CN101524299A - 调准可植入天线的系统和方法 - Google Patents

调准可植入天线的系统和方法 Download PDF

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CN101524299A
CN101524299A CN200910126642A CN200910126642A CN101524299A CN 101524299 A CN101524299 A CN 101524299A CN 200910126642 A CN200910126642 A CN 200910126642A CN 200910126642 A CN200910126642 A CN 200910126642A CN 101524299 A CN101524299 A CN 101524299A
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implantable
shell
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CN101524299B (zh
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J·A·科
M·S·奥尔蒂斯
M·J·斯托克斯
C·H·Y·陈
J·S·埃兹奥里诺
K·D·费尔德
E·W·汤普森
D·C·耶茨
D·N·普莱西亚
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Ethicon Endo Surgery Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031—Implanted circuitry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
    • A61B5/036—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs by means introduced into body tracts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/07—Endoradiosondes
    • A61B5/076—Permanent implantations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/005—Gastric bands
    • A61F5/0053—Gastric bands remotely adjustable
    • A61F5/0059—Gastric bands remotely adjustable with wireless means
    • 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
    • A61N1/37211—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
    • A61N1/37229—Shape or location of the implanted or external antenna
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0242—Operational features adapted to measure environmental factors, e.g. temperature, pollution
    • A61B2560/0247—Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value
    • A61B2560/0257—Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value using atmospheric pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2250/0001—Means for transferring electromagnetic energy to implants
    • A61F2250/0002—Means for transferring electromagnetic energy to implants for data transfer

Abstract

本发明提供了调准可植入天线的系统和方法。更具体地说，本发明提供的可植入限制系统具有天线，该天线能够以容易的和可预期的方式运动，以获得有效地与外部装置通信的期望方位。天线可以可运动的方式连接到外壳，使天线能够相对于外壳浮动和/或自由运动。外壳可以是万向元件的一部分或者系统的其他组成元件。天线可包括辅助天线获得期望方位的重物或磁元件。本发明还提供了用于与可植入限制装置经皮通信的方法。

Description

调准可植入天线的系统和方法
技术领域
本发明涉及如下系统和方法，该系统和方法用于以可预期的并且是可靠的方式使可植入天线与外部读取器调准，由此方便天线和读取器之间的功率耦合和/或数据传输。
背景技术
