WO2016026235A1 - 一种生物可降解药物支架 - Google Patents

一种生物可降解药物支架 Download PDF

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Publication number
WO2016026235A1
WO2016026235A1 PCT/CN2014/092641 CN2014092641W WO2016026235A1 WO 2016026235 A1 WO2016026235 A1 WO 2016026235A1 CN 2014092641 W CN2014092641 W CN 2014092641W WO 2016026235 A1 WO2016026235 A1 WO 2016026235A1
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Prior art keywords
ring
diamond
rings
stent
biodegradable drug
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PCT/CN2014/092641
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English (en)
French (fr)
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吴天根
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东莞天天向上医疗科技有限公司
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Publication of WO2016026235A1 publication Critical patent/WO2016026235A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body

Definitions

  • the present invention relates to stent placement techniques, and more particularly to a biodegradable drug stent.
  • the basic requirements for human body cavity implant devices include: after the device is implanted into the human body cavity organ, it can not only provide sufficient mechanical support for the implanted organ, but also release the drug slowly and continuously and uniformly into the lumen of the living body. In the wall, to effectively control the foreign body reaction caused by implanting the prosthesis.
  • a drug-releasing vascular stent is an implanted prosthesis that meets the above criteria.
  • the stent is a common cylindrical device that keeps the lumen open and sometimes dilates blood vessels or other anatomical lumens such as ureters and bile ducts.
  • Stents are often used for stenosis of the stenosis caused by vascular atherosclerosis.
  • Stenosis refers to the narrowing or tightening of the lumen in the body.
  • the stent plays a supporting role in the lumen to prevent vascular restenosis after angioplasty.
  • Restenosis refers to the recurrence of stenosis of a vascular lumen or heart valve after successful treatment such as balloon dilation, stent implantation, valvuloplasty, and the like.
  • the stent can be made from a variety of materials, including metal and polymeric materials.
  • biodegradable polymer stents have many advantages: First, after the biodegradable stent is implanted into the official cavity, after the expansion and support of the stenotic cavity is completed, it can be automatically absorbed by the body, thereby avoiding the non-degradable stent. Late thrombosis and restenosis sequelae caused by long-term retention in the body.
  • the degradable polymer can be filled with a drug for inhibiting vascular restenosis. After the stent is implanted, the drug is slowly released with the degradation of the stent, thereby effectively controlling the vascular restenosis in a long-term manner. In traditional metal drug stents, the drug can only be sprayed onto the surface of the metal stent and released within 28 days of stent implantation.
  • the disadvantage of the biodegradable drug stent is that the two S-shaped connecting arms of the honeycomb structure have only one connecting structure of the second ring, so in the case of expansion, the stent may not be able to Provide sufficient radial support, so there is still a need to improve its structure.
  • a biodegradable drug stent having a tubular shape including a plurality of first circular rings arranged in a longitudinal direction, the first circular ring having a sinusoidal waveform in a circumferential direction, and a plurality of first circular rings being longitudinally aligned;
  • a second ring is disposed between the longitudinally adjacent first rings, the second ring is formed by a plurality of diamond-shaped circumferential connections in the circumferential direction, and the two first rings are longitudinally adjacent to the second ring
  • a connecting arm is connected between the wave crest and the second ring, so that the two first ring and the second ring and the plurality of connecting arms form a plurality of honeycomb structures and a plurality of diamond-shaped structures, and each honeycomb shape
  • the structure includes two diamond-shaped structures that are symmetrically disposed with a transverse centerline of the honeycomb structure.
  • one end of the connecting arm is connected to the peak of the first ring, and the other end of the connecting arm is connected to the midpoint of the side of the diamond of the second ring corresponding to the peak of the first ring, so that the peaks of the four first rings Forming a honeycomb structure with a diamond shape and four connecting arms of the second ring, and the peaks of the two first rings and one half of the two sides of the diamond ring of the second ring and the two connecting arms form a diamond-shaped structure .
  • the transverse diagonal length of the diamond of the second ring is equal to the two sinusoidal wavelengths of the first ring, and the longitudinal diagonal length of the diamond of the second ring is smaller than the longitudinal spacing of the two first rings.
