ПИКТОГРАММНЫЙ ДИСПЛЕЙ С ОБОЗНАЧЕНИЯМИ ДЛЯ ИЗМЕРИТЕЛЬНОГО ПРИБОРА

Изобретение относится к средствам медицинской диагностики. Измерительный прибор выполнен с возможностью определения и регистрации концентрации анализируемого вещества в пробе жидкости, помещаемой на тестовый датчик, и включает дисплей, отображающий информацию для пользователя; сегмент на дисплее, предназначенный для отображения пиктограммного обозначения "до события" и "после события"; кнопку, позволяющую пользователю взаимодействовать с измерительным прибором и позволяющую помечать концентрацию анализируемого вещества соответствующим пиктограммным обозначением «до события» или «после события». Запоминающее устройство регистрирует результаты определения концентрации анализируемого вещества. Способ маркировки концентрации анализируемого вещества включает контакт тестовой полоски с измерительным прибором, предназначенным для определения концентрации анализируемого вещества в жидкости; отображение концентрации на дисплее; выбор обозначения "до события" или "после события"; и регистрацию значения ...

СПОСОБ ИЗГОТОВЛЕНИЯ СТЕРИЛИЗОВАННОГО И ТАРИРОВАННОГО МЕДИЦИНСКОГО УСТРОЙСТВА НА ОСНОВЕ БИОСЕНСОРА (ВАРИАНТЫ)

Изобретение относится к области изготовления медицинских устройств. Способ изготовления стерилизованного и тарированного медицинского устройства на основе биосенсора (например, медицинского устройства с объединенными в одно целое биосенсором и ланцетом), содержащее реагент биосенсора (например, реагент биосенсора из специфического фермента для анализируемого вещества и медиатора). Стерилизацию осуществляют, например, гамма-излучением. Затем тарируют реагент биосенсора стерилизованного медицинского устройства на основе биосенсора. Другой способ изготовления стерилизованного и тарированного медицинского устройства на основе биосенсора включает в себя вначале сборку и упаковывание множества медицинских устройств с реагентом биосенсора, затем стерилизацию облучением для создания множества стерилизованных, упакованных медицинских устройств на основе биосенсора. После этого тарируют стерилизованные и упакованные медицинские устройства на основе биосенсора. Тарирование можно выполнять, используя ...

ИЗМЕРИТЕЛЬНЫЙ ПРИБОР И СПОСОБ РАЗМЕЩЕНИЯ ДАТЧИКА

Группа изобретений относится к области медицинской техники. Измерительный прибор содержит считывающий блок и блок управления. Считывающий блок включает датчик, который формирует сигнал в соответствии с состоянием вещества и выполнен с возможностью имплантации под кожу пациента; основную часть, которая удерживает датчик, причем основная часть выполнена с возможностью размещения на коже пациента; и регулируемый механизм, который прикреплен к основной части и дает возможность изменять по меньшей мере одно из положения и ориентации датчика. Блок управления выполнен с возможностью прикрепления к основной части и выполняет обработку после приема сигнала, сформированного датчиком. Раскрыты альтернативный вариант выполненияизмерительного прибора и варианты считывающего блока, используемого в измерительном приборе. Технический результат заключается в повышении точности определения параметров тканевой текучей среды или крови организма в теле. 4 н. и 7 з.п. ф-лы, 16 ил.

СТРОБИРОВАННАЯ АМПЕРОМЕТРИЯ

Изобретение относится к области электрохимических методов анализа. Предложена система датчика, устройство и способы для определения концентрации анализируемого вещества в образце. Последовательности стробированных амперометрических импульсов, включающие в себя многочисленные рабочие циклы последовательных возбуждений и релаксаций, обеспечивают более короткое время анализа и/или улучшают точность и/или воспроизводимость анализа. Раскрытые последовательности стробированных амперометрических импульсов могут снижать погрешности анализа, являющиеся результатом гематокритного эффекта, изменения объемов цокольного зазора, неустановившихся режимов, медиаторного фона, недозаполнения, изменений температуры в образце и одиночного набора калибровочных констант. 6 н. и 24 з.п. ф-лы, 3 табл., 11 ил.