特别是在美国，随着肥胖人数持续增加，并且所知道的肥胖对健康的负面影响越来越多，肥胖变得越来越受到关注。人的体重超过理想体重100磅或者更多的病理性肥胖尤其引起严重健康问题的极大风险。因此，大量的注意力被聚焦到治疗肥胖患者上。治疗病理性肥胖的一种方法是围绕胃的上部设置限制装置，诸如细长的束带。胃束带典型地包括具有固定端点的填充了流体的弹性囊，该囊紧邻食道-胃结合部的下部围绕胃，以便在束带上方形成小的胃袋并在胃中形成减小了的人造口。当流体注入囊中时，束带抵靠胃膨胀，从而在胃中形成食物摄取限制部分或者人造口。为了减少这种限制，将流体从束带中去除。束带的作用是减小可利用的胃的容积，并由此在变得“饱胀”之前减少可被消耗掉的食物量。
食物限制装置还包括类似地围绕胃上部的以机械方式调节的胃束带。这些胃束带包括任意数量的弹性材料或者传动装置以及驱动构件，以便调节胃束带。另外，胃束带已经被发展为包括液压和机械驱动元件。还已知的是，通过将可膨胀的弹性囊植入到胃腔本身中来限制胃腔中可用的食物容积。囊填充有流体以便抵靠胃壁膨胀，并且由此减少胃内可用的食物容积。
使用上述食物限制装置的每一种进行安全有效的处理都要求所述装置被有规律地监测并调节以改变施加到胃上的限制程度。传统地，调节胃束带要求在皮下注射针和注射器被用于穿刺患者皮肤并流体被从囊中除去期间按照规定看医生。最近，已经发展了能够以非侵入方式调节束带的可植入泵。外部程序装置使用遥测技术与植入的泵通信，以便对泵进行控制。在按照规定看医生期间，医生将程序装置的手持部分放置在胃植入物附近并将命令信号传递给植入物。植入物又调节束带并将响应命令传递给程序装置。
植入物(诸如上述的那些)包括电子器件，这些电子器件要求足以用于期望功能(诸如对胃束带进行调节)的功率源。这样的装置可通过电池或电容器在内部提供功率，而其他装置可通过外部连接的功率源或者无源遥测系统提供功率。当从外部连接时，植入物和外部装置之间的效率随着它们之间的距离增加而显著降低。而且，穿过组织会造成显著功率损失。此外，正确地调准内部天线和外部读取器以便为植入物提供功率和/或在二者之间传输数据是很困难和耗时的。
因此，仍需要能够便于可植入天线和外部装置之间的功率耦合和/或数据传输的系统和方法。
发明内容
此处提供了可植入限制系统的各个方面。在一个这样的方面中，所述系统包括能够在通路中形成限制的可植入的限制装置。所述系统还可包括：可植入的外壳(例如传感器外壳)；和可植入的天线，该可植入天线以可运动的方式连接到外壳，使得天线可与外部装置调准以便与外部装置通信。天线可有效地与外部装置通信，以便将向外部装置供给的能量经皮传输到天线。天线还可有效地与外部装置通信(例如传送和/或接收)各种类型的数据。
如下所述，天线可响应于多种因素而运动。例如，天线可响应于如下的至少一种而运动：手动操作、磁力、电磁力、重力、和浮力。为方便进行这种运动，系统可包括连接到天线的至少一个磁元件，其中，所述至少一个磁元件被构造成与外部磁构件调准。而且，所述天线可包含有效地用于通过重力将天线调准在一期望方位的元件(例如重物)。在这种例子中，天线可基本上是环形的并且重物可以被定位在天线的下方并且基本上沿着天线的中心轴线。而且，外壳可以是万向元件(gimbal element)的至少一部分，使得天线可以围绕第一轴线自由旋转并且还可以围绕第二轴线自由旋转，其中第一轴线与第二轴线基本垂直。
系统还可包括可植入的传感器，该传感器被构造成测量系统参数的工作值和生理参数的值的至少一个。在使用中，天线可有效地将工作值或者生理值与外部装置通信。例如，可植入传感器可为压力传感器。
天线可设置在或连接到各种形式的外壳。例如，天线可被设置在传感器外壳上，该传感器外壳以可运动的方式安装到能够接合到解剖学位置(例如筋膜)的基底外壳。在这种例子中，天线可以固定方式安装在传感器外壳上，而传感器外壳可以可运动的方式(例如通过球窝接头)安装到基底外壳上。
在另一方面中，本发明提供了一种可植入的限制系统，该限制系统包括可在患者体内形成限制的可植入的胃限制装置。系统还可包括可植入的传感器，该传感器被构造成测量系统参数的值和生理参数的值的至少一个。此外，系统可包括与可植入传感器相通信的可植入的天线，其中该可植入天线可被构造成与外部装置通信并且能够获得有效的方位以使天线与外部装置通信。在此方面中，天线可响应于如下的至少一种来运动到有效的方位：手动操作、磁力、电磁力、和重力。
天线可被构造成以各种方式运动到有效的方位。例如，天线可被以可运动的方式连接到外壳。在这种例子中，天线可以固定方式安装在外壳上，而外壳又以可运动的方式装配到基底外壳上。可植入天线还可被连接到外壳，其中该外壳是万向元件的至少一部分，使得天线可以围绕第一轴线自由旋转并且还可以围绕第二轴线自由旋转，其中第一轴线与第二轴线基本垂直。
此外，本发明还提供了多种用于与可植入限制系统经皮通信的方法。在一个这样的方面中，所述方法包括将限制系统植入患者体内，其中所述系统包括：限制装置，用于有效地在通路中形成限制；和天线，用于有效地与外部装置进行通信以接收和发送能量和数据的至少一种。该方法还可包括：使天线相对于外壳的至少一部分运动，从而使天线与外部装置调准以便进行通信。例如，天线可响应于以下至少一种而以期望的方位与外部装置调准：手动操作、磁力、电磁力、和重力。
更具体地说，本发明涉及如下内容：
(1)、一种可植入的限制系统，包括：
能够在通路中形成限制的可植入的限制装置；
可植入的外壳；和
可植入的天线，该可植入的天线以可运动的方式连接到所述外壳，使得所述天线能够与外部装置调准以便与所述外部装置通信。
(2)、如第(1)项所述的系统，还包括连接到所述天线的至少一个磁元件。
(3)、如第(2)项所述的系统，其中，所述至少一个磁元件被构造成与外部磁构件调准。
