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CN108601597A - 锥形螺旋线圈支气管瓣膜 - Google Patents

锥形螺旋线圈支气管瓣膜 Download PDF

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Publication number
CN108601597A
CN108601597A CN201780007849.3A CN201780007849A CN108601597A CN 108601597 A CN108601597 A CN 108601597A CN 201780007849 A CN201780007849 A CN 201780007849A CN 108601597 A CN108601597 A CN 108601597A
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China
Prior art keywords
coil
wire
distal end
flow
unconstrained
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丹尼尔·J·福斯特
布莱恩·L·施密特
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Boston Scientific Scimed Inc
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Scimed Life Systems Inc
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Publication of CN108601597A publication Critical patent/CN108601597A/zh
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Abstract

本发明涉及用于组织体积减小和通过身体的物质流动的控制的系统和方法。根据本发明的各个实施例的系统包括由线卷形成的止逆阀，其可通过管状内腔，诸如内窥镜的工作通道或导管进行部署。

Description

锥形螺旋线圈支气管瓣膜
相关申请的交叉引用
本申请要求于2016-02-26提交的美国临时申请序列号62/300,498的优先权的权益，其公开内容全部通过引用并入本文。
技术领域
本申请涉及医疗装置和医疗过程领域。更特别地，本申请涉及用于减小肺体积的装置和方法。
背景技术
在某些肺部疾病，诸如肺气肿中，病变的肺组织可能异常扩张，这会压迫膈肌和邻近的健康肺组织并干扰正常的呼吸。就肺气肿而言，患病肺组织失去了弹性和在呼气期间有效地排出空气的能力。针对这些疾病的最常见的治疗涉及减小患病的肺部体积，例如通过手术切除病变的肺组织而进行。然而，外科肺切除是相对侵入性的、耗时的和昂贵的，且具有一些风险，包括感染、漏气、出血过多等。出于这个原因，微创的体积减小术已引起了兴趣，诸如由Pulmonx Corporation(Redwood City，CA)销售的支气管内瓣膜和由PneumRxTM(Mountain View，California)销售的形状记忆线圈。线圈能够通过支气管镜被部署至远侧支气管中并呈现螺旋或鸟巢的形状，以使得当其被部署在远侧支气管的长度内时，该装置聚集并推动源于周围肺组织的空气。然而，形状记忆线圈旨在减小肺组织的相对小部分的体积，且因此可能需要放置多个线圈在肺内以实现所需的体积减小。
发明内容
本发明在其各个方面中提供了改进的系统和方法，通过提供用作止逆阀的螺旋结构以允许目标肺组织的放气但却防止再充胀来进行肺体积减小的。
在一个方面中，本发明涉及一种用于调节在身体内的物质流动的系统，其包括线材，该线材被配置成在不受约束时形成锥形缠绕线圈且被配置成以细长的未缠绕的形态插入患者体内。锥形线圈的特征在于每个线圈环的小于一个丝直径(丝直径为线材的直径，其也被称为线材规格)的锥度。换句话说，在线圈不受约束时，第一环的第一外径优选为大于或等于相邻环的内径，该相邻环具有大于第一外径的第二外径。通过实例而非限制地说明，如果线材具有1mm的直径，则在线圈的相邻环之间的锥度(在第一环的外径和具有更大外径的相邻的第二环的内径之间的差)小于1mm。该线材可以具有任何合适的直径，例如，5、4、3、2、1、0.9、0.8、0.7、0.6、0.5、0.4、0.3、0.25、0.125或0.1mm；在每种情况下，在线圈的相邻环之间的锥度将小于线材的直径。线圈还具有小于物质(例如，血液、血浆、空气等)沿线圈的锥度减小的方向(即，从线圈的宽端至窄端)通过患者的体腔的流动期间在线圈的内和外表面之间的压力差的弹簧常数。通过实例而非限制地，如果物质是空气且线圈被设置在肺中，当肺泡压比大气压大至少2mmHg时，线圈将打开。