CN105916544B - 无引线心脏起搏设备 - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N1/057—Anchoring means; Means for fixing the head inside the heart
- A61N1/0573—Anchoring means; Means for fixing the head inside the heart chacterised by means penetrating the heart tissue, e.g. helix needle or hook
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- 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
- A61N1/362—Heart stimulators
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- 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
- A61N1/37205—Microstimulators, e.g. implantable through a cannula
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- A—HUMAN NECESSITIES
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- 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
- A61N1/37518—Anchoring of the implants, e.g. fixation
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- 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
- A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N1/057—Anchoring means; Means for fixing the head inside the heart
- A61N2001/0578—Anchoring means; Means for fixing the head inside the heart having means for removal or extraction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N1/057—Anchoring means; Means for fixing the head inside the heart
- A61N2001/058—Fixing tools
Abstract
可植入无引线起搏设备与包括可植入无引线起搏设备的医疗设备系统。实例可植入无引线起搏设备可以包括起搏封盒。起搏封盒可以包括壳体。壳体可以具有近端区域与远端区域。可以沿着远端区域布置的第一电极。一个或多个锚定构件可以联接到远端区域。锚定构件每个都可以包括具有复合弯曲部的区域。
Description
相关申请的交叉引用
本申请要求2013年8月16日提交的美国临时申请第61/866,799的优先权,其全部内容通过引用的方式包含于此。
技术领域
本公开涉及医疗设备、以及用于制造医疗设备的方法。更具体地说,本公开涉及无引线心脏起搏设备。
背景技术
