CN108670509A - 一种自膨胀式锥形冠状动脉支架 - Google Patents

一种自膨胀式锥形冠状动脉支架 Download PDF

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CN108670509A
CN108670509A CN201810361534.5A CN201810361534A CN108670509A CN 108670509 A CN108670509 A CN 108670509A CN 201810361534 A CN201810361534 A CN 201810361534A CN 108670509 A CN108670509 A CN 108670509A
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support body
annular support
coronary stent
muscle
distal end
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申祥
蒋婷
蒋佳宝
邓永泉
纪松
朱洪飞
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Jiangsu University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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
    • A61F2/915Stents 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91575Adjacent bands being connected to each other connected peak to trough

Abstract

本发明提供了一种自膨胀式锥形冠状动脉支架,包括沿所述冠状动脉支架轴向依次排列的若干组环状支撑体和连接在每相邻两组所述环状支撑体之间的连接体,所述冠状动脉支架由镍钛合金微管激光雕刻而成。所述连接体宽度W和所述支撑体筋宽度H沿所述冠状动脉支架轴向从近端到远端依次呈递减趋势。每相邻两组支撑体单元波开口角α沿所述锥形冠状动脉支架轴向从近端到远端依次减小,使得所述冠状动脉支架内径从其近端到远端逐渐减小,以适应锥形血管的形态,避免支架近端贴壁不良,远端过度扩张等问题,降低支架对锥形血管壁的伤害。所述支撑体支撑筋的形状呈狗骨头形状,提高了冠状动脉支架的支撑性能和疲劳强度。

