WO2020228440A1 - 一种血管支架 - Google Patents

一种血管支架 Download PDF

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Publication number
WO2020228440A1
WO2020228440A1 PCT/CN2020/082923 CN2020082923W WO2020228440A1 WO 2020228440 A1 WO2020228440 A1 WO 2020228440A1 CN 2020082923 W CN2020082923 W CN 2020082923W WO 2020228440 A1 WO2020228440 A1 WO 2020228440A1
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WO
WIPO (PCT)
Prior art keywords
stent
section
blood vessel
bare
mesh
Prior art date
Application number
PCT/CN2020/082923
Other languages
English (en)
French (fr)
Inventor
王丽文
黄定国
朱清
张琳琳
张兆夺
Original Assignee
上海蓝脉医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海蓝脉医疗科技有限公司 filed Critical 上海蓝脉医疗科技有限公司
Priority to EP20806335.4A priority Critical patent/EP3967278A4/en
Priority to SG11202112425SA priority patent/SG11202112425SA/en
Priority to KR1020217040471A priority patent/KR102618910B1/ko
Priority to BR112021022525A priority patent/BR112021022525A2/pt
Publication of WO2020228440A1 publication Critical patent/WO2020228440A1/zh

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Classifications

    • 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
    • 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
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • 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
    • A61F2250/001—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 a diameter
    • 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
    • A61F2250/0015—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 density or specific weight
    • A61F2250/0017—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 density or specific weight differing in yarn density
    • 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
    • A61F2250/0039—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 diameter

Definitions

  • the invention relates to the field of vascular interventional medicine, and in particular to a blood vessel stent.
  • Venous disease is currently a common disease in vascular surgery diseases, especially iliac vein compression syndrome, which refers to a syndrome in which iliac artery compression leads to intraluminal adhesions, stenosis or occlusion, resulting in various clinical symptoms.
  • iliac vein compression syndrome refers to a syndrome in which iliac artery compression leads to intraluminal adhesions, stenosis or occlusion, resulting in various clinical symptoms.
  • the incidence of iliac vein compression syndrome is 20%-40%.
  • the braided stent is a net-like structure made of one or more filaments. The braided stent has received more and more advantages due to its good flexibility, strong supporting force and good adhesion. attention.
  • the technical problem to be solved by the present invention is to provide a blood vessel stent which has strong supporting strength and excellent flexibility.
  • the technical solution adopted by the present invention to solve the above-mentioned technical problems is to provide a blood vessel stent, including a stent body, the stent body is a net-like structure woven by metal wires, wherein the stent body includes an axial connection
  • the mesh density of the first bracket section and the second bracket section are different from the mesh density of the second bracket section.
  • the stent body has a variable diameter structure in the axial direction, and the proximal diameter D1 of the stent body is larger than the distal diameter D2.
  • the diameter D1 of the proximal end of the stent body is 8-22 mm, and the diameter D2 of the distal end of the stent body is 6-20 mm.
  • the mesh of the stent body is a diamond-shaped mesh
  • the side length A of the diamond-shaped mesh is 1-5 mm
  • the included angle ⁇ of the diamond-shaped mesh is 90°-160°.
  • the shorter of the two diagonals of the diamond-shaped mesh in the first bracket segment has a length of 1-4 mm, and the longer of the two diagonals of the diamond-shaped mesh in the second bracket segment
  • the short diagonal length is 2-6mm.
  • the blood vessel stent further includes a first bare section, the first bare section includes at least one first protrusion formed by braiding a metal wire in the circumferential direction, and the distal end of the first bare section is connected to the first The proximal end of a stent section is connected, and the distal end of the first stent section is connected to the proximal end of the second stent section.
  • the proximal end of the first stent segment includes at least one third protrusion formed by braiding metal wires in the circumferential direction, and the vertex of the first protrusion of the first bare segment is close to the first stent segment.
  • the apexes of the third protrusion on the end are on the same axis.
  • the apex of the first protrusion at the proximal end of the first bare section and the apex of the third protrusion at the proximal end of the first stent section are equally spaced along the circumferential direction of the blood vessel stent.