多种医疗设备已经被开发用于医疗使用,例如,心脏使用。这些设备中的一些包括导管、引导件、起搏器等。这些设备通过多种不同制造方法中的任一种制造并且可以根据多种方法中的任一种使用。已知的医疗设备与方法,每个都具有一定优点与弊端。存在提供另选医疗设备以及用于制造与使用医疗设备的另选方法的持续需求。
发明内容
本公开为医疗设备提供了设计、材料、制造方法、以及使用另选。实例医疗设备可以包括可植入无引线起搏设备。可植入无引线起搏设备可以包括起搏封盒。起搏封盒可以包括壳体。壳体可以具有近端区域与远端区域。可以沿着远端区域布置第一电极。一个或多个锚定构件可以联接到远端区域。锚定构件每个都可以包括具有复合弯曲部的区域。
可植入无引线起搏设备系统可以包括传送导管,此传送导管具有近端区域、远端保持部分、与形成在其中的腔体。推动构件可以可滑动地布置在腔体内。无引线起搏设备可以可滑动地容纳在远端保持部分内。无引线起搏设备可以包括具有近端区域与远端区域的壳体。可以沿着远端区域布置第一电极。包括第一锚定构件的多个锚定构件可以联接到远端区域。第一锚定构件能够在当无引线起搏设备布置在远端保持部分内时的第一构造与当无引线起搏设备前进到远端保持部分外部时的第二构造之间转换。远端保持部分可以具有纵轴。当第一锚定构件处于第一构造中时,第一锚定构件可以基本上平行于纵轴布置。当第一锚定构件处于所述第二构造中时,第一锚定构件可以包括具有复合弯曲部的区域。
另一个实例可植入无引线起搏设备系统可以包括传送导管,此传送导管具有近端区域、远端保持部分、以及形成在其中的腔体。推动构件可以可滑动地布置在腔体内。无引线起搏设备可以可滑动地容纳在远端保持部分内。无引线起搏设备可以包括具有近端区域与远端区域的壳体。可以沿着远端区域布置第一电极。包括第一锚定构件的多个锚定构件可以联接到远端区域。第一锚定构件能够在当无引线起搏设备布置在远端保持部分内时的第一构造与当无引线起搏设备前进到远端保持部分外部时的第二构造之间转换。当第一锚定构件处于第一构造中时,第一锚定构件的接触部分可以与远端保持部分的内壁表面接触。接触部分可以邻近第一锚定构件的远端定位。当第一锚定构件处于所述第二构造中时,第一锚定构件可以包括具有复合弯曲部的区域。
上面对一些实施方式的概述不旨在描述本公开的每个公开的实施方式或者每个实施。下面的附图与详细描述,更具体地示例了这些实施方式。
附图说明
联系附图考虑下面的详细描述将会更加完整地理解本公开,在附图中:
图1是植入在心脏内的实例无引线起搏设备的平面图;
图2是实例无引线起搏设备的立体图;
图3A是通过线3A—3A所取的横截面视图;
图3B是另选横截面视图;
图3C是另选横截面视图;
图4是邻近心脏组织定位的实例医疗设备系统的局部横截面侧视图;
图5是附接到实例无引线起搏设备的局部横截面侧视图;
图6是邻近心脏组织定位的另一个实例医疗设备系统的局部横截面侧视图;以及
图7是邻近心脏组织定位的另一个实例医疗设备系统的局部横截面侧视图。
尽管本公开可修改到多种变型与另选形式,已经通过实例的方式在附图中示出了其具体细节并且将更加详细地描述。然而,应该理解的是本发明的不将本发明限于所述的特定实施方式。相反地,本公开将覆盖属于本发明的精神和范围内的全部变型、等效物、与另选物。
具体实施方式
对于下面定义的术语来说,除非在权利要求或在本说明书中的其它地方给出不同的定义,否则将应用这些定义。
无论是否明确地指出,这里的全部数值都认为通过术语“大约”修改。术语“大约”大体上表示本领域技术人员将会考虑等于引用值(即具有相同的功能或结果)的数值的范围。在多种情形中,术语“大约”可以包括大约到最接近有效数字的数值。
通过端点引用数值范围包括此范围内的全部数值(例如,1至5包括1、1.5、2、2.75、3、3.80、4、和5)。
如在本说明书与所附权利要求中使用的,除非内容清楚地另外指明,否则单数形式“一个”、“一”和“此”包括复数的参照物。如在本说明书与所附权利要求中使用的,除非内容清楚地另外指明,否则术语“或者”大体上在包括“和/或”的意义上使用。
