CN108578025A - 一种兼顾柔顺性与支撑性的球囊扩张式血管支架 - Google Patents

一种兼顾柔顺性与支撑性的球囊扩张式血管支架 Download PDF

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CN108578025A
CN108578025A CN201810361542.XA CN201810361542A CN108578025A CN 108578025 A CN108578025 A CN 108578025A CN 201810361542 A CN201810361542 A CN 201810361542A CN 108578025 A CN108578025 A CN 108578025A
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support body
annular support
intravascular stent
muscle
dowel
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申祥
蒋佳宝
邓永泉
纪松
朱洪飞
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Jiangsu University
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    • 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
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    • 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
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    • A61F2002/91558Adjacent bands being connected to each other connected peak to peak
    • 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
    • A61F2002/91566Adjacent bands being connected to each other connected trough to trough
    • 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof

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Abstract

本发明提供了一种兼顾柔顺性与支撑性的球囊扩张式血管支架,所述血管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筋;所述血管支架环状支撑体由316L不锈钢管激光雕刻而成,连接筋由镍钛合金材料加工而成,通过激光焊接技术实现316L不锈钢材料环状支撑体与镍钛合金材料连接筋的连接,构成所述血管支架,综合改善了血管的支撑性与柔顺性,保证其能够顺利到达病变部位,减少对血管壁的损伤,并能够提高支架长期服役的能力,有效撑开血管保证血液流通,减少血管内再狭窄的发生。同时改变了环状支撑体筋的形状,进一步增强了支架支撑性,增大了与斑块的接触面积,减小了血管内的再狭窄的发生,并提高了血管支架的疲劳寿命。

