WO2020108129A1 - 植入式器械 - Google Patents

植入式器械 Download PDF

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Publication number
WO2020108129A1
WO2020108129A1 PCT/CN2019/110986 CN2019110986W WO2020108129A1 WO 2020108129 A1 WO2020108129 A1 WO 2020108129A1 CN 2019110986 W CN2019110986 W CN 2019110986W WO 2020108129 A1 WO2020108129 A1 WO 2020108129A1
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WO
WIPO (PCT)
Prior art keywords
equal
less
particulate matter
wall thickness
average content
Prior art date
Application number
PCT/CN2019/110986
Other languages
English (en)
French (fr)
Inventor
付文超
林文娇
秦莉
Original Assignee
先健科技(深圳)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
Application filed by 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to JP2021549728A priority Critical patent/JP2022509719A/ja
Priority to EP19889922.1A priority patent/EP3888709A4/en
Priority to KR1020247006090A priority patent/KR20240027161A/ko
Priority to US17/288,685 priority patent/US12016975B2/en
Priority to KR1020217019367A priority patent/KR102644029B1/ko
Priority to AU2019388052A priority patent/AU2019388052A1/en
Publication of WO2020108129A1 publication Critical patent/WO2020108129A1/zh
Priority to US18/632,615 priority patent/US20240277496A1/en

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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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • 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
    • 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
    • A61F2210/0057—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof stretchable
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0012—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting elasticity, flexibility, spring rate or mechanical tension
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for

Definitions

  • the invention relates to the technical field of interventional medical devices, in particular to an implantable device.
  • Vascular stent as a mesh tubular implantable medical device can be used for the treatment of various vascular diseases.
  • the vascular stent is implanted in the diseased segment to support the narrow occlusion segment blood vessels, reduce the elastic retraction and reshaping of the blood vessels, and keep the lumen blood circulation smooth.
  • the vascular stent is generally formed of a metal material or a polymer material.
  • the vascular stent is generally cut or braided and then pressed onto the delivery balloon or contracted into the delivery sheath to be fixed on the delivery system. During this process, the stent outer diameter may be reduced by more than 50% and undergo large deformation.
  • the vascular stent is released and the vascular stent is expanded, and the outer diameter of the vascular stent is expanded by more than 200%, and undergoes greater deformation.
  • the vascular stent undergoes repeated large deformations during crimping and expansion.
  • the stent after implantation in the body, the stent will flex, stretch, or even twist in the blood vessel with the movement of the blood vessel and the contraction and relaxation of the blood vessel, and the stent will bear periodic loads (such as radial pulsation squeezing effect, axial stretching) in the blood vessel Function and bending effect, etc.), which puts forward higher requirements on the plastic deformation capacity of the stent.
  • the current stent has insufficient plastic deformation ability, which leads to the stent easily breaking due to fatigue after implantation, and even breaking during expansion.
  • the broken stent rod will cause local mechanical vascular irritation, inflammation and neointimal hyperplasia; on the other hand, the broken stent rod will cause the destruction of the local stent structure, leading to thrombosis and blood flow Blocking, which affects the blood supply of the organ, not only makes the local area of the stent lose radial support performance, it is difficult to play the role of radial support, but also may bring great clinical risks to patients.
  • the plastic deformation ability of the vascular stent is mainly related to its structural design and stent material.
  • the structural design of the stent is certain, the plastic deformation ability of the material itself will play a larger role.
  • the plastic deformation ability of a metal-based material depends on its microstructure.
  • the microstructure includes grain size and orientation, metallographic structure, second phase particulate matter and dislocation structure, etc.
  • the plastic deformation ability corresponding to different microstructures is It is very different, and the microstructure can be optimized to optimize the plastic deformation ability of the material.
  • An implantable device includes a metal matrix, the metal matrix contains particles, and the size of the particles is above 1 ⁇ m, wherein:
  • the wall thickness of the metal substrate is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the largest size of the particulate matter is less than or equal to 15 ⁇ m, and the average content of the particulate matter is less than or equal to 40 ppm;
  • the wall thickness of the metal substrate is greater than 0.12 mm and less than or equal to 0.2 mm, the size of the largest particulate matter is less than or equal to 20 ⁇ m, and the average content of the particulate matter is less than or equal to 100 ppm;
  • the wall thickness of the metal substrate is greater than 0.2 mm and less than or equal to 0.3 mm, the size of the largest particulate matter is less than or equal to 25 ⁇ m, and the average content of the particulate matter is less than or equal to 220 ppm.
  • the wall thickness of the metal substrate is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the size of the largest particulate matter is less than or equal to 10 ⁇ m, and the average content of the particulate matter is less than or equal to 40ppm;
  • the wall thickness of the metal substrate is greater than 0.12 mm and less than or equal to 0.2 mm, the size of the largest particulate matter is less than or equal to 15 ⁇ m, and the average content of the particulate matter is less than or equal to 100 ppm;
  • the wall thickness of the metal substrate is greater than 0.2 mm and less than or equal to 0.3 mm, the size of the largest particulate matter is less than or equal to 20 ⁇ m, and the average content of the particulate matter is less than or equal to 220 ppm.
  • the maximum size of the particulate matter is less than or equal to 10 ⁇ m, and the average content of the particulate matter is less than or equal to 20 ppm ;
  • the wall thickness of the metal substrate is greater than 0.12 mm and less than or equal to 0.2 mm, the size of the largest particulate matter is less than or equal to 15 ⁇ m, and the average content of the particulate matter is less than or equal to 50 ppm;
  • the wall thickness of the metal substrate is greater than 0.2 mm and less than or equal to 0.3 mm, the size of the largest particulate matter is less than or equal to 20 ⁇ m, and the average content of the particulate matter is less than or equal to 110 ppm.
  • the wall thickness of the metal matrix is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the largest particle size is less than or equal to 15 ⁇ m, and the theoretical overexpansion capability of the metal matrix is When 25 to 45%, the average content of the particulate matter is less than or equal to 20 ppm;
  • the wall thickness of the metal matrix is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the largest particle size is less than or equal to 15 ⁇ m, and the theoretical overexpansion capacity of the metal matrix is greater than 45%, the particles
  • the average content is less than or equal to 40ppm;
  • the wall thickness of the metal substrate is greater than 0.12 mm and less than or equal to 0.2 mm, the largest particle size is less than or equal to 20 ⁇ m, and the theoretical overexpansion capacity of the metal substrate is 25 to 45%, the particles The average content is less than or equal to 50ppm;
  • the wall thickness of the metal matrix is greater than 0.12 mm and less than or equal to 0.2 mm, the size of the largest particle is less than or equal to 20 ⁇ m, and the theoretical overexpansion capacity of the metal matrix is greater than 45%, the average content of the particles Less than or equal to 100ppm;
  • the wall thickness of the metal substrate is greater than 0.2 mm and less than or equal to 0.3 mm, the largest particle size is less than or equal to 25 ⁇ m, and the theoretical overexpansion capacity of the metal substrate is 25 to 45%, the particles
  • the average content is less than or equal to 110ppm;
  • the wall thickness of the metal matrix is greater than 0.2 mm and less than or equal to 0.3 mm, the largest particle size is less than or equal to 25 ⁇ m, and the theoretical overexpansion capacity of the metal matrix is greater than 45%, the average content of the particles Less than or equal to 220ppm.
  • the wall thickness of the metal matrix is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the largest particle size is less than or equal to 15 ⁇ m, and the theoretical overexpansion capability of the metal matrix is When 25 to 45%, the average content of the particulate matter is less than or equal to 10 ppm;
  • the wall thickness of the metal matrix is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the largest particle size is less than or equal to 15 ⁇ m, and the theoretical overexpansion capacity of the metal matrix is greater than 45%, the particles
  • the average content is less than or equal to 20ppm;
  • the wall thickness of the metal substrate is greater than 0.12 mm and less than or equal to 0.2 mm, the largest particle size is less than or equal to 20 ⁇ m, and the theoretical overexpansion capacity of the metal substrate is 25 to 45%, the particles The average content is less than or equal to 25ppm;
  • the wall thickness of the metal matrix is greater than 0.12 mm and less than or equal to 0.2 mm, the size of the largest particle is less than or equal to 20 ⁇ m, and the theoretical overexpansion capacity of the metal matrix is greater than 45%, the average content of the particles Less than or equal to 50ppm;
  • the wall thickness of the metal substrate is greater than 0.2 mm and less than or equal to 0.3 mm, the largest particle size is less than or equal to 25 ⁇ m, and the theoretical overexpansion capacity of the metal substrate is 25 to 45%, the particles The average content is less than or equal to 55ppm;
  • the wall thickness of the metal matrix is greater than 0.2 mm and less than or equal to 0.3 mm, the largest particle size is less than or equal to 25 ⁇ m, and the theoretical overexpansion capacity of the metal matrix is greater than 45%, the average content of the particles Less than or equal to 110ppm.