  • the length L3 of the first bare section in the axial direction is 1-10 mm.
  • the number of first protrusions of the first bare section is 1-10.
  • the blood vessel stent further includes a second naked section, the second naked section includes at least one second protrusion formed by braiding a metal wire in the circumferential direction, and the proximal end of the second naked section is connected to the first The distal ends of the two stent segments are connected.
  • first bare section and the first stent section partially overlap in the axial direction, and the first bare section partially extends beyond the first stent section in the axial direction.
  • the angle between the extension direction of the first bare section and the axial direction of the blood vessel stent is 0°-60°.
  • the mesh density of the first bare section and the mesh density of the second bracket section are both smaller than the mesh density of the first bracket section.
  • the present invention has the following beneficial effects:
  • the blood vessel stent body includes a first stent section and a second stent section with different mesh densities.
  • the mesh density of the stent body changes, which is beneficial for different applications.
  • the location of the venous lesion area for example, for the iliac vein, the right iliac vein is compressed by the right iliac artery, and the location is located at the beginning of the right iliac vein, which requires high compression resistance, so the stent structure here can be high
  • the weaving structure of the density mesh, and the area that needs strong support strength and anti-extrusion performance according to the anatomical structure in the later period can be high-density mesh weaving, and the degree of mesh density can be different according to different needs. Areas with high bending performance can adopt a braided structure with low mesh density.
  • the venous stent can treat various venous diseases.
  • Adhesion performance according to the anatomical shape of blood vessels, there are variable diameter structures that can conform to the shape of blood vessels and are suitable for various blood vessel diameters.
  • Figure 1 is a schematic diagram of the structure of a blood vessel stent in an embodiment of the invention
  • FIG. 2 is a schematic diagram of the structure of a grid unit in an embodiment of the present invention.
  • Figure 3 is a schematic diagram of a vein being compressed in an embodiment of the present invention.
  • FIG. 4 is a schematic diagram of the use state of the blood vessel stent after implantation in the human body in the embodiment of the present invention
  • Figures 5(a) to 5(d) are schematic diagrams of partial distribution of the first bare segment in an embodiment of the present invention.
  • the first naked section 131 The first bump 14 grid unit
  • proximal and distal are used as orientation words, where “proximal” means the end close to the heart; “distal” means the end far away from the heart.
  • proximal means the end close to the heart; “distal” means the end far away from the heart.
  • distal means the end far away from the heart.
  • the term “or” is usually used in the meaning including “and/or”, unless the content clearly indicates otherwise.
  • the blood vessel stent 1 provided in this embodiment includes a stent body 10, which is woven into a mesh tubular structure by metal wires, and has a plurality of mesh units 14, and the stent body 10 includes an axial direction Connecting the first stent section 11 and the second stent section 12, the proximal area of the stent body 10 is woven into the first stent section 11 by metal wires, the first stent section 11 has a smaller mesh diameter and a larger mesh density; The distal region of the stent body 10 is woven into the second stent section 12 by metal wires.
  • the second stent section 12 has a larger mesh diameter and a smaller mesh density.
  • the compressed part of the vein needs strong support strength, which can make the mesh of the stent body 10 dense, increase the support strength and local anti-extrusion performance; while the uncompressed part and the cross-joint part need good flexibility, the stent can be made here
  • the mesh becomes larger, increasing its flexibility and adhesion.
  • L2 is the first stent section 11, the mesh in this area is small, the distance H1 between the two opposite vertices of the grid unit in the axial direction is preferably 1-4 mm, and L4 is the second
  • the stent section 12 has a large area mesh, and the distance H2 between two opposite vertices of the area grid unit in the axial direction is preferably 2-6 mm.
  • the stent body 10 can have a variable diameter or an equal diameter structure in the axial direction.
  • the variable diameter stent is more in line with the anatomical structure of the vein and is more suitable for the characteristics of venous blood vessels. It has greater advantages for long-segment lesions, and the variable diameter stent can better Comply with blood vessel shape.
  • Isometric stents can be applied to a small number of lesions. The lesions are short and the diameter changes little. Isometric stents can be applied.
