CN101516259A - 用于植入式传感器的固定装置 - Google Patents
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- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
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- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
- A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
- A61N1/3962—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion in combination with another heart therapy
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
- A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
Abstract
一种用于植入式医疗器材例如植入式生理传感器的固定装置,包括近端毂部、从所述毂部呈放射状地并朝远端方向延伸的中间部和从所述近端部朝远端方向延伸的远端部,该远端部适用于与目标脉管的内表面配合以将所述植入式医疗器材固定在所述脉管内。所述固定装置可呈现适合通过导管输送的收缩状态,以及适合在展开后固定在脉管内的扩张状态。中间部以倾斜角从近端部延伸,使得固定装置可以在首次展开之后被缩回并重新收缩于输送导管内(如有必要或期望重新定位或移除植入式医疗器材)。
Description
相关申请的交叉引用
根据35U.S.C.§119,本发明要求2006年9月15日提交的美国临时申请60/844,821的优先权,通过引用将其并入本文。
技术领域
本发明涉及用于将植入式医疗器材固定在体内的医疗器材及方法。具体地,本发明涉及用于将植入式生理传感器和其它植入式医疗器材固定在患者心血管系统内的装置和方法。
背景技术
已知可在患者体内植入医疗器材以监测一个或多个生理参数并/或提供治疗功能。例如,可在体内放置传感器或变送器以监测各种特性,如温度、血压、变形、流体流动、化学性质、电性、磁性等。此外,可植入医疗器材,实施一个或多个治疗功能,如药物输送、心脏起搏、心脏除颤、电刺激等。
一个特别重要的参数是血压。可用一个或多个植入式压力传感模块与心律管理(CRM)装置相连,以方便CRM装置设置的优化。在这样的系统中,压力传感模块经静脉输送至目标血管(例如,肺动脉)、并采用各种固定技术固定在该血管内。对于精确并可靠地测量所期望的参数,传感模块的精确放置是重要因素。此外,在某些环境下,有必要在首次展开后重新定位植入式传感器,或者将该传感器整个地从患者体内移除。
因此,需要一种将植入式医疗器材放置并固定在患者体内的装置和方法。具体地,需要一种在首次展开之后能被精确地重新定位和再展开的固定系统。
发明内容
在一实施例中,本发明是一种设置为通过输送导管输送的植入式传感器组件,所述传感器组件包括:植入式传感器和固定装置,所述固定装置连接至所述传感器,并适合于在所述输送导管内呈现收缩状态及在所述输送导管外呈现扩张状态。所述固定装置包括:近端的毂部;中间部,所述中间部铰接至所述毂部并从所述毂部向远端方向并呈放射状延伸,所述中间部设置为,当所述固定装置处于所述扩张状态时,呈现相对于所述毂部基本上倾斜的角;以及远端部,当所述固定装置处于扩张状态时,所述远端部从所述中间部向远端方向延伸,并适合于和脉管的内表面配合。所述中间部设置成可在呈现所述扩张状态之后,使所述固定装置缩进所述输送导管,并呈现所述收缩状态。
在另一实施例中,本发明是一种植入式传感器组件,包括:传感器,所述传感器包括密封地包围传感器元件的壳体;和固定装置。所述固定装置包含:近端的传感器连接部,其与所述壳体相连;和可放射状扩张的装置,其从所述传感器连接部延伸,用以与脉管的内表面配合。
在又一实施例中,本发明是一种展开植入式传感器组件的方法。在一实施例中,所述方法包括将输送导管的远端定位于体腔内的第一位置。接着,本发明包括从所述输送导管的远端展开所述传感器组件的固定装置部分,使得所述固定装置部分呈扩张状态。在一实施例中,本发明还包括:将所述固定装置部分缩回至所述输送导管内,使得所述固定装置部分呈收缩状态;将所述输送导管的远端重新定位于所述体腔内的第二位置;以及从所述输送导管的远端重新展开所述传感器组件的固定装置部分,使得所述固定装置部分重新呈现扩张状态。
