WO2019096158A1 - 血管支架 - Google Patents

血管支架 Download PDF

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Publication number
WO2019096158A1
WO2019096158A1 PCT/CN2018/115416 CN2018115416W WO2019096158A1 WO 2019096158 A1 WO2019096158 A1 WO 2019096158A1 CN 2018115416 W CN2018115416 W CN 2018115416W WO 2019096158 A1 WO2019096158 A1 WO 2019096158A1
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WO
WIPO (PCT)
Prior art keywords
support
blood vessel
vessel stent
support mechanism
proximal
Prior art date
Application number
PCT/CN2018/115416
Other languages
English (en)
French (fr)
Inventor
王永胜
李建民
高国庆
Original Assignee
杭州唯强医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201711147219.4A external-priority patent/CN109793600A/zh
Priority claimed from CN201711147217.5A external-priority patent/CN108938160B/zh
Application filed by 杭州唯强医疗科技有限公司 filed Critical 杭州唯强医疗科技有限公司
Priority to US16/764,154 priority Critical patent/US11406517B2/en
Priority to EP18879329.3A priority patent/EP3711717A4/en
Publication of WO2019096158A1 publication Critical patent/WO2019096158A1/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
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Definitions

  • the invention belongs to the technical field of medical instruments, and relates to a blood vessel stent, in particular to a blood vessel stent for treating a lesion close to a bifurcation of a blood vessel.
  • the vascular stent is implanted to support the expansion of the diseased blood vessel, so that the blood flow of the diseased blood vessel is restored.
  • the blood vessels can be opened by placing a common vascular stent.
  • some vascular stenosis lesions are located near the vascular bifurcation (ie, the starting point of the branch vessel extending from the main vessel), at which point the vascular stent needs to completely cover the lesion.
  • the vascular stent needs to cover a region of the blood vessel other than the lesion, such as an adjacent disease-free or almost disease-free region of the blood vessel, to expand the blood vessel in an emergency or in the future. Therefore, when the stenotic lesion is located near the vascular bifurcation, the vascular stent must cover the mouth of the branch vessel.
  • the oral plane of the branch vessel is generally not perpendicular to the axis extending plane of the branch vessel, as the branch vessel typically does not extend out of the main vessel at an angle of 90°, for example extending the main vessel at an angle between 40° and 60°. As shown in Figs. 1A and 1B, in this case, the ordinary stent does not sufficiently cover the lesion.
  • iliac vein compression syndrome is caused by continuous mechanical compression of the right common iliac artery and the fifth lumbar vertebrae and arterial pulsation caused by venous lumen adhesion, intimal hyperplasia, fibrosis caused by stenosis and occlusion.
  • the stent used for the iliac vein needs strong support. Since the vascular stent dedicated to the vein is rarely provided in the market at present, it is clinically mainly to use the arterial stent to treat the iliac vein stenosis, but the radial support force of the vascular stent is weak to meet the demand.
  • the iliac vein graft has a physiologically curved pelvic walking, so the corresponding vascular stent needs to have good flexibility.
  • the bilateral iliac veins flow into the inferior vena cava in an inverted "Y" shape, in which the right iliac vein runs steeply, at an angle of about 20 degrees to the inferior vena cava, and the angle between the left iliac vein and the inferior vena cava is about 40. degree.
  • the commonly used intravenous or peripheral arterial stents are mostly straight-tube stents; in addition, because the left common iliac vein is between the right iliac artery and the lumbar vertebrae, it is not easy to accurately position and release when the stent is implanted, and the stent is easily jumped into the lower part when released.
  • Vena cava; iliac vein involving the inferior vena cava lesions the stent needs to protrude into the inferior vena cava for expansion, but the protruding stent may affect the blood flow of the contralateral iliac vein, and even lead to contralateral iliac vein thrombosis.
  • a stent may be partially inserted into the main vessel in any branch vessel.
  • the stent suspended in the branch vessel of the main vessel is not stabilized by the long-term erosion of the main bloodstream or the contralateral branch vessel blood flow.
  • FIG. 1B when the straight tube type stent is used for the bifurcation of the blood vessel, since the diameter of the branch blood vessel and the main blood vessel are large, a large bend occurs at the bifurcation, so the straight tube is selected.
  • the type of stent is likely to cause turbulence or turbulence due to adverse effects of adherence on the contralateral blood, which increases the risk of thrombosis in the stent.
  • the technical problem to be solved by the present invention is that, in view of the defects of the prior art, a blood vessel stent for treating a lesion close to a bifurcation of a blood vessel is provided, which can prevent the stent from protruding into the main blood vessel and can well cover and attach the lesion portion.
  • the blood vessel stent of the present invention comprises a plurality of axially connected corrugated supports, the tubular support comprises a proximal support mechanism, a middle support mechanism and a distal support mechanism; the central support mechanism and the distal support mechanism respectively a closed-loop structure; the proximal support mechanism includes a first support portion coupled to the middle support mechanism and a second support portion disposed at a proximal end of the first support portion; the first support portion is a closed loop structure; The support portion is an open loop structure, and the proximal end surface of the second support portion is a non-flush structure to provide local support in the circumferential direction.
  • proximal end surface of the second support portion is an inclined plane, an inclined curved surface or an inclined wave surface.
  • proximal end surface is an inclined plane, and the angle between the proximal end surface and the axis of the blood vessel stent is ⁇ , 90°> ⁇ >0°.
  • the wave-shaped support members of the proximal support mechanism have the same wavelength, and the peak units of the adjacent wave-shaped support members are connected to the trough units to form a mesh, and at least the number of meshes of the second support portion is gradually reduced from the distal end to the proximal end.
  • At least the amplitude of the corrugated support of the second support portion gradually becomes longer from the inner side of the blood vessel stent to the outer side.
  • middle zone support mechanism the proximal support mechanism and the distal support mechanism are connected by a circumferentially spaced connection assembly.
  • corrugated supports of the central zone support mechanism are connected by circumferentially spaced connection assemblies.
  • the corrugated support comprises a plurality of support units; each support unit comprises a crest unit, a trough unit, a pole connected between the crest unit and the trough unit; each connection assembly comprises at least one connecting rod; the connection One end of the rod is connected to the crest unit or the trough unit of the corrugated support member, and the other end of the connecting rod is connected to the wave rod of the adjacent corrugated support member, or the two ends of the connecting rod respectively connect the peaks of the adjacent two corrugated support members Unit and trough unit.
  • each connection component includes at least two connecting rods, and the adjacent two connecting rods are arranged in a figure-eight shape or an inverted figure-eight shape.
  • the projections of the connecting components disposed between adjacent three wave-shaped supports are not overlapped or partially overlapped in the plane of the vertical axial plane.
  • the connecting rod is a straight rod, a shaped rod with a curved structure shaped rod or a curved structure or a combination thereof.
  • the wave rod is a straight rod, a shaped rod with a curved structure shaped rod or a curved structure or a combination thereof.
  • connection assembly a portion of the adjacent two corrugated supports that is not connected to the connection assembly is suspended.
