CN105899166B - 无线型血管内基于支架的电极 - Google Patents

无线型血管内基于支架的电极 Download PDF

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Publication number
CN105899166B
CN105899166B CN201480072391.6A CN201480072391A CN105899166B CN 105899166 B CN105899166 B CN 105899166B CN 201480072391 A CN201480072391 A CN 201480072391A CN 105899166 B CN105899166 B CN 105899166B
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Prior art keywords
stent
aorta
mast
antenna
electrode
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CN105899166A (zh
Inventor
艾米尔·达刚
约阿夫·卡提兹
法比安·利普曼
艾隆·荷曼
坦宏·费尔德
那达夫·法勒
加尔·艾瑞亚佛
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Enopace Biomedical Ltd
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Enopace Biomedical Ltd
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Priority to CN201810648157.3A priority Critical patent/CN108836586B/zh
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    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0043—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in electric properties, e.g. in electrical conductivity, in galvanic properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings

Abstract

本发明涉及一种装置及方法，包括一支架(20)，其包括一支架体(52)，其包括一个大致呈圆柱形的远端部分(56)，以及一大致呈圆柱形的中间部分(58)。所述中间部分包括多个中间部分支撑环(60)通过多个桥接段(64)彼此间弹性相互链接，使所述中间部分弯曲。所述远端部分包括至少一远端部分支撑环(66)。所述支架被设置为使得当所述支架体其处在一构造径向压缩状态时，所述至少一远端部分支撑环施加一向外径向力大于由各所述中间部分支撑环所施加的一向外径向力。多个天线柱(46)，从所述远端部分纵向突出，以及一天线环形设置于所述天线柱上(28)。其他应用亦被描述于本文中。

Description

无线型血管内基于支架的电极
相关申请的交叉引用
本申请主张由达刚(Dagan)于2013年11月06日申请的美国临时申请案申请号为61/900,461的优先权，临时申请案名称:＂无线型血管内基于支架的电极＂，其公开内容引入本文作为参考。
本申请引用国际申请号为PCT/IL2013/050375(公开号为WO 13/164,829)，申请日:2013年05月02日，申请案名称:＂无线型血管内基于支架的电极＂，其主张下列美国临时申请案的优先权，其公开内容引入本文作为参考:
●由达刚于2012年05月02日申请的美国临时申请案申请号为61/641,388，临时申请案名称:＂无线型血管内基于支架的电极＂；
●由达刚于2012年10月16日申请的美国临时申请案申请号为61/714,277，临时申请案名称:＂无线型血管内基于支架的电极＂；以及
●由达刚于2013年03月07日申请的美国临时申请案申请号为61/773,919，临时申请案名称:＂无线型血管内基于支架的电极＂。
本申请引用由达刚申请的美国申请案，申请号为13/741,154(公开号为2014/0180391)，其为国际申请号为PCT/IL2012/000336(公开号为WO 13/035092)，申请日:2012年09月09日，申请案名称:＂无线型血管内基于支架的电极＂进入美国国家阶段的申请，其主张由达刚于2011年11月09日申请的美国临时申请案的优先权，申请号为61/532,660，临时申请案名称:＂无线型血管内基于支架的电极＂。
本申请引用由达刚于2011年08月16日申请的美国申请案，申请号为13/210,778(公告号为US 8,626,290)，所述美国申请案为由高思(Gross)于2010年12月01日，申请号为12/957,799(公告号为US 8,626,299)，申请案名称:＂体主动脉和迷走神经刺激＂的美国部分连续案，其为由高思于2010年06月02日申请，申请号为12/792,227(公开号为US 2010/0305392)，申请案名称:＂体主动脉和迷走神经刺激＂的美国部分连续案，其主张由雷斯纳(Reisner)申请于2009年06月02日，申请案名称:＂体主动脉和迷走神经刺激＂的美国专利临时申请案第61/183,319号的优先权以及由达刚申请于2010年05月05日，申请案名称:＂体主动脉和迷走神经刺激＂的美国专利临时申请案第61/331,453号的优先权。
所有申请案之内容均有相关并入此处作为参考。
技术领域
本发明部分应用大致涉及一种医疗设备，特别是本发明部分应用涉及一种用于放置于血管内的基于支架的电极。
背景技术
心脏衰竭是一种心脏的结构或功能的损害问题减少其提供足够的血流量，以满足身体需要能力的状况。所述状况损害生活质量，在西方世界是住院率和死亡的首要原因。心脏衰竭的治疗通常是针对去除促发原因，预防心脏功能恶化，和充血状态的控制。
高血压或慢性高血压，是一个非常普遍的医疗状况，这会导致中风、心脏病发作、心脏衰竭。有多种可用于治疗高血压的治疗方式，包括改变生活方式和药物治疗。
发明内容
