 and Fig.
  • first pipe diameter section 121 has two first wave pieces 1211, and each first wave piece 1211 can be regarded as having a Z shape or a W shape by a plurality of rods. Shapes are arranged continuously and connected to form a closed-loop structure.
  • Each first wave element 1211 includes a plurality of crests and troughs, and the crests and troughs are arranged alternately in the circumferential direction. Specifically, the number of crests and the number of troughs of two adjacent first wave elements 1211 are equal, and the number of crests is equal to the number of troughs.
  • the near-end vertex is defined as the peak
  • the far-end vertex is defined as the trough.
  • the trough i.e. the apex at the far end
  • the first corrugated part 1211 at the proximal end in the first pipe diameter section 121 and the crest i.e.
  • the wave crests (i.e., the apexes at the proximal end) and the troughs (i.e., the apex at the distal end) of the first wave element 1211 at the distal end are axially opposite and far away from each other, so that the two first wave elements 1211 enclose and form a plurality of waves arranged at intervals in the circumferential direction.
  • the first mesh 101 The first mesh 101 .
  • the first wave parts 1211 can expand and contract in the radial direction, so that adjacent peaks and adjacent wave troughs between each first wave part 1211 can approach or move away from each other.
  • the diameter of the first wave member 1211 becomes larger, and the axial interval between the crest and the trough becomes smaller, while the circumferential interval becomes larger.
  • the first corrugated part 1211 expands and opens, which can spread the thrombus, establish a blood flow channel, and realize the pre-passing function; and cut the thrombus through the first corrugated part 1211 , the cut thrombus partially enters the first wave member 1211 and is captured by the first mesh 101 .
  • the proximal end of the first support rod 123 and the proximal end of the second support rod 124 are connected with the apex of the first wave piece 1211 located at the distal end in the first pipe diameter section 121 adjacent to the proximal end, for example, connected with the first wave piece 1211
  • the proximal apex of the first corrugated member 1211 is connected, and the distal apex of the first corrugated member 1211 is free to hang in the air, so as to play the role of hooking the thrombus.
  • Both the distal end of the first support rod 123 and the distal end of the second support rod 124 are connected to the apex of the first corrugated part 1211 located at the proximal end in the first pipe diameter section 121 adjacent to the distal end, for example, connected to the first corrugated part 1211.
  • the proximal apex of piece 1211 is connected.
  • the proximal first tube diameter section 121 One of the two adjacent first tube diameter sections 121 located at the proximal end is defined as the proximal first tube diameter section 121 , and the other is the distal first tube diameter section 121 .
  • the proximal end of the transition section 122 can be connected to part of the vertices of the proximal first pipe diameter section 121, while retaining part of the vertices of the proximal first pipe diameter section 121 as free endpoints, and the transition The distal end of the segment 122 is connected to all vertices of the distal first diameter segment 121 , leaving no free end points of the distal first diameter segment 121 .
  • the thrombectomy stent 1 when the thrombectomy stent 1 is subjected to axial pulling force, it can ensure the uneven radial force of the first pipe diameter section 121 at the proximal end of the transition section 122, so as to realize the partial area of the first pipe diameter section 121 at the proximal end. radial shrinkage, while the other part of the region does not experience radial shrinkage. And at the same time, the uniformity of the force on the proximal end of the first distal pipe diameter section 121 in the radial direction is ensured.
  • the uniformity of the radial force on the proximal end of the first distal pipe diameter section 121 can be the A pipe diameter section 121 provides supporting force to ensure localized radial contraction under the action of the next dislocated transition section 122 .
  • the transition section 122 further includes a second pipe diameter section 125 and a plurality of support arms 126, and the plurality of support arms 126 are arranged at intervals along the circumference of the second support body 12, the first The proximal end of the two pipe diameter sections 125 is connected to the distal ends of the first support rod 123 and the second support rod 124, and the distal end of the second pipe diameter section 125 is connected to the first pipe diameter adjacent to the distal end through a plurality of support arms 126.
  • the proximal connection of segment 121 In the naturally expanded state, the radial dimension of the first pipe diameter section 121 is larger than the second pipe diameter section 125.
  • Such an arrangement not only ensures the flexibility of the thrombectomy support 1, but also makes the radial and axial direction of the thrombectomy support 1 It has a certain supporting force, and at the same time improves the capture efficiency of thrombus by the thrombus retrieval support 1 .
  • the second pipe diameter section 125 includes a plurality of second corrugated parts 1251, and the plurality of second corrugated parts 1251 are sequentially connected end to end along the axial direction of the thrombus retrieval support 1, and two adjacent second corrugated parts 1251 forms a plurality of second meshes 102 arranged circumferentially.
  • the shape of the second mesh 102 is a rhombus-like structure, and herein, a rhombus-like structure is defined as a quadrilateral structure with at least two adjacent sides equal. Referring to Fig.
  • the shape of the second mesh 102 in this embodiment is that two groups of adjacent sides are respectively equal, that is, a group of adjacent sides located at the proximal end are equal, and a group of adjacent sides located at the far end are equal. Both sides are equal.
  • the second mesh 102 may also be a mesh structure of other shapes, such as a triangle, a rectangle, or a polygon, etc., which are not limited in this application.
  • each second wave piece 1251 can be considered to be Z-shaped or W-shaped by a plurality of rods A closed-loop or non-closed-loop structure formed by continuous arrangement.
  • Each second corrugated part 1251 includes a plurality of crests and a plurality of troughs, and the second corrugated part 1251 can expand and contract in the radial direction, so that the adjacent crests and adjacent troughs between the second corrugated parts 1251 can be mutually move closer or farther away.
  • the diameter of the second wave member 1251 becomes larger, and the axial interval between the crest and the trough becomes smaller, while the circumferential interval becomes larger.
  • the second corrugated part 1251 expands and opens to expand the thrombus, establish a blood flow channel, and realize the pre-pass function; and cut the thrombus through the second corrugated part 1251 , the cut thrombus partially enters the second wave member 1251 and is captured by the second mesh 102 .
  • the second wave piece 1251 at the distal end continuously forms a closed-loop structure in the circumferential direction
  • the second wave piece 1251 at the proximal end forms a discontinuous circle in the circumferential direction. non-closed structure.
  • the plurality of rods of the second wave member 1251 at the distal end extend continuously in a Z-shape or a W-shape in the circumferential direction, and the crests and troughs thereof are alternately arranged in the circumferential direction.
  • the second wave member 1251 at the proximal end includes a plurality of wave units arranged at intervals in the circumferential direction, and the wave units may be V-shaped, Z-shaped, W-shaped, etc. formed by connecting a plurality of rods.
  • the circumferential end of each wave unit of the proximal second wave element 1251 is discontinuous with adjacent wave units.
  • the second wave element 1251 at the proximal end of the second tube diameter section 125 includes two wave units spaced apart in the circumferential direction.
  • the corrugated unit has an inverted V-shaped structure, including a proximal apex and two distal apexes, and each distal apex is converging with a corresponding wave crest in the second distal corrugated part 1251, thereby connecting with the distal second corrugated part 1251
  • a plurality of discontinuous second meshes 102 are jointly formed.
  • Each wave-shaped unit of the proximal second corrugated part 1251 is not connected with other wave-shaped units, that is, there is an interval between adjacent wave-shaped units, thereby forming a larger hole than the second mesh 102 at the proximal end of the second pipe diameter section 125.
  • Network port 102a FIG.
  • FIG. 7 shows that there are two second mesh holes 102 and mesh ports 102a and they are arranged alternately in the circumferential direction.
  • the larger mesh opening 102a is beneficial to capture the escaped thrombus during the retraction process of the thrombus retrieval stent 1 so as to trap it into the thrombus retrieval stent 1 .
  • two adjacent second corrugated parts 1251 configured to form the second mesh 102 are defined as the proximal second corrugated part 1251 and the distal second corrugated part 1251 .
  • the axial dimension of the proximal second undulating piece 1251 is smaller than the axial dimension of the distal second undulating piece 1251, so that the area of the second mesh 102 formed by adjacent two second undulating pieces 1251 is approximately in the axial direction. The end is small and the far end is large.
  • the distance between the first pipe diameter section 121 and the second pipe diameter section 125 can be shortened.
  • increase the space for the thrombus retrieval stent 1 to catch the thrombus making it easier for the thrombus to be embedded in the thrombus retrieval stent 1, which will enhance the anchoring effect on the thrombus block, and reduce the chance of the thrombus escaping, ensuring that the thrombus retrieval stent 1 can catch the thrombus.
  • the efficiency of trapping thrombus is improved.
  • Both the proximal end of the first support rod 123 and the proximal end of the second support rod 124 are connected to the apex of the first wave piece 1211 at the far end in the adjacent first pipe diameter section 121, for example, to the top of the first wave piece 1211
  • the proximal apex is connected, and the distal apex of the first wave member 1211 can hang freely in the air, so as to hook the thrombus.
  • Both the distal end of the first support rod 123 and the distal end of the second support rod 124 are connected to the apex of the second corrugated part 1251 located at the proximal end of the adjacent second pipe diameter section 125, for example, to the apex of the second corrugated part 1251 Proximal vertex connection.
  • the proximal end of the support arm 126 is connected to the apex of the second wave piece 1251 at the distal end of the second pipe diameter section 125, for example, connected to the proximal apex of the second wave piece 1251, and the distal apex of the second wave piece 1251 can be Free to hang in the air to play the role of hooking thrombus.
  • the distal end of the support arm 126 is connected to the apex of the proximal first corrugated member 1211 in the distally adjacent first diameter section 121 , for example, connected to the proximal apex of the first corrugated member 1211 .
  • the proximal end of the transition section 122 is connected to the proximal apex of the first corrugated member 1211 adjacent to the proximal end.
  • the first corrugated member 1211 The distal apex is suspended in the air as a free end, and the distal end of the transition section 122 is connected to the proximal apex of the first wave element 1211 adjacent to the distal end.
  • the proximal end of the transition section 122 may also be connected to the distal apex of the first wave element 1211 adjacent to the proximal end;
  • the distal apex of the first wave element 1211 is connected, and at this time, the proximal apex of the first wave element 1211 is suspended as a free end.
  • the difference between the above two different design structures is that the transition section 122 between the two adjacent first pipe diameter sections 121 has been turned upside down (that is, along the direction from the proximal end to the distal end or the distal end to the proximal end), thereby changing the position and orientation of the free end point.
  • the preferred embodiment should be to set the free end point at the distal end of the first diameter section 121 .
  • the proximal apex 1211a of the first corrugated member 1211 at the distal end of the first pipe diameter section 121 is a fixed apex
  • the distal apex 1211b is a floating free terminal.
  • Both the proximal apex 1211c and the distal apex 1211d of the first corrugated member 1211 located at the proximal end of the first diameter section 121 are fixed apexes. That is to say, the most distal end of the first pipe diameter section 121 forms a free end point.
  • the proximal apex 1251a of the second wave piece 1251 located at the distal end of the second pipe diameter section 125 is a fixed apex
  • the distal apex 1251b of the second pipe diameter section 125 located at the distal end of the second wave piece 1251 is a suspended free end point.
  • Both the proximal apex 1251c and the distal apex 1251d of the second corrugated member 1251 at the proximal end of the second tube diameter section 125 are fixed apexes. That is to say, the most distal end of the second pipe diameter section 125 forms a free end point.
  • the proximal end of the first support rod 123 and the proximal end of the second support rod 124 are connected with the proximal apex 1211a of the first wave piece 1211 located at the far end in the first pipe diameter section 121, and the distal end of the first support rod 123 and The distal end of the second support rod 124 is connected to the proximal apex 1251c of the second wave piece 1251 located at the proximal end in the adjacent second pipe diameter section 125 .
  • the proximal end of the support arm 126 is connected to the proximal apex 1251a of the second wave piece 1251 located at the distal end of the second tube diameter section 125, and the distal end of the support arm 126 is connected to the proximal end of the adjacent first tube diameter section 121.
  • the proximal vertices 1211c of a wave member 1211 are connected.
  • the distal free end point 1211b of the first pipe diameter section 121 extends toward the fixed vertices 1211a on both sides as the first catch unit 121a, and the first catch unit 121a is connected to the second catch unit 121a.
  • a support rod 123 and a second support rod 124 are alternately arranged and connected to each other, and the first capture unit 121a may be V-shaped, W-shaped, zigzag or U-shaped to improve the efficiency of capturing thrombus.
  • Fig. 7 shows that the number of first capturing units 121a is four, and the first support rod 123 and the second support rod 124 are opposite and located between two adjacent first capturing units 121a.
  • the part of the distal free end point 1251b of the second diameter section 125 extending toward the fixed vertices 1251a on both sides is used as the second catch unit 125a, and the second catch unit 125a and the support arms 126 are alternately arranged and connected to each other.
  • the second capturing unit 125a may be in a V-shaped, W-shaped, zigzag or U-shaped structure, so as to improve the efficiency of capturing thrombus.
  • FIG. 7 shows that the number of the second catch units 125a is four, and the second catch units 125a and the support arms 126 are arranged alternately along the circumferential direction.
  • a first receiving space 121 b is formed between the first catching unit 121 a and the first support rod 123 and between the first catching unit 121 a and the second support rod 124 .
  • the first catch unit 121a may extend radially outward or inward.
  • a second receiving space 125b is formed between the second catching unit 125a and the supporting arm 126 .
  • the second catch unit 125a extends radially outward or inward.
  • both the first catch unit 121a and the second catch unit 125a extend radially outward or inward.
  • the bending direction of the first catching unit 121 a is opposite to that of the first support bar 123 and the second support bar 124
  • the bending direction of the second catching unit 125 a is opposite to that of the supporting arm 126 .
  • the spaces between the first storage space 121b and the second storage space 125b are increased, thereby providing more accommodation space for the thrombus, so that the thrombus can enter the inner cavity of the thrombus retrieval support 1, thereby further improving the thrombus retrieval support 1 against thrombus. capture efficiency.
  • the first capture unit 121a and the second capture unit 125a are inserted into the thrombus, or clamp the thrombus in the first storage space 121b and the second storage space 125b Therefore, the anchoring effect of the thrombus retrieval support 1 on the thrombus is improved. Since the first capture unit 121a and the second capture unit 125a are evenly distributed around the second stent body 12, the flexibility of the thrombus retrieval stent 1 is enhanced, and the thrombus capture by the thrombus retrieval stent 1 is also improved. efficiency.
  • the thrombectomy support 1 described above also has the following characteristics, that is, the thrombectomy support 1 has a semi-free state and a free state.
  • the semi-free state i.e. a partially released state
  • the working state of thrombus compression, or the working state of the second stent body 12 of the thrombectomy stent 1 being constrained by other constraining elements.
  • the free state (that is, the fully released state) means that the second stent body 12 of the thrombectomy stent 1 is in a fully expanded working state, or in a completely free (that is, not constrained by other constraining elements) working state.
  • the thrombectomy stent 1 is not fully expanded, and at least part of the structure of the second stent body 12 is approximately a single-layer tubular structure.
  • the thrombectomy stent 1 is fully expanded, and the second stent body 12 has an approximately double-layer tubular structure, and the radial dimension of the first diameter section 121 is greater than that of the second diameter section 125 .
  • the radial distance between the free end point of the distal end of the first tube diameter section 121 and the proximal apex of the second tube diameter section 125 adjacent to its distal end gradually decreases.
  • the radial distance between the fixed apex of the proximal end of the first pipe diameter section 121 and the free end point of the distal end of the second pipe diameter section 125 adjacent to its proximal end gradually decreases.
  • the thrombectomy bracket 1 has two states of semi-free and free
  • at least part of the structure of the second bracket body 12 is an approximate single-layer tubular structure, and the mesh on the single-layer mesh structure
  • the grid space is small, so as to avoid the blockage of the inner cavity caused by all the thrombus entering the inner cavity of the thrombectomy stent 1, so the single-layer tubular structure can be used as a blood flow channel.
  • the single-layer tubular structure ensures the radial support force of the entire thrombus retrieval stent 1, so that the thrombus retrieval stent 1 can quickly establish a blood flow channel to recover before the thrombus is removed. Block the blood flow of the blood vessel, and then realize the pre-opening function of the blood flow channel in the early stage of thrombectomy, so as to improve the safety of the thrombectomy operation.
  • the first pipe diameter section 121 with a large pipe diameter has a larger grid structure, and the first pipe diameter section 121 and the second pipe diameter section 125 There is a certain space between them, so that all the thrombus can enter the inner cavity of the thrombus retrieval bracket 1, which improves the efficiency of thrombus retrieval.
  • the thrombectomy support 1 adopts a segmented design, that is, the first pipe diameter section 121 and the second pipe diameter section 125 are sequentially spaced and evenly arranged, so that the flexibility of the thrombectomy support 1 can be improved and the thrombectomy support can be ensured. 1.
  • the thrombus retrieval stent 1 can withstand large deformation to conform to the shape of the blood vessel.
  • a plane parallel to the central axis of the thrombectomy support 1 is defined as a reference plane.
  • the orthographic projection of the first pipe diameter section 121 on a reference plane partly overlaps the orthographic projection of the second pipe diameter section 125 on the reference plane.
  • the orthographic projection of the first pipe diameter section 121 on the reference plane does not overlap with the orthographic projection of the second pipe diameter section 125 on the reference plane.
  • the overall structure or partial structure of the second stent body 12 is a single-layer tubular structure with an approximate closed-loop structure, and the metal coverage of the single-layer tubular structure is denser, thereby reducing thrombus entering the single-layer tubular structure.
  • the thrombectomy support 1 has a cavity for blood flow in a partially released state, which improves the safety of the thrombectomy operation.
  • the first support rod 123 , the second support rod 124 , and the support arm 126 are all straight rod-shaped structures.
  • the first support rod 123 , the second support rod 124 , and the support arm 126 all have a curved structure, and are bent inward or outward relative to the second support body 12 .
  • the cutting of the thrombus can be reduced, and more accommodation space can be provided for the thrombus, so that the thrombus can enter and take out.
  • the lumen of the thrombus stent 1 improves the capture efficiency of the thrombus by the thrombus retrieval stent 1 .
  • the first support rod 123 and the second support rod 124 are straight rod-shaped structures, and the first support rod 123 and the second support rod 124 are approximately parallel to the axial direction of the second support body 12 , so that the entire thrombectomy stent 1 can be compressed to form a single-layer tubular structure with approximately the same outer diameter in the axial direction and a closed-loop structure, so as to realize the pre-passing function of the blood flow channel and reduce brain damage during the operation.
  • the thrombectomy bracket 1 also includes a third bracket body 13 connected to the distal end of the second bracket body 12, the third bracket body 13 is connected to the second bracket body 12 in a smooth transition, and the third bracket body 13 It communicates with the inside of the second bracket body 12 so that the inside of the thrombus retrieval bracket 1 forms a continuous channel.
  • the third stent body 13 can further catch the thrombus that falls off or overflows from the second stent body 12, so that the thrombus that falls off or overflows from the second stent body 12 can enter the internal channel of the third stent body 13, thereby effectively preventing the thrombus from being removed from the thrombus. Break away from the inside of the bracket 1 to improve the catching efficiency.
  • the third stent body 13 includes a catch section 131 and an extension section 132.
  • the proximal end of the catch section 131 is connected to the second pipe diameter section 122 at the far end of the second stent body 12 through a plurality of support arms 126, and the distal end of the catch section 131 is connected to at the proximal end of the extension section 132.
  • the capturing section 131 has a plurality of third mesh holes 103 arranged along the circumferential direction
  • the extension section 132 has a plurality of fourth mesh holes 104 arranged along the circumferential direction.
  • the area of the third mesh 103 is larger than the area of the first mesh 101 , the area of the second mesh 102 and the area of the fourth mesh 104 .
  • the distal ends of the extension sections 132 can converge with each other, so that the distal end of the thrombectomy stent 1 is closed to form the distal closed end of the thrombus retrieval stent 1, so as to prevent the thrombus captured in the thrombus retrieval stent 1 from being released from the closed distal end. escape. It can be understood that in other embodiments, the distal ends of the extension section 132 may not converge with each other, for example, the distal end of the extension section 132 is open, or, the distal end of the extension section 132 may be connected with a capture net.
  • first bracket body 11, second bracket body 12 and third bracket body 13 can be integrally formed, thereby facilitating the manufacture of the bolt-removing bracket 1, and ensuring that the first bracket body 11, the second bracket body The stability and reliability of the mutual connection of the bracket body 12 and the third bracket body 13 .
  • the thrombus retrieval stent 1 can be processed by laser cutting a nickel-titanium tube material, so as to effectively prevent the thrombus from detaching from the thrombus retrieval stent 1 .
  • the third bracket body 13 is arranged at the far end of the thrombus retrieval bracket 1, and the catch section 131 of the third bracket body 13 is provided with a plurality of third meshes 103 along the circumferential direction, and the extension section 132 of the third bracket body 13 is arranged along the circumferential direction.