Description

一种兼顾柔顺性与支撑性的球囊扩张式血管支架
技术领域
本发明涉及医疗器械制造技术领域的一种血管支架,具体涉及一种兼顾柔顺性与支撑性的球囊扩张式血管支架。
背景技术
近年来,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,严重危及着人类生命健康与安全。根据美国心脏协会统计数据分析,心血管疾病已经成为人类生命健康的头号杀手。目前针对由血管狭窄引起的心血管疾病的治疗有药物治疗、外科手术和介入治疗三大类。血管支架介入术治疗是目前发展最为迅速并得到临床广泛运用的一种有效治疗血管阻塞疾病主要方式,具有微创、高效等特点。
血管支架根据介入术过程中支架扩张机制的不同,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。根据制造支架的材料不同,又可以分为316L医用不锈钢支架、镍钛合金支架、钴铬合金支架、生物可降解镁合金支架等等。球囊扩张式支架通常使用的材料为医用不锈钢,而自膨胀支架通常使用的材料为镍钛合金。球囊扩张式支架介入术是将单一材料通常为不锈钢材料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丝到达病变部位,接着球囊膨胀,对支架进行扩张以便撑开狭窄的血管,从而恢复血流畅通。这种不锈钢材料的支架支撑性好,但由于支架材料固有的特性使得其不易变形,柔顺性欠佳。自膨胀式支架介入术首先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,撑开狭窄病变血管,恢复血流畅通。这种自膨胀式支架特点是柔顺性好,对血管壁伤害较小,但同样由于其材料固有的特性使得用镍钛合金加工而成的支架它的支撑性相对来说比较差。由此可见,柔顺性好是镍钛合金支架的长处,而支撑性好是不锈钢支架的长处。
在支架的性能指标中,支架的柔顺性能和支撑性能在手术过程和手术后对临床效果都起着至关重要的作用。支架的柔顺性能会影响到支架的在输送导管里的过弯能力,柔顺性差会拉直甚至损伤血管,或很难到达病变部位。支架的支撑性会影响支架长期服役的能力,如果支架的支撑性很差,就不能撑开狭窄处的血管,或者手术中即使能够撑开,手术后的再狭窄发生率也会比较高。目前存在的问题是,不锈钢支架的支撑性好,但是柔顺性差,而镍钛合金支架正好相反,镍钛合金支架的柔顺性好,但是支撑性差。
发明内容
针对现有技术中存在不足,本发明提供了一种兼顾柔顺性和支撑性的球囊扩张式血管支架,取长补短,把球囊扩张式不锈钢支架支撑性好的优点和自膨胀式镍钛合金支架柔顺性好的优点充分结合起来,达到综合性能最好的效果。解决不锈钢支架的支撑性好,但是柔顺性差,而镍钛合金支架正好相反,镍钛合金支架的柔顺性好,但是支撑性差,而不能达到兼顾柔顺性和支撑性的问题。
本发明的技术方案是:一种兼顾柔顺性与支撑性的球囊扩张式血管支架,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筋;
所述环状支撑体沿血管支架纵向依次排列,每相邻两组的所述环状支撑体呈镜面对称分布,每一组所述环状支撑体包括若干正弦单元波,所述单元波沿所述血管支架的周向依次排列;
所述环状支撑体为不锈钢材质制成,连接筋为镍钛合金制成。
上述方案中,所述环状支撑体的筋厚保持不变,而环状支撑体的筋宽却有规律地变化,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0.5-0.65倍,支撑体筋的整体形状呈现“领结”的模样。
上述方案中,球囊扩张式血管支架为模块化设计,包括环状支撑体模块和连接筋模块。
上述方案中,所述环状支撑体模块和连接筋模块通过焊接连接。
上述方案中,所述不锈钢为316L不锈钢。
上述方案中,所述连接筋为L型或V型或W型或S型或其的组合型连接筋中的任意一种。
本发明与现有技术相比具有以下有益效果:
1.本发明通过激光焊接技术将316L不锈钢材料制成的支撑体与镍钛合金材料制成的连接筋连接,将不锈钢支架支撑性好和镍钛合金支架柔顺性好的优点充分结合起来,综合改善了血管的支撑性与柔顺性,保证其能够顺利到达病变部位,减少对血管壁的损伤,并能够提高支架长期服役的能力,有效撑开血管保证血液流通,减少血管内再狭窄的发生。
2.本发明改变了所述环状支撑体的形状,所述血管支架支撑体的筋厚保持不变,而支撑体的筋宽却有规律地变化,即从支撑体波峰处开始到筋的中端,筋的宽度由大变小,从筋的中端到波谷的过程中筋的宽度又由小变大,支撑筋中间处宽度为波峰波谷处的0.5-0.65倍,支撑体筋的整体形状呈现“领结”的模样。血管支架在承受周向压力时,波峰波谷处应变剧烈,并向支撑筋中间处减弱。所述支撑体增强了波峰波谷处强度,同时增加了支架与斑块接触面积,减少了血管内再狭窄的发生。与均匀的支撑筋相比,最大应变值有显著降低,使得支架支撑性得到进一步增强,同时,提高了支架的疲劳寿命。
3.本发明球囊扩张式血管支架为模块化设计,包括环状支撑体模块和连接筋模块,可以根据实际的数量需求,将所述环状支撑体模块和连接筋模块通过焊接连接。
附图说明
图1为本发明所述兼顾柔顺性与支撑性的血管支架结构示意图;
图2为本发明所述兼顾柔顺性与支撑性的血管支架结构展开示意图;
图3为单个环状支撑体结构展开示意图。
图中,1、环状支撑体;2、连接筋;3、焊接点;4、波谷;5、波峰。
具体实施方式
下面结合附图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。
一种兼顾柔顺性与支撑性的球囊扩张式血管支架,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之间的连接筋2;所述环状支撑体1沿血管支架纵向依次排列,每相邻两组的所述环状支撑体1呈镜面对称分布,每一组所述环状支撑体1包括若干正弦单元波,所述单元波沿所述血管支架的周向依次排列;所述环状支撑体1为不锈钢材质制成,连接筋2为镍钛合金制成。
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0.5-0.65倍,支撑体筋的整体形状呈现“领结”的模样。
球囊扩张式血管支架为模块化设计,包括环状支撑体模块和连接筋模块。所述环状支撑体模块和连接筋模块通过焊接连接。
所述连接筋2为L型或V型或W型或S型或其的组合型连接筋中的任意一种。
所述连接筋2的截面形状为矩形,筋厚和筋宽都保持不变。
图1和图2所示为本发明所述的一种兼顾柔顺性与支撑性的球囊扩张式血管支架的一种实施方式。所述血管支架的设计和加工呈现模块化,包含支撑体模块和连接筋模块。支撑体模块由316L不锈钢管激光雕刻制成,连接筋模块由镍钛合金材料加工而成。
本实施方式中,所述血管支架有八组环状支撑体1,每组环状支撑体1拥有六个正弦单元波,相邻两个环状支撑体1之间通过三个连接筋2连接,连接筋2分别与相邻环状支撑体1的波峰连接,且相邻的连接筋2之间间隔一个正弦单元波,连接筋2均采用L型。
支撑体模块与连接筋模块的连接通过激光焊接完成,激光焊接点3位于连接筋2与环状支撑体1接触的两端。所述血管支架中支撑体模块和连接筋模块的多少取决于支架的长度,根据支架的长度进行增减。
所述环状支撑体1的筋厚保持不变,而环状支撑体1的筋宽却有规律地变化。如图3所示,波峰波谷的筋宽为W2,环状支撑体1中间处筋宽为W1。从支撑体波峰5处开始到筋的中端,筋的宽度由大变小,从筋的中端到波谷4的过程中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,支撑体筋中间处宽度W1是波峰波谷处W2的0.5-0.65倍,支撑体筋的整体形状呈现“领结”的模样。
所述血管支架连接筋2的截面形状为矩形,筋厚和筋宽都保持不变。
本发明通过激光焊接技术将316L不锈钢材料制成的环状支撑体1与镍钛合金材料制成的连接筋2连接,将不锈钢支架支撑性好和镍钛合金支架柔顺性好的优点充分结合起来,综合改善了血管的支撑性与柔顺性,保证其能够顺利到达病变部位,减少对血管壁的损伤,并能够提高支架长期服役的能力,有效撑开血管保证血液流通,减少血管内再狭窄的发生。
本发明改变了所述环状支撑体1的形状,所述环状支撑体1的筋厚保持不变,而支撑体的筋宽却有规律地变化,即从环状支撑体11波峰处开始到筋的中端,筋的宽度由大变小,从筋的中端到波谷的过程中筋的宽度又由小变大,支撑筋中间处宽度为波峰或波谷处的0.5-0.65倍,支撑体筋的整体形状呈现“领结”的模样。血管支架在承受周向压力时,波峰波谷处应变剧烈,并向支撑筋中间处减弱。所述环状支撑体1增强了波峰波谷处强度,同时增加了支架与斑块接触面积,减少了血管内再狭窄的发生。较均匀的支撑筋相比,最大应变值有显著降低,使得支架支撑性得到进一步增强,同时,提高了支架的疲劳寿命。
所述实施例为本发明的优选的实施方式,但本发明并不限于上述实施方式,在不背离本发明的实质内容的情况下,本领域技术人员能够做出的任何显而易见的改进、替换或变型均属于本发明的保护范围。