  • the stent body 10 is a variable-diameter stent in the axial direction
  • the proximal diameter D1 of the stent body 10 is preferably 8-22 mm
  • the distal diameter D2 of the stent body 10 is preferably 6-20 mm.
  • the difference between the proximal diameter D1 and the distal diameter D2, that is, the reduced diameter size may be 2 mm or 4 mm.
  • the metal wire of the braided blood vessel stent 1 can be made of memory alloy, stainless steel, titanium alloy, nickel alloy, cobalt-chromium alloy and biodegradable material; preferably, the stent body 10 is braided by NiTi (nickel titanium) wire with a wire diameter Between 0.1-0.5 mm, the entire blood vessel stent 1 can be made of one wire or multiple wires. One wire weaving has few connection points; while multiple wires weaving have good wall adhesion performance and high processing efficiency.
  • the mesh unit 14 woven by the metal wire is a diamond mesh; the side length of the diamond mesh is A, and the angle of the diamond is ⁇ .
  • the number of wires affects each other.
  • the shorter the side length A the larger the angle ⁇ , the stronger the support strength/extrusion resistance and the better the bending performance of the manufactured stent; the greater the side length A Longer, the smaller the angle ⁇ , the weaker the support strength/extrusion resistance of the bracket and the poorer bending performance.
  • the number of metal wires is preferably 8-32, the length of the side length A is between 1-5 mm, and the angle ⁇ is between 90° and 160°. Good implementation effect.
  • the vascular stent 1 will be extended to the inferior vena cava 2. If the extension length is too long, the blood flow of the contralateral vein will be affected in the long term, and it will be extended. If the stent is too dense, it will also affect the blood flow of the contralateral vein and cause the contralateral vein to be occluded in the long term.
  • the proximal end of the stent body 10 is provided with a first bare section 13 which includes at least one first protrusion 131 formed by braiding a metal wire in the circumferential direction.
  • the distal end of the first bare section 13 and the second The proximal end of a stent section 11 is connected, and the distal end of the first stent section 11 is connected to the proximal end of the second stent section 12.
  • the first bare section 13 and the first stent section 11 are partially axially connected. Overlap, and the first bare section 13 partially extends beyond the first stent section 11 in the axial direction.
  • the distal end of the stent body 10 is provided with a second bare section (not shown).
  • the second bare section includes at least one second protrusion (not shown) formed by braiding a metal wire in the circumferential direction.
  • the proximal end of the second bare section The distal end of the second stent section 12 is connected, and the distal end of the first stent section 11 is connected to the proximal end of the second stent section 12.
  • the proximal first bare segment 13 can effectively treat iliac-inferior cavity lesions.
  • the length of the first bare segment 13 is not long and the number will not affect the blood flow of the contralateral vein; the distal second bare segment can affect the distal lesions
  • the branch of the vein is expanded without affecting the blood flow of other branches.
  • the length L3 of the first protrusion 131 in the axial direction is preferably 1-10 mm, and the angle ⁇ formed between the extension direction of the first protrusion 131 and the axial direction of the stent body may be 0-60°,
  • the number of first protrusions 131 is controlled within 1-10, and the relationship between the first bare section 13 and the proximal apex of the first stent section 11 is shown in Figures (a) to 5(d).
  • the proximal end of the first stent section includes at least one third protrusion formed by braiding metal wire in the circumferential direction, and the apex of the first protrusion at the proximal end of the first bare section 13 and the first protrusion at the proximal end of the first stent section 11
  • the apexes of the three protrusions can be on the same axis. This structure has strong applicability.
  • the apex of the third protrusion at the proximal end of the first stent section 11 can also be at the first protrusion at the proximal end of the two adjacent first bare sections 13 Between the apexes of the structure, the structure has good adhesion; preferably, the apex of the first protrusion at the proximal end of the first bare section 13 and the apex of the third protrusion at the proximal end of the first stent section 11 are along the vascular stent 1 Since the vein anatomical structure is elliptical, the first naked section 13 can also be designed as a heightened structure, a contoured structure or a spiral structure, etc., to adapt to different vein shapes.
