WO2024098970A1 - 一种血栓取栓支架装置 - Google Patents

一种血栓取栓支架装置 Download PDF

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Publication number
WO2024098970A1
WO2024098970A1 PCT/CN2023/120084 CN2023120084W WO2024098970A1 WO 2024098970 A1 WO2024098970 A1 WO 2024098970A1 CN 2023120084 W CN2023120084 W CN 2023120084W WO 2024098970 A1 WO2024098970 A1 WO 2024098970A1
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WO
WIPO (PCT)
Prior art keywords
proximal
distal
rod
stent
rods
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PCT/CN2023/120084
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English (en)
French (fr)
Inventor
杨文广
周求雄
王玉强
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上海珩畅医疗科技有限公司
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Application filed by 上海珩畅医疗科技有限公司 filed Critical 上海珩畅医疗科技有限公司
Publication of WO2024098970A1 publication Critical patent/WO2024098970A1/zh

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    • 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
    • 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

Definitions

  • the present invention relates to a medical device, and more particularly to a thrombus removal stent device for treating acute or subacute pulmonary embolism.
  • Pulmonary embolism is a general term for a group of diseases or clinical syndromes caused by endogenous or exogenous emboli blocking the pulmonary artery or its branches, resulting in pulmonary circulation and right heart dysfunction.
  • the thrombi caused by pulmonary embolism are generally large in size, blocking the main trunk of the pulmonary artery, the left and right pulmonary trunks, and the segmental arteries or branch arteries of the left and right pulmonary branches. It is mainly caused by thrombi from the venous system (or the right heart) blocking the pulmonary artery or its branches.
  • Acute or subacute thrombosis may cause shock or hypotension in patients, and the patient's condition changes rapidly.
  • the clinical mortality rate may be as high as 15%.
  • Existing pulmonary embolism thrombectomy devices are mainly implemented with pure braided stents, or use an auxiliary thrombus separation device inside the suction catheter to assist in thrombus suction.
  • the thrombi that are targeted tend to be fresh thrombi or easily accessible free floating thrombi, but the thrombus removal effect is not significant for hard and adherent thrombi in subacute thrombi.
  • braided stents can prevent thrombi from escaping, they are not ideal for subacute thrombi (two to four weeks after thrombus formation) or thrombi that are a little longer (more than four weeks). Suctioning them cannot capture and suck such thrombi out of the body. Often, the catheter is easily blocked by these thrombi during the suction process, causing the catheter to fail to work normally.
  • Some acute embolisms can also be treated by thrombolysis or assisted thrombus aspiration to achieve immediate vascular opening, but most pulmonary embolisms are subacute thromboembolism. Most patients with subacute thromboembolism are not satisfied with the treatment effects of thrombolysis or assisted aspiration, and the effects of assisted thrombectomy with the new braided stent retriever or thrombus crusher that appeared later are not obvious.
  • thrombectomy devices for acute or subacute pulmonary embolism are limited in their effectiveness for thrombus removal of old, strongly adherent pulmonary thrombi due to structural limitations. Moreover, such thrombi are often large in size, making it impossible for existing devices to completely remove them or to remove them at all.
  • the present invention at least solves the problems of the thrombectomy stent device, such as small internal space, poor adhesion to the vascular wall, and insufficient flexibility in operation when handling large thrombi during surgery.
  • the present invention also adopts the following technical solution:
  • a thrombus removal stent device characterized in that it comprises: an expandable stent, the expandable stent comprising a proximal support portion and a distal support portion
  • the proximal support part comprises a plurality of proximal rods and a proximal grid formed by the plurality of proximal rods
  • the distal dense mesh part comprises a plurality of distal rods and a distal grid formed by the plurality of distal rods
  • the number of the proximal rods is less than the number of the distal rods, and at least one of the length, width and wall thickness of the proximal rods is greater than the length, width and wall thickness of the distal rods
  • the proximal rods comprise a first connecting part and a second connecting part, the first connecting part forms a convergence end
  • the distal rods comprise a third connecting part and a fourth connecting part, the fourth connecting part forms a convergence end
  • the second connecting part and the third connecting part are
  • the aperture of the proximal grid of the thrombus retriever stent device is larger than the aperture of the distal grid.
  • the proximal grid of the thrombus removal stent device includes a first grid portion and a second grid portion, wherein the first grid portion is a grid close to the first connecting portion, and the second grid portion is a grid close to the second connecting portion; the aperture of the first grid portion is larger than the aperture of the second grid portion.
  • the first connecting portion of the thrombus remover stent device includes three first proximal rods, each of which has a rod width of 0.3-0.5 mm and a rod wall thickness of 0.15-0.5 mm.
  • the second connecting portion of the thrombus removal stent device includes multiple second proximal rods, each of which has a rod width of 0.15-0.5 mm and a rod wall thickness of 0.15-0.5 mm; the number of second proximal rods is greater than the number of the first proximal rods.
  • one end of the first proximal rod of the thrombus retriever stent device forms four forks, and each of the forks forms one of the second proximal rods.
  • the proximal rod or the distal rod of the thrombus retriever stent device includes a support rod, and the development structure is arranged on the support rod.
  • the convergence end formed by the first connecting portion of the thrombus remover stent device is nested in the proximal developing ring.
  • the constricted end formed by the fourth connecting portion of the thrombus removal stent device is nested in the non-invasive tip.
  • the proximal support portion and the distal dense mesh portion of the thrombus retriever stent device are both laser cut structures; or, the proximal support portion is a laser cut structure, and the distal dense mesh portion is a woven dense mesh structure.
  • the present invention proposes an improved thrombus removal stent device for old thrombi that are larger in size and have strong vascular adhesion, which simultaneously meets the requirements of having a larger internal space, better adhesion to the vascular wall, better radial support force, and flexible and efficient operability required for handling large thrombi during surgery.
  • FIG1 is a schematic diagram of the overall structure of a thrombus treatment device
  • Figure 2 is a schematic diagram of the bracket assembly structure
  • FIG3 is a schematic diagram of the support structure
  • FIG4 is a schematic diagram of the proximal support portion of the stent
  • FIG5 is a schematic diagram of the dense mesh portion at the distal end of the stent
  • FIG6 is a schematic diagram of a proximal mesh structure of a stent according to an embodiment of the present invention.
  • FIG7 is a schematic diagram of a proximal mesh structure of a stent according to another embodiment of the present invention.
  • FIG8 is a schematic diagram of a distal woven dense mesh stent
  • FIG9 is a schematic diagram of a support development structure
  • FIG10 is a schematic diagram of stent device delivery
  • FIG11 is a schematic diagram of the stent device being delivered to position
  • FIG12 is a schematic diagram of stent release
  • FIG. 13 is a schematic diagram of stent thrombectomy.
