WO2024051673A1 - 取栓支架及取栓装置 - Google Patents

取栓支架及取栓装置 Download PDF

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Publication number
WO2024051673A1
WO2024051673A1 PCT/CN2023/116927 CN2023116927W WO2024051673A1 WO 2024051673 A1 WO2024051673 A1 WO 2024051673A1 CN 2023116927 W CN2023116927 W CN 2023116927W WO 2024051673 A1 WO2024051673 A1 WO 2024051673A1
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WO
WIPO (PCT)
Prior art keywords
connection unit
distal end
proximal end
open
thrombectomy
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Application number
PCT/CN2023/116927
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English (en)
French (fr)
Inventor
陈泉
李思漪
唐辉强
李丹妮
方宇
Original Assignee
深圳市先健神康医疗有限公司
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Application filed by 深圳市先健神康医疗有限公司 filed Critical 深圳市先健神康医疗有限公司
Publication of WO2024051673A1 publication Critical patent/WO2024051673A1/zh

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Classifications

    • 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
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges

Definitions

  • the present application belongs to the technical field of medical devices, and specifically relates to a thrombectomy stent and a thrombectomy device having the thrombectomy stent.
  • Stroke also known as stroke, is a local brain dysfunction caused by acute cerebrovascular disease. The clinical symptoms last for more than 24 hours. It has the characteristics of high morbidity, mortality, disability and recurrence rate. It usually occurs after 50 years of age. Aged and above. At present, the incidence of stroke in our country is increasing year by year, and it has become the number one cause of death in our country.
  • Acute ischemic stroke is nerve tissue damage caused by ischemic necrosis of local brain tissue due to sudden obstruction of cerebral blood flow.
  • Acute ischemic stroke is the most common type of stroke and the main cause of death and disability among middle-aged and elderly people. Especially acute stroke caused by large vessel occlusion is dangerous and has high mortality and disability rates. Once a stroke occurs, it will cause huge physical and mental harm to the patient, and also impose a heavy burden on the patient's family and society. Recanalization of blood vessels is the key to the treatment of acute ischemic stroke.
  • Current conventional methods for treating acute ischemic stroke include two categories: interventional thrombolysis and mechanical thrombectomy. Drug thrombolysis within 4 to 5 hours of onset is the first choice for the treatment of acute ischemic stroke.
  • interventional device thrombectomy has gradually developed and shown good clinical application prospects.
  • the treatment method of interventional device thrombectomy has wider applicability and can quickly recanalize occluded blood vessels, reduce the incidence of drug complications, and improve patient prognosis.
  • the self-expanding thrombectomy stents have the following problems: for leukocyte-rich white thrombus/hard thrombus, the thrombus is rich in fiber and has strong viscoelasticity, while the self-expanding stent has the following problems: The radial force of the stent is insufficient to allow the mesh rod of the stent to penetrate into the white blood clot, causing thrombectomy failure; for soft red blood clots, the cutting effect of the stent rod during the thrombectomy process can easily cut large thrombi into smaller ones. Thrombus can easily cause small thrombi to escape to distal blood vessels, causing distal blood vessel occlusion, resulting in thrombectomy failure.
  • the purpose of this application is to at least solve the problem of completely capturing the thrombus and the easy escape of the fallen thrombus during thrombectomy. This purpose is achieved in the following ways.
  • a thrombectomy stent includes:
  • Capture area the capture area is provided with at least one open branch arranged along its axial direction, the distal end of the open branch is an open structure, the open branch has a branch channel inside, the branch channel and the open structure
  • the open branch includes a first connection unit, a second connection unit and at least one third connection unit, and the third connection unit connects the first connection unit and the second connection unit, wherein the third connection unit
  • the projection of a connecting unit on the radial section of the thrombectomy bracket coincides with the radial section of the thrombectomy bracket, the branch channel runs through the first connecting unit, and the second connecting unit has a second The free end of the connecting unit, the free end of the second connecting unit is closer to the distal end than the distal end of the first connecting unit and the distal end of the third connecting unit.
  • a thrombectomy device including:
  • the thrombectomy bracket is connected to the distal end of the pushing member
  • the thrombectomy bracket may be provided inside the loader, the thrombectomy bracket has a compressed state inside the loader and an expanded state outside the loader;
  • the thrombectomy stent is the thrombectomy stent according to the above.
  • Figure 1 is a schematic structural diagram of a thrombectomy stent according to an embodiment of the present invention.
  • FIG. 2 is a schematic structural view of the thrombectomy stent in FIG. 1 from another angle.
  • Figure 3 is a schematic structural diagram of the thrombectomy stent of Figure 1 from another angle.
  • Figure 4 is a schematic structural diagram of a capture area in an embodiment.
  • Figure 5 is a schematic structural diagram of an open branch according to an embodiment.
  • Figure 6 is a schematic structural diagram of a collection area in an embodiment.
  • FIG. 7 is a schematic structural diagram of a guide rod covering a buffer member in a collection area according to an embodiment.
  • FIG. 8 is a schematic structural diagram of the guide rod in the collection area without being covered with a buffer member in one embodiment.
  • Figure 9 is a schematic structural diagram of an opening area in an embodiment.
  • Figure 10 is a schematic structural diagram of a thrombectomy device according to an embodiment.
  • Figure 11 is a schematic structural diagram of a push member according to an embodiment.
  • Figure 12 is a schematic diagram of the connection structure between the pusher and the thrombus retrieval bracket according to one embodiment.
  • FIG. 13 is an exploded schematic diagram of the connection structure between the pusher and the thrombus retrieval bracket according to one embodiment.
  • Figure 14 is a schematic diagram of the proximal structure of the opening area in one embodiment.
  • FIG. 15 is a schematic cross-sectional structural diagram of the connection structure between the pusher and the thrombus retrieval bracket according to one embodiment.
  • Figure 16 is a schematic cross-sectional view of the connection structure between the pusher and the thrombus retrieval bracket according to one embodiment.
  • Figure 17 is a schematic cross-sectional view of the connection structure between the pusher and the thrombus retrieval bracket according to one embodiment.
  • Figure 18 is a schematic structural diagram of a thrombectomy stent according to an embodiment.
  • Figure 19 is a schematic diagram of the proximal structure of the opening area in one embodiment.
  • Figure 20 is a schematic cross-sectional view of the connection structure between the pusher and the thrombus retrieval bracket according to one embodiment.
  • FIG. 21 is a schematic cross-sectional view of the connection structure between the pusher and the thrombus retrieval bracket according to one embodiment.
  • Figure 22A is a schematic diagram of a thrombectomy stent with a developing structure and the developing structure in one embodiment.
  • Figure 22B is a schematic view of the thrombectomy stent with a developing structure in Figure 22A and another perspective view of the developing structure.
  • Figure 22C is a schematic diagram of the thrombectomy stent with a developing structure in Figure 22A and another schematic view of the developing structure.
  • FIG. 23A is a schematic diagram of a thrombectomy stent with a developing structure and the developing structure in one embodiment.
  • FIG. 23B is a schematic view of the thrombectomy stent with a developing structure in FIG. 23A and another perspective view of the developing structure.
  • FIG. 23C is a schematic view of the thrombectomy stent with a developing structure in FIG. 23A and the developing structure from another angle.
  • Figure 23D is a detailed schematic diagram of Figure 23A.
  • Figure 24 is a schematic structural diagram of a microcatheter inserted into a blood vessel according to an embodiment.
  • Figure 25 is a schematic structural diagram of a thrombectomy stent inserted into a microcatheter according to an embodiment.
  • Figure 26 is a schematic structural diagram of the opening area when thrombus is penetrated according to one embodiment.
  • Figure 27 is a schematic structural diagram of the capture area capturing thrombus according to an embodiment.
  • Figure 28 is a schematic structural diagram of the thrombectomy stent according to an embodiment when it is retracted into the catheter.
  • Figure 29 is a schematic structural diagram of the capture area capturing thrombus in a curved blood vessel according to an embodiment.
  • FIG. 30 is an enlarged structural schematic diagram of part A in FIG. 29 .
  • first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections shall not be referred to as restricted by these terms. These terms are only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.
  • spatially relative terms may be used herein to describe the relationship of one element or feature to another element or feature as shown in the figures. These relative terms, such as “inner”, “outer”, “inner” ”, “outside”, “below”, “below”, “above”, “above”, etc. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” or “beneath” the other elements or features. Features above”. Thus, the example term “below” may include an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • proximal and distal are defined here as commonly used terms in the field of interventional medicine. Specifically, “distal” means the end far away from the operator during the surgical operation, “proximal” means the end close to the operator during the surgical operation, “axial” means its length direction, and “radial” means perpendicular to The “axial” direction.
  • the self-expanding thrombectomy stents have the following problems: for leukocyte-rich white thrombus/hard thrombus, the thrombus is rich in fiber and has strong viscoelasticity, while the self-expanding stent has the following problems: The radial force is not enough to cause the stent's mesh rod to penetrate into the white blood clot, causing thrombectomy failure; for soft red blood clots, the cutting effect of the stent rod during the thrombectomy process can easily cut large thrombi into smaller ones. Thrombus can easily cause small thrombi to escape to distal blood vessels, causing distal blood vessel occlusion, resulting in failure of thrombectomy.
  • a first aspect of the present invention proposes a thrombectomy stent 100 .
  • the thrombectomy stent 100 includes an opening area 10 , a capture area 10 , and an opening area 10 . Zone 20 and Collection Zone 30.
  • the opening area 10 is used to penetrate thrombus.
  • the capturing area 20 is connected to the opening area 10 and is located at the distal end of the opening area 10.
  • the capturing area 20 is provided with at least one open branch 21 arranged along its axial direction.
  • the collection area 30 is connected to the capturing area 10.
  • the thrombectomy stent 100 may include only the capturing area 20 , or only the capturing area 20 and the opening area 10 , or only the opening area 10 and the collection area 30 .
  • the thrombectomy stent 100 is a self-expanding mesh-tubular structure with a hollow interior, thereby ensuring that the thrombectomy stent 100 has a certain deformation ability in order to compress the thrombectomy stent 100 within the delivery device. Or it can automatically return to the expanded state after being released in the delivery device, so as to facilitate the capture of thrombus and thereby ensure the normal circulation of blood in the blood vessel after implantation.
  • the capture area 20 may be a structure with openings at both ends, and the capture area 20 is provided with at least one open branch 21 .
  • the number of open branches 21 depends on the overall length of the thrombectomy stent 100. Generally, 1 to 5 open branches 21 can be provided.
  • the multiple open branches 21 spirally extend from the proximal end of the thrombectomy stent 100 around the axis of the thrombectomy stent 100.
  • the distal end of the thrombus retrieval stent 100 forms a spiral structure surrounding the axis of the thrombus retrieval stent 100, and the capture area development wire 711 (see FIG. 22B) is wound around the spiral structure.
  • the above-mentioned spiral structure has good bending performance, can cause little stimulation to blood vessels, and will not cause damage to blood vessels.
  • there is no need to provide a spiral extension and only a certain angle is required between two adjacent open branches 21 along the circumferential direction of the capture area 20 .
  • the distal end of the open branch 21 is an open structure.
  • the open branch 21 has a branch channel 201 inside.
  • the branch channel 201 communicates with the open structure.
  • the open branch 21 includes a first connection unit 211 and a second connection unit 211 .
  • the connection unit 212 and at least one third connection unit 213 connect the first connection unit 211 and the second connection unit 212 .
  • the projection of the first connection unit 211 on the radial section of the thrombectomy stent 100 coincides with the radial section of the thrombectomy stent 100
  • the branch channel 201 runs through the first connection unit 211
  • the second connection unit 212 has a second connection unit free end 2120, which is closer to the distal end than the distal end of the first connection unit 211 and the distal end of the third connection unit 213.
  • the open structure here It means that the distal ends of the open branches 21 do not come together to form a closed structure, but have an open structure.
  • the third connection unit 213 connects the first connection unit 211 and the second connection unit 212 and plays the role of supporting the first connection unit 211 and the second connection unit 212; the first connection unit 211 is in the radial direction of the thrombectomy bracket 100.
  • the projection on the cross-section coincides with the radial cross-section of the thrombectomy stent 100, and the branch channel 201 runs through the first connection unit 211, so that larger red blood clots can enter the branch channel 201 relatively completely through the first connection unit 211.
  • the branch channel 201 can also enter the branch channel 201 through the first connection unit 211 and be captured; the second connection unit 212 is provided with The second connection unit free end 2120 is closer to the distal end than the distal end of the first connection unit 211 and the second connection unit 212 in order to be located in the branch channel 201 when passing through the curved blood vessel.
  • the thrombus in the blood vessel is easily squeezed by the blood vessel to escape, and the second connection unit 212 can fit the blood vessel wall well through the free end 2120 of the second connection unit, intercept the escaping thrombus at the distal end, and allow the thrombus to return to the branch channel 201 , effectively capture and collect thrombi, thereby reducing or avoiding secondary embolism in blood vessels.
  • a developing point can be set on the free end 2120 of the second connection unit to facilitate the realization of the developing function in the body.
  • the material of the development point is well known to those skilled in the art. Clinicians can monitor the position of the development point through vascular imaging equipment, such as DSA (digital subtraction angiography), thereby determining the free end 2120 of the second connection unit in the blood vessel. s position.
