CN1713234B - 对植入的医疗装置的低频经皮遥测系统 - Google Patents

对植入的医疗装置的低频经皮遥测系统 Download PDF

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CN1713234B
CN1713234B CN2005100796695A CN200510079669A CN1713234B CN 1713234 B CN1713234 B CN 1713234B CN 2005100796695 A CN2005100796695 A CN 2005100796695A CN 200510079669 A CN200510079669 A CN 200510079669A CN 1713234 B CN1713234 B CN 1713234B
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CN1713234A (zh
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小威廉·L·哈斯勒
小丹尼尔·F·德卢戈斯
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Ethicon Endo Surgery Inc
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    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • A61N1/37223—Circuits for electromagnetic coupling
    • 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
    • A61N1/378—Electrical supply
    • A61N1/3787—Electrical supply from an external energy source

Abstract

一种可植入医疗装置有利地利用低频(例如，100kHz或以下)与外部控制模块进行遥测通信，避免了由于植入装置的金属壳体的涡电流及人体组织而产生的功率消耗，由此允许使用诸如钛这样的金属壳体的更小型植入装置和/或允许更强的遥测信号，从而允许更深的植入。

Description

对植入的医疗装置的低频经皮遥测系统
技术领域
本发明涉及遥测系统，尤其涉及能够与低频经皮能量传递(TET)系统结合使用以在外部控制模块和医疗植入装置之间传输数据的低频遥测系统。
背景技术
将医疗装置手术植入到患者体内以获得多种有益效果是公知的。为了在患者体内正确地工作，医疗植入装置和外部控制模块之间的可靠而恒定的通信连接常常是必须的，从而监视植入装置的性能或某些患者参数和/或要求植入装置进行某些操作。该通信连接在传统上用工作频率在100kHz到30MHz以上的遥测系统实现。这些较高的频率用于使所需的线圈尺寸最小化，因此能够使线圈安装在植入装置壳体中。将遥测线圈放置到植入装置壳体外部以便使用更大的线圈也是公知的。然后由于电导线必须在植入装置壳体外部延伸到线圈，因此这样做增加了植入装置的复杂性和费用，并且对保持壳体的密封和避免对外部线圈的损害提出了挑战。
尽管高频遥测信号减小了所需的线圈尺寸，但是该信号也减小了系统中收发器之间的有效通信距离。植入的收发器常常必须被放置到患者皮肤表面的紧下方以便有效地与外部收发器通信。在较短的波长下(即，较高的频率)，当通过组织时信号在较短的距离上耗散。
100kHz以上的高频遥测信号更可能导致产生电磁干扰或与其它通信设备的相容性问题，因此在联邦规章中出现了附加的限制。遵守该规章增加了开发该植入装置的时间和复杂度，并且还要限制传输功率。
从遥测系统的使用中受益的可植入装置的一个例子是人造括约肌，尤其是可调整束胃带，该束胃带包括一中空弹性气囊，其具有围绕患者的食管-胃连接处紧下方的胃部位的若干固定端点。这些气囊可以通过将盐水溶液引入到气囊中而膨胀和收缩。在通常公知的可调整束胃带中，该盐水溶液必须用注射针注射到皮下端口来到达位于皮肤表面之下的该端口。所述端口通过导管与所述束胃带液压连通。尽管有效，但理想的是避免必须用注射针调节流体体积，原因在于这可能导致感染的危险，以及会给患者带来不便和不舒服。
与前述医疗植入装置不同，用于人造括约肌的注入器装置通常植入到皮肤的较厚真皮层和脂肪组织下方。这对于通常接受可调整束胃带作为对病理性肥胖的治疗的患者来说尤其如此。而且，更深地植入可以使就诊者更加舒服。然而，组织的厚度对于有效通信造成困难。
因此，为了提供初级和次级收发器之间的更大的有效通信范围，并且尽可能遵守FCC规定，非常需要在比通常使用的更低频率下增强对带有深植入的医疗装置的遥测。
发明内容
本发明通过提供一种在小于100kHz的频率下工作的用于可植入医疗装置的遥测系统克服了现有技术的上述和其它缺点，有利地使涡电流损失最小化和允许使用金属壳体以获得更小的植入尺寸.在遥测系统传送较大功率时，低频避免了加热人体组织.而且，低频遥测系统包括包含在密封的可植入装置中的遥测线圈，从而保证该装置的完整性.