应该指出的是,在本说明书中涉及“实施方式”、“一些实施方式”、“其它实施方式”等,指示此描述的实施方式可以包括一个或多个特定特征、结构、和/或特点。然而,此列举不是必要地意味着全部实施方式都包括特定的特征、结构、和/或特点。另外地,当结合一个实施方式描述特定的特征、结构、和/或特点时,应该理解的是,除非清楚地相反陈述,否则无论是否清晰地描述,此特征、结构、和/或特点还可以与其它实施方式结合使用。
应该参照其中在不同附图中的类似元件以相同附图标记标示的附图来领会下面的详细描述。不必要地按比例的附图,描绘了示例性实施方式并且不意欲限定本发明的范围。
心脏起搏器向心脏组织提供电刺激以致使心脏收缩并且由此将血液泵送通过脉管系统。传统的起搏器通常包括电引线,此电引线从皮下或肌下植入的脉冲发生器延伸到定位在心室的内壁或外壁附近的电极。作为传统起搏器的另选,提出了自容纳或无引线心脏起搏器。无引线心脏起搏器可以采用可以固定到心室中的心脏内植入部位的相对小的封盒的形式。可以容易理解的是,无引线起搏设备在跳动心脏内的植入可能由于心脏功能而变得离开原位。相应地,可能期望于无引线起搏设备包括锚定机构和/或一个或多个锚定构件以协助将起搏设备固定到心脏。
图1示出了植入在心脏H的室(诸如例如右心室RV)中的实例可植入无引线起搏设备10。设备10可以包括具有远端区域14和近端区域16的外壳或壳体12。一个或多个锚定构件18可以布置在远端区域14附近。锚定构件18可以用于将设备10附接到心脏H的组织壁,或者另外地将可植入设备10锚定到患者的解剖部。对接构件20可以布置在壳体12的近端区域16附近。对接构件20可以用于方便可植入设备10的传送和/或取回。
图2是设备10的立体图。这里能够看到对接构件20可以从壳体12的近端区域16延伸出。在至少一些实施方式中,对接构件20可以包括头部22以及在壳体12与头部22之间延伸的颈部24。头部22能够与传送和/或取回导管接合。例如,如果期望从患者取回设备10,可以将取回导管推进到邻近设备10的位置。诸如勒除器、系绳、臂或者其它适当结构的取回机构可以从取回导管延伸并且与头部22接合。当适当地接合时,可以将设备10从心脏组织拉出,并且最终地从患者移除。
可植入设备10可以包括邻近壳体12的远端区域14定位的第一电极26。还可以沿着壳体12限定第二电极28。例如,壳体12可以包括传导材料并且可以沿着其长度的一部分绝缘。沿着近端区域16的部分可以是不绝缘的,以便限定第二电极28。电极26/28可以传感和/或起搏电极以提供电治疗和/或传感能力。第一电极26能够抵靠心脏H的心脏组织定位或者另外地与心脏H的心脏组织接触,同时第二电极28可以与第一电极26隔开,并且由此与心脏组织隔开。
设备10还可以包括在壳体12内的脉冲发生器(例如,电路)与电源(例如,电池),以将电信号提供到电极26、28。脉冲发生器与电极26/28之间的电联通可以向心脏组织提供电刺激和/或传感生理状态。
正如名称指出的,锚定构件18可以用于将设备10锚定到目标组织。可以将适当数量的锚定构件18用于设备10。例如,设备10可以包括一个、两个、三个、四个、五个、六个、七个、八个、或更多个锚定构件。在至少一些实施方式中,锚定构件18可以采取抓钩的形式,所述抓钩能够刺穿心脏组织、循环通过心脏组织的一部分、并且然后从心脏组织向回延伸到外部。这样做时,可能期望锚定构件18具有到心脏组织中的相对浅的穿入部。此外,可能期望锚定构件18布置为与第一电极26隔开。其它构造是可预期的。
为了实现这些与其它目标,锚定构件18可以具有复合弯曲结构。为了本公开的目的,复合弯曲部结构可以理解为包括多个不同弯曲区域的结构。例如,至少一些锚定构件18可以包括基部区域30、第一弯曲区域32、大体直线区域34、第二弯曲区域36、以及端部区域38。基部区域30可以定位在锚定构件18与壳体12之间的交叉部处。在一些实施方式中,基部区域30可以固定到壳体12。在其它实施方式中,基部区域30可以可枢轴地附接到壳体12。根据这些实施方式,基部区域30可以具有相对于壳体12的一些移动自由。在一些情形中,致动机构可以联接到锚定构件18,使得在植入手术过程中临床医生可以枢转锚定构件18。例如,可转移机械特征,诸如线、系绳等,可以联接到壳体12,其能够将运动传输到锚定构件18。
