CN105473093B - 具有至肾神经调制球囊的改善的粘附力的柔性电路 - Google Patents
具有至肾神经调制球囊的改善的粘附力的柔性电路 Download PDFInfo
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Abstract
本发明公开了一种用于肾神经调制的球囊。所述球囊可包括聚合物材料,其形成具有外表面和包括被选择性地粘附至所述球囊壁的所述外表面的基底的柔性电路的球囊壁。粘合剂被选择性地施加至所述球囊的所述外表面、所述柔性电路或两者,从而使所述粘合剂被选择性地沉积在所述至少两个片的至少一部分上或沉积在所述至少两个片的所述至少一部分上且至远侧条杆的一部分。所述至少两个片的所述部分、或所述至少两个片的所述部分和所述远侧条杆的一部分被粘附至所述球囊的所述外表面,且所述柔性电路的其余部分相关于所述球囊的所述外表面自由地移动。
Description
相关申请的交叉引用
本申请根据35U.S.C.§119要求于2013年8月22日提交的序列号为61/868,863的美国临时申请的优先权,其整个内容以引用方式并入本文。
背景技术
已开发出各种各样的体内医疗器械以用于医疗用途,如在血管内使用。这些器械中的一些包括导丝、导管等。这些器械是通过各种不同的制造方法中的任何一种进行制造并可根据各种方法中的任何一种进行使用。在已知的医疗器械和方法中,各自具有某些优点和缺点。持续地需要提供替代的医疗器械以及用于制造和使用医疗器械的替代方法。
发明内容
在一个方面,本发明涉及一种用于肾神经调制的球囊,球囊包括聚合物材料,其形成具有内表面和外表面的球囊壁,且包括由聚合物材料制成的基底的柔性电路被选择性地粘附至球囊壁的外表面,柔性电路中的每一个的基底包括远侧片和近侧片以及连接至少两个片的远侧条杆,粘合剂被选择性地施加至球囊的外表面、柔性电路或这两者,从而使粘合剂被选择性地沉积在至少两个片的至少一部分上或沉积在至少两个片的至少一部分上且至远侧条杆的一部分,其中至少两个片的该部分或至少两个片的该部分以及远侧条杆的一部分被粘附至球囊的外表面,且柔性电路的其余部分关于球囊的外表面自由移动。
在另一个方面,本发明涉及一种制造肾脏去神经球囊的方法,该方法包括提供预先成型的球囊,该球囊包括本体部分、腰部和圆锥部分;提供至少两个柔性电路,每个柔性电路的基底包括至少两个片和远侧条杆;选择性地将粘合剂施加至球囊的外表面、至少两个柔性电路或这两者从而使在至少两个片的一部分或在至少两个片的一部分和远侧条杆的一部分处与球囊的外表面相接触的柔性电路中的每一个的基底被粘附至球囊且柔性电路物其余部分关于球囊的外表面自由地移动。
对于本领域的普通技术人员来说,在审阅下面的具体实施方式和权利要求后,本发明的这些和其他方面、实施例和优点将立即变得显而易见。
附图说明
图1为具有被设置在其远端的根据本发明的肾神经调制球囊的导管的侧视图。
图2为图1中沿截面2‐2所截取的径向横截面。
图3为图1中沿截面3‐3所截取的径向横截面。
图4为具有被设置在其上的柔性电路的肾神经调制球囊的一个实施例的侧视图。
图5为具有被设置在其上的柔性电路的肾神经调制球囊的另一个实施例的侧视图。
图6示出用于肾神经调制球囊上的柔性电路的一个实施例。
图7‐12为柔性电路的内表面,例如被施加至球囊的表面的平面视图,其示出选择性地被设置在其上的粘合剂的各种实施例。