  • the wall thickness of the metal substrate is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the largest particle size is less than or equal to 10 ⁇ m, and the theoretical overexpandability of the metal substrate is When 25 to 45%, the average content of the particulate matter is less than or equal to 10 ppm;
  • the wall thickness of the metal substrate is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the largest particle size is less than or equal to 10 ⁇ m, and the theoretical overexpansion capacity of the metal substrate is greater than 45%, the particles
  • the average content is less than or equal to 20ppm;
  • the wall thickness of the metal substrate is greater than 0.12 mm and less than or equal to 0.2 mm, the largest particle size is less than or equal to 15 ⁇ m, and the theoretical overexpansion capacity of the metal substrate is 25 to 45%, the particles The average content is less than or equal to 25ppm;
  • the wall thickness of the metal matrix is greater than 0.12 mm and less than or equal to 0.2 mm, the largest particle size is less than or equal to 15 ⁇ m, and the theoretical overexpansion capacity of the metal matrix is greater than 45%, the average content of the particles Less than or equal to 50ppm;
  • the wall thickness of the metal substrate is greater than 0.2 mm and less than or equal to 0.3 mm, the largest particle size is less than or equal to 20 ⁇ m, and the theoretical overexpansion capacity of the metal substrate is 25 to 45%, the particles The average content is less than or equal to 55ppm;
  • the wall thickness of the metal matrix is greater than 0.2 mm and less than or equal to 0.3 mm, the largest particle size is less than or equal to 20 ⁇ m, and the theoretical overexpansion capacity of the metal matrix is greater than 45%, the average content of the particles Less than or equal to 110ppm.
  • the material of the metal matrix is selected from one of nitriding iron, pure iron, cobalt-chromium alloy, and magnesium alloy.
  • the implantable device is a vascular stent, a biliary stent, an esophageal stent, or a urethral stent.
  • the vascular stent is a coronary vascular stent or a peripheral vascular stent.
  • the material of the metal substrate is prepared by first performing electroslag remelting treatment, and then performing vacuum arc melting.
  • Tests have proved that according to the wall thickness of the metal matrix of the implantable device, the size and average content of the particulate matter can be reasonably controlled, the microstructure of the metal matrix can be optimized, and the plastic deformation ability of the implantable device is improved to reduce the implantation. Risk of abnormal breakage of the implantable device.
  • FIG. 1 is a schematic structural view of a metal base of an implantable device according to an embodiment
  • FIG. 2 is a schematic view of the axial expansion of the metal base of the implantable device shown in FIG. 1;
  • SEM scanning electron microscope
  • FIG. 5 is a scanning electron microscope (SEM) image of the fracture of the coronary vascular stent of Comparative Example 2.
  • SEM scanning electron microscope
  • the size of the particle referred to herein is the maximum distance between two points on the edge of the particle in the same plane.
  • the implantable device is a vascular stent, a biliary stent, an esophageal stent, or a urethral stent.
  • the vascular stent is a coronary vascular stent or a peripheral vascular stent.
  • the implantable device includes a metal base 100, and the metal base 100 is a hollow lumen structure.
  • the metal substrate 100 includes a plurality of wave coils 110 arranged along the axis Y and a connecting member 120 connecting two adjacent wave coils 110.
  • the wave coil 110 includes a plurality of wave structures 112 arranged along the circumferential direction Z.
  • the material of the metal base 100 is a metal material.
  • the material of the metal substrate 100 is one of nitriding iron, pure iron, cobalt-chromium alloy, and magnesium alloy. It can be understood that, in other embodiments, the material of the metal substrate 100 may be other metals or alloys than the above-listed metals and alloys, any of which can meet the requirements of implantable devices and has good biocompatibility with the organism Both metals and alloys can be used.
  • the material forming the metal substrate 100 contains a plurality of particles, which results in the formation of a plurality of particles in the metal substrate 100, and the size of the particles is greater than or equal to 1 ⁇ m.
  • the particulate matter includes externally introduced inclusions, and also includes endogenous inclusions or the second phase.
  • Particulate matter may be derived from foreign materials introduced during the smelting process of metal materials. For example, in the smelting process of iron and steel materials, oxides and silicates are formed due to the addition of deoxidizers, and sulfides and nitrides formed by the reduced solubility of certain elements (such as sulfur and nitrogen) during the solidification of steel. These The particulate matter is too late to be discharged and remains in the steel. It is difficult to completely avoid the generation of particles, and the distribution of these particles is random, and it is difficult to accurately control their distribution.
  • the size and content of the particulate matter will adversely affect the microstructure of the metal matrix 100, and thus have a certain degree of deterioration in the plastic deformation ability of the metal matrix 100.
  • the degree of deterioration is mainly related to the distribution of particulate matter and the size of the particulate matter.
  • the distribution of particles in the severely deformed area of the metal matrix 100 is more likely to cause abnormal fracture of the implantable device.
  • the larger the size of the particulate matter the more severe the continuity damage to the material, and the more likely it is to cause implantable abnormal fracture. Therefore, the control of particulate matter can reduce the risk of fracture of implantable devices. Therefore, it is necessary to reduce the content of particulate matter, because the lower the content of particulate matter, the lower the probability of its distribution in the deformed part of the implantable device, and the smaller the harm.
  • the smaller the size of the particulate matter the smaller the damage to the continuity of the material, and the smaller the harm.
  • the smaller the size of the implantable device the smaller the size of the particulate matter.
  • thin wall design is currently preferred. The thinner the wall thickness, the greater the need to control the size of the particulate matter. It has been found through research that for particles in metal-based materials, when the size of the particles is less than 1 ⁇ m, these sub-micron or nano-sized particles have little effect on the plastic deformation ability of the material, and can even play a strengthening effect to improve the strength of the material .
  • the particulate matter when the size of the particulate matter is more than 1 ⁇ m, the particulate matter will destroy the continuity of the material, which may cause the plasticity, toughness and fatigue performance of the material to decrease. If these particulate matter appear in the deformed position of the metal matrix 100, it is very easy to make the metal matrix 100 in Abnormal rupture occurs at these locations (such as rupture during expansion). Therefore, it is necessary to control the size and content of particles above 1 ⁇ m.
  • the wall thickness of the metal substrate 100 is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the size of the largest particulate matter is less than or equal to 15 ⁇ m, and the average content of particulate matter is less than or equal to 40 ppm.
  • the wall thickness of the metal substrate 100 is greater than 0.12 mm and less than or equal to 0.2 mm, the size of the largest particulate matter is less than or equal to 20 ⁇ m, and the average content of particulate matter is less than or equal to 100 ppm.
  • the wall thickness of the metal substrate 100 is greater than 0.2 mm and less than or equal to 0.3 mm, the size of the largest particulate matter is less than or equal to 25 ⁇ m, and the average content of particulate matter is less than or equal to 220 ppm.
  • the wall thickness of the metal substrate 100 is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the size of the largest particulate matter is less than or equal to 10 ⁇ m, and the average content of particulate matter is less than or equal to 40 ppm.
  • the wall thickness of the metal substrate 100 is greater than 0.12 mm and less than or equal to 0.2 mm, the size of the largest particulate matter is less than or equal to 15 ⁇ m, and the average content of particulate matter is less than or equal to 100 ppm.
  • the wall thickness of the metal substrate 100 is greater than 0.2 mm and less than or equal to 0.3 mm, the size of the largest particulate matter is less than or equal to 20 ⁇ m, and the average content of particulate matter is less than or equal to 220 ppm.
  • the wall thickness of the metal substrate 100 is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the size of the largest particulate matter is less than or equal to 10 ⁇ m, and the average content of particulate matter is less than or equal to 20 ppm.
  • the wall thickness of the metal substrate 100 is greater than 0.12 mm and less than or equal to 0.2 mm, the size of the largest particulate matter is less than or equal to 15 ⁇ m, and the average content of particulate matter is less than or equal to 50 ppm.
  • the wall thickness of the metal substrate 100 is greater than 0.2 mm and less than or equal to 0.3 mm, the size of the largest particulate matter is less than or equal to 20 ⁇ m, and the average content of particulate matter is less than or equal to 110 ppm.
  • the wall thickness of the metal substrate 100 is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the size of the largest particle is less than or equal to 15 ⁇ m, and the theoretical overexpansion capacity of the metal substrate 100 is 25 to 45% , The average particle content is less than or equal to 20ppm.
  • the wall thickness of the metal matrix is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the size of the largest particulate matter is less than or equal to 15 ⁇ m, and the theoretical overexpansibility of the metal matrix 100 is greater than 45%, the average content of particulate matter is less than or equal to 40 ppm.
  • the wall thickness of the metal substrate 100 is greater than 0.12 mm and less than or equal to 0.2 mm, the size of the largest particle is less than or equal to 20 ⁇ m, and the theoretical overexpansion capacity of the metal substrate 100 is 25 to 45%, the average particle content is less than or equal to 50 ppm .
  • the wall thickness of the metal matrix 100 is greater than 0.12 mm and less than or equal to 0.2 mm, the size of the largest particulate is less than or equal to 20 ⁇ m, and the theoretical overexpansion capability of the metal matrix 100 is greater than 45%, the average content of particulates is less than or equal to 100 ppm.
  • the wall thickness of the metal substrate 100 is greater than 0.2 mm and less than or equal to 0.3 mm, the size of the largest particle is less than or equal to 25 ⁇ m, and the theoretical overexpansion capacity of the metal substrate 100 is 25 to 45%, the average particle content is less than or equal to 110 ppm .