依据本发明部分实施例，一支架被设置于一管腔内，例如一受试者的一血管的一管腔，如受试者的主动脉。一般而言，所述支架定义一支架体，多个从所述支架体的一远端突出的天线柱，多个从所述支架体的一远端突出的电极柱，及一个或多个耦合组件用于耦合一控制胶囊至所述支架体的内表面。进一步一般地，一天线通过被缝合到从所述支架体突出的所述天线柱而被连接至所述支架，多个线圈电极通过放置于对应的电极柱上耦合至所述支架，以及一控制胶囊由所述耦合组件耦合至所述支架。部分实施例中，一控制单元与一传输器设置于所述受试者体外。所述控制单元通过所述传输器传送一讯号及/或功率至所述支架。所述天线接收所传输的讯号及/或功率，所述控制胶囊驱动多个所述电极以驱动一电流进入血管内，以响应所述天线接收所述讯号及/或功率。部分实施例中，所述支架包括一大致呈圆柱形的支架体，其包括一个大致呈圆柱形的远端部分，以及一个大致呈圆柱形的中间部分。所述支架体的中间部分，其包括多个中间部分支撑环，各所述多个中间部分支撑环包括多个中间部分支柱，多个所述中间部分支撑环为彼此相邻并通过多个桥接段彼此间弹性相互链接，从而使所述大致呈圆柱形的中间部分弯曲。所述支架体的远端部分，从所述天线柱突起，包括至少一远端部分支撑环。所述支架体的远端和中间部分被设置为使得当所述支架体其构造径向压缩时(例如当所述支架体扩张抵触所述受试者的血管内壁)，所述至少一远端部分支撑环施加一向外径向力大于由各所述中间部分支撑环所施加的一向外径向力。
部分实施例中，各所述天线柱定义一近端部分与一远端部分，其各用于分别在没有任何力被施加到所述天线柱时被配置为大致呈直线状。一柔性连接处设置在所述天线柱的近端部分和远端部分之间的，所述近端部分和远端部分被配置为相对于彼此在柔性连接处柔性弯曲。部分实施例中，所述柔性连接处被成形以定义一单一正弦波、1.5个正弦波或不同数量的正弦波。
一般而言，所述支架放置于所述受试者主动脉内，使所述支架的远端在受试者的主动脉弓附近。部分实施例中，支架被放置使得电极被设置成与左锁骨下动脉的主动脉分叉和主动脉与第五肋间动脉分叉之间。部分实施例中，所述控制胶囊驱动所述电极以驱动一电流进入所述受试者的主动脉，为了受试者治疗的状况诸如充血性心脏衰竭、心脏舒张功能衰竭及/或高血压，如由达刚申请的美国申请案，申请号为13/210,778(公开号为US2012/0035679)，由高思申请的美国申请案，申请号为12/957,799(公开号为US 2011/0137370)，及/或由高思申请的美国申请案，申请号为12/792,227(公开号为US 2011/0305392)，所有申请案之内容均有相关并入此处作为参考。
应该注意的是，在本申请的上下文中，术语“近侧”和“远侧”将被理解为相对于该支架的一个接入点到受试者的身体。因此，支架的远端进一步是从所述接入点在支架的端部，和所述支架的近端是最接近于所述接入点在支架的端部。对于其中在支架放置在受试者的主动脉内的应用中，术语“远侧”通常指的支架或更接近受试者的左心室主动脉，而术语“近侧”的部分装置支架的一部分或主动脉进一步是从受试者的左心室。
因此依据本发明部分实施例，提供一种用于与成形以定义其一管腔的一管状结构使用的装置，其特征在于，所述装置包括：
一支架，被设置为放置于所述管腔内，所述支架包括：
一大致呈圆柱形的支架体，包括一个大致呈圆柱形的远端部分，以及一个大致呈圆柱形的中间部分，
其中所述支架体的中间部分包括多个中间部分支撑环，所述多个中间部分支撑环各包括多个中间部分支柱，多个所述中间部分支撑环为彼此相邻并通过多个桥接段彼此间弹性相互链接，从而使所述大致呈圆柱形的中间部分弯曲，
所述支架体的远端部分包括至少一远端部分支撑环，且所述支架体的远端和中间部分被设置为使得当所述支架体处在其一构造径向压缩状态时，所述至少一远端部分支撑环施加一向外径向力大于由各所述中间部分支撑环所施加的一向外径向力；及
多个天线柱，从所述远端部分纵向突出；以及
一天线，环形设置于所述天线柱上。
部分实施例中：
所述管状结构的管腔包括一受试者的一血管的一管腔，
所述支架被设置为放置于所述血管的管腔内，以及
所述支架体的远端和中间部分被构造使得所述至少一远端部分支撑环施加于所述血管的一壁的一径向力大于由各所述中间部分支撑环所施加的一径向力。
部分实施例中：所述管状结构的管腔包括一受试者的一血管的一管腔，
所述血管包括一弯曲部分成形以定义一曲线，所述血管的一内壁于所述血管的弯曲部分定义：一内部区，位于所述曲线的一内侧上；以及一外部区，位于所述曲线的一外侧上，
所述支架被设置为放置于所述血管的管腔内并位于所述血管的弯曲部分，以及
所述中间部分支撑环为彼此相邻并彼此间弹性相互链接，从而促使所述支架体沿所述血管的内壁的外部区的一纵向扩张大于沿所述血管的内壁的内部区的一纵向扩张。
部分实施例中：多个所述中间部分支撑环为彼此相邻并彼此间弹性相互链接，从而促使所述支架体沿所述血管的内壁的外部区的一纵向扩张以及促使所述支架沿所述血管的内壁的内部区的一纵向压缩。
部分实施例中：所述至少一远端部分支撑环包括多个增厚远端部分支柱，所述多个增厚远端部分支柱各具有一截面积大于多数的所述中间部分支柱，以及
所述至少一远端部分支撑环通过包括所述增厚远端部分支柱被设置用于施加一较大向外径向力。
部分实施例中，大多数的所述增厚远端部分支柱的每一个较长于大多数的所述中间部分支柱的每一个。
部分实施例中，所述支架体更包括一大致呈圆柱形的近端部分，所述支架体的近端部分包括一近端部分支撑环，所述支架体的近端及中间部分被配置为使得当所述支架体处在其所述径向压缩状态时，所述近端部分支撑环施加一向外径向力大于由各所述中间部分支撑环所施加的一向外径向力。
部分实施例中：所述近端部分支撑环包括多个增厚近端部分支柱，所述多个增厚近端部分支柱各具有一截面积大于大多数的所述中间部分支柱的每一个，以及
所述近端部分支撑环通过包括所述增厚近端部分支柱被设置用于施加一较大向外径向力。
部分实施例中，大多数的所述增厚近端部分支柱的每一个较长于大多数的所述中间部分支柱的每一个。
部分实施例中，所述支架体的远端部分更包括一第二远端部分支撑环，所述第二远端部分支撑环定义多个面向远端的V形支柱对，以及所述至少一远端部分支撑环定义多个面向近端的V形支柱对，且所述第二远端部分支撑环和所述至少一远端部分支撑环彼此耦合，使得所述第二远端部分支撑环的每个面向远端的V形支柱对耦合到所述至少一远端部分支撑环的其中一个所述面向近端的V形支柱对，从而形成一封闭钻石型单元。
部分实施例中，
所述装置更包括多个电极；
所述支架更包括多个电极柱，所述多个电极柱耦合至所述至少一远端部分支撑柱，各所述电极通过被放置在各所述电极柱上而被耦合至所述支架，以及
所述远端部分的封闭单元排列被配置为在所述管状结构的管腔内径向扩张，从而使：
各所述电极的一近端与所述管状结构的一内壁接触，并且
所述电极的近端与所述内壁的多个接触点大致外切一平面，一垂直于所述平面的垂直面则在所述接触点大致平行于所述结构的一局部纵向轴线。
部分实施例中，所述第二远端部分支撑环弹性耦合于所述至少一远端部分支撑环，从而使所述支架体的远端部分弯曲。
依据本发明部分实施例，更提供一种用于与成形以定义其一管腔的一管状结构使用的装置，其特征在于，所述装置包括：
