WO2023072227A1 - 血管支架 - Google Patents

血管支架 Download PDF

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Publication number
WO2023072227A1
WO2023072227A1 PCT/CN2022/128151 CN2022128151W WO2023072227A1 WO 2023072227 A1 WO2023072227 A1 WO 2023072227A1 CN 2022128151 W CN2022128151 W CN 2022128151W WO 2023072227 A1 WO2023072227 A1 WO 2023072227A1
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WO
WIPO (PCT)
Prior art keywords
vascular stent
support
groove
connecting rods
connecting rod
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PCT/CN2022/128151
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English (en)
French (fr)
Inventor
李�杰
常兆华
Original Assignee
上海微创医疗器械（集团）有限公司
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Publication of WO2023072227A1 publication Critical patent/WO2023072227A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • A61F2002/91541—Adjacent bands are arranged out of phase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91575—Adjacent bands being connected to each other connected peak to trough

Definitions

  • the invention relates to the technical field of medical instruments, in particular to a blood vessel stent.
  • Atherosclerosis is currently considered to be a chronic inflammatory disease that starts at a young age and lasts for decades, and clinical symptoms of atherosclerosis usually appear in adulthood.
  • the basic pathological change is the formation of plaques on the intima of the arteries, including lipid streaks, fibrous plaques, and atheromatous plaques, which can cause vascular lumen stenosis or thrombosis.
  • the interventional medical treatment of vascular stents has become the main treatment method for such vascular diseases.
  • the other is to adjust the overall structure of the vascular stent, such as adjusting the length of the vascular stent, the number of support rings, the number of connecting rods, etc., to improve the intravascular hydrodynamic environment by changing the flexibility of the vascular stent, but blood flows through the blood vessel Eddy currents are still generated during stenting, which usually increases the risk of in-stent restenosis.
  • a vascular stent comprising: a plurality of support rings and a plurality of connecting rods, the plurality of support rings are distributed at intervals along the central axis of the vascular stent, each of the plurality of connecting rods is connected to each Between two adjacent supporting rings, the wall thickness of at least a part of each of the plurality of connecting rods is smaller than the thickness of the plurality of supporting rings.
  • At least part of inner sides of the plurality of connecting rods and/or the plurality of support rings are streamlined corresponding to the axial direction of the vascular stent.
  • each of the plurality of support rings is formed by connecting a plurality of support rods around the central axis of the vascular stent, and the plurality of adjacent support rods are connected end-to-end by reinforcing rings and form an angle.
  • each of the plurality of connecting rods is a non-linear structure, including a warp segment structure and a weft segment structure, the inner wall surface of the support rod and/or the weft section structure is a streamlined smooth surface.
  • At least one of the inner side wall and the outer side wall of at least one of the plurality of connecting rods has at least one groove, and the wall thickness of the connecting rod at the groove is smaller than the wall thickness of the support ring. thick.
  • the groove wall of the groove forms a smooth transition zone corresponding to the axial direction of the vascular stent.
  • each of the plurality of support rings is formed by connecting a plurality of support rods around the central axis of the vascular stent, and the plurality of adjacent support rods are connected end-to-end by reinforcing rings and form an angle.
  • Both ends of each of the plurality of connecting rods are respectively connected to the two reinforcing rings of the two adjacent supporting rings.
  • the notch of the groove is located in the area of the connecting rod and has a fillet, or the fillet is at least partially located in the reinforcing ring.
  • the at least one of the plurality of connecting rods includes a plurality of grooves, and in the schematic axial section of the vascular stent, at least a part of the side wall of the at least one of the plurality of connecting rods
  • the contour lines of the connecting rods have a sine wave or cosine wave structure, and the grooves are formed by the area between the adjacent crests on the same side wall of the at least one of the plurality of connecting rods.
  • the troughs located on different sidewalls of the at least one of the plurality of connecting rods are aligned and distributed.
  • the groove located on the axially outermost side of the at least one of the plurality of connecting rods is at least partially located in the reinforcing ring of the support ring.
  • the non-groove area of at least one of the plurality of connecting rods, or/and the cross-section of the support ring perpendicular to the axis is an arc that protrudes toward the central axis of the vascular stent shaped structure.
  • the thickness of at least one of the plurality of connecting rods at the bottom of the groove is smaller than the thickness of the wall of the support ring and greater than or equal to half of the thickness of the wall of the support ring.
  • a reinforcement part is further provided on the plurality of connecting rods, and the wall thickness of the reinforcement part is greater than the wall thickness of at least a part of the plurality of connecting rods.
  • the wall thickness of at least a part of the connecting rod is smaller than the wall thickness of the support ring, so that the overall flexibility of the vascular stent is increased, the passage rate of the vascular stent in the blood vessel is improved, and it is easier to introduce into the lesion position of the blood vessel; the wall thickness
  • the larger support ring can still improve the good radial support force and ensure the shape of the vascular stent after expansion in the blood vessel.
  • the vascular stent can be designed with different wall thicknesses in the designated position area, and the detailed structure of the vascular stent can be adjusted to achieve the effect that the vascular stent has different wall thicknesses, so that the thinned position (ie, the connecting rod ) flexibility, while ensuring the strength of the rest of the unreduced wall thickness (that is, the support ring), so that the vascular stent as a whole still maintains good support performance.
  • FIG. 1 is a schematic diagram of a partial structure of a vascular stent provided by an embodiment of the present invention
  • Fig. 2 is the axial partial sectional schematic diagram at A-A place of Fig. 1;
  • Fig. 3 is the axial partial sectional schematic diagram at B-B place of Fig. 1;
  • FIG. 4 is a schematic diagram of a partial structure of a vascular stent provided by another embodiment of the present invention.
  • Fig. 5 is a schematic partial axial cross-sectional view of a vascular stent provided by another embodiment of the present invention.
  • Fig. 6 is a schematic partial axial cross-sectional view of a vascular stent provided by another embodiment of the present invention.
  • Fig. 7 is a schematic partial axial cross-sectional view of a vascular stent provided by another embodiment of the present invention.
  • Fig. 8 is a schematic partial axial cross-sectional view of a vascular stent provided by another embodiment of the present invention.
  • FIG. 9 is a schematic cross-sectional view of a connecting rod of a vascular stent provided by an embodiment of the present invention.
  • Fig. 10 is a schematic diagram of the environment when blood flows through the support rod of the vascular stent provided by an embodiment of the present invention.
  • Fig. 11 is a schematic structural view of the streamlined surface of the connecting rod provided by an embodiment of the present invention.
  • first and second are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features.
  • the features defined as “first” and “second” may explicitly or implicitly include at least one of these features.