  • 1-stent device 2-delivery catheter, 3-handle, 4-non-invasive guide tip, 5-expandable stent, 6-inner push rod, 7-proximal developing ring, 8-outer push rod, 9-developing structure.
  • PE-clot material BV-human blood vessel; 501-proximal end convergence rod of the stent, 502-first proximal rod, 503-second proximal rod, 504-second proximal rod, 505-second proximal rod, 514-developing support rod, 515-second proximal rod, 516-second proximal rod, 517-second proximal rod, 518-second proximal rod, 509-first grid part, 510-second grid part, 519-first grid part, 520-second grid part, 521-second grid part, 524-second grid part, 522-proximal support part of the stent; 506-distal rod, 507-distal rod, 508-distal
  • the terms “mounted”, “connected”, “connected” and “coupled” should be understood in a broad sense, for example, they may be fixedly connected. It can be connected, detachably connected, or integrally connected; it can be mechanically connected or electrically connected; it can be directly connected, indirectly connected through an intermediate medium, or the internal communication of the two elements. However, if other words can achieve the same purpose, the words can be replaced by other expressions.
  • proximal/proximal end refers to the end close to the operator, while the distal/distal end refers to the end away from the operator or entering the human blood vessel.
  • the present invention discloses a stent device 1, which is installed near the top of a delivery catheter 2 of a thrombus treatment device, and the delivery catheter 2 is controlled by a handle 3, so as to further control the stent device 1.
  • the stent device 1 mainly includes a non-invasive guide head 4, an expandable stent 5, an inner push rod 6, a proximal developing ring 7, an outer push rod 8 and other components.
  • the stent device 1 is embedded in the delivery catheter 2, the inner push rod 6 is connected to the handle 3, and is connected to the distal end 508 of the expandable stent 5, and the outer push rod 8 is fixed to the handle 3, and the inner push rod 6 can be adjusted by the handle 3 to achieve control of the outline diameter size of the stent 5.
  • the main body of the stent device 1 is an expansion stent 5, which is composed of a stent proximal support portion 522 and a stent distal dense mesh portion 523.
  • the stent proximal support portion 522 and the stent distal dense mesh portion 523 respectively include a plurality of interconnected support rods, wherein the proximal support portion 522 (i.e., the interconnected support rods extending from the proximal support portion 522) is a proximal rod, and the distal dense mesh portion 523 (i.e., the interconnected support rods extending from the distal dense mesh portion 523) is a distal rod.
  • proximal rods/distal rods are respectively connected to each other to form a grid structure
  • the grid structure composed of multiple proximal rods is a proximal grid
  • the grid structure composed of multiple distal rods is a distal grid.
  • multiple interconnected support rods form an overall structure that can move between a constrained state and an expanded state.
  • the expandable stent 5 is a shuttle-shaped or elliptical structure, and the size of its outer contour changes through the axial relative movement of the inner and outer push rods. From the overall structure, the proximal grid unit area is large, and the distal grid unit area is small.
  • the proximal grid is composed of two to six large-area units, and the adjacent large-area units are composed of the same number of small-area units.
  • the area of each large grid unit at the proximal end is smaller than that of the distal grid unit that is mirror-symmetrical with respect to the central axis.
  • the distal grid is composed of units that are an even multiple of the proximal large-area grid, and the multiple is 2 to 6 times, and the size of the distal grid units is basically the same.
  • the proximal grid unit and the distal grid unit are connected by an "I"-shaped node, and the connection node is the highest point of the contour of the expandable stent 5.
  • FIG. 3 distinguishes the proximal support portion 522 of the stent and the distal dense mesh portion 523 of the stent
  • the proximal support portion 522 of the stent formed by the proximal rod and the distal dense mesh portion 523 of the stent formed by the distal rod are interconnected to form a cage-like structure.
  • the proximal rod includes a first connection portion and a second connection portion, and the first connection portion forms a convergence end, which is located on the left side shown in FIG. 3 .
  • the distal rod includes a third connection portion and a fourth connection portion, and the fourth connection portion forms a convergence end, which is located on the right side shown in FIG. 3 .
  • connection portion and the third connection portion are interconnected at the central vertical line position shown in FIG. 3 , and the vertical line is only used as an identifier to roughly divide the proximal support portion 522 of the stent and the distal dense mesh portion 523 of the stent, and does not have a separation entity, nor does it indicate the specific proportions of the proximal support portion 522 of the stent and the distal dense mesh portion 523 of the stent.
  • the proximal support portion 522 of the bracket mainly includes one or more groups of proximal convergence end rods 501, a first proximal rod 502, a second proximal rod 503, a second proximal rod 504, a developing support rod 514, and a second proximal rod 505.
  • the first proximal rod 502 is relatively thick
  • the rod width is between 0.3mm and 0.5mm
  • the bracket wall thickness is between 0.15mm and 0.5mm
  • the number of rods is between three and six.
  • the second proximal rods 503, 504 and 505 have a rod width between 0.15mm and 0.5mm, a wall thickness between 0.15mm and 0.5mm, and a rod number between 12 and 24.
  • the number of rods of the developing support rod 514 is generally half of the second proximal rod 504, but the present invention is not limited thereto.
  • the proximal convergence end rod 501 is divided into three to six first proximal rods 502. Each first proximal rod 502 is further divided into two second proximal rods 503. Each second proximal rod 503 is further divided into two second proximal rods 504. Each second proximal rod 504 is further divided into two second proximal rods 505.
  • the area formed by the connection of the above five support rods (501, 502, 503, 504, 505) is the first grid part 509, which is relatively closer to the first connection part, that is, the position of the proximal convergence end rod 501.
  • the proximal rods constituting three to six first grid parts 509 constitute the second connection part of the expansion stent 5.
  • the first proximal rod 502 is thicker and thicker than other support rods, which improves the rigid support of the large opening during the thrombus capture process, making the thrombus removal efficiency higher.
  • the first proximal rods 502 have fewer rods and are longer, so that the expandable stent 5 can have better compliance when entering the delivery catheter 2, so that the expandable stent 5 can be recycled and reused.
  • the second proximal rod 503, the second proximal rods 504, and 505 can be bifurcated to form (development) branch rods, and a development structure is set on the branch rods.
  • development development branch rods
  • the development branch rod can be set at other positions of the proximal rod (the first proximal rod, the second proximal rod) and/or the distal rod, which can achieve the technical purpose of the present invention and achieve the technical effect of the present invention.
  • the development structure 9 can be fixed on the proximal rod by gluing.
  • the second proximal rod 504 can also be fixed on the second proximal rod 504 by laser welding.