  • vascular stent after the vascular stent is inflated, at least the outer portion of the proximal support mechanism located outside the vascular stent gradually extends outwardly toward the vascular stent in a distal end toward the proximal end.
  • proximal support mechanism extends outwardly and expands to form a dilatation portion, and an angle ⁇ between the outer contour of the expansion portion and the axis of the blood vessel stent satisfies: 30° ⁇ >0°.
  • the outer diameter of the stent is gradually enlarged from the distal end to the proximal end to form a tapered structure.
  • proximal end of the stent proximal support mechanism and/or the distal end of the distal support mechanism are provided with a plurality of support points.
  • the support point is a hollow structure, and a development point is disposed inside the hollow structure.
  • the proximal end surface of the blood vessel stent of the invention is non-flush flat structure, and can provide circumferential local support; the proximal end surface tilt angle of the non-flush structure can be set according to the specific condition of the blood vessel bifurcation, and the blood vessel stent can be prevented from protruding into the trunk
  • the blood vessels are well covered and attached to the lesion.
  • FIGS. 1A and 1B are schematic views showing the structure of an implanted blood vessel of a conventional blood vessel stent.
  • Fig. 2 is a schematic view showing the structure of a blood vessel stent according to a first embodiment of the present invention.
  • FIG. 2A and 2B are schematic views showing the structure of the blood vessel stent of Fig. 2 in different states of use.
  • Fig. 3 is a schematic view showing the structure of a blood vessel stent according to a second embodiment of the present invention.
  • 3A to 3C are schematic views showing the structure of the blood vessel stent of Fig. 3 in different states of use.
  • Fig. 4 is a schematic view showing the structure of a blood vessel stent according to a third embodiment of the present invention.
  • FIG. 4A is a schematic view showing the structure of the blood vessel stent of FIG. 4.
  • Fig. 5 is a schematic view showing the structure of a blood vessel stent according to a fourth embodiment of the present invention.
  • Fig. 5A is a schematic view showing the structure of the blood vessel stent of Fig. 5;
  • Fig. 6 is a schematic view showing the structure of a blood vessel stent according to a fifth embodiment of the present invention.
  • Fig. 6A is a schematic view showing the structure of the blood vessel stent of Fig. 6;
  • Fig. 7 is a schematic view showing the structure of a blood vessel stent of the present invention.
  • the following structure is a structure in which the blood vessel stent is inflated.
  • the proximal end refers to the end of the blood vessel stent after being implanted into the blood vessel;
  • the axial direction refers to the direction of the central axis of the blood vessel stent;
  • the radial direction refers to the direction perpendicular to the central axis;
  • the inner side of the stent refers to the bracket.
  • the side near the bifurcation of the bifurcated vessel is the outside of the stent relative to the other side of the stent.
  • the blood vessel stent of the first embodiment of the present invention has a tubular shape and can be an equal diameter structure; it can be a non-equal diameter structure, such as a tapered tube structure; or a cone-shaped tubular shape and a straight tubular shape. Reducing structure.
  • the outer diameter of the blood vessel stent is expanded from the distal end to the proximal end.
  • the blood vessel stent of the first embodiment of the present invention includes a proximal support mechanism 110, a middle support mechanism 120 and a distal support mechanism 130 which are sequentially disposed.
  • the proximal support mechanism 110, the central support mechanism 120, and the distal support mechanism 130 may be directly connected to each other or may be connected by a connection assembly 122.
  • the proximal support mechanism 110, the central support mechanism 120, and the distal support mechanism 130 are all closed loop structures.
  • the projection of the closed loop structure in the plane of the vertical axis is a closed loop.
  • the proximal support mechanism 110, the intermediate support mechanism 120, and the distal support mechanism 130 each include a plurality of undulating supports 121 disposed in the axial direction.
  • Each corrugated support member 121 includes a plurality of support units 1210 that are connected end to end.
  • Each support unit 1210 includes a crest unit 1211, a trough unit 1213, and a pole 1212 connected between the crest unit 1211 and the trough unit 1213.
  • the shape of the rod 1212 is a straight rod, a shaped rod with a curved structure or a shaped rod with a curved structure, or a combination thereof.
  • the profiled rod means that the rod 1212 is a non-straight rod, and the curved structure refers to a curved portion on the rod 1212, and the curved portion can enhance the bending or stretching performance of the rod 1212.
  • the curved structure can be placed anywhere on the pole 1212, preferably in the middle of the pole 1212.
  • the profiled rod with a curved or curved structure is an arcuate rod, a straight rod provided with an arcuate portion, a Z-shaped rod or an S-shaped rod.
  • the wave rod 1212, the crest unit 1211, and the trough unit 1213 of each support unit 1210 are a unitary structure or a connection structure.
  • the corrugated support member 121 may also be a unitary structure or a connection structure.
  • the blood vessel stent of the invention is made by laser cutting heat setting material, and the heat setting material may be selected from stainless steel, tantalum, cobalt-based alloy, platinum, nickel titanium alloy and novel titanium alloy, and the preferred material is nickel titanium alloy.
  • the crest units 1211 of the adjacent wave-shaped supports 121 are connected to the trough units 1213 in a one-to-one correspondence to form a grid.
  • the wave-shaped support members 121 have the same wavelength and the same amplitude.
  • the same wavelength means that the length of each waveform of the wave-shaped support member 101 in the circumferential direction is the same.
  • the waveform of the corrugated support 121 may also be different, that is, without limiting the amplitude of the waveform, the wavelength of each waveform of the corrugated support 121 is such that the crest unit 1211 and the trough unit of the axially adjacent corrugated support 101 are made. 1213 one-to-one correspondence can form a grid.
  • the proximal support mechanism 110 is a flush structure of the end faces. At least the outer portion of the proximal support mechanism 110 located outside the vascular stent extends progressively toward the proximal side of the stent from the distal end toward the proximal end. After the vascular stent is implanted into the branch vessel, the outer portion of the proximal support mechanism 110 or the proximal support mechanism 110 is gradually expanded outwardly, thereby making the stent of the vascular stent better.
  • the outer portion refers to a portion of the corrugated support 121 that extends away from the side of the blood vessel and extends a length in the circumferential direction.
  • the specific width of the outer portion and the angle of the eversion can be determined according to the diameter of the actual branch vessel, the diameter of the branch vessel and the diameter of the main vessel, and the like. The factors are determined.
  • the portion surrounded by the broken line in Figs. 2 and 2A is the outer portion.
  • the outer portion of the proximal support mechanism 110 is gradually expanded outwardly, and extends to the outside of the blood vessel stent to form an expansion portion.
  • the angle ⁇ between the contour of the expansion portion and the axis of the blood vessel stent satisfies: 30° ⁇ ⁇ >0°. In the present embodiment, ⁇ is preferably 30°. As shown in FIG.
  • the proximal support mechanism 110 extends all the way toward the outside of the stent in a circumferential direction to form a bell-shaped expansion.
  • the angle ⁇ between the everted dilatation portion and the axis of the blood vessel stent is 20°.
  • the distal support mechanism 130 is formed by axially connecting a plurality of corrugated supports 121 having a plurality of support units 1210 having the same wavelength.