  • “plurality” means at least two, such as two, three, etc., unless otherwise specifically defined.
  • the first feature may be in direct contact with the first feature or the first and second feature may be in direct contact with the second feature through an intermediary. touch.
  • “above”, “above” and “above” the first feature on the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature.
  • “Below”, “beneath” and “beneath” the first feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is less horizontally than the second feature.
  • the vascular stent includes: a plurality of support rings 100 and a plurality of connecting rods 200, and the plurality of support rings 100 are distributed at intervals along the length direction of the vascular stent, each A connecting rod 200 is connected between every two adjacent supporting rings 100 , and at least a part of each plurality of connecting rods 200 has a wall thickness smaller than that of the supporting rings 100 .
  • the above-mentioned vascular stent can be self-expandable or balloon-expandable.
  • the vascular stent can be cut from a metal pipe, that is, the connecting rod 200 and the support ring 100 of the vascular stent are integrally formed.
  • the connecting rod 200 of the vascular stent and the support ring 100 may also be connected by means of welding or the like.
  • the vascular stent has biocompatibility, and its material can be degradable or non-degradable.
  • each support ring 100 may be formed by connecting a plurality of support rods 110 end-to-end through a reinforcement ring 120 , may be wave-shaped, and mainly serve to support blood vessels.
  • the wall thickness of the support rods 110 is 0.08 mm to 0.2 mm
  • every two adjacent support rods 110 are connected by a reinforcing ring 120 and form an angle (see FIG. 1 )
  • adjacent support rings 100 are connected by a connecting rod 200 .
  • the connecting rod 200 mainly plays the role of connecting the supporting ring 100 and is a key factor affecting the overall flexibility of the stent.
  • both ends of the connecting rod 200 are respectively connected to two reinforcing rings 120 of two adjacent supporting rings 100 .
  • the reduced wall thickness of the connecting rod 200 is more bendable, and the flexibility of the vascular stent is enhanced, which is more conducive to adhering to the vessel wall A, so as to prevent the vascular stent from warping and damaging the intima after the vascular stent is expanded.
  • the side wall of the connecting rod 200 close to the central axis of the vascular stent, that is, the inner wall, is in contact with the blood.
  • the shear stress of the blood on the blood vessel wall A is increased due to the reduced wall thickness, which can effectively avoid restenosis of the blood vessel. .
  • the overall wall thickness of the connecting rod 200 is smaller than the wall thickness of the support ring 100, or a part of the wall thickness of the connecting rod 200 is smaller than the wall thickness of the support ring 100, as long as the flexibility and radial support force of the vascular stent are ensured,
  • only the end of the connecting rod 200 close to the reinforcing ring 120 connected to the supporting rod 110 has a wall thickness equal to the thickness of the supporting rod 110 , while the thickness of other parts of the connecting rod 200 is smaller than the thickness of the supporting rod 110 .
  • the wall thickness of at least a part of the connecting rod 200 is smaller than the wall thickness of the support ring 100, which can increase the flexibility of the vascular stent while maintaining the anti-extrusion property of the vascular stent, improve the passage rate of the vascular stent in the blood vessel, and make it easier
  • the support ring 100 with a thicker wall can still improve the good radial support force and ensure the shape of the vascular stent after expansion in the blood vessel.
  • the vascular stent can be designed with different wall thicknesses in the designated position area, and the detailed structure of the vascular stent can be adjusted to achieve the effect that the vascular stent has different wall thicknesses, so that the thinned position (ie, the connecting rod 200) while ensuring the strength of the rest of the unreduced wall thickness (that is, the support ring 100), so that the vascular stent as a whole still maintains good support performance.
  • At least part of the connecting rod 200 and/or the support ring 100 on the side contacting the blood flow surface, that is, the inner side is streamlined corresponding to the blood flow direction.
  • the side of the connecting rod 200 and the supporting ring 100 contacting the surface of the blood flow, that is, the inner side is arranged as a streamlined structure corresponding to the direction of blood flow.
  • the inner side of the connecting rod 200 has a streamlined structure in the axial direction of the central axis of the vascular stent.
  • the inner side of the reinforcing ring 120 of the ring 100 has a streamlined structure, and in some embodiments, the inner surface of the reinforcing ring 120 is arc-shaped.
  • Connecting rod 200 and/or support ring 100 refers to one of the following combinations: (1) connecting rod 200, (2) supporting ring 100, (3) connecting rod 200 and supporting ring 100, each supporting ring 100 comprising a plurality of supporting rod 110 and a plurality of reinforcement rings 120 connecting the plurality of support rods 110 .
  • the surface of the connecting rod 200 may be streamlined, and the streamlined structure extends to the support ring 100 .
  • the "thickness of the support ring 100" in the text refers to the maximum thickness of the support ring 100, and in some embodiments, the thickness of the support ring 100 is a uniform thickness.
  • the "corresponding to the direction of blood flow” means that the streamlined drag reduction target direction of the structure surface is the direction of blood flow or the general direction of blood flow, that is, "corresponding to the direction of blood flow is streamlined” means that in the direction of blood flow, the vascular stent can The streamlined structure reduces blood flow resistance.
  • the streamlined surfaces of the connecting rod 200 and the support ring 100 have the same or substantially the same direction as the blood flow direction.
  • the surface meets the following conditions to be called a streamlined surface: (1), the surface structure is smooth and has no edges and corners in a specific direction; (2), the climbing angle is greater than or equal to 135° and less than 180°, where the climbing angle refers to the angle between the line between the lowest point and the highest point on the slope and the inner wall of the connecting rod 200; (3) the distance between the lowest point and the highest point on the slope Can not be less than half of the total wall thickness of the connecting rod 200.
  • each support ring 100 is formed by connecting a plurality of support rods 110, and the adjacent support rods 110 are connected by a reinforcing ring 120 and form an angle; the connecting rods 200
  • the two ends of the two adjacent support rings 100 are respectively connected to the two reinforcement rings 120, the connecting rod 200 is a non-linear structure, the contour line includes a warp segment and a weft segment, and the support rod 110 and/or the weft segment contact the blood flow
  • the surface is a streamlined smooth surface.
  • the streamlined smooth surface can mean that the cross-sectional contour line of the connecting rod 200 along the blood flow direction is streamlined, including circular, semicircular, and curved shapes.
  • the streamlined smooth surface extends from the connecting rod 200 to the part of the supporting rod 110 .
  • the meridian segment structure of the connecting rod 200 refers to the part of the connecting rod 200 perpendicular to the blood flow direction
  • the latitudinal segment structure refers to the part of the connecting rod 200 parallel or substantially parallel to the blood flow direction.