Description

一种自膨胀式锥形冠状动脉支架
技术领域
本发明涉及医疗器械制造技术领域的一种冠状动脉支架,具体涉及一种自膨胀式锥形冠状动脉支架。
背景技术
近年来,人们的物质生活水平提高,随之而来的包括肥胖、过多食用动物性脂肪、精神负担过重因素,使得心血管疾病成为威胁人类生命健康的头号杀手。由冠状动脉粥样硬化性心脏病引起的各类急慢性血管阻塞疾病,已被公认为危及人类生命健康的最严重疾病之一。针对由血管狭窄引起的心血管疾病,治疗方法分为药物治疗、外科手术和介入治疗三大类。采用药物治疗的方法往往时间周期长、见效慢、副作用大,容易产生对药物的依赖性;外科手术则对病人产生永久性的伤害;而基于医用血管支架的介入性治疗方法,由于其微创伤和高效性,成为目前治疗血管狭窄的一种新型方法。
血管支架根据介入术过程中支架膨胀机制的不同,可以把支架分为球囊扩张式血管支架和自膨胀式血管支架。球囊扩张式支架介入术是将激光雕刻而成的血管支架预先压握装在折叠好的球囊上,然后随着球囊一起沿着导引导管到达病变部位,球囊膨胀后撑开狭窄的血管,恢复血流畅通。球囊扩张式支架通常使用的材料为医用不锈钢,这种支架卸载后易发生回弹,不能满足一些特殊血管形状的需要。自膨胀式支架介入术是将支架在体外进行热处理成型,然后将支架压握在输送导管内,在到达患者病变血管位置后,从输送靶管中推出支架后能够自动恢复其压握前的形状,撑开狭窄血管,恢复血流畅通。这种自膨胀式支架特点是对血管壁的损伤较小,支架膨胀后残余的弹力使支架与血管壁始终保持紧贴状态,适用于形状复杂的病变血管。目前市场上传统的血管支架膨胀后的形状都为圆柱状。但由于人体血管在有些地方呈锥形形状,即沿长度方向呈渐缩状,如颈动脉,股动脉,冠状动脉。当圆直血管支架植入到锥形血管中,除了使血管支架的贴壁性能达不到预期效果外,还会过度扩张锥形血管的远端,所以锥形血管远端的损伤要比近端大很多,更容易诱发再狭窄。
冠状动脉支架作为一种长期植入的医疗器械,在不断经受循环流动载荷的作用下,血流速度以持续的峰值和谷值变化的,支架也随着高低压力发生形态变化,作为金属材料的支架在外力的反复作用下产生疲劳。支架疲劳寿命严重影响着介入术效果的好坏。
发明内容
为解决现有技术方案的不足,本发明提供一种自膨胀式锥形冠状动脉支架。所述支架的锥形管状体结构适用于颈动脉、股动脉、冠状动脉等轴向内径变化较明显的病变血管。在保证自膨胀式支架柔顺性优势的前提下,通过改变支架结构的设计参数来提高支架的支撑强度,提高支架在循环流动载荷作用下的抗疲劳强度,并减少支架近端贴壁不良、远端过度扩张、再狭窄等介入术后并发症的出现,降低支架对锥形血管壁的伤害。
本发明的技术方案是:一种自膨胀式锥形冠状动脉支架,包括若干组环状支撑体和连接在每相邻两组所述环状支撑体之间的连接体;
所述环状支撑体沿冠状动脉支架轴向方向依次排列,每一组所述环状支撑体包括若干正弦单元波,所述单元波沿冠状动脉支架的周向依次排列;
所述连接体为S型,所述S型连接体连接在前一组环状支撑体的波谷和与之相邻的下一组环状支撑体的波峰处,所述波峰和波谷相邻;
所述环状支撑体的每组波峰和波谷的数量和波高保持不变,沿冠状动脉支架纵向从近端至远端布置的每组环状支撑体的单元波开口角分别为α1、α2、α3、、、αn,α1、α2、α3、、、αn沿冠状动脉支架纵向从近端至远端以0.85~0.95的等比数列依次减小,即α2=(0.85~0.95)α1,α3=(0.85~0.95)α2、、、αn=(0.85~0.95)α(n-1)
上述方案,所述环状支撑体的筋厚保持不变,而环状支撑体的筋宽H却有规律地变化,即从环状支撑体的波峰处开始到筋的中端,环状支撑体筋的宽度由大变小,从筋的中端到波谷的过程中环状支撑体筋的宽度又由小变大,环状支撑体的筋宽对于中间处的A轴呈对称分布,且中间处的宽度最窄,为波峰或波谷处的0.4~0.5倍,所述支撑体筋呈狗骨头形状。
上述方案,所述环状支撑体筋的截面呈矩形。
上述方案,沿冠状动脉支架纵向从近端至远端布置的每组环状支撑体的筋宽度分别为H1、H2、H3、、、Hn,H1、H2、H3、、、Hn沿冠状动脉支架纵向从近端至远端以0.90~0.95的等比数列依次减小,即H2=(0.90~0.95)H1,H3=(0.90~0.95)H2、、、Hn=(0.90~0.95)H(n-1)
上述方案,所述冠状动脉支架由镍钛合金微管激光雕刻而成。
上述方案,沿冠状动脉支架纵向从近端至远端布置的每组连接体的筋宽分别为W1、W2、W3、、、Wn,W1、W2、W3、、、Wn沿冠状动脉支架纵向从近端至远端以0.90~0.95的等比数列依次减小,即W2=(0.90~0.95)W1,W3=(0.90~0.95)W2、、、Wn=(0.90~0.95)W(n-1)
与现有技术相比,本发明的有益效果是:
