WO2019096159A1 - 外周血管支架 - Google Patents

外周血管支架 Download PDF

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Publication number
WO2019096159A1
WO2019096159A1 PCT/CN2018/115417 CN2018115417W WO2019096159A1 WO 2019096159 A1 WO2019096159 A1 WO 2019096159A1 CN 2018115417 W CN2018115417 W CN 2018115417W WO 2019096159 A1 WO2019096159 A1 WO 2019096159A1
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WIPO (PCT)
Prior art keywords
unit
rod
adjacent
support
peripheral vascular
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PCT/CN2018/115417
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English (en)
French (fr)
Inventor
王永胜
李建民
高国庆
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杭州唯强医疗科技有限公司
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Publication of WO2019096159A1 publication Critical patent/WO2019096159A1/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
    • A61F2002/9155—Adjacent bands being connected to each other

Definitions

  • the present invention relates to a medical device, and more particularly to a peripheral vascular stent that can be used to treat peripheral vascular diseases.
  • Peripheral vascular disease is a common manifestation of systemic atherosclerosis and can induce systemic arteriosclerosis and cardiovascular morbidity and mortality. After peripheral angiogenesis, the vascular lumen becomes narrow, and the blood flow into the lower limbs becomes smaller, causing insufficient blood supply to the lower limbs and causing limb necrosis.
  • Venous diseases mainly include various types of diseases such as venous stenosis, venous thrombosis and venous reflux.
  • the vein is susceptible to arterial compression leading to stenosis.
  • the left common iliac vein is co-compressed by the right common iliac artery and the fifth lumbar vertebrae.
  • iliac vein compression syndrome This syndrome can occur on both sides, but it is more common on the left side.
  • the incidence of iliac vein compression syndrome in adults is very high, reaching 20% to 34%. Because women's lumbosacral physiology is more obvious than men, women aged 23 to 45.5 account for the majority (70% to 84%). Studies have shown that iliac vein disease not only has a high incidence, but also is the main cause of secondary varicose veins, deep venous insufficiency and deep vein thrombosis.
  • the main methods of treating peripheral vascular disease include medical treatment and surgical treatment.
  • medical treatment is to delay the progression of venous sclerosis of lower extremities by means of antihypertensive, lipid-lowering, anti-platelet aggregation, etc., but it can not completely eliminate the vascular stenosis, occlusion and other organic diseases.
  • Surgical treatment is divided into open surgery and intravascular intervention.
  • the intravascular interventional method has the advantages of minimally invasive, simple operation, exact curative effect, and reusable operation, and is the development direction of diagnosis and treatment of vascular diseases.
  • the interventional treatment instruments used in the intravascular interventional method are mainly balloon expansion stents and self-expanding stents.
  • Self-expanding stents are currently used in peripheral vascular interventional treatments.
  • Self-expanding stents include open-loop self-expanding stents and closed-loop self-expanding stents.
  • the unit ring of the open-loop self-expanding bracket is connected with the unit ring by a plurality of connecting rods.
  • the open-loop self-expanding stent has the advantages of excellent flexibility and adhering performance, and has the disadvantages that the radial supporting force is weak and the window opening area is large.
  • Each unit ring of the closed-loop self-expanding bracket is connected with the unit ring by a connecting rod.
  • the advantage of the closed-loop self-expanding stent is that the radial support force is strong and the window opening area is small, and the disadvantages are poor flexibility and poor adherence performance.
  • the peripheral open-loop self-expanding arteriovenous stents in the market are easy to bend and conform to after expansion.
  • the disadvantage is that due to the small metal coverage and the relatively small radial support force, it is easy to cause tissue prolapse and cause restenosis.
  • the stent waveform is easily stretched to cause vascular damage.
  • the existing peripheral closed-loop self-expanding arteriovenous stent in the market is a repeating unit ring, which has a large metal coverage and a large radial supporting force, and can uniformly cover the blood vessel wall to prevent the plaque from falling off.
  • the design flexibility is relatively poor and cannot accommodate curved and complex lesions.
  • the vascular stent Since the vascular stent needs to be compressed, transported and expanded during the operation of the vascular stent, the vascular stent must have good compressibility, transport compliance and expansion uniformity, which is proposed for the material and structural design of the vascular stent. Very high requirements, but the existing brackets are not yet able to achieve these technical performance very well.
  • the technical problem to be solved by the present invention is to provide a peripheral blood vessel stent which can maintain the axial joint strength and the radial support force and can ensure the overall flexibility.
  • a peripheral blood vessel stent which is a tubular structure, comprising: a plurality of axially arranged corrugated support rings and at least one connecting assembly circumferentially spaced between adjacent two support rings; the support ring
  • the support unit is composed of end to end; each support unit includes a crest unit, a trough unit, a pole connected between the crest unit and the trough unit; each connection assembly includes at least two circumferentially arranged connecting rods; each connection One end of the rod is fixed to a crest unit and/or a trough unit of a support ring, and the other end of each connecting rod is fixed to a pole of an adjacent support ring.
  • each connecting component is arranged in a figure-eight or an inverted figure-eight shape.
  • each connecting rod is fixed on the crest unit/or trough unit of one support ring, and the other end of each connecting rod is fixed in the middle of the pole of the adjacent support ring.
  • connecting members are uniformly and circumferentially disposed between adjacent two supporting rings in a circumferential direction, and the connecting rods in each connecting assembly are arranged in the same manner or regularly arranged repeatedly.
  • the projections disposed between adjacent three support rings do not overlap or partially overlap the projections on the plane of the vertical axis.
  • the projections between the adjacent support rings, the projections on the plane of the vertical axis do not overlap or partially overlap.
  • connecting members between the support rings are arranged in a spiral shape or staggered in the axial direction.
  • the wave rod of the supporting unit is a straight rod, a shaped rod with a curved structure or an arc structure, and the wave rod is integrated with the wave crest unit and the trough unit or a connecting structure.
  • the connecting rod is a straight rod, a shaped rod with a curved structure or a curved structure, or a combination thereof.
  • the profiled rod is a curved rod, a straight rod provided with an arc portion, a Z-shaped rod or an S-shaped rod.
  • connecting rod and the supporting unit are a unitary structure or a connecting structure.
  • peripheral vascular stent is a tubular structure of equal diameter extension or a tubular structure of non-equal diameter extension.
  • each connecting component between the adjacent two supporting rings forms a closed loop connecting unit with the corresponding supporting unit.
  • one ends of the two connecting rods of each closed-loop connecting unit are respectively connected with two adjacent trough units on the supporting ring, and the other end of one connecting rod and one side of the corresponding trough unit on the axially adjacent supporting ring The other end of the connecting rod is connected to the other end of the connecting rod on the other side of the corresponding trough unit on the axially adjacent supporting ring.
  • one ends of the two connecting rods of each closed-loop connecting unit are respectively connected with two trough units of the supporting ring which are separated by at least one trough unit, and the other end of one connecting rod and the corresponding trough unit on the axially adjacent supporting ring
  • the middle of the pole of one side is connected, and the other end of the other connecting rod is connected to the middle of the pole of the axially adjacent supporting ring on the side of the corresponding trough unit.
  • closed loop connection unit shares an intermediate pole.
  • peripheral blood vessel stent is provided with two kinds of closed-loop connecting units which are alternately arranged in the axial direction between the adjacent two supporting rings.
  • the projections of the two closed-loop connecting units on the plane of the vertical axis do not overlap or partially overlap.
  • the peripheral vascular stent of the present invention realizes the connection between the support rings through the connecting component, the connecting rods in each connecting component are circumferentially arranged to cooperate to provide a certain radial supporting force; and the connecting rod and the supporting unit form a closed loop connecting unit,
  • the axial joint strength of the peripheral vascular stent is improved; the axially adjacent connecting members are arranged in a spiral arrangement or staggered in the axial direction, and the projections of the axially adjacent closed-loop connecting units on the vertical axial plane do not overlap.