一支架，被设置为放置于所述管腔内，所述支架包括：
一大致呈圆柱形的支架体，包括多个支柱；
至少一电极柱，自所述支架体突出；及
多个天线柱，从所述支架体的一端部纵向突出，所述天线柱从所述电极柱纵向分开；
一天线，环形设置于所述天线柱周围，从而使所述天线柱从
所述支架体的端部分开所述天线；以及
至少一电极，通过被放置于所述电极柱上而耦合至所述支架。
部分实施例中，所述管状结构的管腔包括一受试者的一血管的一管腔，且所述支架被设置为放置于所述受试者的血管的所述管腔内。
部分实施例中，所述血管的管腔包括所述受试者的一主动脉的一弯曲部分的一管腔，所述支架被设置为放置于所述受试者的主动脉的弯曲部分的管腔内。
部分实施例中，所述至少一电极是一线圈电极。
部分实施例中，所述支架定义一或多个耦合组件，所述装置更包括一控制胶囊，所述控制胶囊被配置为：
通过所述耦合组件耦合到所述支架，
接收来自所述天线的电能；以及
使用所接收的所述电能通过所述电极驱动一电流。
部分实施例中，所述至少一电极柱为包括多个电极柱；
所述至少一电极包括多个电极，所述多个电极被配置为通过被放置于所述多个电极柱的各电极柱上而耦合至所述支架；以及
所述多个电极柱被环绕设置于所述支架的小于75％的一周长。
部分实施例中，所述多个电极柱被环绕设置于所述支架的小于50％的周长。
部分实施例中，所述多个电极柱被环绕设置于所述支架的小于30％的周长。
部分实施例中，所述支架定义一或多个耦合组件，所述装置更包括一控制胶囊，所述控制胶囊被配置为：
通过所述耦合组件耦合到所述支架，
接收来自所述天线的电能；以及
使用所接收的所述电能通过所述电极驱动一电流。
部分实施例中，所述多个电极柱及所述多个耦合组件被环绕配置于所述支架的小于75％的周长，且所述多个耦合组件相对于所有由所述支架定义的所述电极柱旋转位移。
部分实施例中，所述多个电极柱及所述耦合组件被环绕配置于所述支架的小于50％的周长。
依据本发明部分实施例，更额外提供一种方法，所述方法包括步骤：
将一自体扩张支架插入一受试者的一主动脉的弯曲部分，所述自体扩张支架具有多个电极、一天线及一与其连接的控制胶囊；以及
使所述支架变为锚固到所述受试者的主动脉的一内壁，从而使得所有所述电极和所述控制胶囊围绕设置于所述主动脉的小于75％的一圆周。
部分实施例中，使所述支架变为锚固到所述受试者的主动脉的内壁的步骤包括：使所述支架变为锚固到所述受试者的主动脉的内壁，从而使得所有所述电极和所述控制胶囊围绕于所述主动脉的小于50％的圆周。
部分实施例中，通过操作一控制单元以传送射频功率到所述天线，使所述控制胶囊接收来自所述天线的电能，并使用所述电能驱动一电流经由所述电极进入所述主动脉。
部分实施例中，使所述支架变为锚固到所述受试者的主动脉的内壁的步骤包括：使所述支架变为锚固到所述受试者的主动脉的内壁，从而使得所述控制胶囊相对于所有所述电极旋转位移。
部分实施例中，使所述支架变为锚固到所述受试者的主动脉的内壁的步骤包括：使所述支架变为锚固到所述受试者的主动脉的内壁，从而使得所述控制胶囊沿主动脉的弯曲部分的一外部区设置在所述主动脉的弯曲部分的一曲率小于所述主动脉的弯曲部分的的一内部区的一曲率的位置处。
依据本发明部分实施例，更额外提供一种用于与成形以定义其一管腔的一管状结构使用的装置，所述装置包括：
一支架，被设置为放置于所述管腔内，所述支架包括：
一大致呈圆柱形的支架体，包括多个支柱；及
多个天线柱，从所述支架体的一端部纵向突出，各所述天线柱包括：
一远端部分与一近端部分，分别在没有任何力被施加到所述天线柱时被配置为大致呈直线状；及
一柔性连接处，设置在所述天线柱的近端部分和远端部分之间，所述近端部分和远端部分被配置为相对于柔性连接处彼此柔性弯曲；以及
一天线，环形设置于所述天线柱的的远端部分上，从而使所述天线柱从所述支架体的端部分开所述天线。
部分实施例中，所述管状结构的管腔包括一受试者的一血管的一管腔，且所述支架被设置为放置于所述受试者的血管的所述管腔内。
部分实施例中，所述柔性连接处被成形以定义一单一正弦波。
部分实施例中，所述柔性连接处被成形以定义1.5个正弦波。
部分实施例中，所述柔性连接处被成形以定义2个或以上的正弦波。
部分实施例中，所述血管的管腔包括所述受试者的一主动脉的一弯曲部分的一管腔，所述支架被设置为放置于所述受试者主动脉的弯曲部分的管腔内。
部分实施例中，所述柔性连接处被配置为促使所述天线柱的远端部分相对于所述天线柱的近端部分弯曲，从而使所述天线柱至少部分地与所述主动脉的弯曲部分的一曲率保持一致，即使位在所述主动脉的弯曲部分的一内部区且在所述主动脉的弯曲部分的一曲率大于所述主动脉的弯曲部分的的一外部区的一曲率的位置处。
部分实施例中，更包括一自体扩张线体，所述自体扩张线体耦合至所述天线，并且被配置为在所述受试者主动脉的弯曲部分内自体扩张，从而带动所述天线接触所述主动脉的一内壁，并且所述柔性连接处被配置为促使所述天线柱的远端部分相对于所述天线柱的近端部分进行弯曲，因而带动所述天线接触所述主动脉的内壁，即使在所述主动脉的弯曲部分的内部区处。
依据本发明部分实施例，更额外提供一种用于与一血管使用的装置，其特征在于，所述装置包括：
一支架，被设置为放置于所述血管内，所述支架包括：
一大致呈圆柱形的支架体，包括多个波浪状支撑环：
一最远端波浪状支撑环，包括N个最远端环支柱对；
及
一第二波浪状支撑环，邻接所述最远端波浪状支撑环，所述第二波浪状支撑环包括N/2个第二环支柱对；
多个天线柱，从所述最远端波浪状支撑环纵向突出；及多个电极柱，从所述最远端波浪状支撑环突出；以及
一天线，环形设置于所述天线柱上。
部分实施例中，各所述最远端环支柱对包括两个支柱，分别耦合在所述最远端波浪状支撑环的一相应近端交界处，
相邻的所述最远端环支柱对在所述最远端波浪状支撑环的多个相应远端交界处被相互耦合，
各所述第二环支柱对的各支柱分别被耦合到所述最远端波浪状支撑环的一相应近端交界处，从而定义N/2个封闭单元排列，
所述多个天线柱从所述最远端波浪状支柱环的多个相应远端交界处纵向突出，以及
所述多个电极柱从所述最远端波浪状支柱环的多个相应近端交界处突出。
部分实施例中：
各所述最远端环支柱对包括两个支柱，分别耦合在所述最远端波浪状支撑环的一相应近端交界处，
相邻的所述最远端环支柱对在所述最远端波浪状支撑环的多个相应远端交界处被相互耦合，
各所述第二环支柱对的各支柱分别被耦合到所述最远端波浪状支撑环的一相应近端交界处，从而定义N/2个封闭单元排列，
所述多个天线柱从所述最远端波浪状支柱环的多个相应远端交界处纵向突出，以及
所述多个电极柱从所述最远端波浪状支柱环的多个相应近端交界处突出。
部分实施例中，更包括多个电极，各所述电极通过被放置在多个所述电极柱中的其中一个上而被耦合至所述支架。
部分实施例中，各所述电极柱分别从多个连续的近端交界处的相应其中一个突出。