  • DSA digital subtraction angiography
  • both ends of the third connection unit 213 are connected to the first connection unit 211, the proximal ends of the second connection unit 212 are connected to the third connection unit 213 and the first connection unit 211 respectively, and the free end of the second connection unit 2120 extends distally.
  • the first connection unit 211 , the second connection unit 212 and the third connection unit 213 are arranged along the circumferential direction, and the branch channel 201 passes through the first connection unit 211 , the second connection unit 212 and the middle area surrounded by the third connection unit 213 and passes out from the first connection unit 211 .
  • Such an arrangement can make the space of the branch channel 201 larger and easily capture large thrombus completely.
  • the proximal end of the second connection unit 212 can also be connected to the third connection unit 213. That is to say, the first connection unit 211 is connected to the third connection unit 213, and the second connection unit 212 is also connected to the third connection unit 213. Three connection units 213 are connected. Specifically, the second connection unit 212 may be located between the first connection unit 211 and the third connection unit 213. At this time, the branch channel 201 is divided into two, namely the first connection unit 211 and the second connection unit 212. The passage between the second connection unit 212 and the third connection unit 213; or the third connection unit 213 can also be located between the first connection unit 211 and the second connection unit 212. In this case, the branch channel 201 is divided into two, which are the channel between the first connection unit 211 and the third connection unit 213, and the channel between the second connection unit 212 and the third connection unit 213.
  • the first connection unit 211 is provided with a first mesh 2113 for capturing thrombus
  • the second connection unit 212 is provided with a second mesh 2123 for capturing thrombus.
  • the thrombus can be engaged with the first mesh 2113 and the second mesh. hole 2123, or from the first mesh hole 2113 and the second mesh hole 2123 into the thrombectomy stent 100, thereby preventing the thrombus from falling and escaping.
  • the third connection unit 213 is used to provide supporting force for the open branch 21, thereby preventing the open branch 21 from being depressed in the circumferential direction after being squeezed by the blood vessel, and avoiding the formation of a gap between the open branch 21 and the inner wall of the blood vessel, thereby reducing or avoiding thrombus.
  • the shape of the third connection unit 213 is not limited, and can be V-shaped, W-shaped, arc-shaped, wavy-shaped and other regular or irregular shapes, as long as it can play a supporting role. Can.
  • the first connection unit 211 includes a first connecting rod 2111 and a second connecting rod 2112. Both ends of the second connecting rod 2112 are respectively connected to both ends of the first connecting rod 2111 to form the first mesh. 2113, the branch channel 201 runs through the first mesh 2113.
  • the first connection unit 211 may be a mesh structure formed by more than two rods, and multiple rods are connected end to end in order to form the mesh structure. Compared with a mesh structure surrounded by multiple connecting rods, a mesh structure composed of only two connecting rods has a certain deformation ability, thereby making the first connection unit 211 more suitable for being inserted into curved blood vessels and adapting to blood vessels. The bending direction has better flexibility.
  • the first connecting rod 2111 and the second connecting rod 2112 may be of an integrated structure or a split structure and connected together.
  • the third connection unit 213 includes a third link 2131 and a fourth link 2132.
  • the distal end of the third link 2131 is connected to the distal end of the fourth link 2132.
  • the third link 2131 The proximal end of 2131 is connected to the part between the distal end and the proximal end of the second connecting rod 2112, or connected to the fourth connecting rod 2132 of the adjacent third connecting unit 213, and the proximal end of the fourth connecting rod 2132 is connected to the third connecting rod 2132.
  • the part between the distal end and the proximal end of one connecting rod 2111 is connected, or connected to the third connecting rod 2131 of the adjacent three connecting unit 213.
  • the number of the third connection unit 213 may be multiple or one, and the specific number may be determined according to the radial size of the thrombectomy stent 100 and the required support strength.
  • the open branch 21 only includes one third connection unit 213, the proximal end of the third link 2131 is connected to the part between the distal end and the proximal end of the second link 2112, and the proximal end of the fourth link 2132 is connected to the third connecting unit 213. between the distal end and the proximal end of a connecting rod 2111 The parts are connected, thereby improving the radial support strength of the open branch 21.
  • the open branch 21 includes more than one third connection unit 213
  • the plurality of third connection units 213 are sequentially connected along the circumferential direction of the open branch 21 .
  • the proximal end of the third link 2131 of the third connection unit 213 close to the second link 2112 is connected to the second link 2112
  • the proximal end of the fourth link 2132 of the third connection unit 213 close to the second link 2112 is connected to the second link 2112.
  • the end is connected to the proximal end of the third connecting rod 2131 of the adjacent third connecting unit 213, and the proximal end of the fourth connecting rod 2132 of the third connecting unit 213 close to the second connecting unit 212 is connected to the first connecting rod 2111.
  • the proximal end of the third connecting rod 2131 of the third connecting unit 213 close to the second connecting unit 212 is connected to the proximal end of the fourth connecting rod 2134 of the adjacent third connecting unit 213.
  • the plurality of third connection units 213 can also be arranged along the axial direction of the open branch 21.
  • the third links 2131 of all the third connection units 213 are in contact with the distal end and proximal end of the second link 2112.
  • the proximal ends of the fourth connecting rods 2132 of all third connecting units 213 are connected to the portions between the distal ends and the proximal ends of the first connecting rods 2111 .
  • a part of the third connecting unit 213 can also be arranged in the circumferential direction and a part in the axial direction, as long as it can play a supporting role.
  • the second connection unit 212 includes a fifth link 2121 and a sixth link 2122.
  • the distal end of the fifth link 2121 is connected to the distal end of the sixth link 2122, and the proximal end of the fifth link 2121 is connected to the distal end of the fifth link 2121.
  • the proximal end of the sixth link 2122 is connected to the portion between the distal end and the proximal end of the fourth link 2132 .
  • the proximal end of the fifth connecting rod 2121 can be connected to any position of the first connecting unit 211, and the proximal end of the sixth connecting rod can be connected to any position of the third connecting unit 213, as long as the second connection can be guaranteed.
  • the free end 2120 of the unit is closer to the distal end than the distal end of the first connection unit 211 and the distal end of the third connection unit 213. There is no fixed support structure between the proximal end and the distal end of the second connection unit 212, thereby maintaining the third connection unit 212.
  • the degree of freedom of the two connection units 212 is sufficient. The degree of freedom here means that the second connection unit 212 is not bound by other connection units, and the free end 2120 of the second connection unit has certain mobility.
  • the second connection unit 212 is only composed of the fifth connecting rod 2121 and the sixth connecting rod 2122. Compared with the mesh structure formed by multiple connecting rods, the mesh structure composed of only two connecting rods is easier to install. Deformation occurs, thereby further allowing the second connection unit 212 to have a certain degree of freedom, making the deformed second connection unit 212 more suitable for being inserted into curved blood vessels and adapting to the bending direction of the blood vessels, so that the free end 2120 of the second connection unit is always attached Close the inner wall of blood vessels to prevent the escape of blood clots.
  • the fifth connecting rod 2121, the sixth connecting rod 2122, part of the fourth connecting rod 2132 and part of the first connecting rod 2111 are enclosed to form a second mesh 2123.
  • the second mesh 2123 also has the function of capturing fallen thrombi.
  • the proximal end of the open branch 21 has an extension portion 210 , wherein the proximal end of the open branch 21 is the proximal end of the first connection unit 211 .
  • at least two open branches 21 include a first open branch 21a and a second open branch 21b.
  • the proximal end of at least one of the at least two open branches has an extension 210, and the proximal end of the second open branch 21b is Or the extension part 210 of the second open branch 21b is connected to the part between the distal end and the proximal end of the first connection unit 211 of the first open branch 21a to form the first connection point 211a.
  • the portion between the distal end and the proximal end of the first connecting unit 211 may be the portion between the distal end and the proximal end of the first connecting rod 2111 or the portion between the distal end and the proximal end of the second connecting rod 2112 .
  • the proximal ends of the open branches 21 do not have extension portions 210 , and adjacent open branches 21 are directly connected.
  • the proximal end of the first connection unit 211 to the first connection point 211a is the first line portion 21121, and the first line portion 21121 and part of the second open branch 21b
  • the first connection units 211 are connected in series to form a spiral structure surrounding the axis of the thrombectomy stent 100 .
  • first line portion 21121 is a part of the second connecting rod 2112 of the first connecting unit 211 of the first open branch 21a, and part of the first connecting unit 211 of the second open branch 21b refers to the second open branch 21b. At least part of the length of the first connecting rod 2111 of the first connecting unit 211 or at least part of the length of the second connecting rod 2112.
  • both the proximal end of the first open branch 21a and the proximal end of the second open branch 21b have an extension part 210.
  • the extension part 210 of the first open branch 21a, the first line part 21121, the extension part 210 of the second open branch 21b and part of the first connection unit 211 of the second open branch 21b are connected in series from the proximal end to the distal end, forming A spiral structure surrounding the axis of the thrombectomy stent 100 .
  • the proximal end of the first open branch 21a has an extension 210.
  • the extension part 210 of the first open branch 21a, the first line part 21121 and the first connection unit 211 of part of the second open branch 21b are connected in series from the proximal end to the distal end, forming a spiral structure surrounding the axis of the thrombectomy stent 100. .
  • the proximal end of the second open branch 21b has an extension 210.
  • the first line portion 21121, the extension portion 210 of the second open branch 21b and part of the first connection unit 211 of the second open branch 21b are connected in series from the proximal end to the distal end, forming a spiral structure surrounding the axis of the thrombectomy stent 100 .
  • At least two open branches 21 further include a third open branch 21c, the proximal end of the third open branch 21c or the extension 210 of the third open branch 21c and the first connection unit 211 of the second open branch 21b. The portion between the distal end and the proximal end is connected to form a second connection point 211b.
  • the proximal ends of the open branches 21 do not have extension portions 210 , and adjacent open branches 21 are directly connected.
  • the proximal end of the first connection unit 211 to the second connection point 211b is the second line portion 21122, and the first line portion 21121, the second line portion 21122 and part of the third
  • the first connection units 211 of the open branch 21c are connected in series from the proximal end to the distal end, forming a spiral structure surrounding the axis of the thrombectomy stent 100.
  • the second line portion 21122 is a part of the second connecting rod 2112 of the first connecting unit 211 of the second open branch 21b, and part of the first connecting unit 211 of the third open branch 21c refers to the third open branch 21c. At least part of the length of the first connecting rod 2111 of the first connecting unit 211 or at least part of the length of the second connecting rod 2112 .
  • the proximal ends of the first open branch 21a, the second open branch 21b, and the third open branch 21c all have extension portions 210.
  • the extension part 210 and the first line part 21121 of the first open branch 21a, the extension part 210 and the second line part 21122 of the second open branch 21b, the extension part 210 of the third open branch 21c, part of the third open branch 21c The first connection units 211 are connected in series from the proximal end to the distal end, forming a spiral structure surrounding the axis of the thrombectomy stent 100 .
  • the proximal end of the first open branch 21a has an extension 210.
  • the extension part of the first open branch 21a, the first line part 21121, the second line part 21122, and the first connection unit 211 of part of the third open branch 21c are connected in series from the proximal end to the distal end to form an axis around the thrombectomy stent 100. spiral structure.
  • the proximal end of the second open branch 21b has an extension 210.
  • the first line portion 21121, the extension portion 210 of the second open branch 21b, the second line portion 21122, and the first connection unit 211 of part of the third open branch 21c are connected in series from the proximal end to the distal end to form a surrounding thrombectomy stent 100 The spiral structure of the axis.
  • the proximal end of the third open branch 21c has an extension portion 210.
  • the first line part 21121, the second line part 21122, the extension part 210 of the third open branch 21c, and part of the first connection unit 211 of the third open branch 21c are connected in series from the proximal end to the distal end, forming a surrounding thrombectomy stent 100 The spiral structure of the axis.
  • both the proximal end of the first open branch 21a and the proximal end of the second open branch 21b have an extension part 210.
  • the extension part 210 and the first line part 21121 of the first open branch 21a, the extension part 210 and the second line part 21122 of the second open branch 21b, and the first connection unit 211 of part of the third open branch 21c are arranged from the proximal end to the far end.
  • the ends are connected in series in sequence to form a spiral structure surrounding the axis of the thrombectomy stent 100 .
  • the proximal end of the first open branch 21a and the proximal end of the third open branch 21c each have an extension portion 210.
  • the extension part 210 of the first open branch 21a, the first line part 21121, the second line part 21122, the extension part 210 of the third open branch 21c, and the first connection unit 211 of part of the third open branch 21c are arranged from the proximal end to the far end. The ends are connected in series in sequence to form a spiral structure surrounding the axis of the thrombectomy stent 100 .
  • the proximal end of the second open branch 21b and the proximal end of the third open branch 21c each have an extension portion 210.
  • the first line portion 21121, the extension portion 210 of the second open branch 21b, the second line portion 21122, the extension portion 210 of the third open branch 21c, and the first connection unit 211 of part of the third open branch 21c are arranged from the proximal end to the distal end.
  • the ends are connected in series in sequence to form a spiral structure surrounding the axis of the thrombectomy stent 100 .
  • the thrombectomy stent 100 further includes a collection area 30 , which is connected to the capture area 20 and is located at the distal end of the capture area 20 .
  • the far end is a closed structure with mesh.