  • Figures 5(a) to 5(d) can be extended into the inferior vena cava, in which Figure 5(a) the first bare section 13 is a separate structure, specifically, the apex of the proximal end of the first stent section 11 Between the apexes of the proximal ends of two adjacent first bare sections 13, and the height of each first protrusion 131 is the same in the axial direction, this structure can extend the vascular stent 1 into the inferior vena cava to ensure its vascular shape , It can also ensure the adhesion performance of the vascular stent 1 to the iliac vein; in Fig.
  • the apex of the first protrusion at the proximal end of the first bare section 13 and the proximal end of the first stent section 11 The apexes of the third protrusions are located on the same axis, and the heights of the apexes of the first protrusions 131 are the same in the axial direction.
  • This structure can make the blood vessel stent 1 have good adhesion performance, strong support strength and anti-extrusion performance.
  • the first bare section 13 in Figure 5(d) is a heightened structure. Specifically, the height of the apex of the first protrusion 131 in the axial direction gradually increases.
  • the vascular stent 1 of this structure can be implanted in the inferior vena cava.
  • the short first protrusion 131 is located at the bifurcation of the inferior vena cava, and the long first protrusion 131 is located at the straight section of the inferior vena cava, which facilitates the smooth flow of blood in the contralateral vein.
  • the first bare section 13 can be prepared in different structures according to requirements.
  • a second bare section can also be added at the distal end to avoid affecting the blood flow of other branches.
  • the structure, number, and shape of the second bare section are similar to those of the first bare section 13, and different structures are woven according to requirements.
  • the vascular stent 1 provided by the present invention has a change in mesh density, which is beneficial to be used in venous diseased areas at different locations.