在本发明的一个方案，遥测电路越过在具有电感和电容组合的初级和次级谐振储能电路之间的物理边界通信，所述电感和电容组合被选择成用于在25-100kHz的范围内共振。因此，可植入医疗装置可以与包含在其整体中的次级遥测线圈一起被深植入并且仍能获得可靠的遥测。
从附图及其描述应当明显看出本发明的这些和其它目标和优点。
附图说明
结合到说明书中并且作为说明书一部分的附图示出了本发明的实施例，其与上述本发明的概括描述以及下述实施例的具体描述一起用于解释本发明的原理。
图1是显示遥控系统的结构图，该遥控系统包括本发明的可植入医疗装置系统的低频功率和遥测系统；
图2是显示本发明的低频TET功率系统和遥测系统的示意图；
图3是显示适用于本发明的滤波器的一个典型形式的示意图；
图4A是显示图1的遥控系统的初级和次级功率和遥测线圈的磁场的图示；
图4B是显示图1另一实施例的功率和遥测系统的初级和次级线圈的磁场的图示，在该实施例中初级功率和遥测线圈放置在铁氧体磁心周围。
具体实施方式
现在详细参考附图，在所有图中相同的数字表示相同的元件，在图1中，遥控可植入医疗装置系统10包括遥控系统12，该遥控系统有利地通过TET功率系统14执行经皮能量传递(TET)和通过遥测系统16执行遥测。TET功率系统14和遥测系统16的内部部分18、20分别位于可植入医疗装置(“植入装置”)22中，这两者的外部部分24，26分别位于外部控制模块28中。植入装置22和外部控制模块28由物理边界30间隔，该物理边界在所示的形式中由一般包括脂肪组织厚层的真皮组织组成。
可以从改进型的TET供电和遥测受益的可植入双向注入装置公开于申请日为2004年5月28日的四个共同未决并且共同拥有的专利申请中，所述申请的全部内容结合于此以作参考，其名称为(1)“用于液压控制可调整束胃带的压电驱动式气囊式注入器”，发明人为William L.Hassler，Jr.，序列号为10/857,762；(2)“用于可调整束胃带的液压控制的金属气囊式位置反馈”，发明人为William L.Hassler，Jr.，Daniel F.Dlugos，Jr.，Rocco Crivelli，序列号为10/856,971；(3)“作为遥控式束胃带使用的热力驱动式可逆注入器泵”，发明人为William L.Hassler，Jr.，Daniel F.Dlugos，Jr，序列号为10/857,315；(4)“用于液压控制可调整束胃带的带有体积制动的双向注入器泵”，发明人为William L.Hassler，Jr.，Daniel F.Dlugos，Jr.，序列号为10/857,763。
遥测系统16的外部部分26包括用于发射询问命令和从植入装置22接收响应数据的初级收发器32.初级收发器32电连接到一初级控制器34以输入和接收来自用户或自动编程器的命令数据信号.特别地，初级控制器34与初级遥测判优器36通信，该判优器负责缓解和缓冲经过初级遥测输出接口逻辑电路38到达初级收发器32的上行遥测通信以及从初级收发器32经过初级遥测接口差分放大器输入逻辑电路40的下行遥测通信.初级收发器32在选定射频(RF)通信频率下共振以产生下行交变磁场42，该交变磁场将命令数据传输到植入装置22.
遥测系统16的内部部分18还包括与初级收发器32成间隔关系的次级收发器44，并且位于植入装置22的壳体(未示出)内的边界30的相反侧。在本发明中，次级收发器38电连接到次级控制器46。特别地，次级控制器46与次级遥测判优器48通信，该判优器负责缓解和缓冲经过次级遥测输出接口逻辑电路50到达次级收发器44的上行遥测通信以及从次级收发器44经过次级遥测接口差分放大器输入逻辑电路52发出的下行遥测通信。次级收发器44通过用于下行通信的交变磁场36和用于上行通信的交变磁场54磁耦合到初级收发器32。来自初级收发器32的磁通量在次级收发器44中产生电命令信号。该命令信号被应用到植入装置22中的次级控制器46以指示植入装置22的工作。类似地，次级收发器44电连接到控制器46以将命令响应信号从植入装置22传输到遥测系统16的外部部分26。当要求数据传输时，收发器44在选定RF频率下共振以产生上行交变磁场54。上行磁场54耦合到初级收发器32中，该初级收发器32产生输入到初级控制器34的电信号。
仍然参考图1，TET功率系统14的外部部分24还包括初级供电电路56，该初级供电电路通过功率放大器60电耦合到电源58以在选定功率信号RF频率下共振。初级电路56响应由电源58提供的电信号而产生交变磁场62。TET功率系统14的内部部分18包括与初级供电电路56成分隔关系的次级供电电路64。次级供电电路64位于与植入装置22中的初级供电电路56相反的边界30的一侧上。次级供电电路64通过交变磁场62电耦合到初级供电电路56。次级供电电路64从磁场62中产生电功率信号66。功率信号66被功率调节电路68整流和调节并且并应用到植入装置驱动器70，从而为植入装置22的各种有源部件供电。
在图2中，显示了属于遥控系统12的TET功率系统14和遥测系统16的谐振电路部分。特别地，初级收发器32包括并联调谐储能电路72，该储能电路具有由一个或多个与电感线圈76并联的电容器75组成的电容。电容器75和线圈76被调谐为当控制器34施加电压时在特定频率下产生共振。类似地，次级收发器44包括并联调谐储能电路78，该储能电路具有电容80和电感线圈62，其被调谐为在与初级遥测储能电路72相同的频率下发生共振。同样如图2所示，初级供电电路56包括并联调谐储能电路，该储能电路带有被调谐为低功率频率的电容86和线圈88。次级供电电路64包括串联调谐储能电路，该储能电路带有同样被调谐为低频级的电容92和线圈94。在TET系统的所示形式中，通过匹配高Q值，低阻抗的初级调谐储能电路84和低Q值，低阻抗的次级调谐储能电路90，低初级供电电路56在10kHz尤其是5kHz以下的共振频率传输大约1瓦的功率。