部分实施例中：
所述天线柱的数量为2/N个，以及
各所述天线柱从一个相应的远端交界处突出，从而交替状的远端交界处被耦合到所述天线柱。
部分实施例中，N是介于9和15之间的偶数整数。
部分实施例中，N是12。
本发明将在下文中更详细地具体参考附图及图式说明描述本发明的实施例。
附图说明
图1为根据本发明部分实施例中一支架具有多个电极与设置于其上的一天线，所述支架被放置于一受试者主动脉内的示意图；
图2A-2B为根据本发明部分实施例中一自体扩张支架显示其一扩张结构的三维结构对应示意图；
图3为根据本发明部分实施例中一支架放置于一血管内的结构示意图；
图4为根据本发明部分实施例中一天线柱用以支撑一天线示意图；以及
图5为根据本发明部分实施例中示意图为根据本发明部分实施例中一支架放置于一血管内的结构示意图。
具体实施方式
现在参考图1，其为按照本发明的部分实施例的一自体扩张支架20放置在一管状结构的内部、至少一电极22(图2A-B)，以及一般的多电极，被设置在支架上的示意图。对于部分实施例，支架20被放置在受试者的血管内，支架20通常被置于受试者的主动脉23内，如图所示。也可参考图2A-B，其为根据本发明的部分实施例的所述支架处在其一膨胀构造，且不存在受试者的解剖结构的示意图。值得注意的是，所述支架如图1所示。并且该支架的外观通常如图所示并且参照图1-3及图2A-B和图3-5描述。
通常情况下，一控制单元24和一传输器26被设置在受试者的身体之外，如图1所示。对于部分实施例(未示出)，控制单元和/或传输器被植入(例如，皮下植入)受试者的体内。典型地，一天线28和一个控制胶囊30(图2A-B)被连接到支架20。控制单元24通过传输器26向支架20发送信号及/或电能。天线28接收所发射的信号及/或电能，和控制胶囊30驱动电极以驱动电流到血管中，以回应于所述天线接收信号。对于部分实施例，控制胶囊30通过从天线28向传输器26发送信号以发送数据至控制单元24。因此，对于部分实施例，天线28还可以做为传输器，和传输器26也可以做为接收器。通常情况下，发射机26和天线28通过电感耦合相互通信。对于部分实施例，控制单元24使用计算机为可编程的。例如，用户(例如医生)可以使用一个计算机(未示出)使用一个标准的通信协议，诸如蓝牙，便于计算机和控制单元24之间的通信进行编程控制单元24。
典型地，电极22被放置在接触主动脉测，这是描述于达刚所申请的US 13/210,778(已公告为US8,626,290)、高思所申请的的US 12/957,799(已公告为US8,626,299)及/或高思所申请的US 12/792,227(已公开为US2010/0305392)。所有这些都通过引用并入本文的实施例。主动脉部位是典型地位于与左锁骨下动脉的主动脉分叉并与第五肋间动脉的主动脉分叉之间。进一步典型地，主动脉部位是与左锁骨下动脉和主动脉与第四肋间动脉分叉处，例如主动脉的分叉之间，左锁骨下动脉的主动脉分叉和主动脉与分叉之间第一肋间动脉。对于部分实施例，主动脉部位是主动脉与第一和第五肋间动脉分叉之间。
通常情况下，一个电流被驱动到受试者的主动脉，例如为了治疗为诸如充血性心脏衰竭、心脏舒张功能衰竭及/或高血压。例如，描述于达刚所申请的US 13/210,778(已公告为US8,626,290)、高思所申请的的US 12/957,799(已公告为US8,626,299)及/或高思所申请的US 12/792,227(已公开为US2010/0305392)。所有这些都通过引用并入本文的实施例。对于部分实施例，支架20由镍钛合金管(或由不同的材料，如不锈钢制成的管)具有大于0.2mm(例如，0.4mm以上)，及/或小于0.7毫米(例如，小于0.6毫米)的壁厚。对于部分实施例中，支架的长度超过25毫米(例如，大于30mm)，及/或小于100毫米(例如，小于40毫米)。支架被定型设定为所述支架为一期望膨胀构造，使用本领域已知的技术。对于部分实施例，将支架被定型设置为使得在其膨胀构造(即，在没有任何力作用在支架)，所述支架具有大于10mm(例如，大于15mm)及/或小于60毫米(例如，小于50毫米)的最大外径。所述支架通常被配置从而使其扩张构造被部署在受试者的主动脉内，支架本身通过至少支架体末端锚固到主动脉内(典型地，整个支架体)并扩张从而接触主动脉的内壁。所述支架通常被配置从而使其扩张构造被部署在受试者的主动脉内，支架维持电极22与主动脉部位接触，并且支架保持天线28在开放构造中，如在下文进一步详细描述。
支架20通常通过输送系统经皮下(例如经股)配置成放置在血管内(例如主动脉)，例如，使用12Fr尺寸–2Fr尺寸导管(例如，162Fr尺寸导管)。为了便于支架经皮放置到血管(例如主动脉)，使用导管，所述支架为卷曲的。典型地，所述支架具有小于20fr尺寸(例如，182Fr尺寸或更小)，及/或多于8Fr尺寸的卷曲轮廓(例如，10Fr尺寸或更多)。通常情况下，支架20定义一所述支架一近端的耦合组件31。对于部分实施例，所述耦合组件被设置在沿所述支架的近端外的支架长度的位置。过程中经由导管插入支架，输送系统维持所述支架相对使用耦合组件代替导管。为了放置支架在血管内的一部署位置，导管是在部署位置缩回，以使得所述支架从导管舒张。通过支架的径向扩张抵触血管内壁使所述支架变为锚固到所述受试者的主动脉的内壁。接着，耦合组件被从输送系统分离，并且将导管从血管抽出。
对于部分实施例，在被放置在血管内，所述支架被设置为部分地缩回导管相对于支架，从而使得(a)在所述血管内的预定位置所述电极22接触血管壁，和(b)支架的一近端部分设置在导管内，使得支架可被收回到导管。对于部分实施例，在血管内的电极对所述受试者的血管的电刺激的当前位置的反应被确定。反应于此，将支架(a)完全部署在支架的当前位置，(B)缩回到导管，并在血管中的不同的位置重新设置，或(c)缩回到导管，并从受试者的身体移除(例如，如果当所述支架设置后，受试者在任何位置对血管的电刺激无反应)。或者或另外，支架20被放置在血管(例如，主动脉内)内之前，一定位装置被放置在血管中，所述定位装置包括刺激电极。受试者的血管在使用定位装置的多个刺激电极刺激部位被电刺激，并受试者在血管内相应位置的电刺激反应被监视。接着，定位装置从血管中缩回，并且所述支架20被放置在血管内。在其中在血管内设置支架20的位置被确定，通过使用定位装置中的监视受试者对于各对应位置刺激的反应。
通常情况下，在所述支架被设置在血管内时，支架20的顺应性使得血管保持基本上的脉动。进一步典型地，支架和与其耦合组件(如控制胶囊30)被成形，例如，当所述支架在血管内被设置时，从而基本上维持通过血管的血流量。