(4)、如第(1)项所述的系统，其中，所述天线能够响应于如下的至少一种而运动：手动操作、磁力、电磁力、重力、和浮力。
(5)、如第(1)项所述的系统，还包括可植入的传感器，该传感器被构造成测量系统参数的工作值和生理参数的值的至少一个，其中所述天线能够有效地将所述工作值或者生理值与所述外部装置通信。
(6)、如第(5)项所述的系统，其中，所述天线被设置在传感器外壳上，该传感器外壳以可运动的方式安装到能够接合解剖学位置的基底外壳。
(7)、如第(6)项所述的系统，其中，所述天线以固定方式安装在所述传感器外壳上。
(8)、如第(6)项所述的系统，其中，所述传感器外壳以可运动的方式通过球窝接头安装到所述基底外壳上。
(9)、如第(1)项所述的系统，其中，所述外壳是万向元件的至少一部分，使得所述天线能够围绕第一轴线自由旋转并且还能够围绕第二轴线自由旋转，其中所述第一轴线与所述第二轴线基本垂直。
(10)、如第(1)项所述的系统，其中，所述天线被连接到有效地用于通过重力将天线调准在期望方位的重物。
(11)、如第(10)项所述的系统，其中，所述天线包含能够有效地用于通过重力将天线调准在期望方位的元件。
(12)、如第(11)项所述的系统，其中，所述元件包括重物。
(13)、如第(1)项所述的系统，其中，所述天线能够有效地与所述外部装置通信，以便将向所述外部装置供给的能量经皮传输到所述天线。
(14)、一种可植入的限制系统，包括：
能够在患者体内形成限制的可植入的胃限制装置；
可植入的传感器，该传感器被构造成测量系统参数的值和生理参数的值的至少一个；和
与所述可植入的传感器相通信的可植入的天线，该可植入的天线被构造成与外部装置通信并且能够获得使所述天线与所述外部装置通信的有效的方位。
(15)、如第(14)项所述的系统，其中，所述天线能够响应于如下的至少一种而运动到所述有效的方位：手动操作、磁力、电磁力、重力、和浮力。
(16)、如第(14)项所述的系统，其中，所述天线被以可运动的方式连接到外壳。
(17)、如第(14)项所述的系统，其中，所述天线以固定方式安装在外壳上，而该外壳又以可运动的方式装配到基底外壳上。
(18)、如第(14)项所述的系统，其中，所述可植入的天线被连接到外壳，其中该外壳是万向元件的至少一部分，使得所述天线能够围绕第一轴线自由旋转并且还能够围绕第二轴线自由旋转，其中所述第一轴线与所述第二轴线基本垂直。
(19)、一种用于与可植入的限制系统经皮通信的方法，包括：
将限制系统植入患者体内，其中所述限制系统包括：限制装置，其用于有效地在通路中形成限制；和天线，其用于有效地与外部装置进行通信以接收和发送能量和数据的至少一种；和
使所述天线相对于外壳的至少一部分运动，从而使所述天线能够与所述外部装置调准以便与其进行通信。
(20)、如第(19)项所述的方法，其中，所述天线能够响应于以下至少一种而以期望的方位与所述外部装置调准：手动操作、磁力、电磁力、重力和浮力。
附图说明
通过下结合附图的详细描述，本发明将会被更全面的理解，其中：
图1A是食物摄入限制系统的一种实施方式的示意图；
图1B是图1A的食物摄入限制系统的可植入部分的一种实施方式的透视图；
图2A是图1A的食物摄入限制装置的透视图；
图2B是围绕患者的胃食管结合部应用的图2A的食物摄入限制装置的示意图；
图3是图1A的注射端口外壳的一种实施方式的透视图；
图4是图1A的传感器外壳的一种实施方式的透视图；
图5示出了图1A的传感器外壳的一种实施方式；
图6是用于图5的传感器的变阻电路的实施方式的示意图；
图7是显示出图1A的食物摄入限制装置的内部和外部组成元件的实施方式的框图；
图8是可植入天线的视图，其中该可植入天线连接到万向元件，从而允许天线至少相对于第一和第二轴线自由运动；
图9是可植入天线的视图，其中该可植入天线连接到重物，从而允许天线响应于已知的重力采取已知的方位；
图10A是以可运动方式连接到基体的外壳的一种实施方式的剖视图；
图10B是以可运动方式连接到基体的外壳的一种替代实施方式的剖视图；
图10C是图10A的外壳的剖视图，其中外壳还包括磁元件。
具体实施方式
现在将描述一些示例性实施方式以提供对本文中公开的装置、系统和方法的结构、功能、制造以及用途的原理的全面理解。这些实施方式的一个或多个例子在附图中示出。本领域技术人员将会理解，在本文中具体描述并在附图中示出的装置和方法都是非限制性的示例性实施方式，本发明的范围仅仅由权利要求书来限定。结合一种示例性实施方式示出或描述的特征可与其他实施方式的特征组合。这种修改和变化也都包含在本发明的范围内。
此处提供了用于与可植入限制系统相通信的系统和方法。总的来说，可植入限制系统包括一些类型的内部天线，所述内部天线可被连接到可植入传感器或与可植入传感器相通信，该可植入传感器被构造成测量一个或多个工作参数(例如压力)和/或一个或多个生理参数。在使用中，该内部天线可以是能够与外部天线耦合以便允许可植入系统被供以功率、和/或能够在内部天线和外部天线之间发送和/或接收数据(例如压力读数)的任何类型的天线。
为便于这种耦合和/或通信，系统和天线可以被以多种方式构造，以便能够获得并保持正确调准。例如，天线可以被连接到外壳或者外壳的一部分，使得天线可以相对于外壳或外壳的该部分进行运动。在一种实施方式中，天线可被连接到万向元件，以便允许天线可以围绕至少第一轴线和第二轴线自由地摆动、运动和/或旋转，其中第一轴线与第二轴线彼此垂直。在其他实施方式中，天线可以被连接到和/或包括重物或加重的部分。在这样的实施方式中，天线位置的调准是已知的并可以通过使患者采取某一方位(例如站立)而容易地再现。在其他实施方式中，天线可以与至少一个磁元件相通信(例如耦合)，该磁元件被构造成与外部磁体调准，从而使该天线与外部天线或读取器调准。在另一种实施方式中，天线可被设置在可植入外壳上，该可植入外壳又以可运动的方式(例如通过球窝安装)安装到基底外壳，使得天线可以相对于基底外壳自由地运动，而基底外壳可被固定到解剖学位置(例如缝合到组织)。由此，目前公开的实施方式提供了用于方便地在可植入系统和外部读取器之间进行功率耦合和/或数据传输的可靠的系统和方法。
