WO2017012386A1 - 一种生物可降解金属血管支架及其应用 - Google Patents

一种生物可降解金属血管支架及其应用 Download PDF

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Publication number
WO2017012386A1
WO2017012386A1 PCT/CN2016/080642 CN2016080642W WO2017012386A1 WO 2017012386 A1 WO2017012386 A1 WO 2017012386A1 CN 2016080642 W CN2016080642 W CN 2016080642W WO 2017012386 A1 WO2017012386 A1 WO 2017012386A1
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Prior art keywords
blood vessel
vessel stent
biodegradable metal
main body
stent according
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PCT/CN2016/080642
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English (en)
French (fr)
Inventor
袁广银
陈晨忻
吴卫
弗朗切斯科米里亚瓦卡
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上海交通大学
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Priority to US15/554,206 priority Critical patent/US10463513B2/en
Publication of WO2017012386A1 publication Critical patent/WO2017012386A1/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
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    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • A—HUMAN NECESSITIES
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    • 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
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    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • A61F2002/91541—Adjacent bands are arranged out of phase
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
    • 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
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    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91583—Adjacent bands being connected to each other by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
    • A—HUMAN NECESSITIES
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    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0059—Additional features; Implant or prostheses properties not otherwise provided for temporary
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    • A61F2310/00041—Magnesium or Mg-based alloys

Definitions

  • the invention relates to a medical device for interventional treatment of vascular stenosis, in particular to a biodegradable metal blood vessel stent for treating peripheral blood vessels and coronary stenosis or occlusion.
  • vascular stents Peripheral intravascular or intracoronary stenting is currently one of the most effective methods for treating stenosis.
  • the development of vascular stents has mainly gone through the process from bare metal stents to drug-eluting stents to biodegradable stents.
  • the medically used vascular stent is mainly made of a medical metal material such as stainless steel or nickel-titanium alloy, and is sprayed with a drug-eluting stent coated with a polymer drug-loaded coating.
  • Drug-eluting stents can inhibit smooth muscle cell regeneration by releasing anti-proliferative drugs, thereby reducing the rate of restenosis of blood vessels, but the metal stent itself is biologically inert, and remains in the body for a long time after implantation in the human body, and there will still be late thrombosis. risk.
  • restenosis occurs in the vascular site of the stent, it must be treated by surgery, which further increases the complexity of the procedure due to the early implantation of the permanent stent.
  • the biodegradable stent is in service in the body. After the blood vessel is restored, the stent is absorbed by the human body, effectively avoiding this problem.
  • biodegradable stents there are three main types of biodegradable stents: polymer polymer stents, iron alloy stents and magnesium alloy stents.
  • the biodegradable polymer material has good biocompatibility, but the strength, hardness and rigidity are much lower than that of the metal material.
  • the degradable polymer scaffold needs to increase the wire diameter size, and the mechanical properties still have a large gap with the metal scaffold.
  • the ferroalloy stent has good mechanical properties, but the degradation rate is very low, and the service time is too long. After the recovery of the vessel wall, the ferroalloy stent still maintains high integrity, and also has the risk of developing late thrombosis.
  • Biodegradable magnesium alloy or zinc alloy material has good mechanical properties and biocompatibility, and is known as “revolutionary metal biomaterial”. It is a hot research topic in the field of biomaterials at home and abroad.
  • the newly developed medical magnesium alloy material achieves uniform and controllable degradation.
  • the magnesium alloy stent can not only provide high support strength of the metal stent, but also can be absorbed by the human body after 6 to 12 months, thereby avoiding long-term foreign body stimulation on the blood vessel wall. To reduce the rate of vascular restenosis, showing great advantages and potential.
  • the invention patent of CN103110465 discloses a magnesium alloy vascular stent with moderate metal coverage, good radial support force and good flexibility; the magnesium alloy stent disclosed in the utility model patent CN2936196Y Magnesium alloy vascular stent with excellent mechanical properties. Magnesium disclosed in the above two patents The alloy stent design emphasizes the deformation of the balloon expansion process, but due to the relatively weak room temperature deformation property of the magnesium alloy material, the magnesium alloy stent is easily deformed due to the severe tensile plastic deformation during the crimping process.