  • the crest units 1131 of the adjacent corrugated supports 121 are connected to the trough units 1121 in a one-to-one correspondence to form a grid.
  • the structure of the distal support mechanism 130 is the same as that of the first support portion 111 of the proximal support mechanism 110, and details are not described herein.
  • a plurality of support points 1126 can be disposed at the proximal end of the proximal support mechanism 110 and the distal end of the distal support mechanism 130.
  • the support point 1126 is a rounded convex structure provided on the crest unit 1211 of the wave support 100, and may be a solid structure or a structure with a center hole. The number and spacing of the support points 1126 are set according to actual needs, and are not limited herein.
  • the developing material is filled in the central hole at the support point 1126 to form a development point for developing the position of the blood vessel stent in the blood vessel during surgery.
  • the development point may also be additionally disposed at other locations of the ends of the proximal support mechanism 110 and the distal support mechanism 130.
  • the central support mechanism 120 and the proximal support mechanism 110 and the distal support mechanism 130 are each connected by a circumferentially spaced connection assembly 122.
  • the support unit 1210 of the corrugated support member 121 that is not connected to the connection assembly 122 is suspended, that is, there is no connection or suspension between the crest unit 1211 and the trough unit 1213 of the axially adjacent support unit 1210 that is not connected to the connection assembly 122.
  • the axially adjacent corrugated supports 121 in the central zone support mechanism 120 are also connected by a circumferentially spaced connection assembly 122. There is no connection or dangling between the corrugated supports 121 of the adjacent two figures that are not connected to the connection assembly 122.
  • the axially adjacent two corrugated supports 121 are unconnected or suspended between adjacent two connection assemblies 122.
  • No connection means that there is no connection between the crest unit 1211 of the corrugated support 121 and the axially adjacent trough unit 1213, so that the adjacent two corrugated supports 121 have a large relative movement or bending space in the radial direction and the axial direction.
  • Each connection assembly 122 includes at least one connecting rod 1221.
  • the connecting rod 1221 and the corresponding supporting unit 1210 are connected. Two ends of the connecting rod 1221 may be connected to the axially adjacent crest unit 1211 and the trough unit 1213; one end of the connecting rod 1221 is connected to the crest unit 1211 or the trough unit 1213 of the corrugated support 121, and one end of the connecting rod 1221 is connected to the axial phase Adjacent to the pole 1212. In this embodiment, both ends of the connecting rod 1221 are connected to the axially adjacent crest unit 1211 and the trough unit 1213.
  • the connecting rod 1221 and the corresponding supporting unit 1210 are an integrally formed structure or a connecting structure.
  • the integral molding is formed by laser cutting and shaping of the pipe. Since the two-wave support members 121 of the central support mechanism 120 are not synchronized, that is, the crest units 1211 of the axial one-wave support member 121 are alternately arranged with the trough units 1213 of the axially adjacent corrugated support members 121.
  • the connecting rod 1221 is obliquely connected between the axially adjacent crest unit 1211 and the trough unit 1213.
  • the circumferentially adjacent connecting rods 1221 may be arranged in parallel or may not be arranged in parallel, that is, the circumferentially adjacent connecting rods 1221 are arranged in a figure-eight shape or an inverted figure-eight shape.
  • the connecting rods 1221 between the adjacent two corrugated supports 121 are arranged in the same manner in the circumferential direction or repeatedly arranged according to a certain rule.
  • the projections of the connecting members 122 between the axially adjacent figures, the planes in the vertical axis do not overlap or partially overlap.
  • the connecting members 122 are arranged in a spiral or staggered arrangement in the axial direction.
  • the spiral arrangement means that the axially adjacent connecting components are arranged in a spiral arrangement
  • the staggered arrangement means that the peaks of the axially adjacent connecting components are not on the same axis as the troughs.
  • the connecting rods 1221 are evenly distributed in groups in the circumferential direction, and the connecting rods 1221 between the adjacent three corrugated supporting members 121 are staggered in the axial direction, so that the connecting assembly 122 can withstand greater local tension and pressure, and the blood vessel bracket can be stretched and contracted. Or even deformation when bending.
  • the connecting rod 1221 is a straight rod, a shaped rod with a curved structure or a shaped rod of a curved structure, or a combination thereof.
  • the connecting rod 1221 is a straight rod.
  • connection assembly 122 disposed between the adjacent corrugated support members 121 of the central support mechanism 120 and the connection assembly 122 or the central support mechanism 120 and the distal support mechanism 130 disposed between the proximal support mechanism 110 and the intermediate support mechanism 120
  • the connection components 122 disposed therebetween may be the same or different.
  • the blood vessel stent of the second embodiment is substantially the same as the first embodiment, and has a tubular shape, and includes a proximal support mechanism 110 , a middle support mechanism 120 and a distal support mechanism 130 .
  • the vascular stent may be an isometric structure after expansion, as shown in FIG. 3A; or may be a non-equal structure, such as a tapered tube structure, as shown in FIG. 3B.
  • the proximal support mechanism 110 includes a first support portion 111 coupled to the mid-region support mechanism 120 and a second support portion 112 disposed at a proximal end of the first support portion 111.
  • the first support portion 111 is a closed loop structure.
  • the number of meshes of the second support portion 112 is gradually reduced from the distal end to the proximal end such that the second support portion 112 is an open loop structure.
  • the open-loop finger-shaped support member 121a is separated from the head and tail, that is, the wave-shaped support members 121a are adjacent to each other or spaced apart from each other, and the projection in the plane of the vertical axis is approximately C-shaped.
  • the first support portion 111 includes a plurality of corrugated supports 121 disposed in the axial direction.
  • the second support portion 112 includes a plurality of corrugated support members 121a disposed in the axial direction.
  • the proximal end faces of the second support portion 112 are not flush, the axial lengths of the respective positions in the radial direction are different, so that the second support portion 112 can provide partial support.
  • the proximal end faces of the second support portions 112 are not flush, that is, the axial lengths of the respective positions of the second support portions 112 in the circumferential direction are different.
  • the proximal end face refers to the surface of the proximal end of the blood vessel stent.
  • the blood vessel stent has a tubular structure with a proximal end surface that is annular.
  • proximal end of the second support portion 112 is non-flush, a proximal end portion of the inclined or zigzag shape is formed, that is, the non-flush structure of the second support portion 112 has various forms.
  • the proximal end portion of the present embodiment adopts an inclined structure corresponding to the shape of the branch blood vessel near the blood vessel bifurcation. After the stent is expanded, the proximal end face of the second support portion 112 is in an inclined plane, a curved surface or a wave surface.
  • the second supporting portion 112 is gradually extended from the inner side to the outer side of the radial direction by the first supporting portion 111, and the equidistant length forms an inclined plane, and the non-equidistant lengthwise forms a curved surface or a wave surface. In this embodiment, it is preferable to extend the equidistance, and the proximal end surface is an inclined plane.
  • the difference between the outermost and innermost heights of the second support portion 112 is 0-30 mm, preferably 5-20 mm.