如示于图如图2A所示，支架20通常定义便于控制胶囊30耦合至支架的一个或多个耦合组件40。对于部分实施例，如图所示，支架定义了定义孔的环。所述控制胶囊是通过将突起自控制胶囊背部的多个凸出物插入所述环内。如图所示，控制胶囊通常被配置为耦合到所述支架使得控制胶囊被设置在支架的内表面上。对于部分实施例，控制胶囊的长度大于10毫米，小于30毫米(例如，小于25毫米)，及/或10-30毫米(例如，10-25毫米)。通常，胶囊的宽度和深度分别是大于1毫米(例如，大于2毫米)，小于5毫米(例如，小于3毫米)，及/或1-5毫米(例如，2-3个毫米)。
通常情况下，至少一电极22被配置为耦合到支架20。对于部分实施例，电极22为一线圈并通过被放置在自所述支架的本体突出的一电极柱42上而耦合到支架20。所述电极22一般设置在一电极结构，其被用于当所述电极结构设置在所述电极柱上，所述电极22与天线和支架体电性分离。例如，如参考于达刚所申请的US 2014/0180391图8A-B所描述的电极结构，其通过引用并入本文。对于部分实施例，电极柱42被成形以定义为突起44，例如，当电极结构被连接到电极柱，以防止电极结构朝向支架本体滑动。通常，至少两电极(例如，至少三个电极)，及/或小于十二个的电极(例如，小于六个电极)联接到所述支架20，各电极被放置在从所述支架本体突出各个电极柱上。例如，三至五个电极(例如，四个电极)可联接到所述支架20，各电极被放置在从所述支架本体突出各个电极柱上。
通常，所述天线28是由一个金属线，例如，金线制成。为了使传输器26经由电感耦合天线28进行通信，其典型地期望为天线于血管内完全展开，使得天线与血管的内壁接触。对于部分实施例，为了使受试者的血管内的天线扩张，镍钛合金线29被耦合到所述金线，且所述镍钛合金线是依照天线的所需扩张构造形状设置。输送导管的远端用于输送支架20并在支架的设置位置缩回，如上所述。输送导管的缩回使得受试者的血管内部的镍钛合金线自体扩张，并且由于镍钛合金线耦合至金线，镍钛合金线使天线扩张到所需的展开结构(例如，使得天线与血管的内壁接触)。典型地，所述天线包括多个金线圈。例如，天线可以包括多于两圈，及/或小于十二圈，例如2-12圈或2-6圈。对于部分实施例，所述天线包括六圈的金线圈，六圈金属圈被从它们彼此分离成三层，如图所示。对于部分实施例，该天线线圈被成形为波状构造，如图所示。
天线28和镍钛合金线29通常由被缝合到天线柱46，其从支架20的支架体突出并与所述电极柱42分开。如上所述，对于部分实施例，天线28用来接收电能供应所述控制胶囊30以通过电极22来驱动一电流。典型地，所述天线通过感应耦合来接收电能，例如由传输器26(示于图1)不同的传输器朝向天线28发射RF能量以通过天线产生的一磁场。。所述磁场通过天线28以由天线28产生一感应电流。所述电流通过天线28又产生磁场，其可以产生通过支架20本体的一感应电流，其可与天线电流产生干扰，并降控制胶囊的供电效率。所述天线柱被构造，使得当所述天线被固合到所述天线柱，所述天线从所述支架本体的远端隔开。对于部分实施例，从所述支架体的远端分离所述天线，这些柱减少在支架体生成的感应电流的强度，通过通过天线产生的感应电流，从而提高了控制胶囊的供电的效率。部分实施例中，各个天线柱46的一长度L(图3)小于20毫米，例如，小于15毫米，及/或大于1毫米，例如，大于5毫米。
如上所述，所述支架20定义多个从所述天线柱46分出的所述电极柱42，所述电极柱和天线柱被设置用于提供所述电极和所述天线之间的一纵向间隔。以这种方式，在所述天线和所述电极之间的电性干扰相对于所述电极被放置在天线柱而被相对降低。
通常，天线28则以有线方式耦合到控制胶囊30(电线未示出)，而控制胶囊是用所述天线的所述感应电流供电。对于部分实施例，所述天线感应电流为控制胶囊的电能唯一来源。控制胶囊通常被配置为通过电极22驱动一电流进入到血管(例如，刺激血管)，及/或通过电极以接收所述血管的电参数。典型地，控制胶囊则以有线方式连接到所述电极22(电线未示出)，并且，若包括一个以上的电极22，在实施例中，有时，所述控制胶囊以有线方式连接到每个电极22。对于部分实施例，所述支架20是成形为定义一个电线保持件48其用于设置定位，相对于所述支架本体，耦合至所述天线和(多个)所述电极至所述控制胶囊的导线，通过所述导线缠绕于所述电线保持件定义的多个槽中。
如上所述，典型地至少两个电极22(例如，至少三个电极)，及/或小于十二个电极(例如，小于六个电极)联接到支架20，各电极被放置在从支架体突出各电极柱。例如，3-5个电极(例如，四个电极)被连接到支架20，各电极被放置在从所述支架本体突出的各个电极柱。对于部分实施例，电极22通常被平均地设置围绕支架20圆周上。如图2A-B，电极22未平均围绕支架20的圆周设置。如图1所示，支架20通常放置在受试者的主动脉内，在主动脉弓的附近主动脉弯曲部分。所述弯曲部分定义曲线的一内部区域25，在其中所述弯曲部分的曲率较大，以及曲线的一外部区域27，在其中所述弯曲部分的曲率较小。在由本申请的发明人进行的实验，主动脉刺激在主动脉部位施加到十二人类受试者，如上所述。刺激在位于主动脉部位的主动脉相应的圆周位置施加，测量受试者的反应。如果一个人的视角是降主动脉沿着从升主动脉朝向主动脉弓的底部，和弯曲部分外部区域的中心(即，所述位置在所述主动脉的弯曲部分的曲率是最小)被指定12点的位置观看，确定所述受试者典型地反应最好在主动脉部位在7点钟和12点钟位置之间的圆周位置刺激。
因此，典型地，3-5个电极(例如，四个电极)被连接到支架20，使得当支架被放置在受试者的主动脉内，所述电极放置在与主动脉接触在主动脉部位，如上所述，并在圆周的位置是5点钟和1点钟位置之间(例如，7点钟和12点钟位置之间)。对于部分实施例，支架20限定3-5电极柱42(例如，4电极职位)，电极柱被周围设置小于75％，例如，小于50％，或支架20圆周的30％以下，使得电极与主动脉的圆周的相应部分相接触。以这种方式，使用一给定量的电流，在具有受试者期望效果的角度，驱动电流到主动脉部位的效率，大于如果当前是被周围的整个圆周均匀地应用在主动脉的主动脉部位的效率。
实施例中，所述支架20被放置在主动脉的一弯曲部分内，通常期望的是控制胶囊(其具有平坦的表面)被置于朝向曲线的外侧，其中主动脉内壁的曲率低于主动脉内壁朝向曲线内侧的的曲率。因此，被控制胶囊耦合一个或多个耦合组件40中，典型地当支架被设置在主动脉内，使得所述耦合组件(甚至是控制胶囊)被设置在9点钟和3点钟之间的位置(例如，10点钟和2点钟之间位置)，向其中，以及所述多个电极柱和电极被布置在5点钟和1点钟位置(例如间，7点钟和12点钟之间位置)。进一步典型地，所有的电极柱，以及所述一个或多个耦合组件40(或包括控制胶囊)环绕设置于所述支架的小于75％的一周长，例如，不少于50％左右的的支架周长。另外，当从所述支架的近端沿着从支架观察(即，从端支架从该天线柱突出的相对端)连接到支架的远端(即，支架的端部从从该天线柱突出端)，一个或多个连接组件40(因此，该控制胶囊)被设置在从所有的电极柱的顺时针旋转位移(例如，小于30度的顺时针转动位移)，如图所示。