  • the wall thickness of the metal substrate 100 is greater than 0.2 mm and less than or equal to 0.3 mm, the size of the largest particle is less than or equal to 25 ⁇ m, and the theoretical overexpansion capacity of the metal substrate 100 is greater than 45%, the average content of particles is less than or equal to 220 ppm.
  • the wall thickness of the metal substrate 100 is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the size of the largest particle is less than or equal to 15 ⁇ m, and the theoretical overexpansion capacity of the metal substrate 100 is 25 to 45% , The average particle content is less than or equal to 10ppm.
  • the wall thickness of the metal matrix 100 is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the size of the largest particle is less than or equal to 15 ⁇ m, and the theoretical overexpansion capacity of the metal matrix 100 is greater than 45%, the average content of the particles is less than or equal to Equal to 20ppm.
  • the wall thickness of the metal substrate 100 is greater than 0.12 mm and less than or equal to 0.2 mm, the size of the largest particle is less than or equal to 20 ⁇ m, and the theoretical overexpansion capacity of the metal substrate 100 is 25 to 45%, the average content of the particles is less than or equal to 25 ppm .
  • the wall thickness of the metal substrate 100 is greater than 0.12 mm and less than or equal to 0.2 mm, the size of the largest particle is less than or equal to 20 m, and the theoretical overexpansion capacity of the metal substrate 100 is greater than 45%, the average particle content is less than or equal to 50 ppm.
  • the wall thickness of the metal substrate 100 is greater than 0.2 mm and less than or equal to 0.3 mm, the size of the largest particle is less than or equal to 25 ⁇ m, and the theoretical overexpansion capacity of the metal substrate 100 is 25 to 45%, the average particle content is less than or equal to 55 ppm .
  • the wall thickness of the metal substrate 100 is greater than 0.2 mm and less than or equal to 0.3 mm, the size of the largest particle is less than or equal to 25 ⁇ m, and the theoretical overexpansion capacity of the metal substrate 100 is greater than 45%, the average particle content is less than or equal to 110 ppm.
  • the size of the largest particle is less than or equal to 10 ⁇ m, and the theoretical overexpansion capacity of the metal substrate 100 is 25-45% ,
  • the average particle content is less than or equal to 10ppm.
  • the wall thickness of the metal substrate 100 is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the size of the largest particle is less than or equal to 10 ⁇ m, and the theoretical overexpansion capacity of the metal substrate 100 is greater than 45%, the average particle content is less than or equal to 20 ppm .
  • the wall thickness of the metal substrate 100 is greater than 0.12 mm and less than or equal to 0.2 mm, the size of the largest particle is less than or equal to 15 ⁇ m, and the theoretical overexpansion capacity of the metal substrate 100 is 25 to 45%, the average particle content is less than or equal to 25 ppm .
  • the wall thickness of the metal substrate 100 is greater than 0.12 mm and less than or equal to 0.2 mm, the size of the largest particle is less than or equal to 15 ⁇ m, and the theoretical overexpansion capability of the metal substrate 100 is greater than 45%, the average particle content is less than or equal to 50 ppm.
  • the wall thickness of the metal substrate 100 is greater than 0.2 mm and less than or equal to 0.3 mm, the size of the largest particle is less than or equal to 20 ⁇ m, and the theoretical overexpansion capacity of the metal substrate 100 is 25 to 45%, the average particle content is less than or equal to 55 ppm .
  • the wall thickness of the metal substrate 100 is greater than 0.2 mm and less than or equal to 0.3 mm, the size of the largest particle is less than or equal to 20 ⁇ m, and the theoretical overexpansion capacity of the metal substrate 100 is greater than 45%, the average particle content is less than or equal to 110 ppm.
  • N is defined as the theoretical over-expansion capacity of the metal substrate 100
  • L is defined as the length of one coil 110 of the metal substrate 100 after being completely straightened
  • D is defined as the nominal outer diameter of the metal substrate 100
  • the nominal outer diameter refers to the nominal diameter of the metal base 100 plus twice the wall thickness.
  • the nominal diameter refers to the inner diameter of the metal matrix 100 after expansion (after implantation in the blood vessel and expansion, the inner diameter of the metal matrix 100).
  • the nominal diameter is expressed in the stent specifications.
  • the stent of the 30008 specification has a nominal diameter of 3mm and a nominal length of 8mm after expansion;
  • the stent of the 27538 specification has a nominal diameter of 2.75mm and a nominal length of 38mm after expansion; the 35015 stent
  • the nominal diameter after expansion is 3.5 mm and the nominal length is 15 mm.
  • the area of the detection area is the total area of the detection area.
  • the area occupied by the particles in the detection area refers to the random detection of particles in the detection area with a detection area of 10 mm 2 or more under a magnification of 500 times under a scanning electron microscope. area.
  • the average content of particulate matter is constant, if the size of the particulate matter is large, the number of particulate matter is small, so the probability of the particulate matter appearing at the critical deformation position is small, and the deterioration of the plastic deformation of the implantable device is small.
  • the average content of particulate matter is constant, if the number of particulate matter is large, the size of the particulate matter is small, and even if it appears at the critical deformation position, the plastic deformation of the implantable device is less deteriorated. Therefore, reasonable control of the size and content of the particulate matter is beneficial to avoid the negative impact of the particulate matter on the plastic deformation ability of the implantable device.
  • the material of the metal substrate 100 is prepared by at least one of electroslag remelting and vacuum arc melting.
  • the particulate matter in the metal matrix 100 is mainly derived from its raw materials, and the level (size and average content) of the particulate matter is basically not affected in the preparation process of the metal matrix 100. Therefore, it is necessary to control the level of particulate matter in the raw materials.
  • Electroslag remelting and vacuum arc melting can improve the purity of metal materials, reduce the level of particulates in metal materials, optimize the microstructure of metal materials, and thus optimize the plastic deformation ability of metal materials.
  • Electroslag remelting uses the resistance heat generated by the current through the slag as a heat source to melt the electrode.
  • the molten metal condenses into droplets, passes through the slag layer and enters the metal molten pool.
  • non-metallic inclusions are absorbed by the slag
  • the harmful elements phosphorus, sulfur, lead, antimony, bismuth, tin, etc.
  • Vacuum arc melting means that under vacuum, the material to be melted is used as an electrode, and the water-cooled copper booster is the other electrode. The arc is drawn between the two poles. The melted material is melted by the arc at high temperature and dropped into the booster. It gradually melts and gradually condenses into The smelting method of the ingot, smelting in vacuum, can significantly remove hydrogen and some volatile impurities, and can significantly reduce the content of particles through the floating effect.
  • the material of the metal substrate 100 is prepared by first performing electroslag remelting treatment, and then performing vacuum arc melting. First, electroslag remelting treatment, and then further purification by vacuum arc melting, is conducive to reducing the content of particulate matter.
  • the size of the particulate matter and the average content of the particulate matter are reasonably controlled.
  • the particulate matter in the material can effectively avoid the adverse effect on the microstructure of the metal substrate 100, which is beneficial to improve The plastic deformation ability of the implantable device to reduce the risk of abnormal fracture of the implantable device.
  • the size and average content of the particles can be reasonably controlled to further optimize the microstructure of the metal substrate 100, thereby improving the plastic deformation capability of the implantable device.
  • the particles referred to in the following examples are particles having a size of 1 ⁇ m or more.
  • the samples in the following examples are prepared by grinding and polishing materials on the ECOMet250 semi-automatic grinding and polishing machine produced by BRUKER to obtain a bright section of the mirror surface, and then observing under a scanning electron microscope; or placing the sample in liquid nitrogen Brittle fracture to obtain the cross-section, and then under the scanning electron microscope magnified 500 times to observe.
  • the impact of particles on the plastic deformation ability of the stent is evaluated by expansion test.
  • Some raw materials are randomly selected to make 3 tubes or 3 wires to prepare a vascular stent.
  • the length of the tubes or wires made of the selected raw materials is not less than 1.0 meters If possible, if possible, prepare these tubes or wires as a stent for expansion test, expand the stent until it breaks, and then observe the fracture under the SEM scanning electron microscope produced by Japan Co., Ltd. If no particles are found at the fracture The existence of , indicates that the fracture of the stent is not due to the influence of particles. The particles in the material did not seriously deteriorate the plastic deformation ability of the stent.
  • the raw material is nitriding iron, and the nitriding iron is prepared by first performing electroslag remelting treatment and then by vacuum arc melting treatment. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 15 mm 2. The result was that the size of the largest particles was 5 ⁇ m, and the average content of the particles was 5 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes to prepare a coronary vessel stent with a wall thickness of 0.040 mm. The theoretical overexpansion capacity is 60%.
  • the prepared coronary vessel stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is nitriding iron, prepared by electroslag remelting. Randomly cut part of the material for grinding and polishing to obtain a bright cross-section. The observation area is 10 mm 2. The result is: the size of the largest particulate matter is 10 ⁇ m, and the average content of particulate matter is 10 ppm. Randomly select some raw materials to make three 1.2-meter-long tubes, and prepare a coronary vessel stent with a wall thickness of 0.053 mm. Its theoretical overexpansion capacity is 51%.
  • the prepared coronary vessel stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is pure iron, prepared by vacuum arc melting.