  • a plurality of fourth meshes 104 are provided, and the area of the third mesh 103 is larger than the area of the fourth mesh 104, so that both the large-volume thrombus and the small-volume thrombus escaping from the thrombus retrieval support 1 to the distal end can pass through the third mesh.
  • the hole 103 enters the channel inside the third stent body 13 , and the extension section 132 accommodates the thrombus captured by the third stent body 13 , thereby further improving the capture efficiency of the thrombus retrieval stent 1 .
  • the extension section 132 includes a plurality of third wave parts 1321, and the plurality of third wave parts 1321 are sequentially connected end to end along the axial direction of the thrombus retrieval bracket 1, and two adjacent third wave parts 1321 form a plurality of circumferentially arranged.
  • the fourth mesh 104 In this embodiment, the shape of the fourth mesh 104 is a rhombus structure. Of course, in other embodiments, the fourth mesh 104 can also be a mesh structure of other shapes, such as triangles, rectangles or polygons, etc., which are not limited in this application. .
  • the radial dimension of the third wave piece 1321 in the extension section 132 gradually decreases, which makes two axially adjacent third wave pieces 1321 surround
  • the resulting fourth mesh 104 gradually becomes smaller in size. In this way, the resistance during the pushing process of the thrombectomy support 1 is reduced, and the recovery of the thrombectomy support 1 into the microcatheter is facilitated.
  • Each third wave element 1321 includes a plurality of crests and troughs, and the crests and troughs are arranged alternately in the circumferential direction.
  • the third wave parts 1321 can expand and contract in the radial direction, so that adjacent wave crests and adjacent wave troughs between the third wave parts 1321 can approach or move away from each other.
  • the diameter of the third wave member 1321 becomes larger, and the axial interval between the crest and the trough becomes smaller, while the circumferential interval becomes larger.
  • the third corrugated part 1321 expands and opens to expand the thrombus, establish a blood flow channel, and realize the pre-passing function; and cut the thrombus through the third corrugated part 1321 , the cut thrombus partially enters the third wave member 1321 and is captured by the fourth mesh 104 .
  • the capturing section 131 includes a plurality of reinforcing parts 1311 arranged along the circumferential direction of the third support body 13 , and the third mesh 103 is formed between two adjacent reinforcing parts 1311 .
  • the reinforcing parts 1311 and the third mesh holes 103 are alternately arranged along the circumferential direction of the third support body 13 .
  • Each reinforcing part 1311 includes a grid unit forming the fifth mesh 105 and a skeleton rod 106 disposed at a proximal end of the grid unit, and the proximal end of the skeleton rod 106 is connected with the distal end of the support arm 126 .
  • the area of the third mesh 103 is larger than the area of the fourth mesh 104 and the area of the fifth mesh 105, so that the escaped thrombus can be collected through the third mesh 103, and the collected thrombus can be prevented from being released by the third mesh 103.
  • the fourth mesh 104 and the fifth mesh 105 escape.
  • Figures 1 and 2 illustrate that the number of third mesh holes 103 corresponds to the number of reinforcing parts 1311, and the third mesh holes 103 and reinforcing parts 1311 are arranged alternately along the circumference of the third bracket body 13.
  • the capturing section 131 includes two opposite third mesh holes 103 and two opposite reinforcing parts 1311, the third mesh holes 103 and the reinforcing parts 1311 are arranged side by side and alternately along the circumferential direction of the third bracket body 13 .
  • the third mesh 103 not only the ability of the third mesh 103 to capture the thrombus that is not effectively captured by the second stent body 13 (such as hard thrombus such as organic thrombus, calcified thrombus, and thrombus with larger volume) is improved, but also the third mesh hole 103 is ensured.
  • the radial support force of the stent body 13 avoids excessive deformation of the third stent body 13 and reduces the adherence of the capture section 131 , that is, prevents the capture section 131 of the third stent body 13 from collapsing.
  • the skeleton rod 106 is configured in a Y-shaped configuration.
  • the skeleton rod 106 includes a first reinforcing rod 1061 and a second reinforcing rod 1062, and the second reinforcing rod 1062 is connected to the first reinforcing rod 1061 and the grid unit forming the fifth mesh 105 between.
  • the first reinforcing bar 1061 is configured into a V-shaped structure, and the V-shaped structure includes two near-end vertices and a far-end apex, the two near-end vertices are connected with the distal end of the support arm 126, and the far-end vertices are connected with the second reinforcing bar 1062. remote connection.
  • the capturing section 131 is formed with a third capturing unit 103a at the proximal end of each third mesh hole 103, the proximal end of the third capturing unit 103a is connected to the distal end of the support arm 126, the third capturing unit
  • the distal end of the catcher unit 103 a is configured as a free end and is located between two adjacent support arms 126 in the circumferential direction, or can be understood as located between two adjacent skeleton rods 106 .
  • the third capture unit 103a may be V-shaped, W-shaped, zigzag or U-shaped, etc., to improve the efficiency of capturing thrombus.
  • the third capturing unit 103a is V-shaped and there are two in number, and the two third capturing units 103a are arranged facing each other.
  • the axial length of the third catching unit 103a was no more than half of the axial length of the third mesh 103, so that the impact on the third mesh 103 could be reduced.
  • the coverage ensures that the third mesh 103 provides a sufficiently large entrance for the escaping thrombus, thereby improving the capture efficiency of the thrombus.
  • the third catching unit 103a extends radially outward or inward to form an enlarged third receiving space 103b between the third catching unit 103a and the reinforcing portion 1311 .
  • the third accommodation space 103b is enlarged, which can provide more accommodation space for the thrombus, so that the thrombus can enter the inner cavity of the thrombus retrieval stent 1 , thereby further improving the capture efficiency of the thrombus retrieval stent 1 .
  • the third capture unit 103a When the thrombus retrieval stent 1 is in a free state (that is, in an expanded state), the third capture unit 103a is inserted into the thrombus, or clamps the thrombus in the third accommodation space 103b, thereby improving the anchoring of the thrombus by the thrombus retrieval stent 1 Effect. Since the third capturing units 103a are evenly distributed in the circumferential direction of the third bracket body 13, the flexibility of the thrombus retrieval bracket 1 is enhanced, and the thrombus capture efficiency of the thrombus retrieval bracket 1 is also improved.
  • FIG. 8 illustrates a partial schematic diagram of the connection between the traction guide wire 2 and the proximal end of the thrombectomy bracket 1 in FIG. 1 .
  • the thrombectomy device further includes a proximal connector 14.
  • the proximal connector 14 may be a hollow tubular structure with both ends open.
  • the proximal end of the first bracket body 11 of the thrombectomy bracket 1 converges to the proximal
  • the distal end of the connecting head 14 for example, the proximal end of the first stent body 11 of the thrombectomy stent 1 can be adhesively fixed to the distal end of the proximal connecting head 14 .
  • the outer surface of the proximal connector 14 is provided with a first opening 141 communicating with the interior of the proximal connector 14, and the distal end of the traction guide wire 2 passes through the proximal end of the proximal connector 14 and is opposite to the first opening.
  • the window 141 is opened, the part of the distal end of the pulling guide wire 2 exposed to the first fenestration 141 can be fixed at a fixing head 21, and the fixing head 21 can be a welding joint or an adhesive joint.
  • the distal end of the traction guide wire 2 can be passed through the proximal end of the proximal connector 14, and the traction guide wire 2 can be The distal end is exposed to the first fenestration 141.
  • the part of the traction guide wire 2 exposed to the first fenestration 141 can be fixed by welding or bonding, which is very convenient for the user to operate.
  • the fixed head 21 at the distal end of the traction guide wire 2 can be a spherical joint as shown in FIG. 8 , or a T-shaped joint as shown in FIG.
  • the shapes in this application are only examples, not exhaustive, and thus should not be construed as limiting the application.
  • the expression form of the first window 141 can be as shown in Fig. 9 and Fig. the gap. Regardless of the appearance of the first opening 141 as a hole or a gap, the radial dimension of the fixing head 21 is smaller than the outer diameter of the proximal connecting head 14.
  • the fixing head 21 exceeds the proximal connecting head 14 in the radial direction. Therefore, the radial protrusion of the fixing head 21 is avoided to increase the resistance of retracting the thrombus retrieval support 1 .
  • the thrombectomy device also includes a distal connector 15 and a developing guide wire 16.
  • the distal end of the third bracket body 13 of the thrombus retrieval bracket 1 converges to the proximal end of the distal connector 15, and the distal connector 15
  • a second window 151 communicating with the interior of the distal connecting head 15 is opened on the outer surface.
  • the developing guide wire 16 can be processed by memory alloy, platinum-tungsten alloy or silver-tin alloy.
  • the setting of the developing guide wire 16 can conveniently indicate the position of the distal end of the third support body 13 of the embolectomy support 1 through the position of the developing guide wire 16 under instrument detection.
  • the development guide wire 16 generally extends axially along the thrombectomy support 1, and the distal end of the development guide wire 16 is bent toward the inner side of the thrombectomy support 1, such as in a J shape. The damage of the free end of the guide wire 16 to the blood vessel is visualized.
  • the present invention also provides a thrombectomy system, which includes the thrombectomy device 100 , push rod 200 , loading sheath 300 , microcatheter 400 and sheath tube 500 in any one of the above embodiments.
  • the push rod 200 is connected with the proximal end of the thrombectomy support 1 for pushing and pulling the thrombus retrieval support 1 .
  • the loading sheath 300 is used to accommodate the thrombectomy device 100 in a compressed state.
  • the microcatheter 400 is in communication with the loading sheath 300 , and the lumen in the microcatheter 400 is used to deliver the thrombectomy device 100 .
  • the sheath tube 500 is sleeved outside the microcatheter 400, and the sheath tube 500 extends into the blood vessel along with the microcatheter 400, and is transported to the proximal end of the thrombus in the lesion, and is used to accommodate the thrombus retrieval stent 1 and its Captured thrombus.
  • the thrombectomy device 100 is loaded in the thrombectomy system in a collapsed state before use, and the thrombectomy system includes the above-mentioned push rod 200, loading sheath 300, microcatheter 400 and sheath 500 (refer to FIG. 19 ).
  • the proximal end of the thrombus retrieval bracket 1 is converged and connected to the proximal connector 14 through the first bracket body 11, and the hollow proximal connector 14 communicates with the push rod 200.
  • the push rod 200 is a flexible tube that can bend radially.
  • the proximal end of the guide wire 2 passes through the proximal connector 14 and the push rod 200 in sequence.
  • the loading sheath 300 is sleeved on the outside of the push rod 200. Before use, the thrombectomy support 1 is pre-compressed and introduced into the loading sheath 300, as shown in FIG. 12 .
  • the loading sheath 300 can be connected to the microcatheter 400 through a connector 600 (such as a Luer connector), as shown in FIG. 13 . Then push the proximal connector 14 and the thrombectomy support 1 into the lumen of the microcatheter 400 smoothly through the push rod 200 , as shown in FIG. 14 . Afterwards, the thrombectomy device 100 is delivered to the vascular lesion position where the thrombus is located through the microcatheter 400 (the vascular lesion position can be determined according to angiography or other diagnostic means), so that the thrombectomy stent 1 can be released at the vascular lesion position and can be realized by the push rod 200. The push-pull action is accurately aligned, so that the thrombectomy support 1 can be switched between the compressed state and the released state.
  • a connector 600 such as a Luer connector
  • the sheath tube 500 is sleeved outside the microcatheter 400, and is extended into the blood vessel along with the microcatheter 400, and delivered to the proximal end of the thrombus in the lesion, for receiving the thrombus retrieval stent 1 and the captured thrombus during withdrawal .
  • the perforated guide wire 700 is used to pass through the thrombus 01 in the lesion in advance to establish a vascular access in the thrombus.
  • the microcatheter 400 and the sheath 500 are delivered along the perforated guide wire 700 to the thrombus 01 in the lesion, and the microcatheter 400 is passed over the thrombus 01 , then the microcatheter 400 is fixed, and the perforated guide wire 700 is withdrawn.
  • the thrombus retrieval device 100 is pushed to the position of the thrombus 01 through the push rod 200 , and the position of the thrombus 01 can be determined by means of imaging or other diagnostic means.
  • stop pushing the push rod 200 forward fix the push rod 200 and retract the microcatheter 400, so that the thrombectomy support 1 is released at the distal end of the microcatheter 400, according to the position of the development point on the imaging guide wire 16 , to ensure that the thrombus 01 is located in the effective area of the thrombectomy device 100 , and to completely release the thrombus retrieval stent 1 in the blood vessel, so that the thrombus 01 is embedded in the thrombus retrieval stent 1 .
  • Fig. 19 and Fig. 20 pull the traction guide wire 2 and the push rod 200 at the same time, so as to withdraw the thrombus retrieval holder 1 with the thrombus 01 captured into the sheath tube 500, and complete the removal of the thrombus.
  • the first tube diameter section 121 can adapt to blood vessels of different diameters and ensure the wall-attachment performance with the blood vessels.
  • the shaft The two adjacent first pipe diameter sections 121 are arranged at an included angle in the region of radial contraction, that is, the two axially adjacent first pipe diameter sections 121 are not the same at the radial contraction part, and the radial contraction part
  • the area is misaligned, and it can be understood that the area that does not shrink in the radial direction also has misalignment, which means that when the thrombus retrieval stent 1 is pulled after capturing the thrombus 01 in the blood vessel, the thrombus retrieval stent 1 can pass through the first diameter section 121 without
  • the deformed area maintains its shape in different directions and improves the radial support force. The whole thrombectomy stent 1 will not collapse significantly.
  • the thrombus retrieval stent 1 that can maintain its shape in different directions increases the resistance of the thrombus 01 to escape, and can The thrombus retrieval stent 1 still maintains the contact area with the thrombus 01 in blood vessels with different degrees of curvature, so that the thrombus 01 in different directions can be effectively captured and the risk of thrombus 01 escaping can be reduced.

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Abstract

Disclosed in the present invention are a thrombectomy stent, a thrombectomy apparatus, and a thrombectomy system. The thrombectomy stent comprises a first stent body and a second stent body; the second stent body is arranged at the distal end of the first stent body; the second stent body comprises a plurality of first pipe diameter segments and a plurality of transition segments; the first pipe diameter segments and the transition segments are alternately arranged in the axial direction of the thrombectomy stent, and two adjacent first pipe diameter segments are connected by means of a transition segment; when the proximal end and distal end of the thrombectomy stent are relatively far away from each other in the axial direction, at least a part of the region of each first pipe diameter segment radially shrinks, and the radial shrinkage regions of two first pipe diameter segments that are adjacent to each other in the axial direction are arranged at an angle. According to the present invention, when the thrombectomy stent captures a blood clot in a blood vessel and then is pulled, the thrombectomy stent can maintain a shape in different directions, and the whole thrombectomy stent does not obviously collapse; and the thrombectomy stent capable of maintaining the shape in different directions can increase the escape resistance of the blood clot, thereby being capable of effectively capturing the blood clots in different directions, and reducing the risk of blood clot escape.

Description

取栓支架、取栓装置和取栓系统Thrombectomy stand, thrombectomy device and thrombectomy system 技术领域technical field
本发明涉及医疗器械技术领域,特别涉及一种取栓支架、取栓装置和取栓系统。The invention relates to the technical field of medical devices, in particular to a thrombectomy bracket, a thrombectomy device and a thrombus retrieval system.
背景技术Background technique
血栓是血液中血小板等有形成分在循环血中发生异常聚集而形成的血凝块,血凝块或发生在心脏内壁或血管壁上,造成血管阻塞或栓塞,继发严重身体损伤。血栓形成遍布整个心血管系统,可发生在体内任何部位的血管内,波及全身组织器官,不止局限于心肌梗死,深部静脉血栓形成或脑血管血栓形成等病变。静脉血栓发生率高于动脉血栓,两者比例可达4∶1,静脉血栓占血栓机制的40%~60%,堵塞性冠状动脉血栓形成发生率为15%~95%,90%的血栓伴有动脉粥样硬化斑块。血栓形成造成血管闭塞、血流受阻引起相关的血管支配组织缺血、缺氧甚至坏死而产生相应组织、器官功能障碍的症状。Thrombus is a blood clot formed by the abnormal aggregation of platelets and other formed components in the blood in the circulating blood. The blood clot may occur on the inner wall of the heart or on the wall of the blood vessel, causing blood vessel blockage or embolism, and secondary serious physical injury. Thrombosis spreads throughout the entire cardiovascular system, can occur in blood vessels anywhere in the body, and affects tissues and organs throughout the body, not limited to myocardial infarction, deep venous thrombosis, or cerebrovascular thrombosis. The incidence of venous thrombosis is higher than that of arterial thrombosis, the ratio of the two can reach 4:1, venous thrombosis accounts for 40% to 60% of the thrombus mechanism, the incidence of obstructive coronary thrombosis is 15% to 95%, and 90% of thrombus with Have atherosclerotic plaque. Thrombosis causes vascular occlusion and blockage of blood flow, leading to ischemia, hypoxia and even necrosis of related vascular innervated tissues, resulting in symptoms of corresponding tissue and organ dysfunction.
现在临床多采用抗凝药物和溶栓药物进行治疗,但治疗效果极不明显,血栓阻塞的血管直径越大其治疗效果越差,血管再通率低、需要再通的时间长,且一些患者不适用于溶栓治疗。Anticoagulant drugs and thrombolytic drugs are often used clinically for treatment, but the therapeutic effect is very insignificant. The larger the diameter of the blood vessel blocked by the thrombus, the worse the therapeutic effect is, the recanalization rate is low, and the recanalization time is long, and some patients Not suitable for thrombolytic therapy.
目前采用一些机械装置取栓,其为血栓患者提供了一种新型、高效的血管再通治疗方法,机械取栓手术时间短、相关并发症少,是目前血栓治疗领域的研究热点;根据当前主流介入取栓器械的形状和功能实现形式,可以将其分为:螺旋形、筛网型、毛刷型、抽吸型、支架型。这些主流产品的共同缺陷是在经过弯曲血管时,结构易变形、塌陷,回撤时,在弯曲血管处血栓易脱落,血栓逃逸,对血管造成不同程度的损伤。神经血栓以颈内动脉、大脑中动脉、椎动脉和基底动脉为好发部位,急性血栓的状态多为油腻滑润状态,现有的金属取栓支架很难捕捉完全。At present, some mechanical devices are used to remove thrombus, which provides a new and efficient treatment method for blood vessel recanalization for patients with thrombosis. Mechanical thrombectomy has a short operation time and fewer related complications, and is currently a research hotspot in the field of thrombosis treatment; according to the current mainstream The shape and function of interventional thrombectomy devices can be divided into: spiral, screen type, brush type, suction type, and bracket type. The common defect of these mainstream products is that when passing through a curved blood vessel, the structure is easily deformed and collapsed. When withdrawing, the thrombus is easy to fall off at the curved blood vessel, and the thrombus escapes, causing varying degrees of damage to the blood vessel. The internal carotid artery, middle cerebral artery, vertebral artery, and basilar artery are the most common sites of nerve thrombus. The state of acute thrombus is mostly greasy and slippery. It is difficult to capture it completely with the existing metal thrombectomy stent.
发明内容Contents of the invention
本发明的一个目的在于提供一种改善血栓捕获性能的取栓支架、取栓装置和取栓系统。An object of the present invention is to provide a thrombus retrieval bracket, a thrombus retrieval device and a thrombus retrieval system with improved thrombus capture performance.
为解决上述技术问题,本发明采用如下技术方案:In order to solve the problems of the technologies described above, the present invention adopts the following technical solutions:
根据本发明的一个方面,本发明提供一种取栓支架,该取栓支架包括第一支架本体和第二支架本体;所述第二支架本体设置在所述第一支架本体的远端;所述第二支架本体包括多个第一管径段和多个过渡段;所述第一管径段和所述过渡段沿所述取栓支架的轴向交替排列,相邻的两个所述第一管径段通过所述过渡段连接;在所述取栓支架的近端和远端沿轴向相对远离时,所述第一管径段的至少部分区域径向收缩,且轴向相邻的两个所述第一管径段径向收缩的区域呈角度设置。According to one aspect of the present invention, the present invention provides a thrombectomy bracket, which includes a first bracket body and a second bracket body; the second bracket body is arranged at the distal end of the first bracket body; The second stent body includes a plurality of first diameter sections and a plurality of transition sections; the first diameter sections and the transition sections are arranged alternately along the axial direction of the thrombectomy stent, and two adjacent The first pipe diameter section is connected through the transition section; when the proximal end and the distal end of the thrombectomy bracket are relatively far apart in the axial direction, at least part of the first pipe diameter section shrinks radially, and axially The radial contraction regions of the two adjacent first pipe diameter sections are arranged at an angle.