由于多种原因，提供可运动的天线能够方便与外部装置耦合。假定植入物的尺寸相对较小，由于耦合到介质(即身体组织、空气等)的天线的物理性质，任何这种天线通常都展示出低性能。如果设计正确，更长的天线可比更短的天线耦合得好，并且如果天线不是波长的大小相当的部分(sizable fraction of the wavelength)，该天线的操作会更像探头而不是天线，展示出低增益并且要求更高功率以用于传递和更多的接收器增益以进行补偿。本领域技术人员可以理解，天线必须占据波长的至少大约四分之一并且更理想为大约二分之一的空间以便以有效的方式运行。由于c＝fλ，其中c等于在给定介质中的电磁传播速率，f为频率，并且λ为波长，可以看出，在除了微波的频率处，在植入物中设计和波长的大小相当的部分的天线是不能实现的。如果(假定)有助于传递通过组织(大约13MHz)的通信频率处于工业、科学和医疗(“ISM”)无线频带的一个频带中，则1/4波长天线元件将是大约3.8米长。因此需要一定的折衷方案以便提供与可实现的植入物尺寸的植入物进行有效的传输耦合。因此如上所述，天线可被构造成整个植入装置(例如限制束带、连接管、端口等)的一部分，以便增大其相对尺寸并达到理想尺寸。此外，天线系统的极化会影响耦合，如果系统的元件没有被正确地调准会产生大约20dB的衰减。可以使用圆形极化的天线并且如果天线系统为最优尺寸则可最好地使用。因此，一个优点是在植入物中具有可运动的天线以便优化地耦合天线系统。
虽然本发明可被用于本领域已知的各种限制系统，但是图1A示出了在患者体内使用的食物摄入限制系统10的一种示例性实施方式。如图所示，系统10一般包括可植入部分10a和外部部分10b。图1B示出了位于患者体外的可植入部分10a。如图所示，可植入部分10a包括被构造成围绕患者的胃40的上部定位的可调节胃束带20和例如经过导管50与可调节胃束带20流体连接的注射端口30。注射端口30适于允许流体被引入到胃束带20中以及从胃束带20中除去，从而调节胃束带20的尺寸并由此调节施加到胃40上的压力。因此，注射端口30可被植入到体内可通过组织接触的位置中。典型地，注射端口被定位在患者腹部的皮肤和脂肪组织层下的横向肋下的区域中。医生还典型地将注射端口植入到患者胸骨上。
内部部分10a还可包括与可植入部分10a中的封闭流体流路流体连通的感测或测量装置。在一种实施方式中，感测装置为被构造成测量封闭流体流路的流体压力的压力感测装置。虽然压力感测装置可具有各种构造并可被定位在沿着内部部分10a的任何地方，包括定位在注射端口30中，如在下面进一步描述的那样，在图示的实施方式中压力测量装置为压力传感器的形式，该压力传感器被设置在与注射端口30相邻定位的传感器外壳60中。导管50可包括连接在胃束带20与压力传感器外壳60之间的第一部分和连接在压力传感器外壳60与注射端口30之间的第二部分。虽然能够理解，感测装置可被构造成获得与一个或多个相关参数有关的数据，但是总体上其可在本文中被描述为压力感测装置。
如同在图1A中进一步显示的那样，外部部分10b一般包括数据读取装置70，该数据读取装置70被构造成定位在压力传感器外壳60(其可植入厚的组织下面，例如超过10cm厚)上方的皮肤表面上，以便以非侵入方式与压力传感器外壳60通信(如下详细描述)并由此获得压力测量结果。数据读取装置70可任选地与控制箱90(以无线方式或者有线方式，如在该实施方式中经过电缆组件80)电耦合，该控制箱90可显示压力测量结果、得自数据读取装置70的其他数据、和/或数据警报。虽然在该例子中控制箱90显示为相对于患者处于本地，但控制箱90可相对于患者处于本地或者远程位置处。
图2A更详细地显示了胃束带20。虽然胃束带20可具有各种构造，并且本领域目前已知的各种胃束带都可被用于本发明，但是在图示的实施方式中胃束带20具有大致细长的形状，并带有具有相对的第一端部20a和第二端部20b的支撑结构22，该支撑结构22可形成为一个环，使端部彼此可靠连接。各种配合技术可被用于将端部20a、20b彼此可靠连接起来。在图示的实施方式中，端部20a、20b为配合在一起的带子的形式，并且一个叠置于另一个顶部上。在图示的另一种实施方式中，例如在图1B和2B中，在胃束带20的一端上的支撑结构可包括开口，胃束带20的另一个端部可穿过该开口，从而将两个端部彼此可靠连接。胃束带20还可包括可变容积元件，诸如可膨胀囊24，该可变容积元件设置在支撑结构22一侧上或在支撑结构22一侧上形成，并被构造成与组织邻近定位。囊24可抵靠胃的外壁膨胀或者收缩，从而形成可调节的人造口，以便可控制地限制食物摄入到胃中。
本领域技术人员将会理解，胃束带可具有各种其他构造。此外，在本文中公开的各种方法和装置都可等同应用于其他类型的可植入束带。例如，束带可被用于治疗大便失禁，如同在美国专利No.6461292中描述的那样，该文献的内容通过引用而包含在本申请中。束带还可被用于治疗小便失禁，如同在美国专利公开No.2003/0105385中描述的那样，该文献的内容通过引用而包含在本申请中。束带还可被用于治疗胃灼热和/或返酸，如同在美国专利No.6470892中公开的那样，该文献的内容通过引用而包含在本申请中。束带还可被用于治疗阳痿，如同在美国专利公开No.2003/0114729中描述的那样，该文献的内容通过引用而包含在本申请中。
