WO2019075790A1 - Stent pour vaisseau sanguine - Google Patents

Stent pour vaisseau sanguine Download PDF

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Publication number
WO2019075790A1
WO2019075790A1 PCT/CN2017/109266 CN2017109266W WO2019075790A1 WO 2019075790 A1 WO2019075790 A1 WO 2019075790A1 CN 2017109266 W CN2017109266 W CN 2017109266W WO 2019075790 A1 WO2019075790 A1 WO 2019075790A1
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WO
WIPO (PCT)
Prior art keywords
repeating
blood vessel
repeating unit
vessel stent
support body
Prior art date
Application number
PCT/CN2017/109266
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English (en)
Chinese (zh)
Inventor
胡清
刘继勇
潘幸珍
王志高
秦泗海
谭茂彩
Original Assignee
科塞尔医疗科技苏州有限公司
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Publication date
Application filed by 科塞尔医疗科技苏州有限公司 filed Critical 科塞尔医疗科技苏州有限公司
Publication of WO2019075790A1 publication Critical patent/WO2019075790A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other

Definitions

  • the invention belongs to the field of medical instruments, and in particular relates to a blood vessel stent.
  • Coronary atherosclerosis is one of the major cardiovascular diseases that threaten human life in contemporary society.
  • clinical stent implantation is the main method for the treatment of coronary artery stenosis.
  • interventional therapy is accepted by the vascular surgery community.
  • the patient can accept it. Now many hospitals in China have This work was carried out.
  • tubular stents are the most common type of stent used for coronary stenting.
  • tubular supports are generally fabricated by laser engraving or etching of metal pipes.
  • the tubular support is generally composed of a support body and a connecting body.
  • the support and the connector can be divided into two types, one is called an open-loop structure, such as the BX-Velocity bracket designed by Cordis; the other is called a closed-loop structure, such as Guidant. Designed Multi-Link bracket.
  • the support bodies of most of the brackets are symmetrically arranged along the axial direction of the brackets, and the two ends of the connecting body are respectively connected with the outer side of the arc of the supporting body.
  • the support body and the connecting body are composed of straight segments and circular arc segments.
  • the deformability is poor.
  • the ability of the stent to adapt to blood vessels is poor, which may cause damage to the endometrium. Or an adverse phenomenon such as an inflammatory reaction.
  • vascular stents as a heterologous body in the human body is closely related to the health of the patient after treatment. Therefore, not only the design and material requirements of the bracket are almost ideal, but also the mechanical properties such as support performance, compliant performance, fatigue life and fluid mechanics of the bracket are put forward, so it is necessary to develop a new type of vascular stent. Applied research.
  • the technical problem to be solved by the present invention is to overcome the deficiencies of the prior art and provide a blood vessel stent having different structures.
  • the blood vessel stent has difficulty in forming intravascular restenosis, has good tissue compatibility, and has appropriate supporting force for blood vessels. It affects blood flow, has simple structure, convenient operation and accurate positioning, and can meet the needs of clinical treatment of vascular stenosis.
  • the present invention adopts the following technical solutions:
  • the present application relates to a blood vessel stent comprising a support body and a connecting body,
  • the support body includes a plurality of repeating units.
  • the connecting body comprises a plurality of repeating monomers
  • the plurality of repeating units of the support body are arranged along the axial direction of the bracket,
  • the adjacent repeating units of the support are connected by at least one repeating monomer.
  • the repeating unit is composed of a circular arc segment or a polygonal line segment, and each of the repeating units is asymmetrically arranged along the axial direction of the stent.
  • the repeating monomer is composed of a circular arc segment or a polygonal segment, and each of the repeating monomers is asymmetrically arranged along the axial direction of the stent.
  • the plurality of repeating units of the support body comprise a plurality of first repeating units and a plurality of second repeating units, wherein the first repeating unit and the second repeating unit are alternately arranged, and the supporting body is