在本发明中，初级供电电路56在低频级下工作以便通过植入装置壳体有效地与次级供电电路64通信。在该讨论中，术语“低频”或“低频级”表示低于100千赫(kHz)的频率。如上所述，功率线圈88，94也在低频下共振以使次级功率线圈94能够封闭在密封的植入装置壳体中。
为了在低频级下传输功率和遥测磁场62，42，54，信号滤波器96过滤次级收发器44上接收到的电信号，具体而言是来自储能电路78的电信号.滤波器96从较高能量功率场64去耦合较低能量遥测磁场42.滤波器96可以是被选择成阻止除了遥测共振频率之外的频率的任何类型的滤波设计.
图3显示了适用于本发明的滤波器96的一个典型形式。在本发明中，来自初级或次级遥测线圈82的命令信号被应用到隔离遥测信号和TET功率信号的一系列单极点低通和高通滤波段。对于图3所示的单极点实施例，AC磁场62，42，54在交替时间段中被传输，从而从遥测信号42，54消除功率场62的高Q值。在另一个实施例中，滤波器74包括一个或多个双极点滤波器，例如车比雪夫(Chebyshev)滤波器。该2极滤波器提供了高Q值功率信号的更有效的滤波，并且使AC磁场62，42，54能够同时被传输。为了有效地从较高能量功率信号滤波较低能量遥测信号，两个信号的共振频率至少相差一个数量级。
图4A和4B显示了分别从初级功率线圈88和初级收发器线圈76辐射到皮下次级TET线圈94和遥测线圈82的磁场62和42/54。在图4A所示的形式中，磁场62和42/54都具有双圆环形状，其仅仅较浅地穿透物理边界30到达各自的次级TET功率和遥测线圈94，82，由此减小线圈之间的能量传递以及相应地需要植入装置22至于较浅的位置。图4B显示了本发明的另一个实施例，其在前面引用的名称为“带有高纵横比铁氧体磁心的经皮能量传递初级线圈”的专利申请中更详细地描述，其中初级功率和收发器线圈56，66围绕磁导铁氧体磁心98放置。如图4B所示，铁氧体磁心98的加入导致了磁通量62，42/54从初级线圈88，76向磁心98牵引。磁场62，42/54因此径向地塌缩到磁心98中并且从圆形变为椭圆形。磁场62，42/54地椭圆形状增加了初级和次级遥测线圈76，82以及初级和次级功率线圈88，94之间的耦合效率。与铁氧体磁心98之间的增加的耦合效率在较大的物理距离或在较低功率水平下提高了收发器32，44之间的遥测。
在本发明的一个典型的实施例中，每个初级和次级收发器线圈76，82都由220匝的36号(gauge)线圈线形成。每个线圈76，82都与导致储能电路具有大约25kHz的共振频率的电容并联放置。初级功率线圈88由102匝的绞合线形成，该绞合线由100个独立的30号(gauge)绝缘线圈线组成。所述线圈线与9.2微法的电容并联，这形成了带有高Q值和10kHz尤其是5kHz以下的共振频率的并联调谐储能电路。初级功率线圈88和初级遥测线圈76都放置在具有3英寸长度和0.75英寸直径的铁氧体磁心98周围。使用这些参数和共振频率，初级功率线圈88传输大约1瓦功率，而初级遥测线圈76传输毫瓦级功率。功率和遥测线圈88，76交替传输一段时间，并且遥测系统16在1kHz的波特率下传输数据。在该实验实施例中，初级和次级线圈之间分开3英寸的距离。
在为深植入的医疗装置设计低频遥测系统时，希望使并联调谐储能电路中的两个磁耦合遥测线圈的Q值在10-20的范围内。如果这两个储能电路的Q值低于该范围，那么将难以实现任何有效的深穿透遥测范围。如果Q值高于该范围，那么不单独地调谐每对并联调谐储能电路就难以大量地制造该系统。
也能够使初级(或外部)遥测储能电路具有非常大的Q值(大于100)而同时在植入装置中具有较低的Q值(大约10)。与在植入装置中具有高Q值电路相比这样做的优点在于，更高Q值通常需要更大和更重的线圈和更大的电感。该设置将仍然允许高Q值电路的固有频率包括在低Q值电路的有效频率范围内而不需要单独的调谐或匹配电路。
在深植入遥测系统中的线圈可以使它们的线圈匝数最大以更好地耦合和更好地产生作为遥测媒介的AC磁场.这样做时需要在并联调谐储能电路的共振下不产生明显的高阻抗，线圈周边内的开放横截面积需要被最大化以便提高储能电路之间的磁耦合.使用的线圈具有220匝36号线圈线，当与5600pF的电容并联时，产生25kHz的共振频率，并且计算的Q值为19，在共振下计算的阻抗大约为20千欧.由于寄生损失和其它非线性影响，实际的Q值总是比计算值低大约10％-30％.
尽管通过几个实施例的描述举例说明了本发明，以及尽管相当详细地描述了所列举的实施例，但是本申请的目的并非是要将附加权利要求的范围限制或以任何方式限定到该细节。对于本领域的熟练技术人员来说其它优点和改进是显而易见的。
例如，尽管所述的遥测系统16具有用于可植入医疗装置系统10的特别优点，符合本发明的多个方案具有对于包括无生命物理边界的其它科学和工程方案的应用。例如，可应用在希望能监视和/或控制包含在容器中的驱动器而不损害带有穿过其中的导线或管道的容器的完整性的处理装置中。
而且，遥测系统16可以用于缺少TET功率系统14的情况。作为另一个选择，遥测系统16可以提供单向通信通道而非双向通道。