图2B显示了围绕患者的胃食管结合部应用的可调节胃束带20。如图所示，胃束带20至少大体上围绕胃40的靠近与患者食管42的结合部的上部。优选以胃束带20中含有少量或者不含流体的紧缩构将胃束带20植入后，胃束带20可例如使用生理盐水被膨胀，以缩小人造口开口的尺寸。本领域技术人员将会理解，多种技术，包括机械技术和电技术，都可被用于调节胃束带20。图2B还示出了感测装置41的替代位置，该感测装置41设置在胃束带20的带扣43中。
流体注射端口30也可具有各种构造。在图3中显示的实施方式中，注射端口30具有大致圆柱形外壳，该圆柱形外壳具有远侧面或底面以及从底面向近侧延伸并限定了近侧开口32的周壁。近侧开口32可包括延伸穿过该开口并提供了在外壳中形成的流体容器(在图3中不可见)的入口的针穿刺隔膜34。隔膜34优选设置在足够近侧的位置，使容器的深度足以暴露于针(诸如休伯针)的开口尖端，使流体输送可发生。隔膜34优选被设置成使其在被针穿刺并且针退出后自密封。如图3中进一步显示的那样，注射端口30还可包括导管连接件36，该导管连接件36与容器流体连通并被构造成与导管(例如导管50)联接。本领域技术人员将会理解，外壳可由任意数目的材料制成，包括不锈钢、钛或者聚合物材料，并且隔膜34同样可由任意数目的材料制成，包括硅树脂。
读取装置70还可具有各种构造，一种示例性的压力读取装置在共同拥有的美国专利公开No.2006/0189888和No.2006/0199997中更详细地公开，该文献的内容通过引用而包含于本申请中。一般说来，读取装置70可以非侵入方式测量被植入部分10a中的流体压力，即便在压力感测装置被植入到厚(至少超过10cm)的皮下脂肪组织之下时也是如此。医生可抵靠传感器外壳60的位置和/或其他压力感测装置的位置附近的患者皮肤保持读取装置70，获取所感测的压力数据和此处讨论的可能的其他信息，并观察控制箱90上的显示器上的压力读数(和/或其他数据)。数据读取装置70还可以使用带子、粘合剂和其他公知方法可拆卸地连接到患者(将在下面进一步讨论)，诸如在延长的检查过程中。数据读取装置70可通过传统的布质或纸质手术单操作，并且还可以包括对于每个患者可更换的一次性的罩(未显示)。
如上所述，系统10还可包括用于监测胃限制系统10的工作的一个或多个传感器。所述传感器可被构造用于测量系统10的多种工作参数，包括但不限于：系统中的压力、系统中的温度、蠕动脉冲事件或频率、蠕动脉冲宽度、蠕动脉冲持续时间、和蠕动脉冲幅值。在一种示例性实施方式中，系统可包括压力测量装置形式的传感器，该传感器与封闭流体流路连通并被构造成测量系统内的流体压力，该流体压力对应于由可调节胃束带施加到患者的胃上的限制大小。在使用中，测量流体压力或系统的任何其他控制参数使医生能够评估限制系统的性能。如图4中所示，在图示的实施方式中，压力测量装置为设置在传感器外壳60中的压力传感器62的形式。但是，压力测量装置可设置在可植入部分的封闭液压回路中的任何地方，并且各种示例性位置和构造在共同拥有的美国专利公开No.2006/0211913中更详细地公开，该文献于2006年3月7日提交、题为“Non-Invasive Pressure Measurement In A Fluid AdjustableRestrictive Device”，该文献通过引用而包含在本申请中。一般说来，图示的传感器外壳60包括与可植入部分10a中的流体流体连通的进口60a和出口60b。已经植入的导管50可被改进用于传感器外壳60，诸如通过切割导管50并将带倒刺的连接器(或者任何其他连接器，诸如夹钳、夹片、粘合剂、焊接等)插入到导管50的被切割的端部。传感器62可设置在外壳60中并被构造成响应于液压回路中的流体压力变化并将压力变化转化成数据的可使用形式。
本领域已知的各种压力传感器均可被用作压力传感器62，例如由美国乔治亚州亚特兰大的CardioMEMS公司提供的无线压力传感器，但合适的微机电系统(“MEMS”)压力传感器也可得自任何其他来源，包括但不限于：美国密歇根州伊普西兰蒂的IntegratedSensing Systems公司(ISSYS)和美国马萨诸塞州沃尔瑟姆的RemonMedical Technologies公司。一种示例性的MEMS压力传感器在美国专利No.6855115中描述，该文献的内容通过引用而包含在本申请中，仅用于说明的目的。本领域技术人员还能理解，合适的压力传感器可包括但不限于电容传感器、压敏电阻传感器、硅应变仪传感器或者超声(声学)压力传感器，以及能够测量压力的各种其他装置。
具有设置在其中的传感器62的传感器外壳60的构造的一种实施方式在图5中显示。在该实施例中传感器外壳60包括母板，母板可用作气密容器以防止流体与设置在传感器外壳60中除讨论的用于传感器62的那些之外的任何元件接触。传感器外壳60可由适于在体内使用的任何生物相容性材料制成，诸如聚合物、生物相容性金属以及其他相似类型的材料。此外，传感器外壳60可由任何一种或多种透明(如图5所示)、不透明、半透明和不透射线的材料制成。除其他元件以外还包括微控制器65(例如处理器)的电路板64还可设置在外壳60中，以帮助处理并传递由传感器62收集的压力测量结果以及与胃束带20有关的其他可能数据。如同在下面进一步讨论的那样，电路板64还可包括经皮能量传递(TET)/遥测线圈和电容器。任选地，温度传感器可被集成到电路板64中。微控制器65、TET/遥测线圈、电容器和/或温度传感器可经电路板64或者经任何其他合适的元件通信。如上所述，TET/遥测线圈和电容器可一起形成用于从外部部分10b接收功率并将压力测量结果传递到压力读取装置例如读取装置70的调谐振荡电路。此外，如果没有一些辅助手段，与压力传感器62相关联的遥测元件不能到达置于患者体外的遥测装置，所述辅助手段可通过任何合适数目的中继器(未显示)或其他装置来提供。
