CN109966021A - 一种儿童变径球囊扩张式血管支架 - Google Patents

一种儿童变径球囊扩张式血管支架 Download PDF

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CN109966021A
CN109966021A CN201711470561.8A CN201711470561A CN109966021A CN 109966021 A CN109966021 A CN 109966021A CN 201711470561 A CN201711470561 A CN 201711470561A CN 109966021 A CN109966021 A CN 109966021A
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金龙
张致远
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Beijing Friendship Hospital
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    • 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
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    • 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
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    • 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
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    • A61F2002/9155—Adjacent bands being connected to each other
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
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Abstract

本发明公开了一种用于儿童肝移植术后门静脉狭窄的支架，属于医疗器械领域。支架主体由沿轴向分布的多个环状支撑件构成，相邻的两个环状支撑件通过至少一个连接件连接；支架主体分为三部分，依次为近心端部、中端部和远心端部，中端部的管径最小，远心端部的管径最大。本发明的优点是：用于治疗病变血管因管径不匹配主要集中于直径变化处的狭窄，使血管远心端贴壁性能、近心端扩张性能得到改善，提高支架的生理适应性；可以增加支架与门静脉血管支架的结合面积和摩擦力，增加支架稳定性，降低支架移位发生率；可以减少门静脉腔内血流动力学的改变，使植入支架后再狭窄的风险降低，减少不良事件的发生。

