CN111419476A - 经导管主动脉瓣膜置换手术用辅助球囊结构 - Google Patents
经导管主动脉瓣膜置换手术用辅助球囊结构 Download PDFInfo
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Abstract
本发明公开了一种经导管主动脉瓣膜置换手术用辅助球囊结构,其特征在于,包括球囊头端和球囊本体;所述球囊本体在未膨胀时,两端为锥状、中部为筒状,两端的锥状分为前锥部和后锥部,中间的筒状为筒状部;所述筒状部上设置有乳突结构;所述前锥部和所述后锥部采用半顺应性材料制成,所述筒状部采用非顺应性材料制成。采用本发明的球囊结构进行经导管主动脉瓣膜置换手术,能够准确定位、防滑和抗钙化病变,提高TAVR手术的成功率;能够降低人工介入心脏瓣膜移位或是术后瓣周漏等手术并发症的发生几率;较好形态的人工介入心脏病瓣膜支架的释放,可以使得人工瓣叶更好的工作,同时可以延长人工心脏瓣膜的使用期限。
Description
技术领域
本发明涉及医疗器械技术领域,具体涉及一种经导管主动脉瓣膜置换手术用辅助球囊结构。
背景技术
经导管主动脉瓣膜置换术(Transcather Aortic Valve Replacement,简称TAVR),采用心脏介入导管微创技术,行人工介入心脏瓣膜置换,具有不开胸、风险低、操作简便、创伤小、恢复快和并发症少等优势,特别适合于存在外科手术禁忌症或是外科手术高危的患者。
TAVR手术中,由于瓣叶和主动脉根部的解剖结构特点的异常,部分患者的局部组织解剖质地较为坚硬,球囊预扩张环节,可能会发生球囊滑动,球囊膨胀不理想,或是球囊不能有效膨胀的情况;该种情况的发生,将严重影响TAVR术中TAVR瓣膜支架的释放,尤其是自膨胀式人工介入心脏瓣膜。该状况可导致TAVR术后瓣膜支架与主动脉壁不能有效的贴合,发生瓣膜周围漏,从而影响心脏瓣膜功能。长远角度来考虑,由于瓣膜支架不能有效膨胀,致使瓣膜支架不规则形状的自膨胀,从而影响了人工瓣叶的形态和工作,易增加人工瓣叶的疲劳度,从而减低人工心脏瓣膜的寿命。
发明内容
针对现有技术中的缺陷,本发明提供一种经导管主动脉瓣膜置换手术用辅助球囊结构,该球囊结构能够避免球囊扩张时发生滑动,确保良好的膨胀效果。该球囊结构具有抗钙化和精准定位的功能,能够提高TAVR手术的成功率。
一种经导管主动脉瓣膜置换手术用辅助球囊结构,包括球囊头端和球囊本体;所述球囊本体在未膨胀时,两端为锥状、中部为筒状,两端的锥状分为前锥部和后锥部,中间的筒状为筒状部;所述筒状部上设置有乳突结构;所述前锥部和所述后锥部采用半顺应性材料制成,所述筒状部采用非顺应性材料制成。
上述的辅助球囊结构,还包括导管;所述球囊本体与所述导管的一端部之间通过热焊接或激光焊接的方式密封连接;在所述导管上,所述球囊头端位于所述球囊本体的外侧,且所述球囊头端与所述导管的一端部的端头密封。
上述的辅助球囊结构,所述前锥部和后锥部采用聚酰胺高分子材料制成;所述筒状部采用改良型聚酰胺高分子复合材料制成。
上述的辅助球囊结构,所述筒状部的外径分为五个型号,分别为16mm、18mm、20mm、22mm、24mm和26mm;所述筒状部的长度为40mm。
上述的辅助球囊结构,所述乳突结构包括多个乳突环,同一所述乳突环上包括三个乳突组;其中,在某一所述乳突环位置的所述筒状部的截面上,三个乳突组之间呈120度角周向分布。
上述的辅助球囊结构,每个所述乳突组包括6-10个乳突点,且每个所述乳突组的所有乳突点成单列排布,且每个所述乳突环的所有乳突点位于所述筒状部的同一截面上。
上述的辅助球囊结构,每个所述乳突组中,相邻的两个乳突点之间间隔2mm。
上述的辅助球囊结构,所述乳突点的高度在1.0mm到1.5mm之间。
上述的辅助球囊结构,相邻的两个乳突环之间的区域设置有乳突阵列,所述乳突阵列包括多个阵列单元;每个阵列单元包括至少4个乳突点,其中,包括一个位于中心的中心乳突点和至少三个分布在所述中心乳突点周围的包围乳突点。
上述的辅助球囊结构,所述中心乳突点的高度为1.5mm;所述包围乳突点的高度为1.0mm。
上述的辅助球囊结构,所述导管外涂抹有亲水涂层。