  • the first repeating unit includes a plurality of first arc segments, and the adjacent first arc segments are connected by a first excessive arc, and the bending directions of the plurality of first arc segments of the first repeating unit
  • the second repeating unit of the support body includes a plurality of second circular arc segments, and the adjacent second circular arc segments are connected by a second excessive arc, and the plurality of second repeating units are The second arc segment has the same bending direction.
  • the plurality of the first circular arc segments and the plurality of second circular arc segments have the same radius of curvature.
  • the first repeating unit is obtained by rotating the second repeating unit by 180°.
  • the first excessive arc and the second excessive arc are offset by 0.1 to 0.5 mm in the circumferential direction of the blood vessel stent.
  • the plurality of repeating monomers of the connecting body comprise a plurality of first repeating monomers and a plurality of second repeating monomers, wherein the plurality of first repeating monomers have the same bending direction, and the plurality of second repeating monomers The direction of the bend is the same.
  • one end of the first repeating monomer is connected to the outer side of the first excessive arc, and the other end is connected to the inner side of the second excessive arc; the second repeating monomer Connected to one end The outer side of the second excessive arc is connected to the inner side of the first excessive arc.
  • the first repeating monomer and the second repeating monomer of the linker are rotated by 180°.
  • the first repeating monomer has the same bending direction as the second circular segment of the second repeating unit; the second repeating monomer and the first round of the first repeating unit The arcs have the same bending direction.
  • the first repeating unit and the second repeating unit of the connecting body have a radius of curvature greater than the first repeating unit and the second repeating unit of the supporting body to constitute the first circular arc segment and the second circular arc The radius of the segment curvature.
  • the length of the connecting body in the axial direction of the blood vessel stent is 1 to 1.5 times the length of the support body in the axial direction of the blood vessel stent.
  • the number of the first repeating unit and the second repeating unit of the support body is the same, and the number of units is 4-20.
  • the number of the first repeating monomer and the second repeating monomer of the linker is the same or different, and the number of monomers is 2-16.
  • the number of repeating units is greater than the number of repeating monomers.
  • the distance between the first repeating unit and the second repeating unit in the axial direction of the blood vessel stent is 0.5 to 3 mm.
  • the repeating unit repeating unit has a width of 0.05 to 0.3 mm.
  • the width of the repeating monomer is 40 to 80% of the width of the repeating unit.
  • the support body and the connecting body of the blood vessel stent have the same wall thickness.
  • the present invention has the following advantages compared with the prior art:
  • the blood vessel stent of the invention is particularly suitable for coronary artery, and has good supporting effect on the coronary artery.
  • the support body of the blood vessel stent of the invention comprises a plurality of repeating units, and each repeating unit can effectively coordinate deformation, thereby reducing the axial shortening rate. Provides accurate positioning when released.
  • Figure 1 is a schematic view showing the structure of the stent of the embodiment 1 in a plane
  • FIG. 2 is an enlarged view of a first repeating unit and a second repeating unit
  • Figure 3 is an enlarged view of the first repeating unit
  • Figure 4 is an enlarged view of the second repeating unit
  • Figure 5 is an enlarged view of the first repeating monomer
  • Figure 6 is an enlarged view of the second repeating monomer
  • Figure 7 is a schematic view showing the structure of the stent of the embodiment 2 expanded into a plane
  • Figure 8 is a schematic view showing the structure of the stent of the embodiment 3 expanded into a plane
  • Figure 9 is a schematic view showing the structure of the stent of the embodiment 4 in a plane
  • L2 first repeating unit 1 and second repeating unit 2 are spaced apart in the axial direction of the bracket;