  • the raw material was placed in liquid nitrogen for brittle fracture to obtain a cross-section, and the observation area was 12 mm 2.
  • the result was that the size of the largest particulate matter was 10 ⁇ m, and the average content of the particulate matter was 40 ppm.
  • the prepared coronary vessel stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is cobalt-chromium alloy, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 15 ⁇ m, and the average content of the particulate matter was 20 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes to prepare a coronary vessel stent with a wall thickness of 0.080 mm. Its theoretical overexpansion capacity is 45%.
  • the prepared coronary vessel stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is nitriding iron, and the nitriding iron is prepared by first performing electroslag remelting treatment and then by vacuum arc melting treatment. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 15 mm 2. The result was that the size of the largest particles was 5 ⁇ m, and the average content of particles was 10 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes to prepare a coronary vessel stent with a wall thickness of 0.090 mm. Its theoretical overexpansion capacity is 36%.
  • the prepared coronary vessel stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is nitriding iron, prepared by vacuum arc melting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 5 ⁇ m, and the average content of particulate matter was 10 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes to prepare a coronary vessel stent with a wall thickness of 0.100 mm. Its theoretical overexpansion capacity is 25%.
  • the prepared coronary vessel stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is magnesium alloy, which is prepared by vacuum arc melting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 10 ⁇ m, and the average content of the particulate matter was 20 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes to prepare a coronary vessel stent with a wall thickness of 0.120 mm. The theoretical overexpansion capacity is 60%.
  • the prepared coronary vessel stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is nitriding iron, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 10 ⁇ m, and the average content of particulate matter was 25 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.150 mm. Its theoretical overexpansion capacity is 40%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is nitriding iron material, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 15 ⁇ m, and the average content of particulate matter was 50 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.180 mm. Its theoretical overexpansion capacity is 50%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is cobalt-chromium alloy material, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 15 ⁇ m, and the average content of the particulate matter was 60 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.190 mm. Its theoretical overexpansion capacity is 45%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is nitriding iron, prepared by electroslag remelting. It is prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section, the observation area is 10mm 2 , the result is: the size of the largest particulate matter is 20 ⁇ m, the average content of particulate matter is 100ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.200 mm. Its theoretical overexpansion capacity is 65%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is nitriding iron, prepared by electroslag remelting. It is prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 10 ⁇ m, and the average content of particulate matter was 30 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.200 mm. Its theoretical overexpansion capacity is 35%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is pure iron, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 15 ⁇ m, and the average content of the particulate matter was 80 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.200 mm. Its theoretical overexpansion capacity is 65%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is nitriding iron, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particles was 20 ⁇ m, and the average content of particles was 55 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.230 mm. The theoretical overexpansion capacity is 60%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is nitriding iron, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 15 ⁇ m, and the average content of the particulate matter was 110 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.280 mm. Its theoretical overexpansion capacity is 50%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is nitriding iron, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 18 ⁇ m, and the average content of particulate matter was 40 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.290 mm. Its theoretical overexpansion capacity is 45%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is nitriding iron, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particles was 10 ⁇ m, and the average content of particles was 20 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.300 mm. Its theoretical overexpansion capacity is 25%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is nitriding iron, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 15 ⁇ m, and the average content of the particulate matter was 60 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes and prepare a peripheral vascular stent with a wall thickness of 0.300 mm. Its theoretical overexpansion capacity is 35%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is nitriding iron, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 25 ⁇ m, and the average content of the particulate matter was 220 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.300 mm. Its theoretical overexpansion capacity is 65%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment, and no particulate matter was found at the fracture.
  • the raw material is nitriding iron, which differs from Example 2 in that its average particle content is 50 ppm. Randomly select some raw materials to make three 1.2-meter-long tubes to prepare the same coronary stent as in Example 2.
  • the prepared coronary vessel stent was subjected to an expansion experiment. As a result, particles were found at all 8 fractures of the coronary vessel stent, as shown in FIG. 3, and there were particles in the circle in FIG.
  • the raw material is nitriding iron, which differs from Example 2 in that its maximum particle size is 20 ⁇ m. Randomly select some raw materials to make three 1.2-meter-long tubes to prepare the same coronary stent as in Example 2.
  • the prepared coronary vessel stent was subjected to an expansion experiment. As a result, particulate matter was found at five fractures of the coronary vessel stent, as shown in FIG. 4, and there were particles in the circle in FIG. 4.
  • the raw material is nitriding iron, and the nitriding iron is prepared by first performing electroslag remelting treatment and then by vacuum arc melting treatment. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 15 mm 2. The result was that the size of the largest particles was 5 ⁇ m, and the average content of particles was 25 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes to prepare a coronary vessel stent with a wall thickness of 0.090 mm. Its theoretical overexpansion capacity is 36%.
  • the prepared coronary vascular stent was subjected to an expansion experiment. As a result, particulate matter was found at 6 fractures of the coronary vascular stent.
  • the raw material is nitriding iron, and the nitriding iron is prepared by first performing electroslag remelting treatment and then by vacuum arc melting treatment. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 15 mm 2. The result was that the size of the largest particulate matter was 20 ⁇ m, and the average content of particulate matter was 10 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes to prepare a coronary vessel stent with a wall thickness of 0.090 mm. Its theoretical overexpansion capacity is 36%.
  • the prepared coronary vascular stent was subjected to an expansion experiment. As a result, particulate matter was found at four fractures of the coronary vascular stent.
  • the raw material is nitriding iron material, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 15 ⁇ m, and the average content of the particulate matter was 110 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.180 mm. Its theoretical overexpansion capacity is 50%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment. As a result, particles were found at 8 fractures of the peripheral vascular stent.
  • the raw material is nitriding iron material, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 25 ⁇ m, and the average content of particulate matter was 50 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.180 mm. Its theoretical overexpansion capacity is 50%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment. As a result, particles were found at 8 fractures of the peripheral vascular stent.
  • the raw material is nitriding iron, prepared by electroslag remelting. It is prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particles was 10 ⁇ m, and the average content of the particles was 55 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.200 mm. Its theoretical overexpansion capacity is 35%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment. As a result, particles were found at 7 fractures of the peripheral vascular stent.
  • the raw material is nitriding iron, prepared by electroslag remelting. It is prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 25 ⁇ m, and the average content of particulate matter was 30 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.200 mm. Its theoretical overexpansion capacity is 35%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment. As a result, particulate matter was found at 5 fractures of the peripheral vascular stent.
  • the raw material is nitriding iron, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 15 ⁇ m, and the average content of particulate matter was 120 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes and prepare a peripheral vascular stent with a wall thickness of 0.300 mm. Its theoretical overexpansion capacity is 35%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment. As a result, particles were found at 10 fractures of the peripheral vascular stent.
  • the raw material is nitriding iron, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 30 ⁇ m, and the average content of the particulate matter was 60 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes and prepare a peripheral vascular stent with a wall thickness of 0.300 mm. Its theoretical overexpansion capacity is 35%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment. As a result, particles were found at 8 fractures of the peripheral vascular stent.
  • the raw material is nitriding iron, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 15 ⁇ m, and the average content of the particulate matter was 230 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.280 mm. Its theoretical overexpansion capacity is 50%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment. As a result, particles were found at 8 fractures of the peripheral vascular stent.
  • the raw material is nitriding iron, prepared by electroslag remelting. Randomly cut part of the raw materials for grinding and polishing to obtain a bright cross-section. The observation area was 10 mm 2. The result was that the size of the largest particulate matter was 30 ⁇ m, and the average content of the particulate matter was 110 ppm. Randomly select some raw materials to make three 1.0-meter-long tubes, and prepare a peripheral vascular stent with a wall thickness of 0.280 mm. Its theoretical overexpansion capacity is 50%.
  • the prepared peripheral vascular stent was subjected to an expansion experiment. As a result, particles were found at 8 fractures of the peripheral vascular stent.
  • Example 2 Compared with Comparative Example 1, the average content of particulate matter in Example 2 is lower, the probability of occurrence at the critical deformation position is small, and the adverse effect on the plastic deformation ability of the stent is small; compared with Comparative Example 2, in Example 2 The size of the largest particles is smaller, and the deterioration of the plastic deformation ability of the stent is smaller.
  • Comparative Example 3 Compared with Comparative Example 3, the average content of the particulate matter of Example 5 is lower, the probability of occurrence at the critical deformation position is small, and the adverse effect on the plastic deformation ability of the stent is small; compared with Comparative Example 4, the largest particulate matter of Example 5 The size is smaller, the deterioration of the plastic deformation capacity of the stent is less.
  • Example 12 Compared with Comparative Example 7, the average content of particulate matter in Example 12 is lower, the probability of occurrence at the critical deformation position is small, and the adverse effect on the plastic deformation ability of the stent is small; compared with Comparative Example 8, the largest particulate matter in Example 12 The size is smaller, the deterioration of the plastic deformation capacity of the stent is less.
  • Example 15 Compared with Comparative Example 11, the average content of particulate matter in Example 15 is lower, the probability of occurrence at the critical deformation position is small, and the adverse effect on the plastic deformation ability of the stent is small; compared with Comparative Example 12, the largest particulate matter in Example 15 The size is smaller, the deterioration of the plastic deformation capacity of the stent is less.