上述的辅助球囊结构,所述导管的另一端设有两个接口,分别为第一接口和第二接口;所述第一接口用于连接气相压力源或液相压力源,所述第二接口用于插入导丝。
上述的辅助球囊结构,所述第二接口与所述导管同轴设置。
上述的辅助球囊结构,所述球囊本体上设置有标记点;所述导管在所述球囊本体内设置有出气口。
经导管主动脉瓣膜置换手术用辅助球囊,能够辅助术者在TAVR术中更好、更有效的进行TAVR术前的球囊预扩张,具有重要的临床实用意义。
附图说明
图1为本发明一实施例提供的辅助球囊结构的示意图;
图2为图1中A-A截面图;
图3为本发明一实施例提供的阵列单元的示意图;
图4为本发明一实施例提供的多个阵列单元在相邻两个乳突环之间的区域阵列分布的示意图;
图5为本发明一实施例提供的辅助球囊结构在打压初期临时固定状态的示意图;
图6为本发明一实施例提供的辅助球囊结构在打压后期球囊定位扩张状态的示意图。
附图标记说明如下:
1、球囊头端;2、球囊本体;3、前锥部;4、后锥部;5、筒状部;6、乳突结构;7、导管;8、乳突组;9、中心乳突点;10、包围乳突点;11、第一接口;12、第二接口;13、导丝;14、标记点;15、阵列单元。
具体实施方式
下面将结合附图对本发明技术方案的实施例进行详细的描述。
现有球囊在扩张时,可能会发生球囊“滑动”或是不能有效膨胀,致使不能达到理想的球囊预扩张。为了至少解决滑动或者不能有效膨胀的技术问题,采用如下实施例进行详细阐述。
在本实施例中提供一种经导管7主动脉瓣膜置换手术用辅助球囊结构,如图1所示,该球囊结构包括球囊头端1和球囊本体2;球囊本体2在未膨胀时,两端为锥状、中部为筒状,两端的锥状分为前锥部3和后锥部4,中间的筒状为筒状部5;筒状部5上设置有乳突结构6;前锥部3和后锥部4采用半顺应性材料制成,筒状部5采用非顺应性材料制成。
球囊头端1的外径尺寸小于球囊本体2,球囊头端1用于引导穿入血管;前锥部3和后锥部4采用半顺应性材料制成,筒状部5采用非顺应性材料制成,不同部位具有不同的顺应性;在球囊充气时,半顺应性材料的前锥部3和后锥部4先行膨胀,起到临时固定的作用,防止球囊滑动;继续给球囊充气,非顺应性材料的筒状部5在接受较大压力时小范围扩张膨胀,由于乳突结构6的存在,增加球囊结构与主动脉接触,起到固定作用,能够精准定位,防止滑动。
继续参照图1,上述实施例的球囊结构,还包括导管7;球囊本体2与导管7的一端部之间通过热焊接或激光焊接的方式密封连接;在导管7上,球囊头端1位于球囊本体2的外侧,且球囊头端1与导管7的一端部的端头密封连接;球囊本体2上设置有标记点14;导管7在球囊本体2内设置有出气口。
继续参照图1,在一些实施例中,导管7外涂抹有亲水涂层以有利于导管7推送,减少对血管的损伤,球囊结构的外层无需在涂抹亲水涂层;导管7的另一端设有两个接口,分别为第一接口11和第二接口12;第一接口11用于连接气相压力源或液相压力源;导管7内设置有导丝13通道,第二接口12用于插入导丝13,导丝13位于导丝13通道内,在术中,球囊结构可以沿着导丝13的轨道输送到适当部位;第二接口12与导管7同轴设置。
在一些实施例中,导管7在术中可以作为推送杆,采用金属材料制成,可选的金属材料包括不锈钢、镍钛合金。
在一些实施例中,前锥部3和后锥部4采用聚酰胺高分子材料制成;筒状部5采用改良型聚酰胺高分子复合材料制成。
在一些实施例中,经过临床经验和实际总结,为了适应不同患者、或者适应不同血管内径,优选的,筒状部5的外径分为五个型号,分别为16mm、18mm、20mm、22mm、24mm和26mm;筒状部5的长度为40mm。
在一些实施例中,乳突结构6包括多个乳突环,同一乳突环上包括三个乳突组8;如图2所示,其中,在某一乳突环位置的筒状部5的截面上,三个乳突组8之间呈120度角周向分布。
继续参照图2,在一些优选实施例中,每个乳突组8包括6个乳突点,每个乳突组8的所有乳突点成单列排布,且每个乳突环的所有乳突点位于筒状部5的同一横截面上。
在一些优选实施例中,每个乳突组8中,相邻的两个乳突点之间间隔2mm。
在以上所述的任一实施例中,乳突点的高度在1.0mm到1.5mm之间。