1.本发明改变了连接体的连接方式,采用前一个支撑体的波谷处和与之相邻的下一个支撑体的波峰处相连的方式,改善了镍钛合金冠状动脉支架支撑性。
2.本发明改变了每相邻两组支撑体单元波开口角α,每相邻两组支撑体单元波开口角α沿所述锥形冠状动脉支架轴向从近端到远端依次减小这种结构设计使得恢复原状后的所述冠状动脉支架内径从其近端到远端是逐渐减小的,以适应锥形血管的形态,避免支架近端贴壁不良,远端过度扩张等问题,降低支架对锥形血管壁的伤害。
3.本发明改变了支撑体的形状,从所述支撑体的波峰处到波谷处,其支撑体筋宽度H呈现由宽变窄再变宽的趋势,所述支撑体筋宽度H对于波形的中点处呈对称分布,且中点处宽度最窄,为波峰波谷处0.4~0.5倍,所述支撑体筋呈狗骨头形状。在循环流动载荷作用下,所述支撑体承受的应变从波峰到波谷处呈由强到弱再增强的趋势,所述支撑体适应了循环流动载荷作用下支撑体所受应变规律,因而提高了冠状动脉支架的支撑性能和疲劳强度。
附图说明
图1是本发明所述一种自膨胀式锥形冠状动脉支架的半剖图;
图2是本发明所述一种自膨胀式锥形冠状动脉支架的展开示意图。
图中,1-环状支撑体;2-连接体;3-波峰,4-波谷。
具体实施方式
下面结合附图和具体实施方式对本发明作进一步详细说明,但本发明的保护范围并不限于此。
图1和图2所示为本发明所述自膨胀式锥形冠状动脉支架的一种实施方式,所述自膨胀式锥形冠状动脉支架,包括若干组环状支撑体1和连接在每相邻两组所述环状支撑体1之间的连接体2;
所述环状支撑体1沿冠状动脉支架轴向方向依次排列,每一组所述环状支撑体1包括若干正弦单元波,所述单元波沿冠状动脉支架的周向依次排列;
所述连接体2为S型,所述S型连接体连接在前一组环状支撑体1的波谷4和与之相邻的下一组环状支撑体1的波峰3处,所述波峰3和波谷4相邻。
优选的,本实施方式中所述冠状动脉支架为锥度为1.5的冠状动脉支架,其轴向方向上有六组环状支撑体1,每组环状支撑体1具有六个正弦单元波。每两组环状支撑体1间由两个连接体2连接,所述连接体2相对所述冠状动脉支架中心轴呈对称分布,改善了镍钛合金冠状动脉支架支撑性。
所述环状支撑体1的每组波峰3和波谷4的数量和波高保持不变,沿冠状动脉支架纵向从近端至远端布置的每组环状支撑体1的单元波开口角分别为α1、α2、α3、、、αn,α1、α2、α3、、、αn沿冠状动脉支架纵向从近端至远端以0.85~0.95的等比数列依次减小,即α2=(0.85~0.95)α1,α3=(0.85~0.95)α2、、、αn=(0.85~0.95)α(n-1)。这种结构设计使得恢复原状后的所述若干环状支撑体1构成的支架内径从近端至远端依次减小,以适应锥形血管的形态,避免支架近端贴壁不良,远端过度扩张等问题,降低支架对锥形血管壁的伤害。
所述环状支撑体1的筋厚保持不变,而环状支撑体1的筋宽H却有规律地变化,即从环状支撑体1的波峰处开始到筋的中端,环状支撑体1筋的宽度由大变小,从筋的中端到波谷的过程中环状支撑体1筋的宽度又由小变大,环状支撑体1的筋宽对于中间处的A轴呈对称分布,且中间处的宽度最窄,为波峰或波谷处的0.4~0.5倍,所述支撑体筋呈狗骨头形状。在循环流动载荷作用下,所述环状支撑体1承受的应变从波峰3到波谷4处呈由强到弱再增强的趋势,所述环状支撑体1适应了循环流动载荷作用下支撑体所受应变规律,因而提高了冠状动脉支架的支撑性能和疲劳强度。
所述环状支撑体1筋的截面呈矩形。
沿冠状动脉支架纵向从近端至远端布置的每组环状支撑体1的筋宽度分别为H1、H2、H3、、、Hn,H1、H2、H3、、、Hn沿冠状动脉支架纵向从近端至远端以0.90~0.95的等比数列依次减小,即H2=(0.90~0.95)H1,H3=(0.90~0.95)H2、、、Hn=(0.90~0.95)H(n-1),这样的结构设计可以增加近端的纵向强度,同时保持远端的柔顺性,降低对远端血管的损伤。
所述冠状动脉支架由镍钛合金微管激光雕刻而成。镍钛合金具有良好的生物相容性以及力学性能,利用镍钛合金的形状记忆效应,使其到达病变部位后自行恢复其锥形管体形态,减少支架近端贴壁不良、远端过度扩张、再狭窄等介入术后并发症的出现。
沿冠状动脉支架纵向从近端至远端布置的每组连接体2的筋宽分别为W1、W2、W3、、、Wn,W1、W2、W3、、、Wn沿冠状动脉支架纵向从近端至远端以0.90~0.95的等比数列依次减小,即W2=(0.90~0.95)W1,W3=(0.90~0.95)W2、、、Wn=(0.90~0.95)W(n-1),这样的结构设计可以增加近端的纵向强度,同时保持远端的柔顺性,降低对远端血管的损伤。
上文所列出的一系列的详细说明仅仅是针对本发明的可行性实施例的具体说明,它们并非用以限制本发明的保护范围,凡未脱离本发明技艺精神所作的等效实施例或变更均应包含在本发明的保护范围之内。