对于部分实施例(未示出)，电极柱42平均地在围绕支架20的前端的整个圆周间隔，如上所述。
现在参考图3，这是按照本发明的部分实施例的支架20的示意图。图3示出所述支架的一平面轮廓，其描述(为了说明的目的)所述支架如何出现，如果在所述支架的预定圆周位置形成一个沿所述支架的长度的纵向切口，以及随后所述支架平放于一表面上。如图3所示的支架20，包括一大致呈圆柱形的支架体52，其包括一个大致呈圆柱形的近端部分54、一个大致呈圆柱形的远端部分56以及一个大致呈圆柱形的中间部分58。在本申请的上下文中，术语“部分”应被理解为支架20的圆筒状部分。如进一步在下文描述，一个“部分”，典型地包括一个或多个支撑环，如环状形成的支架，沿着其他组件如耦合组件诸如桥接段或柔性连接处。
中间部分58包括多个中间部分支撑环60，每个中间部分支撑环60包括多个中间部分支柱62。所述中间部分支撑环60为彼此相邻并通过多个桥接段64彼此间弹性相互链接，相邻的环60的弹性相互链接使中间部分弯曲，依次使中间部分在血管中的一弯曲部分设置，例如在受试者主动脉弓附近的主动脉部位，如本文所述。
远端部分56包括至少一个远端部分支撑环66。所述远端部分56和中间部分58被设置为使得当所述支架体52处在其一构造径向压缩状态时，所述至少一远端部分支撑环66施加一向外径向力大于由各所述中间部分支撑环60所施加的一向外径向力。例如，当放置在血管内，血管径向压缩支架体52，以及远端部分支撑环66施加一径向力大于由各所述中间部分支撑环所施加的一径向力，由远端部分支撑环66施加的较大径向力有助于所述远端部分56锚固于所述支架20，也就是说，它通常可以帮助远端部分56留在血管内的期望的位置。此外，通过远端部分支撑环66施加的较大径向力，有助于使远端部分56保持电极22与血管内壁接触，并维持天线28在开放构造中。
对于部分实施例，如示于图3，远端部分支撑环66包括多个增厚远端部分支柱68，各增厚远端部分支柱68各具有一截面积大于多数的所述中间部分支柱62(在图3中所示的例子，每个增厚支柱68比各中间部分支柱62具有更大的截面积)。远端部分支撑环66被配置成通过包括所述增厚远端部分支柱68被设置用于施加一较大向外径向力。对于某些应用，如图3所示，大多数的所述增厚远端部分支柱68的每一个较长于大多数的所述中间部分支柱62的每一个(在图3所示的例子中，每个增厚远端部分支柱68比每个中间部分支62较长)。通常，增厚支柱68的长度的增加有助于减少远端部56可能会导致从增厚支柱68的增加的横截面面积的应变。
所述支架20进一步包括多个天线柱，从所述支架体的一端部纵向突出，所述天线柱通常所上文所叙述。所述装置典型地包括天线28(在图3未示出)，环形设置于所述天线柱周围，所述天线通常由黄金所制成并被如上所述的镍钛合金线29支撑。
再次参照图1，支架20被构造成放置在血管的弯曲部分内。例如，对于部分实施例，支架20被配置在受试者的主动脉内，在受试者的主动脉弓附近的主动脉部位。主动脉部位是典型地与左锁骨下动脉的主动脉分叉并与第五肋间动脉的主动脉分叉之间。进一步典型地，主动脉部位是与左锁骨下动脉和主动脉的与第四肋间动脉分叉处，例如主动脉的分叉之间，左锁骨下动脉的主动脉分叉和主动脉与分叉之间第一肋间动脉。对于部分实施例，主动脉部位是主动脉与第一和第五肋间动脉分叉之间。
如上所述，在主动脉部位的主动脉的内壁定义一内部区域25，其是在曲线内侧而一外部区域27是在曲线的外侧。参照图3所示的描述，相邻的所述中间部分支撑环60的弹性相互链接使中间部分弯曲，有利于所述支架体52沿外部区域27的纵向扩张大于沿内部区域25的纵向扩张。对于部分实施例，相邻的所述中间部分支撑环60的弹性相互链接便于支架体52沿外部区域27的纵向扩张以及支架体52的沿内部区域25的纵向压缩。
对于部分实施例，如图3所示，近端部分54包括一近端部分支撑环70。近端部分54和中间部分58被配置为使得当所述支架体52处在其所述径向压缩状态时(例如，血管内，如上所述)，所述近端部分支撑环70施加一向外径向力大于由各所述中间部分支撑环60所施加的一向外径向力。较大的向外径向力帮助近端部分54锚固就位于所述支架20，如以上所描述的远端部分56。对于部分实施例，如图3所示，所述近端部分支撑环70包括多个增厚近端部分支柱72，所述多个增厚支柱72各具有一截面积大于大多数的所述中间部分支柱62的每一个(在图3所示的例子，每个增厚支柱72具有比每一个中间部分支柱62更大的截面积)。在这样的应用中，所述近端部分支撑环70被配置成通过包括所述增厚近端部分支柱72被设置用于施加一较大向外径向力。对于部分实施例，如图3所示，大多数的所述增厚近端部分支柱72的每一个较长于大多数的所述中间部分支柱62的每一个(在图3所示的例子，每个增厚支柱72较长于每一个中间部分支柱62)。通常，增厚支柱72的长度的增加有助于减少近端部分54，可能会导致从加厚支杆72的增加的横截面面积的应变。
对于部分实施例，如图3所示，远端部分56更包括一第二远端部分支撑环74，所述环74耦合至所述环66以一个封闭的单元结构，例如，所述环74的多个面向远端的V形支柱对76耦合到所述环66的其中一个所述面向近端的V形支柱对，从而形成一封闭钻石型单元。
对于部分实施例，所述支架20更包括多个电极柱42，所述多个电极柱42耦合至所述至少一远端部分支撑柱66，电极柱42一般是如上所述。所述装置更包括多个电极(图2A-B)，各所述电极22通过被放置在各所述电极柱42上而被耦合至所述支架20，如上所述。对于部分实施例，支架20被放置在弯曲的血管内，例如，主动脉弓的附近，以及所述电极22被放置在接触主动脉弓的附近的一主动脉部位，如上所述，及/或达刚所申请的US 13/210,778(公开号为US 2012/0035679)、高思所申请的的US 12/957,799(公开号为US 2011/0137370)及/或高思所申请的US 12/792,227(已公开为US2010/0305392)所有上述申请通过引用并入本文。在这样的应用中，通常优选的是电极22沿曲线不是沿曲线的外侧(或反之亦然)前进，如在大致相同的纵向位置施用电极到血管。远端部分56的封闭结构通常有助于使电极被带动至与血管的内壁大致相同的纵向位置，至少由于减少封闭结构相对的开放结构的灵活性(中间部分58，例如，包括支柱对78的开放结构，在其中相邻的环不是每个面向远端的V形支柱对耦合到面向近端v形支柱对相邻的情况，例如，形成一个封闭钻石型单元，如下文所述，因此，中间部分通常比远端部分56更具弹性)。例如，每个电极的近端抵接血管内壁，而所述电极的近端与所述内壁的多个接触点大致外切一平面，一垂直于所述平面的垂直面则在所述接触点大致平行于所述结构的一局部纵向轴线。