  • the circumferentially spaced connection assembly is such that the axial support force is not excessive; the support unit of the support ring that is not connected to the connecting rod has a greater degree of freedom of bending, The flexibility of the peripheral vascular stent is ensured, so that the peripheral vascular stent can provide good support when bending or stretching.
  • Fig. 1 is a development view of a peripheral blood vessel stent according to a first embodiment of the present invention.
  • Fig. 2 is a partial enlarged view of I of Fig. 1.
  • Fig. 3 is a development view of a peripheral blood vessel stent according to a second embodiment of the present invention.
  • FIG. 4 is a partial enlarged view of M at FIG. 3.
  • Fig. 5 is a development view of a peripheral blood vessel stent according to a third embodiment of the present invention.
  • FIG. 6 to 7 are partial enlarged views of a portion H and a portion N of Fig. 5, respectively.
  • Fig. 8 is a development view of a peripheral blood vessel stent according to a fourth embodiment of the present invention.
  • 9 to 10 are partial enlarged views of a portion D and a portion K of Fig. 4, respectively.
  • Figure 11 is a development view of a peripheral blood vessel stent according to a fifth embodiment of the present invention.
  • Figure 12 is a partial enlarged view of the portion T of Figure 11 .
  • Fig. 13 is a development view of a peripheral blood vessel stent according to a sixth embodiment of the present invention.
  • Figure 16 is a development view of a peripheral blood vessel stent according to a seventh embodiment of the present invention.
  • Figure 19 is a development view of a peripheral blood vessel stent according to an eighth embodiment of the present invention.
  • 20 to 21 are partial enlarged views of a portion W and a portion Z of Fig. 19, respectively.
  • the proximal end is an end close to the heart, as shown by the letter J in Figures 1, 3, 5, 8, 11, 13, 16, 19;
  • One end away from the heart one end represented by the letter Y in Figures 1, 3, 5, 8, 11, 13, 16, 19;
  • the axial direction refers to the central axis direction of the peripheral blood vessel stent, and the direction perpendicular to the central axis is radial.
  • the circumferential direction is the circumferential direction around the central axis of the peripheral vascular stent.
  • a peripheral blood vessel stent is a tubular structure comprising a plurality of axially arranged corrugated support rings 100 and at least one circumferentially spaced between adjacent support rings 100. Connection component 120.
  • the support ring 100 can be arranged in a variety of ways. In order to adapt to the special needs of different blood vessels, the support ring 100 of the peripheral blood vessel stent provided by the present invention is arranged in the axial direction to form a tubular structure having an equal diameter extension, and may also be arranged to form a tubular structure extending non-equal diameter. For example, the diameter of the support ring 100 is sequentially increased or decreased in the axial direction to form a tapered tubular peripheral blood vessel stent.
  • the diameter of the support ring 100 is different at different positions in the axial direction to form various tubular structures of non-equal diameter extension.
  • the peripheral blood vessel stent is a tapered structure composed of a conical tubular shape and a straight tubular shape.
  • the number of the support rings 100 can be set according to actual needs, and the number of the support rings 100 is preferably 8-50.
  • Each support ring 100 is composed of a plurality of support units 110 end to end; each support unit 110 includes a crest unit 111, a trough unit 112, and a wave rod 113 connected between the crest unit 111 and the trough unit 112.
  • Each connection assembly 120 includes at least two connecting rods 121 arranged in a circumferential direction. That is, between the two supporting rings 100, a part of the supporting unit 110 of one of the supporting rings 100 is connected to the supporting unit 110 of the adjacent supporting ring 100 through the connecting component 120; the supporting unit of the other supporting unit 110 corresponding to the adjacent supporting ring 100 There is no connection between 110, and the two can be relatively active.
  • the connecting rods 121 in the connecting assembly 120 connecting the support rings 100 are arranged in the circumferential direction to cooperate to provide a certain radial supporting force.
  • a closed loop connection unit 130I is formed between the connecting rod 121 of each connecting component 120 and the corresponding supporting unit 110.
  • the closed loop connection unit 130I can improve the axial connection strength of the peripheral blood vessel stent.
  • One end of the connecting rod 121 is connected to the crest unit 111 or the trough unit 112, and the other end of the connecting rod 121 is connected to the rod 113.
  • the two ends are connected to the crest unit and the trough unit, which reduces the axial connection strength of the support ring 100 and increases the flexibility between the support rings 100.
  • Such a structure allows the peripheral blood vessel stent to have a certain radial supporting force; since the connecting member 120 is circumferentially spaced apart so that the radial supporting force is not excessive, and there is no bending freedom of the supporting unit 110 connected to the connecting rod 121 Larger, ensuring the flexibility of the peripheral vascular stent.
  • the number of connecting rods 121 in each of the connecting assemblies 120 is determined by the actual required radial support force and compliance. Similarly, the spacing between the connection assemblies 120 and the number of connection assemblies 120 can also be adjusted based on the actual required radial support force and compliance.
  • each support ring 100 is end-to-end connected by a plurality of circumferentially distributed support units 110 to form a sinusoidal waveform.
  • Each support unit 110 includes a crest unit 111, a trough unit 112, and a wave rod 113 connected between the crest unit 111 and the trough unit 112.
  • the crest unit 111 and the trough unit 112 are preferably circular arc-shaped structures, and the angle ⁇ between the adjacent two wave rods 113 is 10-45°, and the proximal end of the adjacent wave rods 113 (near the J end) is a crest unit.
  • 111, the distal ends of the adjacent two wave rods 113 (near the Y end) are connected to the trough unit 112.
  • the trough units 112 of the axially adjacent two support rings 100 face the trough unit 112, and the crest unit 111 faces the crest unit 111.
  • the number of the Poles 113 in the support ring 100 is set according to actual needs, and it is preferable that the number of the Poles 113 in the circumferential direction of each of the support rings 100 is 14-30.
  • the support ring 100 may have substantially the same waveform, that is, a waveform having the same wavelength and the same amplitude, and the waveform of the support ring 100 of the peripheral blood vessel stent may be set as needed.
  • the wavelength may vary depending on the outer diameter of the peripheral blood vessel stent, but preferably has a wavelength of from 0.5 mm to 8.0 mm, particularly preferably from 2.0 mm to 4.0 mm; and the amplitude is preferably from 0.1 mm to 10.0 mm, particularly preferably from 0.3 mm to 3.0 mm.
  • the wave rod 113 of the support unit 110 is a straight rod, a shaped rod with a curved structure or an arc structure, or a combination thereof.
  • the special-shaped rod means that the wave rod 113 is a non-straight rod
  • the curved structure is a structure which is disposed on the straight rod or the special-shaped rod and protrudes to both sides.
  • the curved structure is disposed on the wave rod 113 to enhance the bending or stretching performance of the wave rod 113.
  • the curved structure may be a structure in which the wave rod 113 protrudes to both sides.
  • the curved structure may be disposed at any position of the wave rod 113, preferably at the center of the wave rod 113.
  • the degree and degree of bending of the curved structure can be set according to actual needs.
  • the profiled rod is a curved rod, a straight rod provided with an arc portion, a Z-shaped rod or an S-shaped rod.
  • the wave rod 113 of the support ring 100 is a straight rod.
  • a portion of the wave rod 113 of the support ring 100 can be provided with a curved structure in the middle.
  • the wave rod 113 of each of the support units 110 is integrated with the wave crest unit 111 and the trough unit 112 or has a connection structure.
  • All of the support rings 100 of the peripheral vascular stent can also be a unitary structure or a connecting structure.
  • the peripheral vascular stent is made of a laser-cut heat-setting material.
  • the heat setting material may be selected from the group consisting of stainless steel, ruthenium, cobalt-based alloy, platinum, nickel titanium alloy and titanium alloy, preferably nickel titanium alloy.