在使用中，流体可通过定位在外壳表面(这里指其底面)上的任何位置的开口66进入传感器外壳60并与传感器62的压力感测表面68接触。传感器62典型地相对于母板密封，使进入开口66的流体不能渗透并影响传感器62在压力感测表面68之外的操作。当流体流进和流出开口66时，传感器62可测量与压力感测表面68接触的流体的压力。例如，压力感测表面68可包括具有可变形表面的隔膜，使得当流体流过开口66时，流体冲击隔膜的表面，引起所述表面机械位移。隔膜的机械位移可通过包括一对可变电阻、硅应变仪的可变电阻电路转化成电子信号。一个应变仪可与隔膜的中央部分连接以测量隔膜的位移，而匹配的第二应变仪可连接在隔膜的外边缘附近。应变仪可使用粘合剂与隔膜连接或者可融合(diffuse)到隔膜结构中。当胃束带20中的流体压力波动时，隔膜的表面可上下变形，从而在应变仪的中央部分中产生阻抗变化。
用于传感器62的可变电阻电路的一种实施方式在图6中显示。所述电路包括第一应变仪96和第二应变仪98，它们形成半补偿惠斯通电桥电路100的两个顶部电阻元件。当第一应变仪96反应于传感器的隔膜的机械位移时，第一应变仪96的变化阻抗改变了通过电桥电路100的顶部的电势。第二应变仪98与第一应变仪96匹配并使惠斯通电桥电路100隔热(athermalize)。第一差分放大器102和第二差分放大器104与电桥电路100连接以测量由于可变电阻应变仪96、98而引起的电桥电路100中电势的变化。特别是，第一差分放大器102测量通过整个电桥电路100的电压，而第二差分放大器104测量通过电桥电路100的应变仪一半的差分电压。对于通过电桥的固定电压而言，应变仪电压之间的差越大，压差越大。来自差分放大器102、104的输出信号可被应用于集成到电路板64中的微控制器65，并且微控制器65可将测量的压力数据传递到置于患者体外的装置。如果需要，也可使用全补偿惠斯通电桥电路以增加压力传感器62的灵敏性和精确性。在全补偿电桥电路中，四个应变仪而不是仅仅两个应变仪与隔膜的表面连接。
图7示出了包括在内部部分10a和外部部分10b中的组成元件的一种实施方式。如图7中所示，外部部分10b包括用于将功率信号传递到内部部分10a的初级TET线圈130。遥测线圈144也被包括用于将数据信号传递到内部部分10a。初级TET线圈130和遥测线圈144组合形成外部天线，例如读取装置70。例如设置在控制箱90中的外部部分10b包括用于控制应用到初级TET线圈130的功率的TET驱动电路134。TET驱动电路134由具有相关存储器138的微处理器136控制。图形用户界面140与微处理器136连接以便输入患者信息、显示数据和医生指令、和/或打印数据和医生指令。通过用户界面140，用户诸如患者或者临床医生可将调节要求传递给医生并且还传递该要求的提出原因。另外，用户界面140可使患者能够读取并响应来自医生的指令和/或压力测量结果警报。
外部部分10b还包括初级遥测收发器142，用于将询问指令传递到植入的微控制器65并从微控制器65接收响应数据包括感测的压力数据。初级收发器142与微处理器136电连接以便输入并接收指令和数据信号。初级收发器142驱动遥测线圈144，从而以选定的RF通信频率谐振。谐振电路可生成将指令数据传输到微控制器65的下行交变磁场146。作为替代，收发器142可接收来自内部部分10a中的次级TET/遥测线圈56(“内部天线”)传递的遥测信号。接收的数据可被存储在与微处理器136相关联的存储器138中。功率源150可为控制箱90提供能量以便为内部部分10a中的元件提供功率。环境压力传感器152与微处理器136连接。微处理器136可使用来自环境压力传感器152的信号以便对于大气压环境下的变化(例如由于气压条件或者高度的变化)调节接收的压力测量结果，以便增加压力测量结果的精确性。
图7还示出了内部部分10a的元件，在该实施方式中这些元件被包括在传感器外壳60中(例如在电路板64上)。如图7中所示，次级TET/遥测线圈156接收来自外部天线的功率/通信信号。次级线圈156形成调谐振荡电路，其与初级TET线圈130感应耦合，为植入物或者初级遥测线圈144提供功率以接收和传递数据。遥测收发器158控制与次级线圈156的数据交换。另外，内部部分10a包括整流器/功率调节器160、微控制器65、与微控制器65相关联的存储器162、温度传感器112、压力传感器62和信号调节电路164。植入的元件可将压力测量结果(由于温度等而带有或不带有调节部分)从传感器62经外部天线(初级TET线圈130和遥测线圈144)输送到控制箱90。压力测量结果可被存储在存储器138中并被相对于环境压力进行调节、在控制箱90的显示器上显示和/或可能实时传递到患者的远程位置处的远程监测站。
如上所述，本发明的系统可以各种方式构造，以便允许通过外部读取器为该可植入系统提供功率和/或与外部读取器通信。在示例性的实施方式中，系统可包括可植入天线156，该可植入天线156被构造成响应于某些力而容易地并且可预期地与某些外部参考点(例如外部读取器70)调准。例如，天线156可被构造成响应于施加到与天线156通信的磁构件上的磁力或电磁力而与外部读取器70调准。而且，天线156可被构造成响应于施加到天线156的重力而与外部读取器70调准。例如，天线156可被构造成在患者采取某一姿势(例如站立)时采取已知的方位。简言之，本发明的系统可包括用于使可植入天线156与外部读取器70或某些其他外部参考点容易地并且可靠地调准的任何机构和/或构造。