  • the object of the present invention is to provide a novel biodegradable metal blood vessel stent and the use thereof, and the shape of the degradable magnesium alloy or zinc alloy blood vessel stent can provide good mechanical properties for the stent through its special repeated structural unit design. Long effective service life meets the practical requirements for degradable vascular stents in the clinic.
  • the present invention provides a biodegradable metal blood vessel stent comprising a plurality of main structural support rings, a plurality of said main structural support rings are sequentially connected to form a tubular structure, and a plurality of adjacent main body unit support rings are arranged
  • the connecting rods are connected, and each of the main structural support rings includes a plurality of body units connected in a wavy structure.
  • the blood vessel stent has any two adjacent body structure support rings which are mirror-symmetric with each other.
  • the connecting rod has an "n"-shaped structure, and is composed of an arc portion and two straight portions disposed at both ends of the curved portion, and the outer side of the curved portion has a smooth curved shape.
  • the inner side is a smooth circular curve structure with two symmetrical intersections.
  • the number of the main body units in the circumferential direction of the blood vessel stent is 4-8.
  • the connecting rods in the circumferential direction of the blood vessel stent are arranged in a spiral shape in space, and the number is 2 to 4.
  • the main body unit comprises a top portion, two elliptical arc portions, two straight rod portions and two inflection curve portions, two of the elliptical arc portions are located at two ends of the top, and the two of the straight rod portions Each is connected to an elliptical arc portion, and each of the two inflection curves is connected to the straight rod portion.
  • the top side of the main body unit is provided with a convex unit, the height of the convex unit is 0.01-1 mm, the long axis of the elliptical arc portion is 0.1-0.5 mm, and the short axis is 0.05-0.40 mm. .
  • the blood vessel stent has an outer diameter of 1 to 5 mm, a wall thickness of 0.1 to 0.3 mm, a length of 10 to 100 mm, a metal rod width of the main body unit of 0.1 to 0.3 mm, and a connecting rod width of 0.06 to 0.25 mm.
  • the center line of the curved portion of the connecting rod has a radius of approximately 0.10 to 0.30 mm.
  • it is made of a magnesium alloy or a zinc alloy material.
  • the invention also provides a use of a biodegradable metal vascular stent as described above for the treatment of coronary vascular or peripheral vascular disease.
  • the present invention has the following beneficial effects:
  • the biodegradable metal vascular stent has good biocompatibility and is uniformly degraded in the body. After the blood vessel is completely reconstructed at the lesion, the stent is absorbed by the human body, thereby effectively avoiding long-term foreign body stimulation of the vascular tissue.
  • magnesium alloy or zinc alloy material in the yield strength, elongation, breaking strength and other mechanical properties of the material compared to stainless steel, cobalt-chromium alloy, titanium alloy and other permanent support materials have a certain gap, so the existing permanent support design in the pressure grip
  • the excessive deformation introduced during the expansion process is not suitable for magnesium alloy or zinc alloy material.
  • the biodegradable metal blood vessel stent is added by the inflection, the larger deformation arc, the protrusion outside the deformation arc, and the smoothly changing support.
  • the width of the rod makes the stress concentration during the crimping and expansion process significantly improved, and the plastic deformation is uniformly dispersed to a larger extent. Therefore, the biodegradable metal blood vessel stent has good radial support force, good flexibility, and pressure.
  • the grip and the balloon are uniformly deformed during the expansion process, are not easily broken, and have low residual stress.
  • the biodegradable metal blood vessel stent adopts a finely adjusted arc and a contour of the inflection edge to make the two stiffnesses match each other, and participate in the pressure grip and the expansion deformation together, and the adjacent support rods are parallel to each other to fully utilize the space when the end point is pressed. At the same time of dispersing plastic deformation, the elastic rebound after the crimping is reduced.
  • the biodegradable metal blood vessel stent has a unique shape design, which makes the plastic deformation during the crimping and expanding process less, and reduces the mechanical damage that may be introduced during the deformation process; the stress concentration in the stent is effectively improved and reduced.