  • the collection area 30 is an internally hollow and self-expanding mesh tubular structure, and specifically may be a multi-mesh structure, that is, there are multiple meshes in one circumferential direction.
  • the proximal end of the collection area 30 is open and the distal end is closed, so that when the fallen thrombus cannot be captured by the capture area 20, it can enter the interior of the collection area 30 through the proximal opening of the collection area 30.
  • the distal sealing structure of the collection area 30 prevents thrombus from escaping, thereby effectively capturing and collecting thrombus and avoiding secondary embolization of blood vessels.
  • the distal end of the collection area 30 has multiple guide rods.
  • the outside of the rod is covered with a buffer member 33, and the distal end of at least one guide rod among the plurality of guide rods is set beyond the distal ends of the remaining guide rods.
  • the guide rod includes one first guide rod 31 and three second guide rods 32, and the distal end of the first guide rod 31 exceeds the second guide rod 32.
  • the distal end is covered with a buffer member 33 on the outside of the first guide rod 31 and the second guide rod 32 , thereby forming a closed end at the distal end of the collection area 30 .
  • the buffer member 33 can be made of a spring made of an X-ray opaque material.
  • the spring can be made of platinum-tungsten alloy, platinum-iridium alloy and other materials, and the spring has a certain degree of flexibility.
  • Clinicians can monitor the position of the X-ray opaque spring through vascular imaging equipment, such as DSA (digital subtraction angiography), thereby determining the distal position of the collection area 30 of the endovascular thrombectomy stent 100 .
  • vascular imaging equipment such as DSA (digital subtraction angiography)
  • laser welding, glue dispensing or soldering may be used to connect the guide rod and the buffer member 30 .
  • the guide rods include two first guide rods 31 and two second guide rods 32, and the distal ends of the first guide rods 31 exceed the second guide rods 31.
  • the distal end of the guide rod 32 and the outside of the first guide rod 31 and the second guide rod 32 are covered with a buffer member 33, which can also form a closed end at the distal end of the collection area 30 and has an elongated Ends.
  • the opening area 10 has a certain radial support strength to facilitate penetration and collection of thrombi.
  • the open area 10 has multiple closed meshes along the same circumferential direction, specifically 4, 6, 8 or more.
  • the open area 10 may also have an open structure at both ends; or, the proximal end of the open area 10 may have a closed structure, and the proximal end of the open area 10 may have an open structure.
  • first connecting rod 11 at the proximal end of the opening area 10, and the thrombectomy stent 100 is connected to the delivery device through the first connecting rod 11, so as to be transported into the blood vessel to capture and collect thrombi.
  • the thrombus is first squeezed and penetrated through the opening area 10. If any thrombus occurs during the penetration process, falling, the fallen thrombus is captured and collected through the first mesh 2113 and the second mesh 2123 of the capture area 20, so that the fallen thrombus is stuck to the inside of the first mesh 2113 and the second mesh 2123, Or enter the interior of the thrombectomy stent 100 from the first mesh 2113 and/or the second mesh 2123, thereby preventing the thrombus from escaping, effectively capturing and collecting the thrombus, thereby reducing or avoiding secondary embolism in the blood vessel, without
  • the thrombus captured by the first mesh 2113 and the second mesh 2123 is collected through the distal collection area 30, or the small thrombus free inside the thrombectomy stent 100 can also be collected through the distal collection area 30,
  • the thrombectomy device 1 includes a loader 200 , a pusher 300 and a thrombectomy bracket 100 .
  • the loader 200 may be a hollow tube made of a double-layered or multi-layered polymer melt.
  • the innermost layer material is polytetrafluoroethylene with a small friction coefficient.
  • the loader 200 can accommodate the collapsed thrombectomy stent 100 within its lumen.
  • the inner diameter 200 of the loader will be less than or equal to the inner diameter of the microcatheter, preferably 0.45-0.53mm, and the length shall not be less than 500mm.
  • At least part of the pushing member 300 is disposed inside the loader 200 and can move along the axial direction of the loader 200 . In other embodiments, loader 200 may not be included.
  • the proximal end of the thrombus retrieval bracket 100 is provided with at least one connecting rod, and the connecting rod is provided with at least one mounting hole.
  • the distal end of the pusher 300 is connected and fixed to the connecting rod through at least one mounting hole, so that the pusher 300 is connected to the thrombus retrieval bracket. .
  • the thrombectomy stent 100 has a compressed state inside the loader 200 and an expanded state outside the loader 200 .
  • the thrombus retrieval stent 100 can move in the axial direction within the loader 200 under the action of the pusher 300, and finally extends to the outside of the loader 200, and is inserted into the microcatheter.
  • the thrombectomy stent 100 is the thrombectomy stent 100 of any of the above embodiments.
  • the pushing member 300 is provided with at least one mounting hole, and the distal end of the connecting rod is connected and fixed to the pushing member 300 through at least one mounting hole, so that the pushing member 300 is connected to the thrombus retrieval bracket 100 .
  • the thrombectomy device 1 further includes a sleeve 400 , and the proximal end of the connecting rod is connected to the distal end of the pusher 300 and are jointly located inside the sleeve 400 , and fixed through the pipe sleeve 400.
  • the thrombectomy device 1 may not include the sleeve 400.
  • the proximal end of the thrombus retrieval stent 100 is only provided with the first connecting rod 11, the proximal end of the first connecting rod 11 is connected to the distal end of the pushing member 300 and is jointly arranged inside the tube sleeve 400, so that the tube can be connected through the tube.
  • the sleeve 400 fixes the relative position of the proximal end of the first connecting rod 11 and the distal end of the pusher 300, so that the pusher 300 can drive the thrombectomy bracket 100 to move without changing the relative position.
  • the thrombectomy device 1 also includes a filling piece 500.
  • the filling piece 500 is provided inside the pipe sleeve 400 and is used to fill the pipe sleeve 400. gap, and seal both ends of the pipe sleeve 400.
  • the proximal end of the first connecting rod 11 and the distal end of the pushing member 300 are clamped and fixed by the pipe sleeve 400 to further fix the first connecting rod 11 and the pushing member 300 .
  • the filling member 500 can be made of tin or medical glue.
  • the sleeve 400 can be made of tantalum ring, platinum-iridium ring or other X-ray opaque materials, so that the proximal position of the thrombectomy stent 100 can be determined by observing the position of the sleeve 400, and then the position of the thrombectomy stent 100 in the blood vessel can be positioned. .
  • the thrombectomy stent can be effectively improved.
  • the reliability of the connection between the thrombectomy bracket 100 and the pusher 300 prevents the thrombectomy bracket 100 from being disconnected from the pusher 300 and ensures the smooth progress of the thrombectomy process.
  • At least one mounting hole is provided on the connecting rod, and the distal end of the pushing member 300 is connected to the at least one mounting hole.
  • connection method can be laser welding, soldering, gluing, etc., so that the pusher 300 drives the bolt removal bracket 100 to move.
  • the pusher 300 includes a large diameter section 310 and a small diameter section 320 located at the distal end of the large diameter section 310 .
  • the radial size of the small diameter section 320 is smaller than the large diameter section 320 .
  • the radial size of the diameter section 310, the small diameter section 310 passes through the mounting hole and is connected to the first connecting rod 11.
  • the large-diameter section 310 is provided at the proximal end of the pusher 300 and has certain support strength and deformation resistance, so that the pusher 300 can be controlled and moved through the large-diameter section 310 .
  • the small-diameter section 320 is provided at the distal end of the pushing member 300 and has a certain deformation ability, so that it can easily pass through the installation hole and be connected to the first connecting rod 11 .
  • the pusher 300 also includes a transition section 330.
  • the two ends of the transition section 330 are respectively connected to the large diameter section 310 and the small diameter section 320.
  • the radial size of the transition section 330 is given by The large diameter section 310 gradually decreases toward the small diameter section 320 .
  • transition section 330 By providing the transition section 330, a smooth transition is made between the large diameter section 310 and the small diameter section 320 with different radial sizes, thereby ensuring uniform stress on the pusher 300 and preventing breakage during the process of pushing the thrombus retrieval stent 100.
  • the pusher 300 is generally made of nickel-titanium material, and the total length is not less than the length of a commonly used microcatheter.
  • the total length L1 of the pusher 300 is generally 1500 ⁇ 2200mm, and the large diameter
  • the outer diameter of the segment 310 is selected from 0.35 to 0.45mm, preferably 0.4mm.
  • the overall length L2 of the small diameter section 320 and the transition section 330 is set to 200 to 400 mm, preferably 350 mm.
  • the radial size of the small-diameter section 320 of the pushing member 300 is selected from 0.08 to 0.12 mm, preferably 0.1 mm, to ensure that the small-diameter section 320 has a certain deformation ability.
  • the proximal end of the thrombus retrieval bracket 100 is provided with a connecting rod.
  • the connecting rod is provided with at least one mounting hole.
  • the distal end of the pushing member 300 passes through at least one mounting hole and is connected to
  • the fixing part 340 is provided, and the maximum size of the fixing part 340 is larger than the diameter of the mounting hole.
  • the fixing member 340 uses laser welding to form a ball head at the distal end of the pushing member 300 . It can be understood that the fixing member 340 can be in various shapes, such as strip shape, cube shape or various irregular shapes, as long as it cannot penetrate through the mounting hole.
  • the pushing member 300 is provided with at least one mounting hole, and the distal end of the connecting rod is connected to the fixing member 340 after passing through the at least one mounting hole, and the maximum size of the fixing member 340 is larger than the diameter of the mounting hole.
  • the first connecting rod 11 is provided with only one first mounting hole 111, and the diameter of the first mounting hole 111 is slightly larger than the radial size of the small diameter section 320, thereby ensuring that the small diameter section 320 can pass through the first mounting hole 111 .
  • the distal end of the small-diameter section 320 that passes through the first mounting hole 111 is set into a ball head by laser welding, thereby ensuring that the distal end of the small-diameter section 320 is clamped to one side of the first mounting hole 111 and ensuring that the pipe sleeve 400
  • the fixing effect of the filling piece 500 on the small diameter section 320 prevents relative displacement in the axial direction between the pushing piece 300 and the pipe sleeve 400 during the pushing and recycling process.
  • the first connecting rod 11 is provided with two first mounting holes 111 spaced apart along the axial direction, and the diameters of the two first mounting holes 111 are equal. Slightly larger than the radial size of the small diameter section 320 , thereby ensuring that the small diameter section 320 can pass through the first mounting hole 111 .
  • the distal end of the small diameter section 320 passes through the first mounting hole 111 at the proximal end and the first mounting hole at the distal end in sequence. 111 and then set into a ball head by laser welding, thereby further improving the fixing effect of the push member 300 through the two first mounting holes 111 .
  • the first connecting rod 11 is provided with two first mounting holes 111 spaced apart along the axial direction, and the diameters of the two first mounting holes 111 are equal. Slightly larger than the radial dimension of the small diameter section 320 . After the distal end of the small diameter section 320 passes through the first proximal mounting hole 111 and the distal first mounting hole 111 in sequence, it passes through the proximal first mounting hole 111 again, and is then set into a ball head by laser welding. , thereby further improving the fixing effect on the pushing member 300 through the two first mounting holes 111 .
  • the proximal end of the thrombus retrieval bracket 100 is provided with at least two connecting rods, and the two connecting rods are respectively provided with at least one mounting hole.
  • the pusher 300 The far ends of are connected to the mounting holes on the two connecting rods respectively.
  • the proximal end of the thrombus retrieval bracket 100 is provided with a first connecting rod 11 and a second connecting rod 12 .
  • the first connecting rod 11 and the second connecting rod 12 are respectively arranged in the axial direction and spaced apart.
  • the first connecting rod 11 and the second connecting rod 12 are respectively provided with mounting holes, and are connected to the pushing member 30 through the mounting holes.
  • the proximal end of the first connecting rod 11 is provided with a first mounting hole 111
  • the proximal end of the second connecting rod 12 is provided with a second mounting hole 121
  • the first The mounting hole 111 and the second mounting hole 121 are provided correspondingly.
  • the distal end of the small diameter section 320 is provided with a fixing piece 340.
  • the maximum size of the fixing piece 340 is larger than the diameter of any one of the first mounting hole 111 and the second mounting hole 121.
  • the fixing member 340 uses laser welding to form a ball head at the distal end of the pushing member 300 .
  • the inner diameter of the pipe sleeve 400 is slightly smaller than or equal to the radial dimension of the first connecting rod 11 and the radial dimension of the second connecting rod 12 .
  • the sum of the radial size and the radial size of the small diameter section 320 achieves an interference fit effect.
  • the maximum dimension of the fixing member 340 is slightly larger than the radial dimension of the small diameter section 320 .
  • the first connecting rod 11 is provided with two first mounting holes 111 spaced apart along the axial direction
  • the second connecting rod 12 is provided with two first mounting holes 111 spaced apart along the axial direction.
  • Two second mounting holes 121 After the distal end of the small diameter section 320 passes through the first mounting hole 111 and the second mounting hole 121 at the proximal end in sequence, it extends toward the distal end and passes through the second mounting hole at the distal end in sequence again.
  • the capture area 20 is provided with a capture area developing element 71; the opening area 10 is wound with an opening area developing wire 72, and the opening area developing wire 72 includes a non-overlapping first opening.