对于部分实施例，如图3所示，第二远端部分支撑环74弹性耦合于所述至少一远端部分支撑环66，从而使所述支架体的远端部分56弯曲。例如，图3所示，所述环74和所述环66通过多个柔性连接处80耦合，对于部分实施例包括弹簧。连接处80便于所述环66和所述环74相对于彼此的移动，所述移动包括大致横向于所述支架的纵轴和血管运动。所述环74和所述环66的弹性联接利于远端部分56在曲率相对高的位置设置，例如主动脉内、主动脉弓附近。
对于部分实施例，各天线柱46包括一近端部分82与一远端部分84及一柔性连接处85。近端部分82与远端部分84被配置为分别在没有任何力被施加到所述天线柱时被配置为大致呈直线状，所述近端部分82和远端部分84被配置为相对于柔性连接处彼此柔性弯曲。所述天线柱46的弹性帮助所述天线柱设置在所述血管的一具有相对高曲率的部份，例如，主动脉内的血管，邻近的主动脉弓的部分的天线柱的位置，如本文所述。对于部分实施例，所述柔性连接处85被成形以定义一0.5-3的正弦波。例如，所述柔性连接处被成形以定义一单一正弦波，如图所示。可选地，所述柔性连接处被成形以定义1.5个正弦波，如参照图4描述如下，或不同数量的正弦波(例如，2个正弦波或3个正弦波)。对于部分实施例，所述柔性连接处85具有不同的形状，以促进所述近端部分82和远端部分84相对于彼此柔性弯曲。
如上所述，天线28(图2A-B)环形地设置在天线柱上，从而使所述天线柱从所述支架体52的端部分开所述天线28。为了使传输器26通过电感应与天线28耦合进行通信，通常希望所述天线在血管内成为完全展开，使得天线与血管的内壁接触。所述镍钛合金线29，其耦合到天线，通常在受试者的血管内自体扩张，并且使得黄金天线展开使得天线与血管的内壁接触。对于部分实施例，通过促进所述柱46的远端部分84相对于所述柱所述近端部分82相对弯曲，连接处85便于从支架体的外表面向所述柱的远侧部分径向弯曲。以这种方式，被设置在主动脉的弯曲部分的内部区域25的所述柱(图1)能够弯曲如以至少部分地与所述主动脉的曲率相符。由于天线被耦合(通常，通过缝合)到柱的远端部分，这些柱的弯曲通常是以促进天线充分扩张，连讯息。如使得天线被抵接在主动脉的内壁，甚至是主动脉的弯曲部分的一内部区域25。
对于部分实施例，至少部分支撑环60和70被成形以定义波浪状支撑环。例如，图3示出每个支撑环60和70成形为定义波浪状支撑环。每个波状状支撑环包括多个支柱对，例如，多个V形支柱对78。每个所述支柱对78包括两个支柱62彼此耦合在波浪状支撑环中的相应的近端交界处86。典型地，多个桥接段64彼此耦合波浪状的行至所述环74。对于部分实施例，每个桥接段64耦合第一环中的一第一支柱对78至相邻的环的第二支柱对78。例如，图3显示每个桥接段64耦合第一环中的所述第一支柱对78的一近端交界处86至相邻的环中的所述第二支柱对的一近端交界处。每个桥接段64耦合到更远侧环的交界处的近端侧，并且耦合到到更近侧环的连接点的远端侧。
通常情况下，一个预定的环60的各近端交界处86通过一个桥接段64被直接耦合至一恰好的近端交界处，(a)一属于相邻环的支柱对被设置为预定的环近端，以及(b)属于相邻环的支柱对被设置为预定的环远端。这种结构通常增加支架20，相对于结构(未示出)其中一个或多个近端交界处86直接耦合到的近端交界处两者(a)和(b)的灵活性。进一步典型地，如图3所示。桥接段64设置于相邻环的一预定对的近端交界处两反侧交替的对之间因此，每对的桥接段64之间有一对相对的近端交界处没有以桥接段耦合。以这种方式，中间部分58包括支柱对78的开放结构，在其中它不是每个面向远端的V形支柱对耦合到相邻环面向近侧v形支柱对的情况下，以形成一个封闭的钻石型单元。
对于部分实施例，如图所示，至少一些桥接段64包括一部分88其大致呈直的和刚性的。当支架20被纵向拉伸，桥接段64的部分88有利于传输拉伸力到与它们所连接的各个支柱对78，和支柱对回应于于拉伸力变形。例如，对于部分实施例，当支架20被纵向拉伸，桥接段64的部分88被构造为至少部分倒置的V形支柱对78(即，至少部分地增加了由V支柱形对定义的角度)。
对于部分实施例，至少一些桥接段64包括弹性部分90，例如，一个正弦弹性部分90。当支架20被纵向拉伸，部分拉伸力可被传递到桥接段64的弹性部分90，以及弹性部分可以变形，例如伸展，以响应拉伸。对于部分实施例，弹性部分90促进支架20设置于相对高曲率的区域，例如主动脉弓附近(如上所述)，通过促进支架20的弯曲。
现在参考图4，其是天线柱46的示意图，根据本发明的部分实施例。如上所述，对于部分实施例，每一天线柱46包括一远端部分82、一近端部分84和一柔性连接处85。如上所述，典型地，所述柔性连接处85被成形以定义一0.5-3的正弦波。例如，所述柔性连接处被成形以定义一单一正弦波，如图3所示。可选地，所述柔性连接处被成形以定义1.5个正弦波，如参照图4。对于部分实施例，成形连接处来定义1.5正弦波增加连接处相对的接合如图3所示。对于部分实施例，所述柔性连接处成形被定义为不同数量的正弦波(例如，2个正弦波或3个正弦波)。对于部分实施例，所述柔性连接处85具有不同的形状，以促进所述近端部分82和远端部分84相对于彼此柔性弯曲。如图4所示，远端部分84的天线柱通常定义凹口100，其被构造成便于使天线28和镍钛合金属线29(示于图2A-B)缝合至天线柱。
现在参考图5，为按照本发明的部分实施例的支架20示意图。图5示出所述支架的一平面轮廓，其描述(为了说明的目的)所述支架如何出现，如果在所述支架的预定圆周位置形成一个沿所述支架的长度的纵向切口，以及随后所述支架平放于一表面上。如本实施例中图5所示的支架20，包括一大致呈圆柱形的支架体52，其包括多个多个波浪状支撑环106。一最远端波浪状支撑环108，包括N个最远端环V形支柱对110。一第二波浪状支撑环112，邻接所述最远端波浪状支撑环108，所述第二波浪状支撑环包括N/2个第二环V形支柱对114。对于部分实施例，N是偶整数大于9及/或小于15，例如，10-14。例如，图5示出一应用，其中，N是12。由此，图5示出12个最远端环V形支柱对110和6个第二环V形支柱对114。
支架20进一步包括多个天线柱46，从所述最远端波浪状支撑环108纵向突出及多个电极柱42，从所述最远端波浪状支撑环突出。支架20通常包括多个耦合组件31，如上所述，在支架的近端，为了便于控制胶囊30的耦合到支架。
对于部分实施例，如图5所示，各所述最远端环支柱对110包括两个支柱，分别耦合在所述最远端波浪状支撑环108的一相应近端交界处116。相邻的所述最远端环支柱对110在所述最远端波浪状支撑环108的多个相应远端交界处118被相互耦合。各所述第二环支柱对114的各支柱120分别被耦合到所述最远端波浪状支撑环108的一相应近端交界处116，从而定义N/2个封闭单元排列122(例如N/2个封闭钻石型单元)。多个天线柱46从所述最远端波浪状支柱环108的多个相应远端交界处118纵向突出，以及所述多个电极柱42从所述最远端波浪状支柱环108的多个相应近端交界处116突出。所述最远端波浪状支柱环108及第二波浪状支撑环112的构造，如上面刚刚描述的，典型地有助于大致稳定支架20的远端部分。例如，最远端波浪状支柱环108和第二波浪状支撑环112的构造可以有助于维持天线柱46及/或电极柱42在一个期望方向(例如，如以维持在对准天线柱46和/或电极柱42与支架和/或血管的局部纵向轴线)。