虽已公开了多个实施例,本领域普通技术人员还可从下面的详细描述清楚理解本发明的其它实施例,该详细描述说明和记载了本发明的例示性实施例。因此,附图和详细描述应认为是例示性的而非限制性的。
附图说明
图1是根据本发明一实施例的心律管理系统的示意图,包括脉冲生成器和植入在心脏肺动脉内的植入式传感器模块。
图2A和图2B分别为图1所示传感器组件的侧视图和近端视图。
图3A和图3B分别为根据本发明另一实施例的传感器组件的侧视图和近端视图。
图4为根据本发明另一实施例的传感器组件的侧视图。
图5A至图5D是图3A至图3B的传感器组件的侧视图,根据本发明一实施例,所述装置从输送导管展开。
图6A至图6D分别为根据本发明另一实施例的用于传感器组件或其它植入式医疗器材的固定装置的立体图、侧视图、俯视图和远端视图。
图7至图10根据本发明其它实施例的用于传感器组件或其它植入式医疗器材的其它固定装置的示意立体图。
图11为流程图,示出了根据本发明一实施例的展开植入式传感器组件的方法。
本发明可具有各种改动形式和可选形式,在附图中通过举例方式示出了具体实施例,并将在下文作详细说明。但本发明并不限于所描述的具体实施例。相反,本发明覆盖所附权利要求界定的本发明范围内的全部改动形式、等价形式和可选形式。
具体实施方式
图1为根据本发明一实施例的心律管理系统5的示意图,包括脉冲生成器6、通信线路8和植入在心脏20的肺动脉16内的植入式传感器组件10。如本领域已知的那样,脉冲生成器6通常植在患者胸腔或腹部内的皮下植入位置。如图所示,心脏20通常包括上腔静脉22、右心房24、右心室26、心室隔膜28、右心室流出道30、左心室32和左心房34。如图所示,右心室流出道30通向肺动脉16,该肺动脉与右心室以肺动脉瓣38隔开。
脉冲生成器6可以是本领域已知的或以后开发的任何植入式医疗器材,向患者传递电治疗刺激。在一实施例中,脉冲生成器6为起搏器。在另一实施例中,脉冲生成器是植入式心脏除颤器。在其它实施例中,脉冲生成器6同时包括起搏和除颤功能。在所示实施例中,脉冲生成器6和植入式传感器组件10由通信线路8通信连接,该通信线路可以是有线或无线通信线路。
如图1所示,传感器组件10包括植入式传感器50和与传感器50连接的固定装置54。如下文将详细讨论的,固定装置54是可扩张结构,其可呈现适合于将传感器组件10经静脉输送至期望的植入位置(例如,通过输送导管)的收缩状态,还可呈现,如图1所示,其中固定装置54与肺动脉16的内表面配合的扩张状态。有利地,固定装置54还设定为便于在首次展开后固定装置54缩回至输送导管内,从而可将传感器组件10重新定位在同一或不同脉管内,或者,完全从患者体内移走。
在图1所示的实施例中,传感器组件10植在患者的主肺动脉16内。在另一实施例中,传感器组件10植在肺动脉16的支脉内(例如,右肺动脉或左肺动脉)。在另一实施例中,传感器组件10可植在患者脉管系统的其它区域或植在其它体腔内。
传感器50设置为通过通信线路8与脉冲生成器6通信,该通信线路可以是有线的或无线的。本领域已知有各种无线通信线路,对于可使用的无线通信具体种类和/或方式没有限制。例如,可以使用超声波、声通信、射频通信等。在一实施例中,传感器50包括用于声学遥测的声波发送器/接收器,该发送器/接收器用于向/从脉冲生成器6发射和/或接收超声信号。在一些实施例中,传感器50可设置成,通过其它有线或无线通信线路与一个或多个其它植入式医疗器材(例如,另一脉冲生成器或如药物输送装置之类的其它治疗装置)通信。在其它实施例中,传感器50设置成通过无线通信线路与患者体外的装置通信。
传感器50可设定为实施一项或多项指定功能,其包括进行一项或多项生理测量。传感器50可设定为测量任意已知生理参数,诸如,例如体内的血压、温度、血液或流体流动、变形、电学特性、化学特性、或磁性。待测量的具体参数以及传感器组件10的植入位点,根据患者特定的治疗需求来确定。在一实施例中,传感器50用于测量肺动脉16内的血压(例如,如图1所示)。在所示实施例中,传感器50适用于储存和/或发送血液数据至脉冲生成器6或位于患者体外的装置(例如,监视器或编程器)。
图2A和图2B分别为根据本发明一实施例的传感器组件10处于扩张状态的侧视图和近端视图。如图2A至图2B所示,传感器50包括形成有近端64的壳体60,固定装置54包括近端的毂部68、中间部72和远端部76。在所示实施例中,毂部68与传感器壳体60连接。在其它实施例中,传感器50可与固定装置54的其它部分(例如,接近远端部76的远端的部分)连接。