  • the developing structure 9 can make the expandable stent 5 have a developing effect under DSA (Digital subtraction angiography), and can enable the operator to monitor the contour size of the expandable stent 5 in the blood vessel in real time during the operation.
  • DSA Digital subtraction angiography
  • the developing structure can be a curved structure as shown in Figure 9, or an anchored hole-shaped structure, or an I-beam structure, or other forms of developing structures, all of which can achieve the technical purpose of the present invention and achieve the technical effect of the present invention, and the present invention is not limited thereto.
  • the second proximal rod 504 and the second proximal rod 505 in the proximal support portion 522 of the stent constitute the second grid portion 510.
  • the second proximal rods 503, 504 and 505 constitute the second grid portion 524.
  • Part of the proximal rods that constitute the second grid portion 510 and the second grid portion 524 in the expandable stent 5 are the second connecting portion.
  • the second connecting portion and the third connecting portion are interconnected.
  • the number of support rods of the second connecting portion is usually 12 to 24.
  • the proximal rods in the first connecting portion and the second connecting portion area are mainly used to capture and obtain large-load thrombi, and to separate thrombi from the vascular wall.
  • the structure of the second grid portion enables the expandable stent 5 to have a high radial support force, and can provide better adhesion to the blood vessel during the thrombus removal process, so that the expandable stent 5 can remove more adherent emboli along the vascular wall, and can obtain thrombus removal capabilities that other thrombus removal methods cannot obtain.
  • the proximal support portion 522 of the bracket mainly comprises a proximal convergence end rod 501, a first proximal rod 502, a second proximal rod 515, a developing support rod 514, a second proximal rod 516, a second proximal rod 517, and a second proximal rod 518.
  • the first proximal rod 502 is relatively thick, with a rod width between 0.3mm and 0.5mm, a bracket wall thickness between 0.15mm and 0.5mm, and the number of rods is between three and six.
  • the second proximal rods 515, 516, 517, and 518 have a rod width of 0.15-0.5mm, a wall thickness of 0.15-0.5mm, and a rod number between 12 and 24.
  • the number of rods of the developing support rod 514 is generally half of the second proximal rod 515, but the present invention is not limited thereto.
  • the proximal convergence end rod 501 is further divided into three first proximal rods 502.
  • Each first proximal rod 502 is further divided into four second proximal rods, two outer rods are second proximal rods 515, and two inner rods are second proximal rods 518.
  • the second proximal rod 515 is further divided into two second proximal rods 516.
  • the second proximal rod 518 is further divided into two second proximal rods 517.
  • One of the two second proximal rods 515 is divided into a developing support rod 514 at a position slightly closer to the bifurcation of the second proximal rod 516, and a developing structure 9 is placed on the developing support rod 514, as shown in FIG. 9 .
  • the developing structure 9 can be fixed to the second proximal rod 515 by gluing, or by laser welding.
  • the area formed by connecting the proximal convergent end rod 501, the first proximal rod 502, the second proximal rod 515, and the second proximal rod 516 is the first grid part 519, and the proximal rods constituting three to six first grid parts 519 constitute the first connecting part of the expandable stent 5.
  • the second proximal rod 515 , the second proximal rod 516 , the second proximal rod 517 , and the second proximal rod 518 are connected to form the second grid section 521.
  • the proximal rods of the expandable stent 5 that form the second grid section 520 and the second grid section 521 are the second connecting parts.
  • the second connecting part is connected to the third connecting part.
  • the stent proximal support portion 522 with different radial support effects can be obtained, and these different combinations and selections are all within the protection scope of the present invention.
  • the stent distal dense mesh portion 523 is composed of a stent distal rod 506, a stent distal rod 507, and a stent distal convergent end rod 508.
  • the stent distal rods 506, 507 and the stent distal convergent end rod 508 have a rod width between 0.15 mm and 0.5 mm, a rod wall thickness between 0.15 mm and 0.5 mm, and a rod number between 12 and 24, but the present invention is not limited thereto.
  • the second proximal rod 505 and the stent distal rod 506 constitute the stent distal grid 511, and the stent distal rod 506 and the stent distal rod 507 constitute the stent distal grid 512.
  • the second proximal rod 516 and the stent distal rod 506 constitute the stent distal grid 511, and the stent distal rod 506 and the stent distal rod 507 constitute the stent distal grid 512.
  • the distal rods constituting the stent distal grid 511 and the stent distal grid 512 together form a third connection portion.
  • the third connection portion is interconnected with the second connection portion.
  • the stent distal rod 507 and the stent distal convergence end rod 508 constitute the stent distal grid 513, forming a distal convergence end, and the position of the stent distal convergence end rod 508 becomes the fourth connection portion of the expansion stent 5.
  • the stent distal grids 511, 512 and 513 are in the form of a dense mesh, and their expanded shape presents a form in which the grid area gradually decreases from the top of the expansion stent to the distal end.
  • the apertures of the distal grid are smaller than those of the proximal grid, so that the captured thrombus can be securely surrounded inside the stent to prevent the thrombus from escaping.
  • the number of proximal rods of the expandable stent 5 is less than the number of distal rods, and at least one of the length, width, and wall thickness of the proximal rods is greater than the length, width, and wall thickness of the distal rods.
  • the main function of the proximal rod and its stent proximal support part 522 is not entirely to capture thrombus and prevent thrombus escape, but also to provide better radial support. Therefore, the proximal rod adopts a longer, thicker rod body with thicker rod wall, which can have higher support strength and provide greater radial support force. In addition, the larger opening formed in the proximal rod also provides better support effect due to the greater strength of the proximal rod, because more and denser rods are not conducive to improving radial strength, but will weaken radial strength;
  • the main function of the distal rod and its stent distal dense mesh part 523 is to better capture the thrombus and prevent the thrombus from escaping. Therefore, the distal rod adopts a thinner and denser structure to form a dense mesh woven structure.
  • the hemispherical structure similar to the "basket” can make the stent distal dense mesh part 523 better contain the thrombus and prevent the thrombus from escaping.
  • the expandable stent 5 can be made of shape memory materials such as nickel titanium materials, and can be manufactured by a variety of processing methods.
  • the proximal support portion 522 of the stent and the distal dense mesh portion 523 of the stent can be made of the same material.
  • a nickel titanium tube is used to cut the preliminary outline of the stent under a laser cutting machine, and then processed into the form of the expandable stent 5 shown in Figures 3 to 7 by heat setting.
  • the proximal support portion 522 of the stent and the distal dense mesh portion 523 of the stent can be made of different materials.
  • the proximal support portion 522 of the stent is still made of shape memory materials such as nickel titanium materials, and a nickel titanium tube is used to cut the outline of the proximal support portion 522 of the stent under a laser cutting machine.