根据本发明的另一个方面,本发明还提供一种取栓装置,该取栓装置包括上述的取栓支架和与所述取栓支架相连的牵引导丝;所述牵引导丝与所述取栓支架的近端相连,以用于推拉所述取栓支架。According to another aspect of the present invention, the present invention also provides a thrombectomy device, which includes the above-mentioned thrombus retrieval bracket and a traction guide wire connected with the thrombus retrieval bracket; The proximal end of the thrombus support is connected to push and pull the thrombus retrieval support.
根据本发明的又一个方面,本发明还提供一种取栓系统,该取栓系统包括上述的取栓装置、以及推杆、装载鞘和微导管;所述推杆与所述取栓支架的近端相连,以用于推拉所述取栓支架;所述装载 鞘用于收容在压缩状态下的所述取栓装置;所述微导管用于与所述装载鞘相连通,所述微导管内的管腔用于输送所述取栓装置。According to another aspect of the present invention, the present invention also provides a thrombectomy system, which includes the above-mentioned thrombectomy device, a push rod, a loading sheath, and a microcatheter; The proximal end is connected to push and pull the thrombectomy bracket; the loading sheath is used to accommodate the thrombectomy device in a compressed state; the microcatheter is used to communicate with the loading sheath, and the microcatheter The inner lumen is used to deliver the thrombectomy device.
由上述技术方案可知,本发明实施例至少具有如下优点和积极效果:It can be seen from the above technical solutions that the embodiments of the present invention have at least the following advantages and positive effects:
本发明实施例的取栓支架中,第一管径段能够适应不同直径的血管,保证与血管的贴壁性能,在此基础上,由于在取栓支架的近端和远端沿轴向相对远离时,轴向相邻的两个第一管径段在径向收缩的区域呈角度设置,即轴向相邻的两个第一管径段在径向收缩的部位不一样,径向收缩的区域发生了错位,可以理解径向未发生收缩的区域也发生错位,这意味着取栓支架在血管内捕获血栓后受到牵拉时,取栓支架在不同方向能够维持外形,取栓支架整体将不会发生明显的塌陷,能够在不同方向维持外形的取栓支架可增加血栓逃逸的阻力,并还能够使取栓支架在不同弯曲程度的血管中依然保持与血栓的接触面积,从而可以有效抓捕不同方位的血栓,降低血栓逃逸的风险。In the thrombectomy stent according to the embodiment of the present invention, the first diameter section can adapt to blood vessels of different diameters to ensure the wall-attachment performance of the blood vessel. On this basis, since the proximal and distal ends of the thrombectomy When they are far away, the two axially adjacent first pipe diameter sections are arranged at an angle in the radially contracted area, that is, the two axially adjacent first pipe diameter sections are not the same in the radially contracted part, and the radially contracted It is understandable that the region that has not shrunk in the radial direction is also dislocated, which means that when the thrombus retrieval stent is pulled after capturing the thrombus in the blood vessel, the thrombus retrieval stent can maintain its shape in different directions, and the overall shape of the thrombus retrieval stent There will be no obvious collapse, and the thrombus retrieval stent that can maintain its shape in different directions can increase the resistance of the thrombus to escape, and can also keep the thrombus retrieval stent in contact with the thrombus in vessels with different degrees of curvature, so that it can effectively Capture thrombus in different directions to reduce the risk of thrombus escape.
附图说明Description of drawings
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图示出的结构获得其他的附图。In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments of the present invention. For those skilled in the art, other drawings can also be obtained according to the structures shown in these drawings without creative effort.
图1为本发明一实施例的取栓装置的结构示意图;Fig. 1 is a schematic structural view of a thrombectomy device according to an embodiment of the present invention;
图2为图1所示的取栓装置在周向相对偏转90度后的结构示意图;Fig. 2 is a structural schematic diagram of the thrombectomy device shown in Fig. 1 after the relative deflection of 90 degrees in the circumferential direction;
图3为图1所示的取栓装置的取栓支架在轴向受拉状态下的结构示意图;Fig. 3 is a schematic structural view of the thrombectomy bracket of the thrombectomy device shown in Fig. 1 under axial tension;
图4为图2所示的取栓装置的取栓支架在轴向受拉状态下的结构示意图;Fig. 4 is a schematic structural view of the thrombectomy bracket of the thrombectomy device shown in Fig. 2 under axial tension;
图5为沿图1中沿剖面线Ⅱ-Ⅱ的截面示意图;Fig. 5 is a schematic cross-sectional view along section line II-II in Fig. 1;
图6为沿图1中沿剖面线Ш-Ш的截面示意图;Fig. 6 is a schematic cross-sectional view along the section line Ш-Ш in Fig. 1;
图7为图1所示的取栓装置中A处的放大结构示意图;Fig. 7 is a schematic diagram of an enlarged structure at A in the thrombectomy device shown in Fig. 1;
图8为图1所示的牵引导丝与取栓支架近端连接的结构示意图;Fig. 8 is a structural schematic diagram of the connection between the traction guide wire shown in Fig. 1 and the proximal end of the thrombectomy bracket;
图9为牵引导丝与取栓支架近端连接的另一实施例的结构示意图;Fig. 9 is a structural schematic diagram of another embodiment in which the traction guide wire is connected to the proximal end of the thrombectomy bracket;
图10为牵引导丝与取栓支架近端连接的又一实施例的结构示意图;Fig. 10 is a structural schematic diagram of another embodiment in which the traction guide wire is connected to the proximal end of the thrombectomy bracket;
图11为图1所示的显影导丝与取栓支架远端连接的结构示意图;Fig. 11 is a structural schematic diagram of the connection between the development guide wire shown in Fig. 1 and the distal end of the thrombectomy bracket;
图12是包括图1的取栓装置的取栓系统在组装前的结构示意图;Fig. 12 is a schematic structural view of the thrombectomy system including the thrombectomy device of Fig. 1 before assembly;
图13是图12的取栓装系统组装后使用时的结构示意图;Fig. 13 is a structural schematic view of the bolt removing system of Fig. 12 when assembled and used;
图14是图13所示取栓系统中的取栓装置在微导管中推送状态的示意图;Fig. 14 is a schematic diagram of the pushing state of the thrombectomy device in the thrombectomy system shown in Fig. 13;
图15为图1所示的取栓装置取栓过程的第一状态示意图;Fig. 15 is a schematic diagram of the first state of the thrombectomy device shown in Fig. 1 during the thrombectomy process;
图16为图1所示的取栓装置取栓过程的第二状态示意图;Fig. 16 is a schematic diagram of the second state of the thrombectomy device shown in Fig. 1 during the thrombectomy process;
图17为图1所示的取栓装置取栓过程的第三状态示意图;Fig. 17 is a schematic diagram of the third state of the thrombectomy device shown in Fig. 1 during the thrombectomy process;
图18为图1所示的取栓装置取栓过程的第四状态示意图;Fig. 18 is a schematic diagram of the fourth state of the thrombectomy device shown in Fig. 1 during the thrombectomy process;
图19为图1所示的取栓装置取栓过程的第五状态示意图;Fig. 19 is a schematic diagram of the fifth state of the thrombectomy device shown in Fig. 1 during the thrombectomy process;
图20为图19所示的取栓装置的第五状态另一视角的示意图。Fig. 20 is a schematic view from another perspective of the fifth state of the thrombus removing device shown in Fig. 19 .
具体实施方式Detailed ways
体现本发明特征与优点的典型实施方式将在以下的说明中详细叙述。应理解的是本发明能够在不同的实施方式上具有各种的变化,其皆不脱离本发明的范围,且其中的说明及图示在本质上是当作说明之用,而非用以限制本发明。Typical embodiments that embody the features and advantages of the present invention will be described in detail in the following description. It should be understood that the present invention is capable of various changes in different embodiments without departing from the scope of the present invention, and that the description and illustrations therein are illustrative in nature and not limiting. this invention.
在本申请的描述中,需要理解的是,术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本申请和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本申请的限制。In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", " Orientation indicated by rear, left, right, vertical, horizontal, top, bottom, inside, outside, clockwise, counterclockwise, etc. The positional relationship is based on the orientation or positional relationship shown in the drawings, which is only for the convenience of describing the application and simplifying the description, and does not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, Therefore, it should not be construed as limiting the application.
此外,术语“第一”、“第二”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个所述特征。在本申请的描述中,“多个”的含义是两个以上,即两个或更多个,除非另有明确具体的限定。In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of said features. In the description of the present application, "plurality" means two or more, that is, two or more, unless otherwise specifically defined.
在本申请的描述中,需要说明的是,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通。对于本领域的普通技术人员而言,可以具体情况理解上述术语在本申请中的具体含义。In the description of this application, it should be noted that unless otherwise specified and limited, the terms "installation", "connection", and "connection" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connected, or integrally connected; it can be mechanically connected or electrically connected; it can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application in specific situations.
为便于描述和理解,本文定义“近端”是指靠近操作者的一端,“远端”是指远离操作者的一端。具体地,近端是指供用户或机器操作的一端或者用于连接其它器件的一端。远端是指器械可自由插入到动物或人体体内的一端。For the convenience of description and understanding, "proximal end" is defined herein as the end close to the operator, and "distal end" is defined as the end away from the operator. Specifically, the proximal end refers to an end for operation by a user or a machine, or an end for connecting to other devices. The distal end is the end of the device that can be freely inserted into the animal or human body.
本发明实施例提供的取栓支架和取栓装置,用于在血管堵塞血管时,疏通堵塞的血管,抓捕堵塞血管中的血栓。该取栓装置包括取栓支架和牵引导丝,牵引导丝与取栓支架相连,并可穿设于取栓支架内。取栓支架具有径向可伸缩性能,使得取栓支架具有坍缩状态和自然膨胀状态。在坍缩状态下,可便于取栓支架经微导管在血管内进行递送,输送至病变部位。当到达病变部位后,撤出微导管,可使取栓支架恢复自然膨胀状态,进而对病变部位血栓进行切割和捕获,最后回撤带有血栓的取栓支架,从而取出血栓,实现堵塞血管的疏通。The thrombectomy stent and the thrombus retrieval device provided by the embodiments of the present invention are used to dredge the blocked blood vessel and catch the thrombus in the blocked blood vessel when the blood vessel is blocked. The thrombectomy device includes a thrombectomy bracket and a traction guide wire, the traction guide wire is connected with the thrombectomy bracket and can be passed through the thrombectomy bracket. The thrombectomy stent has radial stretchability, so that the thrombectomy stent has a collapsed state and a natural expansion state. In the collapsed state, the thrombectomy stent can be easily delivered in the blood vessel through the microcatheter and delivered to the lesion site. When the lesion is reached, the microcatheter is withdrawn to restore the thrombus retrieval stent to its natural expansion state, and then cut and capture the thrombus in the lesion, and finally withdraw the thrombus retrieval stent with the thrombus, thereby removing the thrombus and realizing the occlusion of the blood vessel. dredge.
首先请参阅图1,本实施例的取栓装置100包括取栓支架1和牵引导丝2。First please refer to FIG. 1 , a thrombectomy device 100 in this embodiment includes a thrombectomy support 1 and a traction guide wire 2 .
其中,取栓支架1大致呈空心管状结构,其外周壁可呈网格或网孔结构,该网格或网孔结构可以包括规则或不规则的孔状结构。牵引导丝2穿过取栓支架1的近端,并与取栓支架1的近端连接。牵引导丝2的近端可与外界相连,在完成血栓捕获后,通过牵拉牵引导丝2向血管的近端运动,可带动取栓支架1朝向血管近端回撤。Wherein, the thrombectomy bracket 1 is roughly in the shape of a hollow tube, and its peripheral wall may be in a grid or mesh structure, and the grid or mesh structure may include regular or irregular hole-like structures. The traction guide wire 2 passes through the proximal end of the thrombectomy support 1 and is connected with the proximal end of the thrombectomy support 1 . The proximal end of the pulling guide wire 2 can be connected to the outside world. After the thrombus is captured, the pulling guide wire 2 is pulled to move toward the proximal end of the blood vessel, which can drive the thrombectomy stent 1 to retreat toward the proximal end of the blood vessel.
取栓支架1具有坍缩状态和自然膨胀状态。在坍缩状态下,取栓支架1的径向尺寸最小,便于在血管内进行递送,以将取栓支架1输送至病变部位。The thrombectomy support 1 has a collapsed state and a naturally expanded state. In the collapsed state, the radial dimension of the thrombectomy stent 1 is the smallest, which is convenient for delivery in blood vessels, so as to deliver the thrombectomy stent 1 to the lesion.
取栓支架1可采用如具有形状记忆特性的金属材质或具有弹性的高分子材料制成,以便取栓支架1被释放到血管内后自膨胀而形成大致管状或笼状结构。具体地,取栓支架可以通过激光切割镍钛管材形成,也可以通过激光切割镍钛板材然后卷曲热定型而成,还可以是编织而成,例如采用镍钛丝材料编织而成,又或者也可以使用具有弹性的塑料材料加工而成。在取栓支架1被释放到血管内且径向无外部压力时,取栓支架1自行膨胀,径向尺寸变大。在自然膨胀状态下,取栓支架1撑开病变部位处的血栓,并利用其外周壁上的网格或网孔结构对该血栓进行切割,使血栓嵌入取栓支架1内,并被取栓支架1捕获。随后,牵拉牵引导丝2向血管的近端运动,可控制取栓支架1连同其内捕获的血栓回撤,疏通堵塞的血管。The thrombectomy stent 1 can be made of metal material with shape memory or elastic polymer material, so that the thrombectomy stent 1 can self-expand after being released into the blood vessel to form a roughly tubular or cage-like structure. Specifically, the thrombectomy stent can be formed by laser cutting a nickel-titanium tube, or by laser-cutting a nickel-titanium plate and then crimping and heat-setting, or braided, for example, braided by using nickel-titanium wire material, or Can be machined from elastic plastic material. When the thrombectomy stent 1 is released into the blood vessel and there is no radial external pressure, the thrombectomy stent 1 expands by itself, and the radial dimension becomes larger. In the naturally expanded state, the thrombus retrieval stent 1 stretches the thrombus at the lesion, and cuts the thrombus by using the grid or mesh structure on its peripheral wall, so that the thrombus is embedded in the thrombus retrieval stent 1 and is removed. Bracket 1 captures. Subsequently, pulling the pulling guide wire 2 to move toward the proximal end of the blood vessel can control the retraction of the thrombus retrieval stent 1 and the thrombus captured therein, and dredge the blocked blood vessel.
参考图1和图2,取栓支架1包括第一支架本体11和第二支架本体12。第一支架本体11的近端与牵引导丝2的远端连接,第一支架本体11的远端与第二支架本体12的近端连接,第一支架本体11与第二支架本体12连接共同形成用于抓捕血栓的管状结构。在回撤取栓支架1时,牵引导丝2能够通过第一支架本体11更容易地将第二支架本体12一起回撤至微导管中。Referring to FIG. 1 and FIG. 2 , the thrombectomy bracket 1 includes a first bracket body 11 and a second bracket body 12 . The proximal end of the first stent body 11 is connected to the distal end of the traction guide wire 2, the distal end of the first stent body 11 is connected to the proximal end of the second stent body 12, and the first stent body 11 and the second stent body 12 are connected together. Forms a tubular structure that traps thrombus. When the thrombectomy stent 1 is withdrawn, the pulling guide wire 2 can more easily withdraw the second stent body 12 into the microcatheter through the first stent body 11 .
第二支架本体12包括多个第一管径段121和多个过渡段122,第一管径段121和过渡段122沿取栓支架1的轴向交替排列,相邻的两个第一管径段121通过过渡段122连接。在取栓支架1的近端和远端沿轴向相对远离时,即在取栓支架1的近端受到牵拉力回撤取栓支架1时,第一管径段121的至少部分区域径向收缩,且轴向相邻的两个第一管径段121径向收缩的区域呈角度设置。The second stent body 12 includes a plurality of first pipe diameter sections 121 and a plurality of transition sections 122, the first pipe diameter sections 121 and the transition sections 122 are arranged alternately along the axial direction of the thrombectomy stent 1, and the adjacent two first pipe diameter sections The radial sections 121 are connected by a transition section 122 . When the proximal end and the distal end of the thrombectomy bracket 1 are relatively far apart in the axial direction, that is, when the proximal end of the thrombectomy bracket 1 is retracted by a pulling force, at least part of the diameter of the first diameter section 121 is The radial contraction area of the two axially adjacent first pipe diameter sections 121 is arranged at an angle.
为了更加详细地说明,请对比图1和图3,或者对比图2和图4,图1和图2为取栓支架1在其近端受到牵拉之前的两个不同视角方位下的状态示意图,也可以理解为取栓支架1释放到血管后完全自由膨胀开来的状态示意图,此状态下的第一管径段121周向上各区域的径向尺寸近似相等,也即在垂直于纵向的横向截面内,第一管径段的周缘各处到第一管径段中心轴的距离近似相等,近似相等为各区域的径向尺寸差异在5%范围内,相邻两个第一管径段在周向上相对错位,相邻两个过渡段在周向上相对错位。图3和图4分别为图1和图2中所示意的取栓支架1在其近端受到牵拉之后的两个不同视角方位下的状态示意图,也可以理解为回撤抓捕了血栓的取栓支架1的状态示意图,此状态下每个第一管径段121的至少部分区域都发生了明显的径向收缩,即径向塌陷。另外,轴向相邻的两个第一管径段121径向收缩的区域成一定的角度,这可理解为轴向相邻的两个第一管径段121中未塌陷的区域或者塌陷幅度相对较小的区域也呈一定角度。For a more detailed description, please compare Fig. 1 and Fig. 3, or compare Fig. 2 and Fig. 4, Fig. 1 and Fig. 2 are schematic diagrams of states of the thrombectomy bracket 1 in two different viewing angles before its proximal end is pulled , can also be understood as a schematic diagram of the state in which the thrombectomy stent 1 is completely freely expanded after being released into the blood vessel. In this state, the radial dimensions of each region in the circumferential direction of the first pipe diameter section 121 are approximately equal, that is, in the direction perpendicular to the longitudinal direction. In the transverse section, the distances from the periphery of the first pipe diameter section to the central axis of the first pipe diameter section are approximately equal, which means that the radial dimension difference of each area is within 5%, and two adjacent first pipe diameters The segments are relatively dislocated in the circumferential direction, and two adjacent transition segments are relatively dislocated in the circumferential direction. Fig. 3 and Fig. 4 are respectively schematic diagrams of the state of the thrombectomy support 1 shown in Fig. 1 and Fig. 2 in two different viewing angles after its proximal end is pulled, which can also be understood as the retraction to capture the thrombus. A schematic diagram of the state of the thrombectomy stent 1 . In this state, at least part of each first pipe diameter section 121 has obvious radial contraction, that is, radial collapse. In addition, the radial contraction areas of the two axially adjacent first pipe diameter sections 121 form a certain angle, which can be understood as the uncollapsed area or the collapse range of the two axially adjacent first pipe diameter sections 121 Relatively small areas are also angled.
本实施例中,在取栓支架1的近端和远端沿轴向相对远离时,轴向相邻的两个第一管径段121径向收缩的区域在周向相对错位,例如其相对错位的角度为90度,这可以理解为径向尺寸没有明显变化的区域也错位90度设置。以上沿取栓支架1轴向交替错位的结构,使得取栓支架1更容易抓捕血栓。可以理解,在其它实施例,错位的角度也可以呈其它角度设置,本申请对此并不作限定,为便于理解,本申请将以90度错位为例进行示例性说明。In this embodiment, when the proximal end and the distal end of the thrombectomy stent 1 are relatively far apart in the axial direction, the radial contraction areas of the two axially adjacent first tube diameter sections 121 are relatively misaligned in the circumferential direction, for example, they are opposite to each other. The misalignment angle is 90 degrees, which can be understood as a 90-degree misalignment for regions with no significant change in radial size. The above structure of alternating displacement along the axial direction of the thrombectomy support 1 makes it easier for the thrombus retrieval support 1 to capture thrombus. It can be understood that, in other embodiments, the misalignment angle can also be set at other angles, which is not limited in the present application. For ease of understanding, the present application will take a 90-degree misalignment as an example for illustration.