  • the side wall of the connecting rod 200 close to the central axis of the vascular stent (that is, the side close to the blood flow, that is, the inner wall), and/or There is a groove 210 on the side wall (that is, the outer wall) away from the central axis of the vascular stent, and the groove 210 is used to make the wall thickness of the connecting rod 200 smaller than the wall thickness of the support ring 100 .
  • the groove wall of the groove 210 forms a smooth transition region 220 corresponding to the blood flow direction.
  • the smooth transition can make the groove 210 on the inner wall of the connecting rod 200 not form a vortex, which reduces the restenosis rate, and makes the groove 210 on the outer wall of the connecting rod 200 not damage the intima of the blood vessel, reducing the intima hyperplasia.
  • the entire sidewall area of the groove 210 is a smooth transition area 220 .
  • the notch of the groove 210 is located in the region of the connecting rod and has rounded chamfers, or the rounded chamfers are at least partially located on the reinforcing ring 120, and/or between the groove wall and the groove bottom of the groove 210 Has rounded corners. It will be appreciated that in some embodiments the rounded corners form part of the rounded transition region.
  • the groove 210 forms a recessed area on any wall surface of the entire inner or outer wall of the connecting rod 200 along the length direction of the connecting rod 200
  • at least a part of the groove 210 is located on the reinforcing ring of the supporting rod 110 120 , at this time, the fillet of the notch of the groove 210 is located on the reinforcement ring 120 of the support rod 110 .
  • the entire groove 210 is located within any wall surface of the inner wall or the outer wall of the connecting rod 200 , at this time, the notch of the groove 210 itself has rounded chamfers and is provided on the connecting rod 200 .
  • the rounded chamfer can prevent the formation of eddy current at the groove 210 on the inner wall of the connecting rod 200, which reduces the restenosis rate, and prevents the intima of the blood vessel from being damaged at the groove 210 on the outer wall of the connecting rod 200, reducing the intima hyperplasia.
  • the connecting rod 200 has grooves 210, as shown in FIGS. Among them, the outline of at least a part of the sidewall of the connecting rod 200 is in the shape of a sine wave or a cosine wave, and the same sidewall of the connecting rod 200 and the area between adjacent peaks form a groove 210 .
  • the groove 210 of this type of structure can effectively reduce the wall thickness of the connecting rod 200, and the groove of this type of structure is smooth everywhere. It should be noted that when grooves 210 are provided on both the inner wall and the outer wall of the connecting rod 200 , the wave peaks on the two side walls are staggered to ensure that the wall thickness of the connecting rod 200 is effectively reduced.
  • the troughs located on the inner wall and the outer wall of the connecting rod 200 are aligned and distributed. In this way, the wall thickness of the connecting rod 200 can be effectively reduced, and at the same time, the force on the connecting rod 200 can be made uniform.
  • the groove 210 located on the outermost axial side of the connecting rod 200 is at least partially located in the reinforcing ring 120 of the supporting ring 100 .
  • the axial direction herein refers to the direction of the central axis of the vascular stent, and the length direction of the connecting rod 200 is consistent with the axial direction. It should be noted that when the groove 210 of the sine wave or cosine wave structure forms a concave area along the length direction of the connecting rod 200 on any side surface of the entire connecting rod 200, that is, the sine wave and cosine wave structure are completely located within the range of the connecting rod 200 The inner and smooth transition zone 220 is entirely within the range of the connecting rod 200 .
  • the groove wall of the outermost groove 210 in the axial direction extends to all In the reinforcement ring 120 of the support ring 100 mentioned above, the smooth transition zone 220 is partly located in the reinforcement ring 120 .
  • the smooth transition or smooth transition can prevent the formation of eddy currents at the groove 210 on the inner wall of the connecting rod 200, thereby reducing the restenosis rate.
  • the cross-section along the blood flow direction of 120 is an arc-shaped structure protruding toward the central axis of the vascular stent.
  • the cross-section of the support rod 110, the non-groove area of the connecting rod 200 or the reinforcement ring 120 is set to an arc-shaped structure, so that the outer wall of this part of the cross-section is relatively smooth compared with the rectangular cross-section.
  • the wall thickness of at least a part of the connecting rod 200 is less than the wall thickness of the support ring 100 and greater than or equal to one-half of the wall thickness of the support ring 100, and the thickness of the connecting rod 200 at the bottom of the groove is less than
  • the wall thickness of the support ring 100 is greater than or equal to half of the wall thickness of the support ring 100 . It can be understood that when the groove 210 does not exceed the range of the connecting rod 200 , the thickness of the support ring 100 is uniform.
  • the thickness of the connecting rod 200 at the bottom of the groove for example, can be set to one-half, two-thirds, three-quarters, etc. of the thickness of the support ring 100 .
  • the thickness of the connecting rod 200 at the bottom of the groove may be 0.05 mm-0.07 mm. In this way, the strength of the connecting rod 200 can be ensured, and the generation of the eddy current phenomenon at the connecting rod 200 can be suppressed.
  • a reinforcing part 300 is further provided on the connecting rod 200 , and the wall thickness of the reinforcing part 300 is greater than that of at least a part of the connecting rod 200 .
  • the wall thickness of the reinforcing part 300 can be the same as that of the support rod 110 of the support ring 100, so as to ensure that the connecting rod 200 has sufficient strength and the extrusion resistance of the vascular stent.
  • the shape of the reinforcement part 300 may be an "S" shape placed horizontally, a wave shape, a broken line shape, and the like.
  • one end of the reinforcement part 300 is connected to the connecting rod 200 , and the other end of the reinforcement part 300 is connected to the reinforcement ring 120 of the support ring 100 .
  • the vascular stent includes a plurality of support rings 100 and a plurality of connecting rods 200; the plurality of support rings 100 are spaced along the central axis of the vascular stent
  • the adjacent supporting rings 100 are connected by connecting rods 200, and the two ends of the connecting rods 200 are respectively connected with the two reinforcing rings 120 of the two adjacent supporting rings 100.
  • each support ring 100 is formed by connecting a plurality of support rods 110 end-to-end around the central axis of the vascular stent through a reinforcement ring 120 , and the wall thickness D1 of the support rods 110 is 0.1 mm.
  • a part of the outer wall of the connecting rod 200 has a groove 210, the distance D2 between the bottom of the groove 210 and the outer wall of the connecting rod 200 (ie the wall thickness of the connecting rod 200) is 0.05m, and the groove 210 does not exceed the connecting rod 200.
  • the groove wall of the groove 210 forms a smooth transition zone 220 corresponding to the direction of blood flow.
  • the bottom has rounded chamfers.