  • the rate of corrosion of the biodegradable metal stent in the blood environment, so the biodegradable metal stent has a long corrosion fatigue life and a long effective service time.
  • the stent of the present invention can also be used as a degradable stent for the treatment of other stenosis, such as esophageal stent, tracheal stent, bile duct stent, pancreatic duct stent, and catheter. Brackets, etc.
  • Figure 1 is a schematic perspective view of a biodegradable metal blood vessel stent of the present invention
  • FIG. 2 is a schematic plan view showing the planar development of the biodegradable metal blood vessel stent of the present invention
  • Figure 3 is a front elevational view showing the structure of the main unit of the present invention.
  • Figure 4 is a front elevational view showing the structure of the connecting rod of the present invention.
  • FIGS. 1 to 4 The structure of a biodegradable metal blood vessel stent according to this embodiment is as shown in FIGS. 1 to 4, and includes a plurality of main structural support rings 3, and a plurality of main structural supports 3 rings are sequentially connected to form a tubular structure, and two adjacent main body units.
  • the support rings 3 are connected by a plurality of connecting rods 2, and the main structural support ring 3 comprises a plurality of main body units 1 connected in a wavy structure.
  • any two adjacent ones of the main body structural support rings 3 are mirror-symmetrical to each other.
  • the connecting rod 2 has an "n"-shaped structure composed of an arc portion 21 and two straight portions 22 provided at both ends of the curved portion 21, and the outer side of the curved portion 21 is deformed.
  • the number of the main body units in the circumferential direction of the vascular stent is 4-8, and 8 is selected in the embodiment; the connecting rods in the circumferential direction of the vascular stent are arranged in a spiral shape in space, and the number is 2 to 4, in this embodiment It is three.
  • the main body unit 1 has a structure similar to a "V" shape, including a top portion, two elliptical arc portions 12, two straight rod portions 13, and two inflection curve portions 14, two elliptical arc portions 12 Located at both ends of the top, the two straight rod portions 13 are each connected to an elliptical arc portion 12, and the two inflection curve portions 14 are each connected to the straight rod portion 13.
  • the top portion of the main unit 1 is further provided with a convex unit 11 having a height of 0.01 to 1 mm, wherein the elliptical arc portion 12 has a major axis of 0.1 to 0.5 mm and a minor axis of 0.05 to 0.40 mm.
  • the main body unit and the connecting rod in the blood vessel stent are made of a magnesium alloy material, and the outer diameter of the blood vessel stent is 1 to 5 mm, the wall thickness is 0.1 to 0.3 mm, and the length is 10 to 100 mm; the width of the metal rod of the main unit is 0.1 to 0.3. Mm, the width of the connecting rod is 0.06 to 0.25 mm, and the radius of the center line of the curved portion of the connecting rod is approximately 0.10 to 0.30 mm.
  • the biodegradable metal vascular stent can spray a polymer drug-loaded coating on the surface, and the stent is uniformly deformed during the pressure-clamp expansion process, which is favorable for maintaining the integrity of the polymer drug-loaded coating and reducing the risk of coating wrinkles and peeling. .
  • the biodegradable metal blood vessel stent maintains good support and flexibility of the stent while avoiding local stress accelerated corrosion caused by stress concentration caused by large plastic deformation.
  • the most preferred material of the biodegradable metal blood vessel stent is Mg-Nd-Zn-Zr magnesium alloy, but it is not Limited to the magnesium alloy material, for other biomagnesium alloys and zinc alloy materials, the parameters such as elastic modulus, Poisson's ratio, density, etc. vary little, according to yield strength, elongation, static tensile curve and expected crimping and expansion dimensions.
  • the inner and outer contour lines of the elliptical arc portion 12 of the main body unit and the inflection curve portion 14 of the main body unit can be slightly adjusted without changing the shape of the main body unit 1.
  • the number of the main body units 1 in the circumferential direction of the blood vessel stent is 4 to 8, and the number of the connecting rods is 2 to 4, and the connecting rods 2 are arranged in a spiral shape in space.