结合图5和图6,图5和图6分别为相邻的两个第一管径段121的横截面示意图,第一管径段121 具有径向相对设置的第一区域12a和第二区域12b、以及相对设置的第三区域12c和第四区域12d,第一区域12a、第三区域12c、第二区域12b、第四区域12d沿第二支架本体12的周向依次排布。需要说明的是,所述“区域”可包括点、线、面中的至少一种。在取栓支架1的近端和远端沿轴向相对远离时,第一区域12a和第二区域12b径向收缩,第三区域12c和第四区域12d维持径向尺寸不变,或者第三区域12c和第四区域12d径向收缩尺寸小于第一区域12a的径向收缩尺寸,和/或小于第二区域12b径向收缩尺寸。本实施例中,第一区域12a和第二区域12b可以理解为面,第三区域12c和第四区域12d可以理解为点或线,即第三区域12c和第四区域12d为第一区域12a与第二区域12b相交的点或者相交的线。即,第一区域12a和第二区域12b分别为径向相对的两侧表面,而第三区域12c和第四区域12d为所述两侧表面的周向两末端的汇合处。5 and 6, FIG. 5 and FIG. 6 are schematic cross-sectional views of two adjacent first pipe diameter sections 121, respectively, the first pipe diameter section 121 has a first area 12a and a second area diametrically opposite to each other. 12b , and the third area 12c and the fourth area 12d oppositely arranged, the first area 12a , the third area 12c , the second area 12b , and the fourth area 12d are sequentially arranged along the circumferential direction of the second bracket body 12 . It should be noted that the "area" may include at least one of a point, a line, and a plane. When the proximal end and the distal end of the thrombectomy stent 1 move away from each other in the axial direction, the first region 12a and the second region 12b shrink radially, the third region 12c and the fourth region 12d maintain the same radial size, or the third The radially contracted size of the region 12c and the fourth region 12d is smaller than the radially contracted size of the first region 12a, and/or smaller than the radially contracted size of the second region 12b. In this embodiment, the first area 12a and the second area 12b can be understood as surfaces, and the third area 12c and the fourth area 12d can be understood as points or lines, that is, the third area 12c and the fourth area 12d are the first area 12a A point or a line intersecting with the second region 12b. That is, the first area 12a and the second area 12b are respectively diametrically opposite two side surfaces, and the third area 12c and the fourth area 12d are the confluence of the circumferential ends of the two side surfaces.
其中,第一管径段121径向收缩时,第一管径段121径向收缩区域的径向尺寸在周向呈中间小两端大。即上述第一区域12a和第二区域12b径向收缩后,第一区域12a的径向尺寸和第二区域12b的径向尺寸皆由其中心朝向两侧逐渐增大,直至与第三区域12c和第四区域12d的径向尺寸相等。Wherein, when the first pipe diameter section 121 shrinks radially, the radial dimension of the radial contraction area of the first pipe diameter section 121 is smaller in the middle and larger at the two ends in the circumferential direction. That is, after the above-mentioned first region 12a and the second region 12b shrink radially, the radial size of the first region 12a and the radial size of the second region 12b gradually increase from the center to both sides until they are aligned with the third region 12c. It is equal to the radial dimension of the fourth region 12d.
以上区域的收缩规律可以理解为,在轴向相邻的两个第一管径段121中(图5和图6),该两个第一管径段121中的第一区域12a和第二区域12b同时在周向发生了错位,该错位的角度等于该两个第一管径段121径向收缩区域错位的夹角,例如该错位角度为90度。并且,该两个第一管径段121中的第三区域12c和第四区域12d也在周向发生错位,该错位的角度等于该两个第一管径段121径向收缩区域错位的夹角,例如该错位角度为90度。The contraction law of the above regions can be understood as, in the two axially adjacent first pipe diameter sections 121 (Fig. 5 and Fig. 6), the first area 12a and the second At the same time, the area 12b is misaligned in the circumferential direction, and the angle of the misalignment is equal to the included angle of the misalignment of the radial contraction areas of the two first pipe diameter sections 121 , for example, the misalignment angle is 90 degrees. Moreover, the third area 12c and the fourth area 12d in the two first pipe diameter sections 121 are also misaligned in the circumferential direction, and the angle of the misalignment is equal to the gap between the radial contraction areas of the two first pipe diameter sections 121. Angle, for example, the misalignment angle is 90 degrees.
在利用牵引导丝2回撤取栓支架1时,取栓支架1的近端受到牵拉力作用,第一管径段121的部分区域发生径向收缩,即发生径向塌陷。这可以表现为上述的第一区域12a和第二区域12b径向塌陷,第三区域12c和第四区域12d的径向尺寸基本维持不变,或者变化保持在一很小的预设范围内。这样,在回撤取栓支架1途中,即使在过弯曲血管,都可以始终保持第三区域12c和第四区域12d与血管的贴壁性能,且由于轴向相邻的两个第一管径段121的第三区域12c在周向错位90度设置、第四区域12d在周向错位90度设置,使得被取栓支架1抓捕的血栓逃逸的通道不顺畅,阻力加大,难以逃脱。When the thrombectomy stent 1 is withdrawn by the traction guide wire 2, the proximal end of the thrombectomy stent 1 is subjected to a pulling force, and a partial area of the first diameter section 121 shrinks radially, that is, radially collapses. This can be represented by radial collapse of the above-mentioned first region 12a and second region 12b, while the radial dimensions of the third region 12c and fourth region 12d remain substantially unchanged, or vary within a small preset range. In this way, on the way of withdrawing the thrombectomy stent 1, even in an overbent blood vessel, the adherence performance of the third region 12c and the fourth region 12d to the blood vessel can always be maintained, and because the two axially adjacent first diameters The third area 12c of the section 121 is set at a 90-degree circumferential misalignment, and the fourth area 12d is set at a 90-degree circumferential misalignment, so that the thrombus caught by the thrombus retrieval stent 1 has an unsmooth escape channel and increased resistance, making it difficult to escape.
本发明实施例的取栓支架1,第一管径段121能够适应不同直径的血管,保证与血管的贴壁性能,在此基础上,由于在取栓支架1的近端和远端沿轴向相对远离时,轴向相邻的两个第一管径段121在径向收缩的区域呈角度设置,即轴向相邻的两个第一管径段121在径向收缩的部位不一样,径向收缩的区域发生了错位,可以理解径向未发生收缩的区域也发生错位,这意味着取栓支架1在血管内捕获血栓后受到牵拉时,取栓支架1能够通过第一管径段121未发生形变的区域在不同方向维持外形,提高径向支撑力,取栓支架1整体将不会发生明显的塌陷,能够在不同方向维持外形的取栓支架1增加了血栓逃逸的阻力,并还能使取栓支架1在不同弯曲程度的血管中依然保持与血栓的接触面积,从而可以有效抓捕不同方位的血栓,降低血栓逃逸的风险。In the thrombectomy stent 1 of the embodiment of the present invention, the first diameter section 121 can adapt to blood vessels of different diameters and ensure the wall-attachment performance with the blood vessels. When moving relatively far away, the two axially adjacent first pipe diameter sections 121 are arranged at an angle in the radially contracted area, that is, the two axially adjacent first pipe diameter sections 121 are not the same in the radially contracted area , the radial contraction area is dislocated, and it can be understood that the radial contraction area is also dislocated, which means that when the thrombectomy stent 1 is pulled after capturing the thrombus in the blood vessel, the thrombectomy stent 1 can pass through the first tube The undeformed area of the diameter section 121 maintains its shape in different directions and improves the radial support force. The whole thrombectomy stent 1 will not collapse significantly, and the thrombus retrieval stent 1 that can maintain its shape in different directions increases the resistance of the thrombus to escape. , and can also enable the thrombus retrieval stent 1 to still maintain the contact area with the thrombus in blood vessels with different degrees of curvature, thereby effectively capturing thrombus in different directions and reducing the risk of thrombus escape.
在一实施例中,参考图1和图7所示,过渡段122包括沿第二支架本体12的周向间隔设置的第一支撑杆123和第二支撑杆124,第一支撑杆123和第二支撑杆124沿取栓支架1的轴向延伸,并设置于相邻的两个第一管径段121的相向的近端与远端之间。基于本发明的目的,第一支撑杆123和第二 支撑杆124不仅可以用作相邻两个第一管径段121的中间连接件来使用,而且还可以起到驱使其中一端的第一管径段121的至少部分区域发生径向变形的作用。In one embodiment, as shown in FIG. 1 and FIG. 7 , the transition section 122 includes a first support rod 123 and a second support rod 124 arranged at intervals along the circumference of the second bracket body 12 , and the first support rod 123 and the second support rod 123 The two support rods 124 extend along the axial direction of the thrombectomy bracket 1 and are arranged between the proximal and distal ends of two adjacent first tube diameter sections 121 facing each other. Based on the purpose of the present invention, the first support rod 123 and the second support rod 124 can not only be used as intermediate connectors between two adjacent first pipe diameter sections 121, but also can be used to drive the first pipe at one end to Radial deformation occurs in at least a partial area of the diameter segment 121 .
轴向相邻的两个过渡段122在周向相对错位,轴向相邻两个第一管径段121在周向上相对错位,且相邻两个第一管径段121在周向上相对错位的角度,与相邻两个过渡段122在周向上相对错位的角度相等。这意味着,轴向相邻的两根第一支撑杆123周向错位的角度与轴向相邻的两个第一管径段121周向错位的角度相等。本实施例中,第一支撑杆123与第二支撑杆124沿周向间隔180度,且轴向相邻两第一支撑杆123、及两第二支撑杆124分别周向错位90度。The two axially adjacent transition sections 122 are relatively misaligned in the circumferential direction, the two axially adjacent first pipe diameter sections 121 are relatively misaligned in the circumferential direction, and the two adjacent first pipe diameter sections 121 are relatively misaligned in the circumferential direction The angle is equal to the relative misalignment angle of two adjacent transition sections 122 in the circumferential direction. This means that the circumferential misalignment angle of two axially adjacent first support rods 123 is equal to the circumferential misalignment angle of two axially adjacent first pipe diameter sections 121 . In this embodiment, the first support rod 123 and the second support rod 124 are separated by 180 degrees in the circumferential direction, and the axially adjacent two first support rods 123 and the two second support rods 124 are circumferentially misaligned by 90 degrees respectively.
本实施例中,第一管径段121包括多个第一波形件1211,多个第一波形件1211沿取栓支架1的轴向首尾顺次相接,相邻的两个第一波形件1211形成周向排布的多个第一网孔101,本实施例中第一网孔101的形状为菱形结构,当然在其它实施例中,第一网孔101也可以为其它形状的网孔结构,例如三角形、矩形或者多边形等等,本申请不作限定。为便于理解,图1和图7中示意性地列出了第一管径段121具有两个第一波形件1211,各个第一波形件1211可视为由多个杆件呈Z形或W形连续布置并连接形成的闭环结构。In this embodiment, the first pipe diameter section 121 includes a plurality of first corrugated parts 1211, and the plurality of first corrugated parts 1211 are sequentially connected end to end along the axial direction of the thrombus retrieval support 1, and two adjacent first corrugated parts 1211 forms a plurality of first meshes 101 arranged in the circumferential direction. In this embodiment, the shape of the first meshes 101 is a rhombus structure. Of course, in other embodiments, the first meshes 101 can also be meshes of other shapes. Structures, such as triangles, rectangles, or polygons, etc., are not limited in this application. For ease of understanding, Fig. 1 and Fig. 7 schematically show that the first pipe diameter section 121 has two first wave pieces 1211, and each first wave piece 1211 can be regarded as having a Z shape or a W shape by a plurality of rods. Shapes are arranged continuously and connected to form a closed-loop structure.
每一第一波形件1211包括多个波峰和波谷,波峰和波谷在周向上交替排布。具体地,相邻两第一波形件1211的波峰数量相等,波谷数量相等,且波峰数量等于波谷数量。本文中,以图1和图7中的方位为参考,将近端顶点定义为波峰,将远端顶点定义为波谷。则第一管径段121中近端第一波形件1211的波谷(即远端顶点)和远端第一波形件1211的波峰(即近端顶点)汇合连接,近端第一波形件1211的波峰(即近端顶点)和远端第一波形件1211的波谷(即远端顶点)在轴向上相对且相互远离,从而两第一波形件1211围合形成多个沿周向间隔排列的第一网孔101。Each first wave element 1211 includes a plurality of crests and troughs, and the crests and troughs are arranged alternately in the circumferential direction. Specifically, the number of crests and the number of troughs of two adjacent first wave elements 1211 are equal, and the number of crests is equal to the number of troughs. In this paper, with reference to the orientations in Figure 1 and Figure 7, the near-end vertex is defined as the peak, and the far-end vertex is defined as the trough. Then the trough (i.e. the apex at the far end) of the first corrugated part 1211 at the proximal end in the first pipe diameter section 121 and the crest (i.e. the apex at the proximal end) of the first corrugated part 1211 at the far end converge and connect, and the first corrugated part 1211 at the proximal end The wave crests (i.e., the apexes at the proximal end) and the troughs (i.e., the apex at the distal end) of the first wave element 1211 at the distal end are axially opposite and far away from each other, so that the two first wave elements 1211 enclose and form a plurality of waves arranged at intervals in the circumferential direction. The first mesh 101 .
第一波形件1211能够沿径向伸缩,使得各个第一波形件1211之间的相邻波峰之间以及相邻波谷之间可以相互靠近或远离。在自然膨胀时,第一波形件1211的直径变大,且波峰与波谷之间的轴向间隔变小,同时周向间隔变大。当取栓支架1到达病变部位的血栓处后,第一波形件1211自膨胀而张开,可撑开血栓,建立血流通道,实现预通功能;并通过第一波形件1211对血栓进行切割,被切割的血栓部分进入第一波形件1211内,被第一网孔101捕获。The first wave parts 1211 can expand and contract in the radial direction, so that adjacent peaks and adjacent wave troughs between each first wave part 1211 can approach or move away from each other. During natural expansion, the diameter of the first wave member 1211 becomes larger, and the axial interval between the crest and the trough becomes smaller, while the circumferential interval becomes larger. When the thrombus retrieval stent 1 reaches the thrombus in the lesion, the first corrugated part 1211 expands and opens, which can spread the thrombus, establish a blood flow channel, and realize the pre-passing function; and cut the thrombus through the first corrugated part 1211 , the cut thrombus partially enters the first wave member 1211 and is captured by the first mesh 101 .
第一支撑杆123的近端和第二支撑杆124的近端皆与近端相邻的第一管径段121中位于远端的第一波形件1211的顶点连接,例如与该第一波形件1211的近端顶点连接,该第一波形件1211的远端顶点可自由悬空,以起到勾住血栓作用。第一支撑杆123的远端和第二支撑杆124的远端皆与远端相邻的第一管径段121中位于近端的第一波形件1211的顶点连接,例如与该第一波形件1211的近端顶点连接。The proximal end of the first support rod 123 and the proximal end of the second support rod 124 are connected with the apex of the first wave piece 1211 located at the distal end in the first pipe diameter section 121 adjacent to the proximal end, for example, connected with the first wave piece 1211 The proximal apex of the first corrugated member 1211 is connected, and the distal apex of the first corrugated member 1211 is free to hang in the air, so as to play the role of hooking the thrombus. Both the distal end of the first support rod 123 and the distal end of the second support rod 124 are connected to the apex of the first corrugated part 1211 located at the proximal end in the first pipe diameter section 121 adjacent to the distal end, for example, connected to the first corrugated part 1211. The proximal apex of piece 1211 is connected.
定义相邻的两个第一管径段121中位于近端的一者为近端第一管径段121,另一者为远端第一管径段121。事实上,为达到上述目的,可以将过渡段122的近端与近端第一管径段121的部分顶点连接,而保留近端第一管径段121的部分顶点为自由端点,并将过渡段122的远端与远端第一管径段121的所有顶点连接,而不保留远端第一管径段121的自由端点。这样取栓支架1在受到轴向牵拉力时,可以确保过渡段122近端的第一管径段121径向受力的不均匀性,从而实现该近端第一管径段121部 分区域的径向收缩,而另一部分区域近似不发生径向收缩。并同时确保了远端第一管径段121的近端在径向上受力的均匀性,该远端第一管径段121的近端在径向上受力的均匀性可以为该远端第一管径段121提供支撑力,以确保其在下一个错位的过渡段122的作用下发生局部区域的径向收缩。One of the two adjacent first tube diameter sections 121 located at the proximal end is defined as the proximal first tube diameter section 121 , and the other is the distal first tube diameter section 121 . In fact, in order to achieve the above purpose, the proximal end of the transition section 122 can be connected to part of the vertices of the proximal first pipe diameter section 121, while retaining part of the vertices of the proximal first pipe diameter section 121 as free endpoints, and the transition The distal end of the segment 122 is connected to all vertices of the distal first diameter segment 121 , leaving no free end points of the distal first diameter segment 121 . In this way, when the thrombectomy stent 1 is subjected to axial pulling force, it can ensure the uneven radial force of the first pipe diameter section 121 at the proximal end of the transition section 122, so as to realize the partial area of the first pipe diameter section 121 at the proximal end. radial shrinkage, while the other part of the region does not experience radial shrinkage. And at the same time, the uniformity of the force on the proximal end of the first distal pipe diameter section 121 in the radial direction is ensured. The uniformity of the radial force on the proximal end of the first distal pipe diameter section 121 can be the A pipe diameter section 121 provides supporting force to ensure localized radial contraction under the action of the next dislocated transition section 122 .
参考图1和图7,在一实施例中,过渡段122还包括第二管径段125和多根支撑臂126,多根支撑臂126沿第二支架本体12的周向间隔排布,第二管径段125的近端与第一支撑杆123以及第二支撑杆124的远端连接,第二管径段125的远端通过多根支撑臂126与远端相邻的第一管径段121的近端连接。在自然膨胀状态下,第一管径段121的径向尺寸大于第二管径段125,这样的设置不仅确保了取栓支架1的柔顺性,且使得取栓支架1的径向和轴向具有一定的支撑力,同时提高了取栓支架1对血栓的抓捕效率。1 and 7, in one embodiment, the transition section 122 further includes a second pipe diameter section 125 and a plurality of support arms 126, and the plurality of support arms 126 are arranged at intervals along the circumference of the second support body 12, the first The proximal end of the two pipe diameter sections 125 is connected to the distal ends of the first support rod 123 and the second support rod 124, and the distal end of the second pipe diameter section 125 is connected to the first pipe diameter adjacent to the distal end through a plurality of support arms 126. The proximal connection of segment 121. In the naturally expanded state, the radial dimension of the first pipe diameter section 121 is larger than the second pipe diameter section 125. Such an arrangement not only ensures the flexibility of the thrombectomy support 1, but also makes the radial and axial direction of the thrombectomy support 1 It has a certain supporting force, and at the same time improves the capture efficiency of thrombus by the thrombus retrieval support 1 .
本实施例中,第二管径段125包括多个第二波形件1251,多个第二波形件1251沿取栓支架1的轴向首尾顺次相接,相邻的两个第二波形件1251形成周向排布的多个第二网孔102。本实施例中第二网孔102的形状为类似菱形结构,在本文中,定义类似菱形结构为至少相邻两条边相等的四边形结构。参考图7,本实施例中的第二网孔102的形状为两组相邻的边分别相等,即位于近端的一组相邻的两条边相等,位于远端的一组相邻的两条边相等。可以理解的,在其它实施例中,第二网孔102也可以为其它形状的网孔结构,例如三角形、矩形或者多边形等等,本申请不作限定。为便于理解,图1和图7中示意性列出了第二管径段125具有两个第二波形件1251,各个第二波形件1251可视为由多个杆件呈Z形或W形连续布置形成的闭环或非闭环结构。In this embodiment, the second pipe diameter section 125 includes a plurality of second corrugated parts 1251, and the plurality of second corrugated parts 1251 are sequentially connected end to end along the axial direction of the thrombus retrieval support 1, and two adjacent second corrugated parts 1251 forms a plurality of second meshes 102 arranged circumferentially. In this embodiment, the shape of the second mesh 102 is a rhombus-like structure, and herein, a rhombus-like structure is defined as a quadrilateral structure with at least two adjacent sides equal. Referring to Fig. 7, the shape of the second mesh 102 in this embodiment is that two groups of adjacent sides are respectively equal, that is, a group of adjacent sides located at the proximal end are equal, and a group of adjacent sides located at the far end are equal. Both sides are equal. It can be understood that, in other embodiments, the second mesh 102 may also be a mesh structure of other shapes, such as a triangle, a rectangle, or a polygon, etc., which are not limited in this application. For ease of understanding, Fig. 1 and Fig. 7 schematically show that the second pipe diameter section 125 has two second wave pieces 1251, and each second wave piece 1251 can be considered to be Z-shaped or W-shaped by a plurality of rods A closed-loop or non-closed-loop structure formed by continuous arrangement.