图13为柔性电路内表面和球囊外表面的局部视图,其中的每一个均具有激光诱导的微图案。
图14为具有在其上产生的激光诱导的微图案的另一个实施例的柔性电路的内表面的平面视图。
具体实施方式
虽然本发明的实施例可采用许多形式,但在本文中仍详细地描述了本发明的特定实施例。本说明书对本发明的原理进行了示例说明但不旨在将本发明局限于所示的特定实施例。
本发明旨在用于经皮进行肾动脉去神经的器械,特别是可扩张球囊及其制造和使用方法。
高血压是血压升高的慢性医疗疾病。持续性高血压是与各种不利的医疗疾病,包括心脏病发作、心脏衰竭、动脉瘤和中风相关联的显著的风险因素。持续性高血压是慢性肾衰竭的主要原因。服务于肾脏的交感神经系统的机能亢进与高血压及其进展相关。经肾动脉去神经而使肾脏中的神经失活可降低血压且可能成为对常规药物无应答的许多高血压患者的切实可行的治疗选择。
超声、射频能量、微波能量、直接加热元件和具有热或能量源的球囊可被施加至交感神经的区域。
用于治疗肾交感神经的特定方法涉及使用射频能量以破坏肾交感神经的经皮的基于导管的治疗。该方法涉及使用被推进至治疗部位并扩张的可扩张医疗球囊,且经被设置在球囊外部上的柔性电路通过球囊传输能量。
柔性电路被结合至肾脏去神经球囊的外表面。
在球囊插入、再折叠和取回期间,柔性电路的分层可能是一个问题。在本领域中仍需要具有高鲁棒性的用于肾动脉去神经的改进的球囊。
本发明涉及用于肾神经调制的球囊,其包括具有内和外表面以及被粘附地结合至球囊外部的柔性电路的球囊壁。肾神经调制或肾脏去神经有时被用于治疗与高血压和/或充血性心脏衰竭相关的疾病。
虽然在本文中相对于肾神经调制讨论了器械和方法,但可考虑的是这些器械和方法也可用于其他治疗中。
根据本发明的这些器械和方法涉及将射频能量输送至肾神经以永久地修改神经功能。
治疗涉及经导管输送装置将球囊输送至治疗部位,在治疗部位使球囊充胀,将能量输送至柔性电路以进行神经去神经,瘪缩和再折叠球囊,并将球囊拉回至导管输送装置中以从患者体内取回。
在替代实施例中,其他能源,如超声能量、微波能量或直接加热元件可用于肾动脉去神经。
现在转向附图,图1为具有被设置在其远端上的用于肾神经调制的球囊20的导管或导管组件10的侧视图。导管10包括具有用于充胀流体的端口32、电线通过其从柔性电路22上的电极行进到至发电机(未示出)的电插头36的端口33以及导丝内腔34。
球囊20包括被设置在其上的柔性电路22。球囊20是径向可扩张球囊。在使用中,球囊20被输送至患者脉管系统中的治疗部位并用通过端口32供给的流体进行充胀。球囊在远端被结合至外导管轴24的远端且在近端被结合至内导管轴。关于图6更详细解释的每个柔性电路是由基底聚合物材料50所制成的,其包括两个片60、62,每个焊盘含有两对电极,电极经设置在外导管轴内的电线被连接至位于器械的近端的电源。
柔性电路是由相对刚性的聚合材料制成的,其具有用于在电极之间传导电流的铜路径。
图2为图1中沿截面2‐2所截取的横截面视图,其示出了导管10的外轴24、被设置在外轴24内的电极26、充胀内腔28和导丝内腔30。虽然所示的电极26被设置在外轴24内,但在其他实施例中,电极26也可沿外轴24的外表面进行设置。
图3为图1中沿截面3‐3所截取的径向横截面视图,其进一步地示出了被径向联接至电极26的电线38。这些电线为温度传感器和消融电极提供了电力和接地。图4为用于肾神经调制的球囊20的一个实施例的侧视图,其示出了被设置在其内的两个柔性电路22。图4示出了直径为4mm的球囊。球囊20包括本体部分40、近侧圆锥部分42、近侧腰部44、远侧圆锥部分43和远侧腰部45。