  • Other compositions and connection relationships are the same as in the specific embodiment 1.
  • the biodegradable metal blood vessel stent formed by the method can adjust the number of the main body unit and the connecting rod according to the target expansion size without excessive adjustment of the specific main body contour, and can adapt to a larger range of sizes, and has Very good flexibility.
  • the height of the convex unit at the end of the main body unit is 0.01 to 0.06 mm, and the center line of the elliptical arc portion of the main unit is approximately 0.15 to 0.35.
  • Mm the short axis is 0.10 to 0.30 mm, and the metal rod width of the main unit is between 0.1 mm and 0.2 mm.
  • the biodegradable metal blood vessel stent according to the embodiment relates to an outer diameter of the blood vessel stent of 1 mm to 5 mm, a wall thickness of 0.1 mm to 0.2 mm, and a length of the blood vessel stent of 10 mm to 50 mm, and other compositions and connection relationships and a specific embodiment. the same.
  • the biodegradable metal blood vessel stent of the present embodiment is designed to introduce the inflection curve portion 14 in the middle of the straight rod of the main body unit 1, so that the radius of the elliptical arc portion 12 can be increased, the residual stress is more dispersed, and the plastic deformation is more uniform.
  • the biodegradable magnesium alloy is used as the material to process the vascular stent.
  • the curved part of the main unit adopts the same design. Compared with the straight rod design, the maximum principal strain decreases by about 5.2%, and the maximum residual stress decreases by about 7.6%.

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Abstract

