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1.发明授权公开(公告)号：US06512939B1
公开(公告)日：2003-01-28
申请号：US09604179
申请日：2000-06-27
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。
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2.发明授权
公开(公告)号：US6081736A
公开(公告)日：2000-06-27
申请号：US953817
申请日：1997-10-20
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。
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公开(公告)号：US07555328B2
公开(公告)日：2009-06-30
申请号：US11392163
申请日：2006-03-29
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。
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公开(公告)号：US06498043B1
公开(公告)日：2002-12-24
申请号：US09718782
申请日：2000-11-22
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。
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公开(公告)号：US06259937B1
公开(公告)日：2001-07-10
申请号：US09100310
申请日：1998-06-19
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。
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公开(公告)号：US07079881B2
公开(公告)日：2006-07-18
申请号：US10288038
申请日：2002-11-04
IPC分类号： A61N5/00
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.
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7.发明授权
公开(公告)号：US5750926A
公开(公告)日：1998-05-12
申请号：US515559
申请日：1995-08-16
CPC分类号： H01L23/057 , A61N1/3754 , H05K5/0095 , H01L2224/16 , H01L2924/01078 , H01L2924/01079 , H01L2924/09701 , H01L2924/10253 , H01L2924/16152 , H05K1/0306 , H05K3/28 , H05K3/4007
摘要： A thin hermetically sealed electrical feedthrough suitable for implantation within living tissue permits electrical connection between electronic circuits sealed within an hermetically sealed case and electrical terminals or contacts on the outside of the case. The hermetically sealed case is made by hermetically bonding a cover to an insulating layer. The hermetically sealed electrical feedthrough is made by depositing a conductive trace on the insulating layer and then depositing another insulating layer thereover, so that the conductive trace is hermetically encapsulated within the insulating layers. At least two spaced-apart openings are formed in the insulating layers before bonding the cover thereto, exposing the conductive trace. Additional conductive material is then inserted within each of the openings or holes so as to form conductive vias that make electrical contact with the conductive trace. The cover is then hermetically sealed to the insulating layer so that at least one conductive via resides inside of an hermetically sealed cavity formed under the cover, and the other conductive via resides outside of the hermetically sealed cavity. An electrical feedthrough is thus formed through the respective conductive vias and conductive trace so that electrical contact may be made between the outside and inside of the hermetically sealed cavity.
摘要翻译： 适于植入生物组织的薄密封电馈电允许密封在密封的壳体内的电子电路与壳体外部的电气端子或触点之间的电连接。 密封的壳体通过将盖子密封地粘合到绝缘层上而制成。 密封电馈通通过在绝缘层上沉积导电迹线然后在其上沉积另一绝缘层而制成，使得导电迹线气密地封装在绝缘层内。 在将盖接合到其之前，在绝缘层中形成至少两个间隔开的开口，暴露导电迹线。 然后将另外的导电材料插入每个开口或孔中，以便形成与导电迹线电接触的导电通孔。 然后将盖密封到绝缘层，使得至少一个导电通孔位于形成在盖下方的密封空腔的内部，而另一个导电通孔位于密封腔的外部。 因此，通过相应的导电通孔和导电迹线形成电馈通，使得可以在气密密封腔的外部和内部之间进行电接触。
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8.发明授权Implantable enzyme-based monitoring system having improved longevity due to improved exterior surfaces 有权基于植入式酶的监测系统由于改进的外表面而具有改善的寿命公开(公告)号：US06934572B2
公开(公告)日：2005-08-23
申请号：US10286174
申请日：2002-10-31
IPC分类号： A61B5/00
CPC分类号： A61B5/14865 , A61B5/14532
摘要： An implantable enzyme-based monitoring system suitable for long term in vivo use to measure the concentration of prescribed substances such as glucose is provided. In one embodiment, the implantable enzyme-based monitoring system includes at least one sensor assembly, an outer membrane surrounding the sensor assembly and having a window therein, and a polymeric window cover affixed to the outer membrane and covering the window. Preferably, the outer membrane of the monitoring system is silicone and the window cover is a polymer of 2-hydroxyethyl methacrylate (HEMA), N,N,-dimethylaminoethyl methacrylate (DMAEMA) and methacrylic acid (MA). Also provided herein is an implantable enzyme-based monitoring system having at least one sensor assembly, an outer membrane surrounding the sensor assembly and a coating affixed to the exterior surface of the outer membrane, wherein the coating resists blood coagulation and protein binding to the exterior surface of the outer membrane. Preferably, the coating is polyethylene glycol (PEG) and heparin in an 80:20 molar ratio. Finally, provided herein is a method of coating the exterior surface of the outer membrane of an implantable enzyme-based monitoring system comprising the steps of forming hydroxyl groups on the silicone surface by plasma etching; reacting the silicone surface with amino functionalized silane, thereby forming amino groups on the silicone surface; simultaneously, covalently binding polyethylene glycol (PEG) and heparin to the amino groups; and ionically binding heparin to the monitoring system surface.