  • the angle ⁇ between the inclined plane and the axis of the blood vessel stent satisfies: 90°> ⁇ >0°, preferably 60°> ⁇ >30°.
  • the specific inclination angle is set according to the branching angle of the branch blood vessel and the diameter of the blood vessel, and is not limited herein.
  • the non-flush structure can set the inclination angle of the proximal end surface of the blood vessel stent according to the bifurcation condition of the branch blood vessel, so that the proximal end of the proximal support mechanism 110 and the lesion portion at the bifurcation of the blood vessel completely fit together without protruding into the trunk
  • the blood vessel avoids the problem that the prior art vascular stent is implanted into the branch vessel and cannot completely cover the lesion and protrude into the main blood vessel to affect the complications of the contralateral blood flow.
  • the second supporting portion 112 extends from the first supporting portion 111 in the proximal direction in the axial direction, and also gradually extends outward in the radial direction to form an everted bell mouth structure.
  • the degree of valgus should not be too large, and it is preferred that the flared portion extending outwardly from the stent is located at the proximal end of the second support portion 112, preferably the flared portion is located at the longest segment of the second support portion 112.
  • the angle ⁇ between the contour of the expansion portion and the axis of the blood vessel stent satisfies: 30° ⁇ ⁇ > 0°, that is, at least the most of the second support portion 112
  • the angle ⁇ between the long segment and the axis of the blood vessel stent satisfies: 30° ⁇ ⁇ > 0°
  • the second support portion 112 is slightly turned outward.
  • the angle ⁇ of the proximal support mechanism 110 gradually expanding outward in the radial direction from the distal end to the proximal end is 20°.
  • the proximal end of the proximal support mechanism 110 is outwardly expanded to a certain angle, more in line with the bifurcation vascular anatomy, so that the proximal end of the proximal support mechanism 110 achieves a good adherence effect.
  • the vascular stent of the third embodiment is partially modified based on the second embodiment.
  • the blood vessel stent of the second embodiment of the present invention has a tubular shape and includes a proximal support mechanism 110, a middle region support mechanism 120 and a distal support mechanism 130 which are sequentially connected.
  • each connecting component 122 is provided with at least two connecting rods 1221, and one end of each connecting rod 1221 is connected to the crest unit 1211 or the trough unit 1213 of the corrugated support 100, and the other end of each connecting rod 1221.
  • the poles 1212 of adjacent corrugated supports are connected.
  • the connecting rods 1221 in each connecting component 122 may be arranged in parallel, or may be arranged in a figure-eight shape or an inverted figure-eight shape. It is preferably arranged in a figure eight shape or an inverted figure eight shape to increase the radial supporting force.
  • the two connecting rods 1221 of each connecting component 122 of the central support mechanism 120 form a closed loop connecting unit with the supporting unit 1210 of the adjacent corrugated support 100.
  • the closed-loop connecting unit is evenly disposed between the adjacent two corrugated supporting members 121 in the circumferential direction and alternately disposed between the adjacent two corrugated supporting members 121 in the axial direction, so that the blood vessel bracket has good flexibility, scalability and connection strength.
  • the waveform of the blood vessel stent and the corrugated support is maintained in a good shape when bent or stretched. Since the crest unit 1211 of the axial corrugated support 121 faces the crest unit 1211 of the adjacent support 100, the trough unit 1213 of the corrugated support 121 at the proximal end and the pole 1212 of the corrugated support 121 of the distal end are connected.
  • the upper connecting rods 1221 are inclined, that is, the two connecting rods 1221 of each connecting component 122 are symmetrically arranged in a figure-eight shape or symmetrically arranged in an inverted figure-eight shape.
  • the connecting rods 1221 of the connecting member 122 are arranged in the same manner in the circumferential direction.
  • the same arrangement means that the two connecting rods 1221 of each connecting component 122 are arranged in a figure-eight or inverted figure-eight shape.
  • the connection assemblies 122 disposed between adjacent three wave-shaped supports 121 do not overlap or partially overlap the projections in the plane of the vertical axis.
  • both the proximal support mechanism 110 and the pole 1212 of the distal support mechanism 130 select a straight rod
  • the pole 1212 of the middle support mechanism 120 selects a shaped rod, specifically a Z-shaped rod.
  • the blood vessel stent of the fourth embodiment is partially modified based on the second embodiment or the third embodiment.
  • the length of the wave rod 1212 of the axially connected wave support member 121 of the proximal support mechanism 110 is different, and at least the amplitude of the wave-shaped support member 120 of the second support portion 112 is from the inner side of the branch stent The outer side gradually becomes longer.
  • the number of the wave rods 1212 in the axial direction of the proximal support mechanism 110 is the same, and the length of the partial inner wave rods 1212 gradually extends toward the proximal end in the axial direction. That is, the number of the rods 1212 in the axial direction of the proximal support mechanism 110 is the same, and the length of the rod 1212 gradually increases in the direction from the distal end to the proximal end.
  • the length of the wave rod 1212 outside the blood vessel stent is increased by a large degree, and the length of the inner rod of the blood vessel stent 1212 is symmetrically increased and the amplitude of the increase is small. Since the amplitude of the waveform of the wave support member 121 is elongated, a slope is formed at the proximal end surface of the proximal support mechanism 110.
  • the second support portion 112 is gradually expanded outward from the distal end to the proximal end, that is, the second support The portion 112 extends from the first support portion 111 in the proximal direction in the axial direction, and also gradually extends outward in the radial direction to form an everted bell mouth structure.
  • the degree of valgus is not excessively large.
  • the angle ⁇ between the axially longest section of the second support portion 112 and the central axis of the blood vessel stent satisfies: 30° ⁇ ⁇ > 0°, that is, the second support portion 112 is slightly outward. turn.
  • the proximal closed loop region gradually expands radially outward from the distal end to the proximal end by an angle ⁇ of 20°.
  • the tubular structure is expanded outward at a certain angle to the proximal end, which is more consistent with the anatomy of the bifurcated vessel, so that the proximal end of the vascular stent achieves a good adherence effect.
  • the difference from the third embodiment is that at least two crest units 1211 or two trough units 1213 are spaced between the two connecting rods 1221 of each connecting component 121.
  • the connection assembly 122 of the adjacent three-wave shaped support member 121 and the closed-loop connection unit formed by the corresponding wave-shaped support member 121 partially overlap the projection of the plane in the vertical axial direction, which can better ensure the scalability and connection strength of the blood vessel support, and The waveform of the blood vessel stent and the corrugated support 121 is maintained in a good shape when bent or stretched.
  • the proximal support mechanism 110 of the vascular stent of the fifth embodiment includes a first support portion 111 and a second support portion 112.
  • the structure of the portion is the same as that of the second embodiment, and details are not described herein again.
  • the tilted proximal end face of the proximal support mechanism 110 of the fifth embodiment is formed by increasing or decreasing the number of meshes by adjusting the mesh height by adjusting the axial length of the wave rod 1212 of the support unit 1210 compared to the fourth embodiment. , with a more uniform mesh size, with better radial and axial support strength.