作为以上所述实施例的优选实施例,相邻的两个乳突环之间的区域设置有乳突阵列,乳突阵列包括多个阵列单元15;如图3所示,每个阵列单元15包括5个乳突点,其中,包括一个位于中心的中心乳突点9和四个分布在中心乳突点9周围的包围乳突点10;中心乳突点9要高于包围乳突点10;优选的,中心乳突点9的高度为1.5mm;包围乳突点10的高度为1.0mm。
如图4所示,多个阵列单元15之间相邻的两列中,错位分布;也就是,第N列的第a个阵列单元15与第a+1个阵列单元15之间,向左或者向右移动一列的距离后,设置第N±1列的第a个阵列单元15。
以上设置乳突结构6的所有实施例,均是为了防滑以及为了精准定位之用。
采用本发明的球囊结构进行经导管7主动脉瓣膜置换手术,能够准确定位、防滑和抗钙化病变,提高TAVR手术的成功率;能够降低人工介入心脏瓣膜移位或是术后瓣周漏等手术并发症的发生几率;较好形态的人工介入心脏病瓣膜支架的释放,可以使得人工瓣叶更好的工作,同时可以延长人工心脏瓣膜的使用期限。
如图5和图6所示,在采用导管7的第一接口11对球囊结构充气时,半顺应性材料的前锥部3和后锥部4先行膨胀,起到临时固定的作用,防止球囊滑动;继续给球囊结构充气,非顺应性材料的筒状部5在接受较大压力时小范围扩张膨胀,由于乳突结构6的存在,乳突结构6与主动脉瓣环接触,增加球囊结构与主动脉的接触,起到固定作用,能够精准定位,防止滑动。
以上各实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述各实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分或者全部技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的范围,其均应涵盖在本发明的权利要求和说明书的范围当中。
Claims (10)
1.一种经导管主动脉瓣膜置换手术用辅助球囊结构,其特征在于,包括球囊头端和球囊本体;所述球囊本体在未膨胀时,两端为锥状、中部为筒状,两端的锥状分为前锥部和后锥部,中间的筒状为筒状部;所述筒状部上设置有乳突结构;所述前锥部和所述后锥部采用半顺应性材料制成,所述筒状部采用非顺应性材料制成。
2.根据权利要求1所述的球囊结构,其特征在于,还包括导管;所述球囊本体与所述导管的一端部之间通过热焊接或激光焊接的方式密封连接;在所述导管上,所述球囊头端位于所述球囊本体的外侧,且所述球囊头端与所述导管的一端部的端头密封。
3.根据权利要求1所述的球囊结构,其特征在于,所述前锥部和后锥部采用聚酰胺高分子材料制成;所述筒状部采用改良型聚酰胺高分子复合材料制成。
4.根据权利要求1所述的球囊结构,其特征在于,所述筒状部的外径分为五个型号,分别为16mm、18mm、20mm、22mm、24mm和26mm;所述筒状部的长度为40mm。
5.根据权利要求1所述的球囊结构,其特征在于,所述乳突结构包括多个乳突环,同一所述乳突环上包括三个乳突组;其中,在某一所述乳突环位置的所述筒状部的截面上,三个乳突组之间呈120度角周向分布。
6.根据权利要求5所述的球囊结构,其特征在于,每个所述乳突组包括6-10个乳突点,且每个所述乳突组的所有乳突点成单列排布,且每个所述乳突环的所有乳突点位于所述筒状部的同一截面上;每个所述乳突组中,相邻的两个乳突点之间间隔2mm;所述乳突点的高度为1.0mm和/或1.5mm。
7.根据权利要求5所述的球囊结构,其特征在于,相邻的两个乳突环之间的区域设置有乳突阵列,所述乳突阵列包括多个阵列单元;每个阵列单元包括至少4个乳突点,其中,包括一个位于中心的中心乳突点和至少三个分布在所述中心乳突点周围的包围乳突点。
8.根据权利要求7所述的球囊结构,其特征在于,所述中心乳突点的高度为1.5mm;所述包围乳突点的高度为1.0mm。
9.根据权利要求2所述的球囊结构,其特征在于,所述导管外涂抹有亲水涂层。
10.根据权利要求2所述的球囊结构,其特征在于,所述导管的另一端设有两个接口,分别为第一接口和第二接口;所述第一接口用于连接气相压力源或液相压力源,所述第二接口用于插入导丝。
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