  • the area developing wire 721 and the second opening area developing wire 722, the proximal end of the first opening area developing wire 721 and the proximal end of the second opening area developing wire 722 converge to form the opening area developing wire proximal convergence point 723, the first opening area
  • the distal end of the developing wire 721 and the distal end of the second opening area developing wire 722 converge to form the opening area developing wire distal convergence point 724;
  • the collection area 30 is wrapped with a collection area development wire 73, and the collection area development wire 73 includes non-overlapping
  • the first collection area development wire 731 and the second collection area development wire 732, the proximal end of the first collection area development wire 731 and the second collection area development wire 732 converge to form the collection area development wire proximal convergence point 733,
  • the distal ends of the developing wires 731 in one collection area and the distal ends of the developing wires 732 in the second collection area converge to form a distal convergence point 734 of the developing wires in the
  • the opening area 10 is provided with non-overlapping first opening area development wires 721 and second opening area development wires 722, and the collection area 30 is provided with non-overlapping first collection area development wires 731 and second collection area development wires 732, that is, multi-stage development.
  • the wires are distributed to different positions of the opening area 10 or the collection area 30, so that the expansion status of the opening area 10 or the collection area 30 can be judged through the multi-segment development wires with different spatial surfaces caused by different positions, and the nature of the vascular lesions can be further judged and grasped ( For example, whether there is a thrombus or stenosis in the blood vessel), multi-segment imaging at the same time has stronger visualization and is more conducive to the operator's observation.
  • the two ends of the first opening area developing wire 721 and the second opening area developing wire 722 are set to converge respectively, and the two ends of the first collecting area developing wire 731 and the second collecting area developing wire 732 are respectively converged, so that the first opening area
  • the developing wire 721 and the second opening area developing wire 722 are stably fixed on the thrombus retrieval bracket.
  • the first collection area developing wire 731 and the second collection area developing wire 732 can also be stably fixed on the thrombus retrieval bracket, and can reduce development The free end of the wire reduces the possibility of puncturing the lumen of the delivery device or the inner wall of the blood vessel.
  • the capture area development element 71 includes a capture area development wire 711, which is wound around the capture area 20.
  • the capture area development wire 711 extends spirally along the axis of the capture area 20.
  • the capture area development wire 711 The proximal end is far away from the opening area developing wire
  • the end convergence point 724 is connected, and the distal end of the capture area development wire 711 is connected to the proximal convergence point 733 of the collection area development wire.
  • the opening area developing wire 72, the capturing area developing wire 71, and the collecting area developing wire 73 are connected to each other, so that the whole and continuous development of the thrombectomy stent 100 can be observed throughout the operation, which is more conducive to observing the overall shape and position of the thrombectomy stent 100.
  • the operator can determine the location of the patient's thrombus and the nature of the lesion during the operation, as well as the fit between the thrombus retrieval stent 100 and the thrombus, and adjust the surgical strategy based on this to improve the success rate of the thrombus retrieval operation and reduce surgical complications.
  • the opening area developing wire 72, the capturing area developing wire 71 and the collecting area developing wire 73 are arranged to be integrally formed.
  • the first opening area developing wire 721 and the second opening area developing wire 722 start from the opening area developing wire proximal convergence point 723, respectively wind around the opening area 10, and then at the opening area development yarn distal convergence point 724, At this time, the first opening area development yarn 721 and the second opening area development yarn 722 are entangled together to form one development yarn, which is the capture area development yarn 711 (that is to say, the capture area development yarn 711 is composed of multiple strands of development yarns.
  • the capture area development wire 711 spirally extends along the axis of the capture area 20, and separates at the proximal convergence point 733 of the collection area development wire to form a first collection area development wire 731 and a second collection area development wire 732.
  • the first collection area The developing wire 731 and the second collecting area developing wire 732 are wound around the collecting area 30 respectively, and finally converge at the distal convergence point 734 of the collecting area developing wire.
  • the developing wire 72 in the opening area, the developing wire 71 in the capturing area and the developing wire 73 in the collecting area may be configured to be non-integrated and connected by conventional methods such as welding. Compared with the non-one-piece design, the one-piece design can better fix the developing wire on the thrombectomy bracket, and does not have a connecting structure, no free ends, and has a simple structure, making it safer.
  • the thrombus retrieval bracket 100 is composed of multiple bracket rods, in which the capture area 20 includes the capture area bracket rod, the opening area 10 includes the opening area bracket rod, the collection area 30 includes the collection area bracket rod, and the capture area developing wire 71 is wound around the capture area bracket rod.
  • the developing wire 72 in the opening area is wound around the support rod in the opening area
  • the developing wire 73 in the collection area is wound around the support rod in the collection area. That is to say, the developing wire is fixed to the bracket rod by wrapping itself around the bracket rod.
  • the developing wire 711 in the capture area is not only wrapped around the bracket rod in the capture zone to be fixed to the bracket rod in the capture zone, it also needs to be captured along the upper edge of the capture zone 20.
  • the axis of zone 20 extends spirally.
  • the capture area development element 71 includes a capture area development point 712.
  • the capture area development point 712 is embedded in the capture area 20.
  • the first opening area development wire 721 and the second opening area development wire 722 are formed by one
  • the developing yarn is formed by folding a pair of folding points, and the folding point is the distal convergence point 724 of the developing yarn in the open area.
  • the first collecting area developing yarn 731 and the second collecting area developing yarn 732 are formed by folding another developing yarn at another pair of folding points. Formed, another pair of folding points is the convergence point 733 at the proximal end of the development wire in the collection area.
  • This design can avoid the formation of free ends of the developing wire, and is safer. It can be understood that the number of the first opening area developing wires 721 and the second opening area developing wires 722 can be multiple, and the number of the first collection area developing wires 731 and the second collecting area developing wires 732 can be multiple.
  • a development slot 90 is provided on the second connection unit free end 2120 of the second connection unit 212 of each open branch 21.
  • the development slot 90 is used to accommodate the capture area development point 712, specifically, the capture area development point 712. Points 712 are punched into the development tank 90 so that the capture area development points 712 are fixed into the development tank 90.
  • the material of the capture area development points 712 is well known to those skilled in the art, such as gold, platinum, etc.
  • the proximal end of the thrombectomy bracket 100 can also be provided with a proximal development spring 82, and/or the distal end of the thrombectomy bracket 100 can be provided with a distal development spring 81, which can be used
  • a proximal development spring 82 the distal end of the thrombectomy bracket 100 can be provided with a distal development spring 81, which can be used
  • the spring structure can have better flexibility and avoid damage to the blood vessels and the inner wall of the delivery sheath.
  • the proximal development spring 82 is provided at the connection between the first connecting rod 11 and the pushing member 300, or at the connection between the first connecting rod 11, the second connecting rod 12 and the pushing member 300, The flexible spring structure can avoid affecting the control force of the pusher 300 on the thrombus retrieval bracket 100 .
  • the proximal development spring 82 is connected to the proximal convergence point 723 of the development wire in the opening area, and the distal development spring 81 is connected to the distal convergence point 734 of the development wire in the collection area, which can more completely display the intraoperative thrombectomy stent. 100 overall shape and position.
  • the distal developing spring 81 may be the above-mentioned buffer member 33 .
  • DSA digital subtraction angiography
  • angiography is used to perform angiography on the patient to determine the location of the thrombus 3 to be captured in the blood vessel 2 .
  • vascular intervention technology Through vascular intervention technology, the distal end of the microcatheter 600 is transported to a certain distance beyond the thrombus 3.
  • angiography of the distal end of the thrombus 3 is performed through the microcatheter 600 to determine the length of the thrombus 3 and select the appropriate size.
  • Bolt bracket 100 is used to determine the length of the thrombus 3 and select the appropriate size.
  • the thrombectomy stent 100 is pushed into the microcatheter 600 through the loader 200 and transported through the inner cavity of the microcatheter 600.
  • the distal end of the thrombectomy stent 100 reaches the farthest end of the microcatheter 600, as shown in Figure 25
  • fix the pusher 300 keep the whole thrombectomy stent 100 motionless relative to the human body, and withdraw the microcatheter 600 proximally.
  • the thrombectomy stent 100 will move around the thrombus.
  • Position 3 self-expands.
  • the proximal opening area 10 of the expanded thrombectomy stent 100 squeezes the thrombus 3 to one side of the blood vessel 2, and the blood vessel 2 immediately restores partial blood flow and recanalizes, preventing the core infarction area from deteriorating. . Then wait for more than 5 minutes to fully expand the thrombectomy stent 100 and fully integrate the mesh of the opening area 10 with the thrombus 3 .
  • the thrombectomy stent 100 and the microcatheter 600 are slowly withdrawn. At this time, any chopped and fallen thrombi 3 will be captured and collected by the capture area 20 of the thrombectomy stent 100. .
  • the open branch 21 located at the proximal end fails to effectively capture the thrombus 3
  • other open branches located at the distal end will 21 can further capture and collect the fallen thrombus 3 to prevent the thrombus 3 from escaping, and finally fix the thrombus 3 inside the thrombectomy stent 100 .
  • the smaller thrombus 3 will be completely trapped by the distal collection area 30 of the thrombectomy stent 100 .
  • the thrombectomy stent 100 and the microcatheter 600 are continuously withdrawn until the thrombectomy stent 100 is withdrawn into the lumen of the catheter 700 .
  • the fully expanded diameter of the thrombectomy stent 100 will be slightly larger than the lumen of the blood vessel 2, but larger than the outer diameter of the catheter 700.
  • the catheter 700 The head end may have a certain cutting effect on thrombus 3.
  • the doctor can use a syringe or connect a negative pressure suction device to the catheter to extract negative pressure.
  • the negative pressure suction combined with the pulling of the thrombectomy stent 100 can improve the one-time recanalization rate of thrombectomy.
  • the multiple open branches 21 distributed in a spiral on the capture area 20 of the thrombectomy stent 100 can also be used to bring the thrombus 3 cut at the tube opening back to the inner cavity of the catheter 700 .
  • the thrombectomy stent 100 and the thrombus 3 in the thrombectomy stent 100 are all removed from the body, and the entire thrombectomy process is completed.
  • the thrombectomy process of the thrombectomy device 1 in the curved blood vessel 2 is the thrombectomy process of the thrombectomy device 1 in the curved blood vessel 2 . Since the first connection unit 211 and the second connection unit 212 have a certain deformability, after the thrombectomy stent 100 enters the curved blood vessel 2 , the first connection unit 211 and the second connection unit 212 deform and fit into the blood vessel 2 The inner wall thus forms an opening between the two adjacent open branches 21 to facilitate the thrombus 3 to fall into the interior of the open branches 21 and then be captured by the first connection unit 211 or the second connection unit 212 .