  • one end of the connecting arm is connected to the peak of the first ring, and the other end of the connecting arm is connected with the longitudinal apex of the diamond of the second ring corresponding to the peak of the first ring, so that the peaks of the four first rings and one
  • the X-shaped structure formed by the two diamond-shaped connections of the second ring and the four connecting arms form a honeycomb structure, and the peaks of the two first rings and the two diamond-shaped sides of the second ring and the two connecting arms are formed.
  • a diamond-shaped structure is formed by the two diamond-shaped connections of the second ring and the four connecting arms.
  • the transverse diagonal length of the diamond of the second ring is equal to a sine wave wavelength of the first ring, and the longitudinal diagonal length of the diamond of the second ring is smaller than the longitudinal spacing of the two first rings.
  • the pair of connecting arms of the honeycomb structure in the circumferential direction are in a bracket shape.
  • the first ring is composed of a plurality of V-shaped corrugations having peaks and oscillating walls on both sides of the peak.
  • the stent is made of polylactic acid.
  • bracket has at least one additional or embedded identification mark.
  • the identification mark is a dot or a sheet that is impermeable to X-rays.
  • the invention has the beneficial effects that the first ring and the second ring and the plurality of connecting arms of the invention form a plurality of honeycomb structures and a plurality of diamond-shaped structures, and each honeycomb structure comprises two diamond-shaped structures, and the stent is expanded. Afterwards, the interaction of the plurality of honeycomb structures and the diamond-shaped structures forms a stable support structure, thereby enhancing the radial support force of the bracket.
  • the patent application file contains at least one color execution drawing. If it is an official request and the payment of the necessary fee can be paid A copy of the color drawing of this patent or patent application publication is provided.
  • Embodiment 1 is a panoramic view of a stent of Embodiment 1 of the present invention, which is drawn by a two-dimensional automatic microcomputer drawing software.
  • FIG. 2 is a plan view of a first ring of the stent of Embodiment 1 of the present invention, which is drawn by a two-dimensional automatic microcomputer drawing software.
  • FIG. 3 is a plan view showing a second ring and a connecting arm of the bracket of Embodiment 1 of the present invention, which is drawn by a two-dimensional automatic microcomputer drawing software.
  • Figure 4 is a plan view showing the honeycomb structure of the stent of Embodiment 1 of the present invention, which is drawn by a two-dimensional automatic microcomputer drawing software.
  • Fig. 5 is a perspective view showing the stent of the first embodiment of the present invention, which is depicted by a computer simulation.
  • Figure 6 is a photograph of the stent of Example 1 of the present invention on an expanded balloon.
  • Fig. 7 is a X-ray image showing the stent of the first embodiment of the present invention implanted into the porcine coronary artery for 6 months.
  • Fig. 8 is a view showing an intravascular ultrasound image display of the stent of Example 1 of the present invention after 6 months of implantation into a porcine blood vessel.
  • Fig. 9 is a pathological staining picture of the stent of the first embodiment of the present invention after 6 months of implantation into the porcine coronary artery.
  • Fig. 10 is a perspective view showing the expanded stent of the second embodiment of the present invention, which is depicted by a computer simulation.
  • the biodegradable stent of the present invention has increased radial support and geometric stability.
  • Figures 1 through 6 depict a pattern of stent 100 in one embodiment.
  • the stent 100 is tubular, and in particular, after the stent 100 is expanded, as shown in FIGS. 5 and 6, the stent 100 can be implanted and expanded to support the blood vessel.
  • the stent 100 is shown in plan view so that the view of the stent can be clearly presented.
  • the bracket 100 includes a plurality of first circular rings 101 arranged in the longitudinal direction, the first circular ring 101 having a sinusoidal waveform in the circumferential direction, and the plurality of first circular rings 101 being aligned in the longitudinal direction.
  • the first ring 101 is composed of a plurality of V-shaped corrugations 10, that is, a plurality of laterally arranged V-shaped corrugations 10 having a crest 11 and being located on both sides of the crest 11 Swing wall 12.
  • a second ring 102 is disposed between the two longitudinally adjacent first rings 101, and the second ring 102 is circumferentially A plurality of diamond-shaped surround connections are formed.
