WO2020083302A1 - 颅内血栓取出装置 - Google Patents

颅内血栓取出装置 Download PDF

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Publication number
WO2020083302A1
WO2020083302A1 PCT/CN2019/112629 CN2019112629W WO2020083302A1 WO 2020083302 A1 WO2020083302 A1 WO 2020083302A1 CN 2019112629 W CN2019112629 W CN 2019112629W WO 2020083302 A1 WO2020083302 A1 WO 2020083302A1
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WO
WIPO (PCT)
Prior art keywords
thrombectomy device
tubular structure
intracranial
catching
claw
Prior art date
Application number
PCT/CN2019/112629
Other languages
English (en)
French (fr)
Inventor
向建平
周启蒙
朱灵珂
荆洪娟
Original Assignee
杭州亿科医疗器械有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 杭州亿科医疗器械有限公司 filed Critical 杭州亿科医疗器械有限公司
Priority to US17/287,994 priority Critical patent/US20210378692A1/en
Publication of WO2020083302A1 publication Critical patent/WO2020083302A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22034—Gripping instruments, e.g. forceps, for removing or smashing calculi for gripping the obstruction or the tissue part from inside
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop

Definitions

  • the invention belongs to the field of medical instruments, and in particular relates to an intracranial thrombectomy device for performing mechanical thrombectomy treatment.
  • the treatment of intracranial thrombosis is mainly drug thrombolysis and mechanical thrombolysis, but drug thrombolysis has the problems of low thrombolysis success rate and narrow time window (less than 4.5 hours).
  • the time of mechanical thrombolysis treatment The window can be extended to 8 hours and the success rate of thrombectomy is high. Therefore, mechanical thrombectomy has become the most important means of treating patients with acute ischemic stroke.
  • Thrombosis can be roughly divided into the following types:
  • White thrombus (pale thrombus) is mainly composed of many platelet trabeculae that are coral-like, and many neutrophils adhere to the surface, forming a white blood cell border layer, presumably due to the chemotactic effect of cellulose disintegration products
  • the platelet trabeculae form a network of cellulose due to the action of activated clotting factors, and the mesh contains a small amount of blood cells.
  • the naked eye is grayish white, with rough and rippled surface and hard texture, tightly connected to the blood vessel wall.
  • Red thrombus red thrombus
  • dark red to the naked eye fresh red thrombus is moist and has a certain elasticity
  • the old red thrombus becomes dry, fragile, loses its elasticity due to the absorption of water, and it is easy to fall off and cause embolism .
  • Mixed thrombus is a layered structure with alternating red and white stripes, or alternately grayish white and reddish brown.
  • Transparent thrombus hyaline thrombus
  • hyaline thrombus mainly composed of cellulose.
  • An intracranial thrombectomy device has a hollow tubular structure, and has a radially compressed loading state and a radially expanded release state.
  • the axial end of the tubular structure is used to connect the proximal end of the delivery instrument and the other end
  • a plurality of catching claws are also provided, one end of each catching claw is a root connected to the side wall of the tubular structure, and the other end is a tip extending to the axis of the tubular structure, and each catching The claw tilts from the proximal end to the distal end while extending.
  • each optional mode can be carried out separately for the above-mentioned overall plan
  • Combination can also be a combination of multiple optional ways.
  • the tip portion of each catching claw is freely suspended in the inner cavity of the tubular structure.
  • the remaining parts are freely suspended in the inner cavity of the tubular structure.
  • the catching claw and the tubular structure are integrally woven or integrally formed by cutting.
  • part or all of the catching claws as a whole have a curved structure, and the concave part of the bend faces the proximal end.
  • the catching claw includes one or multiple bifurcated rods; the multiple rods converge to one place at the tip of the catching claw, and the rods diverge from each other at the root of the catching claw and are connected to the tubular structure The corresponding position of the side wall.
  • the rod body is one piece, and in the released state, the angle between the line connecting the two ends of the rod body and the axis of the tubular structure is 10 degrees to 60 degrees.
  • the two rod bodies converge in a rounded structure at the tip of the catching claw.
  • the line between the two end points of each rod is used as the first reference line, and the angle between the two first reference lines corresponding to the two rods is 30 degrees to 60 degrees.
  • the line between the two end points of each rod is used as the second reference line.
  • the two second reference lines corresponding to the two rods determine a reference surface.
  • the angle between the axis of the tubular structure and the reference surface is 10 degrees to 60 degrees.
  • the line between the two end points of each rod is used as the second reference line
  • the two second reference lines corresponding to the two rods have The second reference line is a coplanar bisector, and the angle between the bisector and the axis of the tubular structure is 10 degrees to 60 degrees.
  • the line between the two end points of each rod is used as the second reference line, and the two second reference lines corresponding to the two rods determine a reference surface;
  • the projection of the axis of the tubular structure on the reference plane is a projection line
  • the angle between the axis of the tubular structure and the projection line is 10 degrees to 60 degrees.
  • the midpoint of the connecting line between the two rods at the root of the catching claw and the tip of the catching claw is the third reference line; the axis of the tubular structure and the first The angle between the three reference lines is 10 degrees to 60 degrees.
  • the collection claws are distributed in the axial direction of the tubular structure in one group or multiple groups at intervals.
  • the collection claws in the same group include at least two and are sequentially arranged in the circumferential direction of the tubular structure.
  • the tips in the same set of catching claws have a tendency to hug each other.
  • two adjacent catching claws are arranged at the same position or in a misaligned position in the axial direction of the tubular structure.
  • the tubular structure includes a plurality of grid cells.
  • the grid cells include at least a first cell and a second cell.
  • the grid area of a single second cell is 2-6 of the grid area of a single first cell. Times, the root of the catching claw is connected to the corresponding second unit.
  • the area of the first unit is 5-10 mm 2
  • the area of the second unit is 20-30 mm 2 .
  • At least two adjacent first units are openly connected to form a corresponding second unit.
  • first units adjacent to each other are openly connected to form a corresponding second unit.
  • the catching claw is in the connected second unit.
  • the root of the catching claw is located at a proximal end portion in the second unit where the tip of the catching claw extends toward the distal end in the second unit where it is located.
  • the tip of the catching claw extends to the distal part in the second unit.
  • each second unit is not adjacent to each other or at least two second units are adjacent.
  • the intracranial thrombectomy device is provided with a development point at least at least one of the proximal end, the distal end, and the axial central portion.
  • the proximal end of the tubular structure has a plurality of connecting rods that are gradually gathered for connection with the delivery instrument, and a proximal developing point is provided at the gathering place of the plurality of connecting rods.
  • the distal end of the net cover structure gathers, and a distal developing point is provided at the gathering part.
  • a central developing point is provided on the side wall or the catch claw of the tubular structure.
  • the tip of part or all of the catching claws is provided with a developing point.
  • the developing point on the catching claw is circular or straight.
  • all the developing points on each catching claw are arranged along the axis of the tubular structure to form the axis of the developing mark.
  • the net cover structure is an umbrella-shaped structure, and the umbrella-shaped structure includes a plurality of radiation-distributed rods; the tubular structure includes a plurality of grid cells, and the proximal end of each rod is connected to the tubular structure.
  • the consecutive parts are the vertices of the mesh cells or the connection parts of two adjacent mesh cells.
  • the invention further improves the effect of removing the plug by providing a catch claw with an appropriate extension direction and extension length directly inside the plug.