Claims (9)

1.一种遥控系统，包括：
初级控制器，用以输入和接收来自用户或自动编程器的命令数据信号；
初级遥测发射器，其由所述初级控制器激励并且包括与电容电连通以形成谐振储能电路的初级线圈，该谐振储能电路具有100kHz或以下的峰值共振；
次级控制器；以及
次级遥测接收器，其传递从所述初级遥测发射器传输到所述次级控制器的接收的电磁能，并且包括与电容电连通以形成谐振储能电路的次级线圈，该谐振储能电路具有100kHz或以下的峰值共振，
其中将在所述次级遥测接收器中产生的电命令信号应用到所述次级控制器。
2.根据权利要求1的遥控系统，其中所述初级遥测发射器和次级遥测接收器的谐振储能电路的峰值共振在25-100kHz之间。
3.根据权利要求1的遥控系统，进一步包括封闭所述次级控制器和所述次级遥测接收器的医疗植入装置外壳。
4.根据权利要求1的遥控系统，其中所述线圈进一步包括纵向排列的铁氧体磁心。
5.根据权利要求1的遥控系统，其中所述初级线圈包括多匝绝缘绞合线。
6.根据权利要求1的遥控系统，其中所述次级线圈包括多匝绞合线。
7.根据权利要求1的遥控系统，其中所述初级控制器和初级遥测发射器位于一物理边界的外部，与所述次级控制器和次级遥测接收器空间上分离。
8.根据权利要求6的遥控系统，其中所述初级遥测发射器包括初级收发器，次级遥测接收器包括用于双向遥测和控制的次级收发器。
9.根据权利要求1的遥控系统，进一步包括所述次级遥测接收器和次级控制器之间的带通滤波器。
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