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Abstract

一种取栓支架(100)及取栓装置(1),取栓支架(100)包括捕获区(20),捕获区(20)设有沿其轴向方向设置的至少一个开放分支(21),开放分支(21)的远端为开放结构,开放分支(21)内部具有分支通道(201),分支通道(201)与开放结构相通,开放分支(21)包括第一连接单元(211)、第二连接单元(212)和至少一个第三连接单元(213),第三连接单元(213)连接第一连接单元(211)和第二连接单元(212),其中,第一连接单元(211)在取栓支架(100)的径向截面上的投影与取栓支架(100)的径向截面重合,分支通道(201)贯穿第一连接单元(211)内,第二连接单元(212)具有第二连接单元自由端(2120),第二连接单元自由端(2120)比第一连接单元(211)的远端、第三连接单元(213)的远端更靠近远端。取栓装置(1)包括装载器(200)、推送件(300)和取栓支架(100)。

Description

取栓支架及取栓装置 技术领域
本申请属于医疗器械技术领域,具体涉及一种取栓支架及具有该取栓支架的取栓装置。
背景技术
脑卒中又称脑中风,是急性脑血管病引起的局部脑功能障碍,临床症候持续超过24小时,具有发病率高、死亡率高、致残率高、复发率高的特点,好发于50岁及以上人群。目前我国脑卒中的发病率逐年上升,并已成为我国第一位致死原因。
急性缺血性卒中是由于脑部血流的突然阻塞而引起局部脑组织缺血坏死所导致的神经组织损伤。急性缺血性脑卒中是卒中最常见类型,是中老年人致死和致残的主要疾病。尤其是大血管闭塞所致的急性脑卒中,病情凶险,死亡率、致残率高。一旦发生中风,给患者造成巨大身心危害,也给患者家庭及社会造成沉重的负担。血管的再通是治疗急性缺血性脑卒中的关键。目前治疗急性缺血性脑卒中的常规方法包括两大类:介入溶栓和机械取栓。发病4~5小时内采用药物溶栓是治疗急性缺血性脑卒中的首选方案,但由于时间窗太短,极少数的脑卒中患者才符合药物溶栓的治疗条件。同时,药物溶栓由于治疗时间窗短、血管再通率低、出血并发症发生率高等因素,介入器械取栓逐渐发展,并在临床中表现出良好的应用前景。介入器械取栓的治疗方式适用性更广,且能够快速使闭塞的血管再通,降低药物并发症的发生率,改善患者预后。
现有的介入取栓器械大部分为自膨胀取栓支架,自膨胀取栓支架存在以下问题:对于富含白细胞的白血栓/硬血栓,该血栓富含纤维,粘弹性强,而自膨胀支架的径向力不够使支架的网杆渗透进入白血栓,造成取栓失败;对于质地较软的红血栓,由于取栓过程中,支架杆的切割作用容易将大块血栓切割成体积更小的血栓,容易造成小血栓向远端血管逃逸,引起远端血管闭塞,从而导致取栓失败。
发明内容
本申请的目的是至少解决完整捕获血栓以及取栓过程中掉落的血栓容易发生逃逸的问题。该目的是通过以下方式实现的。
一种取栓支架,包括:
捕获区,所述捕获区设有沿其轴向方向设置的至少一个开放分支,所述开放分支的远端为开放结构,所述开放分支内部具有分支通道,所述分支通道与所述开放结构相通,所述开放分支包括第一连接单元、第二连接单元和至少一个第三连接单元,所述第三连接单元连接所述第一连接单元和所述第二连接单元,其中,所述第一连接单元在所述取栓支架的径向截面上的投影与所述取栓支架的径向截面重合,所述分支通道贯穿所述第一连接单元内,所述第二连接单元具有第二连接单元自由端,所述第二连接单元自由端比所述第一连接单元的远端、所述第三连接单元的远端更靠近远端。
一种取栓装置,包括:
取栓支架;
推送件,所述取栓支架与所述推送件的远端相连;
和/或,装载器,所述取栓支架可设于所述装载器的内部,所述取栓支架具有处于所述装载器内的压缩状态和处于所述装载器外的膨胀状态;
其中,所述取栓支架为根据上述的取栓支架。
本申请的一个或多个实施例的细节在下面的附图和描述中提出。本申请的其它特征、目的和优点将从说明书、附图以及权利要求书变得明显。
附图说明
为了更好地描述和说明这里公开的那些申请的实施例和/或示例,可以参考一幅或多幅附图。用于 描述附图的附加细节或示例不应当被认为是对所公开的申请、目前描述的实施例和/或示例以及目前理解的这些申请的最佳模式中的任何一者的范围的限制。
图1为本发明一实施方式的取栓支架的结构示意图。
图2为图1的取栓支架的另一角度的结构示意图。
图3为图1的取栓支架的又一角度的结构示意图。
图4为一实施方式的捕获区的结构示意图。
图5为一实施方式的开放分支的结构示意图。
图6为一实施方式的收集区的结构示意图。
图7为一实施方式的收集区的导引杆包覆缓冲件的结构示意图。
图8为一实施方式的收集区的导引杆未包覆缓冲件的结构示意图。
图9为一实施方式的开通区的结构示意图。
图10为一实施方式的取栓装置的结构示意图。
图11为一实施方式的推送件的结构示意图。
图12为一实施方式的推送件与取栓支架的连接结构示意图。
图13为一实施方式的推送件与取栓支架的连接结构的分解示意图。
图14为一实施方式的开通区的近端结构示意图。
图15为一实施方式的推送件与取栓支架的连接结构的剖面结构示意。
图16为一实施方式的推送件与取栓支架的连接结构的剖面结构示意图。
图17为一实施方式的推送件与取栓支架的连接结构的剖面结构示意图。
图18为一实施方式的取栓支架的结构示意图。
图19为一实施方式的开通区的近端结构示意图。
图20为一实施方式的推送件与取栓支架的连接结构的剖面结构示意图。
图21为一实施方式的推送件与取栓支架的连接结构的剖面结构示意图。
图22A为一实施方式的具有显影结构的取栓支架及该显影结构的示意图。
图22B为图22A中具有显影结构的取栓支架及该显影结构的另一角度示意图。
图22C为图22A中具有显影结构的取栓支架及该显影结构的又一角度示意图。
图23A为一实施方式的具有显影结构的取栓支架及该显影结构的示意图。
图23B为图23A中具有显影结构的取栓支架及该显影结构的另一角度示意图。
图23C为图23A中具有显影结构的取栓支架及该显影结构的又一角度示意图。
图23D为图23A的细节示意图。
图24为一实施方式的微导管插入至血管内的结构示意图。
图25为一实施方式的取栓支架插入至微导管内的结构示意图。
图26为一实施方式的开通区渗透血栓时的结构示意图。
图27为一实施方式的捕获区捕获血栓时的结构示意图。
图28为一实施方式的取栓支架退回至导管内时的结构示意图。
图29为一实施方式的捕获区在弯曲血管内捕获血栓时的结构示意图。
图30为图29的A部的放大结构示意图。
具体实施方式
下面将参照附图更详细地描述本发明的示例性实施方式。虽然附图中显示了本发明的示例性实施方式,然而应当理解,可以以各种形式实现本发明而不应被这里阐述的实施方式所限制。相反,提供这些实施方式是为了能够更透彻地理解本发明,并且能够将本发明的范围完整的传达给本领域的技术人员。
应理解的是,文中使用的术语仅出于描述特定示例实施方式的目的,而无意于进行限制。除非上下文另外明确地指出,否则如文中使用的单数形式“一”、“一个”以及“所述”也可以表示包括复数 形式。术语“包括”、“包含”、“含有”以及“具有”是包含性的,并且因此指明所陈述的特征、步骤、操作、元件和/或部件的存在,但并不排除存在或者添加一个或多个其它特征、步骤、操作、元件、部件、和/或它们的组合。文中描述的方法步骤、过程、以及操作不解释为必须要求它们以所描述或说明的特定顺序执行,除非明确指出执行顺序。还应当理解,可以使用另外或者替代的步骤。
尽管可以在文中使用术语第一、第二、第三等来描述多个元件、部件、区域、层和/或部段,但是,这些元件、部件、区域、层和/或部段不应被这些术语所限制。这些术语可以仅用来将一个元件、部件、区域、层或部段与另一区域、层或部段区分开。除非上下文明确地指出,否则诸如“第一”、“第二”之类的术语以及其它数字术语在文中使用时并不暗示顺序或者次序。因此,以下讨论的第一元件、部件、区域、层或部段在不脱离示例实施方式的教导的情况下可以被称作第二元件、部件、区域、层或部段。
为了便于描述,可以在文中使用空间相对关系术语来描述如图中示出的一个元件或者特征相对于另一元件或者特征的关系,这些相对关系术语例如为“内部”、“外部”、“内侧”、“外侧”、“下面”、“下方”、“上面”、“上方”等。这种空间相对关系术语意于包括除图中描绘的方位之外的在使用或者操作中装置的不同方位。例如,如果在图中的装置翻转,那么描述为“在其它元件或者特征下面”或者“在其它元件或者特征下方”的元件将随后定向为“在其它元件或者特征上面”或者“在其它元件或者特征上方”。因此,示例术语“在……下方”可以包括在上和在下的方位。装置可以另外定向(旋转90度或者在其它方向)并且文中使用的空间相对关系描述符相应地进行解释。
为了更加清楚地描述本申请的结构,此处限定术语“近端”及“远端”为介入医疗领域惯用术语。具体而言,“远端”表示手术操作过程中远离操作人员的一端,“近端”表示手术操作过程中靠近操作人员的一端,“轴向”表示其长度方向,“径向”表示垂直于“轴向”的方向。
现有的介入取栓器械大部分为自膨胀取栓支架,自膨胀取栓支架存在以下问题:对于富含白细胞的白血栓/硬血栓,该血栓富含纤维,粘弹性强,而自膨胀支架的径向力不够使支架的网杆渗透进入白血栓,造成取栓失败;对于质地较软的红血栓,由于取栓过程中,支架杆的切割作用容易将大块血栓切割成体积更小的血栓,容易造成小血栓向远端血管逃逸,引起远端血管闭塞,从而导致取栓失败。
结合图1至图3所示,为了解决取栓过程中掉落的血栓容易发生逃逸的问题,本发明的第一方面提出了一种取栓支架100,取栓支架100包括开通区10、捕获区20和收集区30。开通区10用于渗透血栓,捕获区20与开通区10相连并设于开通区10的远端,捕获区20设有沿其轴向方向设置的至少一个开放分支21,收集区30与捕获区20相连并设于开通区10的远端,收集区30用于收集逃逸到远端的血栓。在其他实施例中,取栓支架100可以只包括捕获区20,或者只包括捕获区20与开通区10,或者只包括开通区10和收集区30。
具体地,在本发明的一些实施方式中,取栓支架100为内部中空的自膨胀网管状结构,从而保证取栓支架100具有一定的变形能力,以便将取栓支架100压缩于输送装置内,或从而输送装置内释放后自动恢复至膨胀状态,方便捕获血栓,从而保证植入血管后血管内血液的正常流通。
在图4中,捕获区20可以为两端开口的结构,捕获区20设有至少一个开放分支21。开放分支21的数量根据取栓支架100的总体长度而定,一般可设置1~5个开放分支21,多个开放分支21围绕取栓支架100的轴线由取栓支架100的近端螺旋延伸至取栓支架100的远端,形成围绕取栓支架100轴线的螺旋形结构,捕获区显影丝711(参看图22B)缠绕在螺旋形结构上。上述的螺旋形结构具有良好的弯曲性能,能够对血管刺激小,不会对血管造成损伤。在其他实施例中,不需要设置螺旋延伸,只需相邻设置的两个开放分支21间沿捕获区20的圆周方向间隔一定角度即可。
在图5中,在本实施例中,开放分支21的远端为开放结构,开放分支21内部具有分支通道201,分支通道201与开放结构相通,开放分支21包括第一连接单元211、第二连接单元212和至少一个第三连接单元213,第三连接单元213连接第一连接单元211和第二连接单元212。结合图4和图5,第一连接单元211在取栓支架100的径向截面上的投影与取栓支架100的径向截面重合,分支通道201贯穿第一连接单元211内,第二连接单元212具有第二连接单元自由端2120,第二连接单元自由端2120比第一连接单元211的远端、第三连接单元213的远端更靠近远端。需要说明的是,这里的开放结构 是指开放分支21的远端没有汇聚在一起形成封闭结构,而是具有开口结构。
其中,第三连接单元213连接第一连接单元211和第二连接单元212,起到支撑第一连接单元211和第二连接单元212的作用;第一连接单元211在取栓支架100的径向截面上的投影与取栓支架100的径向截面重合,分支通道201贯穿第一连接单元211内,使较大的红血栓能够较为完整地经第一连接单元211内进入到分支通道201内,并包裹在分支通道201内,避免质地较软的红血栓被切割,质地较硬的白血栓也能经第一连接单元211内进入到分支通道201内从而被捕获;设置第二连接单元212具有第二连接单元自由端2120,第二连接单元自由端2120比第一连接单元211的远端、第二连接单元212的远端更靠近远端,是为了在经过弯曲血管时,位于分支通道201内的血栓容易被血管挤压发生逃逸,而第二连接单元212通过第二连接单元自由端2120能够很好地贴合血管壁,在远端拦截逃逸的血栓,使血栓回到分支通道201内,对血栓进行有效的捕获和收集,进而减少或避免血管发生二次栓塞。
在本实施例中,可以在第二连接单元自由端2120上设置显影点,方便在体内实现显影功能。该显影点的材料为本领域技术人员所熟知的,临床医生可通过血管影像学设备,如DSA(数字减影血管造影)监视该显影点的位置,从而确定血管内第二连接单元自由端2120的位置。具体显影结构的设计,下述有具体介绍。
参看图5,第三连接单元213的两端与第一连接单元211相连,第二连接单元212的近端分别连接于第三连接单元213和第一连接单元211上,第二连接单元自由端2120向远端延伸。其中,可以理解的是,在本实施例中,第一连接单元211、第二连接单元212和第三连接单元213沿圆周方向设置,分支通道201经过第一连接单元211、第二连接单元212和第三连接单元213围绕的中间区域,并从第一连接单元211穿出。如此设置,能够使分支通道201的空间较大,容易完整捕获大血栓。