第一弯曲区域32可以远离壳体12弯曲。换句话说,第一弯曲区域32的曲率可能导致锚定构件18的至少一部分进一步逐步地径向地远离壳体12定位。例如,可能期望锚定构件18延伸或者另外地尽可能远离第一电极26横向地定位,以使邻近第一电极26与心脏的壁接触的地方的组织刺激最小化。此外,第一弯曲区域32(和/或锚定构件18的其它区域)的曲率能够将保持设备固定到心脏的壁同时具有到组织中的相对浅的穿入部。浅的穿入部可以协助减小局部组织刺激和/或心脏壁的损伤。
在一些实施方式中,第一弯曲区域32的曲率半径可以是恒定的。在其它实施方式中,此曲率半径可以沿着第一弯曲区域32改变。例如,第一弯曲区域32可以包括抛物线、双曲线、指数曲线、由一阶多项式限定的曲线、由二阶多项式限定的曲线、由三阶多项式限定的曲线、由四阶多项式或更高阶多项式限定的曲线等。第一弯曲区域32可以完全地位于单个平面内(例如,第一弯曲区域32可以仅沿着两个维度延伸),或者第一弯曲区域32可以位于多于一个的平面内(例如,第一弯曲区域32可以沿着三维延伸)。这些仅是实例。其它曲线、形状、构造等是可预期的。
通常来说,直线区域34,顾名思义,可以是基本上没有弯曲的。通常来说直线区域34可以具有适当的长度。例如,在一些实施方式中,可能期望第一弯曲区域32与第二弯曲区域36之间的较大分离。在此实施方式中,可能期望大体直线区域34具有相对较长的长度。在其它实施方式中,可能期望在弯曲部分32/36之间的较小分离,并且由此大体直线区域34可以相对短。在此外其它实施方式中,锚定构件18可以缺少大体直线区域34。换句话说,第一弯曲区域32可以直接附接到第二弯曲区域36或者另外地是与第二弯曲区域36连续的。
第二弯曲区域36可以朝向壳体12弯曲。在至少一些实施方式中,第二弯曲区域36的曲率可以沿着与第一弯曲区域32相反的方向定向。正如第一弯曲区域32,第二弯曲区域36可以具有恒定或可变的曲率半径。
端部区域38可以是大体直线的,或者端部区域38可以包括曲线。在至少一些实施方式中,端部区域38可以具有可能能够穿透组织的尖端或相对锋利端部。
除了允许设备10固定地锚定到患者的心脏以外,还可以允许锚定构件18短时间再定位设备10。例如,可以经由锚定构件18将设备10固定到患者的心脏。如果期望重新定位设备10,可以使用适当的取回和/或再定位设备来接合设备10,以便可以再定位(例如,将锚定构件18从组织移除并且将设备10移动到另一个期望位置)以及再锚定设备10。
锚定构件18的横截面形状可以改变。例如,至少一些锚定构件18可以具有如图3A中所示的大体长方形横截面形状。根据这些实施方式,锚定构件18的宽度W可以大于厚度T。然而,在其它实施方式中,厚度T可以大于宽度W。在其它实施方式中,如图3B所描绘的,至少一些锚定构件18可以包括具有直径D的大体上圆形横截面形状。其它横截面形状是可预期的。例如,锚定构件18可以具有椭圆形横截面形状(例如,如在图3C中所描述的)、半圆形横截面形状、多边形横截面形状(例如,三角形、方形、四边形、五边形、六边形、八边形等)、其组合(例如,具有圆形边缘或角的多边形形状),或者任何其它适当形状。锚定构件18可以具有沿着其基本上全部长度的相同的横截面形状。另选地,横截面形状可以沿着锚定构件18的长度改变。例如,锚定构件18的部分可以具有大体非圆形横截面形状,并且锚定构件18的其它部分可以具有大体圆形横截面形状。此外,在一些实施方式中,全部锚定构件18都可以具有相同的横截面形状和/或轮廓。在其它实施方式中,给定设备10的多个锚定构件18可以彼此不同。