图8提供了具有可植入天线156的系统的一种示例性实施方式，该可植入天线156能够容易地并且可预期地与外部装置或外部参考点调准。如同本领域技术人员将会理解的那样，可植入天线156可以是能够与外部初级TET线圈130耦合、和/或将数据发送到外部遥测线圈144和从外部遥测线圈144接收数据的任何类型、形状和/或尺寸的天线。例如，如图8所示，天线156为大致环形。如进一步示出的，在该实施方式中，天线156被设置在系统内，使天线156与患者的任何运动无关地自由运动和/或旋转。尽管可以各种方式提供这种自由运动，但是在示例性实施方式中天线156被连接到万向元件200，该万向元件200能够允许天线156与患者的运动无关地自由运动和/或浮动。更具体地说，万向元件200可包括具有第一直径的外环202，其中，外环202的某些部分(例如基底部分B)可被固定到例如传感器外壳60。外环202用作外壳并可具有以可转动的方式连接到该外环202的内环204，该内环204具有第二直径。如图所示，内环204的直径可以小于外环202的直径。因此，内环204在第一接合点202a和第二接合点202b连接到外环202，使内环204可沿着在这些接合点202a和202b之间延伸的轴线旋转。此外，天线156可类似地在第一接合点204a和第二接合点204b连接在内环204内，使天线156可沿着在这些接合点204a和204b之间延伸的第二轴线旋转。因此，在这样一种实施方式中，天线156可围绕在第一组接合点202a和202b之间延伸的第一轴线自由旋转，并且可相对于在第二组接合点204a和204b之间延伸的第二轴线自由旋转，其中第一轴线与第二轴线基本垂直。本领域技术人员可以理解，可使用各种其他万向元件或类万向元件，以便提供各种附加或替代的旋转轴线。
在图8的实施方式中，可以多种方式相对于内环204和外环202操作天线156。例如，天线156可以被成形有、构造有和/或具有一定重物，以便相对于外部装置或参考点将天线156偏压到一定位置或方位。例如，天线可以被制造成始终被定向在期望位置(例如水平的或者如图8中的竖直的位置)，而与患者的运动或姿势无关。在其他实施方式中，天线156可以被制造成当患者处于某一姿势(例如站立)时被定向在特定方向(例如水平或者竖直的)。在另外的实施方式中，天线156可与至少一个磁元件相通信(例如耦合)。由此，当磁力或电磁力被施加到天线156时，天线156可围绕第一和/或第二轴线旋转，以便使天线156与期望的外部装置(例如外部读取器70)调准。又一种实施方式是将天线组件包围在流体填充的室内并使天线组件的一个元件的至少一部分比该组件的其他部分包括更具浮力的材料。在这种构造中，天线可围绕第一和/或第二轴线旋转，以便使天线与期望的外部装置调准。本领域技术人员将会理解或意识到用于使天线沿着第一轴线和/或第二轴线旋转以便使天线相对于期望的外部参考点定向的各种其他方式和/或机构。
在其他实施方式中，可植入天线可被构造成响应于重力而采取已知的方位。例如，在这样一种实施方式中，根据患者的定向或者姿态(例如仰卧、竖立等)以可预期的方式操纵天线156的方位。如本领域技术人员将会理解的那样，天线156可被以各种方式构造以便响应于这样的重力而与外部参考点以可预期的方式调准。例如，如图9的示例性实施方式中所显示的，天线156(再次显示为环形的天线)可被设置在大致圆形的外壳60内，该外壳60设置在例如导管50(图1A、图1B)中，使得天线悬浮在经过系统的流体中。在这样一种实施方式中，传感器和/或内部电子器件的各种组成元件可被包围并且密封在封闭容器67中以防止与流过的流体接触。此外，天线156(其可卷绕在浮动支撑环69周围)可被(例如通过任何数量的柱212)连接到重物210。本领域技术人员将会理解，可选择并优化重物210的形状、尺寸、特性等以提供期望的调准。在该示例性实施方式中，重物210可以被定位(例如悬挂)在天线156的下方并且基本上沿着延伸穿过天线156的中心的中心线，从而允许重力跨过天线156均匀地分布。因此，在该例子中，当患者处于站立姿势时，天线156可以被定向在大致面向上的方向(即水平的，如图9所示)，从而提供可预期的并且容易再现的结果。在其他实施方式中，天线156可被安装在电路板64的周边上或沿着该周边(图1A、图1B和图5)，使得电路板64的加重侧始终指向向下的方向。如本领域技术人员将会理解的那样，几乎任何类型或构造的重物可被以几乎任何方式连接到几乎任何类型或构造的天线，以便使天线在经受已知的重力场时自己以预期的方式调准。此外，天线的几何形状可以是使天线在一个位置更重，由此用作重物。
在另一种实施方式中，天线156可以已知的方位设置在外壳60内或相对于外壳60设置(即固定安装到外壳60上)，该外壳60可以可枢转的方式安装在基底外壳中，该基底外壳被构造成固定在期望的解剖学位置。因此，在植入之后，外壳60(并且因此天线156)可被相对于基底外壳容易地进行操作，以便使天线156与已知的外部参考点(例如外部读取器70)调准。本领域技术人员将会理解，外壳60可以各种方式配合到基底外壳，以便提供这种枢转运动。例如，如图10A所示，外壳60可包括远侧面或底面60D。而且，外壳60可以可枢转的方式连接到基底外壳220，该基底外壳220具有被构造成连接到外壳60的近侧面220P和被构造成置于和/或锚固于期望的解剖学位置(例如筋膜)上的远侧面220D。基底外壳220的远侧面220D可以各种方式锚固到组织。例如，基底外壳220可包括被构造成接收缝线以便将基底外壳220锚固到组织的一个或多个缝线接收构件(未显示)，和/或基底外壳220可包括被构造成放置到组织中的一个或多个锚固件(未显示)。本领域技术人员将会理解，任何技术都可被用于将基底外壳220锚固到组织中。