  • the distal dense mesh portion 523 of the stent can be a woven dense mesh structure, as shown in Figure 8.
  • the distal dense mesh portion 523 of the stent is woven by weaving, and then connected to the cutting stent with better proximal support by perforation, riveting or welding.
  • the present invention does not limit the proximal support portion 522 of the stent and the dense mesh portion 523 of the distal end of the stent.
  • the proximal end convergence rod 501 of the expansion stent 5 has sufficient length to connect to the outer push rod 8.
  • the distal end convergence rod 508 of the expansion stent 5 has sufficient length to connect to the inner push rod 6 and the non-invasive guide head 4.
  • the connection method between the two ends of the expansion stent 5 and the stent device 1 can be Pebax material hot melt or glue bonding.
  • the convergence end formed by the first connection part (the location of the proximal end convergence rod 501 of the stent) is nested in the proximal developing ring 7, and the convergence end formed by the fourth connection part (the location of the distal end convergence rod 508 of the stent) is nested in the non-invasive guide head 4.
  • the proximal developing ring 7, the non-invasive guide head 4 and the developing structure 9 cover the various parts of the expansion stent 5 from the proximal end, the middle part to the distal end, so that the expansion stent 5 can display its overall dynamic shape through the developing device during use.
  • the stent device 1 When the present invention participates in the surgical process, referring to FIG10 , the stent device 1 is introduced into the human blood vessel BV through the delivery catheter 2 and close to the location of the thrombus PE.
  • the outer push rod 8, the inner push rod 6 and the expandable stent 5 are pushed out of the delivery catheter 2 by the handle 3 .
  • the expandable stent 5 is always kept in a constrained state of the minimum outer diameter inside the delivery catheter 2 as shown in the figure.
  • the relative axial distance between the outer push rod 8 and the inner push rod 6 is changed by the handle 3, thereby changing the diameter of the expandable stent 5 from the constrained state to the expanded state.
  • the expanded stent 5 may not be in the proper position after being expanded. In this case, the expandable stent 5 can be withdrawn into the delivery catheter 2 again. After the stent device 1 adjusts the release position of the expandable stent 5, the expandable stent 5 can be released again, so that the expandable stent 5 It can be recycled and reused.
  • the handle 3 is used to adjust it to an outer diameter size that is adapted to the diameter of the blood vessel BV.
  • the developing structure 9 can make the expandable stent 5 have a developing effect under DSA (Digital subtraction angiography), and can monitor the outline size of the expandable stent 5 in the blood vessel in real time to assist the operator in thrombus removal.
  • DSA Digital subtraction angiography
  • the handle 3 is used to control the expanded stent 5 to be dragged proximally out of the blood vessel BV.
  • the expanded stent 5 will capture and scrape the thrombus PE on the wall of the blood vessel BV.
  • the dense mesh structure of the third and fourth connecting parts at the distal end of the stent will enable the captured thrombus to be securely surrounded inside the stent to prevent the thrombus from escaping.
  • the handle 3 and the expanded stent 5 will pull the thrombus PE from the blood vessel BV to the vicinity of the distal suction port of the suction catheter or into the suction catheter, so that the suction catheter will suck out the thrombus PE, or directly pull the thrombus PE out of the body through the suction catheter until the thrombus is completely removed from the body to achieve stent thrombus removal.
  • the delivery catheter 2, the outer push rod 8, the inner push rod 6 and the expandable stent 5 are withdrawn from the human blood vessel BV through the handle 3, and the entire thrombectomy process is completed.
  • the thrombus removal stent device of the present invention has the following beneficial effects:
  • the hollow basket stent designed based on shape memory alloy can be a rod-shaped mesh cutting stent or a stent that is a mixture of a mesh cutting stent and a braided stent. It has the characteristics of a large proximal opening and good support, which is convenient for capturing and removing large thrombi. In addition, the proximal end will not collapse during the thrombectomy process, and the thrombectomy effectiveness for large-load thrombi is higher.
  • the stent has a large radial force, which makes the stent more closely attached to the blood vessel wall, making it easier for the stent to capture thrombi attached to the blood vessel wall, making thrombus removal more thorough and complete;
  • the distal end of the stent is cut or woven with a dense mesh structure, which can prevent the thrombus captured by the stent from escaping, thus avoiding blockage caused by escaping thrombus;
  • the spherical or cage-shaped design of the stent allows for a larger thrombus storage space inside the stent, while still maintaining a high radial support force, thereby improving the stent's ability to accommodate thrombi and making thrombus removal more efficient;
  • the stent can adapt to the adjustment of the handle to meet the corresponding blood vessel size, and at the same time, it can destroy blood clots with the adjustment of the handle.
  • a stent can adapt to a wider range of blood vessel diameters for thrombus removal;
  • the maximum outer diameter of the stent is designed with a developing structure, so that the current size of the stent can be determined by viewing the DSA image during surgery, and the size can be adjusted by the handle to achieve the adjustment and adaptation of the stent to the blood vessel diameter. It can also be a whole-body structure development, covering the inner or outer layer of the developing braided stent;
  • the stent has excellent sheathing performance and is recyclable.
  • the stent release position is not appropriate, the stent can be re-adjusted to the sheathing size and inserted into the sheath tube to re-adjust the stent release position;
  • the stent can be used with a larger suction catheter to achieve suction and stent combined thrombectomy, making pulmonary embolism thrombectomy more efficient.

