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    Alumina insulation for coating implantable components and other microminiature devices
    1.
    发明授权
    Alumina insulation for coating implantable components and other microminiature devices 有权
    用于涂层可植入组件和其他微型设备的氧化铝绝缘

    公开(公告)号：US07235350B2

    公开(公告)日：2007-06-26

    申请号：US10969758

    申请日：2004-10-20

    申请人： Joseph H. Schulman ,  Joseph Y. Lucisano ,  Rajiv Shah ,  Charles L. Byers ,  Shaun M. Pendo

    发明人： Joseph H. Schulman ,  Joseph Y. Lucisano ,  Rajiv Shah ,  Charles L. Byers ,  Shaun M. Pendo

    IPC分类号： B32B3/00 ,  B32B18/00

    CPC分类号： G03F7/70641 ,  A61N1/02 ,  A61N1/375 ,  C23C14/042 ,  H01L21/308 ,  H01L23/291 ,  H01L2924/0002 ,  H05K3/284 ,  Y10T29/49144 ,  Y10T428/24802 ,  Y10T428/24917 ,  Y10T428/24926 ,  Y10T428/265 ,  H01L2924/00

    摘要： A protective, biocompatible coating or encapsulation material protects and insulates a component or device intended to be implanted in living tissue. The coating or encapsulation material comprises a thin layer or layers of alumina, zirconia or other ceramic, less than 25 microns thick, e.g., 5-10 microns thick. The alumina layer(s) may be applied at a relatively low temperature. Once applied, the layer provides excellent hermeticity, and prevents electrical leakage. Even though very thin, the alumina layer retains excellent insulating characteristics. In one embodiment, an alumina layer less than about 6 microns thick provides an insulative coating that exhibits less than 10 pA of leakage current over an area 75 mils by 25 mils area while soaking in a saline solution at temperatures up to 80° C. over a three month period.

    摘要翻译： 保护性的，生物相容的涂层或包封材料保护和绝缘想要植入生物体组织的组件或装置。 涂层或包封材料包括厚度小于25微米，例如5-10微米厚的氧化铝，氧化锆或其它陶瓷的薄层或多层。 氧化铝层可以在相对较低的温度下施加。 一旦施加，该层提供优异的气密性，并防止漏电。 即使非常薄，氧化铝层保持优异的绝缘特性。 在一个实施方案中，小于约6微米厚的氧化铝层提供了一种绝缘涂层，其在75密耳25密耳面积的面积上表现出低于10pA的漏电流，同时在高达80℃的温度下浸入盐水溶液中 一个三个月的时间。

    Implantable enzyme-based monitoring systems adapted for long term use
    2.
    发明授权
    Implantable enzyme-based monitoring systems adapted for long term use 有权
    适用于长期使用的基于植入式酶的监测系统

    公开(公告)号：US06512939B1

    公开(公告)日：2003-01-28

    申请号：US09604179

    申请日：2000-06-27

    申请人： Michael S. Colvin ,  Joseph H. Schulman ,  Lyle Dean Canfield ,  Rajiv Shah

    发明人： Michael S. Colvin ,  Joseph H. Schulman ,  Lyle Dean Canfield ,  Rajiv Shah

    IPC分类号： A61B505

    CPC分类号： A61B5/14865 ,  A61B5/0031

    摘要： Improved implantable monitoring systems suitable for long-term in vivo use to measure the concentration of one or more prescribed substances, such as glucose, are described herein. In particular, an implantable enzyme-based glucose monitoring system is described that includes at least one of the following: means for replenishing the enzyme solution as it is consumed by the enzymatic reaction; means for replenishing the electrolyte solution bathing the electrode assembly; and microprocessing means proximal the electrode assembly. In preferred embodiments, a microprocessor assembly is hermetically associated with the substrate to which the electrode assembly is affixed. Further, the monitoring systems employ one or more reservoir systems in fluid communication with enzyme and electrolyte chambers wherein the enzyme and electrolyte solutions are used. In a further embodiment, the monitoring systems use enzyme and electrolyte reservoir bulbs in fluid communication with the enzyme and electrolyte reservoirs, respectively, and positioned near the skin surface, thereby providing ready access to the enzyme and electrolyte solutions without the need for explantation of the device. Further provided herein is an enzyme solution comprising microspheres in association with the enzyme; whereby the enzyme is immobilized by the microspheres and the microspheres are in a fluid, flowable solution. Also provided herein is a method of extending the useful life of an implantable enzyme-based monitoring system, which method comprises providing means, within the system, to replenish the enzyme and/or electrolyte solution.