  • FIG. 1 is a schematic structural diagram of an intracranial thrombectomy device in an embodiment
  • FIG. 2 is a schematic diagram of the loading state of the intracranial thrombectomy device in FIG. 1;
  • Figure 3 is an expanded view of the intracranial thrombectomy device in Figure 1;
  • FIG. 4 is a schematic structural diagram of an intracranial thrombectomy device in another embodiment
  • FIG. 5 is a partial schematic view of the intracranial thrombectomy device in FIG. 4;
  • 6a is an expanded view of the intracranial thrombectomy device in FIG. 4;
  • 6b is a schematic diagram of the bending tendency of the catching claw in another embodiment
  • 6c is a schematic diagram of the bending tendency of the catching claw in another embodiment
  • 7 to 9 are schematic views of the mesh structure of the intracranial thrombectomy device in another embodiment at different angles;
  • 10 to 11 are different angle schematic views of the mesh structure of the intracranial thrombectomy device in another embodiment
  • 12 and 13a are schematic views of partial development of an intracranial thrombectomy device in another embodiment
  • FIG. 13b is a schematic diagram of the development of the intracranial thrombectomy device in FIG. 13a after bending;
  • 14 to 18 are schematic diagrams of the working process of capturing an ordinary thrombus by the intracranial thrombectomy device in another embodiment
  • FIG. 19 is a schematic diagram of an intracranial thrombus extraction device capturing a larger thrombus with a complicated structure in another embodiment
  • 20 is a schematic diagram of an intracranial thrombectomy device capturing a fragile and shedding thrombus in another embodiment
  • 21 is a schematic structural diagram of an intracranial thrombectomy device in another embodiment
  • 22 to 26 are expanded views of the intracranial thrombectomy device in different embodiments
  • FIG. 27 is an expanded view of an intracranial thrombus extraction device in another embodiment.
  • a component or component
  • it can be directly connected to another component or there can also be a centered component.
  • a component is considered to be “set on” another component, it may be set directly on another component or there may be a centered component at the same time.
  • an intracranial thrombectomy device in this embodiment has a hollow tubular structure 1 as a whole.
  • the intracranial thrombectomy device itself can be laser-engraved from a metal tube, such as a nickel-titanium tube, after heat-setting. In other embodiments, it may be woven from nickel titanium wire.
  • the tubular structure 1 of the intracranial thrombectomy device of this embodiment has a loaded state of radial compression and a released state of radial expansion.
  • the tubular structure 1 has a small outer diameter in radial compression, which can be As the delivery sheath is traversed in the blood vessel to the site of the lesion, and then the delivery sheath is withdrawn, the tubular structure 1 is radially expanded into a released state after being exposed to the blood vessel.
  • the axial end of the tubular structure 1 is a proximal end for connecting a delivery device (the delivery device is, for example, a delivery wire), for example, the right end in FIG.
  • the part 3 is connected to the delivery wire, and can pass through the body and realize relative movement with the delivery sheath.
  • the other end of the tubular structure 1 is the distal end closed by the mesh cover structure 2, for example, the left end in FIG. 1, the mesh cover structure 2 is generally umbrella-shaped, diverging from the distal end to the proximal end and docking with the tubular structure 1, which is convenient Capture smaller volumes of thrombus.
  • proximal and distal ends mentioned in this manual have the same meaning in the overall direction, that is, in use, the distal end is the end adjacent to the lesion or thrombus site, and the proximal end is the end away from the lesion or thrombus site. End control of intracranial thrombectomy device.
  • the tubular structure 1 is also provided with a plurality of catching claws 4, one end of each catching claw 4 is a root 42 connected to the side wall of the tubular structure 1, and the other end is a tip 41 extending to the axis of the tubular structure 1, and each catching The claw 4 is inclined from the proximal end to the distal end while extending.
  • FIG. 1 shows the general direction in which the catching claws 4 extend.
  • the tip 41 of the catching claws 4 extends toward the axis of the tubular structure 1, and is arranged obliquely with respect to the axis as a whole, that is, the same catching In the claw 4, the tip 41 is closer to the distal end relative to the root 42.
  • This inclination method is more conducive to loading the tubular structure 1 and the collection claw 4, and the tube structure 1 and the collection claw 4 enter the delivery sheath during reprinting Tube, the catch claw 4 will gradually straighten, without turning over to the outside of the delivery sheath.
  • the tubular structure 1 includes a plurality of grid units, has good radial support force, and compliance, and has a strong combination of the collection claw 4 and the distal mesh cover structure 2
  • the development point may be a metal material such as platinum-tungsten alloy, platinum-iridium alloy, or tantalum alloy, but it is not limited to this.
  • Intracranial thrombectomy device and can provide good radiopacity.
  • the proximal portion of the connecting portion 3 may be provided with a proximal development point 5
  • the distal portion of the mesh structure 2 may be provided with a distal development point 6
  • the central portion of the claw 4 may be provided with a central development position Point 7.
  • each catching claw 4 In the released state of the tubular structure 1, the tip portion of each catching claw 4 is freely suspended in the inner cavity of the tubular structure 1. In a preferred embodiment, in the released state, each catching claw 4 except for the root 42 has the rest All are freely suspended in the inner cavity of the tubular structure 1.
  • the root 42 of the catching claw 4 is connected and fixed to the border of the adjacent cell, while the remaining parts up to the tip 41 are suspended in the cell where they are.
  • each catch The claw 4 protrudes toward the axis of the tubular structure 1 and is not bound by other components, that is, suspended in the lumen of the tubular structure 1, which is more convenient for adapting and anchoring into different shapes of thrombus into the lumen of the tubular structure 1.
  • the trapping claws 4 and the tubular structure 1 may be formed by integral weaving or integral cutting.
  • part or all of the catching claws 4 in the released state, have a curved structure as a whole, and the concave part of the bend faces toward the proximal end. That is, the catching claw 4 gradually extends from the root to the tip while approaching the axis of the tubular structure in a curved manner while extending to the distal end; the curved concave surface toward the proximal end should be understood to be roughly oriented, that is, the curved shape is relative to the distal end Arc-shaped or similar to arc-shaped, the closer to the tip, the faster the trend toward the axis of the tubular structure.
  • Part or all or the collecting claws as a whole have a curved structure with the above characteristics. It should be understood that at least a part of the collecting claws have a curved structure. Of course, all the collecting claws may have the curved structure with the above characteristics.
  • the curved structure should be understood as the overall shape of the catching claw, that is, it does not extend along a straight line or in a certain plane, but on a curved surface or a slightly more complicated Extend in space.
  • each collection claw in a released state, it is rod-shaped and extends along straight lines. In another embodiment, in the released state, each catching claw extends in its own plane.
  • the catching claw 4 includes a plurality of rods in a bifurcated structure; the plurality of rods converge to one place at the tip 41 of the catching claw 4, and each rod body is at the root 42 of the catching claw 4
  • the sides diverge from each other and connect to the corresponding positions of the side walls of the tubular structure.
  • the angle between the line connecting the two ends of the rod body and the axis of the tubular structure is 10 degrees to 60 degrees.
  • the rod body itself it may be a straight rod or adopt the above-mentioned curved structure.
  • All of the catching claws can be made of straight rods; or all of the above-mentioned curved structures; or part of the straight rods can be made of the above-mentioned curved structures.
  • rod bodies 43 there are two rod bodies, namely a rod body 43 and a rod body 44 that converge at the tip 41 of the catching claw 4.
  • the rod body 43 Converges with the rod 44 in a rounded structure.
  • the connecting line serves as the first reference line
  • the angle between the two first reference lines corresponding to the two rods is 30 degrees to 60 degrees.
  • the angle between the two first reference lines affects the tendency of the two rods to move closer to each other. The greater the angle, the more obvious the tendency to move closer to each other.
  • the appropriate angle between the two first reference lines also has a certain effect on the trapping effect of the thrombus.
  • This embodiment Provides a preferred range, which is more conducive to improving the thrombus trapping effect.
  • the main difference is that in the expanded view, the number of cells arranged in the width direction is small, and the number of catching claws 4 arranged in the width direction is three, surrounded by The tubular structure 1 has a smaller diameter behind it.
  • the number of the catching claws 4 arranged in the width direction of the expanded view is four, and the tubular structure 1 has a larger diameter after being enclosed.