图4示出了传送导管100,例如传送导管100可以用于将设备10传送到解剖部(例如心脏)内的适当部位处。导管100可以包括近端构件或区域140与远端构件或保持部分146。推动构件142可以布置(例如,可滑动地布置)在近端区域140内。推动构件142的头部区域144可以布置在远端保持部分146内。头部区域144能够与设备10的对接构件20接合。推动构件142可以用于将设备10“推动”到远端保持部分146外部,以将设备10布置并且锚定在目标区域148内(例如,心脏的诸如右心室的区域)。导管100可以推进通过脉管系统到目标区域148。例如,导管100可以通过股静脉前进到下腔静脉中,通过三尖瓣到右心房中,,并且到右心室中。目标区域148可以是右心室的一部分。例如,目标区域148可以是心尖附近的右心室的一部分。目标区域148还可以是其它区域,包括心脏的其它区域(例如,由右心房、左心室、左心房)、血管、或者其它适当目标。
锚定构件18能够在第一构造与第二构造之间转换。例如,当设备10布置在传送导管100的远端保持部分146内时,锚定构件18可以处于第一构造中。当这样构造时,锚定构件18可以以大体上更加直化的构造从设备10向远端延伸。换句话说,锚定构件18可以沿着远端方向定向。例如,导管100可以具有纵轴X并且锚定构件18可以与大体上平行于导管100的纵轴X的纵轴Y相应。然而,锚定构件18无需精确地平行于导管100的纵轴X延伸,并且替代地可以大体上沿着远端方向定向。
当设备10适当地定位在目标区域148附近时,推动构件142可以向远端前进以向远端地推动设备10,以使锚定构件18与目标区域148接合。这样做时,锚定构件可以转换到如图5中所示的第二构造。当处于第二构造中时,锚定构件18可以具有复合弯曲部构造。锚定构件18的复合弯曲部可以有助于引导锚定构件18横向地远离组织进入点,并且然后在与进入点横向隔开的位置处回到组织外部。
在至少一些实施方式中,当在更加直化构造中时锚定构件18仍可以保持复合曲率(例如,尽管以改变的形状)。例如,当设备10布置在传送导管内时,锚定构件18仍可以保持复合弯曲部。在其它实施方式中,形成在锚定构件18中的一个或多个曲线可以是基本上直化的,使得当在更加直化构造中时锚定构件18可以不再视为具有复合弯曲部。当转换到第二构造时(例如,其可以视为布置、植入、传送、或“未偏置”构造),锚定构件18可以具有或另外地返回到包括复合弯曲部的形状。
当在第一构造中时,锚定构件18的一部分可以与远端保持部分146的内壁表面接合。与远端保持部分146的内壁表面接合的锚定构件18的部分可以定位在锚定构件18的远端附近。例如,如图4中所示,第二弯曲区域36可以与远端保持部分146的内壁表面接合。其它布置是可预期的。例如,图6示出了包括锚定构件118与对接构件120的设备110(其可以在形式与功能上与这里公开的其它设备类似)。这里可以看到,第一弯曲区域132可以与远端保持部分146的内壁表面接合。
图7示出了包括锚定构件218与对接构件220的设备210(其可以在形式与功能上与这里公开的其它设备类似)。在此实施方式中,从第二弯曲区域232延伸到尖端238的锚定构件218的一部分可以抵靠远端保持部分146的内壁表面平坦放置。
可以用于设备10和导管100(和/或这里公开的其它设备/导管)的多个部分的材料可以包括通常与医疗设备相关的这些材料。例如,设备10和/或导管100可以由金属、金属合金、聚合物(下面公开了其一些实例)、金属聚合物合成物、陶瓷、及其组合等,或者其它适当材料制成。