  • a connecting arm 13 is connected between the peaks of the two first rings 101 in the longitudinal direction of the second ring 102 (such as the peak 11 marked in FIG. 1) and the second ring 102, that is, the first ring
  • Each of the peaks of the 101 is connected to the second ring 102 through a corresponding one of the connecting arms 13, so that the two first rings 101 and the second ring 102 and the plurality of connecting arms 13 form a plurality of honeycomb structures 103 and more A diamond-shaped structure 105.
  • each of the honeycomb structures 103 includes two diamond-shaped structures. As shown in FIG. 4, the two diamond-shaped structures 105 are symmetrically disposed on the lateral center line of the honeycomb structure 103.
  • the transverse diagonal length (a) of the diamond of the second ring 102 is equal to the two sinusoidal wavelengths (c) of the first ring 101, and the second ring 102
  • the longitudinal diagonal length (b) of the diamond is smaller than the longitudinal spacing of the two first rings 101, so that the second ring 102 is better placed between the corresponding two first rings 101, so that the honeycomb structure 103 is more stable.
  • one end of the connecting arm 13 is connected to the peak 11 of the first ring 101, and the other end of the connecting arm 13 is connected to the second ring of the peak 11 of the first ring 101.
  • the midpoints 14 of the sides of the diamonds of 102 are connected such that the peaks 11 of the four first rings 101 and the one diamond of the second ring 102 and the four connecting arms 13 form a honeycomb structure 103, the two first rings
  • the crest 11 and the half of one of the diamond sides of the second ring 102 and the two connecting arms 13 form a diamond-shaped structure 105.
  • the diamond of the second ring 102 is formed as a connection structure between the connecting arms 13, and the longitudinal apex 15 of the diamond of the second ring 102 is located just in the middle of the two peaks 11, which enhances the structural stability and enhances the bracket. Radial support force. And the two honeycomb structures 103 are connected by an X-shaped structure, so that the honeycomb structures 103 are equally stable.
  • the pair of connecting arms 13 of the honeycomb structure 103 in the circumferential direction are in the shape of a bracket, as shown by a pair of connecting arms 13 as shown in FIG. 4, so that the pair of connecting arms 13 can accommodate the rhombic longitudinal direction of the lower second ring 102.
  • the convex angle and the structure are more stable.
  • the stent 100 of the present invention is made of a polymeric material that contains a decomposing group that is compatible with surrounding tissues, fluids such as blood vessels. Polymer material medical devices need to be slowly decomposed to avoid tissue overload or inflammatory reactions that cause restenosis.
  • the stent 100 of the present invention can be made of polylactic acid.
  • the stent 100 of the present invention has at least one additional or embedded identification mark 104, which may be an X-ray opaque spot or sheet, such that an X-ray opaque spot or sheet may be attached thereto.
  • the surface of the stent 100 is either embedded therein for the purpose of detecting or identifying the stent 100 after implantation.
  • Figure 5 shows the state after the stent 100 has been expanded.
  • Figure 6 shows the morphology of the stent 100 on the dilatation balloon, as shown in Figure 5, after the balloon has been withdrawn.
  • Figure 7 shows an X-ray image of the stent 100 implanted in the porcine coronary for 6 months, showing that the implanted vessel wall is smooth and free of any vascular stenosis.
  • Figure 8 shows an intravascular ultrasound image display of the stent 100 after 6 months of implantation into the porcine blood vessel, showing that the implanted stent is fully distracted without any retraction.
  • Figure 9 shows the pathological section of the stent 100 after 6 months of implantation, confirming that the stent is excellently distracted, and no retraction or breakage occurs.
  • the present embodiment is different from the first embodiment in that one end of the connecting arm 13 is connected to the peak 11 of the first ring 101, and the other end of the connecting arm 13 corresponds to the peak 11 of the first ring 101.
  • the longitudinal apexes 15 of the diamonds of the second ring 102 are connected such that the X-shaped structure formed by the crests 11 of the four first rings 101 and the two diamonds of the second ring 102 and the four connecting arms 13 form a honeycomb shape
  • the structure 103 is formed, and the crests 11 of the two first rings 101 and the two rhombic sides of the second ring 102 and the two connecting arms 13 form a diamond-shaped structure 105.