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Abstract

一种血栓取栓支架装置（1），包括：膨胀支架（5），膨胀支架（5）包括近端支撑部分（522）和远端密网部分（523）。近端支撑部分（522）包括多根近端杆，及由多根近端杆构成的近端网格；远端密网部分（523）包括多根远端杆，及由多根远端杆构成的远端网格；近端杆的数量小于远端杆的数量，且近端杆的杆长、杆宽、杆壁厚度其中至少之一大于远端杆的杆长、杆宽、杆壁厚度。近端杆包括第一连接部和第二连接部，第一连接部形成收束端；远端杆包括第三连接部和第四连接部，第四连接部形成收束端；第二连接部和第三连接部互相连接，使得近端支撑部分（522）和远端密网部分（523）互相连接形成笼状结构。支架有较大的径向支撑力，较佳的血管管壁贴合性，及处理大型血栓时需要的灵活的操作性。

Description

一种血栓取栓支架装置 技术领域
本发明涉及一种医疗器械，更具体地说，涉及一种针对急性或亚急性肺部栓塞症治疗用的血栓取栓支架装置。
背景技术
肺栓塞是由内源性或外源性栓子阻塞肺动脉或其分支引起肺循环和右心功能障碍的一组疾病或临床综合征的总称。肺栓塞引起的血栓普遍呈现出体积较大的特点，堵塞在肺动脉主干，左右肺主干以及左右肺分支的段动脉或支动脉位置。其主要是由来自静脉***(或右心的血栓阻塞肺动脉或其分支所致。急性或亚急性血栓症可能会导致患者休克或低血压，患者病情变化快，临床病死率可能高达15％。
现有肺栓塞取栓装置主要是趋于纯编织支架实施，或者采用抽吸导管内部辅助血栓分离装置辅助血栓抽吸，针对的血栓栓子偏于新鲜血栓或者易于获取的游离漂浮血栓，但是针对于亚急性血栓中的偏硬的贴壁的栓子取栓效果并不显著。编织支架虽然可以防止血栓逃逸，但是却对亚急性血栓(血栓形成后二至四周)或者时间再长一点(四周以上)的血栓获取效果并不理想。对其进行抽吸也无法捕获并将此类血栓抽吸到体外，往往抽吸过程中导管还容易被这些栓子堵塞，造成导管无法正常工作。
部分急性栓塞也可以通过溶栓的手段实施治疗，或者辅助血栓抽吸术实施即刻血管开通，而肺栓塞多数是亚急性血栓栓塞症，大多数的亚急性血栓栓塞症患者对溶栓或者辅助抽吸实施的治疗效果并不满意，而后来出现的新型编织支架取栓或碎栓装置辅助抽吸取栓效果也并不明显。
如上所述，目前针对急性或亚急性肺部栓塞症的取栓装置由于结构所限，对于具有陈旧性，强附着性特点的肺部血栓的取栓效果非常有限。不仅如此，此类血栓往往还伴随着体积较大的特点，使得现有的器械无法将其完全去除或者根本无法去除。
发明内容
基于现状，针对具有体积较大的、血管附着性较强的陈旧特点的性急性或亚急性肺部栓塞症，本发明至少解决了取栓支架装置，内部空间较小，血管管壁贴合性不佳，以及术中处理大型血栓时操作性不够灵活等问题。
为实现上述目的，本发明还采用如下技术方案：
一种血栓取栓支架装置，其特征在于，包括：膨胀支架，膨胀支架包括近端支撑部分和远端 密网部分；近端支撑部分包括多根近端杆，以及由所述多根近端杆构成的近端网格；远端密网部分包括多根远端杆，以及由所述多根远端杆构成的远端网格；近端杆的数量小于远端杆的数量，且近端杆的杆长、杆宽、杆壁厚度其中至少之一大于远端杆的杆长、杆宽、杆壁厚度；近端杆包括第一连接部和第二连接部，第一连接部形成收束端；远端杆包括第三连接部和第四连接部，第四连接部形成收束端；第二连接部和第三连接部互相连接，使得近端支撑部分和远端密网部分互相连接形成笼状结构。
作为本发明的一种实施方式，血栓取栓支架装置近端网格的孔径大于远端网格的孔径。
作为本发明的一种实施方式，血栓取栓支架装置近端网格包括第一网格部分和第二网格部分，其中第一网格部分为靠近所述第一连接部的网格，所述第二网格部分为靠近所述第二连接部的网格；第一网格部分的孔径大于第二网格部分的孔径。
作为本发明的一种实施方式，血栓取栓支架装置第一连接部包括三根第一近端杆，每一根所述第一近端杆的杆宽为0.3-0.5mm，杆壁厚为0.15-0.5mm。
作为本发明的一种实施方式，血栓取栓支架装置第二连接部包括多根第二近端杆，每一根所述第二近端杆的杆宽为0.15-0.5mm，杆壁厚为0.15-0.5mm；第二近端杆的数量大于所述第一近端杆的数量。
作为本发明的一种实施方式，血栓取栓支架装置第一近端杆的一个末端形成四根分叉，每一根所述分叉形成一根所述第二近端杆。
作为本发明的一种实施方式，血栓取栓支架装置近端杆或所述远端杆上包括支杆，所述支杆上设置显影结构。
作为本发明的一种实施方式，血栓取栓支架装置第一连接部形成的收束端嵌套在近端显影环内。
作为本发明的一种实施方式，血栓取栓支架装置第四连接部形成的收束端嵌套在无创导头内。
作为本发明的一种实施方式，血栓取栓支架装置近端支撑部分和远端密网部分均为激光切割结构；或者，近端支撑部分为激光切割结构，所述远端密网部分为编织密网结构。
在上述技术方案中，本发明针对体积较大的、血管附着性较强的陈旧性血栓提出了一种改进的取栓支架装置，其同时满足具有较大的内部空间，较佳的血管管壁贴合性，更好的径向支撑力，以及术中处理大型血栓时需要的灵活高效的操作性。
附图说明
图1是血栓治疗装置的整体结构示意图；
图2是支架装配结构示意图；
图3是支架结构示意图；
图4是支架近端支撑部分示意图；
图5是支架远端密网部分示意图；
图6是本发明一种实施方式的支架近端网孔结构示意图；
图7是本发明另一种实施方式的支架近端网孔结构示意图；
图8是远端编织密网支架示意图；
图9是支架显影结构示意图；
图10是支架装置输送示意图；
图11是支架装置输送到位示意图；
图12是支架释放示意图；
图13是支架取栓示意图。
图中：1-支架装置，2-输送导管，3-手柄，4-无创导头，5-膨胀支架，6-内推杆，7-近端显影环，8-外推杆，9-显影结构。PE-凝块物质，BV-人体血管；501-支架近端收束端杆，502-第一近端杆，503-第二近端杆，504-第二近端杆，505-第二近端杆，514-显影支杆，515-第二近端杆，516-第二近端杆，517-第二近端杆，518-第二近端杆，509-第一网格部分，510-第二网格部分，519-第一网格部分，520-第二网格部分，521-第二网格部分，524-第二网格部分，522-支架近端支撑部分；506-远端杆，507-远端杆，508-支架远端收束端杆，511-支架远端网格1，512-支架远端网格2，513-支架远端网格3，523-支架远端密网部分。
具体实施方式