  • the blood vessel stent of the invention is mainly suitable for use in human blood vessels, and is particularly suitable for use in coronary arteries (see Fig. 1).
  • the vascular stent is mounted on the balloon of the stent delivery system.
  • the vascular stent is in a compressed state, and when the conveyor transports the vascular stent to the lesion position, the balloon is filled by the pressure pump.
  • the blood vessel stent is expanded outward to an expanded state to support the coronary artery, the blood vessel stent has a first cross section in a compressed state, a second cross section in an expanded state, and a diameter of the first cross section Less than the diameter of the second cross section.
  • the first cross section and the second cross section are perpendicular to the axis of the blood vessel stent.
  • the outer diameter of the second cross section is 2 to 8 mm, preferably 2 to 5 mm.
  • the material of the blood vessel stent is one or more of stainless steel, memory alloy, titanium alloy, tantalum alloy, cobalt chromium alloy, biodegradable metal, biodegradable polymer, magnesium alloy, and pure iron.
  • Stainless steel can be made of SUS-316L stainless steel or the like.
  • the memory alloy may be a Ni-Ti alloy, a Cu-Al-Mn alloy or the like.
  • Cobalt chromium The alloy may be CoCr-L605 cobalt chromium alloy or the like.
  • Biodegradable metal is a metal that can be decomposed in the human body, such as pure magnesium, magnesium alloy, pure iron and iron alloy.
  • the biodegradable polymer may be a biodegradable polymer such as polylactic acid, polyglycolic acid, poly(lactic acid- ⁇ -caprolactone), poly(glycolic acid- ⁇ -caprolactone).
  • a biodegradable polymer material can be applied to the degradable metal in the body as a material for the vascular stent.
  • the blood vessel stent of the present invention can be molded in one time by laser engraving.
  • Laser engraving production process Firstly, the cutting path is created by CAM based on the bracket design drawing; secondly, the metal or polymer material is laser-cut; finally, the surface finish is improved by pickling and electrochemical processes to make the edges of the edges round.
  • the blood vessel stent includes a support body and a connecting body, the support body includes a plurality of repeating units, and the connecting body includes a plurality of repeats.
  • Monomer, a plurality of repeating units of the support are arranged along the axial direction of the support, and adjacent repeating units of the support are connected by at least one repeating monomer.
  • the plurality of repeating units of the support body include a plurality of first repeating units 1 and a plurality of second repeating units 2, and the first repeating unit 1 and the second repeating unit 2 are alternately arranged at intervals, and the first repeating unit 1 obtained by rotating the second repeating unit 2 by 180°.
  • the plurality of repeating monomers of the connecting body include a plurality of first repeating monomers 3 and second repeating monomers 4, and the first repeating monomer 3 and the second repeating monomer 4 of the connecting body are rotated by 180° owned.
  • the first repeating unit 1 has a first excessive arc 12
  • the second repeating unit 2 has a second excessive arc 22, the first excessive arc 12 and the second excessive arc 22 is 0.1 to 0.5 mm in the circumferential direction.
  • the first repeating unit 1 and the second repeating unit 2 of the support body are arranged asymmetrically along the axial direction of the stent, and are spaced apart from each other by 0.1 to 0.5 mm in the axial direction.
  • the adjacent repeating units of the support are connected by at least one first repeating monomer 3 or second repeating monomer 4.
  • the number of the first repeating unit 1 and the second repeating unit 2 of the support is the same, and the number of units is 4-20.
  • the number of the first repeating monomer 3 and the second repeating monomer 4 of the linker is the same or different, and the number of monomers is 2-16.
  • the number of the first repeating unit 1 and the second repeating unit 2 of the support is larger than the number of the first repeating monomer 3 and the second repeating monomer 4 of the connecting body.
  • the repeating unit of the support body and the repeating unit of the connecting body are composed of arc segments connected.
  • the first repeating unit 1 of the support body comprises a plurality of first circular arc segments 11, 13, and the adjacent first circular arc segments 11, 13 are connected by a first excessive arc 12, the first