  • the catch claw 4 also adopts a curved structure as a whole in the released state, that is, it extends from the root to the tip while approaching the axis of the tubular structure in a curved manner while extending distally; the curved concave surface faces the proximal end and bends
  • the shape is arc-shaped or similar to arc-shaped, and the closer to the tip, the faster the trend toward the axis of the tubular structure.
  • each catching claw 4 includes two rod bodies, which are a rod body 45 and a rod body 46, respectively.
  • the connecting line between the two end points of each rod body serves as a second reference line.
  • the angle between the bisector 47 and the axis L of the tubular structure 1 is 10 degrees to 60 degrees. It is further preferably 30 degrees to 60 degrees.
  • the angle between the bisector 47 and the axis L of the tubular structure 1 determines the tendency of the catch claw 4 to bend and bend.
  • the appropriate trend also has a certain effect on the trapping effect of thrombus.
  • This embodiment provides a preferred range, more Helps to improve the effect of thrombus capture.
  • each catching claw 4 includes two rod bodies, namely a rod body 45 and a rod body 46.
  • the connecting line between the two end points of each rod body serves as the second The reference line
  • the two second reference lines corresponding to the two rods determine a reference surface M; the angle between the axis L of the tubular structure and the reference surface is 10 degrees to 60 degrees.
  • the projection of the axis L of the tubular structure on the reference plane M is the projection line L '; the angle between the axis L and the projection line L' is 10 degrees to 60 degrees.
  • the angle between the axis L and the projection line L ⁇ determines the tendency of the catch claw 4 to bend and bend.
  • the appropriate trend also has a certain effect on the trapping effect of the thrombus.
  • the preferred range is provided in this embodiment, which is more conducive to improving the thrombus. Catching effect.
  • each catching claw 4 includes two rod bodies, namely a rod body 45 and a rod body 46, respectively.
  • the two rod bodies are at the midpoint of the line at the root of the catching claw
  • the connection line between P and the tip O of the catching claw is the third reference line OP; the angle between the axis L of the tubular structure and the third reference line OP is 10 degrees to 60 degrees.
  • the angle between the axis L and the third reference line OP determines the tendency of the catch claw 4 to bend and bend.
  • the appropriate trend also has a certain effect on the trapping effect of the thrombus.
  • the preferred range is provided in this embodiment, which is more conducive to improvement Thrombosis trapping effect.
  • the plurality of catching claws 4 form a three-dimensional space into which the thrombus can be embedded.
  • Adjacent rods form a dense grid unit on the radial cross-section of the tubular structure 1, which can effectively intercept the shedding of thrombus.
  • the collection claws are distributed in the axial direction of the tubular structure in one group or multiple groups at intervals.
  • each dashed box can be regarded as a group of collection claws.
  • Fig. 6 there are two groups of catch claws distributed as a whole.
  • At least two catching claws in the same group are arranged in sequence in the circumferential direction of the tubular structure.
  • FIG. 3 there are four catching claws in the same group, and in FIG. 6, there are three catching claws.
  • two adjacent catching claws are located in the axial direction of the tubular structure. Same or misaligned arrangement.
  • the tips in the same set of catching claws tend to hug each other, which can effectively intercept the thrombus and the hollow tubular structure 1 to form a three-dimensional space in which the thrombus can be embedded, greatly improving the firmness of the thrombus fixation.
  • the tubular structure 1 includes a plurality of grid cells, for example, as can be seen in FIG. 3, the grid cells include at least the first cell 12 and the second cell 11, and the grid area of a single second cell 11 is a single
  • the mesh area of the first unit 12 is 2-6 times, for example, 4 times, and the root 42 of the catch claw is connected to the corresponding second unit.
  • Each grid unit preferably adopts a closed-loop structure with strong radial support.
  • a second unit 11 with a larger grid area is provided, so that the tubular structure 1 as a whole has better flexibility;
  • each capturing claw includes two rod bodies, namely a rod body 43 and a rod body 44, the proximal end of the rod body 44 Connected to the vertex of the second unit 11, the rod 43 is the same.
  • the catching claws are located in the second unit 11 with a large mesh area, and the two complement each other, making it easy to catch the thrombus with a complicated structure and not easy to fall off.
  • the shape of the grid cell itself, it may be a quadrilateral or a hexagon, but it is not limited to this.
  • two closed grid units with different areas are used to form a hollow tubular structure 1.
  • the smaller first unit 12 provides a higher radial support force, while the larger second unit 11 easily captures the larger size.
  • the area of the first unit 12 is 5-10 mm 2 and the area of the second unit 11 is about 20-30 mm 2 .
  • first unit 12 and the second unit 11 may be formed in such a manner that at least two adjacent first units 12 are open to communicate to form a corresponding second unit 11; for example, as shown in FIGS. 3 and 6 Four first units adjacent to each other are openly connected to form a corresponding second unit.
  • the catching claw 4 in the loading state, is located in the connected second unit 11, the root 42 of the catching claw 4 is located at the proximal end of the second unit 11 where the catching claw 4
  • the tip 41 extends toward the distal end in the second unit 11 where it is located.
  • the tip 41 of the catching claw 4 extends to the distal part of the second unit 11 where it is, that is, the axial direction of the second unit 11 as much as possible.
  • each second unit is not adjacent to each other or at least two second units are adjacent.
  • the second units corresponding to the same set of catching claws are sequentially adjacent in the circumferential direction.
  • the mesh cover structure has a structural center located at the distal side of the intracranial thrombectomy device, and the radiation center diverges from the structural center toward the proximal side into an umbrella-shaped structure.
  • the open end of the structure is docked with the distal end of the tubular structure.
  • the mesh cover structure can prevent the thrombus from escaping or escaping, and effectively avoid the occurrence of secondary vascular embolism.
  • the center of the structure is at the axis of the tubular structure, which can make the umbrella structure more symmetrical and easy to load.
  • the tubular structure is distributed with a number of grid cells near the distal end.
  • the first unit 13 and the first unit 14 can be seen.
  • the umbrella structure includes a plurality of rods radiating from the distal end to the proximal end, and the mesh structure includes six rods. For example, the rod 21 and the rod 22 in the figure.
  • connection part between the proximal end of each rod part and the tubular structure is the apex of the grid unit or the connection part between two adjacent grid units.
  • the rod portion 21 is connected to the adjacent parts of the first unit 13 and the first unit 14.
  • the development point can be set at the distal end of the mesh structure or the tubular structure.
  • the development point 61 is set at the apex part of the distal end of the first unit.
  • the difference is that the net cover structure includes 12 rods, and the structure is denser.
  • the tubular structure is distributed with several grid cells near the distal end.
  • the first cell 15 and the first cell 16 can be seen.
  • the rod 23 in the figure is connected to the apex of the first cell 15, and the rod 24 is connected to the first cell. 15 and the adjacent part of the first unit 16.
  • the mesh structure is composed of multiple radiating rods or connected by extension lines of smaller grid cells.
  • the number of rods is 4 ⁇ 12.
  • the clamp between the rod and the axis of the tubular structure The angle is 15 ⁇ 45 °, forming a distal grid unit of appropriate size, which can prevent the thrombus from falling off and escaping.
  • the denser the mesh cover structure can prevent the thrombus from falling off and escaping.
  • the number of rods and the angle to the axis of the tubular structure have a certain effect on the degree of compaction.
  • the transportability of the intracranial thrombectomy device As well as compactness, it is easy to capture fragile thrombi, such as red thrombus.
  • the development point may be a metal material such as platinum-tungsten alloy, platinum-iridium alloy, or tantalum alloy, but it is not limited to this.
  • Intracranial thrombectomy device and can provide good radiopacity.
  • the connecting portion 3 includes a plurality of connecting rods that are gradually gathered for connection with the delivery instrument, and a proximal developing point 5 is provided at the gathering position of the plurality of connecting rods. 5 Mainly welded to the connection point of the intracranial thrombectomy device and the delivery guide wire through the imaging ring and the coil.