这允许线圈在患者体内充当止逆阀的作用：物质的正常流动将足以打开线圈且允许物质沿减小的锥度的方向流过锥形线圈，同时线圈限制或防止物质沿线圈的增加的锥度的方向流动。在一些情况下，线材的远端形成了锥形线圈的最宽部分，例如，限定了具有基本上恒定直径的一个或多个(例如，多个)相邻环。线材的远端还可选地包括保持结构(诸如翼片或副翼)和/或球或圆形顶端中的一个或多个。在一些情况下，线材的近端形成锥形线圈的最窄部分，且可选地包括至少部分地阻挡锥形线圈的最窄部分的端部和一个或多个环的膜。在一些情况下，系统还包括装置，诸如导管或支气管镜，且线材可通过装置的内腔插入；在这些实施例中，线材的近端也许能够可逆地联接至被设置在装置的内腔中的推杆。线材能够包括镍钛诺、不锈钢或具有形状记忆的合金或聚合物，和/或可以具有一个或多个平坦表面(例如，线材的横截面在一些情况下可以是矩形的)。在一些实施例中，线圈在不受约束的形态中具有远端和在弹簧常数、线材厚度和节距中的一个或多个中不同于远端的近端。根据本发明的这个方面的系统在防止回流和/或调节在体腔中的脉动流动中是有用的，且可以用于肺体积减小。
在另一个方面中，本发明涉及一种治疗患者的方法，其包括在患者的支气管(该术语通常是指在肺内的通路，包括支气管、细支气管或其他气道)内设置止逆阀，该止逆阀包括被绕成锥形线圈的线材，该锥形线圈的特征在于在不受约束时每个线圈环的小于一个丝直径的锥度，以及小于在呼气期间发生在线圈的内和外表面之间的压力差的弹簧常数(即，当肺泡压比大气压高至少2mmHg时，线圈打开)。对线圈进行定位，以使得宽的部分位于在支气管内的窄的部分的远侧。在一些情况下，线圈可经支气管镜或导管输送，且可以按细长的形态通过支气管镜的工作通道或导管的内腔插入支气管中，其中其呈现程控的锥形线圈的形状。在一些情况下，线材的近端被可逆地联接至在支气管镜的工作通道内的推杆。如上所述，线材能够包括一个或多个平坦表面，且在一些情况下，可以具有矩形横截面。线材还能够包括膜或涂层。
在又一个方面中，本发明涉及一种用于调节在患者身体内的物质流动的器械，其包括线材，该线材被配置成在不受约束时形成锥形线圈且被配置成以细长的形态插入患者体内。锥形线圈的特征在于每个线圈环的小于一个丝直径(丝直径为线材的直径，其也被称为线材规格)的锥度。上面更详细地描述了锥度的细节。线圈还具有小于在呼气期间发生在线圈的内和外表面之间的压力差的弹簧常数(即，当肺泡压比大气压高至少2mmHg时，线圈打开)。线材的远端能够形成锥形线圈的最宽部分，且可以包括具有基本上恒定直径的一个或多个(例如，多个)相邻环，如上所述。替代地或额外地，线材的远端能够包括保持结构，诸如副翼或翼片，其将与体腔壁交互以有助于将线圈保持在位。如上所述，线材的远端还可选地包括球或圆形顶端。线材的近端可以限定锥形线圈的最窄部分，且可以包括至少部分地阻挡锥形线圈的最窄部分的端部和一个或多个环的膜。线材可以通过另一个装置，诸如导管或支气管镜的内腔插入，在这种情况下，线材的近端可以被可逆地联接至另一个装置的内腔中的推杆。线材还能够包括镍钛诺。在一些情况下，锥形线圈在不受约束时具有在近端和远端不同的弹簧常数、线材直径或节距。如上面所讨论的，线材能够包括平坦表面且可以是矩形或正方形横截面。
在又一个方面中，本发明涉及一种系统，其包括被配置成在不受约束时形成锥形线圈的线材和诸如导管或内窥镜的装置，该装置具有被定尺寸为允许插入在受约束形态中的线材的内腔。如上所述，锥形线圈的特征在于在不受约束时每个线圈环的小于一个丝直径的锥度，以及线圈具有小于物质在从线圈的宽的部分向线圈的窄的部分通过体腔的流动期间发生在线圈的内和外表面之间的压力差的弹簧常数。该系统能够被用于减少体腔内的回流，如下所述：将装置插入体腔中，且设置线材以使得锥形线圈的宽的远侧部分相对于线圈的窄的近侧部分被设置在内腔内的远侧。一旦部署好，线圈则用作止逆阀，这允许在远侧至近侧的方向上(即，在线圈的锥度减小的方向上)流过内腔，且同时减少在近侧至远侧方向上(即，在线圈的锥度增加的方向上)的回流。通过内腔的流动可选地是脉动的或周期性的，且内腔能够是血管、心脏或其腔室、支气管、细支气管或其他肺部通道以及食管和分流管，无论其是自然发生的还是手术形成的。在每种情况下，线圈优选地被定位成使得线圈的锥度在正常流动(即，物料从线圈的宽端流动至窄端)方向上减小，且在回流(即，物料的流动受阻于相反方向)的方向上增加。
附图说明
下面参考附图描述本发明的各方面，其中相同的数字指代相同的元件，且其中：
图1和图2为在闭合(1)和打开(2)形态中的线圈瓣膜的示意图。
图3示出被部署在患者的支气管内的线圈的示意图。
图4A、4B和4C为线圈瓣膜通过导管或支气管镜进行部署的示意图。
除非在以下说明书中另外提供外，否则附图不一定按比例绘制，其重点在于说明本发明的原理。
具体实施方式