  • the proximal support mechanism 110 gradually expands radially outward from the distal end to the proximal end by an angle ⁇ of 10°.
  • the vascular stent expands outwardly at a certain angle of expansion, which is more consistent with the anatomy of the bifurcated vessel, so that the proximal end of the vascular stent achieves a good adherence effect.

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Abstract

一种血管支架，包括若干沿轴向相连接的波状支撑件（121），管状支架包括依次连接的近端支撑机构（110）、中区支撑机构（120）和远端支撑机构（130）；中区支撑机构（120）和远端支撑机构（130）分别为闭环结构；近端支撑机构（110）包括与中区支撑机构（120）连接的第一支撑部（111）及设置在第一支撑部（111）近端的第二支撑部（112）；第一支撑部（111）为闭环结构；第二支撑部（112）为开环结构，第二支撑部（112）的近端端面为非齐平的结构以提供周向上的局部支撑。该血管支架可避免突入主干血管影响对侧分支血管的血液回流及良好地贴附及覆盖病变部位。

Description

血管支架 技术领域
本发明属于医疗器械技术领域，涉及一种血管支架，尤其涉及一种用于治疗靠近血管分叉处病变的血管支架。
背景技术
对血管狭窄或者闭塞性病变等心血管疾病，通过植入血管支架来支撑扩张病变血管，使病变血管的血流恢复通畅。
对于普通血管狭窄病变，放入普通血管支架就可以撑开血管。然而，有些血管狭窄病变位于血管分叉处(即从主干血管伸出的分支血管的起点处)附近，此时血管支架需完全覆盖病变部位。在一些情况下，血管支架需要覆盖病变部位以外的血管区域，如相邻的无病变或几乎无病变的血管区域，以在紧急情况或将来将血管撑开。因此，当血管狭窄病变位于血管分叉附近时，血管支架必须覆盖分支血管的口部。分支血管的口部平面通常不垂直于分支血管的轴线延伸平面，因为分支血管通常不是以90°的角度伸出主干血管，例如是以40°-60°之间的角度伸出主干血管。如图1A及1B所示，在这种情况下，普通支架不能充分覆盖病变部位。
例如髂静脉压迫综合征，是由于左髂总静脉受右髂总动脉与第五腰椎持续性的机械压迫及动脉搏动造成静脉腔内粘连、内膜增生、纤维化引起管腔狭窄、闭塞而导致左下肢静脉回流障碍。故用于髂静脉的支架需要有较强的支撑力。由于目前市场较少提供专用于静脉的血管支架，临床上，主要是使用动脉血管支架来治疗髂静脉狭窄，但动脉血管支架径向支撑力较弱不能满足需求。另外，髂静脉贴具有生理弯曲的骨盆行走，故对应的血管支架需有良好的柔顺性。此外，双侧髂静脉向上汇入下腔静脉呈现倒“Y”形态，其中右髂静脉走行较陡直，与下腔静脉成角约20度，左髂静脉与下腔静脉成角呈大约40度。而目前常用 的静脉或外周动脉血管支架多为直管型支架；另外因左髂总静脉处于右髂动脉和腰椎之间，支架植入时不易准确定位释放，支架释放时极易前跳进入下腔静脉；髂静脉累及下腔静脉病变，需要将支架突入下腔静脉以进行扩张，但突入的支架可能影响对侧髂静脉的血液回流，甚至导致对侧髂静脉血栓形成。有报道指出单边支架进入下腔静脉发生率为7-10％，由此导致对侧髂静脉血栓发生率为15％。另外，有临床病例显示，髂静脉前壁由于右髂动脉的搏动以及位于闭塞部位，髂静脉的远端常成“漏斗状”，支架近端进入下腔静脉过少，支架的外侧又不能完全覆盖髂静脉病变部位，直管型支架由于锚定力不足极易被挤压到髂静脉远端，从而导致治疗失败。
如图1A所示，血管狭窄病变部位位于靠近血管的分叉处时，因为分支血管分叉的角度并非直角，如果要完全覆盖病变部位，在任一分支血管放入支架会有部分突入主干血管，悬浮于主干血管的分支血管的支架，会受主干血流或对侧分支血管血流的长期冲刷而不稳固。另外，如图1B所示，将直管型支架用于血管的分叉处时，由于分支血管与主干血管的管径相差较大，分叉处会出现较大的折弯，因此选用直管型支架极可能由于贴壁不良影响对侧血液回流形成紊流或涡流，会增加于支架内形成血栓的风险。
发明内容
本发明要解决的技术问题在于，针对现有技术的缺陷，提供一种用于治疗靠近血管分叉处病变的血管支架，可以避免血管支架突入主干血管并能良好覆盖及贴附病变部位。
本发明血管支架，包括若干沿轴向相连接的波状支撑件，管状支架包括依次连接的近端支撑机构、中区支撑机构和远端支撑机构；所述中区支撑机构和远端支撑机构分别闭环结构；所述近端支撑机构包括与中区支撑机构连接的第一支撑部及设置在第一支撑部近端的第二支撑部；所述第一支撑部为闭环结构；所述第二支撑部为开环结构，第二支撑部的近端端面为非齐平的结构以提供周 向上的局部支撑。
进一步地，所述第二支撑部的近端端面是一个倾斜的平面、倾斜的弧面或倾斜的波浪面。
进一步地，所述近端端面为倾斜的平面，近端端面与血管支架的轴线的夹角为α，90°＞α＞0°。
进一步地，所述近端支撑机构的波状支撑件的波长相同，相邻波状支撑件的波峰单元连接波谷单元形成网格，至少第二支撑部的网格数量由远端向近端逐步减少。
进一步地，至少第二支撑部的波状支撑件的振幅由血管支架内侧向外侧逐渐变长。
进一步地，所述中区支撑机构、近端支撑机构与远端支撑机构之间通过沿周向间隔设置的连接组件相连接。
进一步地，所述中区支撑机构的波状支撑件之间通过周向间隔设置的连接组件相连接。
进一步地，所述波状支撑件包括若干支撑单元；每一支撑单元包括波峰单元、波谷单元、连接在波峰单元和波谷单元之间的波杆；每一连接组件包括至少一个连接杆；所述连接杆的一端连接一波状支撑件的波峰单元或波谷单元且所述连接杆的另一端连接相邻波状支撑件的波杆，或者所述连接杆的两端分别连接相邻两波状支撑件的波峰单元与波谷单元。
进一步地，每一连接组件包括至少两个连接杆，相邻两连接杆呈八字形或倒八字形设置。
进一步地，相邻三波状支撑件之间设置的连接组件在垂直轴向的平面的投影不重叠或部分重叠。
进一步地，所述连接杆为直杆、带有弯曲结构异形杆或弧形结构的异形杆或是它们的组合。
进一步地，所述波杆为直杆、带有弯曲结构异形杆或弧形结构的异形杆或 是它们的组合。
进一步地，相邻两波状支撑件中没有与连接组件连接的部分悬空。