  • the vascular stent includes a plurality of support rings 100 and a plurality of connecting rods 200; the support ring 100; The central axis is distributed at intervals. Adjacent support rings 100 are connected by connecting rods 200, wherein each support ring 100 is formed by connecting a plurality of support rods 110 end-to-end around the central axis of the vascular stent through a reinforcing ring 120, and the wall thickness D1 of the support rods 110 is 0.1mm .
  • the shape is an "S" placed horizontally.
  • the distance D2 ie the wall thickness of the connecting rod 200
  • the groove 210 does not exceed the entire connecting rod 200
  • Any side surface of the range produces a concave area, and the groove wall of the groove 210 forms a smooth transition zone 220 corresponding to the direction of blood flow.
  • the vascular stent includes a plurality of support rings 100 and a plurality of connecting rods 200 ; the plurality of support rings 100 are distributed at intervals along the central axis of the vascular stent. Adjacent support rings 100 are connected by connecting rods 200, wherein each support ring 100 is formed by connecting a plurality of support rods 110 end-to-end around the central axis of the vascular stent through a reinforcing ring 120, and the wall thickness D1 of the support rods 110 is 0.1mm ; Both ends of the connecting rod 200 are respectively connected to the two reinforcing rings 120 of the two adjacent supporting rings 100 .
  • a groove 210 is arranged on the inner wall and the outer wall of the connecting rod 200.
  • the two grooves 210 are aligned and distributed and the distance D2 (ie the wall thickness of the connecting rod 200) between the groove bottoms is 0.05 mm.
  • the groove 210 does not exceed the entire A concave area is formed on any side surface of the connecting rod 200 range, and the groove wall of the groove 210 forms a smooth transition zone 220 corresponding to the direction of blood flow. There is a round chamfer between the groove wall and the groove bottom.
  • the vascular stent includes a plurality of support rings 100 and a plurality of connecting rods 200 ; the plurality of support rings 100 are distributed at intervals along the central axis of the vascular stent. Adjacent support rings 100 are connected by connecting rods 200, wherein each support ring 100 is formed by connecting a plurality of support rods 110 end-to-end around the central axis of the vascular stent through a reinforcing ring 120, and the wall thickness D1 of the support rods 110 is 0.1mm ; The two ends of the connecting rod 200 are respectively connected with the two reinforcement rings 120 of the two adjacent support rings 100 .
  • the inner wall of the connecting rod 200 has a plurality of grooves 210, and in the schematic diagram of the axial section of the vascular stent, the contour line of the inner wall is a sinusoidal wave structure, with 2 troughs and 1 peak, and the gap between adjacent troughs and peaks
  • the radial distance D3 is 0.05 m, and the two grooves located on the outermost sides in the axial direction of the connecting rod are located in the reinforcement ring 120 of the support ring 100 .
  • the vascular stent includes a plurality of support rings 100 and a plurality of connecting rods 200 ; the plurality of support rings 100 are distributed at intervals along the central axis of the vascular stent. Adjacent support rings 100 are connected by connecting rods 200 .
  • each supporting ring 100 is formed by connecting a plurality of supporting rods 110 end to end through a reinforcing ring 120 around the central axis of the vascular stent, and the wall thickness D1 of the supporting rods 110 is 0.1mm; the two ends of the connecting rods 200 are connected with two adjacent The two reinforcement rings 120 of the support ring 100 are respectively connected.
  • the outer wall of the connecting rod 200 has a plurality of grooves 210, and in the schematic diagram of the axial section of the vascular stent, the contour line of the inner wall is a cosine wave structure, with 3 troughs and 2 peaks, and the diameter between adjacent troughs and peaks is The distance D3 in direction is 0.05m, and the two grooves located on the outermost sides in the axial direction of the connecting rod are located in the reinforcement ring 120 in the support ring 100 .
  • the vascular stent includes a plurality of support rings 100 and a plurality of connecting rods 200; the plurality of support rings 100 are distributed at intervals along the central axis of the vascular stent. Adjacent support rings 100 are connected by connecting rods 200 .
  • each supporting ring 100 is formed by connecting a plurality of supporting rods 110 end to end through a reinforcing ring 120 around the central axis of the vascular stent, and the wall thickness D1 of the supporting rods 110 is 0.1mm; the two ends of the connecting rods 200 are connected with two adjacent The two reinforcement rings 120 of the support ring 100 are respectively connected.
  • Both the inner wall and the outer wall of the connecting rod 200 are provided with a plurality of grooves 210, and in the schematic diagram of the axial section of the vascular stent, the outline of the inner wall has a cosine wave structure, both of which have 2 troughs and 1 peak, located on the two side walls The troughs are aligned and the radial distance D4 between two aligned troughs is 0.05 mm.
  • the two grooves on each side wall of the connecting rod 200 axially located on the outermost side of the connecting rod are located in the reinforcing ring 120 of the support ring 100. middle.
  • the cross-sections of the non-groove regions of the support rod 110 and the connecting rod 200 of the support ring 100 are all set to face the blood vessel An arc-shaped structure with a convex central axis.