一种生物可降解金属血管支架，包括若干主体结构支撑环（3），若干主体结构支撑环（3）依次相连环绕形成管状结构，相邻两个主体结构支撑环（3）间由若干个连接杆（2）连接，每个主体结构支撑环（3）包括连接成波浪形结构的若干个主体单元（1）。该血管支架具有良好的支撑力、柔顺性及疲劳强度，可用于外周血管及冠状动脉血管狭窄疾病的治疗。

Description

一种生物可降解金属血管支架及其应用 技术领域
本发明涉及一种介入治疗血管狭窄的医疗器械，具体涉及一种治疗外周血管及冠状动脉血管狭窄或阻塞的生物可降解金属血管支架。
背景技术
外周血管内或冠状动脉内支架植入术是目前治疗血管狭窄的最有效的方法之一。血管支架的发展主要经历了从金属裸支架，到药物洗脱支架，再到生物可降解支架的过程。目前医学上应用的血管支架主要是由不锈钢、镍钛合金等医用金属材料制造，喷覆有高分子载药涂层的药物洗脱支架。
药物洗脱支架可以通过抗增殖药物的释放来抑制平滑肌细胞再生，从而降低血管的再狭窄率，但金属支架本身是生物惰性的，植入人体后长期留在体内，仍然会有发生晚期血栓的风险。当植入支架的血管部位发生再狭窄时，必须通过手术来处理，由于早先植入的永久支架，会进一步增加手术的复杂性。生物可降解支架在体内服役，待血管恢复后，支架被人体吸收，有效地规避了这个问题。目前生物可降解支架主要有三种：高分子聚合物支架、铁合金支架和镁合金支架。生物可降解高分子材料具有良好的生物相容性，但是强度、硬度、刚度相较金属材料低很多，可降解高分子支架需要增大丝径尺寸，力学性能仍与金属支架有较大差距。铁合金支架具有良好的力学性能，但降解速度很低，服役时间过长，在血管壁恢复后铁合金支架仍保持较高完整性，同样具有发生晚期血栓的风险。
生物可降解镁合金或锌合金材料具有良好的力学性能和生物相容性，被誉为“革命性金属生物材料”，是目前国内外生物材料领域研究的热点。最新研发的医用镁合金材料，实现了均匀可控降解，镁合金支架不仅可以提供金属支架的高支撑强度，还可以在6～12个月后被人体吸收，从而避免对血管壁的长期异物刺激，降低血管再狭窄率，表现出了巨大的优势与潜力。
专利公开号为CN103110465的发明专利中公开了一种金属覆盖率适中、较好的径向支撑力、柔顺性良好的镁合金血管支架；专利公开号为CN2936196Y的实用新型专利中公开的镁合金支架具有优良力学性能的镁合金血管支架。以上两个专利中所公开的镁 合金支架设计着重球囊扩张过程的变形，但是由于镁合金材料相对较弱的室温变形性能，镁合金支架在压握过程中，支撑环弧形部分远端由于剧烈的拉伸塑性变形容易造成材料损伤，较大的弹性回缩以及较高的残余应力；并且传统的等径圆弧轮廓设计无法在剧烈的压握、扩张变形中最有效的分散应力，令镁合金支架在撑开后有较高的残余应力，导致局部区域腐蚀过快，在腐蚀疲劳寿命方面仍存在问题。
发明内容
本发明的目的是提供一种新型的生物可降解金属血管支架及其应用，该可降解镁合金或锌合金血管支架形状，通过其特殊的重复结构单元设计，为支架提供良好的力学性能、较长的有效服役寿命以满足临床中对可降解血管支架的实用要求。
本发明是通过以下技术方案实现的：
第一方面，本发明提供了一种生物可降解金属血管支架，包括若干主体结构支撑环，若干所述主体结构支撑环依次相连环绕形成管状结构，相邻两个主体单元支撑环间由若干个连接杆连接，每个主体结构支撑环包括连接成波浪形结构的若干个主体单元。
作为优选方案，所述血管支架，其任意相邻两个所述主体结构支撑环互呈镜面对称。
作为优选方案，所述连接杆呈“n”形结构，由弧形部和设置于所述弧形部的两端的两个直形部组成，且所述弧形部的外侧呈光滑曲线形，内侧为两个对称相交的平滑圆弧曲线结构。
作为优选方案，所述血管支架周向上主体单元的数量为4～8个。
作为优选方案，所述血管支架周向上的连接杆在空间上呈螺旋状排列，且数量为2～4个。
作为优选方案，所述主体单元包括顶部、两个椭圆弧部、两个直杆部以及两个拐折曲线部，两个所述椭圆弧部位于顶部的两端，两个所述直杆部各与一椭圆弧部相连，两个所述拐折曲线部各与一直杆部相连。
作为优选方案，所述主体单元的顶部外侧设有凸起单元，所述凸起单元的高度为0.01～1mm，所述椭圆弧部的长轴为0.1～0.5mm，短轴为0.05～0.40mm。凸起单元凸起单元
作为优选方案，所述血管支架的外径为1～5mm，壁厚为0.1～0.3mm，长度为10～100mm；主体单元的金属杆宽度为0.1～0.3mm，连接杆宽度为0.06～0.25mm，连接杆弧形部分的中心线近似半圆的半径为0.10～0.30mm。