图5为用于肾神经调制的球囊20的一个实施例的侧视图,其示出了被设置在其上的四个柔性电路22。替代地,球囊20可具有3个、5个或更多的被设置在其上的柔性电路。
5、6、7或8mm直径的较大的球囊可包括较大数量的柔性电路,如3个或更多的柔性电路。
在该实施例中,每个柔性电路是由聚合物基材50制成的。聚合物基材50可包括聚酰亚胺材料,如可从特拉华州威尔明顿的DuPontTM购得的聚酰亚胺。
柔性电路的复合特性产生了与聚合物球囊相比更为刚性的结构,聚合物球囊可阻碍球囊在瘪缩后但在被拉回到引导管内之前进行有效的再折叠。例如,这可进一步地在再次进入导引导管中并通过肾动脉的弯曲的体腔过度弯曲期间产生高剪切和弯曲力。
在该实施例中,柔性电路由通过远侧条杆部分64连接的两个片60、62限定。近侧条杆部分66从片62延伸至接近球囊的近侧腰部(见图1),其中电极38(见图2和3)被焊接至其处。电线38随后通过端口33至用于发电机(未在图1中示出)的插头36。
每个柔性电路,如在图6中所示,具有被联接至安装在用于各个温度控制反馈的铜迹线上的热敏电阻54的两个电极对52以及共享的接地56。在该实施例中,电极52是由金制成的但也可由任何合适的材料,如铂、不锈钢、钴合金以及其他非氧化性材料制成。每个柔性电路形成有益的完整的双极电路,这是因为其减少了源于所接近的非标靶的身体组织,如脂肪组织的治疗变化的影响或由于血流冷却效应中的变化而导致的能量损失。
柔性电路进一步包括可光刻印刷在其上的铜电线。
在该实施例中,电极是按空间进行布置的以实现360°圆周覆盖并沿纵向按偏离球囊的方式相间隔,这产生了避免消融可能导致对健康的肾组织造成损伤的单个周环的动脉覆盖,这也可能产生血管创伤和狭窄。因此,由各个柔性电路22所提供的离散的治疗位置是按空间进行布置的以提供用于去神经的血管的完全的圆周覆盖,且同时使对健康血管的负面影响最小化。
球囊可由非顺应性聚合物材料或半顺应性或顺应性聚合物材料制成。
顺应性球囊是由相对较软或柔性的聚合材料制成的。这些材料的实例为热塑性聚合物、热塑性弹性体、聚乙烯(高密度、低密度、中密度、线性低密度)、聚乙烯的各种共聚物和混合物、离聚物、聚酯、聚氨酯、聚碳酸酯、聚酰胺、聚氯乙烯或丙烯腈‐丁二烯‐苯乙烯共聚物。合适的共聚物材料、聚烯烃材料可从E.I.DuPont de Nemours and Co.(特拉华州威尔明顿)以商品名离聚物购得。
中间顺应性球囊由聚醚嵌段酰胺(PEBA)共聚物和尼龙材料制成。
非顺应性球囊是由相对刚性或硬性的聚合材料制成的。这些材料是热塑性聚合物和热固性聚合材料。这种材料的一些实例为聚(对苯二甲酸乙二醇酯)、聚酰亚胺、热塑性聚酰亚胺、聚酰胺、聚酯、聚碳酸酯、聚苯硫醚、聚丙烯和刚性聚氨酯。由聚(对苯二甲酸乙二醇酯)制成的非顺应性球囊通常被称之为PET球囊。
在一些实施例中,球囊由非顺应性聚合物材料,如聚对苯二甲酸乙二醇酯(PET)所制成。
柔性电路22被设置在球囊20的外表面上。合适地,柔性电路22经粘结结合被设置在球囊20的表面上。
粘合剂被选择性地施加至柔性电路22或球囊20,其中基底聚合物材料50的内表面与球囊20的外表面相接触。已发现可通过选择性地将粘合剂置于柔性电路22的基底50上而减少在电路上的应力,从而在进行再折叠和取回期间减少在球囊和柔性电路之间的不良的故障模式。