  • Each connecting component 120 includes at least two connecting rods 121. However, if too many connecting rods 121 are provided, the radial supporting force of the circumferential blood vessel stent is too strong, and the flexibility is weakened. Therefore, the number of connecting rods 121 is 2-6, preferably 2-3.
  • the connecting rod 121 There are various ways of fixing the connecting rod 121. As shown in FIGS. 1 to 2, for the adjacent three support rings 100a, 100b, and 100c disposed in the proximal to distal direction, the trough unit 112 of the support ring 100a and the corresponding wave rod 113 of the support ring 100b are provided. A connecting rod 121 is disposed between the middle portions, and a connecting rod 121 is disposed between the trough unit 112 of the supporting ring 100b and the middle portion of the corresponding rod 113 in the supporting ring 100c.
  • the support ring and the connecting rod of the circumferential vascular stent are arranged as above.
  • the two connecting rods 121 of each connecting component 120 may be arranged in parallel, or may be arranged in a figure eight shape or an inverted figure eight shape. Preferably, it is arranged in a figure-eight or an inverted figure-eight, and in the case where the number of the connecting rods 121 is the same, the arrangement can increase the radial supporting force.
  • the closed-loop connecting unit 130I formed between the connecting rod 121 of each connecting component 120 and the supporting unit 110 improves the axial joint strength and the radial supporting force of the peripheral blood vessel stent.
  • the connecting rod 121 of each connection component 120 of the adjacent two support rings 100 is connected at the proximal end.
  • the trough unit 112 of the support ring 100 and the pole 113 of the distal support ring 100 are such that the two connecting rods 121 are inclined, so that the two connecting rods 121 of each connecting component 120 form a figure-eight or inverted figure-eight arrangement.
  • the connecting rods 121 in each connecting assembly 120 are symmetrically arranged along the axis of symmetry of the parallel axes.
  • the connecting rod 121 and the supporting unit 110 are a unitary structure or a connecting structure.
  • the integral molding is formed by laser cutting and shaping of the tube, that is, the laser beam is cut into a hollow tube to form a specific waveform, and then heated and shaped to form a bracket.
  • the connecting members 120 between the adjacent two support rings 100 are arranged in a circle at equal intervals in the circumferential direction.
  • the arrangement of the connecting rods 121 in each of the connecting assemblies 120 is arranged in the same manner or repeatedly arranged in a regular manner.
  • the arrangement in the same manner means that the connecting rods 121 of each ring connecting assembly 120 are arranged in the circumferential direction in the same manner, for example, in a figure-eight or inverted figure-eight arrangement.
  • the two connecting rods 121 of each connecting component 120 are arranged in a figure-eight shape.
  • the regular repeating arrangement means that each ring connecting component 120 is repeatedly arranged along the circumferential direction according to a certain rule.
  • the two connecting rods 121 of the adjacent connecting component 120 are alternately arranged in eight characters and inverted eight characters; or two adjacent connecting components.
  • the connecting rods 121 of 120 are alternately arranged with different distances.
  • the projections of the connecting members 120 between the two axially adjacent turns do not overlap or partially overlap the projections on the plane of the vertical axis.
  • the axially adjacent connecting members 120 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, so that the peripheral blood vessel supports are compliant.
  • the sex is better and can be adapted to the complex vascular structure, so that the connecting component 120 can withstand greater local tension and pressure, and the peripheral vascular stent can be deformed evenly when being stretched or bent.
  • the connecting rod 121 is a straight rod, a shaped rod with a curved structure or an arc structure, or a combination thereof.
  • the connecting rod 121 is preferably a curved connecting rod 121 which may have a length of from 0.3 mm to 12 mm, preferably from 0.5 mm to 5 mm.
  • the curved structure refers to a structure in which the connecting rod 121 protrudes to both sides.
  • the curved structure may be disposed at any position of the connecting rod 121, preferably at the center of the connecting rod 121.
  • the degree and degree of bending of the curved structure can be set according to actual needs.
  • each connecting rod 121 of each connecting component 120 are arranged in a symmetrical manner, and each connecting rod 121 has an angle of 20 to 160 degrees with respect to the horizontal direction, preferably 30 to 150 degrees.
  • the proximal ends of the two connecting rods 121 are respectively connected to two adjacent trough units 112 on the support ring 100, wherein the distal end of one connecting rod 121 and the left side of the corresponding trough unit 112 on the axially adjacent supporting ring 100
  • the middle of the connecting rod 113 is connected, and the distal end of the other connecting rod 121 is connected with the central portion of the rod 113 on the right side of the corresponding trough unit 112 on the axially adjacent supporting ring 100, thereby forming the closed-loop connecting unit 130I, which is improved.
  • the axial connection strength and radial support force of the peripheral vascular stent are respectively connected to two adjacent trough units 112 on the support ring 100, wherein the distal end of one connecting rod 121 and the left
  • the peripheral blood vessel stent of the second embodiment of the present invention has a substantially tubular structure, and includes a plurality of axially arranged corrugated support rings 100 and circumferentially spaced apart from the adjacent two support rings 100. At least one connection component 120 between.
  • the structure of the support ring 100 is the same as that of the support ring 100 of the first embodiment, and will not be described again.
  • the peripheral vascular stent of the second embodiment is different from the peripheral vascular stent of the first embodiment in that the two connecting rods 121 of each connecting component 120 are arranged in an inverted eight-word symmetry.
  • the distal ends of the two connecting rods 121 are respectively connected to two adjacent crest units 111 on the support ring 100, and the proximal end of one connecting rod 121 and the rod on the left side of the corresponding supporting crest unit 111 on the axially adjacent supporting ring 100
  • the middle portion of 113 is connected, and the proximal end of the other connecting rod 121 is connected with the middle portion of the rod 113 on the right side of the corresponding peak unit 111 on the axially adjacent support ring 100, forming a closed loop connecting unit 130M, and the peripheral blood vessel bracket is improved.
  • Axial connection strength and radial support force are respectively connected to two adjacent crest units 111 on the support ring 100, and the proximal end of one connecting rod 121 and the rod on the left side of the corresponding supporting crest unit 111 on the axially adjacent supporting ring 100
  • the middle portion of 113 is connected, and the proximal end of the other connecting rod 121 is connected with the middle portion of the rod
  • the peripheral vascular stent of the third embodiment of the present invention has a tubular structure, and includes a plurality of axially arranged corrugated support rings 100 and at least one circumferentially spaced between adjacent support rings 100. Connection component 120.
  • the structure of the support ring 100 is the same as that of the support ring 100 of the first embodiment, except that, as shown in FIG. 6 and FIG. 7, the peripheral blood vessel stent of the third embodiment is provided with two kinds of closed-loop connecting units 130H and 130N, and the axial direction is alternated.
  • the projections are disposed between the adjacent two support rings 100, and the projections on the plane of the vertical axis do not overlap.
  • the two connecting rods 121 of the closed-loop connecting unit 130H are arranged in a symmetrical manner, and the proximal ends of the two connecting rods 121 are respectively connected to the adjacent two peak units 111, and the distal end of one connecting rod 121 is
  • the axially adjacent support ring 100 is connected to the middle of the wave rod 113 on the left side of the corresponding trough unit 112, and the distal end of the other connecting rod 121 and the right side of the corresponding trough unit 112 on the axially adjacent support ring 100 The middle of 113 is connected.
  • the two connecting rods 121 of the closed-loop connecting unit 130N are arranged in an inverted eight-word symmetry.
  • the proximal end of one connecting rod 121 and the adjacent rod on the left side of the corresponding supporting peak unit 111 on the axially adjacent supporting ring 100 are 113.
  • the middle end of the connecting rod 121 is connected to the middle of the rod 113 on the right side of the corresponding peak unit 111 on the axially adjacent support ring 100, and the proximal ends of the two connecting rods 121 are respectively adjacent to the adjacent ones.
  • Two crest units 111 are connected.
  • a three-connection assembly 120 is preferably disposed between two adjacent support rings 100.