在其他实施例中,第二连接单元212的近端也可以连接在第三连接单元213上,也就是说,第一连接单元211与第三连接单元213相连,第二连接单元212也与第三连接单元213相连。具体地,第二连接单元212可以位于第一连接单元211与第三连接单元213之间的位置,此时,分支通道201被分成两个,分别为第一连接单元211与第二连接单元212之间的通道,以及第二连接单元212与第三连接单元213之间的通道;或者,第三连接单元213还可以位于第一连接单元211与第二连接单元212之间的位置,此时,分支通道201被分成两个,分别为第一连接单元211与第三连接单元213之间的通道,以及第二连接单元212与第三连接单元213之间的通道。
其中,第一连接单元211设有用于捕获血栓的第一网孔2113,第二连接单元212设有用于捕获血栓的第二网孔2123,血栓能够卡接于第一网孔2113和第二网孔2123内,或者从第一网孔2113和第二网孔2123进入至取栓支架100内,从而防止血栓掉落逃逸。第三连接单元213用于为开放分支21提供支撑力,从而防止开放分支21在受到血管挤压后沿周向方向发生凹陷,避免开放分支21与血管的内壁间形成间隙,从而减少或避免血栓发生逃逸现象,可以理解的,第三连接单元213的形状可以不限,可以为V字型,W字型、圆弧形、波浪形等其他规则或不规则形状,只要能起到支撑作用即可。
在一些实施方式中,第一连接单元211包括第一连杆2111和第二连杆2112,第二连杆2112的两端分别与第一连杆2111的两端相连形成所述第一网孔2113,分支通道201贯穿第一网孔2113。在其他实施例中,第一连接单元211可以为超过两个杆围合成的网孔结构,多个杆依次首尾相连围成该网孔结构。相较于由多个连杆合围成的网孔结构,仅由两个连杆组成的网孔结构具有一定的变形能力,从而使第一连接单元211更加适应穿设于弯曲血管中,适应血管的弯曲方向,灵活性更好。其中,第一连杆2111与第二连杆2112可以为一体式结构,或分体式结构并连接在一起。
在本发明的一些实施方式中,第三连接单元213包括第三连杆2131和第四连杆2132,第三连杆2131的远端和第四连杆2132的远端相连,第三连杆2131的近端与第二连杆2112的远端和近端之间的部分相连,或与相邻的第三连接单元213的第四连杆2132相连,第四连杆2132的近端与第一连杆2111的远端和近端之间的部分相连,或与相邻的三连接单元213的第三连杆2131相连。
具体地,第三连接单元213的数量可以为多个或一个,具体数量可根据取栓支架100的径向尺寸和所需的支撑强度而定。当开放分支21仅包括一个第三连接单元213时,第三连杆2131的近端与第二连杆2112的远端和近端之间的部分相连,第四连杆2132的近端与第一连杆2111的远端和近端之间 的部分相连,从而提高开放分支21的径向支撑强度。当开放分支21包括超过一个第三连接单元213时,多个第三连接单元213沿开放分支21的周向方向依次连接设置。其中靠近第二连杆2112的第三连接单元213的第三连杆2131的近端与第二连杆2112相连,靠近第二连杆2112的第三连接单元213的第四连杆2132的近端与相邻设置的第三连接单元213的第三连杆2131的近端相连,靠近第二连接单元212的第三连接单元213的第四连杆2132的近端与第一连杆2111相连,靠近第二连接单元212的第三连接单元213的第三连杆2131的近端与相邻设置的第三连接单元213的第四连杆2134的近端相连。
可以理解的,多个第三连接单元213还能沿开放分支21的轴向方向设置,此时所有的第三连接单元213的第三连杆2131均与第二连杆2112的远端和近端之间的部分相连,所有的第三连接单元213的第四连杆2132的近端均与第一连杆2111的远端和近端之间的部分相连。或者,还可以设置一部分第三连接单元213沿周向设置,一部分沿轴向设置,只要能起到支撑作用即可。
在一些实施方式中,第二连接单元212包括第五连杆2121和第六连杆2122,第五连杆2121的远端和第六连杆2122的远端相连,第五连杆2121的近端与第一连杆2111的远端和近端之间的部分相连,第六连杆2122的近端与第四连杆2132的远端和近端之间的部分相连。在其他实施例中,第五连杆2121的近端可以与第一连接单元211的任意位置连接,第六连杆的近端与第三连接单元213的任意位置连接,只要能保证第二连接单元自由端2120比第一连接单元211的远端、第三连接单元213的远端更靠近远端,在第二连接单元212的近端和远端之间无任何固定支撑结构,从而保持第二连接单元212的自由度即可。这里的自由度是指第二连接单元212不被其它连接单元束缚,第二连接单元自由端2120具有一定的活动能力。
具体地,第二连接单元212仅由第五连杆2121和第六连杆2122组成,相较于多个连杆合围成的网孔结构,仅由两个连杆组成的网孔结构更容易发生变形,从而进一步使第二连接单元212具有一定的自由度,使变形的第二连接单元212更加适应穿设于弯曲血管中,适应血管的弯曲方向,使第二连接单元自由端2120始终贴合血管内壁,从而防止血栓逃逸。
进一步地,第五连杆2121、第六连杆2122、部分第四连杆2132和部分第一连杆2111合围成第二网孔2123,第二网孔2123同样具有捕获掉落血栓的作用。通过第一连接单元211的第一网孔2113和第二连接单元212的第二网孔2123共同捕获血栓,能够更加全面的对血栓进行收集,提高取栓的成功率。
在本实施例中,开放分支21的近端具有延伸部210,其中,开放分支21的近端为第一连接单元211的近端。结合图4和图5,至少两个开放分支21包括第一开放分支21a和第二开放分支21b,至少两个开放分支中至少一个的近端具有延伸部210,第二开放分支21b的近端或者第二开放分支21b的延伸部210与第一开放分支21a的第一连接单元211的远端和近端之间的部分相连,形成第一连接点211a。该第一连接单元211的远端和近端之间的部分可以为第一连杆2111的远端和近端之间的部分或者第二连接杆2112的远端和近端之间的部分。
具体地,在一实施例中,开放分支21的近端均不具有延伸部210,相邻开放分支21之间直接相连。其中,在第一开放分支21a的第一连接单元211上,第一连接单元211的近端至第一连接点211a为第一线部21121,第一线部21121与部分第二开放分支21b的第一连接单元211串联,形成围绕取栓支架100轴线的螺旋形结构。需要说明的是,第一线部21121为第一开放分支21a的第一连接单元211的第二连接杆2112的一部分,部分第二开放分支21b的第一连接单元211是指第二开放分支21b的第一连接单元211的第一连接杆2111的至少部分长度或者第二连接杆2112的至少部分长度。
在一实施例中,第一开放分支21a的近端和第二开放分支21b的近端均具有延伸部210。其中,第一开放分支21a的延伸部210、第一线部21121、第二开放分支21b的延伸部210和部分第二开放分支21b的第一连接单元211从近端至远端依次串联,形成围绕取栓支架100轴线的螺旋形结构。
在一实施例中,第一开放分支21a的近端具有延伸部210。其中,第一开放分支21a的延伸部210、第一线部21121和部分第二开放分支21b的第一连接单元211从近端至远端依次串联,形成围绕取栓支架100轴线的螺旋形结构。
在一实施例中,第二开放分支21b的近端具有延伸部210。其中,第一线部21121、第二开放分支21b的延伸部210和部分第二开放分支21b的第一连接单元211从近端至远端依次串联,形成围绕取栓支架100轴线的螺旋形结构。
在一实施例中,至少两个开放分支21还包括第三开放分支21c,第三开放分支21c的近端或者第三开放分支21c的延伸部210与第二开放分支21b的第一连接单元211的远端和近端之间的部分相连,形成第二连接点211b。
在一实施例中,开放分支21的近端均不具有延伸部210,相邻开放分支21之间直接相连。其中,在第二开放分支21b的第一连接单元211上,第一连接单元211的近端至第二连接点211b为第二线部21122,第一线部21121、第二线部21122与部分第三开放分支21c的第一连接单元211从近端至远端依次串联,形成围绕取栓支架100轴线的螺旋形结构。需要说明的是,第二线部21122为第二开放分支21b的第一连接单元211的第二连接杆2112的一部分,部分第三开放分支21c的第一连接单元211是指第三开放分支21c的第一连接单元211的第一连接杆2111的至少部分长度或者至少部分第二连接杆2112的至少部分长度。
在一实施例中,第一开放分支21a的近端、第二开放分支21b的近端和第三开放分支21c的近端均具有延伸部210。其中,第一开放分支21a的延伸部210、第一线部21121、第二开放分支21b的延伸部210、第二线部21122、第三开放分支21c的延伸部210、部分第三开放分支21c的第一连接单元211从近端至远端依次串联,形成围绕取栓支架100轴线的螺旋形结构。
在一实施例中,第一开放分支21a的近端具有延伸部210。其中,第一开放分支21a的延伸部、第一线部21121、第二线部21122、部分第三开放分支21c的第一连接单元211从近端至远端依次串联,形成围绕取栓支架100轴线的螺旋形结构。
在一实施例中,第二开放分支21b的近端具有延伸部210。其中,第一线部21121、第二开放分支21b的延伸部210、第二线部21122、部分第三开放分支21c的第一连接单元211从近端至远端依次串联,形成围绕取栓支架100轴线的螺旋形结构。
在一实施例中,第三开放分支21c的近端具有延伸部210。其中,第一线部21121、第二线部21122、第三开放分支21c的延伸部210、部分第三开放分支21c的第一连接单元211从近端至远端依次串联,形成围绕取栓支架100轴线的螺旋形结构。
在一实施例中,第一开放分支21a的近端和第二开放分支21b的近端均具有延伸部210。其中,第一开放分支21a的延伸部210、第一线部21121、第二开放分支21b的延伸部210、第二线部21122、部分第三开放分支21c的第一连接单元211从近端至远端依次串联,形成围绕取栓支架100轴线的螺旋形结构。
在一实施例中,第一开放分支21a的近端和第三开放分支21c的近端均具有延伸部210。其中,第一开放分支21a的延伸部210、第一线部21121、第二线部21122、第三开放分支21c的延伸部210、部分第三开放分支21c的第一连接单元211从近端至远端依次串联,形成围绕取栓支架100轴线的螺旋形结构。
在一实施例中,第二开放分支21b的近端和第三开放分支21c的近端均具有延伸部210。其中,第一线部21121、第二开放分支21b的延伸部210、第二线部21122、第三开放分支21c的延伸部210、部分第三开放分支21c的第一连接单元211从近端至远端依次串联,形成围绕取栓支架100轴线的螺旋形结构。
结合图1和图6所示,在本发明的一些实施方式中,取栓支架100还包括收集区30,收集区30与捕获区20相连并设于捕获区20的远端,收集区30的远端为具有网孔的封闭结构。
具体地,收集区30为内部中空且自膨胀网管状结构,具体可以为多网孔结构,即一个圆周方向上具有多个网孔。收集区30的近端端部开口设置,远端端部封闭设置,从而在掉落的血栓在无法被捕获区20捕获的情况下,通过收集区30的近端开口进入至收集区30的内部,并通过收集区30的远端封闭结构防止血栓逃逸,从而对血栓进行有效的捕获和收集,避免造成血管的二次栓塞。
结合图6和图7所示,在本发明的一些实施方式中,收集区30的远端具有多个导引杆,多个导引 杆的外部包覆有缓冲件33,且多个导引杆中至少一个导引杆的远端超出其余导引杆的远端设置。
具体地,在本发明的一些实施方式中,导引杆包括一个第一导引杆31和三个第二导引杆32,第一导引杆31的远端超出第二导引杆32的远端,并在第一导引杆31和第二导引杆32的外部共同包覆有缓冲件33,从而在收集区30的远端形成封闭端。同时由于第一导引杆31的远端超出第二导引杆32的远端设置,从而在收集区30的远端形成细长的端部,降低收集区30的远端的刚度,使收集区30的远端具有一定的柔软性,从而当收集区30的远端在于血管内壁或其他组织相抵接时,容易发生变形,减少或避免对血管造成伤害。其中,缓冲件33可以采用不透X射线材料的弹簧制成,弹簧可采用铂钨合金、铂铱合金等材料,同时弹簧具备一定的柔软性。临床医生可通过血管影像学设备,如DSA(数字减影血管造影)监视不透X射线的弹簧的位置,从而确定血管内取栓支架100的收集区30的远端位置。具体地,可采用激光焊接、点胶或锡焊的方式连接导引杆和缓冲件30。
如图8所示,在本发明的一些实施方式中,导引杆包括两个第一导引杆31和两个第二导引杆32,第一导引杆31的远端超出第二导引杆32的远端,并在第一导引杆31和第二导引杆32的外部共同包覆有缓冲件33,同样能够在收集区30的远端形成封闭端,并具有细长的端部。
如图9所示,开通区10具有一定的径向支撑强度,以便对血栓进行渗透和收集。开通区10沿同一圆周方向具有多个封闭的网孔,具体可以为4个、6个、8个或更多个。其中,开通区10也可以为两端开口结构;或者,开通区10的近端为封闭结构,开通区10的近端为开口结构。
在本发明的一些实施方式中,开通区10的近端还有第一连接杆11,取栓支架100通过第一连接杆11与输送装置相连,从而输送至血管中,进行血栓的捕获和收集。
根据本实施例的取栓支架100,通过在开通区10的远端设置捕获区20,在进行血管内取栓时,首先通过开通区10挤压渗透血栓,在渗透过程中如有血栓发生掉落,通过捕获区20的第一网孔2113和第二网孔2123对掉落的血栓进行捕获和收集,使掉落的血栓卡接至第一网孔2113和第二网孔2123的内部,或从第一网孔2113和/或第二网孔2123进入取栓支架100的内部,从而防止血栓逃逸,对血栓进行有效的捕获和收集,进而减少或避免血管发生二次栓塞落,而未被第一网孔2113和第二网孔2123捕获的血栓通过远端的收集区30进行收集,或者在取栓支架100的内部游离的小血栓也能通过远端的收集区30进行收集,从而对血栓进行全面有效的捕获和收集,减少或避免血栓发生逃逸现象,进而减少或避免血管的二次栓塞。