进一步地，血管支架膨胀后，至少位于血管支架外侧的近端支撑机构的外侧部分沿远端向近端的方向逐步向血管支架外延伸扩张。
进一步地，所述近端支撑机构向血管支架外延伸扩张形成扩张部，扩张部外侧轮廓线与血管支架的轴线的夹角β满足：30°≥β＞0°。
进一步地，血管支架膨胀后，血管支架的外径由远端向近端逐步扩大形成锥形结构。
进一步地，所述支架近端支撑机构的近端和/或远端支撑机构的远端设置多个支撑点。
进一步地，所述支撑点为中空结构，所述中空结构内部设置有显影点。
本发明血管支架的近端端面为非齐平的结构，可提供周向局部支撑；可根据血管分叉处的具体情况来设置非齐平结构的近端端面倾斜角度，可以避免血管支架突入主干血管并能良好覆盖及贴附病变部位。
附图说明
下面将结合附图及实施例对本发明作进一步说明。
图1A及1B是现有血管支架的植入血管的结构示意图。
图2是本发明实施例一的血管支架展开时的结构示意图。
图2A及2B是图2的血管支架不同使用状态的结构示意图。
图3是本发明实施例二的血管支架展开时的结构示意图。
图3A至3C是图3的血管支架不同使用状态的结构示意图。
图4是本发明实施例三的血管支架展开时的结构示意图。
图4A是图4的血管支架使用状态的结构示意图。
图5是本发明实施例四的血管支架展开时的结构示意图。
图5A是图5的血管支架使用状态的结构示意图。
图6是本发明实施例五的血管支架展开时的结构示意图。
图6A是图6的血管支架使用状态的结构示意图。
图7是本发明血管支架植入血管的结构示意图。
具体实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
需要说明的是，以下结构是血管支架膨胀后的结构。
方位定义：本发明中，近端是指血管支架植入血管后靠近心脏的一端；轴向是指血管支架的中心轴线的方向；径向是指与中心轴线垂直的方向；支架内侧是指支架膨胀时，靠近分叉血管分叉处的一侧，相对支架内侧的另一侧为支架外侧。
实施例一
如图2、2A及2B所示，本发明实施例一的血管支架，呈管状，可以为等径结构；可以为非等径结构，如锥管结构；还可以为锥管状与直管状组成的变径结构。优选为血管支架膨胀后外径由远端向近端逐步扩大的锥形结构。本发明实施例一的血管支架包括依次设置的近端支撑机构110、中区支撑机构120和远端支撑机构130。近端支撑机构110、中区支撑机构120和远端支撑机构130之间可以直接相连，也可以通过连接组件122相连。
近端支撑机构110、中区支撑机构120和远端支撑机构130均为闭环结构。闭环结构在垂直轴向的平面的投影为封闭环形。近端支撑机构110、中区支撑机构120和远端支撑机构130均包括沿轴向设置的多个波状支撑件121。
每一波状支撑件121包括若干首尾相连接的支撑单元1210。每一支撑单元1210包括波峰单元1211、波谷单元1213、连接在波峰单元1211和波谷单元1213之间的波杆1212。
在血管支架展开成平面时，波杆1212的形状为直杆、带有弯曲结构的异 形杆或带有弧形结构的异形杆、或是它们的组合。异形杆是指波杆1212为非直杆，弯曲结构是指波杆1212上的弯曲部分，弯曲部分能加强波杆1212的弯曲或伸展性能。弯曲结构可以设置在波杆1212的任意位置，优选设置在波杆1212中部。所述带有弯曲结构或弧形结构的异形杆为弧形杆、设有弧形部的直杆、Z形杆或S形杆。
每一支撑单元1210的波杆1212、波峰单元1211和波谷单元1213为一体结构或连接结构。波状支撑件121也可以是一体结构或连接结构。本发明血管支架通过激光切割热定型材料制成，热定型材料可选用不锈钢、钽、钴基合金、铂、镍钛合金及新型钛合金，优选材料为镍钛合金。
相邻波状支撑件121的波峰单元1211与波谷单元1213一一对应相连形成网格。本实施例中，波状支撑件121的波长相同及振幅相同。波长相同是指波状支撑件101在周向上的每一波形的长度相同。在其他实施例中，波状支撑件121的波形也可以不同，即无需限定波形的振幅，波状支撑件121的每一波形的波长只要使得轴向相邻波状支撑件101的波峰单元1211与波谷单元1213一一对应连接形成网格即可。
本实施例中，近端支撑机构110是端面齐平结构。至少位于血管支架外侧的近端支撑机构110的外侧部分由远端向近端方向逐步向支架外侧延伸扩张。在血管支架植入分支血管后，近端支撑机构110的外侧部分或近端支撑机构110整体逐步向外扩张，则使得血管支架的贴壁性更好。外侧部分是指远离血管交叉的一侧且沿周向延伸一段长度的波状支撑件121的部分，外侧部分的具体宽度以及外翻角度大小可以根据实际分支血管直径、分支血管与主干血管直径差等因素确定。如图2及2A中虚线包围的部分为外侧部分。如图2A所示，所述近端支撑机构110的外侧部分逐步向外扩张，向血管支架外侧延伸扩张形成扩张部，扩张部轮廓线与血管支架的轴线的夹角β满足：30°≥β＞0°。本实施例中，优选β为30°。如图2B所示，在其他实施方式中，近端支撑机构110周向全部向支架外侧逐步延伸扩张，形成一个喇叭口形状的扩张部。外翻扩张部 与血管支架的轴线的夹角β为20°。
远端支撑机构130由多个具有相同波长的支撑单元1210的波状支撑件121轴向连接形成，相邻波状支撑件121的波峰单元1131与波谷单元1121一一对应相连形成网格。远端支撑机构130的网格与近端支撑机构110的第一支撑部111的结构相同，在此不再赘述。
近端支撑机构110的近端和远端支撑机构130的远端可设置多个支撑点1126。支撑点1126是在波形支撑件100的波峰单元1211上设置的圆滑凸起结构，可以是实心结构，也可以是中心带孔的结构。支撑点1126数量和间隔根据实际需要设定，在此不作限定。本实施例中，在支撑点1126于中心孔中填充显影材料形成用于手术中显影血管支架在血管中位置的显影点。显影点也可以另外设置在近端支撑机构110和远端支撑机构130的端部的其他位置。
本实施方式中，中区支撑机构120与近端支撑机构110及远端支撑机构130均通过沿周向间隔设置的连接组件122相连。没有与连接组件122连接的波状支撑件121的支撑单元1210悬空，即没有与连接组件122连接的轴向相邻的支撑单元1210的波峰单元1211、波谷单元1213之间无连接或悬空。
本实施方式中，所述中区支撑机构120中的轴向相邻的波状支撑件121之间亦通过沿周向间隔设置的连接组件122相连。没有与连接组件122连接的相邻两图的波状支撑件121之间无连接或悬空。
轴向相邻的两波状支撑件121在相邻两连接组件122之间无连接或悬空。无连接是指波状支撑件121的波峰单元1211与轴向相邻的波谷单元1213之间没有连接，使得相邻两波状支撑件121在径向和轴向上有较大的相对移动或弯曲空间，以增加血管支架的柔顺性。