下面结合附图和实施例，对本发明实施例中的技术方案进一步作清楚、完整地描述。显然，所描述的实施例用来作为解释本发明技术方案之用，并非意味着已经穷举了本发明所有的实施方式。
所述实施例的示例在附图中示出，其中自始至终相同或类似的标号表示相同或类似的元件或具有相同或类似功能的元件。下面通过参考附图描述的实施例是示例性的，旨在用于解释本发明，而不能理解为对本发明的限制。
应当理解，“安装”、“相连”、“连接”、“耦合”应做广义理解，例如，可以是固定连 接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，还可以是两个元件内部的连通。然而，如果其他词语可实现相同的目的，则可通过其他表达来替换所述词语。
如本说明书和权利要求书中所示，除非上下文明确提示例外情形，“一”、“一个”、“一种”和/或“该”等词并非特指单数，也可包括复数。一般说来，术语“包括”与“包含”仅提示包括已明确标识的步骤和元素，而这些步骤和元素不构成一个排它性的罗列，方法或者设备也可能包含其它的步骤或元素。
关于本说明书中的术语“远侧/远端”和“近侧/近端”，其中近端/近侧指的是靠近操作人员的一端，而远端/远侧指的是远离操作人员，或者进入人体血管的一端。
参照图1，本发明公开一种支架装置1，其安装在血栓治疗装置的输送导管2顶部附近，并且输送导管2通过手柄3进行控制，以此进一步对支架装置1进行控制。如图2和图3所示，支架装置1主要包括无创导头4，膨胀支架5，内推杆6，近端显影环7，外推杆8等部件。支架装置1嵌入在输送导管2中，内推杆6与手柄3连接，并且与膨胀支架5的支架远端收束端508连接，外推杆8与手柄3固定，可以通过手柄3调节内推杆6来实现对支架5的轮廓直径大小的控制。
参照图3，支架装置1的主体为膨胀支架5，膨胀支架5由支架近端支撑部分522和支架远端密网部分523组成。如图3所示，支架近端支撑部分522和支架远端密网部分523分别包括多个互连支撑杆，其中靠近支架近端支撑部分522(即由支架近端支撑部分522延伸出的互连支撑杆)为近端杆，而靠近支架远端密网部分523(即由支架远端密网部分523延伸出的互连支撑杆)为远端杆。此外，近端杆/远端杆分别互相连接以构成网格结构，多根近端杆构成的网格结构为近端网格，多根远端杆构成的网格结构为远端网格。通过网格结构，多个互连支撑杆形成可在约束状态和展开状态之间移动的整体结构。
参照图3-图5，膨胀支架5结构上为梭形或椭圆形结构，其外轮廓大小通过内外推杆的轴向相对运动而变化。从整体结构上看，近端网格单元面积大，远端网格单元面积小，近端网格由二至六个大面积单元，且相邻大面积单元的是数量一样的小面积单元组成。近端每个大网格单元相对于中心轴镜像对称的远端网格单元的面积要小。相比而言，远端网格由数量为近端大面积网格偶数倍的单元组成，其倍数为2～6倍，且远端网格单元大小基本一致。近端网格单元和远端网格单元通过“工”字型节点连接，其连接节点为膨胀支架5轮廓的最高点。连接节点旁边有支架轮廓显影标记，其数量为近端大网格单元数量的1～4倍左右。由于膨胀支架5带有临床荧光影像下可视的标记点，手术过程中可清楚看到膨胀支架5变化的 大小。
继续如图3所示，虽然图3区分了支架近端支撑部分522和支架远端密网部分523，但近端杆构成的支架近端支撑部分522和远端杆构成的支架远端密网部分523互相连接成笼状结构。具体而言，近端杆包括第一连接部和第二连接部，第一连接部形成收束端，位于图3所示的左侧部分。远端杆包括第三连接部和第四连接部，第四连接部形成收束端，位于图3所示的右侧部分。第二连接部和第三连接部互相连接于图3所示的中央竖线位置，该竖线仅用作大致区划支架近端支撑部分522和支架远端密网部分523的标识，并非具有分隔实体，也并不表示支架近端支撑部分522、支架远端密网部分523的具体比例。
参照图3、图4、图5和图6，作为本发明的一种实施方式，支架近端支撑部分522主要包括一或多组近端收束端杆501、第一近端杆502，第二近端杆503、第二近端杆504、显影支杆514，第二近端杆505。其中，第一近端杆502相对较粗，杆宽尺寸在0.3mm到0.5mm之间，支架壁厚在0.15mm到0.5mm之间，杆数在三到六个之间。第二近端杆503、504和505杆宽在0.15mm到0.5mm之间，壁厚在0.15mm到0.5mm之间，杆数在12到24个之间。作为本发明的一种实施方式，显影支杆514的杆数一般是第二近端杆504的一半，但本发明并不以此为限。
继续参照图3、图4、图5和图6，近端收束端杆501分为三到六根第一近端杆502。每根第一近端杆502向更远端分为两根第二近端杆503。每根第二近端杆503再向更远端分为两根第二近端杆504。每根第二近端杆504进一步向更远端分为两根第二近端杆505。上述五种支撑杆(501、502、503、504、505)，连接所形成的区域为第一网格部分509，第一网格部分509相对更为靠近第一连接部，即近端收束端杆501所在的位置。构成三到六个第一网格部分509的近端杆组成了膨胀支架5的第二连接部。第一近端杆502相对其他支撑杆更粗更厚，提高了血栓抓捕过程中大开口的刚性支撑，使得取栓效率更高。第一近端杆502杆数较少，而且杆子较长，这样可以使得膨胀支架5进入输送导管2中的顺应性较好，使得膨胀支架5能够重复回收使用。
第二近端杆503、第二近端杆504、505上均可以分叉形成(显影)支杆，并且在支杆上设置显影结构。作为本发明的一种实施方式，每两根第二近端杆504中有一根在第二近端杆505分叉的稍近处分出一根显影支杆514，显影支杆514上放置显影结构9，如图9所示，但本发明并不以此为限。在本发明的其他实施例中，显影支杆可以设置于近端杆(第一近端杆、第二近端杆)和/或远端杆的其他位置，均可以实现本发明的技术目的，达到本发明的技术效果。作为本发明的第二种实施方式，显影结构9可以通过胶水粘接的方式固定在 第二近端杆504上，也可以通过激光焊接的方式固定在第二近端杆504上。显影结构9可以使得膨胀支架5在DSA(Digital subtraction angiography，数字减影血管造影)下有显影作用，术中能够使得操作人员实时监控膨胀支架5在血管内的轮廓大小。作为本发明的第三种实施方式，显影结构可以是图9所示的弯状结构，也可以是锚固的孔状结构，也可以是工字梁结构，或者其他形式的显影结构形式，均可以实现本发明的技术目的，达到本发明的技术效果，本发明不以此为限。