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Abstract

一种血管支架，包括多个支撑环(100)及多个连接杆(200)，多个支撑环(100)沿血管支架的中轴线间隔分布，每一连接杆(200)连接于每两相邻的支撑环(100)之间，且每一连接杆(200)的至少一部分的壁厚小于多个支撑环(100)的厚度。

Description

血管支架
相关申请的交叉引用
本申请要求于2021年11月1日提交中国专利局，申请号为202111282450.0，名称为“血管支架”的中国专利申请的优先权，在此将其全文引入作为参考。
技术领域
本发明涉及医疗器械技术领域，特别是涉及一种血管支架。
背景技术
目前认为动脉粥样硬化是一种慢性炎症性疾病，从年轻开始起病，可长达数十年，动脉粥样硬化的临床症状通常在成年时出现。其基本病理改变是在动脉内膜面形成斑块，有脂质条纹、纤维斑块和粥样斑块，可以引起血管管腔狭窄或血栓形成。其中，血管支架的介入医疗已成为这类血管疾病的主要治疗方式。
然而诸多研究表明，血管支架植入后，血液流经时血管支架附近的血液流动方式会发生改变，而流体环境对血管受损内膜的修复以及支架内再狭窄的产生都起到了重要的作用。经过相关仿真和实验得出，血液对血管壁的剪应力是影响再狭窄的关键因素。由于血管支架的支撑环凸出于血管壁，血液流经时会产生分离再附流动，流速降低而形成流动停滞区，剪应力也随之降低，这样大大增加了血管支架内再狭窄的风险。
针对上述问题，目前主要采取两种技术路线，一种是减小血管支架的壁厚，但是血管支架整体的壁厚变薄也有存在一定的缺陷，壁厚变薄会导致抗挤压 性降低，血管支架无法提供足够的支撑力而撑开病变，此外，随着壁厚变薄血管支架整体更加脆弱，在遭遇钙化病变时很容易发生扭曲变形。另一种是调整血管支架的整体结构，例如调整血管支架的长度、支撑环的个数、连接杆的数目等，通过改变血管支架的柔顺性来改善血管内流体力学环境，但是血液流经血管支架时仍然有涡流产生，通常增加了血管支架内再狭窄的风险。
发明内容
基于此，有必要针对上述问题，提供一种血管支架。
一种血管支架，所述血管支架包括：多个支撑环及多个连接杆，所述多个支撑环沿所述血管支架的的中轴线间隔分布，每一所述多个连接杆连接于每两相邻的支撑环之间，且每一所述多个连接杆的至少一部分的壁厚小于所述多个支撑环的厚度。
在其中一个实施例中，所述多个连接杆和/或所述多个支撑环的内侧的至少部分对应于所述血管支架的轴向为流线型。
在其中一个实施例中，每一所述多个支撑环由多个支撑杆围绕所述血管支架的中轴线连接而成，相邻的所述多个支撑杆通过加强环首尾连接并形成角度。
每一所述多个连接杆的两端与两个相邻的所述支撑环的两个加强环分别连接，每一所述多个连接杆为非直线型结构，包含经线段结构和纬线段结构，所述支撑杆和/或所述纬线段结构的内壁面为流线型平滑面。
在其中一个实施例中，至少一个所述多个连接杆的内侧壁和外侧壁至少一个上具有至少一个凹槽，在所述凹槽处所述连接杆的壁厚小于所述支撑环的壁厚。
在其中一个实施例中，所述凹槽的槽壁对应于血管支架的轴向形成圆滑过渡区。
在其中一个实施例中，每一所述多个支撑环由多个支撑杆围绕所述血管支架的中轴线连接而成，相邻的所述多个支撑杆通过加强环首尾连接并形成角度。
每一所述多个连接杆的两端与两个相邻的所述支撑环的两个所述加强环分别连接。
所述凹槽的槽口位于连接杆区域且具有圆倒角，或所述圆倒角至少部分位于所述加强环中。
在其中一个实施例中，所述凹槽的槽壁与槽底之间具有圆倒角。
在其中一个实施例中，所述至少一个所述多个连接杆包含多个凹槽，且在所述血管支架的轴向剖面示意图中，所述至少一个所述多个连接杆至少一部分侧壁的轮廓线呈正弦波或余弦波形结构，位于所述至少一个所述多个连接杆的同一侧壁且相邻波峰间的区域构成所述凹槽。
在其中一个实施例中，位于所述至少一个所述多个连接杆的不同侧壁的波谷对齐分布。
在其中一个实施例中，位于所述至少一个所述多个连接杆轴向最外侧的凹槽至少部分位于所述支撑环的所述加强环中。
在其中一个实施例中，所述至少一个所述多个连接杆的非凹槽区域、或/和所述支撑环的与轴向垂直的横截面为朝向所述血管支架中轴线凸出的弧形结构。
在其中一个实施例中，至少一个所述多个连接杆在所述凹槽的槽底处的厚度小于所述支撑环壁厚且大于或等于所述支撑环壁厚的二分之一。
在其中一个实施例中，所述多个连接杆上还设置有加强部，所述加强部的壁厚大于至少一部分的所述多个连接杆的壁厚。
上述血管支架，连接杆的至少一部分的壁厚小于支撑环的壁厚，使得血管支架整体的柔顺性增大，提高血管支架在血管内的通过率，更易导入至血管的病变位置处；壁厚较大的支撑环依旧能够提高良好的径向支撑力，保证血管支架在血管内扩张后的形态。可见，该血管支架可以在指定的位置区域进行不同壁厚的设计，对血管支架的细节结构做出调整，以达到血管支架存在不同壁厚的效果，这样既可以保证减薄位置(即连接杆)的柔顺性，同时确保了其余未减薄壁厚的位置(即支撑环)的强度，使得血管支架整体仍保持良好的支撑性能。
附图说明
图1为本发明一实施例提供的血管支架的局部结构示意图；
图2为图1在A-A处的轴向局部剖面示意图；
图3为图1在B-B处的轴向局部剖面示意图；
图4为本发明另一实施例提供的血管支架的局部结构示意图；
图5为本发明另一实施例提供的血管支架的轴向局部剖面示意图；
图6为本发明另一实施例提供的血管支架的轴向局部剖面示意图；
图7为本发明另一实施例提供的血管支架的轴向局部剖面示意图；
图8为本发明另一实施例提供的血管支架的轴向局部剖面示意图；
图9为本发明一实施例提供的血管支架的连接杆的横截面示意图；
图10为本发明一实施例提供的血管支架的支撑杆在血液流经时的环境示意图；
图11为本发明一实施例提供的连接杆的流线型表面的结构示意图。
其中，附图中的标号说明如下：
100、支撑环；110、支撑杆；120、加强环；200、连接杆；210、凹槽；220、圆滑过渡区；300、加强部；A、血管壁；B、血流。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施例的限制。
在本发明的描述中，需要理解的是，术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“壁厚”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”、“轴向”、“径向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。在本发明的描述中，“多个”的含义是至少两个，例如两个，三个等，除非另有明确具体的限定。