  • the wave rod 113 of the distal support ring 100 is arranged as a straight rod; the local portion of the wave rod 113 of the proximal support ring 100 is set as a Z-shaped rod, Z-shaped
  • the rod is preferably disposed in the middle of the pole 113.
  • the peripheral vascular stent of the fourth embodiment of the present invention has a substantially tubular structure, and includes a plurality of axially arranged corrugated support rings 100 and circumferentially spaced between adjacent support rings 100. At least one connection component 120.
  • the structure of the support ring 100 is the same as that of the first embodiment, except that, as shown in FIG. 9 to FIG. 10, the peripheral blood vessel stent of the fourth embodiment is provided with two kinds of closed-loop connecting units 130D and 130K, and the axial directions are alternately arranged adjacent to each other. Between the two support rings 100.
  • the two connecting rods 121 of the closed-loop connecting unit 130D are arranged symmetrically in an inverted figure-eight shape, and the proximal ends of the two connecting rods 121 are respectively connected with two adjacent trough units 112 on the supporting ring 100, and a connecting rod 121
  • the distal end of the rod is connected to the middle of the rod 113 on the right side of the corresponding trough unit 112 on the axially adjacent support ring 100, and the distal end of the other connecting rod 121 and the left side of the corresponding trough unit 112 on the axially adjacent support ring 100
  • the middle portion of the side beam 113 is connected.
  • the two connecting rods 121 of the closed-loop connecting unit 130K are arranged symmetrically in eight characters, and the distal ends of the two connecting rods 121 are respectively connected with two adjacent crest units 111 on the supporting ring 100, and one connecting rod 121
  • the proximal end of the connecting rod is connected to the central portion of the rod 113 on the right side of the corresponding peak unit 111 on the axially adjacent support ring 100, and the distal end of the other connecting rod 122 is adjacent to the left side of the corresponding peak unit 111 on the axially adjacent support ring 100.
  • the middle portion of the side beam 113 is connected.
  • the closed-loop connecting units 130D and 130K are alternately disposed between the adjacent two supporting rings 100, which further improves the axial connection strength and the radial supporting force of the peripheral blood vessel stent, and ensures the overall flexibility of the peripheral blood vessel stent.
  • the peripheral vascular stent of the fifth embodiment of the present invention has a substantially tubular structure, and includes a plurality of axially arranged corrugated support rings 100 and circumferentially spaced apart from adjacent support rings 100. At least one connection component 120 between.
  • the structure of the support ring 100 is the same as that of the first embodiment. The difference is that the proximal ends of the two connecting rods 121 of each connecting component 120 are respectively connected with the two trough units 112 of the supporting ring 100 which are separated by a trough unit 112, and the distal end of one connecting rod 121 is adjacent to the axial direction.
  • the ring 100 is connected to the middle of the rod 113 on the left side of the corresponding trough unit 112, and the distal end of the other connecting rod 121 is connected to the middle of the rod 113 on the right side of the corresponding trough unit 112 on the axially adjacent support ring 100,
  • Forming a closed loop connecting unit 130T improves the axial joint strength and the radial supporting force of the peripheral blood vessel stent.
  • the peripheral vascular stent of the sixth embodiment of the present invention has a substantially tubular structure, and includes a plurality of axially arranged corrugated support rings 100 and at least circumferentially spaced between adjacent support rings 100. a connection component 120
  • the structure of the support ring 100 is the same as that of the first embodiment, except that, as shown in FIG. 14 and FIG. 15, the peripheral blood vessel stent of the sixth embodiment is provided with two kinds of closed-loop connecting units 130P and 130X, and the axial directions are alternately arranged adjacent to each other. Between the two support rings 100.
  • the two connecting rods 121 of the closed-loop connecting unit 130P are arranged in an inverted eight-word symmetry, and the proximal ends of the two connecting rods 121 are respectively connected with two trough units 112 of the supporting ring 100 which are separated by a trough unit 112, one The distal end of the connecting rod 121 is connected to the central portion of the rod 113 on the right side of the corresponding trough unit 112 on the axially adjacent support ring 100, and the distal end of the other connecting rod 121 and the corresponding trough unit on the axially adjacent support ring 100 The middle portion of the wave rod 113 on the left side of 112 is connected.
  • the two connecting rods 121 of the closed-loop connecting unit 13X are arranged in a symmetrical manner, and the distal ends of the two connecting rods 121 are respectively connected to the two crest units 111 of the supporting ring 100 which are separated by a crest unit 111, one
  • the proximal end of the connecting rod 121 is connected to the middle portion of the wave rod 113 on the right side of the corresponding peak unit 111 on the axially adjacent support ring 100, and the proximal end of the other connecting rod 121 and the corresponding peak unit on the axially adjacent support ring 100
  • the middle portion of the wave rod 113 on the left side of 111 is connected.
  • the closed-loop connecting units 130P and 130X are alternately arranged between the adjacent two supporting rings 100, which further improves the axial connection strength and the radial supporting force of the peripheral blood vessel stent, and ensures the overall flexibility of the peripheral blood vessel stent.
  • the S-shaped rod is partially disposed on the wave rod 113, and the connecting rod 121 is a curved rod.
  • the peripheral vascular stent of the seventh embodiment of the present invention has a substantially tubular structure, and includes a plurality of axially arranged corrugated support rings 100 and at least circumferentially spaced between adjacent support rings 100.
  • a connection assembly 120 is shown in FIG. 16, the peripheral vascular stent of the seventh embodiment of the present invention.
  • the structure of the support ring 100 is the same as that of the first embodiment, except that, as shown in FIG. 17 and FIG. 18, the peripheral blood vessel stent of the seventh embodiment is provided with two kinds of closed-loop connecting units 130U and 130V, and the axial directions are alternately arranged adjacent to each other. Between the two support rings 100, the projections of the two closed-loop connecting units 130U and 130V on the plane of the vertical axis only partially overlap.
  • the two connecting rods 121 of the closed-loop connecting unit 130U are arranged symmetrically in eight characters, and the proximal ends of the two connecting rods 121 are respectively spaced apart from the axially adjacent supporting rings 100 by two trough units of three crest units 111. 112 is connected, the distal end of one connecting rod 121 is connected to the middle of the rod 113 on the left side of the corresponding trough unit 112 on the axially adjacent support ring 100, and the distal end of the other connecting rod 121 is adjacent to the axially adjacent support ring 100.
  • the upper portion of the right side of the wave bar 113 corresponding to the trough unit 112 is connected.
  • the two connecting rods of the closed-loop connecting unit 130V are arranged in an inverted eight-word symmetry, and the distal ends of the two connecting rods 121 are respectively connected with two peak units 111 of the supporting ring 100 which are separated by three trough units 112, one connection
  • the proximal end of the rod 121 is connected to the middle portion of the rod 113 on the left side of the corresponding peak unit 111 on the axially adjacent support ring 100, and the proximal end of the other connecting rod 121 and the corresponding peak unit 111 on the adjacent support ring 100 in the axial direction
  • the middle of the wave rod 113 on the right side is connected.
  • the closed-loop connecting units 130U and 130V are axially spaced apart, and the closed-loop connecting units 130U and 130V share the intermediate wave rod 113, which further improves the axial connection strength and the radial supporting force of the peripheral blood vessel stent, and ensures the overall peripheral blood vessel stent. Flexibility.
  • the peripheral vascular stent of the eighth embodiment of the present invention has a substantially tubular structure, and includes a plurality of axially arranged corrugated support rings 100 and at least circumferentially spaced between adjacent support rings 100.
  • a connection assembly 120 is shown in FIG. 19, the peripheral vascular stent of the eighth embodiment of the present invention.
  • the structure of the support ring 100 is the same as that of the first embodiment, except that, as shown in FIG. 20 and FIG. 21, the peripheral blood vessel stent of the eighth embodiment is provided with two kinds of closed-loop connecting units 130W and 130Z, and the axial directions are alternately arranged adjacent to each other. Between the two support rings 100.