  • the second repeating unit 2 includes a plurality of second circular arc segments 21, 23, and adjacent second circular arc segments 21, 23 are connected by a second excessive arc 22, and the plurality of first circular arc segments 11 , 13 and multiple second arcs
  • the curvature radii of the segments 21, 23 are the same.
  • the bending directions of the plurality of first circular arc segments 11, 13 of the first repeating unit 1 are the same, and the bending directions of the plurality of second circular arc segments 21, 23 of the second repeating unit 2 are the same.
  • the first repeating unit 1 has the same bending direction as the second circular arc segments 21, 23 of the second repeating unit 4; the second repeating unit 2 and the first repeating monomer 3
  • the first arc segments 11, 13 have the same bending direction.
  • the radius of curvature of the first repeating monomer 3 and the second repeating monomer 4 of the connecting body is larger than the radius of curvature of the first repeating unit 1 and the second repeating unit 2 of the support.
  • the distance between the first repeating unit 1 and the second repeating unit 2 of the support body in the axial direction of the blood vessel stent is 0.5 to 3 mm.
  • the distance in the longitudinal direction of the first repeating monomer 3 and the second repeating monomer 4 of the connecting body is the axial length of the first repeating unit 1 and the second repeating unit 2 of the support 1 to 1.5 times.
  • the width of the first repeating unit 1 and the second repeating unit 2 of the support is 0.05 to 0.3 mm.
  • the length of the first repeating monomer 3 and the second repeating monomer 4 of the connecting body in the axial direction of the blood vessel stent is 40 to the width of the first repeating unit 1 and the second repeating unit 2 of the support. 80%.
  • the support body and the connecting body of the blood vessel stent have the same wall thickness.
  • the support body of the blood vessel stent of the present invention comprises a plurality of repeating units, and the first repeating unit and the second repeating unit are alternately arranged, and at least one of the adjacent repeating units of the supporting body is at least one
  • the connecting bodies composed of arcs or broken lines are connected, and each repeating unit can effectively coordinate the deformation, thereby reducing the axial shortening rate and playing the positioning accurately.
  • adjacent repeating units of the support of the blood vessel stent of the present invention are connected by at least one first repeating monomer or second repeating monomer, and the circular arc segments have the same radius of curvature and the same bending direction.
  • Each repeating unit can effectively disperse the load, thereby improving the fatigue strength.
  • the repeating unit of the support body and the repeating unit of the connecting body are all connected by a circular arc segment, as shown in FIG. 1 . 6 is shown.
  • the repeating unit of the support body and the repeating monomer of the connecting body are composed of polygonal line segments. Connected, as shown in Figure 7.
  • the repeating unit of the support body and the repeating unit of the connecting body are all connected by a circular arc segment, as shown in FIG. 1 . 6 is shown.
  • the first repeating unit 1 and the second repeating unit 2 of the support body are connected by a circular arc segment, and the first repeating monomer 3 and the second repeating monomer 4 of the connecting body are Connected by a line segment, as shown in Figure 8.
  • the repeating unit of the support body and the repeating unit of the connecting body are all connected by a circular arc segment, as shown in FIG. 1 . 6 is shown.
  • the first repeating unit 1 and the second repeating unit 2 of the support are connected by a fold line segment, and the first repeating monomer 3 and the second repeating monomer 4 of the connecting body are The arc segments are connected in series, as shown in Figure 9.
  • the blood vessel stent of the invention is particularly suitable for the coronary artery, has good support effect on the coronary artery, and has less damage to the coronary wall, and can effectively avoid the formation of intravascular restenosis after the stent implantation, and further, the blood vessel stent of the present invention It can well locate in the coronary artery, improve the accuracy of release, and is easy to operate.
  • the vascular stent of the invention has simple structure, convenient production and low cost, and has important practical significance and good clinical application prospect.