如图所示,中间部72从毂部68向远端方向且呈放射状延伸,而远端部76从中间部72向远端方向延伸,形成从中间部72至远端部76的连续过渡。在所示实施例中,中间部72形成于多个细长支撑杆82,所述细长支撑杆从毂部68向远端方向并呈放射状延伸。在该构造中,支撑杆82与毂部68有效地铰接,这使得固定装置54在被缩回进输送导管的时候可以收缩。还是如图所示,远端部76从中间部72向远端方向延伸,并包括多个细长的、在它们大约中部的位置互连的弓形部件,以形成界定出腔体77的总体呈管形支架状结构,该腔体用于使体液(如血液)流过其中植入有传感器组件10的脉管(例如,肺动脉)。在所示扩张状态中,至少是所述支架状远端76,且在一些实施例中,至少是构成中间部72的支撑杆82的部分,适用于向肺动脉(或其它脉管)的内表面施加径向力并与所述内表面卡合,以将传感器组件10固定在里面。
如图所示,近端的毂部68以及与之连接的传感器50,呈放射状定位于或靠近固定装置54的外周边84。因此,在所示实施例中,传感器50位于或非常靠近其中植入有传感器组件10的脉管(例如,肺动脉)的管壁。因此,如图2B中可能最清楚地看到的那样,固定装置54形成的腔体77对于传感器组件10的其它部分基本上是畅通无阻的,因此,腔体77为血液流动、其它医疗器材(例如导管、电导线)等提供了基本上畅通无阻的通道。
在所示实施例中,近端的毂部68总体为环形结构,并环绕传感器50的壳体延伸。在其它实施例中,毂部68没有完全围绕传感器壳体60延伸。又在其它实施例中,毂部68可省略该环形结构。例如,毂部68包括结合在或靠近固定装置54的近端,总体呈直线形的部件,该部件可转向以形成固定装置54的中间部。
固定装置54可通过本领域已知的方法与传感器50连接。例如,固定装置可焊接、硬钎焊、软钎焊、粘合于传感器壳体60,或者通过卷曲或使用如搭扣环之类的机械紧固结构固定于传感器壳体60。作为可选方式,传感器壳体60可与固定装置54或其部分一体成形。简言之,本发明不对任何连接传感器50和固定装置54的具体方法有要求。而且,在一些实施例中,传感器50可摩擦连接至固定装置(例如,如图2A至图2B所示,在传感器50的局部与环形毂部68之间设计为过盈配合)。当将固定装置54留在患者脉管系统内其被植入的位置时,这样的实施方式便于移除和/或更换传感器50。
还是如图2A所示,在固定装置54的扩张状态下,中间部72的支撑杆82向远端方向并相对毂部68向外发散,使得至少是中间部72最靠近毂部68的部分相对于通过毂部68纵向延伸的轴线A10形成大体为倾斜的角α。如下文将详细说明的那样,优选地,中间部72相对轴线A10的倾斜方向应方便固定装置54在展开后缩回至输送护套内,从而,在最初展开后,如有需要,可以对传感器组件10重新定位及/或将其整个从体内移除。例如,专门的通管线或其它保持元件可以可拆卸地连接于传感器50的近端64(或连接至固定装置54的近端毂部68),提供用于将固定装置54在展开后缩回进输送导管的手段。
固定装置54的具体尺寸根据具体植入位置和所需的固定强度而改变。一般地,固定装置54具有扩张的外远端部直径D10和长度L10,该直径和长度选择为能向其中植入有传感器组件10的目标脉管的内表面施以径向力,并与该内表面摩擦配合。例如,如上所述,在一实施例中,传感器组件10用于植入在肺动脉16内。在各种实施例中,固定装置54的长度L10为约20mm至约60mm,扩张后直径D10为约16mm至约50mm。在一实施例中,长度L10为约50mm,扩张直径D10为约38mm。在一实施例中,长度L10为约50mm,扩张直径D10为约32mm。然而,需强调的是,这些例子仅用于说明,且具体植入位置可能要求其它的长度L10和扩张直径D10。
图3A和图3B分别为根据本发明另一实施例的传感器组件110的侧视图和近端视图。如图3A至图3B所示,传感器组件110包括传感器150和固定装置154,该固定装置如同上述固定装置54,包括壳体160和近端164,且固定装置154包括近端毂部168、中间部172以及远端部176。在所示实施例中,毂部168与传感器壳体160连接。在其它实施例中,传感器150可连接至固定装置154的其它部分。远端部176包括多个互相连接的波浪状部件,所述部件设置为形成总体为管形的支架状结构,以形成腔体177供流经脉管(例如,肺动脉)的体液(例如,血液)通过,该脉管中植入有传感器组件110。
传感器组件110在许多方面与上述传感器组件10相似,主要的区别是,在传感器组件110中,毂部168呈放射状地位于由远端部176形成的腔体177内,且中间部172包括多个支撑杆182,所述支撑杆从毂部168以与轮子上的轮辐类似的方式向远端方向并呈放射状延伸。在所示实施例中,毂部168基本上位于腔体177的中心位置。在另一实施例中,毂部168可从腔体177的径向中心偏离。