Claims (6)

1.一种兼顾柔顺性与支撑性的球囊扩张式血管支架,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)之间的连接筋(2);
所述环状支撑体(1)沿血管支架纵向依次排列,每相邻两组的所述环状支撑体(1)呈镜面对称分布,每一组所述环状支撑体(1)包括若干正弦单元波,所述单元波沿所述血管支架的周向依次排列;
所述环状支撑体(1)为不锈钢材质制成,连接筋(2)为镍钛合金制成。
2.根据权利要求1所述的一种兼顾柔顺性与支撑性的球囊扩张式血管支架,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0.5-0.65倍。
3.根据权利要求1所述的一种兼顾柔顺性与支撑性的球囊扩张式血管支架,其特征在于,球囊扩张式血管支架为模块化设计,包括环状支撑体模块和连接筋模块。
4.根据权利要求3所述的一种兼顾柔顺性与支撑性的球囊扩张式血管支架,其特征在于,所述环状支撑体模块和连接筋模块通过焊接连接。
5.根据权利要求1所述的一种兼顾柔顺性与支撑性的球囊扩张式血管支架,其特征在于,所述不锈钢为316L不锈钢。
6.根据权利要求1所述的一种兼顾柔顺性与支撑性的球囊扩张式血管支架,其特征在于,所述连接筋(2)为L型或V型或W型或S型或其的组合型连接筋中的任意一种。
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