  • the X-shaped structure of the second ring 102 becomes a connection structure between the connecting arms 13, which enhances structural stability and enhances the radial supporting force of the bracket.
  • the transverse diagonal length of the diamond of the second ring 102 is equal to one sine wave wavelength of the first ring 101, and the longitudinal diagonal length of the diamond of the second ring 102 is smaller than the longitudinal direction of the two first rings 101.
  • the spacing allows the second ring 102 to be better placed between the corresponding two first rings 101, making the honeycomb structure 103 more stable.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Optics & Photonics (AREA)
  • Chemical & Material Sciences (AREA)
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  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
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Abstract

一种生物可降解药物支架（100），该支架（100）呈管状，包括多个沿纵向排列的第一圆环（101）。该第一圆环（101）在圆周方向呈正弦波形，且多个第一圆环（101）沿纵向对齐；两个沿纵向相邻的第一圆环（101）之间设置有第二圆环（102），该第二圆环（102）在圆周方向由多个菱形环绕连接构成，并且两个第一圆环（101）沿纵向靠近该第二圆环（102）的波峰与第二圆环（102）之间均连接有一条连接臂（13），使两个第一圆环（101）与第二圆环（102）及多条连接臂（13）形成多个蜂巢形结构（103）和多个钻石形结构（105），且每一蜂巢形结构（103）包括两个钻石形结构（105），支架（100）扩张后，多个蜂巢形结构（103）及钻石形结构（105）的交互链接，形成一稳固的支撑结构，从而增强支架的径向支撑力。

Description

一种生物可降解药物支架 技术领域
本发明涉及支架置入技术，尤其涉及一种生物可降解药物支架。
背景技术
临床上，对人体官腔植入器械的基本要求包括：器械被植入人体官腔器官后，不仅能提供所植入器官足够的机械支撑力，又可以缓慢、持续、均匀释放药物到生物体内管腔壁内，以有效控制由植入假体所导致的异物反应。
药物释放血管支架就是符合以上标准的一种植入假体。支架是普通圆柱形装置，可以保持管腔通畅，有时可以扩张血管或者其他解剖管腔如输尿管、胆管。支架经常用于血管动脉粥样硬化导致的官腔狭窄性疾病。管腔狭窄是指体内的管腔变窄或者紧缩。在本项治疗手段当中，支架在管腔中起支撑作用以防止血管成形术后血管再狭窄发生。再狭窄是指血管管腔或者心脏瓣膜在进行诸如球囊扩张、支架植入、瓣膜成形术等成功治疗后再次发生的狭窄。