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Abstract

一种植入式器械，包括金属基体（100），金属基体（100）内含有尺寸在1um以上的颗粒物，当金属基体（100）的壁厚大于或等于0.04mm且小于或等于0.12mm时，最大的颗粒物的尺寸小于或等于15um，且颗粒物的平均含量小于或等于40ppm；当金属基体（100）的壁厚大于0.12mm且小于或等于0.2mm时，最大的颗粒物的尺寸小于或等于20um，颗粒物的平均含量小于或等于100ppm；当金属基体（100）的壁厚大于0.2mm且小于或等于0.3mm时，最大的颗粒物的尺寸小于或等于25um，颗粒物的平均含量小于或等于220ppm。根据金属基体（100）的壁厚合理控制颗粒物的尺寸及颗粒物的平均含量，能够提高植入式器械的塑性变形能力。

Description

植入式器械 技术领域
本发明涉及介入医疗器械技术领域，特别是涉及一种植入式器械。
背景技术
血管支架作为一种网管状植入式医疗器械，可以用于各种血管疾病的治疗。将血管支架植入病变段以支撑狭窄闭塞段血管，减少血管弹性回缩及再塑形，保持管腔血流通畅。
血管支架一般由金属材料或高分子材料形成。血管支架一般经切割或者编织成型后需压握在输送球囊上或者收缩进输送鞘中以固定在输送系统上，这一过程中支架外径可能减少50％以上，经历较大的变形。将血管支架输送至病变部位后，释放血管支架，并扩张血管支架，血管支架的外径又被扩大200％以上，经历更大的变形。压握和扩张过程中血管支架经受反复的大变形。并且，植入体内后，支架在血管内会伴随血管的移动以及血管收缩舒张而发生屈曲、伸展，甚至扭转，支架在血管内承受周期性载荷(如径向脉动挤压作用、轴向拉伸作用及弯曲作用等)，这就对支架的塑性变形能力提出较高的要求。然而，目前的支架存在着塑性变形能力不够，从而导致支架在植入后容易因疲劳而发生断裂，甚至在扩张过程中即发生断裂。如此会产生不良后果：一方面，断裂的支架杆会导致局部机械性血管刺激，产生炎症和新生内膜增生；另一方面，支架杆断裂会引起局部支架结构的破坏，导致血栓形成和血流阻滞，从而影响器官的血流供应，这不仅仅会使支架的局部区域丧失径向支撑性能，难以起到径向支撑的作用，还有可能给患者带来极大的临床风险。
血管支架的塑性变形能力主要与其结构设计和支架材料有关，当支架的结构设计一定时，材料本身的塑性变形能力将起到较大的作用。金属基材料的塑性变形能力取决于其显微结构，显微结构包括晶粒大小和取向、金相组织、第二相颗粒物和位错结构等等，不同的显微结构对应的塑性变形能力有很大不同， 可以通过对显微结构的进行优化以优化材料的塑性变形能力。
发明内容
基于此，有必要提供一种塑性变形能力较好的植入式器械。
一种植入式器械，包括金属基体，所述金属基体内含有颗粒物，所述颗粒物的尺寸在1μm以上，其中：
当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm时，最大的所述颗粒物的尺寸小于或等于15μm，且所述颗粒物的平均含量小于或等于40ppm；
当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm时，最大的所述颗粒物的尺寸小于或等于20μm，所述颗粒物的平均含量小于或等于100ppm；
当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm时，最大的所述颗粒物的尺寸小于或等于25μm，所述颗粒物的平均含量小于或等于220ppm。
在其中一个实施例中，当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm时，最大的所述颗粒物的尺寸小于或等于10μm，且所述颗粒物的平均含量小于或等于40ppm；
当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm时，最大的所述颗粒物的尺寸小于或等于15μm，所述颗粒物的平均含量小于或等于100ppm；
当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm时，最大的所述颗粒物的尺寸小于或等于20μm，所述颗粒物的平均含量小于或等于220ppm。
在其中一个实施例中，当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm时，最大所述颗粒物的尺寸小于或等于10μm，且所述颗粒物的平均含量小于或等于20ppm；
当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm时，最大的所述颗粒物的尺寸小于或等于15μm，所述颗粒物的平均含量小于或等于50ppm；
当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm时，最大的所述颗粒物的尺寸小于或等于20μm，所述颗粒物的平均含量小于或等于110ppm。
在其中一个实施例中，当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的所述颗粒物的尺寸小于或等于15μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于20ppm；
当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的所述颗粒物的尺寸小于或等于15μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于40ppm；
当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm，最大的所述颗粒物的尺寸小于或等于20μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于50ppm；
当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm，最大的所述颗粒物的尺寸小于或等于20μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于100ppm；
当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm，最大的所述颗粒物的尺寸小于或等于25μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于110ppm；
当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm，最大的所述颗粒物的尺寸小于或等于25μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于220ppm。
在其中一个实施例中，当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的所述颗粒物的尺寸小于或等于15μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于10ppm；
当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的所述颗粒物的尺寸小于或等于15μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于20ppm；
当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm，最大的所述颗粒物的尺寸小于或等于20μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于25ppm；
当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm，最大的所述颗粒 物的尺寸小于或等于20μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于50ppm；
当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm，最大的所述颗粒物的尺寸小于或等于25μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于55ppm；
当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm，最大的所述颗粒物的尺寸小于或等于25μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于110ppm。
在其中一个实施例中，当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的所述颗粒物的尺寸小于或等于10μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于10ppm；
当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的所述颗粒物的尺寸小于或等于10μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于20ppm；
当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm，最大的所述颗粒物的尺寸小于或等于15μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于25ppm；
当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm，最大的所述颗粒物的尺寸小于或等于15μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于50ppm；
当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm，最大的所述颗粒物的尺寸小于或等于20μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于55ppm；
当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm，最大的所述颗粒物的尺寸小于或等于20μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于110ppm。
在其中一个实施例中，所述金属基体的材料选自渗氮铁、纯铁、钴铬合金及镁合金中的一种。
在其中一个实施例中，所述植入式器械为血管支架、胆道支架、食道支架或尿道支架。
在其中一个实施例中，所述血管支架为冠脉血管支架或外周血管支架。
在其中一个实施例中，所述金属基体的材料通过先进行电渣重熔处理，然后再进行真空电弧熔炼制备得到。
经试验证明，根据植入式器械的金属基体的壁厚，合理地控制颗粒物的尺寸以及平均含量，能够优化金属基体的显微结构，有利于提高植入式器械的塑性变形能力，以降低植入式器械异常断裂的风险。
附图说明
图1为一实施方式的植入式器械的金属基体的结构示意图；
图2为图1所示的植入式器械的金属基体的轴向展开示意图；
图3为实施例2的冠脉血管支架的断口的扫描电镜(SEM)图；
图4为对比例1的冠脉血管支架的断口的扫描电镜(SEM)图；
图5为对比例2的冠脉血管支架的断口的扫描电镜(SEM)图。
具体实施方式
为了便于理解本发明，下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳的实施例。但是，本发明可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使对本发明的公开内容的理解更加透彻全面。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
本文所指的颗粒物的尺寸为同一平面内颗粒物的边缘上的两点的最大距离。
一实施方式的植入式器械，该植入式器械为血管支架、胆道支架、食道支 架或尿道支架。在一实施方式中，血管支架为冠脉血管支架或外周血管支架。
如图1所示，植入式器械包括金属基体100，金属基体100为镂空的管腔结构。
请一并参阅图2，金属基体100包括多个沿轴向Y排列的波圈110及连接相邻两个波圈110的连接件120。波圈110包括多个沿周向Z排列的波形结构112。
金属基体100的材料为金属材料。在一实施方式中，金属基体100的材料为渗氮铁、纯铁、钴铬合金及镁合金中的一种。可以理解，在其他实施方式中，金属基体100的材料可以为除上述列举的金属和合金以外的其他金属或合金，任何能够满足植入式器械的要求且与生物体的生物相容性较好的金属和合金均可应用。