  • the distal portion of the mesh cover structure 2 is gathered together, and a distal developing point 6 is provided at the gathering portion.
  • the distal developing point 6 is in the form of a spring coil, and the rod portion of the mesh cover structure 2 is welded to be gathered together.
  • a central developing point may be provided at the tip 41 of some catching claws 4, such as the central developing point 71 and the central developing point 72 in FIG. 3.
  • the central developing point is ring-shaped or straight. It can be fixed to the tip of the corresponding catch claw by welding or riveting.
  • a proximal imaging point 5, a distal imaging point 6, and a central imaging point are provided at the same time, that is, multiple imaging points penetrate the entire intracranial thrombus extraction device, and the intracranial thrombus is removed through the above several imaging structures
  • the device has overall good radiopacity.
  • FIG. 12 the development effect is illustrated in the circle; FIG. 13a, the development effect is illustrated in the box.
  • the tubular structure 1 of the intracranial thrombectomy device is released.
  • the tip of the delivery sheath 8 may also be provided with a development point, combined with the proximal development point 5 and the distal development Point 6 and multiple central imaging points provide good overall visualization for the intracranial thrombectomy device.
  • all the development points located on each catching claw are arranged along the axis of the tubular structure to form the development marking axis L1.
  • the collection claws 4 are divided into three groups in the axial direction, and the tip of two collection claws in each group has development points, and all the development points on each collection claw are along the tubular shape.
  • the axis of the structure is arranged to form the axis of the development logo.
  • the central development point 73, the central development point 74, and the central development point 75 are taken as examples. They are generally arranged along the axial direction, and the overall position of the tubular structure 1 can be displayed and reflected. They are all located at the axis, so the radial edge position of the tubular structure and the relative position in the blood vessel can be indirectly known.
  • the imaging axis L1 can accurately reflect the axis position of the tubular structure.
  • the intracranial thrombectomy device captures a common thrombus.
  • the blood vessel 9 carries the thrombus 10
  • the delivery sheath 8 carries the intracranial thrombectomy device through the thrombus area, and then delivers
  • the sheath 8 is withdrawn, and the intracranial thrombectomy device is released, that is, the tubular structure 1 expands radially, the thrombus 10 gradually enters the lumen of the tubular structure 1, and is positioned under the action of the catching claw 4, and finally the intracranial thrombus is withdrawn
  • the thrombus 10 is removed by the cooperation of the catching claw 4 and the distal mesh cover structure, so that the blood flow is restored to normal.
  • the intracranial thrombectomy device when the intracranial thrombectomy device captures a complex structure with a long and large thrombus, when the tubular structure 1 expands radially, the larger thrombus 10 will enter through the second unit 11 with a larger mesh area The inside of the tubular structure 1 is simultaneously anchored by the catch claws 4 of the corresponding parts. If the mesh area is the first unit with a smaller size, the larger thrombus 11 is not easy to enter the inside of the tubular structure 1 and is difficult to take out. This embodiment can be seen The intracranial thrombectomy device can capture thrombus of complex structure.