СИСТЕМА И СПОСОБ ДЛЯ ОБНАРУЖЕНИЯ ИСПОЛЬЗОВАННЫХ И ВЫСОХШИХ ДАТЧИКОВ

Изобретения относятся к медицине. Способ обнаружения повторного использования индикаторной полоски в биодатчике осуществляют с помощью биодатчика, содержащего процессор и память, хранящую команды для выполнения процессором. Индикаторная полоска содержит сухой реагент и электроды, включающие в себя оголенный электрод, который не находится в контакте с сухим реагентом в неиспользованном состоянии индикаторной полоски. При этом инокулируют индикаторную полоску жидкостью так, чтобы жидкость контактировала с сухим реагентом, оголенным электродом и одним или более другими электродами. Пока электроды находятся в контакте с жидкостью, прикладывают электрический потенциал между оголенным электродом и одним или более другими электродами. Измеряют электрический ток, протекающий между оголенным электродом и одним или более другими электродами в ответ на приложение потенциала. Определяют на основании одного или более параметров измеренного электрического тока, является ли индикаторная полоска полоской ...

СПОСОБ ЛАНЦЕТНОГО ВСКРЫТИЯ КОЖИ ДЛЯ ВЗЯТИЯ ПРОБЫ КРОВИ

... 1. Способ ланцетного вскрытия кожи через внешнюю поверхность кожи для получения пробы крови, при котором обеспечивают инструмент ланцетного вскрытия с заостренным концом и каналом, проходящим вблизи указанного заостренного конца к датчику, установленному на ближнем конце указанного инструмента ланцетного вскрытия, вводят указанный заостренный конец в указанную кожу на первую заданную глубину под указанной внешней поверхностью, причем указанный заостренный конец делает надрез на указанной поверхности кожи, полностью отводят указанный заостренный конец из указанного надреза и отбирают кровь по указанному каналу в указанный датчик. 2. Способ по п.1, в котором указанная первая заданная глубина имеет значение приблизительно 0,25-1,5 мм. 3. Способ по п.1, дополнительно содержит этапы приложения давления на кожу на участке вокруг указанного надреза. 4. Способ по п.3, в котором указанное давление осуществляют с помощью выдавливающего кольца, устанавливаемого на указанной коже до указанного этапа ...

ДЕМПФЕР ВЕРТИКАЛЬНОГО РОТОРА

... 1. Система для измерения уровня анализируемого вещества, содержащая тест-полоску, имеющую средство для измерения уровня анализируемого вещества электрохимическим способом, и хрупкое соединение, расположенное на указанной тест-полоске. 2. Система для измерения уровня анализируемого вещества по п.1, в которой указанное хрупкое соединение содержит токопроводящую дорожку. 3. Система для измерения уровня анализируемого вещества по п.2, в которой указанная токопроводящая дорожка является материалом, выбранным из группы, состоящей из углерода, серебра, платины, палладия, золота, Ir, Pt, вольфрама, железа и алюминия. 4. Система для измерения уровня анализируемого вещества по п.1, в которой указанная токопроводящая дорожка обладает положительным температурным коэффициентом сопротивления. 5. Система для измерения уровня анализируемого вещества по п.2, в которой указанная токопроводящая дорожка содержит первую зону электрического контакта и вторую зону электрического контакта, каждая из которых приспособлена ...

УСТРОЙСТВО И СПОСОБ ИЗМЕРЕНИЯ КОНЦЕНТРАЦИЙ МОЛЕКУЛ ЧЕРЕЗ БАРЬЕР

... 1. Способ обнаружения объектов-мишеней через барьер, включающий в себя следующие стадии: ! - создание зонда, содержащего гель, в который помещены молекулы измерительного агента; ! - размещение зонда в непосредственной близости от объектов-мишеней, так чтобы объекты-мишени вызывали измеримые изменения в характеристике измерительных агентов, при этом указанные измеримые изменения возникают вследствие сил сродства между объектами-мишенями и измерительными агентами, причем силы сродства приводят к указанным измеримым изменениям через указанный барьер; ! - измерение указанных изменений в характеристике измерительных агентов; и ! - заключение о присутствии объектов-мишеней, сделанное на основе указанных изменений. ! 2. Способ по п. 1, отличающийся тем, что измерительные агенты представляют собой ферменты глюкозы. ! 3. Способ по п. 2, отличающийся тем, что указанные ферменты глюкозы представляют собой глюкозоксидазу, глюкозодегидрогеназу или глюкозомутаротазу. ! 4. Способ по п. 1, отличающийся ...