通常，根据本发明的线圈瓣膜100包括被缠绕成细长的锥形线圈的单个线材，当不受约束时(如图1中所示)，其具有非常小或为零的节距(通常被定义为在线圈的相邻绕环之间的距离，或更严格地被限定为在线圈的相邻绕环之间的中心至中心的距离)。线圈100的特征在于在呼气期间，弹簧力小于流动对线圈的表面，例如，空气流动对线圈100的表面，的压力所施加的力。因此，在呼气期间，当在线圈100的内和外表面之间的压力差超过线圈100的弹簧力时，线圈100伸长且线圈100的相邻绕环相分离，如图2中所示，这允许空气在其之间流动直到该力下降至线圈100的恢复力以下，在这一点上，线圈100返回至其闭合位置。众所周知，在人类静息吸气或呼气期间可能存在低至2mmHg的肺泡压(Pa1v)与大气压(Patm)间的压力差。因此，在优选实施例中，线圈将响应于比Patm大至少2mmHg的Pa1v而打开，这允许在其中部署有线圈的支气管的下游的肺部进行排空或出气。
应注意的是，本文所描述的细长的锥形线圈设计不需要在其窄端闭合以充当截至阀。事实上，线圈能够在两端打开，只要在线圈的内、外表面之间的压力差在正常使用期间将超过线圈的弹簧常数即可。然而，线圈可以在其窄端包括覆盖物或其他阻碍结构(未示出)，其有助于限制或防止空气流过在闭合状态的线圈，从而当空气流动时增加在内和外线圈表面之间的压力差。替代地或额外地，可以通过使线圈的窄端变窄而限制通过在其闭形态的线圈的空气流动。
在闭合形态中的线圈100的节距通常很小或为零(即，线材的相邻绕环沿其长度中的全部或大部分是彼此接触的)。在优选实施例中，这是通过使用形状记忆材料，诸如镍钛诺以及设定线圈100的形状以呈现具有很小或为零节距的形状来进行辅助的。在一些情况下，能够通过使用具有一个或多个平坦表面的线材(例如，具有矩形横截面的线材，如Buiser等在美国专利号9,050,092中所述的，该专利通过引用并入本文以用于所有目的)来使节距进一步最小化。
在使用中，如在图3中所示，线圈100能够被部署在，例如，支气管或气道的其他部分中以防止肺的病变部分的充胀。线圈100被部署成使得宽端最接近于被治疗的肺部分且使窄端最远离该肺部分；这允许空气从患病的肺部分流出，但却限制了空气能够流入患病的肺部区域中的流速(或，如果线圈包括覆盖物或逐渐变窄至窄点，则防止了空气返回至患病的肺部区域)。有利地，线圈100能够用导管或支气管镜120被输送至肺，如在图4A、4B和4C中所示。形成瓣膜基部的线圈100的远端优选地被配置成形成环(或多个环)，其具有大于其中要部署线圈100的支气管的内径的直径，因此其在支气管上施加径向向外的保持力。替代地，线圈100的远端被联接至可扩张支架(未示出)。线圈100的远端还可以地包括球形顶端110以防止在部署期间对支气管造成创伤。能够通过推杆推进线圈100使其通过导管或支气管镜120，该推杆能够通过可分离的接头130被结合至线圈100的近端，该接头130可以是可机械分离的或可电解分离的。线圈100还可以在其远端包括一个或多个有助于保持的结构，诸如翼片等(未示出)。
虽然未示出，但还应注意的是，线圈的机械特性可以沿其长度变化，例如，弹簧常数在线圈的窄端附近可相对较低，且类似地，线材的厚度在线圈的最宽端可相对较大，以便进行保持。
尽管前述实例集中于肺体积减小，但本发明的系统和方法还能够适于控制在其他体腔内流动的流体。例如，本发明的瓣膜在流动是脉动的或周期性的背景下，诸如心脏瓣膜、血管等中限制逆行流或回流的方面是特别有用的。
如本文所使用的短语“和/或”应被理解成表示如此结合的元件中的“任一个或两个”，即在一些情况下相结合存在的且在其他情况下相分离存在的元件。除了由“和/或”从句特别标识的元件之外，其他元件可以可选地存在，无论其与特别标识的那些元件是相关的还是不相关的，除非明确指出与此相反。因此，作为非限制性实例，当与诸如“包括”等开放式语言结合使用时，对“A和/或B”的参考能够在一个实施例中指代A却不指代B(可选地为包括除了B之外的元件)；在另一个实施例中，指代B而不指代A(可选地为包括除了A之外的元件)；在另一个实施例中，指代A和B(可选地包括其他元件)；等。
术语“基本上由......组成”表示排除对功能有影响的其他材料，除非在本文中另有定义外。但是，这些其他材料可以共同或单独地以微量存在。
如在本说明书中使用的，术语“基本上”或“约”表示加或减10％(例如，按重量计或按体积计)，且在一些实施例中，为加或减5％。在整个说明书中对“一个实例”、“实例”、“一个实施例”或“实施例”的参考表示结合该实例所描述的特定特性、结构或特征包括在本技术的至少一个实例中。因此，出现在整个说明书中各处的短语“在一个实例中”、“在实例中”、“一个实施例”或“实施例”不一定都是指相同的实例。此外，特定特性、结构、例程、步骤或特征可以按任何合适的方式在本技术的一个或多个实例中进行组合。本文提供的标题仅仅是为了方便，且并不旨在限制或解释所要求保护的技术的范围或含义。
上面已描述了本发明的某些实施例。然而，明确指出的是，本发明不限于这些实施例，而是旨在将对本文明确所述的实施例的添加和修改也包括在本发明的范围之内。而且，要理解的是，在不脱离本发明的精神和范围的情况下，本文所述的各种实施例的特性不是相互排斥的且能够以各种组合和排列存在，即使这样的组合或排列没有在本文进行表达。事实上，在不脱离本发明的精神和范围的情况下，本领域的普通技术人员将想到本文所述实施例的变型、修改和其他实施方案。就这点而言，本发明并不仅仅是由前面的说明性描述限定的。