形成金属基体100的材料中含有多个颗粒物，导致金属基体100内形成有多个颗粒物，颗粒物的尺寸大于或等于1μm。其中，颗粒物包括外部引入的夹杂物，也包括内生的夹杂物或者第二相。颗粒物可能来源于金属材料在冶炼过程中引入的外来物。例如，钢铁材料在冶炼过程中，由于脱氧剂的加入形成氧化物、硅酸盐，以及钢在凝固过程中由于某些元素(如硫、氮)溶解度下降而形成的硫化物、氮化物，这些颗粒物来不及排出而留在钢中。难以实现完全避免颗粒物的产生，同时这些颗粒物的分布是随机的，难以精确控制其分布。
颗粒物的大小和含量会对金属基体100的显微结构产生不良影响，从而对金属基体100的塑性变形能力产生一定程度的恶化影响。恶化影响的程度主要与颗粒物的分布和颗粒物的尺寸有关。颗粒物分布在金属基体100的变形严重区域更容易造成植入式器械的异常断裂。颗粒物的尺寸越大，对材料的连续性破坏越严重，越容易造成植入式的异常断裂。因此，对颗粒物进行控制能够减少植入式器械断裂风险。因此，有必要减少颗粒物的含量，因为颗粒物的含量越少，其分布在植入式器械变形部位的概率就越低，危害越小。
对于颗粒物的尺寸而言，颗粒物的尺寸越小对材料的连续性破坏越小，危害越小。并且，植入式器械的尺寸越小就越要求颗粒物的尺寸越小，特别在血管支架领域，目前倾向于薄壁设计，壁厚越薄就越需要控制颗粒物的尺寸。经 研究发现，对于金属基材料中的颗粒物而言，颗粒物的尺寸小于1μm时，这些亚微米级或者纳米级颗粒物对材料的塑性变形能力基本无影响，甚至可以起到强化效果，提高材料的强度。但当颗粒物的尺寸在1μm以上时，颗粒物将破坏材料的连续性，可能致使材料的塑性、韧性和疲劳性能降低，如果这些颗粒物出现在金属基体100的变形位置，就极易使金属基体100在这些位置发生异常断裂(如扩张时发生断裂)。因此，需要控制尺寸在1μm以上颗粒物的尺寸和含量。
在一实施方式中，当金属基体100的壁厚大于或等于0.04mm且小于或等于0.12mm时，最大的颗粒物的尺寸小于或等于15μm，且颗粒物的平均含量小于或等于40ppm。
当金属基体100的壁厚大于0.12mm且小于或等于0.2mm时，最大的颗粒物的尺寸小于或等于20μm，颗粒物的平均含量小于或等于100ppm。
当金属基体100的壁厚大于0.2mm且小于或等于0.3mm时，最大颗粒物的尺寸小于或等于25μm，颗粒物的平均含量小于或等于220ppm。
在一实施方式中，当金属基体100的壁厚大于或等于0.04mm且小于或等于0.12mm时，最大的颗粒物的尺寸小于或等于10μm，且颗粒物的平均含量小于或等于40ppm。
当金属基体100的壁厚大于0.12mm且小于或等于0.2mm时，最大的颗粒物的尺寸小于或等于15μm，颗粒物的平均含量小于或等于100ppm。
当金属基体100的壁厚大于0.2mm且小于或等于0.3mm时，最大的颗粒物的尺寸小于或等于20μm，颗粒物的平均含量小于或等于220ppm。
在一实施方式中，当金属基体100的壁厚大于或等于0.04mm且小于或等于0.12mm时，最大颗粒物的尺寸小于或等于10μm，且颗粒物的平均含量小于或等于20ppm。
当金属基体100的壁厚大于0.12mm且小于或等于0.2mm时，最大的颗粒物的尺寸小于或等于15μm，颗粒物的平均含量小于或等于50ppm。
当金属基体100的壁厚大于0.2mm且小于或等于0.3mm时，最大的颗粒物的尺寸小于或等于20μm，颗粒物的平均含量小于或等于110ppm。
在一实施方式中，当金属基体100的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的颗粒物的尺寸小于或等于15μm，且金属基体100的理论过扩能力为25～45％时，颗粒物平均含量小于或等于20ppm。
当金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的颗粒物的尺寸小于或等于15μm，且金属基体100的理论过扩能力大于45％时，颗粒物平均含量小于或等于40ppm。
当金属基体100的壁厚大于0.12mm且小于或等于0.2mm，最大的颗粒物的尺寸小于或等于20μm，且金属基体100的理论过扩能力为25～45％时，颗粒物平均含量小于或等于50ppm。
当金属基体100的壁厚大于0.12mm且小于或等于0.2mm，最大的颗粒物的尺寸小于或等于20μm，且金属基体100的理论过扩能力大于45％时，颗粒物平均含量小于或等于100ppm。
当金属基体100的壁厚大于0.2mm且小于或等于0.3mm，最大的颗粒物的尺寸小于或等于25μm，且金属基体100的理论过扩能力为25～45％时，颗粒物平均含量小于或等于110ppm。
当金属基体100的壁厚大于0.2mm且小于或等于0.3mm，最大的颗粒物的尺寸小于或等于25μm，且金属基体100的理论过扩能力大于45％时，颗粒物平均含量小于或等于220ppm。
在一实施方式中，当金属基体100的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的颗粒物的尺寸小于或等于15μm，且金属基体100的理论过扩能力为25～45％时，颗粒物平均含量小于或等于10ppm。
当金属基体100的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的颗粒物的尺寸小于或等于15μm，且金属基体100的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于20ppm。
当金属基体100的壁厚大于0.12mm且小于或等于0.2mm，最大的颗粒物的尺寸小于或等于20μm，且金属基体100的理论过扩能力为25～45％时，颗粒物平均含量小于或等于25ppm。
当金属基体100的壁厚大于0.12mm且小于或等于0.2mm，最大的颗粒物的 尺寸小于或等于20μm，且金属基体100的理论过扩能力大于45％时，颗粒物平均含量小于或等于50ppm。
当金属基体100的壁厚大于0.2mm且小于或等于0.3mm，最大的颗粒物的尺寸小于或等于25μm，且金属基体100的理论过扩能力为25～45％时，颗粒物平均含量小于或等于55ppm。
当金属基体100的壁厚大于0.2mm且小于或等于0.3mm，最大的颗粒物的尺寸小于或等于25μm，且金属基体100的理论过扩能力大于45％时，颗粒物平均含量小于或等于110ppm。
在一实施方式中，当金属基体100的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的颗粒物的尺寸小于或等于10μm，且金属基体100的理论过扩能力为25～45％时，颗粒物平均含量小于或等于10ppm。
当金属基体100的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的颗粒物的尺寸小于或等于10μm，且金属基体100的理论过扩能力大于45％时，颗粒物平均含量小于或等于20ppm。
当金属基体100的壁厚大于0.12mm且小于或等于0.2mm，最大的颗粒物的尺寸小于或等于15μm，且金属基体100的理论过扩能力为25～45％时，颗粒物平均含量小于或等于25ppm。
当金属基体100的壁厚大于0.12mm且小于或等于0.2mm，最大的颗粒物的尺寸小于或等于15μm，且金属基体100的理论过扩能力大于45％时，颗粒物平均含量小于或等于50ppm。
当金属基体100的壁厚大于0.2mm且小于或等于0.3mm，最大的颗粒物的尺寸小于或等于20μm，且金属基体100的理论过扩能力为25～45％时，颗粒物平均含量小于或等于55ppm。
当金属基体100的壁厚大于0.2mm且小于或等于0.3mm，最大的颗粒物的尺寸小于或等于20μm，且金属基体100的理论过扩能力大于45％时，颗粒物平均含量小于或等于110ppm。
其中，定义N为金属基体100的理论过扩能力，定义L为金属基体100的 一个波圈110完全拉直后的长度，定义D为金属基体100的名义外径，
Figure PCTCN2019110986-appb-000001
其中，名义外径是指金属基体100的名义直径加上两倍的壁厚。名义直径是指金属基体100扩张后的内径(植入血管中并扩张完成后，金属基体100的内径)。名义直径表述于支架规格中，例如30008规格支架，其扩张后的名义直径为3mm，名义长度为8mm；27538规格支架，其扩张后的名义直径为2.75mm，名义长度为38mm；35015规格支架，其扩张后的名义直径为3.5mm，名义长度为15mm。
金属基体100中的颗粒物的平均含量为单位面积的金属基体100内，颗粒物在金属基体100中所占的面积。即金属基体100中的颗粒物的平均含量＝检测区域内的颗粒物所占的面积/检测区域的面积。其中，检测区域的面积即检测区域的总面积，检测区域内的颗粒物所占的面积指的是在扫描电镜下放大500倍下随机检测检测面积为10mm 2以上的检测区域中的颗粒物所占的面积。检测区域至少为两个，并分别分布在金属基体100的2个相互垂直的平面上，每个检测区域上的检测面积在5mm 2以上，即颗粒物的平均含量＝多个检测区域内的颗粒物所占的总面积/多个检测区域的总面积。
颗粒物的尺寸越大，颗粒物的数量越多，单位面积的金属基体100上的颗粒物的面积越大。当颗粒物的平均含量一定时，如果颗粒物的尺寸较大，则颗粒物数量就少，如此，颗粒物出现在关键变形位置的概率小，对植入式器械的塑性变形的恶化就小。然而，当颗粒物的平均含量一定时，如果颗粒物的数量较多时，则颗粒物的尺寸就小，即使出现在关键变形位置，对植入式器械的塑性变形的恶化也较小。因此，合理的控制颗粒物的尺寸和颗粒物的含量，有利于避免颗粒物对植入式器械的塑性变形能力产生不良影响。
在一实施方式中，金属基体100的材料通过电渣重熔及真空电弧熔炼中的至少一种方法制备得到。金属基体100中的颗粒物主要来源于其原材料，在金属基体100的制备过程对颗粒物的水平(尺寸和平均含量)基本不影响。因此，需要控制原材料中颗粒物的水平。通过电渣重熔和真空电弧熔炼能够提高金属 材料的纯度，降低金属材料中的颗粒物水平，优化金属材料的显微结构，从而达到优化金属材料的塑性变形能力。
电渣重熔是利用电流通过熔渣产生的电阻热作为热源将电极熔化，熔化的金属汇聚成滴，穿过渣层进入金属熔池，通过渣层的过程中，非金属夹杂为炉渣吸收，有害元素(磷、硫、铅、锑、铋及锡等)通过钢-渣反应和高温汽化得到有效地去除，使钢锭得到提纯，最后在水冷结晶器中凝固成铸件的过程。
真空电弧熔炼是指真空下，被熔材料作为一电极，水冷铜增埚为另一电极，在两极间引弧，被熔材料被电弧高温熔化而滴入增埚中，逐步熔化，逐步冷凝成锭子的冶炼方法，在真空中熔炼，可显著脱除氢与部分易挥发杂质，并通过上浮作用可明显降低颗粒物含量。
在其中一个实施例中，金属基体100的材料通过先进行电渣重熔处理，然后再进行真空电弧熔炼制备得到。先进行电渣重熔处理，再通过真空电弧熔炼进行进一步提纯，有利于减少颗粒物的含量。
根据植入式器械的金属基体100的壁厚合理控制颗粒物的尺寸和颗粒物的平均含量，经试验证明，能够有效地避免材料中的颗粒物对金属基体100的显微结构产生不良影响，有利于提高植入式器械的塑性变形能力，以降低植入式器械异常断裂的风险。
进一步地，根据金属基体100的壁厚及金属基体100的理论过扩能力合理地控制颗粒物尺寸及平均含量，能够进一步优化金属基体100的显微结构，从而提高植入式器械的塑性变形能力。
以下为具体实施例部分(以下实施例以冠脉血管支架和外周血管支架为例，对上述植入式器械做进一步详细的说明，但是本发明保护的范围并不局限于此)。
以下实施例中所指的颗粒物为尺寸在1μm以上的颗粒物。以下实施例中的样品的制备通过在BRUKER公司生产的ECOMet250半自动磨抛机上将材料进行研磨、抛光等以获取镜面光亮的截面，然后在扫描电镜下进行观测；或者将样品置于液氮中进行脆断以获取断面，然后在扫描电镜下放大500倍进行观测。
颗粒物对支架的塑性变形能力的影响通过扩张测试评估，随机挑选部分原 材料制成3根管材或者3条丝材等以制备血管支架，挑选的原材料制成的管材或者丝材的长度不小于1.0米，在工艺条件许可下尽可能将这些管材或者丝材都制备成支架进行过扩测试，将支架扩张直至断裂，之后在日本株式会社生产的SEM扫描电镜下观察断口，如果断口处均未发现颗粒物的存在，说明支架断裂不是因为颗粒物的影响，材料中的颗粒物未对支架的塑性变形能力产生严重的恶化。
实施例1
原材料为渗氮铁，且该渗氮铁通过先进行电渣重熔处理，然后通过真空电弧熔炼处理制备得到。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为15mm 2，结果为：最大颗粒物的尺寸为5μm，颗粒物的平均含量为5ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.040mm的冠脉血管支架，其理论过扩能力为60％。