继续参照图3-图6，支架近端支撑部分522中第二近端杆504和第二近端杆505构成第二网格部分510。第二近端杆503、504和505构成第二网格部分524。膨胀支架5中构成第二网格部分510和第二网格部分524的部分近端杆为第二连接部。第二连接部与第三连接部互相连接。第二连接部的支撑杆数量通常为12～24根。一般而言，第一连接部和第二连接部区域内的近端杆主要用于抓捕、获取大负荷血栓，以及将血栓与血管管壁分离。第二网格部分的结构使得膨胀支架5具有高径向支撑力，能够在取栓过程中与血管提供更好的贴壁性，使得膨胀支架5能够沿血管壁去除更多的贴壁性的栓子，且能够获取其他取栓方式无法获取的取栓能力。
参照图7，作为本发明的另一种实施方式，支架近端支撑部分522主要包含近端收束端杆501、第一近端杆502，第二近端杆515、显影支杆514，第二近端杆516、第二近端杆517、第二近端杆518组成。其中第一近端杆502相对较粗，杆宽在0.3mm到0.5mm之间，支架壁厚在0.15mm到0.5mm之间，杆数在三到六根之间。第二近端杆515、516、517、518杆宽为0.15-0.5mm，壁厚为0.15-0.5mm，杆数在12到24根之间。作为本发明的一种实施方式，显影支杆514的杆数一般是第二近端杆515的一半，但本发明并不以此为限。
继续参照图7，近端收束端杆501向更远端分成三根第一近端杆502。每根第一近端杆502向更远端分成四根第二近端杆，外侧两根为第二近端杆515，内侧两根为第二近端杆518。第二近端杆515向更远端分成两根第二近端杆516。第二近端杆518向更远端分成两根第二近端杆517。每两根第二近端杆515中有一根在第二近端杆516分叉的稍近处分出一根显影支杆514，显影支杆514上放置显影结构9，如图9所示。在一些实例中，显影结构9可以通过胶水粘接的方式固定在第二近端杆515上，也可以通过激光焊接的方式固定在第二近端杆515上。近端收束端杆501、第一近端杆502，第二近端杆515，第二近端杆516连接所形成的区域为第一网格部分519，构成三到六个第一网格部分519的近端杆组成了膨胀支架5的第一连接部。
继续参照图7，第二近端杆515、第二近端杆516、第二近端杆517、第二近端杆518 连接形成第二网格部分520。第二近端杆517、第二近端杆518连接形成第二网格部分521。在此实施例中，膨胀支架5中构成第二网格部分520和第二网格部分521的部分近端杆为第二连接部。第二连接部与第三连接部互相连接。
对比图6和图7可见，图7所示的支架近端支撑部分522中，由第一近端杆502延伸出的第二近端杆515的数量从图6的两根变为了图7的四根。经过多次测试，这种数量上的变化能够对支架近端支撑部分522带来更强的径向支撑力，起到更好的支撑效果。本领域的技术人员可以理解，通过调整第一近端杆502、第二近端杆515、第二近端杆516、第二近端杆517、第二近端杆518的具体数量和连接关系，可以获得不同径向支撑效果的支架近端支撑部分522，这些不同的组合及其选择均属于本发明的保护范围内。
参考图3和图5，支架远端密网部分523由支架远端杆506，支架远端杆507，支架远端收束端杆508组成。作为本发明的一种实施方式，支架远端杆506、507和支架远端收束端杆508的杆宽在0.15mm到0.5mm之间，杆壁厚在0.15mm到0.5mm之间，杆数在12到24个之间，但本发明不以此为限。
继续参考图3和图5。第二近端杆505和支架远端杆506构成支架远端网格511，支架远端杆506和支架远端杆507构成支架远端网格512。或者，在另一种实例中，第二近端杆516和支架远端杆506构成支架远端网格511，支架远端杆506和支架远端杆507构成支架远端网格512。构成支架远端网格511和支架远端网格512的远端杆共同形成第三连接部。。第三连接部与第二连接部互相连接。支架远端杆507和支架远端收束端杆508构成支架远端网格513，形成远端收束端，支架远端收束端杆508所在位置成为膨胀支架5的第四连接部。支架远端网格511、512和513呈密网网格状，其膨胀后的形状呈现从膨胀支架顶部向远端网格面积逐渐变小的形态。远端网格的孔径均小于近端网格的孔径，可以使得抓取的血栓能够牢靠的包围在支架内部，防止血栓逃逸。
通过图3-图8可见，在本发明中，膨胀支架5的近端杆的数量小于远端杆的数量，且近端杆的杆长、杆宽、杆壁厚度其中至少之一大于远端杆的杆长、杆宽、杆壁厚度。之所以采取这样“非对称”的形式，主要有以下的原因：
1.近端杆及其支架近端支撑部分522的主要功能并不完全是捕获血栓并防止血栓逃逸，还有起到更好径向支撑的作用，因此近端杆采用更长、更粗、杆壁更厚的杆体，能够具有更高的支撑强度，提供更大的径向支撑力。此外，近端杆形成较大的开孔也由于近端杆的强度更大而起到更好的支撑效果，因为杆的数量更多、更密并不利于径向强度的提升，反而会弱化径向强度；
2.远端杆及其支架远端密网部分523的主要功能在于更好地捕获血栓并防止血栓逃逸，因此远端杆采用更细、更密的结构，以此能够形成密网编织结构，类似于“网篮”的半球形构造能够使得支架远端密网部分523更好地让血栓容纳在其中，并防止血栓逃逸。
膨胀支架5可由镍钛材料等形状记忆材料制成，其可通过多种加工方法进行制造。在一些实例中，支架近端支撑部分522和支架远端密网部分523可以采用相同的材料制成，此时使用一根镍钛管在激光切割机器下切割出支架的初步轮廓，然后通过热定型的方式加工成为如图3-图7所示的膨胀支架5的形态。在另一些实例中，支架近端支撑部分522和支架远端密网部分523可以采用不同的材料制成，支架近端支撑部分522仍然是由镍钛材料等形状记忆材料制成，并且使用一根镍钛管在激光切割机器下切割出支架近端支撑部分522的轮廓。与支架近端支撑部分522不同的是，支架远端密网部分523可以是编织密网结构，如图8所示。此时，通过编织方式将支架远端密网部分523编织出来，然后通过穿孔、铆接或者焊接等加工方式连接到近端支撑性比较好的切割支架上。当选择不同材料时，本发明对支架近端支撑部分522和支架远端密网部分523不做限制。
继续参考图1～2，膨胀支架5的支架近端收束端杆501留有足够的长度用来连接外推杆8。膨胀支架5的支架远端收束端杆508留有足够的长度连接内推杆6以及无创导头4。膨胀支架5两端与支架装置1的连接方式可以采用Pebax材料热熔，也可以采用胶水粘接的方式。作为本发明的一种优选实施方式，第一连接部(支架近端收束端杆501所在位置)形成的收束端嵌套在近端显影环7内，而第四连接部(支架远端收束端杆508所在位置)形成的收束端嵌套在无创导头4内。近端显影环7、无创导头4及显影结构9覆盖了膨胀支架5从近端、中部到远端各个部分位置，使得膨胀支架5在使用过程中可以通过显影设备显示其整体的动态形态。