适当聚合物的一些实例可以包括聚四氟乙烯(PTFE)、乙烯-四氟乙烯共聚物(ETFE)、聚全氟乙丙烯(FEP),聚甲醛(POM,例如,从美国杜邦可获得的)、块聚醚酯、聚氨酯(例如,聚氨酯85A)、聚丙烯(PP),聚氯乙烯(PVC)、聚醚酯(例如,从帝斯曼工程塑料可获得的),醚或酯基的共聚物(例如,丁烯/聚(亚烷基醚)的邻苯二甲酸和/或其它聚酯弹性体,诸如从美国杜邦可获得的)、聚酰胺(例如,可从拜耳可获得的或从ElfAtochem可获得的)、弹性聚酰胺、嵌段聚酰胺/醚、聚醚酰胺(例如,在商标名下可获得的PEBA)、乙烯-醋酸乙烯共聚物(EVA)、硅树脂、聚乙烯(PE)、聚丙烯高密度聚乙烯、聚丙烯低密度聚乙烯、线性低密度聚乙烯(例如)、聚酯、聚对苯二甲酸丁二醇酯(PBT)、聚对苯二甲酸乙二醇酯(PET)、聚对苯二甲酸乙二醇酯、聚萘二甲酸乙二醇酯(PEN)、聚醚醚酮(PEEK)、聚酰亚胺(PI)、聚醚酰亚胺(PEI)、聚苯硫醚(PPS)、聚苯醚(PPO)、聚对苯二甲酰对苯二胺(例如,)、聚砜、尼龙、尼龙-12(诸如从EMS美国Grilon可获得的),全氟(丙基乙烯基醚)(PFA)、乙烯-乙烯醇共聚物、聚烯烃、聚苯乙烯、环氧树脂、聚偏氯乙烯(PVdC)、聚(BB苯乙烯苯乙烯异丁烯)(例如,SIBS和/或SIBS50A)、聚碳酸酯、离聚体、具有生物相容性的聚合物、其它适当材料、或混合物、组合、其共聚物、聚合物/金属组分等。在一些实施方式中,护套可以与液晶聚合物(LCP)混合。例如,混合物可以含有高达约百分之六的LCP。
适当金属与金属合金的一些实例包括不锈钢,诸如304V、304L、和316LV不锈钢;低碳钢;诸如线性弹性和/或超弹性镍钛诺的镍钛合金;诸如镍-铬-钼合金的其它镍合金(例如,UNS:N06625诸如625、UNS:N06022诸如UNS:N10276诸如其它合金等),镍铜合金(例如,UNS:N04400诸如400、400、400等)、镍-钴-铬-钼合金(例如,UNS:R30035诸如等)、镍钼合金(例如,UNS:N10665诸如),其它镍铬合金、其它镍钼合金、其它镍钴合金、其它镍铁合金、其它镍铜合金、其它镍钨或钨合金等;钴铬合金;钴铬钼合金(例如,UNS:R30003诸如等);富铂不锈钢;钛;其组合等;或者任何其它适当材料。
如这里暗指的,在商业上可获得的族内,镍钛或镍钛诺合金是指示的“线性弹性”或“非超弹性”的类型,尽管其可以在化学常规形状记忆及超弹性品种方面类似,但是其可以显示不同且有用的机械特点。线性弹性和/或非弹性镍钛诺可以与超弹性镍钛诺相区别,原因在于线性弹性和/或非超弹性镍钛诺不像超弹性镍钛诺那样在其应力/张力曲线中显示大量“超弹性高原(superelastic plateau)”或“标志区域”。替代地,在线性弹性和/或非超弹性镍钛诺中,当可恢复张力增加时,应力继续沿着基本上线性或者略微,但不必完全是线性关系增加,直到开始塑性变形或者至少处于以可以通过超弹性镍钛诺观察到的超弹性高原和/或标志区域的更加线性的关系。由此,为了本公开的目的,线性弹性和/或非超弹性镍钛诺也可以称为“基本上”线性弹性和/或非超弹性镍钛诺。
在一些情形中,线性弹性和/或非超弹性镍钛诺还可以与超弹性镍钛诺相区别,原因在于线性弹性和/或非超弹性镍钛诺可以接受高达约2-5%的张力,同时保持基本上弹性(例如,在塑性地变形以前),然而超弹性镍钛诺可以在塑性地变形以前接受高达约8%的张力。这些材料都可以与在塑性变形以前仅可能接收大约0.2%到0.44%张力的诸如不锈钢(可以基于其成分相区别)的其它线性弹性材料相区别。
在一些实施方式中,线性弹性和/或非超弹性镍-钛合金是通过在大的温度范围上的分析差示扫描量热法(DSC)与动态金属热分析(DMTA)可探测的未示出任何马氏体/奥氏体相态改变的合金。例如,在一些实施方式中,在线性弹性和/或非超弹性镍钛合金中可能没有在约-60摄氏度(℃)到约120摄氏度(℃)的范围内通过DSC和DMTA分析可探测的马氏体/奥氏体相态改变。此材料的机械弯曲特性由此对宽泛的温度范围上的温度的影响大体上是惰性的。在一些实施方式中,在周围环境或室温下的线性弹性和/或超弹性镍钛合金的机械弯曲特性与在体温下的机械特性基本相同,例如,由于它们不显示超弹性高原和/或标志区域。换句话说,跨越宽的温度范围,线性弹性和/或非超弹性镍钛合金保持其线性弹性和/或非超弹性特征和/或特性。