与固定装置54类似,图3A和图3B所示的扩张状态中,固定装置154的固定装置中间部172的支撑杆182朝远端方向向外放射,使得中间部172基本上形成相对于通过毂部168纵向延伸的倾斜角α。因此,如同固定装置54,中间部172相对于轴线A110的斜向有利地便于将固定装置154在展开后缩回至输送套管内。
如同上述固定装置54,固定装置154具有扩张的外远端部直径D110和长度L110,该直径和长度选择为能向其中植入有传感器组件10的目标脉管的内表面施以径向力,并与该内表面摩擦配合。在一实施例中,传感器组件110用于植入在肺动脉16内,且固定装置154的长度L110为约20mm至约60mm,扩张直径D110为约16mm至约50mm。在一实施例中,长度L110为约50mm,扩张直径D110为约38mm。在一实施例中,长度L10为约50mm,扩张直径D10为约32mm。然而,需强调的是,这些例子仅用于说明,且具体植入位置可能要求其它的长度L110和扩张直径D110。
图4为根据本发明另一实施例的传感器组件210。如图4所示,传感器组件210包括传感器250和固定装置254。传感器250包括壳体260和近端164,且传感器254包括近端毂部268,中间部272和远端部276。在所示实施例中,毂部268连接至传感器壳体260,但是在其它实施例中,传感器250可连接至固定装置254的其它位置。
如图4中可看到的,传感器组件210的构造基本上与上述传感器组件10类似,与固定装置54相比较其主要区别在于固定装置254细长的远端部276。与固定装置54的远端部76相比,该细长远端部276由于增加了与脉管内表面配合的表面积,可提高固定强度。在用于植入患者肺动脉的传感器组件210的一实施例中,固定装置254的长度L210为约70至约90mm。在一实施例中,长度L210为约80mm。
因此,当处于各图所示的扩张状态时,固定装置54、154和254的中间部和支架状远端部形成用于和脉管(例如,肺动脉)内表面配合的可呈放射状扩张的装置,以将各传感器组件10固定在脉管内。
上述传感器组件10、110和210的各传感器和固定装置可由现在已知的或将来开发的,适合于类似的植入式医疗器材的生物相容材料制成。例如,在各实施例中,传感器壳体60、160和/或260中的任一或全部可由适合用在其它植入式医疗器材的密封壳体上的任意生物相容材料制成。这样的材料包括,但不限于,钛、不锈钢、生物相容聚合物等。应理解,植入式医疗器材和相关固定装置的具体设计要求将主要决定所选的材料。
上述支架状固定装置54、154和/或254可以是自扩张型或球囊扩张型,并且可由现在已知的或将来开发的,任意适用于心血管系统支架或类似植入式器材的材料制成。仅作为例子列举,适用的材料包括不锈钢和多种合金以及聚合物。对于自扩张型的实施例,固定装置54、154、254至少部分由具有期望的形状记忆和/或超弹性特性的材料制成。呈现出适当的形状记忆和超弹性的材料的例子包括形状记忆聚合物以及镍-钛形状记忆合金如镍钛诺(nitinol)。在一些实施例中,固定装置54、154和/或254从镍钛诺管上被激光切割下来。在其它实施例中,固定装置54、154和/或254可基本上由线材产品形成。基于前述内容,本领域普通技术人员可以确定其它适当的材料。
对于本发明的各种实施例,无论处于收缩状态还是扩张状态,固定装置的尺寸基本上根据特定的患者解剖学决定。在一些实施例中,固定装置54、154和/或254设计成其大小在扩张时能与脉管壁的内表面配合。在一实施例中,例如,在固定装置设计成可固定于肺动脉16内时,随着该固定装置流向肺部,该肺动脉出现分支并变细,固定装置可以放置在该肺动脉内,并可以随血流而流动,直至该固定装置固定在所需位置。一旦被固定,传感器可收集期望的数据测量值。当然,如本领域普通技术人员应理解的,固定装置可放置在其它血管内或其它体腔内。
图5A至图5D为侧视图,示意地示出了正从输送导管300展开的传感器组件110。如图5A所示,起初,传感器组件110保持在输送导管300内,其固定装置154处于收缩状态且系绳302可松开地连接于传感器150的近端164。系绳302可以是通管线、引线或具有适用于在传感器组件110从导管300展开时可松开地与传感器150(或毂部168)配合的末端机构的类似结构。例如,系绳302可包括现已转让的共同未决申请,即2006年9月15日提交的名称为″DELIVERY SYSTEM FOR AN IMPLANTABLE PHYSIOLOGIC SENSOR″美国临时专利申请60/844,953和2006年9月15日提交的名称为″MECHANISMFOR RELEASABLY ENGAGING AN IMPLANTABLE MEDICAL DEVICEFOR IMPLANTATION″的美国临时专利申请60/844,948中记载的任意结构。所述申请的内容通过引用为一切目的并入本文。