  • the intracranial thrombectomy device captures a fragile and detachable thrombus in another embodiment
  • the fragile thrombus 10 will enter the inside of the tubular structure 1 and be surrounded by groups at the same time
  • the capturing claw 4 is anchored, and the distal end is matched with a dense mesh cover structure to capture and remove the thrombus. It can be seen that the intracranial thrombus extraction device in this embodiment can capture thrombus of a complex structure.
  • the distal end of the tubular structure 1 is also provided with a mesh cover structure 2, and the catching claw 4 on the tubular structure 1 is provided with a central developing point 7.
  • the remaining structural features can be combined or refer to the foregoing embodiments.
  • the shapes and distribution of the second unit 11 and the first unit 12 are slightly different, and the remaining structural features can be combined or referred to in the foregoing embodiments.
  • the catching claw 4 is in the form of a double rod, which is fixedly connected to the corresponding second unit 11.
  • each second unit 11 is provided with a catching claw 4. Only one of the second units 11 is shown in the figure. The catching claw 4 is shown in the figure, and the other second units 11 are the same.
  • the intracranial thrombectomy device is different from the previous embodiments mainly in that the catching claw 4 is a single rod, the shape and distribution of the second unit 11 and the first unit 12, and other structural features
  • the distal end of the catching claw 4 in the released state may gradually approach the axis of the tubular structure along a straight line, and preferably adopts a curved structure to gradually approach the axis of the tubular structure, for example, along an arc or arc-like path.

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Abstract

一种颅内血栓取出装置，具有镂空的管状结构(1)，且具有径向压缩的装载状态以及径向扩张的释放状态，管状结构(1)的轴向一端为用于连接输送器械的近端，另一端为通过网罩结构(2)封闭的远端，还设有多个捕集爪(4)，各捕集爪(4)一端为与管状结构(1)侧壁相连的根部(42)，另一端为延伸至管状结构(1)轴线(L)部位的尖端(41)，且各捕集爪(4)在延伸的同时由近端向远端倾斜。通过在血栓取出装置内设置合适延伸方向以及延伸长度的捕集爪(4)，进一步提高取栓效果。

Description

颅内血栓取出装置 技术领域
本发明属于医疗器械领域，尤其涉及用于实施机械取栓治疗的颅内血栓取出装置。
 背景技术
颅内血栓的治疗方法主要为药物溶栓和机械溶栓，但药物溶栓治疗存在溶栓成功率低和时间窗窄（小于4.5小时）的问题，相比之下，机械取栓治疗的时间窗可以延长至8小时且取栓成功率较高，因此机械取栓目前已经成为救治急性缺血性卒中患者最重要的一个手段。
血栓大致可分为以下几种类型：
1、白色血栓（pale thrombus）、主要由许多聚集呈珊瑚状的血小板小梁构成，其表面有许多中性白细胞粘附，形成白细胞边层，推测是由于纤维素崩解产物的趋化作用吸引而来。血小板小梁之间由于被激活的凝血因子的作用而形成网状的纤维素，其网眼内含有少量血细胞。肉眼观呈灰白色，表面粗糙有波纹，质硬，与血管壁紧连。
2、红色血栓（red thrombus），肉眼观呈暗红色，新鲜的红色血栓湿润，有一定的弹性，陈旧的红色血栓由于水分被吸收，变得干燥，易碎，失去弹性，并易于脱落造成栓塞。
3、混合血栓（mixed thrombus），呈红色与白色条纹层层相间，亦或是灰白色和红褐色交替的层状结构。
4、透明血栓（hyaline thrombus），主要由纤维素构成。
常规颅内血栓取出装置通常仅能捕获红色血栓和混合血栓，难以捕获复杂结构的血栓，尤其是结构较长、较大或较硬的白色血栓和透明血栓落。
 技术问题
基于此，有必要针对提高大块以及较硬血栓的取栓效果，提供一种改进的颅内血栓取出装置。
 技术解决方案
一种颅内血栓取出装置，具有镂空的管状结构，且具有径向压缩的装载状态以及径向扩张的释放状态，所述管状结构的轴向一端为用于连接输送器械的近端，另一端为通过网罩结构封闭的远端，还设有多个捕集爪，各捕集爪一端为与管状结构侧壁相连的根部，另一端为延伸至管状结构轴线部位的尖端，且各捕集爪在延伸的同时由近端向远端倾斜。
以下还提供了若干可选方式，但并不作为对上述总体方案的额外限定，仅仅是进一步的增补或优选，在没有技术或逻辑矛盾的前提下，各可选方式可单独针对上述总体方案进行组合，还可以是多个可选方式之间进行组合。
可选的，释放状态下，各捕集爪的尖端部位自由悬浮在管状结构的内腔中。
可选的，释放状态下，释放状态下，各捕集爪除根部以外，其余部位均自由悬浮在管状结构的内腔中。
可选的，所述捕集爪与管状结构一体编织成型或一体切割成型。
可选的，释放状态下，部分或全部所述捕集爪整体上为弯曲结构，弯曲的凹陷部位朝向近端。
可选的，所述捕集爪包括一根或分叉结构的多根杆体；多根杆体在捕集爪的尖端汇聚至一处，各杆体在捕集爪的根部相互发散并连接至管状结构侧壁的相应位置。
可选的，所述杆体为一根，在释放状态下，杆体两端点连线与管状结构的轴线之间夹角为10度~60度。
可选的，所述杆体为两根，两根杆体在捕集爪的尖端以圆角结构汇聚。
可选的，所述杆体为两根，在释放状态下，每根杆体的两端点之间的连线作为第一参照线，两根杆体所对应的两第一参照线之间的夹角为30度~60度。
可选的，所述杆体为两根，在释放状态下，每根杆体的两端点之间的连线作为第二参照线，两根杆体所对应的两第二参照线确定一参照面，所述管状结构的轴线与该参照面之间夹角为10度~60度。
可选的，所述杆体为两根，在释放状态下，每根杆体的两端点之间的连线作为第二参照线，两根杆体所对应的两第二参照线之间具有与该两第二参照线共面的平分线，所述平分线与管状结构的轴线之间夹角为10度~60度。
可选的，所述杆体为两根，在释放状态下，每根杆体的两端点之间的连线作为第二参照线，两根杆体所对应的两第二参照线确定一参照面；
所述管状结构的轴线在该参照面上的投影为投影线；
所述管状结构的轴线与所述投影线之间夹角为10度~60度。