取回力可相对较高,例如,约2磅。这些高的取回力会使柔性电路从球囊实现部分或完全的分层。
将粘合剂选择性地置于柔性电路上允许通过设计使柔性电路22的部分自由地移动以减少在系统上的应力,并使球囊在插入、再折叠和取回期间更有效地进行再折叠。减少取回力有助于防止柔性电路从球囊发生不受控制的分层。
图7‐12为柔性电路的内表面,例如被施加至球囊的表面的平面视图,其示出选择性地被设置在其上的粘合剂的各种实施例。
图7示出其中近侧和远侧片60、62中的每一个均包括被选择性地设置在其上的粘合剂70的一个实施例。已发现在片60、62保持相对于彼此的相对位置的条件下,在两个电极之间的空间保持固定,且保持最佳的消融间隔。
图8示出一个替代实施例,其中远侧和近侧片60、62中的每一个包括以与柔性电路22的纵轴线相平行的方式行进的纵向粘合剂70条带。
图9示出一个替代实施例,其中粘合剂70以与导管组件的纵轴线成对角线的方式行进的条带被施加至远侧和近侧片60、62中的每一个。
在图10‐12中所示的替代实施例中,粘合剂70也被选择性地施加至远侧条杆64和近侧条杆66。
在图10中,粘合剂70点以均匀的图案被施加在远侧和近侧片60、62的每一个上且在远侧条杆64和近侧条杆66上。
图11示出一个实施例,其中粘合剂70以与导管组件的纵轴线相垂直的方式行进的条带进行施加。粘合剂70被施加至远侧和近侧片60、62以及远侧和近侧条杆部分64、66。
图12示出一个替代实施例,其中粘合剂70被施加至远侧和近侧片60、62的全表面,且以均匀的对角线条带被施加至远侧和近侧条杆64、66。
上述实施例仅是用于说明且不旨在限制本发明的范围。在不脱离本发明的范围的情况下,可按许多其他的图案和形状施加粘合剂。
在其为生物相容的医用级粘合剂的条件下,可采用任何合适的粘合剂,包括热塑性和热固性粘合剂。
在一些实施例中,粘合剂为热固性粘合剂。
在一些实施例中,粘合剂为紫外线(UV)可固化粘合剂。
在一个实施例中,粘合剂为氨基甲酸酯‐丙烯酸粘合剂。
可购得的医用级氨基甲酸酯‐丙烯酸粘合剂的一个实例为可从康涅狄格州托灵顿的Corporation购得的204CTH。
粘合剂可被施加至球囊、柔性电路或这两者。合适地,粘合剂被设置在与彼此相接触的球囊和/或柔性电路的至少一部分上。
此外,可通过在施加粘合剂70之前对柔性电路22和/或球囊20进行织构化或表面粗化改善在柔性电路22和球囊20之间的结合。这会使柔性电路22从球囊20的分层更少。然而,与不进行织构化的球囊相比,这也产生了更高的取回力。
一种使球囊20和/或柔性电路22的表面织构化的方法是在被设置在球囊上的柔性电路22的表面上和/或柔性电路被粘附至的球囊20的外表面上产生激光诱导的微图案。在共同转让的同时待审的美国专利申请14/316352中公开了柔性电路和/或球囊的激光蚀刻,其整个内容通过引用并入本文。
在一个实施例中,在柔性电路22和球囊20的每一个的表面上按图案产生激光诱导的微结构,该表面相匹配并产生微锁机构以进一步地减少当球囊被缩回至导管/护套中时柔性电路22会抓住和从球囊20分层的机会。
图13为具有在其上所产生的第一激光诱导的微图案的内表面80的柔性电路22以及具有在其上所产生的第二激光诱导的微图案86的外表面84的局部视图。产生激光诱导的微图案82、86,从而使图案相匹配并产生微锁系统。