在一些实施方式中,线性弹性和/或非超弹性镍钛合金的镍重量百分比可以在约50%到约60%的范围内,剩余部分基本上是钛。在一些实施方式中,组分的镍重量百分比在约54%至57%的范围内。适当的镍钛合金的一个实例是商业上从日本神奈川的FurukawaTechno Mateial Co.可获得的FHP-NT合金。在美国专利第5,238,004和6,508,803中公开了镍钛合金的一些实例,其通过引用的方式包含于此。其它适当材料可以包括ULTANIUMTM(从Neo-Metrics可获得)以及GUM METALTM(从Toyota可获得)。在一些其它实施方式中,超弹性合金,例如超弹性镍钛诺,可以用于实现期望的特点。
在至少一些实施方式中,设备10和/或导管100的一部分或者全部都可以掺杂不透射线材料、由不透射线材料料制成、或者另外地包括不透射线材料。不透射线材料应该理解为在医疗程序过程中能够在荧光屏或者另一个成像技术上产生相对明亮图像的材料。此相对明亮图像协助设备10和/或导管100的使用者确定其位置。不透射线材料的一些实例可以包括,但不限于、黄金、铂、钯、钽、钨合金、加载有不透射线填充物的聚合物材料等。此外,此外其它不透射线标记带和/或线圈也可以并入到设备10和/或导管100的设计中,以实现相同的结果。
在一些实施方式中,将一定程度的磁共振成像(MRI)相容性给予到设备10和/或导管100。例如,设备10和/或导管100(或其部分)可以由基本上不扭曲图像并且形成大量伪影(即,在图像中是间隙)的材料制成。例如,一些铁磁材料可能是不适合的,因为它们可能在MRI图像中形成伪影。设备10和/或导管100(或者其一部分)还可以由MRI机器可以成像的材料制成。显示这些特征的一些材料包括例如钨、钴-铬-钼合金(例如UNS:R30003诸如 等)、镍-钴-铬-钼合金(例如,R30035诸如等)、镍钛诺等、以及其它。
应该理解的是,在多个方面中,本公开仅是描述性的。在不超过本公开的范围的情况下,可以改变细节,尤其关于形状、尺寸、和步骤布置的改变。在适当的程度上,这可以包括将一个实例实施方式的特征中的任一个用途用于其它实施方式中。当然,本发明的范围以其中所附权利要求表述的语言限定。
Claims (11)
1.一种可植入无引线起搏设备,包括:
包括壳体的起搏封盒,所述壳体具有近端区域与远端区域;
第一电极,其沿着所述远端区域布置;以及
一个或多个锚定构件,其联接到所述远端区域,其中所述锚定构件中的每个都能够在第一构造与展开构造之间转换,在所述第一构造中,所述锚定构件中的每个以大体上更加直化的构造从无引线起搏设备向远端延伸,在所述展开构造中,所述锚定构件中的每个都包括具有复合弯曲部的区域,
其中,具有所述复合弯曲部的所述区域包括第一弯曲部分与第二弯曲部分;
其中,所述第一弯曲部分沿着第一方向定向,并且其中所述第二弯曲部分沿着不同于所述第一方向的第二方向定向;并且
其中,所述第一方向与所述第二方向相反。
2.根据权利要求1所述的可植入无引线起搏设备,其中,直线区域布置在所述第一弯曲部分与所述第二弯曲部分之间。
3.根据权利要求1所述的可植入无引线起搏设备,其中,所述一个或多个锚定构件中的每个都包括尖端部分。
4.根据权利要求1所述的可植入无引线起搏设备,其中,当所述一个或多个锚定构件在目标组织内延伸时,所述第一弯曲部分、所述第二弯曲部分或两者都能够致使所述一个或多个锚定构件远离所述第一电极横向地移动。
5.根据权利要求1所述的可植入无引线起搏设备,其中,所述第一弯曲部分、所述第二弯曲部分或两者都具有变化的曲率半径。
6.一种可植入无引线起搏设备系统,所述系统包括:
传送导管,其具有近端部分、远端保持部分与形成在其中的腔体;
推动构件,其可滑动地布置在所述腔体内;
无引线起搏设备,其可滑动地容纳在所述远端保持部分内,所述无引线起搏设备包括:
壳体,其具有近端区域与远端区域;
沿着所述远端区域布置的第一电极;以及
多个锚定构件,其包括联接到所述远端区域的第一锚定构件;