可选的，所述杆体为两根，两根杆体在捕集爪根部处的连线中点与所在捕集爪尖端的连线为第三参照线；所述管状结构的轴线与所述第三参照线之间夹角为10度~60度。
可选的，所述捕集爪在管状结构的轴向上分布一组或间隔分布多组，同组内的捕集爪至少包括两个且在管状结构周向上依次排布。
可选的，释放状态下，同组捕集爪中的尖端具有相互邻近抱拢的趋势。
可选的，同组捕集爪中，相邻两捕集爪在管状结构的轴向上位置相同或错位布置。
同组捕集爪为2、4或6个，在管状结构的轴向上间隔错位。
同组捕集爪为2~4个，在管状结构的轴向上依次同向错位。
可选的，所述管状结构包括多个网格单元，网格单元中至少包括第一单元和第二单元，单个第二单元的网格面积为单个第一单元的网格面积的2~6倍，所述捕集爪的根部与相应的第二单元连接。
可选的，释放状态下，所述第一单元的面积为5~10mm 2，所述第二单元的面积为20~30mm 2。
可选的，至少两个相邻的第一单元开放连通形成一个对应的第二单元。
可选的，四个彼此相邻的第一单元间开放连通形成一个对应的第二单元。
可选的，装载状态下，所述捕集爪处在所连接的第二单元内。
可选的，装载状态下，所述捕集爪的根部位于所在第二单元内的近端部位，所述捕集爪的尖端朝所在第二单元内的远端延伸。
可选的，装载状态下，所述捕集爪的尖端延伸至所在第二单元内的远端部位。
可选的，各第二单元互不相邻或至少有两个第二单元相邻。
可选的，所述颅内血栓取出装置上至少在近端、远端、轴向中部中的至少一处设置显影点。
可选的，所述管状结构近端具有逐渐聚拢的多条连接杆，用于与输送器械连接，在多条连接杆的聚拢部位设有近端显影点。
可选的，所述网罩结构的远端聚拢，且在聚拢部位设有远端显影点。
可选的，在所述管状结构的侧壁或捕集爪上设有中部显影点。
可选的，部分或全部捕集爪的尖端部位设置有显影点。
可选的，捕集爪上的显影点为环形或直条状。
可选的，释放状态下，位于各捕集爪上的所有显影点沿管状结构的轴线排列，形成显影标识轴线。
可选的，所述网罩结构为伞形结构，该伞形结构包括多根辐射分布的杆部；所述管状结构包括多个网格单元，各所述杆部的近端与管状结构的接连部位为网格单元的顶点或相邻两网格单元的连接部位。
 有益效果
本发明通过在取栓直接内设置合适延伸方向以及延伸长度的捕集爪，进一步提高取栓效果。
 附图说明
图1为一实施例中颅内血栓取出装置的结构示意图；
图2为其中图1中颅内血栓取出装置装载状态的示意图；
图3为其中图1中颅内血栓取出装置的展开图；
图4为另一实施例中颅内血栓取出装置的结构示意图；
图5为其中图4中颅内血栓取出装置的局部示意图；
图6a为其中图4中颅内血栓取出装置的展开图；
图6b为另一实施例中捕集爪弯曲趋势的示意图；
图6c为另一实施例中捕集爪弯曲趋势的示意图；
图7~图9为另一实施例中颅内血栓取出装置的网罩结构不同角度示意图；
图10~图11为另一实施例中颅内血栓取出装置的网罩结构不同角度示意图；
图12和图13a分别为另一实施例中颅内血栓取出装置局部显影示意图；
图13b为图13a中颅内血栓取出装置弯曲后的显影示意图；
图14~图18为另一实施例中颅内血栓取出装置捕获普通血栓的工作过程示意图；
图19为另一实施例中颅内血栓取出装置捕获复杂结构较大血栓的示意图；
图20为另一实施例中颅内血栓取出装置捕获易碎易脱落血栓的示意图；
图21为另一实施例中颅内血栓取出装置的结构示意图；
图22~图26为不同的实施方式中颅内血栓取出装置的展开图；
图27为另一实施例中颅内血栓取出装置的展开图。
 本发明的实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
为了更好地描述和说明本申请的实施例，可参考一幅或多幅附图，但用于描述附图的附加细节或示例不应当被认为是对本申请的发明创造、目前所描述的实施例或优选方式中任何一者的范围的限制。
需要说明的是，当组件（或部件）被称为与另一个组件（或部件）“连接”时，它可以直接与另一个组件连接或者也可以存在居中的组件。当一个组件被认为是“设置于”另一个组件，它可以是直接设置在另一个组件上或者可能同时存在居中组件。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。
参见图1，本实施中一种颅内血栓取出装置，整体上具有镂空的管状结构1，颅内血栓取出装置本身可以由金属管，例如镍钛管激光雕刻，经热定型后而成，在其他实施方式中可以由镍钛丝编织而成。
本实施例的颅内血栓取出装置的管状结构1且具有径向压缩的装载状态以及径向扩张的释放状态，装载状态下例如图2，管状结构1径向压缩具有较小的外径，可随输送鞘管在血管内穿行直至病灶部位，而后输送鞘管后撤，管状结构1暴露在血管内后径向扩张进入释放状态。
管状结构1的轴向一端为用于连接输送器械（输送器械例如为输送丝）的近端，例如图1中右侧一端，近端具有稀疏的杆状结构并且收束作为连接部3，连接部3与输送丝相连，可在体内穿行以及实现与输送鞘管的相对运动。
管状结构1的另一端为通过网罩结构2封闭的远端，例如图1中左侧一端，网罩结构2整体上为伞状，由远端向近端发散并与管状结构1对接，便于捕集较小体积的血栓。
本说明书中提及的近端、远端在整体朝向上具有相同含义，即使用状态下，远端为邻近病灶或血栓部位的一端，近端为远离病灶或血栓部位的一端，操作者在近端控制颅内血栓取出装置。
管状结构1上还设有多个捕集爪4，各捕集爪4一端为与管状结构1侧壁相连的根部42，另一端为延伸至管状结构1轴线部位的尖端41，且各捕集爪4在延伸的同时由近端向远端倾斜。
图1中显示了捕集爪4延伸的大致方向，管状结构1在释放状态下，捕集爪4的尖端41朝管状结构1的轴线部位延伸，且整体上相对轴线倾斜布置，即同一捕集爪4中，其尖端41相对于根部42更靠近远端，采用这样的倾斜方式更有利于管状结构1以及捕集爪4进行装载，转载时随着管状结构1以及捕集爪4进入输送鞘管，捕集爪4会逐渐捋直，而不会翻翘至输送鞘管外部。
本实施例的颅内血栓取出装置中，管状结构1包括多个网格单元，具有良好的径向支撑力、以及柔顺性，通过捕集爪4以及远端网罩结构2的结合具有很强的血栓捕获性能，尤其可捕获复杂结构的血栓。
颅内血栓取出装置上至少在近端、远端、轴向中部中的至少一处设置显影点，显影点可采用铂钨合金、铂铱合金或者钽合金等金属材料，但不限于此，分布在颅内血栓取出装置各处，并能提供良好的不透射线性。
在另一实施例中，连接部3近端部位可设置近端显影点5，网罩结构2远端部位可设置远端显影点6，在一些捕集爪4的尖端41部位可设置中部显影点7。
在管状结构1释放状态下，各捕集爪4的尖端部位自由悬浮在管状结构1的内腔中，在优选的实施例中，释放状态下，各捕集爪4除根部42以外，其余部位均自由悬浮在管状结构1的内腔中。
结合图1~图3，捕集爪4的根部42与相邻的单元格边框相连固定，而其余部位直至尖端41均悬浮在所处的单元格中，在管状结构1释放状态下，各捕集爪4探向管状结构1的轴线方向，且并没有其他部件束缚，即悬浮在管状结构1的内腔中，更便于适应且锚定进入管状结构1内腔中不同形状的血栓。
在另一实施例中，各捕集爪4与管状结构1之间可以采用一体编织成型或一体切割成型。
在另一实施例中，释放状态下，部分或全部捕集爪4整体上为弯曲结构，弯曲的凹陷部位朝向近端。即捕集爪4由根部至尖端在向远端延伸的同时以弯曲的方式逐渐靠近管状结构的轴线；弯曲的凹面朝向近端应理解为大致朝向，即相对于远端而言，弯曲形状为弧形或类似与弧形，越邻近尖端，向管状结构的轴线的靠拢趋势越快。
部分或全部或捕集爪整体上为上述特点的弯曲结构，应理解为至少有一部分捕集爪采用弯曲结构，当然也可以是所有的捕集爪均采用上述特点的弯曲结构。
由于释放状态下的捕集爪有可能是三维结构，因此弯曲结构应理解为捕集爪的整体形状特点，即并非沿直线或在某一平面内延伸，而是在某一曲面或略复杂的空间内延伸。
若没有采用上述特点的弯曲结构，则就某一捕集爪而言，其自身沿直线延伸或至少在某一平面内延伸，例如，在另一实施例中，释放状态下，各捕集爪为杆状且分别沿直线延伸。在另一实施例中，释放状态下，各捕集爪分别在各自所处的平面内延伸。
释放状态下，以捕集爪4由根部42至尖端41沿弧线延伸为例，椭圆弧或类似曲线同理，弧线的圆心在该捕集爪4的近端侧，即捕集爪4在整体上沿弧线路径朝管状结构1的轴向延伸，径向渐变的几何设计，更容易捕获复杂结构的血栓；
在另一实施例中，捕集爪4包括一根或分叉结构的多根杆体；多根杆体在捕集爪4的尖端41汇聚至一处，各杆体在捕集爪4的根部42一侧相互发散并连接至管状结构侧壁的相应位置。
在另一实施例中，杆体为一根，释放状态下，杆体两端点连线与管状结构的轴线之间夹角为10度~60度。就杆体本身而言可以是直杆或采用上述的弯曲结构。所有捕集爪可以全采用直杆；或全采用上述的弯曲结构；或部分采用直杆部分采用上述的弯曲结构。