每一第二波形件1251包括多个波峰和多个波谷,第二波形件1251能够沿径向伸缩,使得各个第二波形件1251之间的相邻波峰之间以及相邻波谷之间可以相互靠近或远离。在自然膨胀时,第二波形件1251的直径变大,且波峰与波谷之间的轴向间隔变小,同时周向间隔变大。当取栓支架1到达病变部位的血栓处后,第二波形件1251自膨胀而张开,可撑开血栓,建立血流通道,实现预通功能;并通过第二波形件1251对血栓进行切割,被切割的血栓部分进入第二波形件1251内,被第二网孔102捕获。Each second corrugated part 1251 includes a plurality of crests and a plurality of troughs, and the second corrugated part 1251 can expand and contract in the radial direction, so that the adjacent crests and adjacent troughs between the second corrugated parts 1251 can be mutually move closer or farther away. During natural expansion, the diameter of the second wave member 1251 becomes larger, and the axial interval between the crest and the trough becomes smaller, while the circumferential interval becomes larger. When the thrombus retrieval stent 1 reaches the thrombus in the lesion, the second corrugated part 1251 expands and opens to expand the thrombus, establish a blood flow channel, and realize the pre-pass function; and cut the thrombus through the second corrugated part 1251 , the cut thrombus partially enters the second wave member 1251 and is captured by the second mesh 102 .
在一实施例中,参考图7,第二管径段125中位于远端的第二波形件1251在周向上连续形成闭环结构,位于近端的第二波形件1251在周向不连续而形成非闭环结构。具体地,远端第二波形件1251的多个杆件呈Z形或W形在周向上连续延伸,其波峰和波谷在周向上交替排布。近端第二波形件1251包括多个在周向上间隔设置的波形单元,波形单元可以是多个杆件连接构成的V形、Z形、W形等。近端第二波形件1251的每一波形单元的周向最末端与相邻波形单元不连续。本实施例中,第二管径段125的近端第二波形件1251包括两个周向间隔的波形单元。波形单元呈倒V形结构,包括一个近端顶点和两个远端顶点,每一远端顶点与远端第二波形件1251中一对应的波峰汇合连接,从而与远端第二波形件1251共同围成周向不连续的多个第二网孔102。近端第二波形件1251的各波形单元不与其他波形单元连接,即相邻的波形单元之间间隔,从而在第二管径段125的近端形成相比第二网孔102更大的网口102a。图7示意了第二网孔102和网口102a的数量为两个并且两者在周向交替设置。该更大的网口102a有利于在取栓支架1回撤过程中抓捕逃逸的血栓,以将其捕获到取栓支架1内。In one embodiment, referring to FIG. 7 , in the second tube diameter section 125, the second wave piece 1251 at the distal end continuously forms a closed-loop structure in the circumferential direction, and the second wave piece 1251 at the proximal end forms a discontinuous circle in the circumferential direction. non-closed structure. Specifically, the plurality of rods of the second wave member 1251 at the distal end extend continuously in a Z-shape or a W-shape in the circumferential direction, and the crests and troughs thereof are alternately arranged in the circumferential direction. The second wave member 1251 at the proximal end includes a plurality of wave units arranged at intervals in the circumferential direction, and the wave units may be V-shaped, Z-shaped, W-shaped, etc. formed by connecting a plurality of rods. The circumferential end of each wave unit of the proximal second wave element 1251 is discontinuous with adjacent wave units. In this embodiment, the second wave element 1251 at the proximal end of the second tube diameter section 125 includes two wave units spaced apart in the circumferential direction. The corrugated unit has an inverted V-shaped structure, including a proximal apex and two distal apexes, and each distal apex is converging with a corresponding wave crest in the second distal corrugated part 1251, thereby connecting with the distal second corrugated part 1251 A plurality of discontinuous second meshes 102 are jointly formed. Each wave-shaped unit of the proximal second corrugated part 1251 is not connected with other wave-shaped units, that is, there is an interval between adjacent wave-shaped units, thereby forming a larger hole than the second mesh 102 at the proximal end of the second pipe diameter section 125. Network port 102a. FIG. 7 shows that there are two second mesh holes 102 and mesh ports 102a and they are arranged alternately in the circumferential direction. The larger mesh opening 102a is beneficial to capture the escaped thrombus during the retraction process of the thrombus retrieval stent 1 so as to trap it into the thrombus retrieval stent 1 .
继续参考图7所示,定义构造形成第二网孔102的相邻两个第二波形件1251为近端第二波形件1251和远端第二波形件1251。近端第二波形件1251的轴向尺寸小于远端第二波形件1251的轴向尺寸,使得相邻两个第二波形件1251围合形成的第二网孔102的面积在轴向呈近端小远端大。如此,基于近端第二波形件1251在轴向上较短,远端第二波形件1251在轴向上较长,可以缩短第一管径段121与第二管径段125之间的距离,增大取栓支架1抓捕血栓的空间,使得血栓更容易嵌入到取栓支架1中,这样将增强对血栓块的锚固效果,并能减小血栓逃逸的机会,确保取栓支架1抓捕血栓的效率提升。Continuing to refer to FIG. 7 , two adjacent second corrugated parts 1251 configured to form the second mesh 102 are defined as the proximal second corrugated part 1251 and the distal second corrugated part 1251 . The axial dimension of the proximal second undulating piece 1251 is smaller than the axial dimension of the distal second undulating piece 1251, so that the area of the second mesh 102 formed by adjacent two second undulating pieces 1251 is approximately in the axial direction. The end is small and the far end is large. In this way, based on the fact that the second wave piece 1251 at the proximal end is shorter in the axial direction and the second wave piece 1251 at the distal end is longer in the axial direction, the distance between the first pipe diameter section 121 and the second pipe diameter section 125 can be shortened. , increase the space for the thrombus retrieval stent 1 to catch the thrombus, making it easier for the thrombus to be embedded in the thrombus retrieval stent 1, which will enhance the anchoring effect on the thrombus block, and reduce the chance of the thrombus escaping, ensuring that the thrombus retrieval stent 1 can catch the thrombus. The efficiency of trapping thrombus is improved.
第一支撑杆123的近端和第二支撑杆124的近端皆与相邻第一管径段121中位于远端的第一波形件1211的顶点连接,例如与该第一波形件1211的近端顶点连接,该第一波形件1211的远端顶点可自由悬空,以起到勾住血栓作用。第一支撑杆123的远端和第二支撑杆124的远端皆与相邻的第二管径段125位于近端的第二波形件1251的顶点连接,例如与该第二波形件1251的近端顶点连接。Both the proximal end of the first support rod 123 and the proximal end of the second support rod 124 are connected to the apex of the first wave piece 1211 at the far end in the adjacent first pipe diameter section 121, for example, to the top of the first wave piece 1211 The proximal apex is connected, and the distal apex of the first wave member 1211 can hang freely in the air, so as to hook the thrombus. Both the distal end of the first support rod 123 and the distal end of the second support rod 124 are connected to the apex of the second corrugated part 1251 located at the proximal end of the adjacent second pipe diameter section 125, for example, to the apex of the second corrugated part 1251 Proximal vertex connection.
支撑臂126的近端与第二管径段125位于远端的第二波形件1251顶点连接,例如与该第二波形件1251的近端顶点连接,该第二波形件1251的远端顶点可自由悬空,以起到勾住血栓作用。支撑臂126远端与远端相邻的第一管径段121中位于近端的第一波形件1211的顶点连接,例如与该第一波形件1211的近端顶点连接。The proximal end of the support arm 126 is connected to the apex of the second wave piece 1251 at the distal end of the second pipe diameter section 125, for example, connected to the proximal apex of the second wave piece 1251, and the distal apex of the second wave piece 1251 can be Free to hang in the air to play the role of hooking thrombus. The distal end of the support arm 126 is connected to the apex of the proximal first corrugated member 1211 in the distally adjacent first diameter section 121 , for example, connected to the proximal apex of the first corrugated member 1211 .
需要说明的是,以上说明了沿取栓支架1轴向上,过渡段122的近端与近端相邻的第一波形件1211的近端顶点连接,此时,该第一波形件1211的远端顶点悬空以作为自由端点,过渡段122的远端与远端相邻的第一波形件1211的近端顶点连接。可以理解的是,在其它实施例中,过渡段122的近端也可以与近端相邻的第一波形件1211的远端顶点连接;过渡段122的远端与远端相邻第一波形件1211的远端顶点连接,此时,该第一波形件1211的近端顶点悬空以作为自由端点。需要解释的是,上述两种不同的设计结构的区别,只是将相邻的两个第一管径段121之间的过渡段122进行了上下翻转(即沿着近端至远端或远端至近端的方向进行翻转),从而改变了自由端点的位置和朝向。当然,在考虑方便取栓支架1收鞘的前提下,优选的实施例应是将该自由端点设置在第一管径段121的远端。It should be noted that, it has been described above that along the axial direction of the thrombectomy stent 1, the proximal end of the transition section 122 is connected to the proximal apex of the first corrugated member 1211 adjacent to the proximal end. At this time, the first corrugated member 1211 The distal apex is suspended in the air as a free end, and the distal end of the transition section 122 is connected to the proximal apex of the first wave element 1211 adjacent to the distal end. It can be understood that, in other embodiments, the proximal end of the transition section 122 may also be connected to the distal apex of the first wave element 1211 adjacent to the proximal end; The distal apex of the first wave element 1211 is connected, and at this time, the proximal apex of the first wave element 1211 is suspended as a free end. It should be explained that the difference between the above two different design structures is that the transition section 122 between the two adjacent first pipe diameter sections 121 has been turned upside down (that is, along the direction from the proximal end to the distal end or the distal end to the proximal end), thereby changing the position and orientation of the free end point. Certainly, under the premise of considering the convenience of retracting the sheath of the stent 1 for thrombectomy, the preferred embodiment should be to set the free end point at the distal end of the first diameter section 121 .
为便于理解,本文将以图7示意的优选实施例进行展开说明,该实施例中,第一管径段121位于远端的第一波形件1211的近端顶点1211a为固定顶点,远端顶点1211b为悬空的自由端点。第一管径段121位于近端的第一波形件1211的近端顶点1211c和远端顶点1211d皆为固定顶点。也即是说,第一管径段121最远端形成自由端点。For ease of understanding, this paper will use the preferred embodiment shown in FIG. 7 for expansion and description. In this embodiment, the proximal apex 1211a of the first corrugated member 1211 at the distal end of the first pipe diameter section 121 is a fixed apex, and the distal apex 1211b is a floating free terminal. Both the proximal apex 1211c and the distal apex 1211d of the first corrugated member 1211 located at the proximal end of the first diameter section 121 are fixed apexes. That is to say, the most distal end of the first pipe diameter section 121 forms a free end point.
第二管径段125位于远端的第二波形件1251的近端顶点1251a为固定顶点,第二管径段125位于远端的第二波形件1251的远端顶点1251b为悬空的自由端点。第二管径段125位于近端的第二波形件1251的近端顶点1251c和远端顶点1251d皆为固定顶点。也即是说,第二管径段125的最远端形成自由端点。The proximal apex 1251a of the second wave piece 1251 located at the distal end of the second pipe diameter section 125 is a fixed apex, and the distal apex 1251b of the second pipe diameter section 125 located at the distal end of the second wave piece 1251 is a suspended free end point. Both the proximal apex 1251c and the distal apex 1251d of the second corrugated member 1251 at the proximal end of the second tube diameter section 125 are fixed apexes. That is to say, the most distal end of the second pipe diameter section 125 forms a free end point.
第一支撑杆123的近端和第二支撑杆124的近端与第一管径段121中位于远端的第一波形件1211的近端顶点1211a连接,第一支撑杆123的远端和第二支撑杆124的远端与相邻的第二管径段125中位于近端的第二波形件1251的近端顶点1251c连接。支撑臂126的近端与第二管径段125位于远端的第二波形件1251的近端顶点1251a连接,支撑臂126的远端与相邻第一管径段121中位于近端的第一 波形件1211的近端顶点1211c连接。The proximal end of the first support rod 123 and the proximal end of the second support rod 124 are connected with the proximal apex 1211a of the first wave piece 1211 located at the far end in the first pipe diameter section 121, and the distal end of the first support rod 123 and The distal end of the second support rod 124 is connected to the proximal apex 1251c of the second wave piece 1251 located at the proximal end in the adjacent second pipe diameter section 125 . The proximal end of the support arm 126 is connected to the proximal apex 1251a of the second wave piece 1251 located at the distal end of the second tube diameter section 125, and the distal end of the support arm 126 is connected to the proximal end of the adjacent first tube diameter section 121. The proximal vertices 1211c of a wave member 1211 are connected.
在一实施例中,继续参考图7,第一管径段121的远端自由端点1211b朝向两侧的固定顶点1211a延伸的部分用作第一抓捕单元121a,第一抓捕单元121a与第一支撑杆123、第二支撑杆124交替设置并彼此连接,第一抓捕单元121a可以为V字形、W字形、锯齿形或者U字形等结构,以提高对血栓的捕捉效率。图7示意了第一抓捕单元121a的数量为四个,第一支撑杆123和第二支撑杆124相对并位于相邻两个第一抓捕单元121a之间。In one embodiment, referring to FIG. 7 , the distal free end point 1211b of the first pipe diameter section 121 extends toward the fixed vertices 1211a on both sides as the first catch unit 121a, and the first catch unit 121a is connected to the second catch unit 121a. A support rod 123 and a second support rod 124 are alternately arranged and connected to each other, and the first capture unit 121a may be V-shaped, W-shaped, zigzag or U-shaped to improve the efficiency of capturing thrombus. Fig. 7 shows that the number of first capturing units 121a is four, and the first support rod 123 and the second support rod 124 are opposite and located between two adjacent first capturing units 121a.
第二管径段125的远端自由端点1251b朝向两侧的固定顶点1251a延伸的部分用作第二抓捕单元125a,第二抓捕单元125a与支撑臂126交替设置并彼此连接。第二抓捕单元125a可以为V字形、W字形、锯齿形或者U字形等结构,以提高对血栓的捕捉效率。图7示意了第二抓捕单元125a的数量为四个,第二抓捕单元125a与支撑臂126沿周向交替设置。The part of the distal free end point 1251b of the second diameter section 125 extending toward the fixed vertices 1251a on both sides is used as the second catch unit 125a, and the second catch unit 125a and the support arms 126 are alternately arranged and connected to each other. The second capturing unit 125a may be in a V-shaped, W-shaped, zigzag or U-shaped structure, so as to improve the efficiency of capturing thrombus. FIG. 7 shows that the number of the second catch units 125a is four, and the second catch units 125a and the support arms 126 are arranged alternately along the circumferential direction.
需要说明的是,第一抓捕单元121a与第一支撑杆123之间以及第一抓捕单元121a与第二支撑杆124之间形成第一收容空间121b。为增大第一收容空间121b,第一抓捕单元121a可沿径向向外或者向内延伸。第二抓捕单元125a与支撑臂126之间形成第二收容空间125b。为增大第二收容空间125b,第二抓捕单元125a沿径向向外或向内延伸。优选地,第一抓捕单元121a和第二抓捕单元125a均沿径向向外或者向内延伸。更优地,第一抓捕单元121a的弯曲方向与第一支撑杆123和第二支撑杆124的弯曲方向相反,第二抓捕单元125a的弯曲方向与支撑臂126的弯曲方向相反。如此,第一收容空间121b和第二收容空间125b的空间增大,从而能够为血栓提供了更多的容纳空间,以便血栓进入取栓支架1的内腔,进而进一步提高取栓支架1对血栓的抓捕效率。当取栓支架1处于自由状态(即膨胀状态)时,第一抓捕单元121a和第二抓捕单元125a插入至血栓中,或将血栓夹持在第一收容空间121b和第二收容空间125b内,从而提高了取栓支架1对血栓的锚固效果。由于第一抓捕单元121a和第二抓捕单元125a均匀地分布在第二支架本体12的周围,从而增强了取栓支架1的柔顺性,同时也提高了取栓支架1对血栓的抓捕效率。It should be noted that a first receiving space 121 b is formed between the first catching unit 121 a and the first support rod 123 and between the first catching unit 121 a and the second support rod 124 . In order to enlarge the first receiving space 121b, the first catch unit 121a may extend radially outward or inward. A second receiving space 125b is formed between the second catching unit 125a and the supporting arm 126 . In order to enlarge the second receiving space 125b, the second catch unit 125a extends radially outward or inward. Preferably, both the first catch unit 121a and the second catch unit 125a extend radially outward or inward. More preferably, the bending direction of the first catching unit 121 a is opposite to that of the first support bar 123 and the second support bar 124 , and the bending direction of the second catching unit 125 a is opposite to that of the supporting arm 126 . In this way, the spaces between the first storage space 121b and the second storage space 125b are increased, thereby providing more accommodation space for the thrombus, so that the thrombus can enter the inner cavity of the thrombus retrieval support 1, thereby further improving the thrombus retrieval support 1 against thrombus. capture efficiency. When the thrombus retrieval stent 1 is in a free state (that is, in an expanded state), the first capture unit 121a and the second capture unit 125a are inserted into the thrombus, or clamp the thrombus in the first storage space 121b and the second storage space 125b Therefore, the anchoring effect of the thrombus retrieval support 1 on the thrombus is improved. Since the first capture unit 121a and the second capture unit 125a are evenly distributed around the second stent body 12, the flexibility of the thrombus retrieval stent 1 is enhanced, and the thrombus capture by the thrombus retrieval stent 1 is also improved. efficiency.
需要说明的是,在一实施例中,本文以上所述的取栓支架1还具有如下特性,即:取栓支架1具有半自由状态和自由状态。其中,所述半自由状态(即部分释放状态)是指取栓支架1至少部分结构处于未完全膨胀的工作状态,例如,在取栓支架1植入血管内的早期,第二支架本体12受血栓压迫的工作状态,或是取栓支架1的第二支架本体12受其它约束元件约束的工作状态。所述自由状态(即完全释放状态)是指取栓支架1的第二支架本体12处于完全膨胀的工作状态,或是处于完全自由(即不受其它约束元件约束)的工作状态。It should be noted that, in an embodiment, the thrombectomy support 1 described above also has the following characteristics, that is, the thrombectomy support 1 has a semi-free state and a free state. Wherein, the semi-free state (i.e. a partially released state) means that at least part of the structure of the thrombectomy stent 1 is in an incompletely expanded working state. The working state of thrombus compression, or the working state of the second stent body 12 of the thrombectomy stent 1 being constrained by other constraining elements. The free state (that is, the fully released state) means that the second stent body 12 of the thrombectomy stent 1 is in a fully expanded working state, or in a completely free (that is, not constrained by other constraining elements) working state.
在半自由状态下(图未示意,可参考申请人于2020年5月30日在先向中国知识产权局提交的专利申请的附图及说明,该在先专利申请的申请号为202010482816.8),取栓支架1未完全膨胀,第二支架本体12的至少部分结构呈近似单层管状结构。在自由状态下,取栓支架1完全膨胀,第二支架本体12呈近似双层管状结构,第一管径段121的径向尺寸大于第二管径段125的径向尺寸。In a semi-free state (not shown in the figure, you can refer to the drawings and descriptions of the patent application submitted by the applicant to the China Intellectual Property Office on May 30, 2020, the application number of which is 202010482816.8), The thrombectomy stent 1 is not fully expanded, and at least part of the structure of the second stent body 12 is approximately a single-layer tubular structure. In the free state, the thrombectomy stent 1 is fully expanded, and the second stent body 12 has an approximately double-layer tubular structure, and the radial dimension of the first diameter section 121 is greater than that of the second diameter section 125 .
在由自由状态切换至半自由状态的过程中,第一管径段121远端的自由端点与其远端相邻的第二管径段125的近端顶点间的径向距离逐渐减小。第一管径段121近端的固定顶点与其近端相邻的第二 管径段125远端的自由端点之间的径向距离逐渐减小。从而保证了单层网状结构具有较小的网格空间。In the process of switching from the free state to the semi-free state, the radial distance between the free end point of the distal end of the first tube diameter section 121 and the proximal apex of the second tube diameter section 125 adjacent to its distal end gradually decreases. The radial distance between the fixed apex of the proximal end of the first pipe diameter section 121 and the free end point of the distal end of the second pipe diameter section 125 adjacent to its proximal end gradually decreases. Thereby ensuring that the single-layer network structure has a smaller grid space.