其中,所述第一锚定构件能够在所述无引线起搏设备布置在所述远端保持部分内时的第一构造与所述无引线起搏设备前进到所述远端保持部分外部时的第二构造之间转换;
其中所述远端保持部分具有纵轴;
其中当所述第一锚定构件处于所述第一构造时,所述第一锚定构件基本上平行于所述纵轴布置;以及
其中当所述第一锚定构件处于所述第二构造时,所述第一锚定构件包括具有复合弯曲部的区域;
其中,具有所述复合弯曲部的所述区域包括第一弯曲部分与第二弯曲部分;
其中,所述第一弯曲部分沿着第一方向定向,并且其中所述第二弯曲部分沿着不同于所述第一方向的第二方向定向;并且
其中,所述第一方向与所述第二方向相反。
7.根据权利要求6所述的系统,其中,当所述第一锚定构件处于所述第一构造时,所述第一锚定构件的接触部分与所述远端保持部分的内壁表面接触。
8.根据权利要求7所述的系统,其中,当所述第一锚定构件处于所述第一构造时,所述接触部分定位在所述第一锚定构件的远端的近端侧。
9.根据权利要求8所述的系统,其中,所述接触部分在所述第一锚定构件的所述远端与在所述第一锚定构件处于所述第一构造时布置在所述远端的近端侧的一点之间延伸。
10.根据权利要求6所述的系统,其中,当所述第一锚定构件在心脏组织内延伸时,所述第一弯曲部分、所述第二弯曲部分或者两者都能够致使所述第一锚定构件远离所述第一电极横向地移动。
11.一种可植入无引线起搏设备系统,所述系统包括:
传送导管,其具有近端部分、远端保持部分与形成在其中的腔体;
推动构件,其可滑动地布置在所述腔体内;
无引线起搏设备,其可滑动地容纳在所述远端保持部分内,所述无引线起搏设备包括:
壳体,其具有近端区域与远端区域;
沿着所述远端区域布置的第一电极;以及
多个锚定构件,其包括联接到所述远端区域的第一锚定构件;
其中所述第一锚定构件能够在所述无引线起搏设备布置在所述远端保持部分内时的第一构造与所述无引线起搏设备前进到所述远端保持部分外部时的第二构造之间转换;
其中当所述第一锚定构件处于所述第一构造时,所述第一锚定构件的接触部分与所述远端保持部分的内壁表面接触;
其中当所述第一锚定构件处于所述第一构造时,所述接触部分定位在所述第一锚定构件的远端的近端侧;以及
其中当所述第一锚定构件处于所述第二构造中时,所述第一锚定构件包括具有复合弯曲部的区域;
其中,具有所述复合弯曲部的所述区域包括第一弯曲部分与第二弯曲部分;
其中,所述第一弯曲部分沿着第一方向定向,并且其中所述第二弯曲部分沿着不同于所述第一方向的第二方向定向;并且
其中,所述第一方向与所述第二方向相反。
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PCT/US2014/049914 WO2015023488A1 (en) | 2013-08-16 | 2014-08-06 | Leadless cardiac pacing devices |
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CN105916544B true CN105916544B (zh) | 2019-11-12 |
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EP3033141A1 (en) | 2016-06-22 |
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US20230256240A1 (en) | 2023-08-17 |
RU2661754C2 (ru) | 2018-07-19 |
AU2014306940A1 (en) | 2016-03-03 |
RU2016109156A (ru) | 2017-09-21 |
AU2014306940B2 (en) | 2017-09-07 |
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