    摘要翻译： 本文描述了适于长期体内使用的改进的可植入监测系统，以测量一种或多种规定物质如葡萄糖的浓度。 特别地，描述了可植入酶的葡萄糖监测系统，其包括以下至少一个：用于在酶反应消耗的时候补充酶溶液的装置; 用于补充洗涤电极组件的电解液的装置; 并且微处理装置近似于电极组件。 在优选实施例中，微处理器组件与固定电极组件的基板气密地相关联。 此外，监测系统采用与酶和电解质室流体连通的一个或多个储存器系统，其中使用酶和电解质溶液。 在另一个实施方案中，监测系统使用分别与酶和电解质储存器流体连通并且定位在皮肤表面附近的酶和电解质储存器灯泡，从而提供对酶和电解质溶液的准备进入，而不需要移除 设备。 本文进一步提供了包含与酶结合的微球的酶溶液; 由此通过微球固定酶，并且微球体处于流动的可流动溶液中。 本文还提供了延长可植入酶的监测系统的使用寿命的方法，该方法包括在系统内提供补充酶和/或电解质溶液的装置。

    Electrochemical sensor and integrity tests therefor
    3.
    发明授权
    Electrochemical sensor and integrity tests therefor 失效
    电化学传感器及其完整性测试

    公开(公告)号：US6088608A

    公开(公告)日：2000-07-11

    申请号：US954171

    申请日：1997-10-20

    申请人： Joseph H. Schulman ,  Rajiv Shah

    发明人： Joseph H. Schulman ,  Rajiv Shah

    IPC分类号： A61B5/00 ,  A61B5/05

    CPC分类号： A61B5/14532

    摘要： An electrochemical sensor includes electronic circuitry for automatically performing on a periodic basis, e.g., every 1 to 24 hours, specified integrity tests which verify proper operation of the sensor.

    摘要翻译： 电化学传感器包括用于自动执行例如每隔1至24小时的指定的完整性测试的电子电路，用于验证传感器的正确操作。

    Implantable substrate sensor with back-to-back electrodes
    5.
    发明授权
    Implantable substrate sensor with back-to-back electrodes 有权
    具有背对背电极的可植入衬底传感器

    公开(公告)号：US07555328B2

    公开(公告)日：2009-06-30

    申请号：US11392163

    申请日：2006-03-29

    申请人： Joseph H. Schulman ,  Charles L. Byers ,  John C. Gord ,  Rajiv Shah ,  Lyle Dean Canfield

    发明人： Joseph H. Schulman ,  Charles L. Byers ,  John C. Gord ,  Rajiv Shah ,  Lyle Dean Canfield

    IPC分类号： A61B5/145

    CPC分类号： A61N1/36585 ,  A61B5/0031 ,  A61B5/14532 ,  A61B5/14546 ,  A61B5/14865 ,  A61B5/4839 ,  A61B2560/0219 ,  A61M5/1723 ,  A61N1/05 ,  A61N1/372 ,  A61N1/3754 ,  H01L23/3107 ,  H01L29/0657 ,  H01L2924/0002 ,  H01L2924/19041 ,  H01L2924/00

    摘要： An implantable substrate sensor has electronic circuitry and electrodes formed on opposite sides of a substrate. A protective coating covers the substrate, effectively hermetically sealing the electronic circuitry under the coating. Exposed areas of the electrodes are selectively left uncovered by the protective coating, thereby allowing such electrodes to be exposed to body tissue and fluids when the sensor is implanted in living tissue. The substrate on which the electronic circuitry and electrodes are formed is the same substrate or “chip” on which an integrated circuit (IC) is formed, which integrated circuit contains the desired electronic circuitry. Such approach eliminates the need for an hermetically sealed lid or cover to cover hybrid electronic circuitry, and allows the sensor to be made much thinner than would otherwise be possible. In one embodiment, two such substrate sensor may be placed back-to-back, with the electrodes facing outward. As required, capacitors that form part of the sensor's electronic circuits are formed on the substrate by placing metalization layers and a dielectric in vacant areas of the substrate surface.