为了方便重定向内部天线，外壳60的远侧面60D和基底外壳220的近侧面220P可被构造成可彼此相对运动。在一种示例性实施方式中，外壳60的远侧面60D和基底外壳220的近侧面220P可被构造成可例如使用球窝结构彼此相对运动。在一种实施方式中，如图10A所示，外壳60的远侧面60D可以是凸形的并且被构造成被接收在基底外壳220的相应的凹形近侧面220P中。这允许外壳60相对于基底外壳220运动，以便在基底外壳220定位在和/或锚固在组织中时重定向外壳60。在另一种实施方式中，如图10B所示，外壳60’的远侧面60’D可包括凹腔并且被构造成接收基底外壳220’的在近侧面220’P上形成的相应凸面。本领域技术人员将会理解，只要外壳60和基底外壳220可彼此相对运动以便允许重定向天线，可使用外壳60和基底外壳220的任何构型。
在另一种实施方式中，如图10C所示，内部天线156和/或外壳60可包括与之相连接的磁元件230，以方便天线156的重定向。磁元件230可具有各种构造并且可使用多个磁元件。在一个例子中，磁元件230为带有通孔的圆柱形磁体的形式。本领域技术人员将会理解，磁体230可以本领域已知的任何方式与外壳60一起设置和/或连接到外壳60。例如，磁体230(或多个磁元件)可被连接到外壳60的外部、连接到外壳60的内部、形成于外壳60内等。在使用中，如图10C所示，磁体230可与外部磁体或外部电磁体232结合使用，外部磁体或外部电磁体232放置在皮肤表面231上。该外部磁体232可用于将力施加到连接到外壳60的磁元件230，以便将外部磁体232与磁元件230调准。这可使外壳60相对于基底外壳220枢转，由此重定向外壳60，使得内部天线朝着皮肤表面231定向。
此外，本发明提供了用于与可植入限制系统经皮通信的方法的多种实施方式。总体而言，本发明的实施方式允许用户以容易并且可预期的方式使可植入天线与外部装置(例如外部天线或读取器)调准。一旦正确调准，可植入天线可容易地与外部天线通信，由此允许可植入系统被供以功率，和/或将各种系统和/或生理参数(例如压力读数)从可植入天线发送到/接收于一些外部天线或读取器。
更具体地说，在一种示例性实施方式中，所述方法包括将限制系统植入患者体内，其中所述系统包括：限制装置，用于有效地在通路中形成限制；和天线，用于有效地与外部装置进行通信以接收和发送能量和数据的至少一种。该方法还可包括：使天线相对于外壳的至少一部分运动，从而使天线与外部装置调准以便进行通信。如上所述，可以使用各种方式或机构以运动和/或操纵可植入天线。例如，天线可响应于以下至少一种而以期望的方位与外部装置调准：手动操作、磁力、电磁力、和重力。
这里所公开的装置可以是一次性使用的，也可以设计成多次使用。然而，在任何一种情况下，在至少一次使用之后，该装置可被修复以重新使用。修复可包括装置的拆卸、接着清洗或更换特定部件和随后的重新组装这些步骤的任意组合。特别地，该装置可以被拆卸，任何数量的特定部件或零件可以有选择地以任意组合被更换或除去。在清洗和/或替换特定部件之后，该装置可在修复设备中或在即将进行手术程序之前由手术队进行重新组装以便以后使用。本领域技术人员将会理解对该装置的修复可利用用于拆卸、清洗/替换、和重新组装的各种技术。这些技术的使用以及产生的修复好的装置也全都在本申请的保护范围内。
在上述实施方式的基础上本领域技术人员将会理解本发明的进一步的特征和优选。因此，除非由权利要求书特别指明，本发明不由特别显示和描述的那些内容来限定。在本文中引证的所有出版物和参考文献通过全文引用而明确包含在本申请中。

Claims (10)

1、一种可植入的限制系统，包括：
能够在通路中形成限制的可植入的限制装置；
可植入的外壳；和
可植入的天线，该可植入的天线以可运动的方式连接到所述外壳，使得所述天线能够与外部装置调准以便与所述外部装置通信。
2、如权利要求1所述的系统，还包括连接到所述天线的至少一个磁元件。
3、如权利要求2所述的系统，其中，所述至少一个磁元件被构造成与外部磁构件调准。
4、如权利要求1所述的系统，其中，所述天线能够响应于如下的至少一种而运动：手动操作、磁力、电磁力、重力、和浮力。
5、如权利要求1所述的系统，还包括可植入的传感器，该传感器被构造成测量系统参数的工作值和生理参数的值的至少一个，其中所述天线能够有效地将所述工作值或者生理值与所述外部装置通信。
6、如权利要求5所述的系统，其中，所述天线被设置在传感器外壳上，该传感器外壳以可运动的方式安装到能够接合解剖学位置的基底外壳。
7、如权利要求6所述的系统，其中，所述天线以固定方式安装在所述传感器外壳上。
8、如权利要求6所述的系统，其中，所述传感器外壳以可运动的方式通过球窝接头安装到所述基底外壳上。
9、如权利要求1所述的系统，其中，所述外壳是万向元件的至少一部分，使得所述天线能够围绕第一轴线自由旋转并且还能够围绕第二轴线自由旋转，其中所述第一轴线与所述第二轴线基本垂直。
10、如权利要求1所述的系统，其中，所述天线被连接到有效地用于通过重力将天线调准在期望方位的重物。
CN200910126642.5A 2008-03-06 2009-03-05 调准可植入天线的系统和方法 Expired - Fee Related CN101524299B (zh)

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