  • the right iliac vein is compressed by the right iliac stent body, where the position is located right from the right iliac vein.
  • the initial section requires high compression resistance, so the support structure here can be a high-density mesh structure, and the later stage can be a high-density structure according to the anatomical structure that requires strong support strength and anti-extrusion performance.
  • the degree of change of mesh density can be different for different clinical needs. Areas with high bending performance can adopt a braided structure with low mesh density.
  • the proximal end of the stent body 10 is provided with a first bare section 13 so that the overall stent can extend from the iliac vein into the inferior vena cava, without affecting the blood flow of the contralateral vein, and ensuring the integrity of the stent after being placed in the vein.
  • the second bare segment at the distal end can cross other vein branches to avoid affecting the blood flow of other branches.
  • the venous stent provided by the invention can treat various venous diseases.
  • the first stent section 11 for the compression site can improve the support strength and anti-extrusion performance
  • the large mesh second stent section 12 for the curved site can be used Increase the flexibility and adhesion performance
  • the anatomical shape of the blood vessel there is a variable diameter structure that can conform to the shape of the blood vessel and is suitable for various blood vessel diameters.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Surgery (AREA)
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  • Inorganic Chemistry (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

本发明公开了一种血管支架，包括支架主体，所述支架主体为由金属丝编织成的网管状结构，其中，所述支架主体包括在轴向上连接的第一支架段和第二支架段，所述第一支架段的网孔密度与所述第二支架段的网孔密度不同。本发明提供的血管支架针对累及下腔静脉和髂股静脉狭窄有裸段可以提高治疗效果，针对压迫部位有网孔密度较大的密网结构可以提高支撑强度和抗挤压性能，针对弯曲部位有网孔密度较小的疏网结构可以增加柔顺性能和贴壁性能；针对血管解剖形态有变径结构可以顺应血管形态，适用于各种血管直径。

Description

一种血管支架 技术领域
本发明涉及血管介入医疗领域，尤其涉及一种血管支架。
 背景技术
静脉疾病目前是血管外科疾病中较常见的疾病，尤其是髂静脉受压综合征，就是指髂动脉受压导致腔内粘连、狭窄或闭塞，从而发生各种临床症状的综合征。髂静脉受压综合征发生率在20%-40%。