摘要翻译： 提供了一种适用于长期体内使用的可植入酶的监测系统，用于测量规定物质如葡萄糖的浓度。 在一个实施方案中，可植入酶基监测系统包括至少一个传感器组件，围绕传感器组件的外部膜并且在其中具有窗口，以及固定到外部膜并覆盖窗户的聚合物窗口盖。 优选地，监测系统的外膜是硅树脂，窗罩是甲基丙烯酸2-羟乙酯（HEMA），甲基丙烯酸N，N，N-二甲基氨基乙酯（DMAEMA）和甲基丙烯酸（MA）的聚合物。 本文还提供了一种植入式酶基监测系统，其具有至少一个传感器组件，围绕传感器组件的外膜和固定到外膜外表面的涂层，其中该涂层抗凝血和蛋白质结合到外部 外膜表面。 优选地，涂层是80:20摩尔比的聚乙二醇（PEG）和肝素。 最后，本文提供了一种涂覆可植入酶基监测系统的外膜的外表面的方法，包括以下步骤：通过等离子体蚀刻在硅氧烷表面上形成羟基; 使硅氧烷表面与氨基官能化硅烷反应，从而在硅氧烷表面上形成氨基; 同时将聚乙二醇（PEG）和肝素共价结合到氨基上; 并将肝素离子结合到监测系统表面。
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9.发明授权Implantable enzyme-based monitoring systems having improved longevity due to improved exterior surfaces 有权可植入的基于酶的监测系统由于改进的外表面而具有改善的寿命公开(公告)号：US06477395B2
公开(公告)日：2002-11-05
申请号：US09395434
申请日：1999-09-14
IPC分类号： A61B500
CPC分类号： A61B5/14865 , A61B5/14532
摘要： An implantable enzyme-based monitoring system suitable for long term in vivo use to measure the concentration of prescribed substances such as glucose is provided. In one embodiment, the implantable enzyme-based monitoring system includes at least one sensor assembly, an outer membrane surrounding the sensor assembly and having a window therein, and a polymeric window cover affixed to the outer membrane and covering the window. Preferably, the outer membrane of the monitoring system is silicone and the window cover is a polymer of 2-hydroxyethyl methacrylate (HEMA), N,N,-dimethylaminoethyl methacrylate (DMAEMA) and methacrylic acid (MA). Also provided herein is an implantable enzyme-based monitoring system having at least one sensor assembly, an outer membrane surrounding the sensor assembly and a coating affixed to the exterior surface of the outer membrane, wherein the coating resists blood coagulation and protein binding to the exterior surface of the outer membrane. Preferably, the coating is polyethylene glycol (PEG) and heparin in an 80:20 molar ratio. Finally, provided herein is a method of coating the exterior surface of the outer membrane of an implantable enzyme-based monitoring system comprising the steps of forming hydroxyl groups on the silicone surface by plasma etching; reacting the silicone surface with amino functionalized silane, thereby forming amino groups on the silicone surface; simultaneously, covalently binding polyethylene glycol (PEG) and heparin to the amino groups; and ionically binding heparin to the monitoring system surface.
摘要翻译： 提供了一种适用于长期体内使用的可植入酶的监测系统，用于测量规定物质如葡萄糖的浓度。 在一个实施方案中，可植入酶基监测系统包括至少一个传感器组件，围绕传感器组件的外部膜并且在其中具有窗口，以及固定到外部膜并覆盖窗户的聚合物窗口盖。 优选地，监测系统的外膜是硅树脂，窗罩是甲基丙烯酸2-羟乙酯（HEMA），甲基丙烯酸N，N，N-二甲基氨基乙酯（DMAEMA）和甲基丙烯酸（MA）的聚合物。 本文还提供了一种植入式酶基监测系统，其具有至少一个传感器组件，围绕传感器组件的外膜和固定到外膜外表面的涂层，其中该涂层抗凝血和蛋白质结合到外部 外膜表面。 优选地，涂层是80:20摩尔比的聚乙二醇（PEG）和肝素。 最后，本文提供了一种涂覆可植入酶基监测系统的外膜的外表面的方法，包括以下步骤：通过等离子体蚀刻在硅氧烷表面上形成羟基; 使硅氧烷表面与氨基官能化硅烷反应，从而在硅氧烷表面上形成氨基; 同时将聚乙二醇（PEG）和肝素共价结合到氨基上; 并将肝素离子结合到监测系统表面。
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10.发明授权
公开(公告)号：US6119028A
公开(公告)日：2000-09-12
申请号：US954166
申请日：1997-10-20
IPC分类号： A61B5/00
CPC分类号： A61B5/14865 , A61B5/14532
摘要： An implantable enzyme-based monitoring system suitable for long term in vivo use to measure the concentration of prescribed substances such as glucose is provided. In one embodiment, the implantable enzyme-based monitoring system includes at least one sensor assembly, an outer membrane surrounding the sensor assembly and having a window therein, and a polymeric window cover affixed to the outer membrane and covering the window. Preferably, the outer membrane of the monitoring system is silicone and the window cover is a polymer of 2-hydroxyethyl methacrylate (HEMA), N,N,-dimethylaminoethyl methacrylate (DMAEMA) and methacrylic acid (MA). Also provided herein is an implantable enzyme-based monitoring system having at least one sensor assembly, an outer membrane surrounding the sensor assembly and a coating affixed to the exterior surface of the outer membrane, wherein the coating resists blood coagulation and protein binding to the exterior surface of the outer membrane. Preferably, the coating is polyethylene glycol (PEG) and heparin in an 80:20 molar ratio. Finally, provided herein is a method of coating the exterior surface of the outer membrane of an implantable enzyme-based monitoring system comprising the steps of forming hydroxyl groups on the silicone surface by plasma etching; reacting the silicone surface with amino functionalized silane, thereby forming amino groups on the silicone surface; simultaneously, covalently binding polyethylene glycol (PEG) and heparin to the amino groups; and ionically binding heparin to the monitoring system surface.
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