系绳302使得使用者(例如,医生或其他医务人员)可以控制传感器组件110相对于导管300的位置。例如,可相对导管300向远端方向推动系绳302以使固定装置154超出导管300的远端304。或者,当系绳302被保持在适当位置时,导管300在近端方向缩回。在另一步骤中,在所示实施例中,当被延伸超出导管300的远端304时,固定装置154自扩张至它的扩张状态。
图5B示出了其固定装置154处于从导管300的远端304部分展开状态的传感器组件110。在图5B的实施例中,固定装置154正进行自扩张,这方面类似于本领域已知的心血管支架。图5C示出了传感器组件110已从导管300的远端304完全展开,而系绳302仍与传感器150的近端164相连接。如图5C所示,固定装置154已完全扩张至它的扩张状态,从而它可与脉管(例如,肺动脉)的内表面配合,以将传感器组件110固定在脉管内。图5C还示出了中间部172相对于传感器150和延伸通过近端部168的纵向轴线A110(参见图3A)、进而相对于输送导管300的倾斜状态。
图5D示出了部分缩回到导管300内的传感器组件110。如图5D所示,固定装置154在如图5C所示被完全展开后,可重新处于其收缩状态并缩回到导管300内。固定装置154的中间部172的构造,更具体地,是中间部172相对于延伸通过近端毂部168的纵向轴线A110的倾斜角(见图3A),赋予了这种收缩性。有效铰接的毂部168和中间部172的所示构造使构成中间部172的部件与毂部168连接,从而固定装置154可在其被缩回进导管300时收缩。应理解,此后,如果需要,固定装置154可在该位置或脉管系统的不同位置重新展开。
图6A至图6D分别为根据本发明另一实施例的固定装置354的立体图、侧视图、俯视图和远端视图。如图6A至图6D所示,固定装置354包括近端毂部368、中间部372和远端部376。与前述固定装置一样,中间部372从毂部368向远端方向延伸,且远端部376从中间部372向远端方向延伸。在所示实施例中,毂部268包括适用于和植入式医疗器材(例如,诸如前述传感器50、150和250之类的植入式生理传感器)连接的环形圈379。如图所示,毂部368还包括多个(对本实施例为两个)从环形圈379向远端方向延伸的柄状部件380、382。与前述固定装置的实施例一样,在一些实施例中可省略环形圈379。或者,毂部368可包括适用于将固定装置354连接至各个植入式医疗器材的其它结构。
如图所示,中间部372包括一对分别从柄状部件380、382向远端方向延伸的铰链部件384、386。还示出了所述铰链部件384包括一对在柄状部件380的远端处铰接的分叉臂(diverging arms)388,389,且所述铰链部件386包括一对在柄状部件382的远端处铰接的分叉臂390,391。
远端部376包括一对脉管配合结构400、402,如图所示,所述脉管配合结构呈巢形爪结构的形式,分别从分叉臂(diverging arms)388,390和389,391的远端延伸。所述爪结构还包括适用于当所述固定装置如图6A至6C所示处于其扩张状态时与目标脉管的内表面摩擦配合的外周表面404、406。因此,当处于各图所示的扩张状态时,中间部372和远端部376形成与脉管(例如,肺动脉)的内表面配合的、可呈放射状扩张的装置,以将传感器组件固定在脉管内。
固定装置354的铰接构造和远端部376的设计使得中间部372和远端部376可向内收缩(如图6A和6C中箭头R所示的方向),以通过导管或类似装置输送固定装置354。此外,固定装置354适合于自扩张至图6A至6C所示的扩张状态,以将与毂部368连接的植入式医疗器材(未示出)固定在目标脉管内。再有,与上述固定装置54、154和254(见图5A至5D)类似,中间部372的铰接构造和中间部372相对于近端部368的倾斜方位使得固定装置354可以在首次展开之后被缩回至输送导管内时收缩。
固定装置354可由上述与固定装置54、154和254相关的任意材料制成。此外,应理解,固定装置354可通过本领域已知的或今后开发的用于制造可扩张植入式医疗器材固定装置等的方法制成。