近几年介入治疗已作为治疗静脉受压的常规术式，目前市面上用于治疗静脉狭窄的支架有切割支架和编织支架，切割支架可以支撑狭窄闭塞段血管，减少血管弹性回缩，保持管腔血流通畅，但也有一些不足之处，如柔顺性不足，易断裂等问题。而编织支架是由一根丝或多根丝编制缠绕而成的网状结构，编织支架由于具有良好的柔顺性、较强的支撑力和良好的贴壁性等优点而受到越来越多的关注。
 技术问题
本发明所要解决的技术问题是提供一种血管支架，同时具有强的支撑强度和优异的柔顺性。
 技术解决方案
本发明为解决上述技术问题而采用的技术方案是提供一种血管支架，包括支架主体，所述支架主体为由金属丝编织成的网管状结构，其中，所述支架主体包括在轴向上连接的第一支架段和第二支架段，所述第一支架段的网孔密度与所述第二支架段的网孔密度不同。
进一步地，所述支架主体在轴向上为变径结构，且所述支架主体的近端直径D1大于其远端直径D2。
进一步地，所述支架主体的近端直径D1为8-22mm，所述支架主体的远端直径D2为6-20mm。
进一步地，所述支架主体的网孔为菱形网孔，所述菱形网孔的边长A为1-5mm，所述菱形网孔的夹角β为90°-160°。
进一步地，所述第一支架段中菱形网孔的两条对角线中较短的对角线长度为1-4mm，所述第二支架段中菱形网孔的两条对角线中较短的对角线长度为2-6mm。
进一步地，所述血管支架还包括第一裸段，所述第一裸段在周向上包括至少一个由金属丝编织形成的第一凸起，所述第一裸段的远端与所述第一支架段的近端连接，所述第一支架段的远端与所述第二支架段的近端连接。
进一步地，所述第一支架段的近端在周向上包括至少一个由金属丝编织形成的第三凸起，所述第一裸段的第一凸起的顶点与所述第一支架段近端的第三凸起的顶点在同一轴线上。
进一步地，所述第一裸段近端的第一凸起的顶点与所述第一支架段近端的第三凸起的顶点沿着所述血管支架的周向等间距分布。
进一步地，所述第一裸段在轴向上的长度L3为1-10mm。
进一步地，所述第一裸段的第一凸起数量为1-10个。
进一步地，所述血管支架还包括第二裸段，所述第二裸段在周向上包括至少一个由金属丝编织形成的第二凸起，所述第二裸段的近端与所述第二支架段的远端连接。
进一步地，所述第一裸段与所述第一支架段在轴向上部分重叠，且所述第一裸段在轴向上部分延伸超出所述第一支架段。
进一步地，所述的第一裸段的延伸方向与所述的血管支架的轴线方向的夹角为0°-60°。
进一步地，所述第一裸段的网孔密度和所述第二支架段的网孔密度均小于所述第一支架段的网孔密度。
 有益效果
本发明对比现有技术有如下的有益效果：本发明提供的血管支架，血管支架主体包括具有不同网孔密度的第一支架段和第二支架段，支架主体网孔密度变化，有利于使用不同位置静脉病变区域，例如对于髂静脉而言，右髂静脉被右髂动脉压迫，此处位置正位于右髂静脉起始段，需要高的抗挤压性能，所以此处的支架结构可以是高密度网孔的编制结构，以及后期根据解剖结构需要强的支撑强度和抗挤压性能区域可以是高密度网孔编制，根据不同需求网孔密度程度可以不同。弯曲性能高的区域可以采用网孔密度低的编制结构，网孔变大可以增加其弯曲性能和柔顺性能更加贴合血管形态；还有支架主体设置成变径结构可以更好的顺应血管形态。特别是支架主体近端设置第一裸段，可以使整体支架伸出髂静脉伸入下腔静脉，而不影响对侧静脉血流，又能保证支架放入静脉后的完整性。而远端设置第二裸段可以跨越其他静脉分支，避免影响其他分支血流。采用本发明提供的静脉血管支架，可以治疗各种静脉疾病。针对累及下腔静脉和髂股静脉狭窄有裸段可以提高治疗效果，针对压迫部位有密网结构可以提高支撑强度和抗挤压性能，针对弯曲部位有大网孔疏网结构可以增加柔顺性能和贴壁性能；针对血管解剖形态，有变径结构可以顺应血管形态，适用于各种血管直径。
 附图说明
图1为本发明实施例中血管支架结构示意图；
图2为本发明实施例中网格单元的结构示意图；
图3为本发明实施例中静脉被压迫的示意图；
图4为本发明实施例中血管支架植入人体后的使用状态示意图；
图5(a)～5(d)为本发明实施例中第一裸段的局部分布示意图。
图中：
1 血管支架          2 静脉             3 动脉
10 支架主体         11 第一支架段      12第二支架段
13 第一裸段         131 第一凸起       14 网格单元
 本发明的实施方式
下面结合附图和实施例对本发明作进一步的描述。
为了更加清楚地描述本发明的结构特征，采用“近端”、“远端”作为方位词，其中“近端”表示在靠近心脏一端；“远端”表示远离心脏一端。术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。