支架可以由多种材料制成，包括金属和聚合物材料。在聚合物支架中，生物可降解聚合物支架具许多优势：首先，可降解支架植入官腔后，在完成对狭窄官腔的扩张、支撑后，可被机体自动吸收，从而避免了由不可降解支架长期滞留体内导致的晚期血栓及再狭窄后遗症。其次，可降解聚合物体内可装有抑制血管再狭窄的药物，支架植入后，药物随支架的降解而缓慢释放，从而长期有效的控制血管再狭窄的方式。在传统金属药物支架中，药物仅可被喷涂于金属支架的表面，并在支架植入后的28天内释放完毕。
但目前聚合物材料支架存在的主要问题是支架的支撑力低，不能完全满足临床冠心病病人的需要。为解决这一问题，本申请人之前申请了中国专利申请号为201280036466.6的发明专利，其中公开了一种生物可降解药物支架的特殊设计，该支架呈管状，包括多个沿纵向排列的第一圆环，该第一圆环在圆周方向呈正弦波形，且多个第一圆环沿纵向对齐；其中，两个相邻的第一圆环沿纵向相互靠近的对应的波峰之间通过S形的连接臂连接，使两个第一圆环与多条S形的连接臂形成多个蜂巢形结构；两个第一圆环之间设置有第二圆环，该第二圆环在圆周方向也呈正弦波形，使第二圆环与S形的连接臂交叉的地方形成X形结构。
其中，这种生物可降解药物支架的不足之处在于：蜂巢形结构的两条S形的连接臂之间，仅具有第二圆环的一条连接结构，因此在扩张的情况下，支架可能不能提供足够的径向支撑力，所以仍需改善其结构。
发明内容
本发明的目的在于针对现有技术的不足而提供一种生物可降解药物支架，其通过增强蜂巢形结构扩张后的稳定性，从而增强支架的径向支撑力，解决上述问题。
为了实现上述目的，本发明采用以下技术方案：
一种生物可降解药物支架，该支架呈管状，包括多个沿纵向排列的第一圆环，该第一圆环在圆周方向呈正弦波形，且多个第一圆环沿纵向对齐；两个沿纵向相邻的第一圆环之间设置有第二圆环，该第二圆环在圆周方向由多个菱形环绕连接构成，并且两个第一圆环沿纵向靠近该第二圆环的波峰与第二圆环之间均连接有一条连接臂，使两个第一圆环与第二圆环及多条连接臂形成多个蜂巢形结构和多个钻石形结构，且每一蜂巢形结构包括两个钻石形结构，该两个钻石形结构以蜂巢形结构的横向中心线对称设置。
其中，连接臂一端与第一圆环的波峰连接，连接臂另一端与该第一圆环的波峰对应的第二圆环的菱形的边的中点连接，使四个第一圆环的波峰与第二圆环的一个菱形及四条连接臂形成一个蜂巢形结构，而两个第一圆环的波峰与第二圆环的一个菱形两条边的一半及两条连接臂形成一个钻石形结构。
其中，第二圆环的菱形的横向对角线长度等于第一圆环的两个正弦波波长，第二圆环的菱形的纵向对角线长度小于两第一圆环的纵向间距。
其中，连接臂一端与第一圆环的波峰连接，连接臂另一端与该第一圆环的波峰对应的第二圆环的菱形的纵向顶点连接，使四个第一圆环的波峰与一个第二圆环的两个菱形连接形成的X形结构及四条连接臂形成一个蜂巢形结构，而两个第一圆环的波峰与第二圆环的两个菱形的一边及两条连接臂形成一个钻石形结构。
其中，第二圆环的菱形的横向对角线长度等于第一圆环的一个正弦波波长，第二圆环的菱形的纵向对角线长度小于两第一圆环的纵向间距。
其中，该蜂巢形结构沿圆周方向的一对连接臂呈括号形。
其中，第一圆环由多个V形的波纹构成，该V形的波纹具有波峰和位于该波峰两侧的摆动壁。
其中，该支架由聚乳酸制成。
其中，该支架至少具有一个附加或嵌入的识别标记。
其中，该识别标记为不透X射线的点状物或片状物。
本发明有益效果在于：本发明第一圆环与第二圆环及多条连接臂形成多个蜂巢形结构和多个钻石形结构，且每一蜂巢形结构包括两个钻石形结构，支架扩张后，多个蜂巢形结构及钻石形结构的交互链接，形成一稳固的支撑结构，从而增强支架的径向支撑力。
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专利申请文件包含至少一种颜色执行图画。如果是官方要求及出具必要费用支付款可以 提供本专利或专利申请出版物彩图图画的复印件。
图1是二维自动微机绘图软件绘制的本发明实施例1的支架的全景图。
图2是二维自动微机绘图软件绘制的本发明实施例1的支架的第一圆环的平面视图。
图3是二维自动微机绘图软件绘制的本发明实施例1的支架的第二圆环及连接臂的平面视图。