  • the two connecting rods 121 of the closed-loop connecting unit 130W are arranged in an inverted eight-word symmetry.
  • the proximal ends of the two connecting rods 121 are respectively spaced apart from the axially adjacent supporting rings 100 by two of the three peak units 111.
  • the trough units 112 are connected, and the distal end of one connecting rod 121 is connected to the middle portion of the rod 113 on the right side of the corresponding trough unit 112 on the axially adjacent support ring 100, and the distal end of the other connecting rod 121 is adjacent to the axial direction.
  • the ring 100 is connected to the middle of the wave rod 113 on the left side of the corresponding trough unit 112.
  • the two connecting rods 121 of the closed-loop connecting unit 130Z are arranged in a symmetrical manner, and the distal ends of the two connecting rods 121 are respectively connected to the two crest units 111 of the supporting ring 100 which are separated by three trough units 112.
  • the proximal end of one connecting rod 121 is connected to the middle portion of the wave rod 113 on the right side of the corresponding peak unit 111 on the axially adjacent support ring 100, and the corresponding peak of the other end of the connecting rod 121 and the axially adjacent support ring 100
  • the middle portion of the wave rod 113 on the left side of the unit 111 is connected.
  • the closed-loop connecting units 130W and 130Z are axially spaced apart, and the closed-loop connecting units 130W and 130Z share the intermediate wave rod 113, which further improves the axial connection strength and the radial supporting force of the peripheral blood vessel stent, and ensures the overall peripheral blood vessel stent. Flexibility.

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Abstract

一种外周血管支架，外周血管支架为管状结构，包括若干沿轴向排列的呈波状的支撑环（100）及沿周向相间隔地设置在相邻的两支撑环（100）之间的至少一连接组件（120）；支撑环（100）由若干支撑单元（110）沿周向首尾相接组成；每一支撑单元（110）包括波峰单元（111）、波谷单元（112）、连接在波峰单元（111）和波谷单元（112）之间的波杆（113）；每一连接组件（120）包括至少两个周向排列的连接杆（121）；每一连接杆（121）的一端固定在一个支撑环（100）的波峰单元（111）或波谷单元（112），每一连接杆（121）的另一端固定在相邻支撑环（100）的波杆（113）。外周血管支架既能保证轴向连接强度和径向支撑力，又能保证整体的柔顺性。

Description

外周血管支架 技术领域
本发明涉及一种医疗器械，尤其涉及一种，可用于治疗外周血管疾病的外周血管支架。
背景技术
外周血管疾病是全身动脉粥样硬化的一种常见表现，可诱发全身动脉硬化和心血管发病率和死亡率。外周血管发生病变后，血管腔变狭窄，注入下肢的血流量变小，引起下肢供血不足，造成肢体坏死等现象。静脉疾病主要包括静脉狭窄、静脉血栓和静脉返流等多种类型的疾病。特别是静脉易受动脉压迫导致管腔狭窄，例如左髂总静脉因右髂总动脉与第五腰椎共同压迫，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，从而引起髂静脉的管腔狭窄、闭塞而导致左下肢静脉回流障碍，造成髂静脉压迫综合症。此综合征双侧均可发生，但以左侧多见。髂静脉压迫综合症在成人的发病率非常高，达到20％～34％，由于女性的腰骶部生理弯曲较男性更为明显，23～45.5岁女性占大多数(70％～84％)。研究表明，髂静脉疾病，不仅发病率高，而且是继发下肢静脉曲张、深静脉瓣膜关闭不全和深静脉血栓形成的主要原因。
治疗外周血管疾病主要方法包括内科治疗和手术治疗。其中内科治疗是通过降压、降脂、抗血小板聚集等方法延缓下肢静脉硬化闭塞的病程进展，但不能从根本上消除血管的狭窄、闭塞等器质性病变。手术治疗分为开放手术和血管腔内介入方法。血管腔内介入方法具有微创、操作简单、疗效确切、可重复操作的优点，是诊治血管性疾病的发展方向。
目前血管腔内介入方法采用的介入治疗器械主要为球囊扩张支架和自扩张支架。自扩张支架是目前在外周血管介入治疗中应用较多的支架，自扩张支架包括开环自扩张支架和闭环自扩张支架。
开环自扩张支架的单元环与单元环之间通过若干个连接杆连接而成。连接杆的方式有三种：波峰对波峰连接用的非弯曲连接杆、波峰对波峰连接用的弯曲连接杆及波峰对波谷连接用的非弯曲连接杆。开环自扩张支架的优点在于具有极好的柔顺性与贴壁性能，而缺点在于径向支撑力稍弱以及开窗面积较大。
闭环自扩张支架的每个单元环与单元环之间都通过连接杆连接而成。闭环自扩张支架的优点在于径向支撑力较强以及开窗面积较小，而其缺点在于柔顺性差、以及贴壁性能不佳。
目前市场的外周开环自扩张动静脉支架在扩张后易弯曲及顺应性好。但缺点是因金属覆盖率小及径向支撑力相对较小，易产生组织脱垂而造成再狭窄，另外因轴向连接强度欠佳，支架波形容易被拉伸造成血管损伤。而市场现有的外周闭环自扩张动静脉支架则是重复单元环，金属覆盖率较大，且具有较大的径向支撑力，可均匀覆盖在血管壁上，防止斑块脱落，但这种设计柔顺性相对较差，不能适应弯曲及复杂病变的血管。由于在血管支架的手术过程中，需要对血管支架进行压缩、输送和扩张，所以血管支架必须具有良好的可压缩性、输送柔顺性和扩张均匀性，这对血管支架的材料和结构设计提出了非常高的要求，但现有支架尚不能很好的实现这些技术性能。
发明内容
本发明要解决的技术问题在于，提供一种既能保持轴向连接强度和径向支撑力并能保证整体的柔顺性的外周血管支架。