将制备得到的冠脉血管支架进行扩张实验，断口处未发现颗粒物。
实施例2
原材料为渗氮铁，通过电渣重熔方式制备而得。随机截取部分材料进行研磨和抛光获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为10μm，颗粒物的平均含量为10ppm。随机挑选部分原材料制成3根1.2米长的管材，制备壁厚为0.053mm的冠脉血管支架，其理论过扩能力为51％。
将制备得到的冠脉血管支架进行扩张实验，断口处未发现颗粒物。
实施例3
原材料为纯铁，通过真空电弧熔炼方式制备而得。将原材料置于液氮中进行脆断，获取断面，观测面积为12mm 2，结果为：最大颗粒物的尺寸为10μm，颗粒物的平均含量为40ppm。随机挑选部分原材料制成3根1.5米长的管材，制备壁厚为0.070mm的冠脉血管支架，其理论过扩能力为65％。
将制备得到的冠脉血管支架进行扩张实验，断口处未发现颗粒物。
实施例4
原材料为钴铬合金，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为15μm，颗粒物的平均含量为20ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.080mm的冠脉血管支架，其理论过扩能力为45％。
将制备得到的冠脉血管支架进行扩张实验，断口处未发现颗粒物。
实施例5
原材料为渗氮铁，且该渗氮铁通过先进行电渣重熔处理，然后通过真空电弧熔炼处理制备得到。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为15mm 2，结果为：最大颗粒物的尺寸为5μm，颗粒物的平均含量为10ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.090mm的冠脉血管支架，其理论过扩能力为36％。
将制备得到的冠脉血管支架进行扩张实验，断口处未发现颗粒物。
实施例6
原材料为渗氮铁，通过真空电弧熔炼方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为5μm，颗粒物的平均含量为10ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.100mm的冠脉血管支架，其理论过扩能力为25％。
将制备得到的冠脉血管支架进行扩张实验，断口处未发现颗粒物。
实施例7
原材料为镁合金，通过真空电弧熔炼方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为10μm，颗粒物的平均含量为20ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.120mm的冠脉血管支架，其理论过扩能力为60％。
将制备得到的冠脉血管支架进行扩张实验，断口处未发现颗粒物。
实施例8
原材料为渗氮铁，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为10μm，颗粒物的平均含量为25ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.150mm的外周血管支架，其理论过扩能力为40％。
将制备得到的外周血管支架进行扩张实验，断口处未发现颗粒物。
实施例9
原材料为渗氮铁材料，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为15μm，颗粒物的平均含量为50ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.180mm的外周血管支架，其理论过扩能力为50％。
将制备得到的外周血管支架进行扩张实验，断口处未发现颗粒物。
实施例10
原材料为钴铬合金材料，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为15μm，颗粒物的平均含量为60ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.190mm的外周血管支架，其理论过扩能力为45％。
将制备得到的外周血管支架进行扩张实验，断口处未发现颗粒物。
实施例11
原材料为渗氮铁，通过电渣重熔方式制备而得。通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为20μm，颗粒物的平均含量为100ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.200mm的外周血管支架，其理论过扩能力为65％。
将制备得到的外周血管支架进行扩张实验，断口处未发现颗粒物。
实施例12
原材料为渗氮铁，通过电渣重熔方式制备而得。通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为10μm，颗粒物的平均含量为30ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.200mm的外周血管支架，其理论过扩能力为35％。
将制备得到的外周血管支架进行扩张实验，断口处未发现颗粒物。
实施例13
原材料为纯铁，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为15μm，颗粒物的平均含量为80ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.200mm的外周血管支架，其理论过扩能力为65％。
将制备得到的外周血管支架进行扩张实验，断口处未发现颗粒物。
实施例14
原材料为渗氮铁，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为20μm，颗粒物的平均含量为55ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.230mm的外周血管支架，其理论过扩能力为60％。
将制备得到的外周血管支架进行扩张实验，断口处未发现颗粒物。
实施例15
原材料为渗氮铁，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为15μm，颗粒物的平均含量为110ppm。随机挑选部分原材料制成3根1.0米长 的管材，制备壁厚为0.280mm的外周血管支架，其理论过扩能力为50％。
将制备得到的外周血管支架进行扩张实验，断口处未发现颗粒物。
实施例16
原材料为渗氮铁，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为18μm，颗粒物的平均含量为40ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.290mm的外周血管支架，其理论过扩能力为45％。
将制备得到的外周血管支架进行扩张实验，断口处未发现颗粒物。
实施例17
原材料为渗氮铁，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为10μm，颗粒物的平均含量为20ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.300mm的外周血管支架，其理论过扩能力为25％。
将制备得到的外周血管支架进行扩张实验，断口处未发现颗粒物。
实施例18
原材料为渗氮铁，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为15μm，颗粒物的平均含量为60ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.300mm的外周血管支架，其理论过扩能力为35％。
将制备得到的外周血管支架进行扩张实验，断口处未发现颗粒物。
实施例19
原材料为渗氮铁，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为25μm，颗粒物的平均含量为220ppm。随机挑选部分原材料制成3根1.0米长 的管材，制备壁厚为0.300mm的外周血管支架，其理论过扩能力为65％。
将制备得到的外周血管支架进行扩张实验，断口处未发现颗粒物。
对比例1
原材料为渗氮铁，与实施例2的区别在于，其平均颗粒含量为50ppm。随机挑选部分原材料制成3根1.2米长的管材，制备与实施例2中相同的冠脉血管支架。
将制备得到的冠脉血管支架进行扩张实验，结果在冠脉血管支架的8个断口处均发现颗粒物，如图3所示，图3的圈内有颗粒物。
对比例2
原材料为渗氮铁，与实施例2的区别在于，其最大颗粒尺寸为20μm。随机挑选部分原材料制成3根1.2米长的管材，制备与实施例2中相同的冠脉血管支架。
将制备得到的冠脉血管支架进行扩张实验，结果冠脉血管支架的5个断口处发现颗粒物，如图4所示，图4的圈内有颗粒物。
对比例3
原材料为渗氮铁，且该渗氮铁通过先进行电渣重熔处理，然后通过真空电弧熔炼处理制备得到。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为15mm 2，结果为：最大颗粒物的尺寸为5μm，颗粒物的平均含量为25ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.090mm的冠脉血管支架，其理论过扩能力为36％。
将制备得到的冠脉血管支架进行扩张实验，结果冠脉血管支架的6个断口处发现颗粒物。
对比例4
原材料为渗氮铁，且该渗氮铁通过先进行电渣重熔处理，然后通过真空电 弧熔炼处理制备得到。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为15mm 2，结果为：最大颗粒物的尺寸为20μm，颗粒物的平均含量为10ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.090mm的冠脉血管支架，其理论过扩能力为36％。
将制备得到的冠脉血管支架进行扩张实验，结果冠脉血管支架的4个断口处发现颗粒物。
对比例5
原材料为渗氮铁材料，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为15μm，颗粒物的平均含量为110ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.180mm的外周血管支架，其理论过扩能力为50％。
将制备得到的外周血管支架进行扩张实验，结果外周血管支架的8个断口处发现颗粒物。
对比例6
原材料为渗氮铁材料，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为25μm，颗粒物的平均含量为50ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.180mm的外周血管支架，其理论过扩能力为50％。
将制备得到的外周血管支架进行扩张实验，结果外周血管支架的8个断口处发现颗粒物。
对比例7
原材料为渗氮铁，通过电渣重熔方式制备而得。通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为10μm，颗粒物的平均含量为55ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.200mm的外周血管支架，其 理论过扩能力为35％。
将制备得到的外周血管支架进行扩张实验，结果外周血管支架的7个断口处发现颗粒物。
对比例8
原材料为渗氮铁，通过电渣重熔方式制备而得。通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为25μm，颗粒物的平均含量为30ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.200mm的外周血管支架，其理论过扩能力为35％。
将制备得到的外周血管支架进行扩张实验，结果外周血管支架的5个断口处发现颗粒物。
对比例9
原材料为渗氮铁，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为15μm，颗粒物的平均含量为120ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.300mm的外周血管支架，其理论过扩能力为35％。
将制备得到的外周血管支架进行扩张实验，结果外周血管支架的10个断口处发现颗粒物。
对比例10