图4是二维自动微机绘图软件绘制的本发明实施例1的支架的蜂巢形结构的平面视图。
图5是电脑仿真插图描绘的本发明实施例1的支架扩张后的立体图。
图6是本发明实施例1的支架在扩张球囊上的照片。
图7是本发明实施例1的支架植入猪冠脉6个月后的X光影像图。
图8是本发明实施例1的支架植入猪血管6个月后的血管内超声图像显示图。
图9是本发明实施例1的支架植入猪冠脉6个月后的病理染色图片。
图10是电脑仿真插图描绘的本发明实施例2的支架扩张后的立体图。
具体实施方式
为了详细说明本发明的技术方案，下面将结合本发明实施例的附图，对本发明实施例的技术方案进行清楚、完整的描述。显然，所描述的实施例是本发明的一部分实施例，而不是全部的实施例。基于所描述的本发明的实施例，本领域普通技术人员在无需创造性劳动的前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例1
在一个实施例中，本发明的生物可降解支架具有增加的径向支撑力和几何稳定性。图1～6描绘了一个实施例中支架100的图案。支架100呈管状，尤其支架100扩张后，如图5和图6所示，使支架100植入扩张后可支撑血管。
在图1～4中，支架100是以平面图表示的，以便支架的视图能够清晰地呈现。
支架100包括多个沿纵向排列的第一圆环101，第一圆环101在圆周方向呈正弦波形，且多个第一圆环101沿纵向对齐。如图2所示，优选的，第一圆环101由多个V形的波纹10构成，即多个横向排列的V形波纹10构成，V形的波纹10具有波峰11和位于波峰11两侧的摆动壁12。
两个沿纵向相邻的第一圆环101之间设置有第二圆环102，第二圆环102在圆周方向由 多个菱形环绕连接构成。并且两个第一圆环101沿纵向靠近第二圆环102的波峰(如图1中标注的波峰11)与第二圆环102之间，均连接有一条连接臂13，即第一圆环101的每个波峰均通过对应的一条连接臂13与第二圆环102连接，使两个第一圆环101与第二圆环102及多条连接臂13形成多个蜂巢形结构103和多个钻石形结构105。且每一蜂巢形结构103包括两个钻石形结构，如图4所示，两个钻石形结构105以蜂巢形结构103的横向中心线对称设置。
优选的，如图2和图3所示，第二圆环102的菱形的横向对角线长度(a)等于第一圆环101的两个正弦波波长(c)，第二圆环102的菱形的纵向对角线长度(b)小于两第一圆环101的纵向间距，使第二圆环102更好地置于对应的两第一圆环101之间，使蜂巢形结构103更加稳定。
在本实施例中，如图1和图4所示，连接臂13一端与第一圆环101的波峰11连接，连接臂13另一端与第一圆环101的波峰11对应的第二圆环102的菱形的边的中点14连接，使四个第一圆环101的波峰11与第二圆环102的一个菱形及四条连接臂13形成一个蜂巢形结构103，两个第一圆环的波峰11与第二圆环102的一个菱形两条边的一半及两条连接臂13形成一个钻石形结构105。此结构，使第二圆环102的菱形成为连接臂13之间的连接结构，第二圆环102的菱形的纵向顶点15刚好位于两个波峰11的中间，增强了结构稳定性，可增强支架的径向支撑力。且两个蜂巢形结构103之间通过X形结构连接，使蜂巢形结构103之间同样稳定。
优选的，蜂巢形结构103沿圆周方向的一对连接臂13呈括号形，如图4中标注的一对连接臂13，使一对连接臂13可以容纳下第二圆环102的菱形的纵向凸出的角，结构更稳定。
本发明的支架100由聚合物材料制成，这种材料需包含分解基团能够与周围组织、液体(如血管)有良好的相容性。聚合物材料医疗设备需缓慢的分解避免造成再狭窄的组织超负荷或炎症反应。例如：本发明的支架100可以由聚乳酸制成。
本发明的支架100至少具有一个附加或嵌入的识别标记104，识别标记104可以为不透X射线的点状物或片状物，使不透X射线的点状物或片状物可以附着在支架100的表面或者镶嵌其中，以达到在植入后检测或识别支架100的目的。
图5展示了支架100扩张后的状态。
图6展示了支架100在扩张球囊上的形态，待球囊撤出后，即如图5所示。