天线28、电极22以及控制胶囊30被连接到支架上，如上所述。对于部分实施例，每个电极柱42从多个连续的近端交界处116中的相应一个突出。例如，图5示出四个电极柱42从四个连续的近端交界处116突出。对于部分实施例，如图3所示，支架20被成形，从而使四个电极柱42从支架本体的最远端状支撑环的四个近端交界处突出。对于部分实施例，如示于图5，天线柱46的数目为N/2，并且每个天线柱46从相应远端交界处118突出，使得备用远端交界处118具有天线柱46与之耦合。
对于部分实施例，如上所述，N是偶整数，大于9及/或小于15，例如，10-14。例如，对于部分实施例，N为12，如图5所示。因此，有12个近端交界处116，以及连续电极柱42(因此，也有连续电极22)彼此大约血管的圆周的1/12隔开12个近端交界处116，和连续电极柱42，当支架20在血内管时为一扩张状态时。
如上所述，典型地，3-5个电极(例如，4个电极)被连接到支架20，使得当支架被放置在受试者的主动脉内，所述电极放置在主动脉部位与主动脉接触，如上所述，并且放置在5点钟和1点钟位置之间的圆周位置(例如，7点钟和12点钟之间位置)。对于部分实施例，支架20定义3-5个电极柱42(例如，4个电极柱)，电极柱被环绕设置小于75％的支架20圆周，例如小于50％或30％以下。典型地，大于1/15及/或小于1/9(例如，1/15-1/9，例如大约1/12)的血管周围的一间距优选为使电极22相对于彼此的间隔。
虽然本发明的部分实施例已描述了关于支架20放置在受试者的主动脉内，本发明的范围包括将支架20设置于受试者的身体的其它血管内，例如，受试者的颈动脉、肺动脉、及/或肾动脉。例如，支架可以放置在肾动脉中，为了治疗肾功能障碍，及/或在肺动脉，以治疗肺动脉高压。或者或另外，所述支架可以放置在肺动脉和/或颈动脉，以用于迷走神经刺激(例如，迷走神经刺激)，例如，为了治疗胃食管反流疾病(GERD)。同样，虽然该支架被示出至少部分地设置在降主动脉中，本发明的范围包括将所述支架在任何位置的主动脉内，如在升主动脉，降主动脉，主动脉弓，或一个它们的组合。
对于部分实施例，受试者的心动周期是通过检测来自受试者的主动脉的电信号经由电极22与技术描述了测定，并导出从在主动脉处检测到的电信号，如受试者的心电图和/或血压，按照高思申请的US 12/792,227(公开号为US 2010/0305392)。对于部分实施例，如在美国2014年中描述的主题的生理参数(如受试者的心脏周期)所使用的天线28检测，例如，达刚申请的US2014/0180391使用的技术，其通过引用并入本文。对于部分实施例，电刺激施加到主动脉与受试者的心脏周期协调，基于在主动脉处检测到的信号。对于部分实施例，响应于检测到的受试者正在经历癫痫发作，受试者的迷走神经，通过驱动电流到受试者的主动脉的刺激。对于部分实施例，一个电流被驱动到受试者的主动脉以治疗睡眠呼吸暂停的受试者。
应该注意的是，尽管本发明的部分实施例已被描述为与支架结合使用中，本发明的范围将包括本文所述的支架移植物，相关的装置和方法。例如，依照上文所描述的技术，一天线可通过从所述支架移植物的所述本体的一远端纵向分开天线的多个柱耦合至所述支架移植物的所述本体。
对于部分实施例，本文中所描述实施例结合由高思申请的WO 07/013065、高思申请的US2009/0198097、高思申请的US2010/0305392，高思申请的US2011/0137370，达冈申请的US2012/0035679及/或达冈申请的US2014/0180391的技术，所有这些都通过引用并入本文的实施例。
本发明的特征会通过上述实施例使本领域技术人员了解本发明细节，实施例仅是例示性的，而非用以限制本发明。相反地，使本领域技术人员了解本发明时，本发明的范围包括上文描述的的组合和各种特征的子组合，以及以及不属于现有技术中的变型和形式修改。

Claims (8)

1.一种用于与成形以定义其一管腔的一管状结构使用的装置，
其特征在于，所述装置包括：
一支架，被设置为放置于所述管腔内，所述支架包括：
一大致呈圆柱形的支架体，包括多个支柱；及
多个天线柱，从所述支架体的一端部纵向突出，各所述天线柱包括：
一远端部分与一近端部分，分别在没有任何力被施加到所述天线柱时被配置为大致呈直线状；及
一柔性连接处，设置在所述天线柱的近端部分和远端部分之间，所述近端部分和远端部分被配置为相对于柔性连接处彼此柔性弯曲；以及
一天线，环形设置于所述天线柱的远端部分上，从而使所述天线柱从所述支架体的端部分开所述天线。
2.根据权利要求1所述的装置，其特征在于，所述管状结构的管腔包括一受试者的一血管的一管腔，且所述支架被设置为放置于所述受试者的血管的所述管腔内。
3.根据权利要求2所述的装置，其特征在于，所述柔性连接处被成形以定义一单一正弦波。
4.根据权利要求2所述的装置，其特征在于，所述柔性连接处被成形以定义1.5个正弦波。
5.根据权利要求2所述的装置，其特征在于，所述柔性连接处被成形以定义2个或大于2个的正弦波。
6.根据权利要求2所述的装置，其特征在于，所述血管的管腔包括所述受试者的一主动脉的一弯曲部分的一管腔，所述支架被设置为放置于所述受试者主动脉的弯曲部分的管腔内。
7.根据权利要求6所述的装置，其特征在于，所述柔性连接处被配置为促使所述天线柱的远端部分相对于所述天线柱的近端部分弯曲，从而使所述天线柱至少部分地与所述主动脉的弯曲部分的一曲率保持一致，即使位在所述主动脉的弯曲部分的一内部区且在所述主动脉的弯曲部分的一曲率大于所述主动脉的弯曲部分的一外部区的一曲率的位置处。
8.根据权利要求7所述的装置，其特征在于，更包括一自体扩张线体，所述自体扩张线体耦合至所述天线，并且被配置为在所述受试者主动脉的弯曲部分内自体扩张，从而带动所述天线接触所述主动脉的一内壁，并且所述柔性连接处被配置为促使所述天线柱的远端部分相对于所述天线柱的近端部分进行弯曲，因而带动所述天线接触所述主动脉的内壁，即使在所述主动脉的弯曲部分的内部区处。
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US20160278951A1 (en) 2016-09-29
US10779965B2 (en) 2020-09-22
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