Description

一种儿童变径球囊扩张式血管支架
技术领域
本发明涉及一种儿童变径球囊扩张式血管支架，属于医疗器械领域。
背景技术
儿童肝移植是解决儿童终末期肝病的有效治疗手段。儿童肝移植的预后受多种因素影响，其中最重要的是并发症的防治。门静脉狭窄是儿童肝移植术后常见血管并发症，若不及时有效治疗，致死率可达24％。由于供体资源的匮乏，亲体及减体积等需技术处理移植物的儿童肝移植手术增加，同时肝移植术后儿童血管并发症发生率显著高于成人，临床上有大量存在儿童肝移植术后门静脉狭窄的患儿被检出。如何提高儿童肝移植术后门静脉狭窄患儿的临床治疗成功率成为急需解决的重要临床问题。
对于儿童肝移植术后门静脉狭窄的患儿治疗方式主要有药物(肝素、香豆类抗凝药、尿激酶等)，手术治疗(静脉分流、重新吻合静脉、再次肝移植)及血管腔内介入治疗(包括球囊扩张成形术、血管支架成形术)。对于肝移植术后患儿，门静脉狭窄多为血管扭曲成角、吻合口狭窄等机械性因素，抗凝血药物治疗效果差。吻合口附近纤维组织增生，供体资源的匮乏可增加手术治疗风险。与上述治疗方式相比，血管腔内治疗儿童肝移植术后门静脉狭窄具有创伤小、手术成功率高、并发症发生率低等优点，已成为肝移植术后门静脉狭窄的首选治疗方法。
目前临床上广泛应用的血管支架成形术均采用不变径的筒型支架。有研究报道，使用血管支架成形术治疗儿童肝移植术后门静脉狭窄的技术成功率为66.7％，临床治疗成功率为73.0％，但是五年长期通畅率未知。解剖学和临床已经证实，肝移植供体与受体门静脉的直径差异，是儿童肝移植术后发生门静脉狭窄以及影响支架成形术临床治疗成功率的重要因素。由于筒型非变径支架无法同时兼顾受体与供体的直径，低龄患儿血管直径随生长发育而增宽，植入圆筒非变径状支架可能引起近心端贴壁不良，远端过度扩张，以上均会引起血管损伤、内膜增生，增加支架内再狭窄甚至门静脉血栓的发生率。因此筒型非变径支架置入患儿血管中后常不能保证患儿门静脉长期通畅，影响术后临床治疗成功率。
发明内容
本发明要解决的技术问题是，提供一种用于儿童肝移植术后门静脉狭窄血管病变的球囊扩张式支架。
为实现上述目的，本发明采用以下技术方案：
一种用于儿童肝移植术后门静脉狭窄的支架，支架主体由沿轴向分布的多个环状支撑件构成，相邻的两个环状支撑件通过至少一个连接件连接；支架主体分为三部分，依次为近心端部、中端部和远心端部，中端部的管径最小，远心端部的管径最大；中端部与其两侧的近心端部和远心端部分别以斜肩自然过渡连接。
所述环状支撑件依次交替设置多个波峰和多个波谷。
所述的波峰和波谷为正弦、余弦、梯形、三角形，二次曲线中的一种。
所述连接件为直线段，弧线段，曲线段中的一种。
所述环状支撑件和连接件的材质为金属丝。
所述金属丝的直径相等，支架为沿长度方向等厚度的网环。
所述金属丝的直径不相等，支架为沿长度方向不等厚度的网环。
所述金属丝的直径为0.4mm-0.6mm。
所述远心端部和所述近心端部通过金属丝连接成一体。
所述金属丝的材质选自铂钨合金、铂金、钛合金、镍钛合金、不锈钢、铑、铼、钯或钨中的一种或几种。优选的材质为不锈钢或者镍钛记忆合金，确保血管内支架的支撑力。
所述近心端直径10-16毫米，适用于成人静脉；远心端部的管径为6-12毫米，适用于低龄儿童门静脉；中端部的管径为5-10毫米，适用于门静脉吻合口直径，确保治疗效果。支架整体呈变径圆筒状，远心端管径小于近心端管径，二者管径相差2-6毫米，中端部为最小管径，与远心端部、近心端部相差4-6毫米，支架的长度为10-70毫米，优选20-40毫米。
所述的血管支架具备显影装置，显影装置为显影标记帖，为铂金材质，在X线下可清晰可见，规格为1mm标记帖，满足定位的准确性。
释放阶段：介入手术时，经皮门静脉穿刺，留置鞘管将导丝插入门静脉内，沿导丝插入支架输送鞘管至门静脉远心端处，退出输送和回收鞘管内芯和导丝，经输送和回收鞘送入血管内支架至鞘管远心端处，根据预先定位标志，将血管内支架前1/2定位于供体门静脉内，后1/2位于受体门静脉内，中端部置入于门静脉吻合口处，使用球囊扩张将支架释放于血管吻合口处。
本发明所述的血管支架扩张后的结构特征，在供体侧支架直径减小明显，可更好地附和移植术后门静脉血管直径沿长度方向变化的客观实际，提高血管支架与人体血管的匹配性，从而改善传统圆直支架在变径血管中扩张后产生的远心端贴壁不良和近心端过度扩张，从而有效抑制内膜增生、支架内再狭窄等不良反应，提高血管腔内治疗儿童肝移植术后门静脉狭窄的临床有效率。
本发明的优点是：儿童肝移植术后门静脉狭窄血管病变的球囊扩张式支架，用于治疗病变血管因管径不匹配主要集中于直径变化处的狭窄，使血管远心端贴壁性能、近心端扩张性能得到改善，提高支架的生理适应性；可以增加支架与门静脉血管支架的结合面积和摩擦力，增加支架稳定性，降低支架移位发生率；可以减少门静脉腔内血流动力学的改变，使植入支架后再狭窄的风险降低，减少不良事件的发生。
下面结合附图对本发明做进一步说明。并非对本发明的限制，凡是依照本发明公开内容进行的本领域等同替换，均属于本发明的保护范围。
附图说明
图1为实施例1的儿童肝移植术后门静脉狭窄病变血管的球囊扩张式支架的结构示意图(侧视图)
图2为实施例2的儿童肝移植术后门静脉狭窄病变血管的球囊扩张式支架的结构示意图(侧视图)
3A-图3E为环状支撑件局部结构示意图
具体实施方式
实施例1
如图1所示，一种用于儿童肝移植术后门静脉狭窄的支架，支架主体(1)由沿轴向分布的多个环状支撑件(2)构成，相邻的两个环状支撑件(2)通过至少一个连接件(3)连接；支架主体(1)分为三部分，依次为近心端部(11)、中端部(12)和远心端部(13)，中端部(12)的管径最小，远心端部(13)的管径最大；中端部(12)与其两侧的近心端部(11)和远心端部(12)分别以斜肩自然过渡连接。
所述环状支撑件(2)依次交替设置多个波峰(21)和多个波谷(22)。所述的波峰(21)和波谷(22)为正弦曲线，所述连接件(3)为直线段。所述环状支撑件(2)和连接件(3)的材质为金属丝。所述金属丝的直径相等，支架为沿长度方向等厚度的网环。所述金属丝的直径为0.5毫米。
远心端部(13)和近心端部(11)通过金属丝连接成一体。所述金属丝的材质为镍钛记忆合金，确保血管内支架的支撑力。
所述近心端(11)直径16毫米，适用于成人静脉；远心端(13)部的管径为12毫米，适用于低龄儿童门静脉；中端部(12)的管径为10毫米，适用于门静脉吻合口直径，确保治疗效果。支架整体呈变径圆筒状，支架的长度为40毫米。
参见图3A-图3E所示，所述环状支撑件(2)的多个波峰(21)和多个波谷(22)还可以是余弦、三角形，二次曲线等其他形状。
根据门静脉生理学特点，本发明支架的近心端部(11)插入供体门静脉血管内，支架的远心端部(13)插入受体门静脉血管内，支架的中端部(12)位于肝移植术后门静脉吻合口。
实施例2
如图2所示，一种用于儿童肝移植术后门静脉狭窄的支架，支架主体(1)由沿轴向分布的多个环状支撑件(2)构成，相邻的两个环状支撑件(2)通过至少一个连接件(3)连接；支架主体(1)分为三部分，依次为近心端部(11)、中端部(12)和远心端部(13)，中端部(12)的管径最小，远心端部(13)的管径最大；中端部(12)与其两侧的近心端部(11)和远心端部(12)分别以斜肩自然过渡连接。
所述环状支撑件(2)依次交替设置多个波峰和多个波谷。所述的波峰和波谷为正弦曲线，所述连接件(3)为直线段。所述环状支撑件(2)和连接件(3)的材质为金属丝。所述金属丝的直径相等，支架为沿长度方向等厚度的网环。所述金属丝的直径为0.6毫米。
远心端部(13)和所述近心端部(11)通过金属丝连接成一体。所述金属丝的材质为镍钛记忆合金，确保血管内支架的支撑力。
参见图3A-图3E所示，所述环状支撑件(2)的多个波峰(21)和多个波谷(22)还可以是余弦、三角形，二次曲线等其他形状。
所述近心端直径10毫米，适用于成人静脉；远心端部的管径为6毫米，适用于低龄儿童门静脉；中端部的管径为5毫米，适用于门静脉吻合口直径，确保治疗效果。支架整体呈变径圆筒状，支架的长度为20毫米。
本发明提供在确保血管内支架支撑力的同时，可更好地附和移植术后门静脉血管直径沿长度方向变化的客观实际，提高血管支架与人体血管的匹配性，从而改善传统圆直支架在变径血管中扩张后产生的远心端贴壁不良和近心端过度扩张，从而有效抑制内膜增生、支架内再狭窄等不良反应，提高血管腔内治疗儿童肝移植术后门静脉狭窄的临床有效率。