Claims (6)

1.一种自膨胀式锥形冠状动脉支架,其特征在于,包括若干组环状支撑体(1)和连接在每相邻两组所述环状支撑体(1)之间的连接体(2);
所述环状支撑体(1)沿冠状动脉支架轴向方向依次排列,每一组所述环状支撑体(1)包括若干正弦单元波,所述单元波沿冠状动脉支架的周向依次排列;
所述连接体(2)为S型,所述S型连接体连接在前一组环状支撑体(1)的波谷(4)和与之相邻的下一组环状支撑体(1)的波峰(3)处,所述波峰(3)和波谷(4)相邻;
所述环状支撑体(1)的每组波峰(3)和波谷(4)的数量和波高保持不变,沿冠状动脉支架纵向从近端至远端布置的每组环状支撑体(1)的单元波开口角分别为α1、α2、α3、、、αn,α1、α2、α3、、、αn沿冠状动脉支架纵向从近端至远端以0.85~0.95的等比数列依次减小,即α2=(0.85~0.95)α1,α3=(0.85~0.95)α2、、、αn=(0.85~0.95)α(n-1)
2.根据权利要求1所述的自膨胀式锥形冠状动脉支架,其特征在于,所述环状支撑体(1)的筋厚保持不变,而环状支撑体(1)的筋宽H却有规律地变化,即从环状支撑体(1)的波峰处开始到筋的中端,环状支撑体(1)筋的宽度由大变小,从筋的中端到波谷的过程中环状支撑体(1)筋的宽度又由小变大,环状支撑体(1)的筋宽对于中间处的A轴呈对称分布,且中间处的宽度最窄,为波峰或波谷处的0.4~0.5倍。
3.根据权利要求1所述的自膨胀式锥形冠状动脉支架,其特征在于,所述环状支撑体(1)筋的截面呈矩形。
4.根据权利要求1所述的自膨胀式锥形冠状动脉支架,其特征在于,沿冠状动脉支架纵向从近端至远端布置的每组环状支撑体(1)的筋宽度分别为H1、H2、H3、、、Hn,H1、H2、H3、、、Hn沿冠状动脉支架纵向从近端至远端以0.90~0.95的等比数列依次减小,即H2=(0.90~0.95)H1,H3=(0.90~0.95)H2、、、Hn=(0.90~0.95)H(n-1)
5.根据权利要求1所述的一种自膨胀式锥形冠状动脉支架,其特征在于,所述冠状动脉支架由镍钛合金微管激光雕刻而成。
6.根据权利要求1所述的一种自膨胀式锥形冠状动脉支架,其特征在于,沿冠状动脉支架纵向从近端至远端布置的每组连接体(2)的筋宽分别为W1、W2、W3、、、Wn,W1、W2、W3、、、Wn沿冠状动脉支架纵向从近端至远端以0.90~0.95的等比数列依次减小,即W2=(0.90~0.95)W1,W3=(0.90~0.95)W2、、、Wn=(0.90~0.95)W(n-1)
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