图7是根据本发明另一实施例,处于已扩张状态的可重新定位固定装置454的立体示意图。如图7所示,固定装置454在处于扩张状态时基本上呈泪滴形圈的形式,且包括近端毂部468、中间部472和远端部476。与上述固定装置一样,中间部472从毂部468向远端方向延伸,且远端部476从中间部472向远端方向延伸。在所示实施例中,毂部468包括构成固定结构(如图2A和图6A至6C所示的环形圈)的环形圈478,用于将固定装置454连接至植入式医疗器材(例如,诸如上述传感器50、150和250之类的植入式生理传感器)。
从图7可清楚看到,固定装置454从毂部468逐渐过渡到中间部472,中间部形成相对于毂部468的倾斜角α,毂部本身的方位最好基本上与其中植入有固定装置454的目标脉管(例如,肺动脉16,见图1)平行。这种构造,以及固定装置454大体呈圈形,使得固定装置454可以在首次展开之后被缩回至输送导管或套管内的时候呈放射状及纵向(如图7中的箭头R和L所指方向)收缩。因此,与上述固定装置54、154、254和354一样,固定装置454使得,植入式医疗器材(例如,植入式传感器)在从输送导管首次展开之后,可以在患者脉管系统内重新定位。
图8是根据本发明另一实施例,处于已扩张状态的可重新定位的固定装置554的立体示意图。如图8所示,固定装置554包括一对圈556、557,这对圈呈背对背设置并在位于或靠近固定装置454和圈556、557高点的连接位置558处连接。从图8可见,至少圈556的形状和构造与上述固定装置454基本类似,并包括近端毂部564、中间部572、和远端部576,这些部分设置为与上述固定装置454的相应部分基本类似或基本相同。在所示实施例中,毂部568包括环形圈578,用于将固定装置554与上述植入式医疗器材连接。还可见到,在所示实施例中,圈557基本上是圈556的镜像,且包括远端部582。固定装置554还包括线圈状连接构件586、588,所述线圈状连接构件延伸在圈556、557之间并与圈556、557连接。
可按与上述固定装置454基本相同的方式操作固定装置554的圈556、557。具体地,圈556、557使得固定装置554可以在首次展开之后被缩回至输送导管或套管内的时候呈放射状及纵向收缩。此外,在一些实施例中,远端部582可形成一种用于连接植入式传感器或其它植入式医疗器材的结构。因此,有利地,图9的实施例允许连接多个植入式传感器(如果有需要)。或者,植入式传感器可连接至远端部582而非连接至近端毂部568,该近端部可用于其它用途(例如,用于将固定装置554连接至系绳或保持部件,以展开固定装置和与该固定装置连接的植入式医疗器材)。
图9是根据本发明另一实施例的,处于已扩张状态的可重新定位固定装置654的立体示意图。从图9可见,固定装置654是固定装置454的变化方式,包括一对圈656、657,这对圈由细长连接件658纵向隔开并连接。如图所示,至少圈656的形状和构造与上述固定装置454基本类似,并包括近端毂部664、中间部672和远端部676,这些部分设置为与上述固定装置454的相应部分基本类似或基本相同。还可以看出,近端毂部668包括环形圈678,用于将固定装置654连接至如上所述的植入式医疗器材。
图10是根据本发明另一实施例的,处于已扩张状态的可重新定位固定装置754的立体示意图。从图10可见,固定装置754是固定装置454的变化方式,包括一对圈756、757,这对圈由细长连接件758、759纵向隔开并连接,在圈756、757处于其扩张状态时,所述连接件处于沿所述固定装置的周缘的位置。至少圈756的形状和构造与上述固定装置454基本类似,并包括近端毂部768、中间部772和远端部776,这些部分设置为与上述固定装置454的相应部分基本类似或基本相同。在所示实施例中,毂部768包括环形圈778,用于将固定装置754连接至如上所述的植入式医疗器材。还可见到,圈756的远端部776与圈757在连接位置788处直接相连。
可按与上述固定装置54、154、254和354基本相同或同样的方式操作圈形固定装置454、554、654和754。具体地,所有前述固定装置设置为可以在首次展开之后被缩回至输送导管或套管内的时候呈放射状及纵向(例如图7中箭头R和L所指方向)收缩。这样,与上述固定装置54、154、254和354一样,这些固定装置使得植入式医疗器材(例如,植入式传感器)在从输送导管首次展开之后,可以在患者脉管系统内重新定位。因此,当其处于各图中所示的扩张状态时,固定装置454、554、654和754的中间部和远端部形成用于和脉管(例如,肺动脉)的内表面配合的可放射状扩张的装置,以将各传感器组件固定在脉管内。