基于取栓支架1具有半自由和自由两种状态,使得取栓支架1在半自由状态时,第二支架本体12的至少部分结构呈近似单层管状结构,且单层网状结构上的网格空间较小,从而可以避免血栓全部进入取栓支架1的内腔所导致内腔的封堵问题,因此单层管状结构可以作为血流通道。此外,取栓支架1在半自由状态时,该单层管状结构保证了整个取栓支架1的径向支撑力,从而使得取栓支架1可以快速建立血流通道,以在血栓清除前就恢复阻塞血管的血液流动,进而在取栓的早期阶段实现血流通道的预通功能,以提高取栓手术的安全性。由于在自由状态时,第二支架本体12呈近似双层管状结构,大管径的第一管径段121具有较大的网格结构,且第一管径段121与第二管径段125之间有一定的空间,从而允许血栓全部进入取栓支架1的内腔,提高了取栓效率。进一步的,取栓支架1采用分段式设计,也即第一管径段121和第二管径段125依次间隔且均匀排布,从而能够提高取栓支架1柔顺性,并确保取栓支架1能够适应不同弯曲形态的血管,同时也能增强对血栓块的锚固效果,例如在血管内受到挤压时,取栓支架1能够承受较大的形变以顺应血管形态。Based on the fact that the thrombectomy bracket 1 has two states of semi-free and free, when the thrombectomy bracket 1 is in the semi-free state, at least part of the structure of the second bracket body 12 is an approximate single-layer tubular structure, and the mesh on the single-layer mesh structure The grid space is small, so as to avoid the blockage of the inner cavity caused by all the thrombus entering the inner cavity of the thrombectomy stent 1, so the single-layer tubular structure can be used as a blood flow channel. In addition, when the thrombectomy stent 1 is in a semi-free state, the single-layer tubular structure ensures the radial support force of the entire thrombus retrieval stent 1, so that the thrombus retrieval stent 1 can quickly establish a blood flow channel to recover before the thrombus is removed. Block the blood flow of the blood vessel, and then realize the pre-opening function of the blood flow channel in the early stage of thrombectomy, so as to improve the safety of the thrombectomy operation. Since the second bracket body 12 is in an approximately double-layer tubular structure in a free state, the first pipe diameter section 121 with a large pipe diameter has a larger grid structure, and the first pipe diameter section 121 and the second pipe diameter section 125 There is a certain space between them, so that all the thrombus can enter the inner cavity of the thrombus retrieval bracket 1, which improves the efficiency of thrombus retrieval. Further, the thrombectomy support 1 adopts a segmented design, that is, the first pipe diameter section 121 and the second pipe diameter section 125 are sequentially spaced and evenly arranged, so that the flexibility of the thrombectomy support 1 can be improved and the thrombectomy support can be ensured. 1. It can adapt to blood vessels with different curved shapes, and can also enhance the anchoring effect on thrombus. For example, when the blood vessel is squeezed, the thrombus retrieval stent 1 can withstand large deformation to conform to the shape of the blood vessel.
在本文中,将与取栓支架1的中轴线相平行的平面定义为参考平面。在所述自由状态下,第一管径段121在一参考平面的正投影与第二管径段125在该参考平面的正投影部分交叠。如此,保证取栓支架1在不同直径的血管内的径向支撑力,从而有效防止取栓支架1在通过血管时发生塌陷,进而提高了血栓抓捕效率,以及在取栓过程中减小了取栓支架1对血管壁造成的损伤。在所述半自由状态下,第一管径段121在参考平面的正投影与第二管径段125在该参考平面的正投影不交叠。如此,取栓支架1处于部分释放状态下,第二支架本体12的整体结构或部分结构呈具有近似闭环结构的单层管状结构,单层管状结构金属覆盖更加密集,从而减少血栓进入单层管状结构的内部,使得取栓支架1在部分释放状态下具有供血流流动的空腔,提高了取栓手术的安全性。Herein, a plane parallel to the central axis of the thrombectomy support 1 is defined as a reference plane. In the free state, the orthographic projection of the first pipe diameter section 121 on a reference plane partly overlaps the orthographic projection of the second pipe diameter section 125 on the reference plane. In this way, the radial support force of the thrombus retrieval stent 1 in blood vessels of different diameters is ensured, thereby effectively preventing the thrombus retrieval stent 1 from collapsing when passing through the blood vessel, thereby improving the thrombus capture efficiency, and reducing the thrombus retrieval process. The damage caused by the thrombectomy stent 1 to the vessel wall. In the semi-free state, the orthographic projection of the first pipe diameter section 121 on the reference plane does not overlap with the orthographic projection of the second pipe diameter section 125 on the reference plane. In this way, when the thrombectomy stent 1 is in a partially released state, the overall structure or partial structure of the second stent body 12 is a single-layer tubular structure with an approximate closed-loop structure, and the metal coverage of the single-layer tubular structure is denser, thereby reducing thrombus entering the single-layer tubular structure. Inside the structure, the thrombectomy support 1 has a cavity for blood flow in a partially released state, which improves the safety of the thrombectomy operation.
在一实施例中,第二支架本体12在所述半自由状态时,第一支撑杆123、第二支撑杆124、以及支撑臂126皆呈直杆状结构。第二支架本体12在所述自由状态时,第一支撑杆123、第二支撑杆124、以及支撑臂126均呈弯曲状结构,且相对第二支架本体12向内弯曲或向外弯曲。如此,在所述自由状态下,由于第一支撑杆123和第二支撑杆124均呈弯曲状结构,从而可以减少对血栓的切割,且可以为血栓提供更多的容纳空间,以便血栓进入取栓支架1的内腔,进而提高了取栓支架1对血栓的抓捕效率。在所述半自由状态下,由于第一支撑杆123和第二支撑杆124均呈直杆状结构,且第一支撑杆123和第二支撑杆124大致平行第二支架本体12的轴向方向,从而使得整个取栓支架1能压缩形成外径沿轴向近似相同的具有闭环结构的单层管状结构,以实现血流通道的预通功能,减少手术过程中的脑损伤。In one embodiment, when the second support body 12 is in the semi-free state, the first support rod 123 , the second support rod 124 , and the support arm 126 are all straight rod-shaped structures. When the second support body 12 is in the free state, the first support rod 123 , the second support rod 124 , and the support arm 126 all have a curved structure, and are bent inward or outward relative to the second support body 12 . In this way, in the free state, since the first support rod 123 and the second support rod 124 are in a curved structure, the cutting of the thrombus can be reduced, and more accommodation space can be provided for the thrombus, so that the thrombus can enter and take out. The lumen of the thrombus stent 1 improves the capture efficiency of the thrombus by the thrombus retrieval stent 1 . In the semi-free state, since the first support rod 123 and the second support rod 124 are straight rod-shaped structures, and the first support rod 123 and the second support rod 124 are approximately parallel to the axial direction of the second support body 12 , so that the entire thrombectomy stent 1 can be compressed to form a single-layer tubular structure with approximately the same outer diameter in the axial direction and a closed-loop structure, so as to realize the pre-passing function of the blood flow channel and reduce brain damage during the operation.
参考图1和图2,取栓支架1还包括连接于第二支架本体12远端的第三支架本体13,第三支架本体13与第二支架本体12平滑过渡连接,且第三支架本体13与第二支架本体12的内部相互连通,以使取栓支架1的内部形成连续的通道。第三支架本体13能够进一步捕捉由第二支架本体12脱落或溢出的血栓,使由第二支架本体12脱落或溢出的血栓能够进入第三支架本体13的内部通道,从而有效防止血栓从取栓支架1内脱离,提高抓捕效能力。1 and 2, the thrombectomy bracket 1 also includes a third bracket body 13 connected to the distal end of the second bracket body 12, the third bracket body 13 is connected to the second bracket body 12 in a smooth transition, and the third bracket body 13 It communicates with the inside of the second bracket body 12 so that the inside of the thrombus retrieval bracket 1 forms a continuous channel. The third stent body 13 can further catch the thrombus that falls off or overflows from the second stent body 12, so that the thrombus that falls off or overflows from the second stent body 12 can enter the internal channel of the third stent body 13, thereby effectively preventing the thrombus from being removed from the thrombus. Break away from the inside of the bracket 1 to improve the catching efficiency.
第三支架本体13包括捕捉段131和延伸段132,捕捉段131的近端通过多个支撑臂126连接于第二支架本体12远端的第二管径段122,捕捉段131的远端连接于延伸段132的近端。其中,捕捉段131具有多个沿周向设置的第三网孔103,延伸段132具有多个沿周向设置的第四网孔104。第三网孔103的面积大于第一网孔101的面积、第二网孔102的面积和第四网孔104的面积。另外,延伸段132的远端可以相互汇聚,以使取栓支架1的远端封闭,形成取栓支架1的远端封闭端,以阻止捕获到取栓支架1内的血栓由封闭的远端逃逸。可以理解,在其它实施例中,延伸段132的远端也可以不相互汇聚,例如延伸段132的远端开口,又或者,该延伸段132的远端可以与捕获网连接。The third stent body 13 includes a catch section 131 and an extension section 132. The proximal end of the catch section 131 is connected to the second pipe diameter section 122 at the far end of the second stent body 12 through a plurality of support arms 126, and the distal end of the catch section 131 is connected to at the proximal end of the extension section 132. Wherein, the capturing section 131 has a plurality of third mesh holes 103 arranged along the circumferential direction, and the extension section 132 has a plurality of fourth mesh holes 104 arranged along the circumferential direction. The area of the third mesh 103 is larger than the area of the first mesh 101 , the area of the second mesh 102 and the area of the fourth mesh 104 . In addition, the distal ends of the extension sections 132 can converge with each other, so that the distal end of the thrombectomy stent 1 is closed to form the distal closed end of the thrombus retrieval stent 1, so as to prevent the thrombus captured in the thrombus retrieval stent 1 from being released from the closed distal end. escape. It can be understood that in other embodiments, the distal ends of the extension section 132 may not converge with each other, for example, the distal end of the extension section 132 is open, or, the distal end of the extension section 132 may be connected with a capture net.
需要说明的是,上述第一支架本体11、第二支架本体12及第三支架本体13可以为一体成型结构,从而方便了取栓支架1的制作,且保证了第一支架本体11、第二支架本体12及第三支架本体13彼此连接的稳定性和可靠性。在一些实施例中,取栓支架1可以通过激光切割镍钛管材料加工而成,从而有效防止血栓从取栓支架1内的脱离。在取栓支架1的远端设置第三支架本体13,且第三支架本体13的捕捉段131沿周向设置有多个第三网孔103,第三支架本体13的延伸段132沿周向设置有多个第四网孔104,第三网孔103的面积大于第四网孔104的面积,从而由取栓支架1逃逸至远端的大体积血栓和小体积血栓均可以从第三网孔103进入到第三支架本体13的内部的通道,并且由延伸段132收容由第三支架本体13所捕获到的血栓,从而进一步提高了取栓支架1的捕捉效率。It should be noted that the above-mentioned first bracket body 11, second bracket body 12 and third bracket body 13 can be integrally formed, thereby facilitating the manufacture of the bolt-removing bracket 1, and ensuring that the first bracket body 11, the second bracket body The stability and reliability of the mutual connection of the bracket body 12 and the third bracket body 13 . In some embodiments, the thrombus retrieval stent 1 can be processed by laser cutting a nickel-titanium tube material, so as to effectively prevent the thrombus from detaching from the thrombus retrieval stent 1 . The third bracket body 13 is arranged at the far end of the thrombus retrieval bracket 1, and the catch section 131 of the third bracket body 13 is provided with a plurality of third meshes 103 along the circumferential direction, and the extension section 132 of the third bracket body 13 is arranged along the circumferential direction. A plurality of fourth meshes 104 are provided, and the area of the third mesh 103 is larger than the area of the fourth mesh 104, so that both the large-volume thrombus and the small-volume thrombus escaping from the thrombus retrieval support 1 to the distal end can pass through the third mesh. The hole 103 enters the channel inside the third stent body 13 , and the extension section 132 accommodates the thrombus captured by the third stent body 13 , thereby further improving the capture efficiency of the thrombus retrieval stent 1 .
延伸段132包括多个第三波形件1321,多个第三波形件1321沿取栓支架1的轴向首尾顺次相接,相邻的两个第三波形件1321形成周向排布的多个所述的第四网孔104。本实施例中第四网孔104的形状为菱形结构,当然在其它实施例中,第四网孔104也可以为其它形状的网孔结构,例如三角形、矩形或者多边形等等,本申请不作限定。另外需要说明的是,在由近端至远端的方向上,延伸段132中的第三波形件1321的径向尺寸逐渐减小,这使得轴向相邻的两个第三波形件1321围合成的第四网孔104的尺寸逐渐变小。如此,减小取栓支架1推送过程中的阻力,并方便取栓支架1回收至微导管中。The extension section 132 includes a plurality of third wave parts 1321, and the plurality of third wave parts 1321 are sequentially connected end to end along the axial direction of the thrombus retrieval bracket 1, and two adjacent third wave parts 1321 form a plurality of circumferentially arranged. the fourth mesh 104. In this embodiment, the shape of the fourth mesh 104 is a rhombus structure. Of course, in other embodiments, the fourth mesh 104 can also be a mesh structure of other shapes, such as triangles, rectangles or polygons, etc., which are not limited in this application. . In addition, it should be noted that, in the direction from the proximal end to the distal end, the radial dimension of the third wave piece 1321 in the extension section 132 gradually decreases, which makes two axially adjacent third wave pieces 1321 surround The resulting fourth mesh 104 gradually becomes smaller in size. In this way, the resistance during the pushing process of the thrombectomy support 1 is reduced, and the recovery of the thrombectomy support 1 into the microcatheter is facilitated.
每一第三波形件1321包括多个波峰和波谷,波峰和波谷在周向上交替排布。第三波形件1321能够沿径向伸缩,使得各个第三波形件1321之间的相邻波峰之间以及相邻波谷之间可以相互靠近或远离。在自然膨胀时,第三波形件1321的直径变大,且波峰与波谷之间的轴向间隔变小,同时周向间隔变大。当取栓支架1到达病变部位的血栓处后,第三波形件1321自膨胀而张开,可撑开血栓,建立血流通道,实现预通功能;并通过第三波形件1321对血栓进行切割,被切割的血栓部分进入第三波形件1321内,被第四网孔104捕获。Each third wave element 1321 includes a plurality of crests and troughs, and the crests and troughs are arranged alternately in the circumferential direction. The third wave parts 1321 can expand and contract in the radial direction, so that adjacent wave crests and adjacent wave troughs between the third wave parts 1321 can approach or move away from each other. During natural expansion, the diameter of the third wave member 1321 becomes larger, and the axial interval between the crest and the trough becomes smaller, while the circumferential interval becomes larger. When the thrombus retrieval stent 1 reaches the thrombus in the lesion, the third corrugated part 1321 expands and opens to expand the thrombus, establish a blood flow channel, and realize the pre-passing function; and cut the thrombus through the third corrugated part 1321 , the cut thrombus partially enters the third wave member 1321 and is captured by the fourth mesh 104 .
具体地,捕捉段131包括多个加强部1311,所述多个加强部1311沿第三支架本体13的周向布置,且相邻的两个加强部1311之间形成第三网孔103。加强部1311和第三网孔103沿第三支架本体13的周向上交替排布。每一加强部1311包括形成第五网孔105的网格单元和设置在网格单元近端的骨架杆106,骨架杆106的近端与支撑臂126的远端连接。本实施例中,第三网孔103的面积大于第四网孔104的面积和第五网孔105的面积,以便于通过第三网孔103收集逃逸的血栓,并避免收集后的血栓由第四网孔104和第五网孔105逃逸。Specifically, the capturing section 131 includes a plurality of reinforcing parts 1311 arranged along the circumferential direction of the third support body 13 , and the third mesh 103 is formed between two adjacent reinforcing parts 1311 . The reinforcing parts 1311 and the third mesh holes 103 are alternately arranged along the circumferential direction of the third support body 13 . Each reinforcing part 1311 includes a grid unit forming the fifth mesh 105 and a skeleton rod 106 disposed at a proximal end of the grid unit, and the proximal end of the skeleton rod 106 is connected with the distal end of the support arm 126 . In this embodiment, the area of the third mesh 103 is larger than the area of the fourth mesh 104 and the area of the fifth mesh 105, so that the escaped thrombus can be collected through the third mesh 103, and the collected thrombus can be prevented from being released by the third mesh 103. The fourth mesh 104 and the fifth mesh 105 escape.
图1和图2示意了第三网孔103的数量和加强部1311的数量相对应,且第三网孔103和加强部 1311沿第三支架本体13的周向交替设置。本实施例中,捕捉段131包括正相对的两个第三网孔103和正相对的两个加强部1311,第三网孔103和加强部1311沿第三支架本体13的周向并排且交替设置。如此,不仅提高了第三网孔103对第二支架本体13未有效抓捕的血栓(例如有机化血栓、钙化血栓等硬血栓及体积较大的血栓)的捕捉性能,同时还确保了第三支架本体13的径向支撑力,并且避免了第三支架本体13过度形变而降低了捕捉段131的贴壁性,即防止第三支架本体13的捕捉段131发生坍塌。Figures 1 and 2 illustrate that the number of third mesh holes 103 corresponds to the number of reinforcing parts 1311, and the third mesh holes 103 and reinforcing parts 1311 are arranged alternately along the circumference of the third bracket body 13. In this embodiment, the capturing section 131 includes two opposite third mesh holes 103 and two opposite reinforcing parts 1311, the third mesh holes 103 and the reinforcing parts 1311 are arranged side by side and alternately along the circumferential direction of the third bracket body 13 . In this way, not only the ability of the third mesh 103 to capture the thrombus that is not effectively captured by the second stent body 13 (such as hard thrombus such as organic thrombus, calcified thrombus, and thrombus with larger volume) is improved, but also the third mesh hole 103 is ensured. The radial support force of the stent body 13 avoids excessive deformation of the third stent body 13 and reduces the adherence of the capture section 131 , that is, prevents the capture section 131 of the third stent body 13 from collapsing.
在一实施例中,骨架杆106构造成Y字形结构。为便于理解,参考图1和图2,骨架杆106包括第一加强杆1061和第二加强杆1062,第二加强杆1062连接于第一加强杆1061和形成第五网孔105的网格单元之间。其中,第一加强杆1061构造成V字形结构,V字形结构包括两近端顶点和一远端顶点,两近端顶点与支撑臂126的远端连接,远端顶点与第二加强杆1062的远端连接。In one embodiment, the skeleton rod 106 is configured in a Y-shaped configuration. For ease of understanding, with reference to Fig. 1 and Fig. 2, the skeleton rod 106 includes a first reinforcing rod 1061 and a second reinforcing rod 1062, and the second reinforcing rod 1062 is connected to the first reinforcing rod 1061 and the grid unit forming the fifth mesh 105 between. Wherein, the first reinforcing bar 1061 is configured into a V-shaped structure, and the V-shaped structure includes two near-end vertices and a far-end apex, the two near-end vertices are connected with the distal end of the support arm 126, and the far-end vertices are connected with the second reinforcing bar 1062. remote connection.
在一实施例中,捕捉段131在每一第三网孔103的近端形成有第三抓捕单元103a,第三抓捕单元103a的近端连接于支撑臂126的远端,第三抓捕单元103a的远端构造为自由端并在周向上位于相邻两支撑臂126之间,或者可以理解为位于相邻两骨架杆106之间。第三抓捕单元103a可以为V字形、W字形、锯齿形或者U字形等结构,以提高对血栓的捕捉效率。图1和图2示意了第三抓捕单元103a为V字形且数量为两个,两个第三抓捕单元103a正对设置。当取栓支架1处于自由状态(即膨胀状态)时,第三抓捕单元103a的轴向长度不超过第三网孔103的轴向长度的一半,如此,可减小对第三网孔103的覆盖,确保第三网孔103为逃逸血栓提供足够大的入口,从而提高对血栓的捕捉效率。In one embodiment, the capturing section 131 is formed with a third capturing unit 103a at the proximal end of each third mesh hole 103, the proximal end of the third capturing unit 103a is connected to the distal end of the support arm 126, the third capturing unit The distal end of the catcher unit 103 a is configured as a free end and is located between two adjacent support arms 126 in the circumferential direction, or can be understood as located between two adjacent skeleton rods 106 . The third capture unit 103a may be V-shaped, W-shaped, zigzag or U-shaped, etc., to improve the efficiency of capturing thrombus. Fig. 1 and Fig. 2 illustrate that the third capturing unit 103a is V-shaped and there are two in number, and the two third capturing units 103a are arranged facing each other. When the thrombectomy support 1 was in a free state (i.e. in an expanded state), the axial length of the third catching unit 103a was no more than half of the axial length of the third mesh 103, so that the impact on the third mesh 103 could be reduced. The coverage ensures that the third mesh 103 provides a sufficiently large entrance for the escaping thrombus, thereby improving the capture efficiency of the thrombus.