    摘要翻译： 可植入衬底传感器具有形成在衬底的相对侧上的电子电路和电极。 保护涂层覆盖基材，有效地气密地密封涂层下的电子电路。 电极的暴露区域选择性地被保护涂层覆盖，从而当传感器植入生物体组织时允许这样的电极暴露于身体组织和流体。 其上形成有电子电路和电极的基板是与其上形成有集成电路（IC）的相同的基板或“芯片”，该集成电路包含所需的电子电路。 这种方法消除了密封的盖或盖以覆盖混合电子电路的需要，并且允许传感器制造得比其他可能的薄得多。 在一个实施例中，两个这样的衬底传感器可以背靠背放置，电极面向外。 根据需要，通过将金属化层和电介质放置在基板表面的空的区域中，形成在传感器的电子电路的一部分的电容器。

    Substrate sensor
    8.
    发明授权
    Substrate sensor 有权
    基板传感器

    公开(公告)号：US06498043B1

    公开(公告)日：2002-12-24

    申请号：US09718782

    申请日：2000-11-22

    申请人： Joseph H. Schulman ,  Charles L. Byers ,  John C. Gord ,  Rajiv Shah ,  Lyle Dean Canfield

    发明人： Joseph H. Schulman ,  Charles L. Byers ,  John C. Gord ,  Rajiv Shah ,  Lyle Dean Canfield

    IPC分类号： H01L2100

    CPC分类号： A61N1/36585 ,  A61B5/0031 ,  A61B5/14532 ,  A61B5/14546 ,  A61B5/14865 ,  A61B5/4839 ,  A61B2560/0219 ,  A61M5/1723 ,  A61N1/05 ,  A61N1/372 ,  A61N1/3754 ,  H01L23/3107 ,  H01L29/0657 ,  H01L2924/0002 ,  H01L2924/19041 ,  H01L2924/00

    摘要： An implantable substrate sensor has electronic circuitry and electrodes formed on opposite sides of a substrate. A protective coating covers the substrate, effectively hermetically sealing the electronic circuitry under the coating. Exposed areas of the electrodes are selectively left uncovered by the protective coating, thereby allowing such electrodes to be exposed to body tissue and fluids when the sensor is implanted in living tissue. The substrate on which the electronic circuitry and electrodes are formed is the same substrate or “chip” on which an integrated circuit (IC) is formed, which integrated circuit contains the desired electronic circuitry. Such approach eliminates the need for an hermetically sealed lid or cover to cover hybrid electronic circuitry, and allows the sensor to be made much thinner than would otherwise be possible. In one embodiment, two such substrate sensors may be placed back-to-back, with the electrodes facing outward. As required, capacitors that form part of the sensor's electronic circuits are formed on the substrate by placing metalization layers and a dielectric in vacant areas of the substrate surface.

    摘要翻译： 可植入衬底传感器具有形成在衬底的相对侧上的电子电路和电极。 保护涂层覆盖基材，有效地气密地密封涂层下的电子电路。 电极的暴露区域选择性地被保护涂层覆盖，从而当传感器植入生物体组织时允许这样的电极暴露于身体组织和流体。 其上形成有电子电路和电极的基板是形成有集成电路（IC）的相同的基板或“芯片”，该集成电路包含所需的电子电路。 这种方法消除了密封的盖或盖以覆盖混合电子电路的需要，并且允许传感器制造得比其他可能的薄得多。 在一个实施例中，两个这样的衬底传感器可以背对背放置，电极面向外。 根据需要，通过将金属化层和电介质放置在基板表面的空的区域中，形成在传感器的电子电路的一部分的电容器。

    Implantable substrate sensor
    9.
    发明授权
    Implantable substrate sensor 失效
    可植入基片传感器

    公开(公告)号：US06259937B1

    公开(公告)日：2001-07-10

    申请号：US09100310

    申请日：1998-06-19

    申请人： Joseph H. Schulman ,  Charles L. Byers ,  John C. Gord ,  Rajiv Shah ,  Lyle Dean Canfield

    发明人： Joseph H. Schulman ,  Charles L. Byers ,  John C. Gord ,  Rajiv Shah ,  Lyle Dean Canfield

    IPC分类号： A61N105

    CPC分类号： A61N1/36585 ,  A61B5/0031 ,  A61B5/14532 ,  A61B5/14546 ,  A61B5/14865 ,  A61B5/4839 ,  A61B2560/0219 ,  A61M5/1723 ,  A61N1/05 ,  A61N1/372 ,  A61N1/3754 ,  H01L23/3107 ,  H01L29/0657 ,  H01L2924/0002 ,  H01L2924/19041 ,  H01L2924/00

    摘要： An implantable substrate sensor has electronic circuitry and electrodes formed on opposite sides of a substrate. A protective coating covers the substrate, effectively hermetically sealing the electronic circuitry under the coating. Exposed areas of the electrodes are selectively left uncovered by the protective coating, thereby allowing such electrodes to be exposed to body tissue and fluids when the sensor is implanted in living tissue. The substrate on which the electronic circuitry and electrodes are formed is the same substrate or “chip” on which an integrated circuit (IC) is formed, which integrated circuit contains the desired electronic circuitry. Such approach eliminates the need for an hermetically sealed lid or cover to cover hybrid electronic circuitry, and allows the sensor to be made much thinner than would otherwise be possible. In one embodiment, two such substrate sensors may be placed back-to-back, with the electrodes facing outward. As required, capacitors that form part of the sensor's electronic circuits are formed on the substrate by placing metalization layers and a dielectric in vacant areas of the substrate surface.