Claims (15)

1.一种用于调节在患者体内的物质流动的系统，其包括：线材，其被配置成在不受约束时形成锥形线圈，所述线材
被进一步配置成以细长形态插入至所述患者体内，
其中(a)所述锥形线圈的特征在于在不受约束时每个线圈环的小于一个丝直径的锥度，以及(b)所述线圈具有小于所述物质流动沿所述线圈的锥度减小的方向通过体腔期间发生在所述线圈的内、外表面之间的压力差的弹簧常数。
2.根据权利要求1所述的系统，其中所述线材的远端形成所述锥形线圈的最宽部分。
3.根据权利要求2所述的系统，其中所述线材的所述远端包括具有基本上恒定直径的多个环。
4.根据权利要求1所述的系统，其中所述线材的远端包括保持结构。
5.根据权利要求1-4中的一项所述的系统，其中所述线材的远端包括球或圆形顶端。
6.根据权利要求1-5中的一项所述的系统，其中所述线材的近端形成所述锥形线圈的最窄部分。
7.根据权利要求6所述的系统，其中所述线材的近端包括至少部分地阻挡所述锥形线圈的最窄部分的膜。
8.根据权利要求6或7中的一项所述的系统，其还包括选自导管和支气管镜所组成的组的装置，其中所述线材可通过所述装置的内腔插入，且所述线材的所述近端被配置成可逆地联接至被设置在所述装置的内腔中的推杆。
9.根据权利要求1-8中的一项所述的系统，其中所述线材包括镍钛诺。
10.根据权利要求1-9中的一项所述的系统，其中所述线圈具有远端以及弹簧常数、线材厚度和在所述不受约束的形态时的节距中的一个或多个不同于远端的近端。
11.根据权利要求1-10中的一项所述的系统，其中所述线材具有矩形横截面。
12.根据权利要求1-10中的一项所述的系统，其中所述线材包括至少一个平坦表面。
13.根据权利要求1-12中的一项所述的系统，其用于防止在体腔内的回流。
14.根据权利要求1-12中的一项所述的系统，其用于调节在体腔内的物料的脉动流动。
15.根据权利要求1-12中的一项所述的系统，其用于肺体积减小。
CN201780007849.3A 2016-02-26 2017-02-23 锥形螺旋线圈支气管瓣膜 Pending CN108601597A (zh)

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