每一连接组件122包括至少一个连接杆1221。连接杆1221与对应的支撑单元1210的连接方式有多种。连接杆1221的两端可以连接轴向相邻的波峰单元1211与波谷单元1213；连接杆1221的一端连接一波状支撑件121的波峰单元1211或波谷单元1213，连接杆1221的一端连接轴向相邻的波杆1212。 本实施例中，连接杆1221的两端连接轴向相邻的波峰单元1211与波谷单元1213。
本实施例中，所述连接杆1221与对应的支撑单元1210为一体成型结构或连接结构。其中，一体成型是采用管材激光切割定型而成。由于中区支撑机构120相邻两波状支撑件121不同步，即轴向一波状支撑件121的波峰单元1211与轴向相邻的波状支撑件121的波谷单元1213交错设置。连接杆1221倾斜连接在轴向相邻的波峰单元1211与波谷单元1213之间。周向相邻的连接杆1221可以平行设置，也可以不平行设置，即周向相邻的连接杆1221呈八字形或倒八字形设置。
相邻两波状支撑件121之间的连接杆1221沿周向的排布方式相同或按照一定的规律重复排布。
轴向相邻两图之间的连接组件122，在垂直轴向上的平面的投影不重叠或部分重叠。连接组件122在轴向上呈螺旋形排布或交错排布。螺旋排布是指轴向相邻的连接组件之间呈螺旋形排布延伸，交错排布是指轴向相邻的连接组件连接的波峰与波谷不在同一条轴线上。连接杆1221沿周向成组均匀分布，且相邻三波状支撑件121之间的连接杆1221沿轴向交错排布，使连接组件122能承受更大的局部拉力和压力，并使血管支架在伸缩或弯曲时变形均匀。
所述连接杆1221为直杆、带有弯曲结构的异形杆或弧形结构的异形杆、或是它们的组合。本实施例中，连接杆1221为直杆。
中区支撑机构120的相邻波状支撑件121之间设置的连接组件122与近端支撑机构110与中区支撑机构120之间设置的连接组件122或中区支撑机构120与远端支撑机构130之间设置的连接组件122，可以相同，也可以不同。
实施例二
请参阅图3、图3A至图3C，实施例二的血管支架与实施例一基本相同，呈管状，包括依次连接的近端支撑机构110、中区支撑机构120和远端支撑机构130。血管支架膨胀后可以为等径结构，如图3A所示；也可为非等径结构， 如锥管结构，如图3B所示。
不同之处在于，近端支撑机构110的近端为非齐平的结构，可提供周向局部支撑，不仅使得血管支架良好贴附并覆盖病变部位且不会突出主干血管。近端支撑机构110包括与中区支撑机构120连接的第一支撑部111及设置在第一支撑部111近端的第二支撑部112。所述第一支撑部111为闭环结构。第二支撑部112的网格数量由远端向近端逐步减少，使得所述第二支撑部112为开环结构。开环指波状支撑件121a首尾分离，即波状支撑件121a首尾相邻或者相距一定间距，在垂直轴向的平面的投影近似成C形。所述第一支撑部111包括沿轴向设置的多个波状支撑件121。所述第二支撑部112包括沿轴向设置的多个波状支撑件121a。
由于第二支撑部112的近端端面非齐平，在径向上各个位置的轴向长度不同，使得第二支撑部112可提供局部支撑。第二支撑部112的近端端面非齐平，即周向上第二支撑部112的各个位置的轴向长度不同。近端端面是指血管支架最近端端部的表面。血管支架为管状结构，其近端端面为环形。由于第二支撑部112近端非齐平，则形成倾斜或锯齿形的近端端部，即第二支撑部112的非齐平结构有多种形式。对应靠近血管分叉处的分支血管的形状，本实施例的近端端部采用倾斜结构。在血管支架膨胀后，所述第二支撑部112的近端端面是一个倾斜的平面、弧面或波浪面中。第二支撑部112由第一支撑部111自径向的内侧向外侧逐步延长长度，等距延长长度形成倾斜平面，非等距延长形成弧面或波浪面。本实施例中优选等距延长，所述近端端面为倾斜的平面。第二支撑部112的最外侧与最内侧的高度之差为0-30mm，优选为5-20mm。所述倾斜的平面与血管支架的轴线的夹角α满足：90°＞α＞0°，优选60°＞α＞30°。具体倾斜角度根据分支血管的分支角度和血管直径进行设定，在此不作限定。
非齐平结构可以根据分支血管的分叉处情况来设定血管支架的近端端面倾斜角度，使得近端支撑机构110的近端与血管分叉处的病变部位完全贴合，而不突入主干血管，避免了现有技术中血管支架植入分支血管后无法完全覆盖 贴合病变部位并突入主干血管影响对侧血流造成并发症的问题。
如图3C所示，第二支撑部112是从第一支撑部111在轴向上开始向近端方向延伸的同时，也在径向上逐步向外延伸，形成外翻的喇叭口结构。外翻的程度不可过大，优选向血管支架外延伸扩张形成的扩张部位于第二支撑部112的近端，优选扩张部位于第二支撑部112的最长段。即至少在第二支撑部112的外侧部分有扩张部，扩张部的轮廓线与血管支架的轴线的夹角β满足：30°≥β＞0°，即至少所述第二支撑部112的最长段与血管支架的轴线的夹角β满足：30°≥β＞0°，第二支撑部112稍向外翻。如图3C所示，在本实施例中，所述近端支撑机构110沿远端到近端的方向沿径向逐渐外扩出的角度β为20°。在近端支撑机构110的近端向外扩张一定的角度，更符合分叉血管解剖学，使近端支撑机构110的近端达到良好的贴壁效果。
实施例三
如图4及4A所示，实施例三的血管支架是以实施例二为基础，进行了部分改进。
本发明实施例二的血管支架，呈管状，包括依次连接的近端支撑机构110、中区支撑机构120和远端支撑机构130。
不同之处在于，每一连接组件122设有至少两个连接杆1221，且每一连接杆1221的一端连接一波状支撑件100的波峰单元1211或波谷单元1213，每一连接杆1221的另一端连接相邻波状支撑件的波杆1212。每一连接组件122中的连接杆1221可以平行设置，也可以呈八字形或倒八字形设置。优选呈八字形设置或倒八字形，以提高径向支撑力。中区支撑机构120的每一连接组件122的两连接杆1221，与相邻波状支撑件100的支撑单元1210形成闭环连接单元。闭环连接单元沿周向均匀设置在相邻两波状支撑件121之间且沿轴向交错设置相邻两波状支撑件121之间，使得血管支架具有良好的柔顺性、可伸缩性和连接强度，并在弯曲或伸缩时使血管支架和波状支撑件的波形维持良好的形态。由于沿轴向波状支撑件121的波峰单元1211正对相邻支撑件100的波 峰单元1211，则连接在近端的波状支撑件121的波谷单元1213与远端的波状支撑件121的波杆1212上的连接杆1221是倾斜的，即每一连接组件122的两连接杆1221呈八字形对称设置或倒八字形对称设置。