如图10所示,本发明的另一方面提出了一种取栓装置1,取栓装置1包括装载器200、推送件300和取栓支架100。其中,装载器200可以为双层或者多层的聚合物熔融而成的中空管,为了降低推送过程的阻力,一般来说,最内层材料为摩擦系数小的聚四氟乙烯。装载器200可以将收缩的取栓支架100容纳其内腔。同时,为了方便将取栓支架100递送到微导管内,装载器的200内径会小于或等于微导管内径,优选0.45~0.53mm,长度不小于500mm。至少部分推送件300设于装载器200的内部并可沿装载器200的轴向方向运动。在其他实施例中,可以不包括装载器200。
取栓支架100的近端设有至少一个连接杆,连接杆上设于至少一个安装孔,推送件300的远端通过至少一个安装孔与连接杆相连并固定,使推送件与取栓支架连接。取栓支架100具有处于装载器200内的压缩状态,和处于装载器200外的膨胀状态。取栓支架100在推送件300的作用下能够在装载器200内沿轴向方向移动,最终伸出至装载器200的外部,并插入至微导管内。其中,取栓支架100为上述任一项实施方式的取栓支架100。
在其他实施例中,推送件300上设有至少一个安装孔,连接杆的远端通过至少一个安装孔与推送件300相连并固定,使推送件300与取栓支架100连接。
结合图10至图13所示,在本发明的一些实施方式中,取栓装置1还包括管套400,连接杆的近端与推送件300的远端相连并共同设于管套400的内部,并通过管套400进行固定。在其他实施例中,取栓装置1也可以不包括管套400。
具体地,当取栓支架100的近端仅设有第一连接杆11时,第一连接杆11的近端与推送件300的远端相连并共同设于管套400的内部,从而通过管套400对第一连接杆11的近端与推送件300的远端的相对位置进行固定,使推送件300能够驱动取栓支架100移动且不会发生相对位置的改变。其中, 为了保证对第一连接杆11的近端与推送件300的远端的固定效果,取栓装置1还包括填充件500,填充件500设于管套400的内部,用于填补管套400内的缝隙,并对管套400的两端进行封口处理。通过管套400对第一连接杆11的近端与推送件300的远端进行夹紧固定,进一步地固定第一连接杆11和推送件300。其中,填充件500可以采用锡或者医用胶等。管套400可选用钽环或者铂铱环等不透X射线材料,从而可通过观察管套400的位置确定取栓支架100的近端位置,进而对取栓支架100在血管内的位置进行定位。
根据本实施例的取栓装置1,通过将连接杆的近端与推送件300的远端相连并共同设于管套400的内部,并通过管套400进行固定,能够有效地提高取栓支架100与推送件300的连接可靠性,防止取栓支架100与推送件300之间脱离连接关系,保证取栓过程的顺利进行。
再次结合图10至图14所示,在本发明的一些实施方式中,连接杆上设有至少一个安装孔,推送件300的远端与至少一个安装孔相连。
具体地,在本发明的一些实施方式中,第一连接杆11上仅设有第一安装孔111,推送件300的远端在第一安装孔111中与第一连接杆11相连,具体连接方式可以选择激光焊接、锡焊、胶粘等方式连接,从而通过推送件300驱动取栓支架100移动。
再次结合图10至图14所示,在本发明的一些实施方式中,推送件300包括大径段310和设于大径段310远端的小径段320,小径段320的径向尺寸小于大径段310的径向尺寸,小径段310穿过安装孔并与第一连接杆11相连。
大径段310设于推送件300的近端,具有一定的支撑强度和抗变形能力,从而通过大径段310操控移动推送件300。小径段320设于推送件300的远端,具有一定的变形能力,从而便于穿过安装孔并与第一连接杆11相连。
再如图11所示,在本发明的一些实施方式中,推送件300还包括过渡段330,过渡段330的两端分别连接大径段310和小径段320,过渡段330的径向尺寸由大径段310朝向小径段320的方向逐渐减小。
通过设置过渡段330,使不同径向尺寸的大径段310和小径段320之间平滑过渡,从而保证推送件300的受力均匀,防止在推送取栓支架100的过程中发生断裂现象。
具体地,为了保证推送件300的抗折性能及推送性能,推送件300一般选用镍钛材料,总长度不小于常用微导管的长度,推送件300的总长度L1一般为1500~2200mm,大径段310的外径尺寸选用0.35~0.45mm,优选0.4mm。根据颅内血管解剖结构,一般来说,小径段320和过渡段330的总体长度L2设置为200~400mm,优选350mm长度。推送件300的小径段320的径向尺寸选用0.08~0.12mm,优选0.1mm,从而保证小径段320的具有一定的变形能力。
结合图10、图14和图15所示,取栓支架100的近端设有一个连接杆,连接杆上设有至少一个安装孔,推送件300的远端穿过至少一个安装孔后连接有固定件340,且固定件340的最大尺寸大于安装孔的直径尺寸。具体地,固定件340为采用激光焊接的方式在推送件300的远端形成球头。可以理解的,该固定件340可以为各种形状,例如长条形、立方体形或各种不规则形状等,只要不能从安装孔中穿出即可。
在其他实施例中,推送件300上设有至少一个安装孔,连接杆的远端穿过至少一个安装孔后连接有固定件340,且固定件340的最大尺寸大于安装孔的直径尺寸。
具体地,在本发明的一些实施方式中,第一连接杆11上仅设有一个第一安装孔111,第一安装孔111的直径尺寸略大于小径段320的径向尺寸,从而保证小径段320能够穿过第一安装孔111。穿过第一安装孔111后的小径段320的远端通过激光焊接的方式设置成球头,从而保证小径段320的远端卡接在第一安装孔111的一侧,同时保证管套400内的填充件500对小径段320的固定效果,防止在推送和回收过程中推送件300与管套400间产生轴向方向的相对位移。
结合图14和图16所示,在本发明的一些实施方式中,第一连接杆11沿轴向方向间隔设有两个第一安装孔111,且两个第一安装孔111的直径尺寸均略大于小径段320的径向尺寸,从而保证小径段320能够穿过第一安装孔111。小径段320的远端依次穿过近端的第一安装孔111和远端的第一安装孔 111后通过激光焊接的方式设置成球头,从而通过两个第一安装孔111进一步地提高对推送件300的固定效果。
结合图14和图17所示,在本发明的一些实施方式中,第一连接杆11沿轴向方向间隔设有两个第一安装孔111,且两个第一安装孔111的直径尺寸均略大于小径段320的径向尺寸。小径段320的远端依次穿过近端的第一安装孔111和远端的第一安装孔111后,再次穿过近端的第一安装孔111,然后通过激光焊接的方式设置成球头,从而通过两个第一安装孔111进一步地提高对推送件300的固定效果。
结合图18和图19所示,在本发明的一些实施方式中,取栓支架100的近端设有至少两个连接杆,且两个连接杆上分别设有至少一个安装孔,推送件300的远端分别与两个连接杆上的安装孔相连。
结合图18和图19所示,取栓支架100的近端设有第一连接杆11和第二连接杆12,第一连接杆11和第二连接杆12分别沿轴向方向设置且间隔开。第一连接杆11和第二连接杆12上分别设有安装孔,并通过安装孔与推送件30相连。
如图20所示,在本发明的一些实施方式中,第一连接杆11的近端设有第一安装孔111,第二连接杆12的近端设有第二安装孔121,且第一安装孔111和第二安装孔121对应设置。小径段320的远端设有固定件340,固定件340的最大尺寸大于第一安装孔111和第二安装孔121中任一个安装孔的直径尺寸,通过将固定件340置于第一安装孔111和第二安装孔121之间,并在第一连接杆11和第二连接杆12的外部套设管套400,从而通过管套400将球头340卡接固定于第一安装孔111和第二安装孔121之间,实现推送件300与取栓支架100间的连接。其中,固定件340为采用激光焊接的方式在推送件300的远端形成球头。
为满足第一连接杆11和第二连接杆12对推送件300的卡接效果,其中,管套400的内径尺寸稍小于或等于第一连接杆11的径向尺寸、第二连接杆12的径向尺寸和小径段320的径向尺寸之和,从而达到过盈配合的效果。其中,固定件340的最大尺寸稍大于小径段320的径向尺寸。
如图21所示,在本发明的一些实施方式中,第一连接杆11设有沿轴向方向间隔设置的两个第一安装孔111,第二连接杆12设有沿轴向方向间隔设置的两个第二安装孔121,小径段320的远端依次穿过近端的第一安装孔111和第二安装孔121后,朝向远端延伸并再次依次穿过远端的第二安装孔121和第一安装孔111,然后再次朝向近端延伸,并再次穿过近端的第一安装孔111和第二安装孔121后焊接有固定件340,从而增加推送件300的连接固定效果。
参看图22A~图22C,在本发明实施例中,捕获区20上设置有捕获区显影元件71;开通区10上缠绕有开通区显影丝72,开通区显影丝72包括不重合的第一开通区显影丝721和第二开通区显影丝722,第一开通区显影丝721的近端和第二开通区显影丝722的近端汇聚形成开通区显影丝近端汇聚点723,第一开通区显影丝721的远端和第二开通区显影丝722的远端汇聚形成开通区显影丝远端汇聚点724;收集区30上缠绕有收集区显影丝73,收集区显影丝73包括不重合的第一收集区显影丝731和第二收集区显影丝732,第一收集区显影丝731的近端和第二收集区显影丝732的近端汇聚形成收集区显影丝近端汇聚点733,第一收集区显影丝731的远端和第二收集区显影丝732的远端汇聚形成收集区显影丝远端汇聚点734。可以理解的,取栓支架100包括开通区10或收集区30中的至少一个。
开通区10设置不重合的第一开通区显影丝721和第二开通区显影丝722,收集区30设置不重合的第一收集区显影丝731和第二收集区显影丝732,也就是多段显影丝分布到开通区10或收集区30的不同位置,从而可以通过不同位置造成的空间异面的多段显影丝来判断开通区10或收集区30的展开状态,进一步判断和掌握血管病变的性质(例如血管内是有血栓还是血管狭窄),同时多段显影,显影性更强,更有利于术者观察。同时,设置第一开通区显影丝721和第二开通区显影丝722的两端分别汇聚,第一收集区显影丝731和第二收集区显影丝732两端分别汇聚,从而使第一开通区显影丝721和第二开通区显影丝722稳定地固定在取栓支架上,第一收集区显影丝731和第二收集区显影丝732也能稳定地固定在取栓支架上,并且能够减少显影丝的自由端,从而减少戳伤输送器管腔或者血管内壁的可能。
在一实施例中,捕获区显影元件71包括捕获区显影丝711,捕获区显影丝711缠绕在捕获区20上,捕获区显影丝711沿捕获区20的轴线螺旋延伸设置,捕获区显影丝711的近端与开通区显影丝远 端汇聚点724连接,捕获区显影丝711的远端与收集区显影丝近端汇聚点733连接。开通区显影丝72、捕获区显影丝71和收集区显影丝73相互连接,做到取栓支架100整体连续的显影,能够在术中全程观察取栓支架100的整体形态和位置,更有利于术者在术中判断患者血栓的位置与病变的性质,以及能够判断取栓支架100与血栓的嵌合状况,并以此调整手术策略,提高取栓手术成功率,减少手术并发症。
其中,开通区显影丝72、捕获区显影丝71和收集区显影丝73设置为一体成型。具体为,第一开通区显影丝721和第二开通区显影丝722从开通区显影丝近端汇聚点723出发,分别在开通区10上缠绕,然后在开通区显影丝远端汇聚点724,此时第一开通区显影丝721和第二开通区显影丝722缠绕在一起合为一股显影丝,即为捕获区显影丝711(也就是说捕获区显影丝711由多股显影丝合成的),该捕获区显影丝711沿捕获区20的轴线螺旋延伸,在收集区显影丝近端汇聚点733分开,形成第一收集区显影丝731和第二收集区显影丝732,第一收集区显影丝731和第二收集区显影丝732分别在收集区30上缠绕,最后在收集区显影丝远端汇聚点734汇聚。在其他实施例中,开通区显影丝72、捕获区显影丝71和收集区显影丝73可以设置为非一体成型,通过焊接等常规方式进行连接。相比于非一体成型设计,一体成型设计能够更好地使显影丝固定在取栓支架上,并且不设置连接结构,无自由端,结构简单,从而更加安全。
取栓支架100由多根支架杆组成,其中捕获区20包括捕获区支架杆,开通区10包括开通区支架杆,收集区30包括收集区支架杆,捕获区显影丝71缠绕在捕获区支架杆上,开通区显影丝72缠绕在开通区支架杆上,收集区显影丝73缠绕在收集区支架杆上。也就是说,显影丝通过自身围绕支架杆缠绕实现与支架杆固定,其中,捕获区显影丝711除了围绕捕获区支架杆缠绕实现与捕获区支架杆固定外,还要在捕获区20上沿捕获区20的轴线螺旋延伸。
参看图23A~图23D,捕获区显影元件71包括捕获区显影点712,捕获区显影点712镶嵌在捕获区20上,第一开通区显影丝721和第二开通区显影丝722是由一根显影丝以一对折点对折形成,对折点为开通区显影丝远端汇聚点724,第一收集区显影丝731和第二收集区显影丝732是由另一根显影丝以另一对折点对折形成,另一对折点为收集区显影丝近端汇聚点733。如此设计,可以避免形成显影丝的自由端,安全性更高。可以理解的,第一开通区显影丝721和第二开通区显影丝722的数量可以为多个,第一收集区显影丝731和第二收集区显影丝732的数量可以为多个。
在图23D中,每一开放分支21的第二连接单元212的第二连接单元自由端2120上设置有显影槽90,该显影槽90用于容纳捕获区显影点712,具体地,捕获区显影点712冲压进入该显影槽90内从而使捕获区显影点712固定到显影槽90内,该捕获区显影点712的材料为本领域技术人员所熟知的,例如金、铂等。