原材料为渗氮铁，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为30μm，颗粒物的平均含量为60ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.300mm的外周血管支架，其理论过扩能力为35％。
将制备得到的外周血管支架进行扩张实验，结果外周血管支架的8个断口处发现颗粒物。
对比例11
原材料为渗氮铁，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为15μm，颗粒物的平均含量为230ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.280mm的外周血管支架，其理论过扩能力为50％。
将制备得到的外周血管支架进行扩张实验，结果外周血管支架的8个断口处发现颗粒物。
对比例12
原材料为渗氮铁，通过电渣重熔方式制备而得。随机截取部分原材料进行研磨和抛光以获取光亮截面，观测面积为10mm 2，结果为：最大颗粒物的尺寸为30μm，颗粒物的平均含量为110ppm。随机挑选部分原材料制成3根1.0米长的管材，制备壁厚为0.280mm的外周血管支架，其理论过扩能力为50％。
将制备得到的外周血管支架进行扩张实验，结果外周血管支架的8个断口处发现颗粒物。
由以上各实施例及对比例可以看出，针对不同的壁厚的血管支架控制材料中颗粒物的水平，可以避免或减少颗粒物对支架塑性变形能力的不良影响。
其中，与对比例1相比，实施例2的颗粒物的平均含量更低，出现在关键变形位置的概率小，对支架塑性变形能力的不良影响小；与对比例2相比，实施例2的最大颗粒物的尺寸更小，对支架塑性变形能力恶化更小。
与对比例3相比，实施例5的颗粒物的平均含量更低，出现在关键变形位置的概率小，对支架塑性变形能力的不良影响小；与对比例4相比，实施例5的最大颗粒物的尺寸更小，对支架塑性变形能力恶化更小。
与对比例5相比，实施例9的颗粒物的平均含量更低，出现在关键变形位置的概率小，对支架塑性变形能力的不良影响小；与对比例6相比，实施例9的最大颗粒物的尺寸更小，对支架塑性变形能力恶化更小。
与对比例7相比，实施例12的颗粒物的平均含量更低，出现在关键变形位置的概率小，对支架塑性变形能力的不良影响小；与对比例8相比，实施例12的最大颗粒物的尺寸更小，对支架塑性变形能力恶化更小。
与对比例9相比，实施例18的颗粒物的平均含量更低，出现在关键变形位置的概率小，对支架塑性变形能力的不良影响小；与对比例10相比，实施例18的最大颗粒物的尺寸更小，对支架塑性变形能力恶化更小。
与对比例11相比，实施例15的颗粒物的平均含量更低，出现在关键变形位置的概率小，对支架塑性变形能力的不良影响小；与对比例12相比，实施例15的最大颗粒物的尺寸更小，对支架塑性变形能力恶化更小。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种植入式器械，包括金属基体，其特征在于，所述金属基体内含有颗粒物，所述颗粒物的尺寸在1μm以上，其中：
    当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm时，最大的所述颗粒物的尺寸小于或等于15μm，且所述颗粒物的平均含量小于或等于40ppm；
    当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm时，最大的所述颗粒物的尺寸小于或等于20μm，所述颗粒物的平均含量小于或等于100ppm；
    当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm时，最大的所述颗粒物的尺寸小于或等于25μm，所述颗粒物的平均含量小于或等于220ppm。
  2. 根据权利要求1所述的植入式器械，其特征在于，
    当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm时，最大的所述颗粒物的尺寸小于或等于10μm，且所述颗粒物的平均含量小于或等于40ppm；
    当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm时，最大的所述颗粒物的尺寸小于或等于15μm，所述颗粒物的平均含量小于或等于100ppm；
    当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm时，最大的所述颗粒物的尺寸小于或等于20μm，所述颗粒物的平均含量小于或等于220ppm。
  3. 根据权利要求1所述的植入式器械，其特征在于，
    当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm时，最大所述颗粒物的尺寸小于或等于10μm，且所述颗粒物的平均含量小于或等于20ppm；
    当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm时，最大的所述颗粒物的尺寸小于或等于15μm，所述颗粒物的平均含量小于或等于50ppm；
    当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm时，最大的所述颗粒物的尺寸小于或等于20μm，所述颗粒物的平均含量小于或等于110ppm。
  4. 根据权利要求1所述的植入式器械，其特征在于，
    当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的 所述颗粒物的尺寸小于或等于15μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于20ppm；
    当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的所述颗粒物的尺寸小于或等于15μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于40ppm；
    当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm，最大的所述颗粒物的尺寸小于或等于20μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于50ppm；
    当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm，最大的所述颗粒物的尺寸小于或等于20μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于100ppm；
    当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm，最大的所述颗粒物的尺寸小于或等于25μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于110ppm；
    当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm，最大的所述颗粒物的尺寸小于或等于25μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于220ppm。
  5. 根据权利要求1所述的植入式器械，其特征在于，
    当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的所述颗粒物的尺寸小于或等于15μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于10ppm；
    当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的所述颗粒物的尺寸小于或等于15μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于20ppm；
    当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm，最大的所述颗粒物的尺寸小于或等于20μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于25ppm；
    当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm，最大的所述颗粒 物的尺寸小于或等于20μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于50ppm；
    当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm，最大的所述颗粒物的尺寸小于或等于25μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于55ppm；
    当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm，最大的所述颗粒物的尺寸小于或等于25μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于110ppm。
  6. 根据权利要求1所述的植入式器械，其特征在于，
    当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的所述颗粒物的尺寸小于或等于10μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于10ppm；
    当所述金属基体的壁厚大于或等于0.04mm且小于或等于0.12mm，最大的所述颗粒物的尺寸小于或等于10μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于20ppm；
    当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm，最大的所述颗粒物的尺寸小于或等于15μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于25ppm；
    当所述金属基体的壁厚大于0.12mm且小于或等于0.2mm，最大的所述颗粒物的尺寸小于或等于15μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于50ppm；
    当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm，最大的所述颗粒物的尺寸小于或等于20μm，且所述金属基体的理论过扩能力为25～45％时，所述颗粒物平均含量小于或等于55ppm；
    当所述金属基体的壁厚大于0.2mm且小于或等于0.3mm，最大的所述颗粒物的尺寸小于或等于20μm，且所述金属基体的理论过扩能力大于45％时，所述颗粒物平均含量小于或等于110ppm。
  7. 根据权利要求1所述的植入式器械，其特征在于，所述金属基体的材料 选自渗氮铁、纯铁、钴铬合金及镁合金中的一种。
  8. 根据权利要求1所述的植入式器械，其特征在于，所述植入式器械为血管支架、胆道支架、食道支架或尿道支架。
  9. 根据权利要求8所述的植入式器械，其特征在于，所述血管支架为冠脉血管支架或外周血管支架。
  10. 根据权利要求1所述的植入式器械，其特征在于，所述金属基体的材料通过先进行电渣重熔处理，然后再进行真空电弧熔炼制备得到。
PCT/CN2019/110986 2018-11-27 2019-10-14 植入式器械 WO2020108129A1 (zh)

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KR1020217019367A KR102644029B1 (ko) 2018-11-27 2019-10-14 임플란트 디바이스
AU2019388052A AU2019388052A1 (en) 2018-11-27 2019-10-14 Implant device
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EP3888709A1 (en) 2021-10-06
KR20240027161A (ko) 2024-02-29
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KR20210094021A (ko) 2021-07-28
EP3888709A4 (en) 2023-01-04

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