СПОСОБЫ ОПРЕДЕЛЕНИЯ КОНЦЕНТРАЦИИ АНАЛИТА И УСТРОЙСТВО ДЛЯ РАСЧЕТА ТЕРАПЕВТИЧЕСКОЙ ДОЗЫ БАЗАЛЬНОГО ИНСУЛИНА

... 1. Способ управления диабетом пользователя с помощью портативного устройства управления диабетическими данными, снабженного датчиком контроля аналита, процессором, соединенным с блоком памяти и дисплеем, при этом способ включает этапы, на которыхизмеряют множество значений концентрации глюкозы в крови пользователя за множество временных интервалов с помощью датчика контроля аналита;собирают данные, характеризующие упомянутое множество значений концентрации глюкозы в крови натощак, с помощью портативного устройства управления диабетическими данными;устанавливают на основании собранных данных, выполнил ли пользователь минимальное количество измерений концентрации глюкозы в крови натощак в течение по меньшей мере одного из четырех предписанных временных интервалов;определяют, указывают ли собранные данные на одну из первой схемы, соответствующей низкой концентрации глюкозы в крови, и второй схемы, соответствующей более низкой концентрации глюкозы в крови, чем в первой схеме, соответствующей ...

ЭЛЕКТРОХИМИЧЕСКИЕ ДАТЧИКИ С ПОЛЕМ НОСИТЕЛЯ

... 1. Электрохимическое сенсорное устройство, содержащее:носитель, имеющий первую и вторую электропроводящие области, которые электрически изолированы друг от друга, причем носитель включает проходящее через него отверстие; иэлектрохимический модуль, установленный на носителе таким образом, что по меньшей мере часть электрохимического модуля проходит через отверстие, причем электрохимический модуль имеет электрохимическую полость с первым электродом в электрической связи с первой проводящей областью носителя, вторым электродом в электрической связи со второй проводящей областью носителя и камерой для приема образца, которая включает в себя слой реагента.2. Устройство по п. 1, при этом носитель согнут вдоль линии сгиба для образования верхней части и нижней части.3. Устройство по п. 2, при этом отверстие проходит через линию сгиба.4. Устройство по п. 1, при этом электрохимический модуль имеет максимальную длину и максимальную ширину, которые меньше максимальной длины и максимальной ширины носителя ...

МИКРОЭЛЕКТРОДЫ В ОФТАЛЬМИЧЕСКОМ ЭЛЕКТРОХИМИЧЕСКОМ ДАТЧИКЕ

... 1. Устанавливаемое на глазу устройство, содержащее:прозрачный полимерный материал, имеющий вогнутую поверхность и выпуклую поверхность, причем вогнутая поверхность выполнена съемно устанавливаемой поверх роговичной поверхности, а выпуклая поверхность выполнена совместимой с движением век, когда вогнутая поверхность установлена таким образом;подложку, по меньшей мере частично заделанную внутри полимерного материала;антенну, расположенную на подложке;двухэлектродный электрохимический датчик, расположенный на подложке и включающий в себя:рабочий электрод, имеющий по меньшей мере один размер менее чем 25 микрометров; иэлектрод сравнения, имеющий по меньшей мере в пять раз большую площадь, чем площадь рабочего электрода; иконтроллер, электрически соединенный с электрохимическим датчиком и антенной, причем контроллер выполнен с возможностью: (i) прикладывания напряжения между рабочим электродом и электродом сравнения, достаточного для генерации амперометрического тока, связанного с концентрацией ...

Instrument for a rapid analysis of blood sugar has a finger pressure point, with an inflow opening for a blood drop and ventilation openings, for the blood to be drawn in by an underpressure for contact with the circuits

The self-absorbent rapid probe, for blood analysis, has upper (1) and lower plates (2) and two electrically conductive circuits (3). The upper plate has a hemispherical finger pressure point (11), with a blood inflow opening (12) at its peak, and a number of ventilation openings (13) to ensure that a blood drop flows through the opening to be absorbed as the finger pressure forces air out through the ventilation holes. Release of the finger pressure gives an underpressure within its original structure to draw the blood into the interior and in contact with the circuits.

Flüssigkeitssensor mit integrierter Lanzette

Messvorrichtung mit einem Biosensor

Analyseinstrument

Analyseinstrument, mit: einem Substrat (1); einer Vielzahl von Elektroden (11, 12, 13) auf dem Substrat; einer Abdeckung (2); Abstandsmitteln (3), die zwischen dem Substrat und der Abdeckung angeordnet sind, wobei die Abstandsmittel (3) untereinander beabstandete Abschnitte aufweisen; und einer Probenkammer (4, 5), die oben und unten zwischen der Abdeckung (2) und dem Substrat (1) und seitlich zwischen den untereinander beabstandeten Abschnitten der Abstandsmittel (3) definiert ist; wobei die Probenkammer (4, 5) eine Kapillare (5) und einen Flüssigkeitssammelabschnitt (4) mit gekrümmten Seitenwänden aufweist, der mit der Kapillare (5) in Verbindung ist und einen Abschnitt aufweist, der breiter als die Kapillare (5) ist.