Claims (10)

1.一种用于儿童肝移植术后门静脉狭窄的支架，其特征在于：支架主体由沿轴向分布的多个环状支撑件构成，相邻的两个环状支撑件通过至少一个连接件连接；支架主体分为三部分，依次为近心端部、中端部和远心端部，中端部的管径最小，远心端部的管径最大；中端部与其两侧的近心端部和远心端部分别以斜肩自然过渡连接。
2.根据权利要求1所述的用于儿童肝移植术后门静脉狭窄的支架，其特征在于：所述环状支撑件依次交替设置多个波峰和多个波谷。
3.根据权利要求2所述的用于儿童肝移植术后门静脉狭窄的支架，其特征在于：所述的波峰和波谷为正弦、余弦、梯形、三角形，二次曲线中的一种。
4.根据权利要求3所述的用于儿童肝移植术后门静脉狭窄的支架，其特征在于：所述连接件为直线段，弧线段，曲线段中的一种。
5.根据权利要求1至4中任何一项所述的用于儿童肝移植术后门静脉狭窄的支架，其特征在于：所述环状支撑件和连接件的材质为金属丝。
6.根据权利要求5所述的用于儿童肝移植术后门静脉狭窄的支架，其特征在于：所述金属丝的直径相等或直径不相等。
7.根据权利要求5或6所述的用于儿童肝移植术后门静脉狭窄的支架，其特征在于：所述金属丝的直径为0.4mm-0.6mm。
8.根据权利要求1所述的用于儿童肝移植术后门静脉狭窄的支架，其特征在于：所述远心端部和所述近心端部通过金属丝连接成一体。
9.根据权利要求5或8所述的用于儿童肝移植术后门静脉狭窄的支架，其特征在于：所述金属丝的材质选自铂钨合金、铂金、钛合金、镍钛合金、不锈钢、铑、铼、钯或钨中的一种或几种。
10.根据权利要求1所述的用于儿童肝移植术后门静脉狭窄的支架，其特征在于：所述远心端部的管径为10-16毫米，中端部的管径为5-10毫米，近心端部管径为6-12毫米，支架的长度为10-70毫米，优选20-40毫米。
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