在本发明中，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系，除非另有明确的限定。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。
在本发明中，除非另有明确的规定和限定，第一特征在第二特征“上”或“下”可以是第一和第二特征直接接触，或第一和第二特征通过中间媒介间接接触。而且，第一特征在第二特征“之上”、“上方”和“上面”可是第一特征在第二特征正上方或斜上方，或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”可以是第一特征在第二特征正下方或斜下方，或仅仅表示第一特征水平高度小于第二特征。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“上”、“下”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。
本发明一实施例提供了一种血管支架，如图1所示，该血管支架包括：多个支撑环100及多个连接杆200，多个支撑环100沿血管支架的长度方向间隔分布，每一连接杆200连接于每两相邻的支撑环100之间，且每一多个连接杆200的至少一部分的壁厚小于支撑环100的厚度。
上述血管支架可以自膨胀式，也可以是球囊扩张式。该血管支架可由金属管材切割而成，即血管支架的连接杆200、支撑环100是一体成型的。在其他 一些实施例中，血管支架的连接杆200与支撑环100也可采用焊接等方式进行连接。该血管支架具有生物相容性，其材质可以是降解的，也可以是不可降解的。
作为一种示例，如图1所示，每一支撑环100可以由多个支撑杆110通过加强环120首尾连接而成，可以为波浪形，主要起到支撑血管的作用。其中，支撑杆110的壁厚为0.08mm～0.2mm，每两个相邻的支撑杆110通过一加强环120连接并形成角度(参见图1)，相邻的支撑环100通过连接杆200连接。连接杆200主要起连接支撑环100的作用，是影响血管支架整体柔顺性的关键因素。在一些实施例中，连接杆200的两端与两个相邻的支撑环100的两个加强环120分别连接。连接杆200的壁厚减小之后更易弯曲，血管支架柔顺性增强，更有利于贴合血管壁A，避免血管支架扩张后血管支架翘起损伤内膜。同时连接杆200靠近血管支架中轴线的侧壁即内壁与血液接触，当血液流经连接杆200时，由于壁厚减小，提高了血液对血管壁A的剪应力，可有效避免血管再狭窄。
需要说明的是，连接杆200整体壁厚小于支撑环100的壁厚，或者连接杆200的一部分壁厚小于支撑环100的壁厚，只要保证血管支架的柔顺性及径向支撑力即可，举例来说，连接杆200只有靠近连接支撑杆110的加强环120的端部的壁厚等于支撑杆110的厚度，而连接杆200的其他部位的厚度则小于支撑杆110的厚度。
上述血管支架，连接杆200的至少一部分的壁厚小于支撑环100的壁厚，能够在保持血管支架抗挤压性的同时增加血管支架的柔顺性，提高血管支架在血管内的通过率，更易导入至血管的病变位置处；壁厚较大的支撑环100依旧能够提高良好的径向支撑力，保证血管支架在血管内扩张后的形态。可见， 该血管支架可以在指定的位置区域进行不同壁厚的设计，对血管支架的细节结构做出调整，以达到血管支架存在不同壁厚的效果，这样既可以保证减薄位置(即连接杆200)的柔顺性，同时确保了其余未减薄壁厚的位置(即支撑环100)的强度，使得血管支架整体仍保持良好的支撑性能。
在本发明的一些实施例中，连接杆200和/或支撑环100的接触血流表面一侧即内侧的至少部分对应于血流方向为流线型。将连接杆200、支撑环100接触血流的表面一侧即内侧设置成对应于血流方向的流线型结构，如连接杆200的度内侧在血管支架中心轴轴向方向有流线型结构，又如支撑环100的加强环120的内侧有流线型结构，在一些实施例中，加强环120内侧的表面为弧线形。如此，可以减小血流在血管支架内产生涡流的几率，改善了血管支架的流体力学环境，减小低剪应力区的产生几率，降低二次狭窄率。连接杆200和/或支撑环100是指以下组合之一：(1)连接杆200、(2)支撑环100、(3)连接杆200和支撑环100，每一支撑环100包含多个支撑杆110和连接多个支撑杆110的多个加强环120。在一实施例中，可以是连接杆200表面为流线型，流线型结构延伸至支撑环100。需要说明的是，当支撑环100的表面为流线型时，全文中“支撑环100的厚度”是指支撑环100的最大厚度，一些实施例中，支撑环100的厚度为均匀厚度。所述“对应于血流方向”是指结构表面流线型的减阻目的方向是血流方向或血流大致方向，即“对应于血流方向为流线型”是指在血流方向上能够使血管支架的血流阻力减小的流线型结构，本实施例中，连接杆200、支撑环100的流线型的表面走向与血流方向相同或大致相同。
下面以连接杆200为例，就流线型表面进行描述，参见图11，表面满足如下条件称为流线型表面：(1)、在特定走向上表面结构光滑无棱角；(2)、 爬坡角度大于等于135°且小于180°，其中爬坡角度是指坡面最低点与最高点之间的连线和连接杆200内壁之间的夹角；(3)坡面最低点与最高点之间的距离不能少于连接杆200总壁厚的一半。
具体到本发明的一些实施例中，如图1所示，每一支撑环100由多个支撑杆110连接构成，相邻的所述支撑杆110通过加强环120连接并形成角度；连接杆200的两端与两个相邻的支撑环100的两个加强环120分别连接，连接杆200为非直线型结构，轮廓线包含经线段和纬线段，支撑杆110和/或纬线段接触血流的表面为流线型平滑面。流线型平滑面可以指连接杆200沿血流方向的横截面轮廓线为流线型，包括圆形、半圆形、带弧形的形状，血流经过支撑杆110、连接杆200表面时，可以大大降低支撑杆110、连接杆200对血流的阻力。优选地，所述流线型平滑面从连接杆200延伸至支撑杆110部分。需要说明的是，连接杆200的经线段结构是指连接杆200中垂直于血流方向的部分，纬线段结构是指连接杆200中平行于或大致平行于血流方向的部分。
在本发明的一些实施例中，如图2、图3、图5至图8所示，连接杆200靠近血管支架中轴线的侧壁(即靠近血流一侧，即内壁)、和/或远离血管支架中轴线的侧壁(即外壁)上具有凹槽210，凹槽210用于使连接杆200的壁厚小于支撑环100的壁厚。如此，无需将设置于支撑环100上的连接杆200的整个壁厚设置为小于支撑环100壁厚，可根据具体实际情况，来灵活设计连接杆200上壁厚变薄区域的长度及位置。应用时，可以根据具体实际情况，选择是在连接杆200靠近血管支架中轴线的侧壁即内壁上设置凹槽210(参见图2、图6)，还是选择在连接杆200远离血管支架中轴线的侧壁即外壁上设置凹槽210(参见图3、图7)，还是选择在连接杆200远离及靠近血管支架中 轴线的侧壁即内壁和外壁上均设置凹槽210(参见图5、图8)，其中当凹槽210设置在连接杆200内壁和外壁上时，使得连接杆200的受力均匀，提高血管支架稳定性。