上述固定结构使得传感器或其它植入式医疗器材可以被固定或紧固在脉管系统的任意部分内。在一特定实施例中,可用已知的导管插入技术将传感器组件输送至脉管系统内的目标植入位点。
图11为根据本发明一实施例的流程图,示出了展开植入式传感器组件(例如,传感器组件10、110、210或利用固定装置354、454、554、654、754中任意一个的传感器组件)的方法。在一实施例中,传感器组件被植入在肺动脉16(见图1)内或其支脉内。如图11所示,采用本领域已知的方法使引导导管经静脉行进,直至其远端位于最接近肺动脉16内植入位点的位置(框810)。例如,在一实施例中,可将Swan Ganz导管插入静脉系统并随血流漂进心脏20并通过心脏漂出至肺动脉16,该导管包含位于或接近其远端的球囊。然后,可利用所述球囊导管将引导线定位于肺动脉16内,接着将第二引导导管部分地定位在肺动脉16内。然而,应强调的是,无论是现在已知的还是以后开发的任何导管插入技术均可用于在肺动脉16内(或脉管系统的其它适当区域)定位传感器组件。
如果临床医师有需要,可以在导管插入之前,将可松开地连接有系绳或其它保持结构的传感器组件预置入引导导管腔体内。或者,引导导管可根据需要置于患者的脉管系统内,且传感器组件和系绳可通过导管腔体行进至最接近导管远端开口的位置。(框812)
然后,可以在仍连接有系绳的情况下,从引导导管的远端展开传感器组件,或至少展开固定装置(框814)。例如,可以通过在使系绳以及传感器组件处于适当位置的同时收回引导导管,或通过将系绳和传感器组件向远端方向推出导管的远端,来展开传感器组件。一旦从引导导管释放,固定装置可自扩张至呈现其扩张状态,并与肺动脉16的内表面配合。或者,对于采用球囊扩张型固定装置的情况,可通过使球囊充气,如本领域已知的,例如,使球囊扩张型脉管支架扩张的方法,来扩张固定装置。
然后,如果需要,可从传感器组件松开系绳,并将系绳和引导导管从患者收回。或者,如果医生决定应该移除或重新定位传感器组件,医生可以通过相对于引导导管朝远端方向拉系绳,将传感器组件,包括固定装置收回至引导导管内(框816)。如图5D所示,固定装置在其被收回至引导导管时收缩,从而在引导导管内重新呈现其收缩状态。然后,所述导管可重新定位于肺动脉内或再置于患者脉管系统的其它区域。然后,固定装置和/或传感器组件可整个地从引导导管重新展开。或者,传感器组件可整个地移出体内(例如,如果判断该传感器不能如期工作,或者如果该固定装置的大小或形状不适合特定患者的解剖学)。
当然,应理解,上述固定结构可用于将生理传感器和/或其它植入式医疗器材固定于患者心血管系统的任意区域,或者在一些实施例中固定于其它体腔内。也就是说,上述固定装置还可将传感器和其它器材有效地固定在除了肺动脉和其支脉之外的脉管内。
此外,在一些实施例中,除了植入式生理传感器之外,或者替代植入式生理传感器,上述固定装置可用于固定治疗输送器材(例如,药物输送器材、刺激电极)。在这种实施例中,治疗功能不限于具体类型,可包括,例如,超声波或药物输送治疗,或任意其它可用目前已知或将来开发的植入式医疗器材施加的治疗。在一些实施例中,固定结构可用于放置多个传感器、执行器或传感器和执行器的组合。在体内放置多个传感器和/或执行器可满足更为全面的治疗和诊断系统,但多个传感器和/或执行器并不是必需的。
可在不脱离本发明范围的条件下对实施例作各种改动和添加。例如,虽然上述实施例涉及了具体特征,本发明的范围还包括具有这些特征的不同组合的实施例和并未包括上述全部特征的实施例。因此,本发明的范围确定为包括落入权利要求书范围的全部可选方式、改动方式和变化方式,以及它们的等同方式。
Claims (20)
1.一种设置为通过输送导管输送的植入式传感器组件,所述传感器组件包括:
植入式传感器;
固定装置,所述固定装置连接至所述传感器,并适合于在所述输送导管内呈现收缩状态及在所述输送导管外呈现扩张状态,所述固定装置包括:
近端的毂部;
中间部,所述中间部铰接至所述毂部并从所述毂部向远端方向并呈放射状延伸,所述中间部设置为,当所述固定装置处于所述扩张状态时,呈现相对于所述毂部基本上倾斜的角;和
远端部,当所述固定装置处于扩张状态时,所述远端部从所述中间部向远端方向延伸,并适合于和脉管的内表面配合,
其中,所述中间部设置成,在呈现所述扩张状态之后,可使所述固定装置缩进所述输送导管,并呈现所述收缩状态。
2.如权利要求1所述的传感器组件,其中所述固定装置在所述毂部处与所述传感器连接。
3.如权利要求2所述的传感器组件,其中所述传感器包括壳体,并且其中所述毂部基本上呈环形且适合于延伸环绕所述传感器壳体的至少一部分。
4.如权利要求1所述的传感器组件,其中至少所述远端部适合于和患者肺动脉的内表面配合。