    摘要翻译： 可植入衬底传感器具有形成在衬底的相对侧上的电子电路和电极。 保护涂层覆盖基材，有效地气密地密封涂层下的电子电路。 电极的暴露区域选择性地被保护涂层覆盖，从而当传感器植入生物体组织时允许这样的电极暴露于身体组织和流体。 其上形成有电子电路和电极的基板是与其上形成有集成电路（IC）的相同的基板或“芯片”，该集成电路包含所需的电子电路。 这种方法消除了密封的盖或盖以覆盖混合电子电路的需要，并且允许传感器制造得比其他可能的薄得多。 在一个实施例中，两个这样的衬底传感器可以背对背放置，电极面向外。 根据需要，通过将金属化层和电介质放置在基板表面的空的区域中，形成在传感器的电子电路的一部分的电容器。

    Implantable enzyme-based monitoring systems adapted for long term use
    10.
    发明授权
    Implantable enzyme-based monitoring systems adapted for long term use 失效
    适用于长期使用的基于植入式酶的监测系统

    公开(公告)号：US6081736A

    公开(公告)日：2000-06-27

    申请号：US953817

    申请日：1997-10-20

    申请人： Michael S. Colvin ,  Joseph H. Schulman ,  Lyle Dean Canfield ,  Rajiv Shah

    发明人： Michael S. Colvin ,  Joseph H. Schulman ,  Lyle Dean Canfield ,  Rajiv Shah

    IPC分类号： A61B5/00

    CPC分类号： A61B5/14865 ,  A61B5/0031

    摘要： Improved implantable monitoring systems suitable for long-term in vivo use to measure the concentration of one or more prescribed substances, such as glucose are described herein. In particular, an implantable enzyme-based glucose monitoring system is described that includes at least one of the following: means for replenishing the enzyme solution as it is consumed by the enzymatic reaction; means for replenishing the electrolyte solution bathing the electrode assembly; and microprocessing means proximal the electrode assembly. In preferred embodiments a microprocessor assembly is hermetically associated with the substrate to which the electrode assembly is affixed. Further, the monitoring systems employ one or more reservoir systems in fluid communication with enzyme and electrolyte chambers wherein the enzyme and electrolyte solutions are used. In a further embodiment, the monitoring systems use enzyme and electrolyte reservoir bulbs in fluid communication with the enzyme and electrolyte reservoirs, respectively, and positioned near the skin surface, thereby providing ready access to the enzyme and electrolyte solutions without the need for explantation of the device. Further provided herein is an enzyme solution including microspheres in association with the enzyme; whereby the enzyme is immobilized by the microspheres and the microspheres are in a fluid, flowable solution. Also provided herein is a method of extending the useful life of an implantable enzyme-based monitoring system, which method includes providing means, within the system, to replenish the enzyme and/or electrolyte solution.

    摘要翻译： 本文描述了适于长期体内使用的改进的可植入监测系统以测量一种或多种规定物质如葡萄糖的浓度。 特别地，描述了可植入酶的葡萄糖监测系统，其包括以下至少一个：用于在酶反应消耗的时候补充酶溶液的装置; 用于补充洗涤电极组件的电解液的装置; 并且微处理装置近似于电极组件。 在优选实施例中，微处理器组件与固定电极组件的基底密封相关。 此外，监测系统采用与酶和电解质室流体连通的一个或多个储存器系统，其中使用酶和电解质溶液。 在另一个实施方案中，监测系统使用分别与酶和电解质储存器流体连通并且定位在皮肤表面附近的酶和电解质储存器灯泡，从而提供对酶和电解质溶液的准备进入，而不需要移除 设备。 本文还提供了包含与酶结合的微球的酶溶液; 由此通过微球固定酶，并且微球体处于流动的可流动溶液中。 本文还提供了延长可植入酶的监测系统的使用寿命的方法，该方法包括在系统内提供补充酶和/或电解质溶液的装置。