在一个实施例中,激光诱导的图案生成在与柔性电路边缘中产生的提升力相垂直的线中。图14为柔性电路22的内表面80或后侧的俯视图,该柔性电路22具有垂直于在柔性电路22的边缘上所诱导的提升力而产生的激光诱导的微图案88,如在图14中所示。这可包括正交延伸越过柔性电路的激光诱导的微图案88(例如,与沿其中柔性电路22的边缘平行于柔性电路22的纵轴线的区域的纵轴线成横向;沿与在其中的柔性电路22的边缘是弯曲的区域中曲率半径相对齐的方向)。当在治疗动脉后将球囊拉回至护套中时,可能会出现在图14中所示的提升力。在典型的手术中,治疗左和右肾动脉。从护套推出球囊以进行第一次治疗,球囊进行充胀,且经电极将能量施加至动脉。接着,球囊进行瘪缩并拉回至护套中以将器械移至第二治疗部位。提升力出现在柔性电路的参考数字90所指示的边缘上。
在一个实施例中,在将柔性电路切成二分体(例如,每个聚合物片为360个二分体以用于高达120个导管)之前对柔性电路进行激光蚀刻,这减少了处理时间和成本。在另一方面,每个球囊被装载至固定物并进行旋转以对球囊表面进行部分激光蚀刻。
已发现可通过对球囊的外表面和/或柔性电路的内表面或结合表面进行织构化而改进电极的附接鲁棒性。
本文所提供的说明书的范围不受限于旨在作为某些实施例的各个方面的单一说明的特定实施例。本文所描述的方法、组合和器械可包括本文单独描述地或与本文所描述的任何其他特性相结合的任何特性。事实上,除了本文所示和描述的那些,根据仅使用常规实验的前述说明和附图,对于本领域的技术人员来说,各种修改将变得显而易见。这种修改和等同物旨在落在所附权利要求的范围中。
美国专利申请公开号US 2013/0165926通过引用并入本文。
美国专利申请号14/070211通过引用并入本文。
美国专利申请号61/891257通过引用并入本文。
在本申请中任何地方所提及的所有公开的文件,包括所有美国专利文件和美国专利公开均通过引用全部明确地并入本文。在本申请中任何地方提供的任何同时待审的申请也因此通过引用全部明确地并入本文。本文对参考的引用或讨论不应被解释为承认其为现有技术。
Claims (15)
1.一种用于肾神经调制的球囊,所述球囊包括:
由聚合物材料制成的球囊壁;
其中所述球囊壁具有内表面和外表面;以及
一个或多个柔性电路,所述柔性电路包括由聚合物材料所制成的基底,所述柔性电路用仅占据所述基底和所述球囊壁的外表面之间界面一些部分的粘合剂被部分地粘附至所述球囊的所述外表面,从而使所述基底的一些部分直接暴露给所述球囊壁的所述外表面并且关于所述球囊壁的所述外表面自由地移动,其中所述球囊和所述柔性电路被构造成折叠。
2.根据权利要求1所述的球囊,其中所述柔性电路中的每一个的所述基底包括至少两个片以及连接所述至少两个片的远侧条杆;
其中所述粘合剂被选择性地施加至所述球囊壁的所述外表面、所述柔性电路或两者,从而使所述粘合剂被选择性地沉积在所述至少两个片的至少一部分上、或沉积在所述至少两个片的至少一部分上和所述远侧条杆的一部分上;
其中所述至少两个片的所述至少一部分、或所述至少两个片的所述至少一部分和所述远侧条杆的一部分,被粘附至所述球囊壁的所述外表面,且所述柔性电路的其余部分关于所述球囊壁的所述外表面自由地移动。
3.根据权利要求2所述的球囊,其中所述柔性电路包括近侧条杆,且其中所述粘合剂被选择性地沉积在所述近侧条杆的一部分上。
4.根据权利要求2所述的球囊,其中所述粘合剂被选择性地沉积在所述至少两个片的所述至少一部分。
5.根据权利要求4所述的球囊,其中所述粘合剂被选择性地沉积在所述至少两个片的全部上。