在另一实施例中，杆体为两根，分别为杆体43和杆体44，杆体43和杆体44在捕集爪4的尖端41处汇聚，为了提高安全性，在另一实施例中，杆体43和杆体44以圆角结构汇聚。
在另一实施例中，杆体为两根，分别为杆体43和杆体44，杆体43和杆体44在捕集爪4的尖端41处汇聚，在释放状态下，每根杆体的两端点之间的连线作为第一参照线，两根杆体所对应的两第一参照线之间的夹角为30度~60度。两第一参照线之间的夹角影响了两根杆体相互靠拢的趋势，夹角越大相互靠拢的趋势越明显。
反之，夹角越小相互靠拢的趋势越不明显，捕集爪4整体上也更狭长，因此两第一参照线之间合适的夹角对血栓的捕集效果也具有一定影响，本实施例中提供了优选的范围，更利于提高血栓捕集效果。
结合图4~图6a，另一实施例中，主要区别在于展开图中，宽度方向上排布的单元格数量较少，宽度方向上排布的捕集爪4的数量为三个，围成管状结构1后具有较小的直径。而图1~图3中展开图宽度方向上排布的捕集爪4的数量为四个，围成管状结构1后具有较大的直径。
本实施例中，释放状态下捕集爪4整体上也采用弯曲结构，即由根部至尖端在向远端延伸的同时以弯曲的方式逐渐靠近管状结构的轴线；弯曲的凹面朝向近端，弯曲形状为弧形或类似与弧形，越邻近尖端，向管状结构的轴线的靠拢趋势越快。
图4~图6a中每个捕集爪4包括的杆体为两根，分别为杆体45和杆体46，在释放状态下，每根杆体的两端点之间的连线作为第二参照线，两根杆体所对应的两第二参照线之间具有与该两第二参照线共面的平分线47，平分线47与管状结构1的轴线L之间夹角为10度~60度，还可以进一步优选30度~60度。
平分线47与管状结构1的轴线L之间夹角决定了捕集爪4倾斜弯曲的趋势，合适的趋势对血栓的捕集效果也具有一定影响，本实施例中提供了优选的范围，更利于提高血栓捕集效果。
参见图6b，另一实施例中，每个捕集爪4包括的杆体为两根，分别为杆体45和杆体46，在释放状态下，每根杆体的两端点之间的连线作为第二参照线，两根杆体所对应的两第二参照线（图中两根粗实线）确定一参照面M；管状结构的轴线L与该参照面之间夹角为10度~60度。或管状结构的轴线L在该参照面M上的投影为投影线L`；轴线L与投影线L`之间夹角为10度~60度。
轴线L与投影线L`之间夹角决定了捕集爪4倾斜弯曲的趋势，合适的趋势对血栓的捕集效果也具有一定影响，本实施例中提供了优选的范围，更利于提高血栓捕集效果。
参见图6c，另一实施例中，每个捕集爪4包括的杆体为两根，分别为杆体45和杆体46，在释放状态下，两根杆体在捕集爪根部处的连线中点P与捕集爪尖端O的连线为第三参照线OP；管状结构的轴线L与第三参照线OP之间夹角为10度~60度。
轴线L与第三参照线OP之间夹角决定了捕集爪4倾斜弯曲的趋势，合适的趋势对血栓的捕集效果也具有一定影响，本实施例中提供了优选的范围，更利于提高血栓捕集效果。
多个捕集爪4形成一个可供血栓嵌入的三维空间。相邻杆体在管状结构1的径向截面上形成致密网格单元，能有效拦截血栓的脱落。
在另一实施例中，捕集爪在管状结构的轴向上分布一组或间隔分布多组，例如图3中，每个虚线框中可视为一组捕集爪，整体上共分布有三组，在图6中捕集爪整体上共分布有两组。
同组内的捕集爪至少包括两个且在管状结构周向上依次排布。例如图3中同组内的捕集爪为四个，图6中同组内的捕集爪为三个，同组捕集爪中，相邻两捕集爪在管状结构的轴向上位置相同或错位布置。
释放状态下，同组捕集爪中的尖端具有相互邻近抱拢的趋势，能有效拦截血栓与镂空的管状结构1构成一个可供血栓嵌入的三维空间，极大提高血栓固定的牢固性。
在另一实施例中，同组捕集爪为2、4或8个，在管状结构的轴向上间隔错位。
在另一实施例中，同组捕集爪为2~4个，在管状结构的轴向上依次同向错位。
 在另一实施例中，管状结构1包括多个网格单元，例如图3中可见，网格单元中至少包括第一单元12和第二单元11，单个第二单元11的网格面积为单个第一单元12的网格面积的2~6倍，例如4倍，捕集爪的根部42与相应的第二单元连接。
 各网格单元优选采用闭环结构，具有较强的径向支撑力，本实施中设置了网格面积较大的第二单元11，使管状结构1整体上具有较好的柔顺性；
网格面积较大的第二单元11便于较大体积的血栓进入管状结构1内部，例如图3每个捕集爪包括的杆体为两根，分别为杆体43和杆体44，杆体44的近端与第二单元11的顶点相连，杆体43同理。捕集爪处在网格面积较大的第二单元11部位两者相辅相成，使其容易捕获结构复杂的血栓且不容易脱落。
就网格单元自身形状而言，可以为四边形或六边形，但不仅限于此。本实施例采用面积不同的两种闭合网格单元组成镂空的管状结构1，较小的第一单元12提供较高的径向支撑力，而较大的第二单元11容易捕获尺寸较大、结构较复杂的血栓以及减少与血管壁的接触面。将较大网格单元和较小网格单元的间隔分布，可以使颅内血栓取出装置具备良好的径向支撑力以及血栓捕获性能。
在管状结构1释放状态下（也视为在展开图中的面积），第一单元12面积为5~10mm 2，第二单元11面积约20~30mm 2。
在另一实施例中，第一单元12与第二单元11的构成方式可以是至少两个相邻的第一单元12开放连通形成一个对应的第二单元11；例如图3和图6中采用四个彼此相邻的第一单元间开放连通形成一个对应的第二单元。
结合图2以及图3，装载状态下，捕集爪4处在所连接的第二单元11内，捕集爪4的根部42位于所在第二单元11内的近端部位，捕集爪4的尖端41朝所在第二单元11内的远端延伸。
为了尽量形成较长的捕集爪4，装载状态下，捕集爪4的尖端41延伸至所在第二单元11内的远端部位，即轴向上尽量撑满所在的第二单元11，第二单元11有多个，在具体布置上各第二单元互不相邻或至少有两个第二单元相邻。本实施例中，同组捕集爪对应的第二单元周向上依次相邻。
参见图7~图9，在另一实施例中，网罩结构具有处在颅内血栓取出装置远端侧的结构中心，并由该结构中心朝近端侧辐射发散为伞形结构，伞形结构的开口端与管状结构的远端的对接。网罩结构的涉及可以防止血栓脱离或逃逸，有效避免二次血管栓塞的发生；结构中心处在管状结构的轴线部位，可使伞形结构位更为对称便于装载。
管状结构在邻近远端部位分布若干网格单元，图中可见第一单元13和第一单元14，伞形结构包括多根由远端向近端辐射分布的杆部，网罩结构包括六根杆部，例如图中的杆部21，杆部22。
各杆部的近端与管状结构的接连部位为网格单元的顶点或相邻两网格单元的连接部位。图7中可见杆部21连接在第一单元13和第一单元14的相邻部位。
网罩结构部位或管状结构的远端可设置显影点，例如图8中可见第一单元远端的顶点部位设置显影点61，其余第一单元远端的顶点部位也相应的设置显影点。
参见图10~图11，在另一实施例中，不同之处在于网罩结构包括12根杆部，结构更为致密。管状结构在邻近远端部位分布若干网格单元，图中可见第一单元15和第一单元16，图中的杆部23连接在第一单元15的顶点，而杆部24连接在第一单元15和第一单元16的相邻部位。
总体而言，网罩结构由辐射的多根杆部构成或利用较小网格单元的延展线连接而成，杆部数量为4~12根，释放状态下，杆部与管状结构轴线的夹角为15~45°，形成尺寸合适的远端网格单元，能防止血栓的脱落和逃逸。
网罩结构越致密越能防止血栓的脱落和逃逸，杆部数量以及与管状结构轴线的夹角据对致密程度有一定影响，本实施例优选的范围中可兼顾颅内血栓取出装置的输送性以及致密性，容易捕获易碎易脱落的血栓，如：红色血栓。
颅内血栓取出装置上至少在近端、远端、轴向中部中的至少一处设置显影点，显影点可采用铂钨合金、铂铱合金或者钽合金等金属材料，但不限于此，分布在颅内血栓取出装置各处，并能提供良好的不透射线性。
结合图1，在另一实施例中，连接部3包括逐渐聚拢的多条连接杆，用于与输送器械连接，在多条连接杆的聚拢部位设有近端显影点5，近端显影点5主要通过显影环以及弹簧圈方式焊接到颅内血栓取出装置与输送导丝连接处。
网罩结构2远端部位聚拢，且在聚拢部位设有远端显影点6，远端显影点6采用弹簧圈形式，将网罩结构2聚拢的杆部焊接到收束在一起。
在一些捕集爪4的尖端41部位可设置中部显影点，例如图3中的中部显影点71以及中部显影点72，中部显影点为环形或直条状。，可以采用焊接或铆接的方式固定在相应捕集爪的尖端。
在优选的方式中，同时设置近端显影点5、远端显影点6以及中部显影点，即多处显影点贯穿整个颅内血栓取出装置，通过上述几处显影结构，使其颅内血栓取出装置具有整体良好的不透射线性。
参见图12，圆框中示意了显影效果；图13a，方框中示意了显影效果。在血管9内，输送鞘管8回撤后，颅内血栓取出装置的管状结构1释放，输送鞘管8的端头部位也可以带有显影点，结合近端显影点5、远端显影点6以及多处中部显影点，给颅内血栓取出装置提供良好的整体显影性。