图7展示了支架100植入猪冠脉6个月后的X光影像图，显示植入的血管壁光滑，无任何血管狭窄方式。
图8展示了支架100植入猪血管6个月后的血管内超声图像显示图，显示植入的支架完全撑开，无任何回缩。
图9展示了支架100置入后6个月的病理切片，证实：支架撑开极好，无回缩、断裂等现象发生。
实施例2
如图10所示，本实施例与实施例1的不同之处在于：连接臂13一端与第一圆环101的波峰11连接，连接臂13另一端与第一圆环101的波峰11对应的第二圆环102的菱形的纵向顶点15连接，使四个第一圆环101的波峰11与一个第二圆环102的两个菱形连接形成的X形结构及四条连接臂13形成一个蜂巢形结构103，而两个第一圆环101的波峰11与第二圆环102的两个菱形的一边及两条连接臂13形成一个钻石形结构105。此结构，使第二圆环102的X形结构成为连接臂13之间的连接结构，增强了结构稳定性，可增强支架的径向支撑力。
优选的，第二圆环102的菱形的横向对角线长度等于第一圆环101的一个正弦波波长，第二圆环102的菱形的纵向对角线长度小于两第一圆环101的纵向间距，使第二圆环102更好地置于对应的两第一圆环101之间，使蜂巢形结构103更加稳定。
最后应当说明的是，以上实施例仅用以说明本发明的技术方案，而非对本发明保护范围的限制，尽管参照较佳实施例对本发明作了详细地说明，本领域的普通技术人员应当理解，对本发明的技术方案进行修改或者等同替换，均属本发明的保护范围。

Claims (10)

  1. 一种生物可降解药物支架，该支架呈管状，包括多个沿纵向排列的第一圆环，该第一圆环在圆周方向呈正弦波形，且多个第一圆环沿纵向对齐；其特征在于：两个沿纵向相邻的第一圆环之间设置有第二圆环，该第二圆环在圆周方向由多个菱形环绕连接构成，并且两个第一圆环沿纵向靠近该第二圆环的波峰与第二圆环之间均连接有一条连接臂，使两个第一圆环与第二圆环及多条连接臂形成多个蜂巢形结构和多个钻石形结构，且每一蜂巢形结构包括两个钻石形结构，该两个钻石形结构以蜂巢形结构的横向中心线对称设置。
  2. 根据权利要求1所述的生物可降解药物支架，其特征在于：连接臂一端与第一圆环的波峰连接，连接臂另一端与该第一圆环的波峰对应的第二圆环的菱形的边的中点连接，使四个第一圆环的波峰与第二圆环的一个菱形及四条连接臂形成一个蜂巢形结构，而两个第一圆环的波峰与第二圆环的一个菱形两条边的一半及两条连接臂形成一个钻石形结构。
  3. 根据权利要求2所述的生物可降解药物支架，其特征在于：第二圆环的菱形的横向对角线长度等于第一圆环的两个正弦波波长，第二圆环的菱形的纵向对角线长度小于两第一圆环的纵向间距。
  4. 根据权利要求1所述的生物可降解药物支架，其特征在于：连接臂一端与第一圆环的波峰连接，连接臂另一端与该第一圆环的波峰对应的第二圆环的菱形的纵向顶点连接，使四个第一圆环的波峰与一个第二圆环的两个菱形连接形成的X形结构及四条连接臂形成一个蜂巢形结构，而两个第一圆环的波峰与第二圆环的两个菱形的一边及两条连接臂形成一个钻石形结构。
  5. 根据权利要求4所述的生物可降解药物支架，其特征在于：第二圆环的菱形的横向对角线长度等于第一圆环的一个正弦波波长，第二圆环的菱形的纵向对角线长度小于两第一圆环的纵向间距。
  6. 根据权利要求2或4所述的生物可降解药物支架，其特征在于：该蜂巢形结构沿圆周方向的一对连接臂呈括号形。
  7. 根据权利要求2或4所述的生物可降解药物支架，其特征在于：第一圆环由多个V形的波纹构成，该V形的波纹具有波峰和位于该波峰两侧的摆动壁。
  8. 根据权利要求2或4所述的生物可降解药物支架，其特征在于：该支架由聚乳酸制成。
  9. 根据权利要求2或4所述的生物可降解药物支架，其特征在于：该支架至少具有一个附加或嵌入的识别标记。
  10. 根据权利要求9所述的生物可降解药物支架，其特征在于：该识别标记为不透X射线的点状物或片状物。
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