5.如权利要求1所述的传感器组件,其中所述传感器包括压力传感器。
6.如权利要求5所述的传感器组件,其中所述压力传感器适合于测量肺动脉血压。
7.如权利要求1所述的传感器组件,其中,当所述固定装置处于扩张状态时,所述传感器位于所述固定装置大约径向中心位置。
8.如权利要求1所述的传感器组件,其中,当所述固定装置处于扩张状态时,所述传感器位于接近所述固定装置周缘的位置。
9.如权利要求1所述的传感器组件,其中所述固定装置为球囊扩张型。
10.如权利要求1所述的传感器组件,其中所述固定装置为自扩张型。
11.如权利要求1所述的传感器组件,其中所述固定装置基本上由形状记忆材料制成。
12.如权利要求11所述的传感器组件,其中所述固定装置基本上由形状记忆镍钛合金制成。
13.一种植入式传感器组件,包括:
传感器,所述传感器包括密封地包围传感器元件的壳体;和
固定装置,所述固定装置包含:
近端的传感器连接部,其与所述壳体相连;和
可放射状扩张的装置,其从所述传感器连接部延伸,用以与脉管的内表面配合。
14.如权利要求13所述的传感器组件,其中用以与脉管内表面配合的所述可放射状扩张的装置设置为呈现适合于在导管内输送的收缩状态和在所述导管外部的扩张状态。
15.如权利要求14所述的传感器组件,其中用以与脉管内表面配合的所述可放射状扩张的装置包括:
多个第一细长部件,当处于所述扩张状态时,所述第一细长部件以相对于所述传感器连接部的倾斜角,从所述传感器连接部向远端方向并呈放射状延伸;和
多个第二细长部件,各所述第二细长部件从至少一个所述第一细长部件向远端方向延伸,
其中当处于所述扩张状态时,至少所述第二细长部件适于和所述脉管的所述内表面配合。
16.如权利要求15所述的传感器组件,其中所述第二细长部件各包括至少一个弓形段,其中相邻的第二细长部件在各弓形段大约中部处互相连接。
17.如权利要求16所述的传感器组件,其中所述传感器连接部基本上呈环形,且适合于延伸环绕所述传感器壳体的至少一部分。
18.一种展开植入式传感器组件的方法,所述方法包括:
将输送导管的远端定位于体腔内的第一位置;
从所述输送导管的远端展开所述传感器组件的固定装置部分,使得所述固定装置部分呈扩张状态;
将所述固定装置部分缩回至所述输送导管内,使得所述固定装置部分呈收缩状态;
将所述输送导管的远端重新定位于所述体腔内的第二位置;以及
从所述输送导管的远端重新展开所述传感器组件的固定装置部分,使得所述固定装置部分重新呈现扩张状态。
19.如权利要求18所述的方法,用于展开植入式压力传感器组件。
20.如权利要求19所述的方法,其中定位输送导管的远端包括,使所述输送导管经静脉前进,以将所述远端定位在肺动脉内。
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- 2007-09-14 AU AU2007296345A patent/AU2007296345B2/en not_active Expired - Fee Related
- 2007-09-14 US US11/855,725 patent/US8057399B2/en active Active
- 2007-09-14 ES ES07842532T patent/ES2369203T3/es active Active
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JP5156749B2 (ja) | 2013-03-06 |
EP2061373B1 (en) | 2011-07-20 |
AU2007296345B2 (en) | 2012-05-31 |
WO2008034077A2 (en) | 2008-03-20 |
ATE516747T1 (de) | 2011-08-15 |
CN101516259B (zh) | 2011-07-20 |
WO2008034077A3 (en) | 2008-07-03 |
US20080071178A1 (en) | 2008-03-20 |
US8057399B2 (en) | 2011-11-15 |
EP2061373A2 (en) | 2009-05-27 |
AU2007296345A1 (en) | 2008-03-20 |
ES2369203T3 (es) | 2011-11-28 |
JP2011501972A (ja) | 2011-01-20 |
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