需要说明的是,第三抓捕单元103a沿径向向外或向内延伸,以在第三抓捕单元103a与加强部1311之间形成增大的第三收容空间103b。如此,第三收容空间103b的空间增大,能够为血栓提供更多的容纳空间,以便血栓进入取栓支架1的内腔,进而进一步提高取栓支架1对血栓的抓捕效率。当取栓支架1处于自由状态(即膨胀状态)时,第三抓捕单元103a插入至血栓中,或将血栓夹持在第三收容空间103b内,从而提高了取栓支架1对血栓的锚固效果。由于第三抓捕单元103a均匀地分布在第三支架本体13周向,从而增强了取栓支架1的柔顺性,同时也提高了取栓支架1对血栓的抓捕效率。It should be noted that the third catching unit 103a extends radially outward or inward to form an enlarged third receiving space 103b between the third catching unit 103a and the reinforcing portion 1311 . In this way, the third accommodation space 103b is enlarged, which can provide more accommodation space for the thrombus, so that the thrombus can enter the inner cavity of the thrombus retrieval stent 1 , thereby further improving the capture efficiency of the thrombus retrieval stent 1 . When the thrombus retrieval stent 1 is in a free state (that is, in an expanded state), the third capture unit 103a is inserted into the thrombus, or clamps the thrombus in the third accommodation space 103b, thereby improving the anchoring of the thrombus by the thrombus retrieval stent 1 Effect. Since the third capturing units 103a are evenly distributed in the circumferential direction of the third bracket body 13, the flexibility of the thrombus retrieval bracket 1 is enhanced, and the thrombus capture efficiency of the thrombus retrieval bracket 1 is also improved.
参考图8所示,图8示意了图1中牵引导丝2与取栓支架1的近端连接的局部示意图。在一实施例中,取栓装置还包括近端连接头14,近端连接头14可以为两端开口且中空的管状结构,取栓支架1的第一支架本体11的近端汇聚至近端连接头14的远端,例如取栓支架1的第一支架本体11的近端可粘接固定于近端连接头14的远端。Referring to FIG. 8 , FIG. 8 illustrates a partial schematic diagram of the connection between the traction guide wire 2 and the proximal end of the thrombectomy bracket 1 in FIG. 1 . In one embodiment, the thrombectomy device further includes a proximal connector 14. The proximal connector 14 may be a hollow tubular structure with both ends open. The proximal end of the first bracket body 11 of the thrombectomy bracket 1 converges to the proximal The distal end of the connecting head 14 , for example, the proximal end of the first stent body 11 of the thrombectomy stent 1 can be adhesively fixed to the distal end of the proximal connecting head 14 .
近端连接头14的外表面开设有与近端连接头14的内部连通的第一开窗141,在牵引导丝2的远端穿过近端连接头14的近端并对位于第一开窗141时,牵引导丝2的远端外露于第一开窗141的部分能够在一固定头21处固定,固定头21可以为一焊接头或者粘接头。例如,为了将牵引导丝2的远端固定于取栓支架1的近端,可以先将牵引导丝2的远端穿过近端连接头14的近端,并使该牵引导丝2的远端外露于第一开窗141,此时可以对牵引导丝2外露于第一开窗141的部分进行焊接固定或者粘接固定,非常方便使用者操作。The outer surface of the proximal connector 14 is provided with a first opening 141 communicating with the interior of the proximal connector 14, and the distal end of the traction guide wire 2 passes through the proximal end of the proximal connector 14 and is opposite to the first opening. When the window 141 is opened, the part of the distal end of the pulling guide wire 2 exposed to the first fenestration 141 can be fixed at a fixing head 21, and the fixing head 21 can be a welding joint or an adhesive joint. For example, in order to fix the distal end of the traction guide wire 2 to the proximal end of the thrombectomy bracket 1, the distal end of the traction guide wire 2 can be passed through the proximal end of the proximal connector 14, and the traction guide wire 2 can be The distal end is exposed to the first fenestration 141. At this time, the part of the traction guide wire 2 exposed to the first fenestration 141 can be fixed by welding or bonding, which is very convenient for the user to operate.
需要说明的是,牵引导丝2远端的固定头21可以为图8所示意的球形接头,也可以是图9所示意 的T形接头,还可以是其它任意形状的接头,固定头21的形状在本申请中仅作为示例,并非穷举,因此不能理解为对本申请的限定。另外,参考图9和图10,第一开窗141的表现形态除了可以为图8所示意的在近端连接头14的外表面设置的开孔外,还可以为图9和图10所示意的缺口。无论第一开窗141的表现形态为开孔还是缺口,固定头21的径向尺寸小于近端连接头14的外径,基于此,可以避免固定头21在径向上超出近端连接头14,从而避免固定头21径向的凸出而增加回撤取栓支架1的阻力。It should be noted that the fixed head 21 at the distal end of the traction guide wire 2 can be a spherical joint as shown in FIG. 8 , or a T-shaped joint as shown in FIG. The shapes in this application are only examples, not exhaustive, and thus should not be construed as limiting the application. In addition, with reference to Fig. 9 and Fig. 10, the expression form of the first window 141 can be as shown in Fig. 9 and Fig. the gap. Regardless of the appearance of the first opening 141 as a hole or a gap, the radial dimension of the fixing head 21 is smaller than the outer diameter of the proximal connecting head 14. Based on this, it can be avoided that the fixing head 21 exceeds the proximal connecting head 14 in the radial direction. Therefore, the radial protrusion of the fixing head 21 is avoided to increase the resistance of retracting the thrombus retrieval support 1 .
参考图11,取栓装置还包括远端连接头15和显影导丝16,取栓支架1的第三支架本体13的远端汇聚至远端连接头15的近端,远端连接头15的外表面开设有与远端连接头15内部连通的第二开窗151。在显影导丝16的近端穿过远端连接头15的远端并对位于第二开窗151时,显影导丝16的近端外露于第二开窗的部分能够在安装头(图未示)处固定。此处的安装头可以理解为固化后的焊剂或者粘接剂,其可通过第二开窗151进入远端连接头15内部以与显影导丝16近端连接。Referring to FIG. 11 , the thrombectomy device also includes a distal connector 15 and a developing guide wire 16. The distal end of the third bracket body 13 of the thrombus retrieval bracket 1 converges to the proximal end of the distal connector 15, and the distal connector 15 A second window 151 communicating with the interior of the distal connecting head 15 is opened on the outer surface. When the proximal end of the development guide wire 16 passes through the distal end of the distal connector 15 and is positioned at the second window 151, the part of the proximal end of the development guide wire 16 exposed to the second window can be mounted on the installation head (not shown in the figure). shown) is fixed. The installation head here can be understood as cured flux or adhesive, which can enter the interior of the distal connection head 15 through the second window 151 to be connected with the proximal end of the development guide wire 16 .
需要说明的是,显影导丝16可以由记忆合金、铂钨合金或银锡合金加工而成。显影导丝16的设置,可以方便在仪器检测下通过显影导丝16的位置指示取栓支架1的第三支架本体13的远端的位置。显影导丝16大体沿取栓支架1轴向延伸,且显影导丝16的远端朝向取栓支架1内侧弯曲,例如呈J形,朝向取栓支架1内侧弯曲的显影导丝16可以有效降低显影导丝16自由端对血管的损伤。It should be noted that the developing guide wire 16 can be processed by memory alloy, platinum-tungsten alloy or silver-tin alloy. The setting of the developing guide wire 16 can conveniently indicate the position of the distal end of the third support body 13 of the embolectomy support 1 through the position of the developing guide wire 16 under instrument detection. The development guide wire 16 generally extends axially along the thrombectomy support 1, and the distal end of the development guide wire 16 is bent toward the inner side of the thrombectomy support 1, such as in a J shape. The damage of the free end of the guide wire 16 to the blood vessel is visualized.
参阅图12至图20,本发明还提供了一种取栓系统,其包括上述任一实施例的取栓装置100、推杆200、装载鞘300、微导管400和鞘管500。Referring to FIG. 12 to FIG. 20 , the present invention also provides a thrombectomy system, which includes the thrombectomy device 100 , push rod 200 , loading sheath 300 , microcatheter 400 and sheath tube 500 in any one of the above embodiments.
其中,推杆200与取栓支架1的近端相连,以用于推拉取栓支架1。装载鞘300用于收容在压缩状态下的取栓装置100。微导管400与装载鞘300相连通,微导管400内的管腔用于输送取栓装置100。鞘管500套设在微导管400外,鞘管500随着微导管400伸入血管内,并输送至病变部位的血栓的近端处,用于在回撤时,收容取栓支架1及其捕获的血栓。Wherein, the push rod 200 is connected with the proximal end of the thrombectomy support 1 for pushing and pulling the thrombus retrieval support 1 . The loading sheath 300 is used to accommodate the thrombectomy device 100 in a compressed state. The microcatheter 400 is in communication with the loading sheath 300 , and the lumen in the microcatheter 400 is used to deliver the thrombectomy device 100 . The sheath tube 500 is sleeved outside the microcatheter 400, and the sheath tube 500 extends into the blood vessel along with the microcatheter 400, and is transported to the proximal end of the thrombus in the lesion, and is used to accommodate the thrombus retrieval stent 1 and its Captured thrombus.
为便于理解,以下将结合图12至图20具体介绍取栓系统的操作使用。For ease of understanding, the operation and use of the thrombectomy system will be described in detail below in conjunction with FIGS. 12 to 20 .
请首先参阅图12至图14,本发明实施例的取栓装置100在使用前,以坍缩的形态装载于取栓系统中,该取栓系统包括上述的推杆200、装载鞘300、微导管400和鞘管500(参考图19)。Please refer to Fig. 12 to Fig. 14 firstly, the thrombectomy device 100 according to the embodiment of the present invention is loaded in the thrombectomy system in a collapsed state before use, and the thrombectomy system includes the above-mentioned push rod 200, loading sheath 300, microcatheter 400 and sheath 500 (refer to FIG. 19 ).
取栓支架1的近端通过第一支架本体11汇聚连接在近端连接头14上,空心的近端连接头14与推杆200相连通,推杆200为可径向弯曲的柔性管,牵引导丝2的近端依次穿出近端连接头14和推杆200。The proximal end of the thrombus retrieval bracket 1 is converged and connected to the proximal connector 14 through the first bracket body 11, and the hollow proximal connector 14 communicates with the push rod 200. The push rod 200 is a flexible tube that can bend radially. The proximal end of the guide wire 2 passes through the proximal connector 14 and the push rod 200 in sequence.
装载鞘300套设在推杆200外部,在使用前,将取栓支架1预先压缩导入装载鞘300内,如图12所示状态。The loading sheath 300 is sleeved on the outside of the push rod 200. Before use, the thrombectomy support 1 is pre-compressed and introduced into the loading sheath 300, as shown in FIG. 12 .
在需要进行取栓操作时,可通过接头件600(如鲁尔接头)将装载鞘300与微导管400相连接,如图13所示状态。进而通过推杆200推动近端连接头14和取栓支架1顺利进入微导管400管腔内,如图14所示状态。之后通过微导管400将取栓装置100输送至血栓所在的血管病变位置(血管病变位置可根据造影或其他诊断手段所确定),以便取栓支架1在血管病变位置释放并可通过推杆200实现推拉动作精准对位,从而使取栓支架1在压缩状态和释放状态之间进行转换。When thrombectomy is required, the loading sheath 300 can be connected to the microcatheter 400 through a connector 600 (such as a Luer connector), as shown in FIG. 13 . Then push the proximal connector 14 and the thrombectomy support 1 into the lumen of the microcatheter 400 smoothly through the push rod 200 , as shown in FIG. 14 . Afterwards, the thrombectomy device 100 is delivered to the vascular lesion position where the thrombus is located through the microcatheter 400 (the vascular lesion position can be determined according to angiography or other diagnostic means), so that the thrombectomy stent 1 can be released at the vascular lesion position and can be realized by the push rod 200. The push-pull action is accurately aligned, so that the thrombectomy support 1 can be switched between the compressed state and the released state.
鞘管500套设在微导管400外,并随着微导管400伸入血管内,且输送至病变部位的血栓的近端处,用于在回撤时,收容取栓支架1和捕获的血栓。The sheath tube 500 is sleeved outside the microcatheter 400, and is extended into the blood vessel along with the microcatheter 400, and delivered to the proximal end of the thrombus in the lesion, for receiving the thrombus retrieval stent 1 and the captured thrombus during withdrawal .
请结合参阅图15至图20所示,在介入取栓支架中,参考图15,利用穿孔导丝700预先穿过病变部位的血栓01,以在血栓中建立血管通路。参考图16,将微导管400和鞘管500顺着穿孔导丝700输送至病变部位的血栓01处,并使微导管400越过血栓01,随后固定微导管400,回撤穿孔导丝700。参考图17所示,通过推杆200将取栓装置100推送至血栓01所在位置,血栓01所在位置可借助于造影或其他诊断手段确定。参考图18所示,停止前推推杆200,固定推杆200并回撤微导管400,使取栓支架1在微导管400的远端释放,根据显影导丝16显影点在影像上的位置,确保血栓01位于取栓装置100有效区域内,并使取栓支架1完全释放在血管内,以使血栓01嵌入到取栓支架1内。Please refer to FIG. 15 to FIG. 20 . In the interventional thrombectomy stent, referring to FIG. 15 , the perforated guide wire 700 is used to pass through the thrombus 01 in the lesion in advance to establish a vascular access in the thrombus. Referring to FIG. 16 , the microcatheter 400 and the sheath 500 are delivered along the perforated guide wire 700 to the thrombus 01 in the lesion, and the microcatheter 400 is passed over the thrombus 01 , then the microcatheter 400 is fixed, and the perforated guide wire 700 is withdrawn. Referring to FIG. 17 , the thrombus retrieval device 100 is pushed to the position of the thrombus 01 through the push rod 200 , and the position of the thrombus 01 can be determined by means of imaging or other diagnostic means. Referring to FIG. 18 , stop pushing the push rod 200 forward, fix the push rod 200 and retract the microcatheter 400, so that the thrombectomy support 1 is released at the distal end of the microcatheter 400, according to the position of the development point on the imaging guide wire 16 , to ensure that the thrombus 01 is located in the effective area of the thrombectomy device 100 , and to completely release the thrombus retrieval stent 1 in the blood vessel, so that the thrombus 01 is embedded in the thrombus retrieval stent 1 .
参考图19和图20,同时拉动牵引导丝2和推杆200,以将取栓支架1带着捕获的血栓01回撤并撤回至鞘管500内,完成对血栓的取出。Referring to Fig. 19 and Fig. 20, pull the traction guide wire 2 and the push rod 200 at the same time, so as to withdraw the thrombus retrieval holder 1 with the thrombus 01 captured into the sheath tube 500, and complete the removal of the thrombus.
参考图19和图20,在牵引导丝2拉动取栓支架1回撤的过程中,第一管径段121能够适应不同直径的血管,保证与血管的贴壁性能,在此基础上,轴向相邻的两个第一管径段121在径向收缩的区域呈夹角设置,即轴向相邻的两个第一管径段121在径向收缩的部位不一样,径向收缩的区域发生了错位,可以理解径向未发生收缩的区域也发生错位,这意味着取栓支架1在血管内捕获血栓01后受到牵拉时,取栓支架1能够通过第一管径段121未发生形变的区域在不同方向维持外形,提高径向支撑力,取栓支架1整体将不会发生明显的塌陷,不同方向能够维持外形的取栓支架1增加了血栓01逃逸的阻力,并还能使取栓支架1在不同弯曲程度的血管中依然保持与血栓01的接触面积,从而可以有效抓捕不同方位的血栓01,降低血栓01逃逸的风险。Referring to Fig. 19 and Fig. 20, during the retraction process of pulling the thrombectomy stent 1 by the traction guide wire 2, the first tube diameter section 121 can adapt to blood vessels of different diameters and ensure the wall-attachment performance with the blood vessels. On this basis, the shaft The two adjacent first pipe diameter sections 121 are arranged at an included angle in the region of radial contraction, that is, the two axially adjacent first pipe diameter sections 121 are not the same at the radial contraction part, and the radial contraction part The area is misaligned, and it can be understood that the area that does not shrink in the radial direction also has misalignment, which means that when the thrombus retrieval stent 1 is pulled after capturing the thrombus 01 in the blood vessel, the thrombus retrieval stent 1 can pass through the first diameter section 121 without The deformed area maintains its shape in different directions and improves the radial support force. The whole thrombectomy stent 1 will not collapse significantly. The thrombus retrieval stent 1 that can maintain its shape in different directions increases the resistance of the thrombus 01 to escape, and can The thrombus retrieval stent 1 still maintains the contact area with the thrombus 01 in blood vessels with different degrees of curvature, so that the thrombus 01 in different directions can be effectively captured and the risk of thrombus 01 escaping can be reduced.
虽然已参照几个典型实施方式描述了本发明,但应当理解,所用的术语是说明和示例性、而非限制性的术语。由于本发明能够以多种形式具体实施而不脱离发明的精神或实质,所以应当理解,上述实施方式不限于任何前述的细节,而应在随附权利要求所限定的精神和范围内广泛地解释,因此落入权利要求或其等效范围内的全部变化和改型都应为随附权利要求所涵盖。While this invention has been described with reference to a few exemplary embodiments, it is understood that the terms which have been used are words of description and illustration, rather than of limitation. Since the present invention can be embodied in many forms without departing from the spirit or essence of the invention, it should be understood that the above-described embodiments are not limited to any of the foregoing details, but should be construed broadly within the spirit and scope of the appended claims. , all changes and modifications falling within the scope of the claims or their equivalents shall be covered by the appended claims.

Claims (31)

  1. 一种取栓支架,其特征在于,包括:A thrombectomy bracket, characterized in that it comprises:
    第一支架本体;the first bracket body;
    第二支架本体,设置在所述第一支架本体的远端;所述第二支架本体包括多个第一管径段和多个过渡段;所述第一管径段和所述过渡段沿所述取栓支架的轴向交替排列,相邻的两个所述第一管径段通过所述过渡段连接;在所述取栓支架的近端和远端沿轴向相对远离时,所述第一管径段的至少部分区域径向收缩,且轴向相邻的两个所述第一管径段径向收缩的区域呈角度设置。The second stent body is arranged at the distal end of the first stent body; the second stent body includes a plurality of first pipe diameter sections and a plurality of transition sections; the first pipe diameter sections and the transition sections are along the The thrombectomy brackets are arranged alternately in the axial direction, and the two adjacent first diameter sections are connected by the transition section; when the proximal end and the distal end of the thrombectomy bracket are relatively far apart in the axial direction, the At least a partial area of the first pipe diameter section is radially contracted, and the radially contracted areas of two axially adjacent first pipe diameter sections are arranged at an angle.
  2. 根据权利要求1所述的取栓支架,其特征在于,轴向相邻的两个所述第一管径段径向收缩的区域在周向相对错位的角度为90度。The thrombectomy bracket according to claim 1, characterized in that, the relative misalignment angle in the circumferential direction of the radially contracted areas of the two axially adjacent first tube diameter sections is 90 degrees.
  3. 根据权利要求2所述的取栓支架,其特征在于,所述第一管径段具有径向相对设置的第一区域和第二区域、以及径向相对设置的第三区域和第四区域,所述第一区域、所述第三区域、所述第二区域以及所述第四区域沿所述第二支架本体的周向依次排布;The thrombectomy bracket according to claim 2, wherein the first pipe diameter section has a first area and a second area arranged radially opposite, and a third area and a fourth area arranged radially opposite, The first area, the third area, the second area and the fourth area are sequentially arranged along the circumferential direction of the second stent body;
    在所述取栓支架的近端和远端沿轴向相对远离时,所述第一区域和所述第二区域径向收缩,所述第三区域和所述第四区域径向尺寸不变;或者所述第三区域和所述第四区域的径向收缩尺寸小于所述第一区域的径向收缩尺寸和/或所述第二区域的径向收缩尺寸。When the proximal end and the distal end of the thrombectomy stent move away from each other in the axial direction, the first region and the second region shrink radially, and the radial dimensions of the third region and the fourth region remain unchanged ; or the radially contracted size of the third area and the fourth area is smaller than the radially contracted size of the first area and/or the radially contracted size of the second area.
  4. 根据权利要求2或3所述的取栓支架,其特征在于,在所述第一管径段径向收缩时,所述第一管径段径向收缩区域的径向尺寸在周向呈中间小两端大。The thrombectomy bracket according to claim 2 or 3, characterized in that, when the first pipe diameter section radially shrinks, the radial size of the radial contraction area of the first pipe diameter section is in the middle of the circumferential direction. Small and big at both ends.
  5. 根据权利要求1至4任一项所述的取栓支架,其特征在于,轴向相邻的两个所述过渡段在周向相对错位,轴向相邻的两个所述第一管径段在周向上相对错位,且轴向相邻的两个所述过渡段周向相对错位的角度与轴向相邻的两个所述第一管径段周向错位的角度相等。The thrombectomy bracket according to any one of claims 1 to 4, characterized in that the two axially adjacent transition sections are displaced relative to each other in the circumferential direction, and the two axially adjacent first pipe diameters The segments are relatively displaced in the circumferential direction, and the circumferential relative displacement angle of the two axially adjacent transition segments is equal to the circumferential displacement angle of the two axially adjacent first pipe diameter segments.