作为优选方案，由镁合金或锌合金材料制成。
第二方面，本发明还提供了一种如前述的生物可降解金属血管支架在冠状动脉血管或外周血管疾病治疗中的应用。
与现有技术相比，本发明具有如下的有益效果：
1、本生物可降解金属血管支架具有良好的生物相容性，在体内均匀降解，在病灶处血管完成正性重构后，支架被人体吸收，有效避免了对血管组织的长期异物刺激。
2、镁合金或锌合金材料在屈服强度、延伸率、断裂强度等材料力学性能方面相较不锈钢、钴铬合金、钛合金等永久支架材料具有一定差距，所以现有的永久支架设计在压握、扩张过程中引入过大的变形量并不适合于镁合金或锌合金材料，本生物可降解金属血管支架通过加入拐折、更大的变形圆弧、变形弧外侧的突起、平滑变化的支撑杆宽度使压握、扩张过程中的应力集中得到显著改善，塑性变形均匀分散至更大的范围，因此本生物可降解金属血管支架具有较好的径向支撑力，良好的柔顺性，在压握及球囊扩张的过程中均匀变形，不易断裂，残余应力低。
3、本生物可降解金属血管支架通过精细调整的圆弧与拐折边缘轮廓，使两者刚度相互匹配，共同参与压握、扩张变形，压握终点时相邻支持杆相互平行充分利用空间，在分散塑性变形的同时，降低了压握后的弹性回弹。
4、本生物可降解金属血管支架通过独特的形状设计使得压握、扩张过程中的塑性变形较小，减小了变形过程中可能引入的机械损伤；支架服役时应力集中有效改善，减小了生物可降解金属支架在血液环境中的腐蚀速率，因此本生物可降解金属支架具有较长的腐蚀疲劳寿命，较长的有效服役时间。
5、本发明支架除了作为血管支架应用于外周和冠状动脉狭窄治疗外，还可作为其他管腔狭窄治疗的可降解支架应用，如食管支架、气管支架、胆管支架、胰管支架、导尿管支架等。
附图说明
通过阅读参照以下附图对非限制性实施例所作的详细描述，本发明的其它特征、目的和优点将会变得更明显：
图1是本发明的生物可降解金属血管支架立体示意图；
图2是本发明的生物可降解金属血管支架的平面展开结构示意图；
图3是本发明中主体单元的结构主视图；
图4是本发明中连接杆的结构主视图。
图中：1、主体单元；2、连接杆；3、主体结构支撑环；11、凸起单元；12、 椭圆弧部；13、直杆部；14、拐折曲线部；21、弧形部；22、直形部。
具体实施方式
下面结合具体实施例对本发明进行详细说明。以下实施例将有助于本领域的技术人员进一步理解本发明，但不以任何形式限制本发明。应当指出的是，对本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进。这些都属于本发明的保护范围。
实施例1
本实施例涉及的一种生物可降解金属血管支架的结构如图1～4所示，包括若干主体结构支撑环3，若干主体结构支撑3环依次相连环绕形成管状结构，相邻两个主体单元支撑环3间由若干个连接杆2连接，主体结构支撑环3包括连接成波浪形结构的若干个主体单元1。
所述血管支架，其任意相邻两个所述主体结构支撑环3互呈镜面对称。
如图4所示，连接杆2呈“n”形结构，由弧形部21和设置于弧形部21的两端的两个直形部22组成，且弧形部21的外侧为经过变形的近似半圆的光滑曲线结构，内侧为两个对称相交的平滑圆弧曲线结构。
血管支架周向上主体单元的数量为4～8个，本实施例中选择为8个；血管支架周向上的连接杆在空间上呈螺旋状排列，且数量为2～4个，本实施例中为3个。
如图2所示，主体单元1呈类似于“V”形的结构，包括顶部、两个椭圆弧部12、两个直杆部13以及两个拐折曲线部14，两个椭圆弧部12位于顶部的两端，两个直杆部13各与一椭圆弧部12相连，两个拐折曲线部14各与一直杆部13相连。
主体单元1的顶部外侧还设有凸起单元11，凸起单元11的高度为0.01～1mm，其中，椭圆弧部12的长轴为0.1～0.5mm，短轴为0.05～0.40mm。
血管支架中的主体单元、连接杆均由镁合金材料制造，血管支架的外径为1～5mm，壁厚为0.1～0.3mm，长度为10～100mm；主体单元的金属杆宽度为0.1～0.3mm，连接杆宽度为0.06～0.25mm，连接杆的弧形部的中心线近似半圆的半径为0.10～0.30mm。