连接组件122的连接杆1221沿周向的排布方式相同。排布方式相同是指每一连接组件122的两连接杆1221都是呈八字形或倒八字形排布。优选相邻三波状支撑件121之间设置的连接组件122，在垂直轴向的平面的投影不重叠或部分重叠。
不同之处还在于，近端支撑机构110和远端支撑机构130的波杆1212都选择直杆，中区支撑机构120的波杆1212选择异形杆，具体为Z形杆。
实施例四
如图5及5A所示，实施例四的血管支架是以实施例二或实施例三为基础，进行了部分改进。
不同之处在于，近端支撑机构110的沿轴向相连接的波形支撑件121的波杆1212长度是不相同，至少第二支撑部112的波状支撑件120的振幅由支血管支架的内侧向外侧逐渐变长。本实施例中，近端支撑机构110轴向一列的波杆1212数目相同，部分内侧波杆1212长度逐渐沿轴向方向向近端延伸。即近端支撑机构110沿轴向的波杆1212数量相同，而波杆1212的长度沿远端至近端的方向逐渐增大。本实施例中，如图5所示，血管支架外侧的波杆1212的长度增加辐度较大，血管支架内侧波杆1212的长度对称增加且增加辐度较小。由于拉长了波形支撑件121的波形的振幅，从而于近端支撑机构110的近端端面形成斜面。
如图5A所示，为了进一步加强血管支架与血管内壁的贴合，在扩张后的近端支撑机构110中，至少第二支撑部112由远端向近端逐步向外扩张，即第二支撑部112是从第一支撑部111沿轴向上开始向近端方向延伸的同时，也在径向上逐步向外延伸，形成外翻的喇叭口结构。外翻的程度不可过大，优选所述第二支撑部112的轴向最长段与血管支架中轴线的夹角β满足： 30°≥β＞0°，即第二支撑部112稍向外翻。如图5A所示，在本实施例中，所述近端闭环区从远端到近端方向上逐渐沿径向外扩出角度β为20°。通过管状结构在近端向外扩张一定的角度，更符合分叉血管解剖学，使血管支架近端达到良好的贴壁效果。
与实施例三的不同之处还在于，每一连接组件121的两个连接杆1221之间间隔至少两个波峰单元1211或两个波谷单元1213。相邻三波状支撑件121的连接组件122与对应波状支撑件121形成的闭环连接单元在垂直轴向的平面的投影部分重叠，可更好地保证血管支架的可伸缩性和连接强度，并在弯曲或伸缩时使血管支架和波状支撑件121的波形维持良好的形态。
实施例五
如图6及6A所示，实施例五的血管支架的近端支撑机构110包括第一支撑部111和第二支撑部112，该部分结构与实施例二相同，在此不再赘述。
相较于实施例四通过调节支撑单元1210的波杆1212轴向长度来调节网格高度，实施例五的近端支撑机构110的倾斜的近端端面是通过增加或者减少网格的数量形成的，具有更均匀大小的网格，具有更佳的径向和轴向支撑强度。
另外，本实施例中，近端支撑机构110从远端到近端方向上逐渐沿径向外扩出角度β为10°。血管支架在近端向外扩张一定的扩出角度，更符合分叉血管解剖学，使血管支架近端达到良好的贴壁效果。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (18)

  1. 一种血管支架，包括若干沿轴向相连接的波状支撑件，其特征在于：管状支架包括依次连接的近端支撑机构、中区支撑机构和远端支撑机构；所述中区支撑机构和远端支撑机构分别闭环结构；所述近端支撑机构包括与中区支撑机构连接的第一支撑部及设置在第一支撑部近端的第二支撑部；所述第一支撑部为闭环结构；所述第二支撑部为开环结构，第二支撑部的近端端面为非齐平的结构以提供周向上的局部支撑。
  2. 根据权利要求1所述的血管支架，其特征在于，所述第二支撑部的近端端面是一个倾斜的平面、倾斜的弧面或倾斜的波浪面。
  3. 根据权利要求2所述的血管支架，其特征在于，所述近端端面为倾斜的平面，近端端面与血管支架的轴线的夹角为α，90°＞α＞0°。
  4. 根据权利要求2所述的血管支架，其特征在于，所述近端支撑机构的波状支撑件的波长相同，相邻波状支撑件的波峰单元连接波谷单元形成网格，至少第二支撑部的网格数量由远端向近端逐步减少。
  5. 根据权利要求2所述的血管支架，其特征在于，至少第二支撑部的波状支撑件的振幅由血管支架内侧向外侧逐渐变长。
  6. 根据权利要求1所述的血管支架，其特征在于，所述中区支撑机构、近端支撑机构与远端支撑机构之间通过沿周向间隔设置的连接组件相连接。
  7. 根据权利要求1所述的血管支架，其特征在于，所述中区支撑机构的波状支撑件之间通过周向间隔设置的连接组件相连接。
  8. 根据权利要求6或7所述的血管支架，其特征在于，所述波状支撑件包括若干支撑单元；每一支撑单元包括波峰单元、波谷单元、连接在波峰单元和波谷单元之间的波杆；每一连接组件包括至少一个连接杆；所述连接杆的一端连接一波状支撑件的波峰单元或波谷单元且所述连接杆的另一端连接相邻波状支撑件的波杆，或者所述连接杆的两端分别连接相邻两波状支撑件的波峰单元与波谷单元。
  9. 根据权利要求8所述的血管支架，其特征在于，每一连接组件包括至少两个连接杆，相邻两连接杆呈八字形或倒八字形设置。
  10. 根据权利要求8所述的血管支架，其特征在于，相邻三波状支撑件之间设置的连接组件在垂直轴向的平面的投影不重叠或部分重叠。
  11. 根据权利要求8所述的血管支架，其特征在于，所述连接杆为直杆、带有弯曲结构异形杆或弧形结构的异形杆或是它们的组合。
  12. 根据权利要求8所述的血管支架，其特征在于，所述波杆为直杆、带有弯曲结构异形杆或弧形结构的异形杆或是它们的组合。
  13. 根据权利要求8所述的血管支架，其特征在于，相邻两波状支撑件中没有与连接组件连接的部分悬空。
  14. 根据权利要求1-7任意一项所述的血管支架，其特征在于，血管支架膨胀后，至少位于血管支架外侧的近端支撑机构的外侧部分沿远端向近端的方向逐步向血管支架外延伸扩张。
  15. 根据权利要求14所述的血管支架，其特征在于，所述近端支撑机构向血管支架外延伸扩张形成扩张部，扩张部外侧轮廓线与血管支架的轴线的夹角β满足：30°≥β＞0°。
  16. 根据权利要求1-7任意一项所述的血管支架，其特征在于，血管支架膨胀后，血管支架的外径由远端向近端逐步扩大形成锥形结构。
  17. 根据权利要求1-7任意一项所述的血管支架，其特征在于，所述支架近端支撑机构的近端和/或远端支撑机构的远端设置多个支撑点。
  18. 根据权利要求17所述的血管支架，其特征在于，所述支撑点为中空结构，所述中空结构内部设置有显影点。
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