一种外周血管支架，为管状结构，其特征在于，包括若干沿轴向排列的呈波状的支撑环及沿周向间隔设置在相邻两支撑环之间的至少一连接组件；所述支撑环由支撑单元首尾相接组成；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两个周向排列的连接杆；每一连接杆的一端固定在一个支撑环的波峰单元和/或波谷单元，每一连接杆的另一端固定在相邻支撑环的波杆。
进一步地，每一连接组件的两连接杆呈八字形或倒八字形排列。
进一步地，每一连接杆的一端固定在一个支撑环的波峰单元/或波谷单元上，每一连接杆的另一端固定在相邻的支撑环的波杆的中部。
进一步地，所述连接组件沿周向均匀且相间隔地设置在相邻两支撑环之间，且每一连接组件中的连接杆以相同的方式排布或规律重复排布。
进一步地，相邻三支撑环之间设置的连接组件，在垂直轴向的平面上的投影不重叠或部分重叠。
进一步地，相邻支撑环之间的连接组件，在垂直轴向的平面上的投影不重叠或部分重叠。
进一步地，这些支撑环之间的连接组件在轴向上呈螺旋形排布或交错排布。
进一步地，所述支撑单元的波杆为直杆、带有弯曲结构或弧形结构的异形杆，所述波杆与波峰单元和波谷单元为一体结构或连接结构。
进一步地，所述连接杆为直杆、带有弯曲结构或弧形结构的异形杆、或是它们的组合。
进一步地，所述异形杆为弧形杆、设有弧形部的直杆、Z形杆或S形杆。
进一步地，所述连接杆与支撑单元之间为一体结构或连接结构。
进一步地，外周血管支架为等径延伸的管状结构或非等径延伸的管状结构。
进一步地，相邻两支撑环之间的每一连接组件与对应的支撑单元形成闭环连接单元。
进一步地，每一闭环连接单元的两个连接杆的一端分别与支撑环上两个相邻的波谷单元连接，其中一个连接杆的另一端与轴向相邻支撑环上对应波谷单元的一侧的波杆的中部连接，另一个连接杆的另一端与轴向相邻支撑环上对应波谷单元的另一侧的波杆的中部连接。
进一步地，每一闭环连接单元的两个连接杆的一端分别与支撑环上间隔有至少一个波谷单元的两波谷单元连接，一个连接杆的另一端与轴向相邻支撑环上对应波谷单元的一侧的波杆的中部连接，另一个连接杆的另一端与轴向相邻 支撑环上对应波谷单元的一侧的波杆的中部连接。
进一步地，所述闭环连接单元共用中间的波杆。
进一步地，所述外周血管支架设有两种闭环连接单元，沿轴向交替设置在相邻的两支撑环之间。
进一步地，所述两种闭环连接单元在垂直轴向的平面上的投影不重叠或者部分重叠。
本发明外周血管支架通过连接组件实现支撑环之间的连接，每一连接组件中的连接杆周向排列，协同提供一定的径向支撑力；并且连接杆与支撑单元之间形成闭环连接单元，改进了外周血管支架的轴向连接强度；轴向相邻的连接组件沿轴向呈螺旋形排布或交错排布，轴向相邻的闭环连接单元在垂直轴向的平面上的投影不重叠或者仅部分重叠，可提供足够的径向支撑力；沿周向间隔设置的连接组件使得轴向支撑力不会过大；支撑环中没有与连接杆连接的支撑单元的弯曲自由度较大，保证了外周血管支架的柔顺性，使得外周血管支架在弯曲或伸缩时均能提供良好的支撑。
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1为本发明实施例一的外周血管支架的展开图。
图2为图1的I处的局部放大图。
图3为本发明实施例二的外周血管支架的展开图。
图4为图3的M处的局部放大图。
图5为本发明实施例三的外周血管支架的展开图。
图6至图7分别为图5的H处及N处的局部放大图。
图8为本发明实施例四的外周血管支架的展开图。
图9至图10分别为图4的D处及K处的局部放大图。
图11为本发明实施例五的外周血管支架的展开图。
图12为图11的T处的局部放大图。
图13为本发明实施例六的外周血管支架的展开图。
图14至图15分别为图13的P处及X处的局部放大图。
图16为本发明实施例七的外周血管支架的展开图。
图17至图18分别为图16的U处及V处的局部放大图。
图19为本发明实施例八的外周血管支架的展开图。
图20至图21分别为图19的W处及Z处的局部放大图。
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。
方位定义：本发明中，外周血管支架植入血管后，近端为靠近心脏的一端，如图1、3、5、8、11、13、16、19中字母J表示的一端；远端为远离心脏的一端，如图1、3、5、8、11、13、16、19中字母Y表示的一端；轴向指外周血管支架的中轴线方向，与中轴线垂直的方向为径向，周向为环绕外周血管支架的中轴线的圆周方向。
实施例一
如图1至图2所示，一种外周血管支架，为管状结构，包括若干沿轴向排列的呈波状的支撑环100及沿周向间隔设置在相邻两支撑环100之间的至少一连接组件120。支撑环100的排布方式可以有多种。为了适应不同血管的特殊需求，本发明提供的外周血管支架的支撑环100沿轴向排布形成等径延伸的管状结构外，还可以排布形成非等径延伸的管状结构。例如，支撑环100的直径沿轴向依次增大或减小，形成锥管状的外周血管支架。或者支撑环100的直径沿轴向在不同位置不相同，形成各种非等径延伸的管状结构，例如，外周血管支架为锥管状与直管状组成的变径结构。可根据实际需要设定支撑环100的数量，优选所述支撑环100的数量为8-50个。
每一支撑环100由若干支撑单元110首尾相接组成；每一支撑单元110包括波峰单元111、波谷单元112、连接在波峰单元111和波谷单元112之间的波杆113。每一连接组件120包括至少两个沿周向排列的连接杆121。即相邻两支撑环100之间，其中一支撑环100的部分支撑单元110通过连接组件120与相邻支撑环100的支撑单元110连接；其他支撑单元110与相邻支撑环100对应的支撑单元110之间无连接，二者可以相对活动。连接支撑环100的连接组件120中的连接杆121沿周向排列，协同提供一定的径向支撑力。每一连接组件120的连接杆121与对应支撑单元110之间形成闭环连接单元130I。闭环连接单元130I可改进外周血管支架的轴向连接强度。连接杆121的一端连接波峰单元111或波谷单元112，连接杆121的另一端连接波杆113。相较现有技术的连接杆的两端连接在波峰单元和波谷单元，降低了支撑环100的轴向连接强度，增加了支撑环100之间的柔顺性。这样的结构，使得外周血管支架具有一定的径向支撑力；由于沿周向间隔设置连接组件120使得径向支撑力不会过大，且没有与连接杆121连接的支撑单元110的弯曲自由度较大，保证了外周血管支架的柔顺性。每一连接组件120中的连接杆121的数量根据实际需要的径向支撑力和柔顺性决定。同样，也可根据实际需要的径向支撑力和柔顺性，调整连接组件120之间的间隔以及连接组件120的数量。
如图1所示，每一支撑环100由多个沿周向分布的支撑单元110首尾相接形成正弦波形。每一支撑单元110包括波峰单元111、波谷单元112、连接在波峰单元111和波谷单元112之间的波杆113。波峰单元111和波谷单元112优选为圆弧形结构，相邻两个波杆113之间的夹角α为10-45°，相邻波杆113近端(靠近J端)相连处为波峰单元111，相邻两个波杆113远端(靠近Y端)相连处为波谷单元112。轴向相邻的两支撑环100的波谷单元112正对波谷单元112，波峰单元111正对波峰单元111。支撑环100中的波杆113数量是根据实际需要设定的，优选每一支撑环100沿周向的波杆113数量为14-30根。
外周血管支架中，所述支撑环100可以具有大致相同的波形，即具有相同 波长及相同振幅的波形，也可以根据需要来设置外周血管支架的支撑环100的波形。波长可根据外周血管支架的外径的不同而不同，但优选波长为0.5mm-8.0mm，特别优选2.0mm-4.0mm；振幅优选为0.1mm-10.0mm，特别优选为0.3mm-3.0mm。
展开成平面时，所述支撑单元110的波杆113为直杆、带有弯曲结构或弧形结构的异形杆、或是它们的组合。异形杆是指波杆113为非直杆，弯曲结构是设置在直杆或异形杆上向两侧突出的结构。弯曲结构设置在波杆113上能加强波杆113的弯曲或伸展性能。弯曲结构可以是波杆113向两侧突出的结构。弯曲结构可以设置在波杆113的任意位置，优选设置在波杆113中部。弯曲结构的弯曲程度和数量可以根据实际需要进行设置。优选所述异形杆为弧形杆、设有弧形部的直杆、Z形杆或S形杆。本实施例中，支撑环100的波杆113为直杆。在其他实施方式中，支撑环100的部分波杆113可于中部设置弯曲结构。