6.根据权利要求2所述的球囊,其中所述粘合剂以垂直于所述球囊的纵轴线的方式行进的条带或以与所述球囊的纵轴线成对角线的方式行进的条带进行选择性地沉积。
7.根据权利要求2所述的球囊,其中所述粘合剂是以均匀的点的图案进行选择性地沉积的。
8.根据权利要求1‐7中任一项所述的球囊,其中形成所述球囊壁的所述聚合物材料是非顺应性聚合物材料。
9.根据权利要求1‐7中任一项所述的球囊,其中所述柔性电路是比形成所述球囊壁的所述聚合物材料更硬的复合材料。
10.根据权利要求1‐7中任一项所述的球囊,其中所述柔性电路、所述球囊或两者包括激光诱导的微图案。
11.根据权利要求1‐7中任一项所述的球囊,其中所述柔性电路的内表面包括第一激光诱导的微图案且所述球囊壁的所述外表面包括第二激光诱导的微图案,且所述第一激光诱导的微图案和所述第二激光诱导的微图案构成微锁系统。
12.根据权利要求1‐7中任一项所述的球囊,其中所述柔性电路、所述球囊或两者包括激光诱导的微图案,其垂直于柔性电路边缘上的提升力。
13.一种用于肾神经调制的球囊,所述球囊包括:
由聚合物材料所制成的球囊壁,所述球囊壁具有内表面和外表面;以及
柔性电路,所述柔性电路包括由聚合物材料所制成的基底,所述柔性电路用仅占据所述基底和所述球囊壁的外表面之间界面一些部分的粘合剂被粘附至所述球囊壁的所述外表面,从而使所述基底的一些部分直接暴露给所述球囊壁的所述外表面并且关于所述球囊壁的所述外表面自由地移动;
其中所述柔性电路包括激光诱导的微图案并且其中所述球囊和柔性电路构造成折叠。
14.根据权利要求13所述的球囊,其中所述柔性电路中的每一个的所述基底包括至少两个片以及连接所述至少两个片的远侧条杆,所述粘合剂被选择性地施加至所述球囊壁的所述外表面、所述柔性电路或两者,从而使所述粘合剂被选择性地沉积在所述至少两个片的至少一部分上、或沉积在所述至少两个片的至少一部分上且至远侧条杆的一部分;
其中所述至少两个片的所述至少一部分、或所述至少两个片的所述至少一部分和所述远侧条杆的一部分,被粘附至所述球囊壁的所述外表面,且所述柔性电路的其余部分关于所述球囊壁的所述外表面自由地移动。
15.根据权利要求13‐14中任一项所述的球囊,其中所述柔性电路的内表面包括第一激光诱导的微图案且所述球囊壁的所述外表面包括第二激光诱导的微图案,且所述第一激光诱导的微图案和所述第二激光诱导的微图案构成微锁系统。
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US10722300B2 (en) | 2020-07-28 |
US20220265346A1 (en) | 2022-08-25 |
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EP4049605A1 (en) | 2022-08-31 |
JP6159888B2 (ja) | 2017-07-05 |
EP3035879A1 (en) | 2016-06-29 |
US20200305973A1 (en) | 2020-10-01 |
JP2016532506A (ja) | 2016-10-20 |
US11350990B2 (en) | 2022-06-07 |
CN105473093A (zh) | 2016-04-06 |
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