请参见图1和图2，本实施例提供的血管支架1，包括支架主体10，支架主体10由金属丝编织成网管状结构，具有多个网格单元14，支架主体10包括在轴向上连接的第一支架段11和第二支架段12，支架主体10的近端区域由金属丝编织成第一支架段11，第一支架段11的网孔孔径较小，网孔密度较大；支架主体10的远端区域由金属丝编织成第二支架段12，第二支架段12的网孔孔径较大，网孔密度较小。静脉被压迫处需要强的支撑强度，可以使支架主体10的网孔变密，增加支撑强度和局部抗挤压性能；而未压迫处以及跨关节处需要好的柔顺性，可以使此处支架的网孔变大，增加其柔顺性和贴壁性。具体地，图1中，L2为第一支架段11，此区域网孔小，此区域网格单元在轴向上的两个相对顶点之间的间距H1优选为1-4mm，L4为第二支架段12，区域网孔大，此区域网格单元在轴向上的两个相对顶点之间的间距H2优选为2-6mm。
支架主体10在轴向上可以是变径也可以是等径结构，其中变径支架更为符合静脉解剖结构，更适合静脉血管特征，对于长段病变优势较大，变径支架可以更好地顺应血管形态。等径支架对于少量病变区域可以适用，病变区域短，直径变化不大，等径支架可以适用。在一实施方式中，支架主体10在轴向上为变径支架，支架主体10的近端直径D1优选为8-22mm，支架主体10的远端直径D2优选为6-20mm。为了更加顺应血管形态，较佳地，近端直径D1与远端直径D2之差，即变径尺寸可以是2mm，也可以是4mm。
编织血管支架1的金属丝可以是记忆合金、不锈钢、钛合金、镍合金、钴铬合金和生物可降解材料；较佳地，支架主体10是由NiTi（镍钛）丝编织而成，丝径在0.1-0.5mm之间，整个血管支架1可以是一根金属丝编制也可以是多根金属丝编制。一根金属丝编制连接点少；而多根金属丝编制贴壁性能好，加工效率高。
请参见图2，较佳地，所述金属丝编织成的网格单元14为菱形网孔；菱形网孔的边长为A，菱形夹角为β，这两个参数和支架主体10所用的金属丝的数量相互影响。支架主体10所用的金属丝的数量固定的情况下，边长A越短，角度β越大，制作出的支架的支撑强度/抗挤压能力就越强，弯曲性能越好；边长A越长，角度β越小，支架的支撑强度/抗挤压能力就越弱，弯曲性能差。边长A固定的情况下，支架所用的丝的数量越多，角度β越小，支架的支撑强度/抗挤压能力就越弱，弯曲性能差，反之金属丝数量越少，角度β越大，支架的支撑强度/抗挤压能力就越强，弯曲性能好；角度β固定的情况下，金属丝的数量越多，边长A越短，支架的支撑强度/抗挤压能力就越强，弯曲性能好；反之，金属丝的数量越少，边长A越长，支架的支撑强度/抗挤压能力就越弱，弯曲性能差。经测试，对于静脉支架，除了需要较强的支撑强度和抗挤压能力，还需要优异的弯曲性能和柔顺性能。因此，在一较佳实施方式中，金属丝的数量优选为8-32根，边长A的长度在1-5mm之间，角度β在90°-160°之间三者相互匹配可以得到较好的实施效果。
请参见图3和图4，如果累及下腔静脉疾病，会将血管支架1伸入至下腔静脉2，如果伸入长度太多，远期会对对侧静脉血流有影响，且如伸入支架段太密，也会对对侧静脉血流有影响，远期会造成对侧静脉闭塞。较佳地，支架主体10近端设置有第一裸段13，第一裸段13在周向上包括至少一个由金属丝编织形成的第一凸起131，第一裸段13的远端与第一支架段11的近端连接，第一支架段11的远端与第二支架段12的近端连接，在一实施方式中，第一裸段13与第一支架段11在轴向上部分重叠，且第一裸段13在轴向上部分延伸超出第一支架段11。支架主体10远端设置有第二裸段（图未示），第二裸段在周向上包括至少一个由金属丝编织形成的第二凸起（图未示），第二裸段的近端与第二支架段12的远端连接，第一支架段11的远端与第二支架段12的近端连接。近端第一裸段13可以有效治疗累及髂-下腔病变，第一裸段13长度不长且个数少不会影响对侧静脉血流；远端第二裸段可以对累及远端病变的静脉分支进行扩张，不影响其他分支血流。请参见图1，第一凸起131在轴向上的长度L3优选为1-10mm，第一凸起131的延伸方向与支架主体的轴线方向之间形成的角度α可以是0-60°，第一凸起131的个数控制在1-10个，且第一裸段13和第一支架段11近端顶点的关系如图(a)～5(d)所示。主要有几下几种结构：
所述第一支架段的近端在周向上包括至少一个由金属丝编织形成的第三凸起，第一裸段13近端的第一凸起的顶点与第一支架段11近端的第三凸起的顶点可以在同一轴线上，该结构适用性强，第一支架段11近端的第三凸起的顶点也可以在两个相邻第一裸段13近端的第一凸起的顶点之间，该结构贴壁性好；较佳地，第一裸段13近端的第一凸起的顶点与第一支架段11近端的第三凸起的顶点沿着血管支架1的周向平均分配，因静脉解剖结构为椭圆形，第一裸段13还可以设计为变高结构、等高结构或螺旋结构等，用于适应不同静脉形态。