本生物可降解金属血管支架可以在表面喷涂高分子载药涂层，在压握扩张过程中，支架变形均匀，有利于保持高分子载药涂层的完整，降低了涂层褶皱与剥落的风险。本生物可降解金属血管支架在避免大塑性变形发生应力集中现象导致的局部应力加速腐蚀的同时，保持支架良好的支撑力和柔顺性。
所述生物可降解金属血管支架最优选的材料为Mg-Nd-Zn-Zr镁合金，但并不局 限于该镁合金材料，对于其他生物镁合金及锌合金材料，由于弹性模量、泊松比、密度等参数变化不大，根据屈服强度，延伸率，静拉伸曲线及预期压握、扩张尺寸，在不改变主体单元1形状的情况下对主体单元的椭圆弧部分12和主体单元的拐折曲线部14的内外轮廓线稍作调整即可适配。
实施例2
本实施例涉及的生物可降解金属血管支架，该血管支架周向上的主体单元1的个数为4～8个、连接杆的数量为2～4个，连接杆2空间上呈螺旋状排列，其他组成与连接关系与具体实施例1相同。由此方式组成的生物可降解金属血管支架，可以根据目标扩张尺寸对主体单元及连接杆数量进行调整，而无需对具体主体单元轮廓做过多调整，可以适配较大范围的尺寸，并且具有很好的柔顺性。
实施例3
本实施例涉及的生物可降解金属血管支架，所述主体单元端部的凸起单元的高度为0.01～0.06mm，主体单元的椭圆弧部的中心线近似椭圆圆弧的长轴为0.15～0.35mm，短轴为0.10～0.30mm，主体单元的金属杆宽度介于0.1mm～0.2mm。
实施例4
本实施例涉及的生物可降解金属血管支架，血管支架的外径为1mm～5mm，壁厚为0.1mm～0.2mm，血管支架的长度为10mm～50mm，其他组成及连接关系与具体实施方式一相同。
实施例5
本实施方式的生物可降解金属血管支架，在主体单元1的直杆中部引入拐折曲线部14的设计，可以令椭圆弧部12的半径增大，残余应力更加分散，塑性变形更加均匀。以生物可降解镁合金为材料加工血管支架，主体单元弧形部分采用相同的设计，扭折设计与直杆设计相比，最大主应变下降约5.2％,最大残余应力下降约7.6％。
以上对本发明的具体实施例进行了描述。需要理解的是，本发明并不局限于上述特定实施方式，本领域技术人员可以在权利要求的范围内做出各种变形或修改， 这并不影响本发明的实质内容。

Claims (10)

  1. 一种生物可降解金属血管支架，其特征在于，包括若干主体结构支撑环，若干所述主体结构支撑环依次相连环绕形成管状结构，相邻两个主体单元支撑环间由若干个连接杆连接，每个主体结构支撑环包括连接成波浪形结构的若干个主体单元。
  2. 如权利要求1所述的生物可降解金属血管支架，其特征在于，所述血管支架，其任意相邻两个所述主体结构支撑环互呈镜面对称。
  3. 如权利要求1所述的生物可降解金属血管支架，其特征在于，所述连接杆呈“n”形结构，由弧形部和设置于所述弧形部的两端的两个直形部组成，且所述弧形部的外侧呈光滑曲线形，内侧为两个对称相交的平滑圆弧曲线结构。
  4. 如权利要求1所述的生物可降解金属血管支架，其特征在于，所述血管支架周向上主体单元的数量为4～8个。
  5. 如权利要求1所述的生物可降解金属血管支架，其特征在于，所述血管支架周向上的连接杆在空间上呈螺旋状排列，且数量为2～4个。
  6. 如权利要求1、2、4或5所述的生物可降解金属血管支架，其特征在于，所述主体单元包括顶部、两个椭圆弧部、两个直杆部以及两个拐折曲线部，两个所述椭圆弧部位于顶部的两端，两个所述直杆部各与一椭圆弧部相连，两个所述拐折曲线部各与一直杆部相连。
  7. 如权利要求6所述的生物可降解金属血管支架，其特征在于，所述主体单元的顶部外侧设有凸起单元，所述凸起单元的高度为0.01～1mm，所述椭圆弧部的长轴为0.1～0.5mm，短轴为0.05～0.40mm。
  8. 如权利要求1所述的生物可降解金属血管支架，其特征在于，所述血管支架的外径为1～5mm，壁厚为0.1～0.3mm，长度为10～100mm；主体单元的金属杆宽度为0.1～0.3mm，连接杆宽度为0.06～0.25mm，连接杆弧形部分的中心线近似半圆的半径为0.10～0.30mm。
  9. 如权利要求1所述的生物可降解金属血管支架，其特征在于，由镁合金或锌合金材料制成。
  10. 一种如权利要求1～9中任意一项所述的生物可降解金属血管支架在冠状动脉血管或外周血管疾病治疗中的应用。
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