具体在本发明的一些实施例中，如图2及图3所示，凹槽210的槽壁对应于血流方向形成圆滑过渡区220。圆滑过渡，可以使得连接杆200的内壁上的凹槽210处不会形成涡流，降低了再狭窄率，及使得连接杆200的外壁上的凹槽210处不会损伤血管内膜，降低内膜增生。需要说明的是，凹槽210的整个侧壁区域为圆滑过渡区220。
具体在本发明的一些实施例中，凹槽210的槽口位于连接杆区域且具有圆倒角，或圆倒角至少部分位于加强环120，和/或凹槽210的槽壁与槽底间具有圆倒角。可以理解，在一些实施例中，圆倒角构成了圆滑过渡区的一部分。需要说明的是，当凹槽210沿连接杆200的长度方向在整个连接杆200内壁或外壁的任一壁面产生凹陷区域时，一个实施例中，凹槽210至少一部分位于支撑杆110的加强环120，此时，凹槽210的槽口的圆倒角位于该支撑杆110的加强环120。在另一实施例中，当整个凹槽210位于连接杆200内壁或外壁的任一壁面范围内，此时，凹槽210的槽口自身具有圆倒角设置于连接杆200。所述圆倒角可以使得连接杆200内壁上的凹槽210处不会形成涡流，降低了再狭窄率，及使得连接杆200外壁上的凹槽210处不会损伤血管内膜，降低内膜增生。
在连接杆200具有凹槽210的前提下，如图6至图8所示，在本发明的一些实施例中，连接杆200包含多个凹槽210，且在血管支架的轴向局部剖面示意图中，连接杆200的至少一部分侧壁的轮廓线呈正弦波或余弦波形状，位于连接杆200的同一侧壁且相邻波峰间的区域构成凹槽210。该类结构的凹 槽210，可以有效减小连接杆200的壁厚，且该类结构的凹槽处处圆滑。需要说明的是，当连接杆200内壁和外壁上均设置凹槽210时，这两个侧壁上的波峰错开分布，以保证连接杆200的壁厚有效减薄。
具体地，如图8所示，位于连接杆200的内壁和外壁的波谷对齐分布。如此，可以有效减小连接杆200的壁厚，同时使得连接杆200受力均匀。
具体地，如图6至图8所示，位于连接杆200轴向最外侧的凹槽210至少部分位于支撑环100的加强环120中。本文中的轴向是指血管支架中轴线的方向，连接杆200的长度方向与轴向方向一致。需要说明的是，当正弦波或余弦波形结构的凹槽210沿连接杆200的长度方向在整个连接杆200任一侧表面产生凹陷区域时，即正弦波和余弦波形结构完全位于连接杆200范围内、圆滑过渡区220全部位于连接杆200范围内。在另一实施例中当正弦波或余弦波形结构的凹槽210超出整个连接杆200范围内的任一侧表面产生凹陷区域此时，轴向上最外侧的凹槽210的槽壁延伸至所述支撑环100的加强环120中，圆滑过渡区220部分位于加强环120中。圆滑过渡或平滑过渡，可以使得连接杆200内壁上的凹槽210处不会形成涡流，降低了再狭窄率。
在连接杆200上具有凹槽210的前提下，如图9及图10所示，本发明的一些实施例中，连接杆200的非凹槽区域(未图示)、支撑杆110或加强环120(未图示)的沿血流方向的横截面为朝向血管支架的中轴线凸出的弧形结构。将支撑杆110、连接杆200的非凹槽区域或加强环120的横截面设置为弧形结构，使得该部分横截面的外壁与矩形的截面相比而言较圆滑，当血液流经血管支架时，不会形成涡流，避免低剪应力区的产生，同样起到降低血管支架内再狭窄的概率。
在本发明的一些实施例中，连接杆200的至少一部分的壁厚小于支撑环 100的壁厚且大于或等于支撑环100壁厚的二分之一，连接杆200在槽底处的厚度小于支撑环100壁厚且大于或等于支撑环100壁厚的二分之一，可以理解，当凹槽210未超出连接杆200的范围时，支撑环100的厚度为均匀厚度。连接杆200在槽底处的厚度，例如可设置为支撑环100壁厚的二分之一、三分之二、四分之三等。示例地，当支撑环100的支撑杆110的壁厚为0.1mm时，连接杆200在槽底处的厚度可为0.05mm-0.07mm。如此，既能保证连接杆200的强度，又可抑制连接杆200处的涡流现象的产生。
在本发明的一些实施例中，如图1及图4所示，连接杆200上还设置有加强部300，加强部300的壁厚大于至少一部分的连接杆200的壁厚。加强部300的壁厚可与支撑环100的支撑杆110的壁厚相同，如此可以保证连接杆200具有足够的强度，保证血管支架的抗挤压性。可选地，加强部300的形状可以为水平置放的“S”形、波浪形、折线形等。可选地，加强部300的一端与连接杆200连接，加强部300的另一端与支撑环100的加强环120连接。
下面结合附图更加详细地对血管支架的结构进行描述。
如图1至图3所示，在本申请的血管支架的一些实施例中，该血管支架包括多个支撑环100及多个连接杆200；多个支撑环100沿血管支架的中轴线方向间隔分布，相邻的支撑环100通过连接杆200连接，连接杆200的两端与两个相邻的支撑环100的两个加强环120分别连接。其中，每一支撑环100由多个支撑杆110围绕血管支架的中轴线通过加强环120首尾连接而成，支撑杆110的壁厚D1为0.1mm。一部分的连接杆200的外壁上具有一个凹槽210，该凹槽210的槽底和连接杆200外壁间的距离D2(即连接杆200的壁厚)为0.05m，该凹槽210未超过连接杆200范围的任一侧表面，凹槽210的槽壁对应于血流方向形成圆滑过渡区220、凹槽210的槽口位于连接杆区域且 具有圆倒角及凹槽210的槽口与槽底间具有圆倒角。
如图4、图5所示，在本申请的血管支架的一些实施例中，该血管支架包括多个支撑环100及多个连接杆200；支撑环100；多个支撑环100沿血管支架的中轴线间隔分布。相邻的支撑环100通过连接杆200连接，其中，每一支撑环100由多个支撑杆110围绕血管支架的中轴线通过加强环120首尾连接而成，支撑杆110的壁厚D1为0.1mm。连接杆200的一端与两个相邻的支撑杆110的加强环120连接，连接杆200的另外一端通过加强部300与另两个相邻的支撑杆110的加强环120连接，该加强部300的形状为水平置放的“S”形。连接杆200的外壁上具有凹槽210，该凹槽210的槽底和连接杆200内壁间的距离D2(即连接杆200的壁厚)为0.05m，该凹槽210未超过整个连接杆200范围的任一侧表面产生凹陷区域，凹槽210的槽壁对应于血流方向形成圆滑过渡区220、凹槽210的槽口位于连接杆区域且具有圆倒角，及凹槽210的槽壁与槽底间具有圆倒角。