图5(a)～5(d)所示几种结构均可伸入下腔静脉，其中图5（a）第一裸段13为相隔结构，具体地，第一支架段11近端的顶点在两个相邻第一裸段13近端的顶点之间，且各个第一凸起131在轴向上的高度相同，这种结构既可将血管支架1伸入下腔静脉保证其血管形态，又能保证血管支架1对髂静脉贴壁性能；图5（b）和（c）中，第一裸段13的近端的第一凸起的顶点与第一支架段11的近端的第三凸起的顶点位于同一轴线上，且各个第一凸起131的顶点在轴向上的高度相同，该结构可以使血管支架1具有良好的贴壁性能、强的支撑强度和抗挤压性能。图5（d）中第一裸段13为变高结构，具体地，第一凸起131的顶点在轴向上的高度逐渐变高，该结构的血管支架1植入下腔静脉后可以使短的第一凸起131位于下腔静脉分叉处，长的第一凸起131位于下腔静脉直段，有利于对侧静脉血流通畅度。第一裸段13可以根据需求编制不同结构。除了近端第一裸段13，远端也可以增加第二裸段，避免影响其他分支血流。第二裸段的结构、数量、形状和第一裸段13类似，根据需求编织不同结构。
本发明提供的血管支架1的网孔密度有变化，有利于用于不同位置静脉病变区域，例如对于髂静脉而言，右髂静脉被右髂支架主体压迫，此处位置正位于右髂静脉起始段，需要高的抗挤压性能，所以此处的支架结构可以是高密度网孔的编制结构，且后期根据解剖结构需要强的支撑强度和抗挤压性能区域可以是高密度编制，根据不同临床需求，网孔密度的变化程度可以不同。弯曲性能高的区域可以采用网孔密度低的编制结构，网孔变大可以增加其弯曲性能和柔顺性能更加贴合血管形态，还有设置成变径支架可以更好的顺应血管形态。特别是支架主体10近端设置有第一裸段13，可以使整体支架伸出髂静脉伸入下腔静脉，而不影响对侧静脉血流，又能保证支架放入静脉后的完整性。而远端设置第二裸段可以跨越其他静脉分支，避免影响其他分支血流。采用本发明提供的静脉血管支架，可以治疗各种静脉疾病。针对累及下腔静脉和髂股静脉狭窄有裸段可以提高治疗效果，针对压迫部位有第一支架段11可以提高支撑强度和抗挤压性能，针对弯曲部位有大网孔第二支架段12可以增加柔顺性能和贴壁性能；针对血管解剖形态，有变径结构可以顺应血管形态，适用于各种血管直径。
虽然本发明已以较佳实施例揭示如上，然其并非用以限定本发明，任何本领域技术人员，在不脱离本发明的精神和范围内，当可作些许的修改和完善，因此本发明的保护范围当以权利要求书所界定的为准。

Claims (14)

  1. 一种血管支架，包括支架主体，所述支架主体为由金属丝编织成的网管状结构，其特征在于，所述支架主体包括在轴向上连接的第一支架段和第二支架段，所述第一支架段的网孔密度与所述第二支架段的网孔密度不同。
  2. 如权利要求1所述的血管支架，其特征在于，所述支架主体在轴向上为变径结构，且所述支架主体的近端直径D1大于其远端直径D2。
  3. 如权利要求2所述的血管支架，其特征在于，所述支架主体的近端直径D1为8-22mm，所述支架主体的远端直径D2为6-20mm。
  4. 如权利要求1所述的血管支架，其特征在于，所述支架主体的网孔为菱形网孔，所述菱形网孔的边长A为1-5mm，所述菱形网孔的夹角β为90°-160°。
  5. 如权利要求4所述的血管支架，其特征在于，所述第一支架段中菱形网孔的两条对角线中较短的对角线长度为1-4mm，所述第二支架段中菱形网孔的两条对角线中较短的对角线长度为2-6mm。
  6. 如权利要求1所述的血管支架，其特征在于，所述血管支架还包括第一裸段，所述第一裸段在周向上包括至少一个由金属丝编织形成的第一凸起，所述第一裸段的远端与所述第一支架段的近端连接，所述第一支架段的远端与所述第二支架段的近端连接。
  7. 如权利要求6所述的血管支架，其特征在于，所述第一支架段的近端在周向上包括至少一个由金属丝编织形成的第三凸起，所述第一裸段的第一凸起的顶点与所述第一支架段近端的第三凸起的顶点在同一轴线上。
  8. 如权利要求6所述的血管支架，其特征在于，所述第一裸段近端的第一凸起的顶点与所述第一支架段近端的第三凸起的顶点沿着所述血管支架的周向等间距分布。
  9. 如权利要求6所述的血管支架，其特征在于，所述第一裸段在轴向上的长度L3为1-10mm。
  10. 如权利要求6所述的血管支架，其特征在于，所述第一裸段的第一凸起数量为1-10个。
  11. 如权利要求6所述的血管支架，其特征在于，所述第一裸段与所述第一支架段在轴向上部分重叠，且所述第一裸段在轴向上部分延伸超出所述第一支架段。
  12. 如权利要求6所述的血管支架，其特征在于，所述的第一裸段的延伸方向与所述的血管支架的轴线方向的夹角为0°-60°。
  13. 如权利要求6所述的血管支架，其特征在于，所述第一裸段的网孔密度和所述第二支架段的网孔密度均小于所述第一支架段的网孔密度。
  14. 如权利要求1-13任一项所述的血管支架，其特征在于，所述血管支架还包括第二裸段，所述第二裸段在周向上包括至少一个由金属丝编织形成的第二凸起，所述第二裸段的近端与所述第二支架段的远端连接。
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