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

Abstract

L'invention concerne un stent pour vaisseau sanguin comprenant un corps de support comprenant une pluralité d'unités de répétition (1, 2), et une pièce de liaison comprenant une pluralité de monomères de répétition (3, 4), les unités de répétition (1, 2) du corps de support sont disposées axialement le long du stent, et au moins un monomère de répétition (3, 4) est connecté entre deux unités de répétition (1, 2) adjacentes du corps de support. Le stent pour vaisseau sanguin présente les avantages que le stent pour vaisseau sanguin est particulièrement applicable aux artères coronaires, et de bons effets de support d'artère coronaire peuvent être réalisés par le stent pour vaisseau sanguin; le corps de support du stent pour vaisseau sanguin comprend les multiples unités de répétition (1, 2). Les diverses unités de répétition (1, 2) peuvent se déformer efficacement de manière coordonnée, en conséquence, le taux de raccourcissement axial peut être réduit, et des effets de positionnement précis peuvent être réalisés pendant la libération.
PCT/CN2017/109266 2017-10-18 2017-11-03 Stent pour vaisseau sanguine WO2019075790A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201710970707.9 2017-10-18
CN201710970707.9A CN107550611B (zh) 2017-10-18 2017-10-18 一种血管支架

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WO2019075790A1 true WO2019075790A1 (fr) 2019-04-25

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WO (1) WO2019075790A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109793941A (zh) * 2019-01-08 2019-05-24 科塞尔医疗科技（苏州）有限公司 一种医用导管用的亲水涂层溶液及其制备方法与使用方法
DE102019112971A1 (de) * 2019-05-16 2020-11-19 Optimed Medizinische Instrumente Gmbh Stent

Citations (5)

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CN201085705Y (zh) * 2007-09-03 2008-07-16 江苏瑞上医疗器械有限公司 激光雕刻径刚纵柔型血管支架
WO2010123387A1 (fr) * 2009-04-23 2010-10-28 Balton Sp. Z.O.O. Endoprothèse de bifurcation et système d'implantation intravasculaire de l'endoprothèse de bifurcation
CN103300951A (zh) * 2013-06-17 2013-09-18 苏州爱瑞德医疗科技有限公司 一种椎动脉支架
US8641755B2 (en) * 2003-04-14 2014-02-04 Tryton Medical, Inc. Prosthesis for treating vascular bifurcations
CN106691647A (zh) * 2015-07-20 2017-05-24 上海交通大学 一种生物可降解金属血管支架及其应用

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Publication number Priority date Publication date Assignee Title
JP3654627B2 (ja) * 2000-04-20 2005-06-02 川澄化学工業株式会社 ステント
JP3146103U (ja) * 2008-07-08 2008-11-06 株式会社日本ステントテクノロジー ステント
CN102813566A (zh) * 2012-04-24 2012-12-12 冯海全 冠脉支架
CN103550017B (zh) * 2013-08-16 2015-12-09 江苏大学 一种适用于锥形血管的血管支架
CN204600807U (zh) * 2015-04-27 2015-09-02 日照天一生物医疗科技有限公司 镁合金血管支架
CN106859821B (zh) * 2017-03-15 2018-06-15 大连理工大学 一种注塑成型的生物可降解聚合物血管支架

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8641755B2 (en) * 2003-04-14 2014-02-04 Tryton Medical, Inc. Prosthesis for treating vascular bifurcations
CN201085705Y (zh) * 2007-09-03 2008-07-16 江苏瑞上医疗器械有限公司 激光雕刻径刚纵柔型血管支架
WO2010123387A1 (fr) * 2009-04-23 2010-10-28 Balton Sp. Z.O.O. Endoprothèse de bifurcation et système d'implantation intravasculaire de l'endoprothèse de bifurcation
CN103300951A (zh) * 2013-06-17 2013-09-18 苏州爱瑞德医疗科技有限公司 一种椎动脉支架
CN106691647A (zh) * 2015-07-20 2017-05-24 上海交通大学 一种生物可降解金属血管支架及其应用

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CN107550611A (zh) 2018-01-09
CN107550611B (zh) 2024-03-15

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