本发明当参与手术过程时，参考图10，通过输送导管2将支架装置1导入人体血管BV，并接近血栓PE所在位置处。通过手柄3控制将外推杆8、内推杆6以及膨胀支架5推出输送导管2。
参考图11，直至膨胀支架5被递送到血栓PE远端位置时，膨胀支架5在输送导管2内部始终保持如图最小外廓直径的约束状态。
参考图12，当膨胀支架5处于血栓PE远端位置时，通过手柄3改变外推杆8与内推杆6的相对轴间距，从而改变膨胀支架5的直径从约束状态变为展开状态。在手术操作中膨胀支架5展开后的位置可能不合适，此时可以将膨胀支架5再次撤回到输送导管2中，随着支架装置1调整好膨胀支架5释放位置后可以将膨胀支架5重新释放出来，使得膨胀支架5 能够重复回收使用。在适当位置展开膨胀支架5后，通过手柄3将其调节到适应血管BV直径的外廓直径尺寸。显影结构9可以使得膨胀支架5在DSA(Digital subtraction angiography，数字减影血管造影)下有显影作用，能够实时监控膨胀支架5在血管内的轮廓大小，辅助术者进行取栓。
参考图13，当展开后的膨胀支架5进行取栓时，通过手柄3控制向近端将膨胀支架5拖出血管BV。拖动过程中膨胀支架5会捕获并刮除血管BV壁上的血栓PE。支架远端第三、第四连接部密网网格结构，将使得抓取的血栓能够牢靠的包围在支架内部，防止血栓逃逸。随手柄3和膨胀支架5将血栓PE从血管BV内拉到抽吸导管远端抽吸口附近或者拉到抽吸导管内，使得抽吸导管将血栓PE吸出，或者直接将血栓PE通过抽吸导管拉出体外，直至将血栓完全移出体外实现支架取栓。
支架取栓完成后，通过手柄3将输送导管2，外推杆8，内推杆6和膨胀支架5从人体血管BV中抽出，至此完成整个取栓过程。
综上所述，本发明的血栓取栓支架装置具有以下的有益效果：
1)基于形状记忆合金设计的镂空网篮支架，可以是杆状分布的网孔切割支架，也可以是网孔切割支架和编织支架混合的支架，具有近端开口大，支撑性好的特点，便于大块血栓捕捉清除，并且在取栓过程中近端不会发生塌陷，针对大负荷血栓取栓有效性更高；
2)支架径向力大，使得支架与血管贴壁性更强，便于支架捕获贴附在血管壁的血栓，使得血栓清除更加彻底完整；
3)支架远端采用切割或编织密网结构，可以使得支架捕获的血栓无法逃逸，避免造成逃逸血栓引起的堵塞；
4)支架球形或笼型设计，使得支架内部有较大的血栓储存空间，但是仍然可以保持较高的径向支撑力，使得支架容纳血栓的能力得到提升，取栓效率更高；
5)支架能够顺应手柄的调节来满足对应的血管尺寸大小，同时配合手柄调节可以起到破坏血栓的作用，一款支架可以适应更宽范围的血管直径取栓；
6)支架最大外径处带有显影结构设计，可以在术中通过查看DSA影像来判断支架当前的大小，从而通过手柄调节其大小实现支架与血管直径的调节适应。也可以是通体结构显影，包覆内层或者外层显影编织支架；
7)支架入鞘性能优越，可回收，当支架释放位置不合适，可以重新将支架调节到入鞘尺寸进入到鞘管内重新调节支架释放的位置；
8)支架可配合较大的抽吸导管口径实现抽吸和支架联合取栓，使得肺栓塞取栓效率得到更 大提升，使得取栓更加彻底，增加取栓有效性。本技术领域中的普通技术人员应当认识到，以上的实施例仅是用来说明本发明，而并非用作为对本发明的限定，只要在本发明的实质精神范围内，对以上所述实施例的变化、变型都将落在本发明的权利要求书范围内。

Claims (10)

  1. 一种血栓取栓支架装置，其特征在于，包括：
    膨胀支架，所述膨胀支架包括近端支撑部分和远端密网部分；
    所述近端支撑部分包括多根近端杆，以及由所述多根近端杆构成的近端网格；
    所述远端密网部分包括多根远端杆，以及由所述多根远端杆构成的远端网格；
    所述近端杆的数量小于所述远端杆的数量，且所述近端杆的杆长、杆宽、杆壁厚度其中至少之一大于远端杆的杆长、杆宽、杆壁厚度；
    所述近端杆包括第一连接部和第二连接部，所述第一连接部形成收束端；
    所述远端杆包括第三连接部和第四连接部，所述第四连接部形成收束端；
    所述第二连接部和第三连接部互相连接，使得所述近端支撑部分和远端密网部分互相连接以在所述膨胀支架处于释放状态时形成笼状结构。
  2. 如权利要求1所述的血栓取栓支架装置，其特征在于：
    所述近端网格的孔径大于远端网格的孔径。
  3. 如权利要求1所述的血栓取栓支架装置，其特征在于：
    所述近端网格包括第一网格部分和第二网格部分，其中第一网格部分为靠近所述第一连接部的网格，所述第二网格部分为靠近所述第二连接部的网格；
    所述第一网格部分的孔径大于第二网格部分的孔径。
  4. 如权利要求3所述的血栓取栓支架装置，其特征在于：
    所述第一连接部包括三根第一近端杆，每一根所述第一近端杆的杆宽为0.3-0.5mm，杆壁厚为0.15-0.5mm。
  5. 如权利要求4所述的血栓取栓支架装置，其特征在于：
    所述第二连接部包括多根第二近端杆，每一根所述第二近端杆的杆宽为0.15-0.5mm，杆壁厚为0.15-0.5mm；
    所述第二近端杆的数量大于所述第一近端杆的数量。
  6. 如权利要求5所述的血栓取栓支架装置，其特征在于：
    所述第一近端杆的一个末端形成四根分叉，每一根所述分叉形成一根所述第二近端杆。
  7. 如权利要求1-6中任意一项所述的血栓取栓支架装置，其特征在于，还包括：
    显影结构，所述近端杆或所述远端杆上包括支杆，所述支杆上设置显影结构。
  8. 如权利要求1-6中任意一项所述的血栓取栓支架装置，其特征在于，还包括：
    近端显影环，所述第一连接部形成的收束端嵌套在近端显影环内。
  9. 如权利要求1-6中任意一项所述的血栓取栓支架装置，其特征在于：
    所述第四连接部形成的收束端嵌套在无创导头内。
  10. 如权利要求1-6中任意一项所述的血栓取栓支架装置，其特征在于：
    所述近端支撑部分和远端密网部分均为激光切割结构；或者，
    所述近端支撑部分为激光切割结构，所述远端密网部分为编织密网结构。
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