如图5所示，在本申请的血管支架的一些实施例中，该血管支架包括多个支撑环100及多个连接杆200；多个支撑环100沿血管支架的中轴线间隔分布。相邻的支撑环100通过连接杆200连接，其中，每一支撑环100由多个支撑杆110围绕血管支架的中轴线通过加强环120首尾连接而成，支撑杆110的壁厚D1为0.1mm；连接杆200的两端与两个相邻的支撑环100的两个加强环120分别连接。连接杆200的内壁和外壁上均设置一个凹槽210，这两个凹槽210对齐分布且槽底间的距离D2(即连接杆200的壁厚)为0.05mm，该凹槽210未超过整个连接杆200范围的任一侧表面产生凹陷区域，凹槽210 的槽壁对应于血流方向形成圆滑过渡区220、凹槽210的槽口位于连接杆区域且具有圆倒角，及凹槽210的槽壁与槽底间具有圆倒角。
如图6所示，在本申请的血管支架的一些实施例中，该血管支架包括多个支撑环100及多个连接杆200；多个支撑环100沿血管支架的中轴线间隔分布。相邻的支撑环100通过连接杆200连接，其中，每一支撑环100由多个支撑杆110围绕血管支架的中轴线通过加强环120首尾连接而成，支撑杆110的壁厚D1为0.1mm；连接杆200的两端分别与两个相邻的支撑环100的两个加强环120分别连接。连接杆200的内壁具有多个凹槽210，并在血管支架的轴向剖面示意图中，内壁的轮廓线呈正弦波形结构，具有2个波谷及1个波峰，且相邻的波谷与波峰间的径向距离D3为0.05m，位于连接杆轴向最外侧的两个凹槽均位于支撑环100的加强环120中。
如图7所示，在本申请的血管支架的一些实施例中，该血管支架包括多个支撑环100及多个连接杆200；多个支撑环100沿血管支架的中轴线间隔分布。相邻的支撑环100通过连接杆200连接。其中，每一支撑环100由多个支撑杆110围绕血管支架的中轴线通过加强环120首尾连接而成，支撑杆110的壁厚D1为0.1mm；连接杆200的两端与两个相邻的支撑环100的两个加强环120分别连接。连接杆200外壁具有多个凹槽210，并在血管支架的轴向剖面示意图中，内壁的轮廓线呈余弦波形结构，具有3个波谷及2个波峰，且相邻的波谷与波峰间的径向距离D3为0.05m，位于连接杆轴向最外侧的两个凹槽均位于支撑环100中的加强环120。
如图8所示，在本申请的血管支架的一些实施例中，该血管支架包括多 个支撑环100及多个连接杆200；多个支撑环100沿血管支架的中轴线间隔分布。相邻的支撑环100通过连接杆200连接。其中，每一支撑环100由多个支撑杆110围绕血管支架的中轴线通过加强环120首尾连接而成，支撑杆110的壁厚D1为0.1mm；连接杆200的两端与两个相邻的支撑环100的两个加强环120分别连接。连接杆200的内壁和外壁均设置有多个凹槽210，并在血管支架的轴向剖面示意图中，内壁的轮廓线呈余弦波形结构，均具有2个波谷及1个波峰，位于两侧壁的波谷对齐且对齐的两个波谷间的径向距离D4为0.05mm,连接杆200每一侧壁上的轴向上位于连接杆最外侧的两个凹槽均位于支撑环100的加强环120中。
如图9所示，在本申请的血管支架的一些实施例中，与其他实施例不同的是，支撑环100的支撑杆110及连接杆200的非凹槽区域的横截面均设置为朝向血管支架中轴线凸出的弧形结构。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (13)

  1. 一种血管支架，其特征在于，包括：多个支撑环及多个连接杆，其中，所述多个所述支撑环沿所述血管支架的的中轴线间隔分布，每一所述多个连接杆连接于每两相邻的支撑环之间，且每一所述多个连接杆的至少一部分的壁厚小于所述多个支撑环的厚度。
  2. 根据权利要求1所述的血管支架，其特征在于，所述多个连接杆和/或所述多个支撑环的内侧的至少部分对应于所述血管支架的轴向为流线型。
  3. 根据权利要求2所述的血管支架，其特征在于，每一所述多个支撑环由多个支撑杆围绕所述血管支架的中轴线连接而成，相邻的所述多个支撑杆通过加强环首尾连接并形成角度；
    每一所述多个连接杆的两端与两个相邻的所述支撑环的两个加强环分别连接，每一所述多个连接杆为非直线型结构，包含经线段结构和纬线段结构，所述支撑杆和/或所述纬线段结构的内壁面为流线型平滑面。
  4. 根据权利要求1或2所述的血管支架，其特征在于，至少一个所述多个连接杆的内侧壁和外侧壁至少一个上具有至少一个凹槽，在所述凹槽处所述连接杆的壁厚小于所述支撑环的壁厚。
  5. 根据权利要求4所述的血管支架，其特征在于，所述凹槽的槽壁对应于血管支架的轴向形成圆滑过渡区。
  6. 根据权利要求4所述的血管支架，其特征在于，每一所述多个支撑环由多个支撑杆围绕所述血管支架的中轴线连接而成，相邻的所述多个支撑杆通过加强环首尾连接并形成角度；
    每一所述多个连接杆的两端与两个相邻的所述支撑环的两个所述加强环分别连接；
    所述凹槽的槽口位于连接杆区域且具有圆倒角，或所述圆倒角至少部分位于所述加强环中。
  7. 根据权利要求4所述的血管支架，其特征在于，所述凹槽的槽壁与槽底之间具有圆倒角。
  8. 根据权利要求4所述的血管支架，其特征在于，所述至少一个所述多个连接杆包含多个凹槽，且在所述血管支架的轴向剖面示意图中，所述至少一个所述多个连接杆至少一部分侧壁的轮廓线呈正弦波或余弦波形结构，位于所述至少一个所述多个连接杆的同一侧壁且相邻波峰间的区域构成所述凹槽。
  9. 根据权利要求8所述的血管支架，其特征在于，位于所述至少一个所述多个连接杆的不同侧壁的波谷对齐分布。
  10. 根据权利要求7所述的血管支架，其特征在于，位于所述至少一个所述多个连接杆轴向最外侧的凹槽至少部分位于所述支撑环的所述加强环中。
  11. 根据权利要求4所述的血管支架，其特征在于，所述至少一个所述多 个连接杆的非凹槽区域、或/和所述支撑环的与轴向垂直的横截面为朝向所述血管支架中轴线凸出的弧形结构。
  12. 根据权利要求4所述的血管支架，其特征在于，所述至少一个所述多个连接杆在所述凹槽的槽底处的厚度小于所述支撑环壁厚且大于或等于所述支撑环壁厚的二分之一。
  13. 根据权利要求1所述的血管支架，其特征在于，所述多个连接杆上还设置有加强部，所述加强部的壁厚大于至少一部分的所述多个连接杆的壁厚。
PCT/CN2022/128151 2021-11-01 2022-10-28 血管支架 WO2023072227A1 (zh)

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