在另一实施例中，释放状态下，位于各捕集爪上的所有显影点沿管状结构的轴线排列，形成显影标识轴线L1。
例如参见图12，图13a和图13b，捕集爪4沿轴向分为三组，每组中其中两个捕集爪的尖端带有显影点，各捕集爪上的所有显影点沿管状结构的轴线排列，形成显影标识轴线，图中以中部显影点73、中部显影点74、中部显影点75为例，大致沿轴向排列，可以展示和体现管状结构1整体位置，由于中部显影点都处在轴线部位，因此可以间接获知管状结构径向的边缘位置以及在血管中的相对位置，若仅在管状结构1侧壁设置显影点，那么在不同视角下，可能会存在较大偏差。本实施例所有显影点形成了显影标识轴线L1，即使在图13b中颅内血栓取出装置弯曲的情况下，显影标识轴线L1仍可以准确的反映出管状结构的轴线位置。
参见图14~图18，另一实施例中颅内血栓取出装置捕获普通血栓的工作过程为，血管9内带有血栓10，输送鞘管8携带颅内血栓取出装置穿过血栓区域，而后输送鞘管8回撤，颅内血栓取出装置释放，即管状结构1径向扩展，血栓10逐渐进入管状结构1的管腔内部，并在捕集爪4的作用下定位，最后回撤颅内血栓取出装置，利用捕集爪4以及远端网罩结构的配合将血栓10取出，使血流恢复通常。
 参见图19，另一实施例中颅内血栓取出装置捕获复杂结构较长较大血栓时，管状结构1径向扩展时，较大的血栓10会经由网格面积较大的第二单元11进入管状结构1内部，同时被相应部位的捕集爪4锚定，若网格面积均为较小的第一单元，则较大的血栓11不易进入管状结构1内部，难以取出，可见本实施例中颅内血栓取出装置可捕获复杂结构的血栓。
 参见图20，另一实施例中颅内血栓取出装置捕获易碎易脱落血栓时，管状结构1径向扩展时，碎易的血栓10会进入管状结构1内部，同时被一组组相互抱拢的捕集爪4锚定，在远端配合致密的网罩结构将血栓捕集取出，可见本实施例中颅内血栓取出装置可捕获复杂结构的血栓。
 参见图21，另一实施例中当然管状结构1远端也带有网罩结构2，管状结构1上的捕集爪4带有中部显影点7其余结构特点可结合或参照前述各实施例。
参见图22~图26，在另外多个实施方式中，第二单元11以及第一单元12的形状和分布略有不同，其余结构特点可结合或参照前述各实施例。各图中捕集爪4为双杆形式，固定连接在相应的第二单元11中，各实施例中每个第二单元11均设置捕集爪4，图中仅在其中一个第二单元11中示意了捕集爪4，其他第二单元11同理。
参见图27，另一实施例中颅内血栓取出装置比照前述各实施例主要区别在于捕集爪4为单根杆状，第二单元11以及第一单元12的形状和分布，以及其余结构特点可结合或参照前述各实施例。本实施例中释放状态下的捕集爪4的远端既可以沿直线逐渐靠拢管状结构的轴线，优选采用弯曲结构的方式逐渐靠拢管状结构的轴线，例如沿弧线或类弧线的路径。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (31)

  1. 一种颅内血栓取出装置，具有镂空的管状结构，且具有径向压缩的装载状态以及径向扩张的释放状态，所述管状结构的轴向一端为用于连接输送器械的近端，另一端为通过网罩结构封闭的远端，其特征在于，还设有多个捕集爪，各捕集爪一端为与管状结构侧壁相连的根部，另一端为延伸至管状结构轴线部位的尖端，且各捕集爪在延伸的同时由近端向远端倾斜。
  2. 根据权利要求1所述的颅内血栓取出装置，其特征在于，释放状态下，各捕集爪的尖端部位自由悬浮在管状结构的内腔中。
  3. 根据权利要求2所述的颅内血栓取出装置，其特征在于，释放状态下，各捕集爪除根部以外，其余部位均自由悬浮在管状结构的内腔中。
  4. 根据权利要求1所述的颅内血栓取出装置，其特征在于，所述捕集爪与管状结构一体编织成型或一体切割成型。
  5. 根据权利要求1所述的颅内血栓取出装置，其特征在于，释放状态下，部分或全部所述捕集爪整体上为弯曲结构，弯曲的凹陷部位朝向近端。
  6. 根据权利要求1所述的颅内血栓取出装置，其特征在于，所述捕集爪包括一根或分叉结构的多根杆体；多根杆体在捕集爪的尖端汇聚至一处，各杆体在捕集爪的根部相互发散并连接至管状结构侧壁的相应位置。
  7. 根据权利要求6所述的颅内血栓取出装置，其特征在于，所述杆体为一根，在释放状态下，杆体两端点连线与管状结构的轴线之间夹角为10度~60度。
  8. 根据权利要求6所述的颅内血栓取出装置，其特征在于，所述杆体为两根，两根杆体在捕集爪的尖端以圆角结构汇聚。
  9. 根据权利要求6所述的颅内血栓取出装置，其特征在于，所述杆体为两根，在释放状态下，每根杆体的两端点之间的连线作为第一参照线，两根杆体所对应的两第一参照线之间的夹角为30度~60度。
  10. 根据权利要求8所述的颅内血栓取出装置，其特征在于，所述杆体为两根，在释放状态下，每根杆体的两端点之间的连线作为第二参照线，两根杆体所对应的两第二参照线确定一参照面，所述管状结构的轴线与该参照面之间夹角为10度~60度。
  11. 根据权利要求1所述的颅内血栓取出装置，其特征在于，所述捕集爪在管状结构的轴向上分布一组或间隔分布多组，同组内的捕集爪至少包括两个且在管状结构周向上依次排布。
  12. 根据权利要求11所述的颅内血栓取出装置，其特征在于，释放状态下，同组捕集爪中的尖端具有相互邻近抱拢的趋势。
  13. 根据权利要求11所述的颅内血栓取出装置，其特征在于，同组捕集爪中，相邻两捕集爪在管状结构的轴向上位置相同或错位布置。
  14. 根据权利要求11所述的颅内血栓取出装置，其特征在于，同组捕集爪为2、4或6个，在管状结构的轴向上间隔错位。
  15. 根据权利要求11所述的颅内血栓取出装置，其特征在于，同组捕集爪为2~4个，在管状结构的轴向上依次同向错位。
  16. 根据权利要求1~15任一项所述的颅内血栓取出装置，其特征在于，所述管状结构包括多个网格单元，网格单元中至少包括第一单元和第二单元，单个第二单元的网格面积为单个第一单元的网格面积的2~6倍，所述捕集爪的根部与相应的第二单元连接。
  17. 根据权利要求16所述的颅内血栓取出装置，其特征在于，释放状态下，所述第一单元的面积为5~10mm 2，所述第二单元的面积为20~30mm 2。
  18. 根据权利要求16所述的颅内血栓取出装置，其特征在于，至少两个相邻的第一单元开放连通形成一个对应的第二单元。
  19. 根据权利要求18所述的颅内血栓取出装置，其特征在于，四个彼此相邻的第一单元间开放连通形成一个对应的第二单元。
  20. 根据权利要求16所述的颅内血栓取出装置，其特征在于，装载状态下，所述捕集爪处在所连接的第二单元内。
  21. 根据权利要求20所述的颅内血栓取出装置，其特征在于，装载状态下，所述捕集爪的根部位于所在第二单元内的近端部位，所述捕集爪的尖端朝所在第二单元内的远端延伸。
  22. 根据权利要求21所述的颅内血栓取出装置，其特征在于，装载状态下，所述捕集爪的尖端延伸至所在第二单元内的远端部位。
  23. 根据权利要求16所述的颅内血栓取出装置，其特征在于，各第二单元互不相邻或至少有两个第二单元相邻。
  24. 根据权利要求1~15任一项所述的颅内血栓取出装置，其特征在于，所述颅内血栓取出装置上至少在近端、远端、轴向中部中的至少一处设置显影点。
  25. 根据权利要求24所述的颅内血栓取出装置，其特征在于，所述管状结构近端具有逐渐聚拢的多条连接杆，用于与输送器械连接，在多条连接杆的聚拢部位设有近端显影点。
  26. 根据权利要求25所述的颅内血栓取出装置，其特征在于，所述网罩结构的远端聚拢，且在聚拢部位设有远端显影点。
  27. 根据权利要求25所述的颅内血栓取出装置，其特征在于，在所述管状结构的侧壁或捕集爪上设有中部显影点。
  28. 根据权利要求1~15任一项所述的颅内血栓取出装置，其特征在于，部分或全部捕集爪的尖端部位设置有显影点。
  29. 根据权利要求27所述的颅内血栓取出装置，其特征在于，释放状态下，位于各捕集爪上的所有显影点沿管状结构的轴线排列，形成显影标识轴线。
  30. 根据权利要求1~15任一项所述的颅内血栓取出装置，其特征在于，颅内血栓取出装置所述网罩结构的远端聚拢在管状结构的轴线附近。
  31. 根据权利要求30所述的颅内血栓取出装置，其特征在于，所述网罩结构为伞形结构，该伞形结构包括多根辐射分布的杆部；所述管状结构包括多个网格单元，各所述杆部的近端与管状结构的接连部位为网格单元的顶点或相邻两网格单元的连接部位。
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CN109965942B (zh) * 2019-03-15 2022-05-27 伊索曼(中山)医疗器械有限公司 用于血管的栓塞取出装置
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