  6. 根据权利要求5所述的取栓支架,其特征在于,所述过渡段包括沿所述第二支架本体的周向间隔设置的第一支撑杆和第二支撑杆,所述第一支撑杆和所述第二支撑杆设于相邻的两个所述第一管径段的相向的近端与远端之间。The thrombectomy bracket according to claim 5, wherein the transition section comprises a first support rod and a second support rod arranged at intervals along the circumference of the second bracket body, the first support rod and the second support rod The second support rod is arranged between the facing proximal and distal ends of two adjacent first pipe diameter sections.
  7. 根据权利要求6所述的取栓支架,其特征在于,所述第一支撑杆与所述第二支撑杆沿周向间隔180度;轴向相邻的两个所述过渡段周向错位90度。The thrombectomy bracket according to claim 6, characterized in that, the first support rod and the second support rod are spaced apart by 180 degrees in the circumferential direction; the two axially adjacent transition sections are circumferentially displaced by 90 Spend.
  8. 根据权利要求6或7所述的取栓支架,其特征在于,所述第一管径段包括多个第一波形件,所述多个第一波形件沿所述取栓支架的轴向首尾顺次相接,相邻的两个所述第一波形件形成周向排布的多个第一网孔。The thrombectomy support according to claim 6 or 7, wherein the first pipe diameter section comprises a plurality of first wave parts, and the first wave parts are along the axial direction of the thrombectomy support. Connecting in sequence, two adjacent first corrugated parts form a plurality of first meshes arranged in the circumferential direction.
  9. 根据权利要求8所述的取栓支架,其特征在于,所述第一支撑杆的近端和所述第二支撑杆的近端皆与近端相邻的所述第一管径段位于远端的第一波形件的顶点连接,所述第一支撑杆的远端和所述第二支撑杆的远端皆与远端相邻的所述第一管径段位于近端的第一波形件的顶点连接。The thrombectomy bracket according to claim 8, characterized in that, both the proximal end of the first support rod and the proximal end of the second support rod are located far from the first pipe diameter section adjacent to the proximal end. The apex of the first corrugated piece at the end is connected, the distal end of the first support rod and the distal end of the second support rod are both adjacent to the distal end of the first wave section at the proximal end. Vertex connections of pieces.
  10. 根据权利要求6或7所述的取栓支架,其特征在于,所述过渡段还包括第二管径段和多根支撑臂,所述多根支撑臂沿所述第二支架本体周向间隔排布,所述第二管径段的近端与所述第一支撑杆 的远端以及所述第二支撑杆的远端连接,所述第二管径段的远端通过所述多根支撑臂与相邻的所述第一管径段的近端连接;The thrombectomy bracket according to claim 6 or 7, wherein the transition section further comprises a second pipe diameter section and a plurality of support arms, and the plurality of support arms are spaced circumferentially along the second bracket body arrangement, the proximal end of the second pipe diameter section is connected to the distal end of the first support rod and the distal end of the second support rod, and the distal end of the second pipe diameter section passes through the plurality of The support arm is connected to the proximal end of the adjacent first pipe diameter section;
    所述取栓支架具有半自由状态和自由状态,在所述半自由状态下,所述取栓支架未完全膨胀,所述第二支架本体的至少部分结构呈大致单层管状结构;在所述自由状态下,所述取栓支架完全膨胀,所述第二支架本体呈大致双层管状结构,所述第一管径段的径向尺寸大于所述第二管径段的径向尺寸。The thrombectomy stent has a semi-free state and a free state. In the semi-free state, the thrombectomy stent is not fully expanded, and at least part of the second stent body has a substantially single-layer tubular structure; In a free state, the thrombectomy stent is fully expanded, the second stent body has a substantially double-layer tubular structure, and the radial dimension of the first diameter section is larger than the radial dimension of the second diameter section.
  11. 根据权利要求10所述的取栓支架,其特征在于,在所述自由状态下,所述第一管径段在参考平面的正投影与所述第二管径段在所述参考平面的正投影部分交叠;在所述半自由状态下,所述第一管径段在所述参考平面的正投影与所述第二管径段在所述参考平面的正投影不交叠;The thrombectomy bracket according to claim 10, wherein in the free state, the orthographic projection of the first pipe diameter section on the reference plane is the same as the orthographic projection of the second pipe diameter section on the reference plane The projections partially overlap; in the semi-free state, the orthographic projection of the first pipe diameter section on the reference plane does not overlap the orthographic projection of the second pipe diameter section on the reference plane;
    其中,所述参考平面为与所述取栓支架的中轴线相互平行的平面。Wherein, the reference plane is a plane parallel to the central axis of the thrombectomy bracket.
  12. 根据权利要求10或11所述的取栓支架,其特征在于,在所述半自由状态,所述第一支撑杆、所述第二支撑杆和所述支撑臂均呈直杆状结构;The thrombectomy bracket according to claim 10 or 11, wherein in the semi-free state, the first support rod, the second support rod and the support arm are all straight rod-shaped structures;
    在所述自由状态,所述第一支撑杆、所述第二支撑杆和所述支撑臂呈弯曲状结构,且沿径向向内弯曲或者向外弯曲。In the free state, the first support rod, the second support rod and the support arm are in a curved structure and are bent radially inward or outward.
  13. 根据权利要求10-12任一项所述的取栓支架,其特征在于,所述第一管径段包括多个第一波形件,所述多个第一波形件沿所述取栓支架的轴向首尾顺次相接,相邻的两个所述第一波形件形成周向排布的多个第一网孔;所述第二管径段包括多个第二波形件,所述多个第二波形件沿所述取栓支架的轴向首尾顺次相接,相邻的两个所述第二波形件形成周向排布的多个第二网孔。The thrombectomy bracket according to any one of claims 10-12, characterized in that, the first pipe diameter section comprises a plurality of first wave parts, and the plurality of first wave parts are along the side of the thrombectomy bracket. The axial end is connected in sequence, and two adjacent first corrugated parts form a plurality of first meshes arranged in the circumferential direction; the second pipe diameter section includes a plurality of second corrugated parts, and the plurality of corrugated parts Two second corrugated parts are connected end-to-end in sequence along the axial direction of the thrombectomy bracket, and two adjacent second corrugated parts form a plurality of second meshes arranged in the circumferential direction.
  14. 根据权利要求13所述的取栓支架,其特征在于,所述第二管径段位于近端的第二波形件在周向不连续,以形成周向不连续的多个所述第二网孔,并在所述第二管径段的近端形成相比所述第二网孔更大的网口。The thrombectomy bracket according to claim 13, characterized in that, the second corrugated part at the proximal end of the second pipe diameter section is discontinuous in the circumferential direction, so as to form a plurality of discontinuous second meshes in the circumferential direction. holes, and a mesh opening larger than that of the second mesh is formed at the proximal end of the second pipe diameter section.
  15. 根据权利要求13或14所述的取栓支架,其特征在于,所述第二管径段位于近端的第二波形件的轴向尺寸小于所述第二管径段位于远端的第二波形件的轴向尺寸,使相邻两个所述第二波形件围合形成的所述第二网孔的面积在轴向呈近端小远端大。The thrombectomy bracket according to claim 13 or 14, wherein the axial dimension of the second wave member at the proximal end of the second pipe diameter section is smaller than the second wave member at the distal end of the second pipe diameter section. The axial dimension of the corrugated member is such that the area of the second mesh formed by two adjacent second corrugated members is smaller at the proximal end and larger at the far end in the axial direction.
  16. 根据权利要求13-15任一项所述的取栓支架,其特征在于,所述第一支撑杆的近端和所述第二支撑杆的近端皆与近端相邻的所述第一管径段中位于远端的第一波形件的顶点连接,所述第一支撑杆的远端和所述第二支撑杆的远端皆与远端相邻的所述第二管径段中位于近端的第二波形件的顶点连接;The thrombectomy bracket according to any one of claims 13-15, characterized in that, both the proximal end of the first support rod and the proximal end of the second support rod are adjacent to the first The apex of the first wave element at the far end in the pipe diameter section is connected, and the distal end of the first support rod and the distal end of the second support rod are both connected to the second pipe diameter section adjacent to the distal end. the apex connection of the second wave member located at the proximal end;
    所述支撑臂近端与近端相邻的所述第二管径段中位于远端的第二波形件的顶点连接,所述支撑臂远端与远端相邻的所述第一管径段中位于近端的第一波形件的顶点连接。The proximal end of the support arm is connected to the apex of the second wave element located at the distal end in the second pipe diameter section adjacent to the proximal end, and the distal end of the support arm is connected to the first pipe diameter section adjacent to the distal end. The vertices of the proximally located first wave members in the segments are connected.
  17. 根据权利要求16所述的取栓支架,其特征在于,所述第一支撑杆的近端和所述第二支撑杆的近端与近端相邻的所述第一管径段中位于远端的第一波形件的近端顶点连接,所述第一支撑杆的远端和所述第二支撑杆的远端与远端相邻的所述第二管径段中位于近端的第二波形件的近端顶点连接;The thrombectomy bracket according to claim 16, characterized in that, the proximal end of the first support rod and the proximal end of the second support rod are located far away from the first pipe diameter section adjacent to the proximal end. The proximal apex of the first corrugated piece at the end is connected, the distal end of the first support rod and the distal end of the second support rod are connected with the second pipe diameter section adjacent to the distal end, which is located at the proximal end. The proximal vertices of the two wave components are connected;
    所述支撑臂的近端与近端相邻的所述第二管径段位于远端的第二波形件的近端顶点连接,所述支撑臂的远端与远端相邻的所述第一管径段位于近端的第一波形件的近端顶点连接。The proximal end of the support arm is connected to the proximal apex of the second wave member whose proximal end is adjacent to the second pipe diameter segment located at the distal end, and the distal end of the support arm is connected to the distal end adjacent to the first wave element. A pipe diameter segment is connected to the proximal apex of the first wave element at the proximal end.
  18. 根据权利要求17所述的取栓支架,其特征在于,所述第一管径段位于远端的第一波形件的近端顶点为固定顶点,远端顶点为自由端点;所述第一管径段位于近端的第一波形件的近端顶点和远端顶点皆为固定顶点;The thrombectomy bracket according to claim 17, wherein the proximal apex of the first corrugated part located at the distal end of the first pipe diameter section is a fixed apex, and the distal apex is a free end; the first tube Both the near-end apex and the far-end apex of the first corrugated member whose radial section is located at the proximal end are fixed apexes;
    所述第二管径段位于远端的第二波形件的近端顶点为固定顶点,所述第二管径段位于远端的第二波形件的远端顶点为自由端点;所述第二管径段位于近端的第二波形件的近端顶点和远端顶点皆为固定顶点。The proximal apex of the second corrugated part at the far end of the second pipe diameter section is a fixed apex, and the distal apex of the second corrugated part at the far end of the second pipe diameter section is a free end point; Both the proximal apex and the distal apex of the second corrugated member whose pipe diameter section is located at the proximal end are fixed apexes.
  19. 根据权利要求18所述的取栓支架,其特征在于,在由所述自由状态切换至所述半自由状态的过程中,所述第一管径段远端的自由端点与其远端相邻的所述第二管径段的近端顶点之间的径向距离逐渐减小;The thrombectomy bracket according to claim 18, characterized in that, in the process of switching from the free state to the semi-free state, the free end point of the distal end of the first pipe diameter section adjacent to the distal end The radial distance between the proximal vertices of the second pipe diameter section gradually decreases;
    所述第一管径段近端的固定顶点与其近端相邻的所述第二管径段远端的自由端点之间的径向距离逐渐减小。The radial distance between the fixed apex at the proximal end of the first pipe diameter section and the free end point at the distal end of the second pipe diameter section adjacent to its proximal end gradually decreases.
  20. 根据权利要求18或19所述的取栓支架,其特征在于,所述第一管径段的远端自由端点朝向两侧的固定顶点延伸的部分用作第一抓捕单元;所述第一抓捕单元与所述第一支撑杆、所述第二支撑杆交替设置并彼此连接;The thrombectomy bracket according to claim 18 or 19, characterized in that, the part of the distal free end point of the first pipe diameter section extending toward the fixed vertices on both sides is used as a first catching unit; The catching unit is arranged alternately with the first support rod and the second support rod and connected with each other;
    所述第二管径段的远端自由端点朝向两侧的固定顶点延伸的部分用作第二抓捕单元;所述第二抓捕单元与所述支撑臂交替设置并彼此连接。The part of the distal free end point of the second pipe diameter section extending toward the fixed vertices on both sides is used as a second catch unit; the second catch unit is arranged alternately with the support arms and connected to each other.
  21. 根据权利要求20所述的取栓支架,其特征在于,所述第一抓捕单元沿径向向外或者向内延伸,以增大在所述第一抓捕单元与所述第一支撑杆之间以及所述第一抓捕单元与所述第二支撑杆之间的第一收容空间;所述第二抓捕单元沿径向向外或者向内延伸,以增大在所述第二抓捕单元与所述支撑臂之间的第二收容空间。The thrombectomy bracket according to claim 20, wherein the first capture unit extends radially outward or inward to increase the distance between the first capture unit and the first support rod. The first accommodation space between the first catch unit and the second support rod; the second catch unit extends radially outward or inward to increase the The second accommodation space between the capture unit and the support arm.
  22. 根据权利要求13-21任一项所述的取栓支架,其特征在于,所述取栓支架还包括连接于所述第二支架本体远端的第三支架本体,所述第三支架本体与所述第二支架本体的内部相互连通,以使所述取栓支架的内部形成连续的通道;The thrombectomy bracket according to any one of claims 13-21, wherein the thrombus retrieval bracket further comprises a third bracket body connected to the distal end of the second bracket body, the third bracket body and The interior of the second bracket body communicates with each other, so that the interior of the thrombectomy bracket forms a continuous channel;
    所述第三支架本体包括捕捉段和延伸段,所述捕捉段的近端通过所述多个支撑臂连接于所述第二支架本体远端的所述第二管径段,所述捕捉段的远端连接于所述延伸段的近端;其中,所述捕捉段具有周向设置的第三网孔,所述第三网孔的面积大于所述第一网孔的面积和所述第二网孔的面积。The third stent body includes a capture section and an extension section, the proximal end of the capture section is connected to the second pipe diameter section at the distal end of the second stent body through the plurality of support arms, the capture section The distal end is connected to the proximal end of the extension section; wherein, the capture section has a third mesh hole arranged circumferentially, and the area of the third mesh hole is larger than the area of the first mesh hole and the first mesh hole. The area of the second mesh.
  23. 根据权利要求22所述的取栓支架,其特征在于,所述延伸段包括多个第三波形件,所述多个第三波形件沿所述取栓支架的轴向首尾顺次相接,相邻的两个所述第三波形件形成周向排布的多个第四网孔;所述延伸段远端相互汇聚,以使所述取栓支架的远端封闭,形成所述取栓支架的远端封闭端。The thrombectomy bracket according to claim 22, wherein the extension section comprises a plurality of third wave parts, and the plurality of third wave parts are connected end to end in sequence along the axial direction of the thrombectomy bracket, Two adjacent third wave parts form a plurality of fourth meshes arranged in the circumferential direction; the distal ends of the extension sections converge to each other, so that the distal ends of the thrombectomy bracket are closed to form the thrombectomy The distal closed end of the stent.
  24. 根据权利要求23所述的取栓支架,其特征在于,所述捕捉段包括多个加强部,所述多个加强部沿所述第三支架本体的周向布置,相邻的两个所述加强部之间形成所述第三网孔,所述加强部和所述第三网孔沿所述第三支架本体的周向上交替排布;每一所述加强部包括形成第五网孔的网格单元和设置在所述网格单元近端的骨架杆,所述骨架杆的近端与对应的所述支撑臂的远端连接;所述第三网孔的面积大于所述第四网孔的面积和所述第五网孔的面积。The thrombectomy bracket according to claim 23, wherein the capturing section includes a plurality of reinforcing parts arranged along the circumferential direction of the third bracket body, and two adjacent The third mesh holes are formed between the reinforcement parts, and the reinforcement parts and the third mesh holes are alternately arranged along the circumferential direction of the third bracket body; each reinforcement part includes a fifth mesh hole grid unit and a skeleton rod arranged at the proximal end of the grid unit, the proximal end of the skeleton rod is connected to the corresponding distal end of the support arm; the area of the third mesh is larger than that of the fourth mesh The area of the hole and the area of the fifth mesh.
  25. 根据权利要求22-24任一项所述的取栓支架,其特征在于,所述捕捉段在每一所述第三网孔的近端形成有第三抓捕单元,所述第三抓捕单元的近端连接于对应的所述支撑臂的远端;所述第三抓捕单元的远端构造为自由端并位于相邻两所述支撑臂之间。The thrombectomy bracket according to any one of claims 22-24, characterized in that, the capture section has a third capture unit formed at the proximal end of each third mesh, and the third capture unit The proximal end of the unit is connected to the distal end of the corresponding support arm; the distal end of the third catching unit is configured as a free end and is located between two adjacent support arms.
  26. 根据权利要求25所述的取栓支架,其特征在于,所述第三抓捕单元沿径向向外或向内延伸以增大所述第三抓捕单元与周向相邻的部分之间的第三收容空间。The thrombectomy bracket according to claim 25, wherein the third capturing unit extends radially outwards or inwards to increase the second distance between the third capturing unit and the adjacent portion in the circumferential direction. Three containment spaces.
  27. 一种取栓装置,其特征在于,包括如权利要求1至26中任意一项所述的取栓支架和与所述取栓支架相连接的牵引导丝;A thrombectomy device, characterized in that it comprises the thrombectomy bracket according to any one of claims 1 to 26 and a traction guide wire connected to the thrombectomy bracket;
    所述牵引导丝与所述取栓支架的近端相连,以用于推拉所述取栓支架。The traction guide wire is connected to the proximal end of the thrombectomy support for pushing and pulling the thrombectomy support.
  28. 根据权利要求27所述的取栓装置,其特征在于,所述取栓装置还包括近端连接头,所述取栓支架的近端汇聚至所述近端连接头的远端;所述近端连接头的外表面开设有与所述近端连接头内部连通的第一开窗;The thrombectomy device according to claim 27, wherein the thrombus retrieval device further comprises a proximal connector, the proximal end of the thrombus retrieval bracket converges to the distal end of the proximal connector; the proximal The outer surface of the terminal connector is provided with a first window communicating with the interior of the proximal connector;
    在所述牵引导丝的远端穿过所述近端连接头的近端并对位于所述第一开窗时,所述牵引导丝的远端外露于所述第一开窗的部分能够在固定头处固定。When the distal end of the traction guidewire passes through the proximal end of the proximal connector and is positioned against the first fenestration, the part of the distal end of the traction guidewire exposed to the first fenestration can be Fix at the fixed head.
  29. 根据权利要求27或28所述的取栓装置,其特征在于,所述取栓装置还包括远端连接头和显影导丝,所述取栓支架的远端汇聚至所述远端连接头的近端;所述远端连接头的外表面开设有与所述远端连接头内部连通的第二开窗;The thrombectomy device according to claim 27 or 28, characterized in that, the thrombus removal device further comprises a distal connector and a developing guide wire, and the distal end of the thrombus removal bracket converges to the distal connector. Proximity; the outer surface of the distal connector is provided with a second window communicating with the interior of the distal connector;
    在所述显影导丝的近端穿过所述远端连接头的远端并对位于所述第二开窗时,所述显影导丝的近端外露于所述第二开窗的部分能够在安装头处固定。When the proximal end of the developing guidewire passes through the distal end of the distal connector and is positioned against the second fenestration, the portion of the proximal end of the developing guidewire exposed to the second fenestration can be Fastened at the mounting head.
  30. 根据权利要求29所述的取栓装置,其特征在于,所述显影导丝沿所述取栓支架的轴向延伸,且所述显影导丝的远端朝向所述取栓支架内侧弯曲。The thrombectomy device according to claim 29, wherein the imaging guide wire extends along the axial direction of the thrombus retrieval bracket, and the distal end of the imaging guide wire is bent toward the inside of the thrombus retrieval bracket.
  31. 一种取栓系统,其特征在于,包括推杆、装载鞘、微导管,以及如权利要求27至30中任意一项所述的取栓装置;A thrombectomy system, characterized by comprising a push rod, a loading sheath, a microcatheter, and the thrombectomy device according to any one of claims 27 to 30;
    所述推杆与所述取栓支架的近端相连,以用于推拉所述取栓支架;The push rod is connected to the proximal end of the thrombectomy bracket for pushing and pulling the thrombectomy bracket;
    所述装载鞘用于收容在压缩状态下的所述取栓装置;The loading sheath is used to accommodate the thrombectomy device in a compressed state;
    所述微导管用于与所述装载鞘相连通,所述微导管内的管腔用于输送所述取栓装置。The microcatheter is used to communicate with the loading sheath, and the lumen in the microcatheter is used to deliver the thrombectomy device.
PCT/CN2023/071080 2022-01-10 2023-01-06 Thrombectomy stent, thrombectomy apparatus, and thrombectomy system WO2023131311A2 (en)

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