参看图22A、图22B、图23A和图23B,取栓支架100的近端还可以设置有近端显影弹簧82,和/或取栓支架100的远端设置有远端显影弹簧81,可以用来显示取栓支架100近端和远端的位置,从而能够判断取栓支架100在体内所在的区域范围,另外设置为弹簧结构能够具有较好的柔顺性,避免损伤血管和输送鞘管内壁。在本实施例中,近端显影弹簧82设置在第一连接杆11与推送件300的连接处上,或者设置在第一连接杆11、第二连接杆12与推送件300的连接处上,该具有柔顺性的弹簧结构能够避免影响推送件300对取栓支架100的操控力。在一实施例中,近端显影弹簧82与开通区显影丝近端汇聚点723连接,远端显影弹簧81与收集区显影丝远端汇聚点734连接,能够更加完整地显示术中取栓支架100的整体形态和位置。远端显影弹簧81可以为上述的缓冲件33。
结合图1、图10、图24至图30所示,对临床上使用本发明的取栓装置1进行血管2内血栓3清除的过程进行说明。首先使用DSA(数字减影血管造影)对患者进行血管造影,确定血管2内待捕获的血栓3的位置。经血管介入技术,将微导管600的远端输送到超过血栓3一定距离,如图24所示,经微导管600进行血栓3远端的血管造影,判断血栓3的长度,选用合适规格的取栓支架100。
将取栓支架100通过装载器200推送至微导管600内,并经微导管600的内腔进行输送,当取栓支架100的远端到达微导管600的最远端时,即如图25所示位置时,固定住推送件300,保持取栓支架100整体相对于人体不动并向近端回撤微导管600,随着微导管600的回撤,取栓支架100将在血栓 3的位置自膨胀展开。
结合图1和图26所示,膨胀后的取栓支架100的近端的开通区10将血栓3挤压至血管2的一侧,血管2即刻恢复部分血流再通,防止核心梗死区域恶化。之后等待大于5分钟,使取栓支架100完全膨胀开,开通区10的网孔与血栓3进行充分融合。
结合图1、图4和图27所示,缓慢的回撤取栓支架100和微导管600,此时如有切碎掉落的血栓3将被取栓支架100的捕获区20进行捕获和收集。在捕获区20对掉落的血栓3的收集过程中,若位于近端的开放分支21未能够有效度对血栓3进行捕获,随着取栓支架100的撤回,相对位于远端的其他开放分支21能够进一步地对掉落的血栓3进行捕获和收集,防止血栓3逃逸,最终将血栓3固定在取栓支架100内部。同时,更细小的血栓3会被取栓支架100的远端的收集区30全部兜住。
结合图1、图4和图28所示,继续回撤取栓支架100和微导管600,直至取栓支架100回撤到导管700的管腔内。一般来说,取栓支架100完全膨胀开的直径尺寸会比血管2的内腔稍大,但比导管700外径更大,在取栓支架100回撤到导管700的内腔时,导管700的头端可能会对血栓3产生一定的切割作用。医生可以对导管采用注射器或者连接负压吸引装置抽取负压,负压吸引结合取栓支架100的抽拉,可提高取栓一次再通率。也可以利用取栓支架100的捕获区20上的螺旋分布的多个开放分支21将管口处被切割的血栓3带回导管700的内腔。最终,将取栓支架100及取栓支架100内的血栓3全部撤出体外,完成整个取栓过程。
结合图29和图30所示,为取栓装置1在弯曲的血管2内的取栓过程。由于第一连接单元211和第二连接单元212具有一定的可变形能力,在取栓支架100进入弯曲血管2后,第一连接单元211和第二连接单元212发生变形并贴合于血管2的内壁,从而在相邻设置的两个开放分支21间的形成开口,便于血栓3掉落至开放分支21的内部,进而被第一连接单元211或第二连接单元212进行捕获。
以上所述,仅为本发明较佳的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到的变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以权利要求的保护范围为准。

Claims (17)

  1. 一种取栓支架,其特征在于,包括:
    捕获区,所述捕获区设有沿其轴向方向设置的至少一个开放分支,所述开放分支的远端为开放结构,所述开放分支内部具有分支通道,所述分支通道与所述开放结构相通,所述开放分支包括第一连接单元、第二连接单元和至少一个第三连接单元,所述第三连接单元连接所述第一连接单元和所述第二连接单元,其中,所述第一连接单元在所述取栓支架的径向截面上的投影与所述取栓支架的径向截面重合,所述分支通道贯穿所述第一连接单元内,所述第二连接单元具有第二连接单元自由端,所述第二连接单元自由端比所述第一连接单元的远端、所述第三连接单元的远端更靠近远端。
  2. 根据权利要求1所述的取栓支架,其特征在于,所述第一连接单元包括第一连杆和第二连杆,所述第二连杆的两端分别与所述第一连杆的两端相连形成第一网孔,所述分支通道贯穿所述第一网孔。
  3. 根据权利要求1所述的取栓支架,其特征在于,所述第三连接单元的两端与所述第一连接单元相连,所述第二连接单元的近端分别连接于所述第三连接单元和所述第一连接单元上,所述第二连接单元自由端向远端延伸。
  4. 根据权利要求3所述的取栓支架,其特征在于,所述第三连接单元包括第三连杆和第四连杆,所述第三连杆的远端和所述第四连杆的远端相连,
    所述第三连杆的近端与所述第一连接单元的远端和近端之间的部分相连,或所述第三连杆的近端与相邻的所述第三连接单元的第四连杆相连;所述第四连杆的近端与所述第一连接单元的远端和近端之间的另一部分相连,或所述第四连杆的近端与相邻的所述第三连接单元的第三连杆相连。
  5. 根据权利要求3所述的取栓支架,其特征在于,所述第二连接单元包括第五连杆和第六连杆,所述第五连杆的远端和所述第六连杆的远端相连,所述第五连杆的近端与所述第一连接单元相连,所述第六连杆的近端与所述第三连接单元相连。
  6. 根据权利要求1所述的取栓支架,其特征在于,所述捕获区设有沿其轴向方向设置的至少两个所述开放分支,且相邻设置的两个所述开放分支间沿所述捕获区的圆周方向间隔一定角度。
  7. 根据权利要求1所述的取栓支架,其特征在于,所述至少两个所述开放分支围绕所述取栓支架的轴线自近端至远端呈螺旋状延伸。
  8. 根据权利要求7所述的取栓支架,其特征在于,所述至少两个开放分支包括第一开放分支和第二开放分支,所述至少两个开放分支中至少一个的近端具有延伸部,所述第二开放分支的近端或者所述第二开放分支的所述延伸部与所述第一开放分支的所述第一连接单元的远端和近端之间的部分相连,形成第一连接点。
  9. 根据权利要求8所述的取栓支架,其特征在于,所述开放分支的近端为所述第一连接单元的近端,在所述第一开放分支的所述第一连接单元上,所述第一连接单元的近端至所述第一连接点为第一线部,所述第一线部与部分所述第二开放分支的所述第一连接单元串联,形成围绕所述取栓支架轴线的螺旋形结构;或者,
    所述第一开放分支的延伸部、所述第一线部、所述第二开放分支的延伸部和部分所述第二开放分支的所述第一连接单元从近端至远端依次串联,形成围绕所述取栓支架轴线的螺旋形结构;或者,
    所述第一开放分支的延伸部、所述第一线部和部分所述第二开放分支的所述第一连接单元从近端至远端依次串联,形成围绕所述取栓支架轴线的螺旋形结构;或者,
    所述第一线部、所述第二开放分支的延伸部和部分所述第二开放分支的所述第一连接单元从近端至远端依次串联,形成围绕所述取栓支架轴线的螺旋形结构。
  10. 根据权利要求9所述的取栓支架,其特征在于,所述至少两个开放分支还包括第三开放分支,所述第三开放分支的近端或者所述第三开放分支的所述延伸部与第二开放分支的所述第一连接单元的远端和近端之间的部分相连,形成第二连接点。
  11. 根据权利要求10所述的取栓支架,其特征在于,在所述第二开放分支的所述第一连接单元上,所述第一连接单元的近端至所述第二连接点为第二线部,所述第一线部、第二线部与部分所述第三开放分支的所述第一连接单元从近端至远端依次串联,形成围绕所述取栓支架轴线的螺旋形结构;或者,
    所述第一开放分支的延伸部、所述第一线部、所述第二开放分支的延伸部、所述第二线部、所述第三开放分支的延伸部、部分所述第三开放分支的所述第一连接单元从近端至远端依次串联,形成围绕所述取栓支架轴线的螺旋形结构;或者,
    所述第一开放分支的延伸部、所述第一线部、所述第二线部、部分所述第三开放分支的所述第一连接单元从近端至远端依次串联,形成围绕所述取栓支架轴线的螺旋形结构;或者,
    所述第一线部、所述第二开放分支的延伸部、所述第二线部、部分所述第三开放分支的所述第一连接单元从近端至远端依次串联,形成围绕所述取栓支架轴线的螺旋形结构;或者,
    所述第一线部、所述第二线部、所述第三开放分支的延伸部、部分所述第三开放分支的所述第一连接单元从近端至远端依次串联,形成围绕所述取栓支架轴线的螺旋形结构;或者,
    所述第一开放分支的延伸部、所述第一线部、所述第二开放分支的延伸部、所述第二线部、部分所述第三开放分支的所述第一连接单元从近端至远端依次串联,形成围绕所述取栓支架轴线的螺旋形结构;或者,
    所述第一开放分支的延伸部、所述第一线部、所述第二线部、所述第三开放分支的延伸部、部分所述第三开放分支的所述第一连接单元从近端至远端依次串联,形成围绕所述取栓支架轴线的螺旋形结构;或者,
    所述第一线部、所述第二开放分支的延伸部、所述第二线部、所述第三开放分支的延伸部、部分所述第三开放分支的所述第一连接单元从近端至远端依次串联,形成围绕所述取栓支架轴线的螺旋形结构。
  12. 根据权利要求1所述的取栓支架,其特征在于,所述取栓支架还包括收集区,所述收集区与所述捕获区相连并设于所述捕获区的远端,所述收集区为具有网孔的远端封闭结构;或/和,所述取栓支架还包括开通区,所述开通区与所述捕获区相连并设于所述捕获区的近端,所述开通区为网孔结构。
  13. 根据权利要求12所述的取栓支架,其特征在于,所述捕获区上设置有捕获区显影元件,所述开通区上缠绕有开通区显影丝,所述收集区上缠绕有收集区显影丝,
    所述开通区显影丝包括不重合的第一开通区显影丝和第二开通区显影丝,
    所述收集区显影丝包括不重合的第一收集区显影丝和第二收集区显影丝,
    其中,所述第一开通区显影丝的近端和所述第二开通区显影丝的近端汇聚形成开通区显影丝近端汇聚点,所述第一开通区显影丝的远端和所述第二开通区显影丝的远端汇聚形成开通区显影丝远端汇聚点,
    所述第一收集区显影丝的近端和所述第二收集区显影丝的近端汇聚形成收集区显影丝近端汇聚点,所述第一收集区显影丝的远端和所述第二收集区显影丝的远端汇聚形成收集区显影丝远端汇聚点。
  14. 根据权利要求12所述的取栓支架,其特征在于,所述收集区的远端具有多个导引杆,多个所述导引杆的外部包覆有缓冲件,且多个所述导引杆中至少一个所述导引杆的远端比其余所述导引杆的远端更靠近远端。
  15. 根据权利要求1所述的取栓支架,其特征在于,相邻的所述开放分支之间具有在所述取栓支架侧面开口的血栓入口。
  16. 一种取栓装置,其特征在于,包括:
    取栓支架;
    推送件,所述取栓支架与所述推送件的远端相连;
    和/或,装载器,所述取栓支架可设于所述装载器的内部,所述取栓支架具有处于所述装载器内的压缩状态和处于所述装载器外的膨胀状态;
    其中,所述取栓支架为根据权利要求1至15中任一项所述的取栓支架。
  17. 如权利要求16所述的取栓装置,其特征在于,所述取栓支架的近端设有至少一个连接杆,
    所述连接杆上设有至少一个安装孔,所述推送件的远端通过至少一个所述安装孔与所述连接杆相连并固定,使所述推送件与所述取栓支架连接;或者,
    所述推送件上设有至少一个安装孔,所述连接杆的远端通过至少一个所述安装孔与所述推送件相 连并固定,使所述推送件与所述取栓支架连接。
PCT/CN2023/116927 2022-09-08 2023-09-05 取栓支架及取栓装置 WO2024051673A1 (zh)

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* Cited by examiner, † Cited by third party
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WO2011119872A1 (en) * 2010-03-24 2011-09-29 Nexgen Medical Systems, Inc. Thrombus removal system and process
CN109688946A (zh) * 2016-09-07 2019-04-26 纽瓦斯克医疗科技有限公司 用于缺血性中风治疗的凝块移除装置
CN111265277A (zh) * 2018-12-05 2020-06-12 先健科技(深圳)有限公司 取栓装置
CN113633343A (zh) * 2020-04-27 2021-11-12 先健科技(深圳)有限公司 取栓装置
CN114027928A (zh) * 2022-01-10 2022-02-11 杭州德诺脑神经医疗科技有限公司 取栓支架、取栓装置和取栓系统

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CN109688946A (zh) * 2016-09-07 2019-04-26 纽瓦斯克医疗科技有限公司 用于缺血性中风治疗的凝块移除装置
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