每一支撑单元110的波杆113与波峰单元111和波谷单元112为一体结构或连接结构。外周血管支架的所有支撑环100也可以是一体结构或连接结构。外周血管支架是通过激光切割热定型材料制成。，所述热定型材料可选用不锈钢、钽、钴基合金、铂、镍钛合金及钛合金，优选为镍钛合金。
每一连接组件120至少包括两连接杆121。但是设置过多的连接杆121，又使得周向血管支架的径向支撑力过强，柔顺性减弱，因此，连接杆121数量为2-6个，优选2-3个。
连接杆121的固定方式有多种。如图1至图2所示，对于沿近端至远端方向设置的相邻的三个支撑环100a、100b及100c，支撑环100a的波谷单元112与支撑环100b中对应的波杆113的中部之间设有连接杆121，支撑环100b的波谷单元112与支撑环100c中对应的波杆113的中部之间设有连接杆121。周向血管支架的支撑环及连接杆依如上规律进行设置。每一连接组件120的两连接杆121可以是平行设置，也可以是呈八字形或倒八字形设置。优选呈八字形或倒八字形排列，在连接杆121的数量相同的情况下，这种排列方式可以提 高径向支撑力。每一连接组件120的连接杆121与支撑单元110之间形成的闭环连接单元130I，改进了外周血管支架的轴向连接强度和径向支撑力。本实施例中，由于支撑环100的波峰单元111与相邻支撑环100的波峰单元111在轴向上对应，即相邻两支撑环100的每一连接组件120的连接杆121连接在近端支撑环100的波谷单元112与远端支撑环100的波杆113上，使得两连接杆121倾斜，这样每一连接组件120的两个连接杆121就形成八字形或倒八字形排列。并且每一连接组件120中的连接杆121是沿平行轴线的对称轴对称设置。所述连接杆121与支撑单元110之间为一体结构或连接结构。其中，一体成型是采用管材激光切割定型而成，即通过激光切割中空管材形成特定的波形，再进行加热定型制作成支架。
相邻两支撑环100之间的连接组件120沿周向等间距排布一圈。每一连接组件120中的连接杆121的排布方式以相同方式排布或规律重复排布。相同方式排布是指每圈连接组件120的连接杆121以相同方式沿周向排布，例如呈八字形或倒八字形排布。本实施例中，每一连接组件120的两个连接杆121呈八字形排布。规律重复排布指的是每圈连接组件120沿周向按照一定规律进行重复排布，例如：相邻连接组件120的两连接杆121呈八字和倒八字交替排布；或者相邻两连接组件120的连接杆121间隔距离不同而交替排布。
轴向相邻两圈之间的连接组件120，在垂直轴向的平面上的投影不重叠或部分重叠。轴向相邻的连接组件120沿轴向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，使得外周血管支架的柔顺性比较好，可以与复杂的血管结构适配，使连接组件120能承受更大的局部拉力和压力，并使外周血管支架在伸缩或弯曲时变形均匀。
所述连接杆121为直杆、带有弯曲结构或弧形结构的异形杆或是它们的组合。所述连接杆121优选为弯曲的连接杆121，其长度可为0.3mm-12mm，优选为0.5mm-5mm。弯曲结构是指连接杆121向两侧突出的结构。弯曲结构可 以设置在连接杆121的任意位置，优选设置在连接杆121中部。弯曲结构的弯曲程度和数量可以根据实际需要进行设定。
如图2所示，每一连接组件120中的两个连接杆121呈八字对称排布，每一连接杆121与水平方向的夹角为20°-160°，优选为30°-150°。所述两个连接杆121的近端分别与支撑环100上两个相邻的波谷单元112连接，其中一个连接杆121的远端与轴向相邻支撑环100上对应波谷单元112的左侧的波杆113的中部连接，另一个连接杆121的远端与轴向相邻支撑环100上对应波谷单元112的右侧的波杆113的中部连接，构成了所述闭环连接单元130I，改进了外周血管支架的轴向连接强度和径向支撑力。
实施例二
如图3及图4所示，本发明实施例二的外周血管支架大致为管状结构，包括若干沿轴向排列的呈波状的支撑环100和沿周向间隔设置在相邻两支撑环100之间的至少一连接组件120。支撑环100的结构与实施例一的支撑环100相同，不再赘述。实施例二的外周血管支架与实施例一的外周血管支架不同的是，每一连接组件120的两个连接杆121呈倒八字对称设置。两个连接杆121的远端分别与支撑环100上两个相邻的波峰单元111连接，一个连接杆121的近端与轴向相邻支撑环100上对应波峰单元111的左侧的波杆113的中部连接，另一个连接杆121的近端与轴向相邻支撑环100上对应波峰单元111的右侧的波杆113的中部连接，构成了一个闭环连接单元130M，改进了外周血管支架的轴向连接强度和径向支撑力。
实施例三
如图5所示，本发明实施例三的外周血管支架为管状结构，包括若干沿轴向排列的呈波状的支撑环100及沿周向间隔设置在相邻两支撑环100之间的至少一连接组件120。支撑环100的结构与实施例一的支撑环100相同，不同之处在于，如图6及图7所示，实施例三的外周血管支架设有两种闭环连接单元130H及130N，轴向交替设置在相邻的两支撑环100之间，且在垂直轴向的平 面上的投影不重叠。
如图6所示，闭环连接单元130H两个连接杆121呈八字对称排布，两个连接杆121的近端分别与相邻的两个波峰单元111相连，而一个连接杆121的远端与轴向相邻支撑环100上对应波谷单元112的左侧的波杆113的中部连接，另一个连接杆121的远端与轴向相邻支撑环100上对应波谷单元112的右侧的波杆113的中部连接。
如图7所示，闭环连接单元130N的两个连接杆121呈倒八字对称排布，一个连接杆121的近端与轴向相邻支撑环100上对应波峰单元111的左侧的波杆113的中部连接，另一个连接杆121的近端与轴向相邻支撑环100上对应波峰单元111的右侧的波杆113的中部连接，而两个连接杆121的近端分别与相邻的两个波峰单元111相连。本实施例中，相邻两支撑环100之间优选设置三连接组件120。
在本实施例中，对于相邻的两支撑环100，远端的支撑环100的波杆113设置为直杆；近端的支撑环100的波杆113的局部设置为Z形杆，Z形杆优选设置在波杆113的中部。
实施例四
如图8所示，本发明实施例四的外周血管支架大致为管状结构，包括若干沿轴向排列的呈波状的支撑环100及及沿周向间隔设置在相邻两支撑环100之间的至少一连接组件120。
支撑环100的结构与实施例一相同，不同之处在于，如图9至图10所示，实施例四的外周血管支架设有两种闭环连接单元130D及130K，轴向交替设置在相邻的两支撑环100之间。
如图9所示，闭环连接单元130D的两连接杆121呈倒八字形对称排布，两连接杆121的近端分别与支撑环100上两个相邻的波谷单元112连接，一连接杆121的远端与轴向相邻支撑环100上对应波谷单元112的右侧的波杆113的中部连接，另一个连接杆121的远端与轴向相邻支撑环100上对应波谷单元 112的左侧的波杆113的中部连接。
如图10所示，闭环连接单元130K的两个连接杆121呈八字对称排布，两个连接杆121的远端分别与支撑环100上两个相邻的波峰单元111连接，一个连接杆121的近端与轴向相邻支撑环100上对应波峰单元111的右侧的波杆113的中部连接，另一个连接杆122的远端与轴向相邻支撑环100上对应波峰单元111的左侧的波杆113的中部连接。
闭环连接单元130D与130K交错设置在相邻的两支撑环100之间，进一步提高了外周血管支架的轴向连接强度和径向支撑力，并保证了外周血管支架整体的柔顺性。
实施例五
如图11及图12所示，本发明实施例五的外周血管支架大致为管状结构，包括若干沿轴向排列的呈波状的支撑环100和及沿周向间隔设置在相邻两支撑环100之间的至少一连接组件120。支撑环100的结构与实施例一相同。不同之处在于，每一连接组件120的两连接杆121的近端分别与支撑环100上间隔有一个波谷单元112的两波谷单元112连接，一个连接杆121的远端与轴向相邻支撑环100上对应波谷单元112的左侧的波杆113的中部连接，另一个连接杆121的远端与轴向相邻支撑环100上对应波谷单元112的右侧的波杆113的中部连接，形成一闭环连接单元130T，改进了外周血管支架的轴向连接强度和径向支撑力。
实施例六
如图13所示，本发明实施例六的外周血管支架大致为管状结构，包括若干沿轴向排列的呈波状的支撑环100和沿周向间隔设置在相邻两支撑环100之间的至少一连接组件120
支撑环100的结构与实施例一相同，不同之处在于，如图14及图15所示，实施例六的外周血管支架设有两种闭环连接单元130P及130X，轴向交替设置在相邻的两支撑环100之间。
如图14所示，闭环连接单元130P的两连接杆121呈倒八字对称排布，两个连接杆121的近端分别与支撑环100上间隔有一个波谷单元112的两波谷单元112连接，一个连接杆121的远端与轴向相邻支撑环100上对应波谷单元112的右侧的波杆113的中部连接，另一个连接杆121的远端与轴向相邻支撑环100上对应波谷单元112的左侧的波杆113的中部连接。
如图15所示，闭环连接单元13X的两个连接杆121呈八字对称排布，两个连接杆121的远端分别与支撑环100上间隔有一个波峰单元111的两波峰单元111连接，一个连接杆121的近端与轴向相邻支撑环100上对应波峰单元111的右侧的波杆113的中部连接，另一个连接杆121的近端与轴向相邻支撑环100上对应波峰单元111的左侧的波杆113的中部连接。
闭环连接单元130P及130X交错间隔设置在相邻两支撑环100之间，进一步提高了外周血管支架的轴向连接强度和径向支撑力，并保证了外周血管支架整体的柔顺性。
其中波杆113的局部设置S形杆，连接杆121为弧形杆。
实施例七
如图16所示，本发明实施例七的外周血管支架大致为管状结构，包括若干沿轴向排列的呈波状的支撑环100及沿周向间隔设置在相邻两支撑环100之间的至少一连接组件120。
支撑环100的结构与实施例一相同，不同之处在于，如图17及图18所示，实施例七的外周血管支架设有两种闭环连接单元130U及130V，轴向交替设置在相邻的两支撑环100之间，两种闭环连接单元130U及130V在垂直轴向的平面上的投影仅部分重叠。
如图17所示，闭环连接单元130U的两个连接杆121呈八字对称排布，两个连接杆121的近端分别与轴向相邻支撑环100的间隔有三个波峰单元111的两波谷单元112连接，一个连接杆121的远端与轴向相邻支撑环100上对应波谷单元112的左侧的波杆113的中部连接，另一个连接杆121的远端与轴向 相邻支撑环100上对应波谷单元112的右侧波杆113的中部连接。
如图18所示，闭环连接单元130V的两连接杆呈倒八字对称排布，两个连接杆121的远端分别与支撑环100上间隔有三个波谷单元112的两波峰单元111连接，一个连接杆121的近端与轴向相邻支撑环100上对应波峰单元111的左侧的波杆113的中部连接，另一个连接杆121的近端与轴向相邻支撑环100上对应波峰单元111的右侧的波杆113的中部连接。
闭环连接单元130U及130V轴向间隔排布，闭环连接单元130U及130V共用中间的波杆113，进一步提高了外周血管支架的轴向连接强度和径向支撑力，并保证了外周血管支架整体的柔顺性。
实施例八
如图19所示，本发明实施例八的外周血管支架大致为管状结构，包括若干沿轴向排列的呈波状的支撑环100及沿周向间隔设置在相邻两支撑环100之间的至少一连接组件120。
支撑环100的结构与实施例一相同，不同之处在于，如图20及图21所示，实施例八的外周血管支架设有两种闭环连接单元130W及130Z，轴向交替设置在相邻的两支撑环100之间。
如图20所示，闭环连接单元130W的两个连接杆121呈倒八字对称排布，两个连接杆121的近端分别与轴向相邻支撑环100的间隔有三个波峰单元111的两个波谷单元112连接，一个连接杆121的远端与轴向相邻支撑环100上对应波谷单元112的右侧的波杆113的中部连接，另一个连接杆121的远端与轴向相邻支撑环100上对应波谷单元112的左侧的波杆113的中部连接。
如图21所示，闭环连接单元130Z的两个连接杆121呈八字对称排布，两个连接杆121的远端分别与支撑环100上间隔有三个波谷单元112的两个波峰单元111连接，一个连接杆121的近端与轴向相邻支撑环100上对应波峰单元111的右侧的波杆113的中部连接，另一个连接杆121的近端与轴向相邻支撑环100上对应波峰单元111的左侧的波杆113的中部连接。
闭环连接单元130W与130Z轴向间隔排布，闭环连接单元130W与130Z共用中间的波杆113，进一步提高了外周血管支架的轴向连接强度和径向支撑力，并保证了外周血管支架整体的柔顺性。
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. 一种外周血管支架，为管状结构，其特征在于，包括若干沿轴向排列的呈波状的支撑环及沿周向间隔设置在相邻两支撑环之间的至少一连接组件；所述支撑环由支撑单元首尾相接组成；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两个周向排列的连接杆；每一连接杆的一端固定在一个支撑环的波峰单元和/或波谷单元，每一连接杆的另一端固定在相邻支撑环的波杆。
  2. 根据权利要求1所述的外周血管支架，其特征在于，每一连接组件的两连接杆呈八字形或倒八字形排列。
  3. 根据权利要求2所述的外周血管支架，其特征在于，每一连接杆的一端固定在一个支撑环的波峰单元/或波谷单元上，每一连接杆的另一端固定在相邻的支撑环的波杆的中部。
  4. 根据权利要求1所述的外周血管支架，其特征在于，所述连接组件沿周向均匀且相间隔地设置在相邻两支撑环之间，且每一连接组件中的连接杆以相同的方式排布或规律重复排布。
  5. 根据权利要求1-4任意一项所述的外周血管支架，其特征在于，相邻三支撑环之间设置的连接组件，在垂直轴向的平面上的投影不重叠或部分重叠。
  6. 根据权利要求5所述的外周血管支架，其特征在于，相邻支撑环之间的连接组件，在垂直轴向的平面上的投影不重叠或部分重叠。
  7. 根据权利要求6所述的外周血管支架，其特征在于，这些支撑环之间的连接组件在轴向上呈螺旋形排布或交错排布。
  8. 根据权利要求1所述的外周血管支架，其特征在于，所述支撑单元的波杆为直杆、带有弯曲结构或弧形结构的异形杆，所述波杆与波峰单元和波谷单元为一体结构或连接结构。
  9. 根据权利要求1所述的外周血管支架，其特征在于，所述连接杆为直 杆、带有弯曲结构或弧形结构的异形杆、或是它们的组合。
  10. 根据权利要求8或9所述的外周血管支架，其特征在于，所述异形杆为弧形杆、设有弧形部的直杆、Z形杆或S形杆。
  11. 根据权利要求1所述的外周血管支架，其特征在于，所述连接杆与支撑单元之间为一体结构或连接结构。
  12. 根据权利要求1所述的外周血管支架，其特征在于，外周血管支架为等径延伸的管状结构或非等径延伸的管状结构。
  13. 根据权利要求1所述的外周血管支架，其特征在于，相邻两支撑环之间的每一连接组件与对应的支撑单元形成闭环连接单元。
  14. 根据权利要求13所述的外周血管支架，其特征在于，每一闭环连接单元的两个连接杆的一端分别与支撑环上两个相邻的波谷单元连接，其中一个连接杆的另一端与轴向相邻支撑环上对应波谷单元的一侧的波杆的中部连接，另一个连接杆的另一端与轴向相邻支撑环上对应波谷单元的另一侧的波杆的中部连接。
  15. 根据权利要求13所述的外周血管支架，其特征在于，每一闭环连接单元的两个连接杆的一端分别与支撑环上间隔有至少一个波谷单元的两波谷单元连接，一个连接杆的另一端与轴向相邻支撑环上对应波谷单元的一侧的波杆的中部连接，另一个连接杆的另一端与轴向相邻支撑环上对应波谷单元的一侧的波杆的中部连接。
  16. 根据权利要求15所述的外周血管支架，其特征在于，闭环连接单元共用中间的波杆。
  17. 根据权利要求13所述的外周血管支架，其特征在于，外周血管支架设有两种闭环连接单元，沿轴向交替设置在相邻的两支撑环之间。
  18. 根据权利要求17所述的外周血管支架，其特征在于，所述两种闭环连接单元在垂直轴向的平面上的投影不重叠或者部分重叠。
PCT/CN2018/115417 2017-11-17 2018-11-14 外周血管支架 WO2019096159A1 (zh)

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