Electrochemical and luminescent sensor structures integrated on common substrate

Test strip for glucose monitoring with discrete testing zones

The present invention relates to a sample measurement system. In particular the invention relates to a sample measurement system for measuring certain selected properties of a liquid substrate, such as the glucose levels in a blood sample. More particularly the invention relates to a sample measurement system for performing electrochemical measurements on a sample, the system comprising a sampling plate 100 (test strip) with a loading port 110 for receiving a liquid substrate; and a measurement device 200 (meter); wherein the sampling plate comprises a sample zone 120 with at least two discrete testing zones (e.g. wells) 122, which sample zone is arranged, in use, to separate the liquid substrate into at least two discrete samples, such that each sample occupies a respective testing zone; and the measurement device is operable to communicate with the sampling plate to measure one or more selected properties of any of the at least two samples. This arrangement provides a sampling plate/test ...

Biosensor iontophoretic sampling and methods of use thereof

Analyte sensor antimicrobial configurations and adhesives

An analyte sensor and methods and systems related thereto, where at least one or more of a lower portion of a sensor tail substrate, at least one electrode, a sensing element, a membrane, and an optional non-electrochemical functional layer comprise an antimicrobial quality. Asymmetric, double-sided adhesive binders suitable for adhering the analyte sensor to a skin surface comprising a non-woven scrim, a first pressure-sensitive adhesive layer, a second pressure-sensitive adhesive layer. Overbandages comprising a vapor-permeable backing, an aperture to circumferentially surround a sensor housing, a contact adhesive layer, first and second peelable release liners, and a third peelable release liner disposed upon an anchoring adhesive strip of the contact adhesive layer.

A monitoring device

A monitoring device comprises monitoring unit 2 having electroanalytical component (3, Fig. 1) and electrical contact 11, and sensor unit 4 (advantageously disposable) having sensor arrangement (5, Fig. 1) and electrical contact (12, Fig. 3). The monitoring unit 2 and sensor unit 4 are held together releasably, and in electrical communication, by a cooperating attachment arrangement, perhaps base plate (8, Fig 2c) and clip mechanism (9, 10, Fig. 2c). The monitoring unit may have casing 6, maybe sealed, comprising recess 7 with walls 20 and 21 having no sharp internal angles; advantageously, this facilitates easy cleaning. Battery charging unit (17, Fig. 5) may instead be inserted into the recess to charge an internal battery via contact 16. The sensor unit may have flow cell(s) (26, Fig. 1) and fluid input and output (22, 23, Fig. 1). The sensor arrangement may comprise electrochemical or optical sensors, and a recognition substrate (enzyme, antibody etc) which binds to the analyte.

Device

An analyte monitoring device 2 for use in contact with the skin 4 comprises a porous membrane 6 comprising an enzyme. Preferably glucose or lactate are detected via a reaction using glucose oxidase or lactate dehydrogenase to yield hydrogen peroxide which is subsequently detected using an electrode 8. Preferably the porous membrane is polyethersulfone or nylon 6, 6 such as Biodyne A or C membrane. Preferably the membrane forms a three dimensional matrix of enzyme having a thickness of less than 300 µm and the average pore size is around 0.3 µm to 0.5 µm. Preferably use of the device is preceded by an additional step such as iontophoresis, ultrasound or microneedle microporation. Methods of use of the device to continuously monitor an analyte such as glucose are disclosed.

STABLE GLUCOSEOXIDASE FORMULATIONS AND PROCEDURES FOR THE PRODUCTION AND USE OF IT

ANALYTTESTSYSTEM FOR THE DETERMINATION OF THE CONCENTRATION OF A ANALYTEN IN A PHYSIOLOGICAL OR AQUEOUS LIQUID

MEDICINE PRODUCT FOR MEASURING GLUCOSE

USE OF REPEATED DATA POINTS AND FILTERING IN A ANALYTSENSOR

PROCEDURE FOR THE BLOOD TEST ADMISSION WITH LANZETTE

ANALYSIS SYSTEM WITH ORGANIC LIGHT-EMITTING DIODE DISPLAY

SENSOR ARRANGEMENT TO TRANSDERMALEN THE ANALYSIS AND PROCEDURE FOR YOUR APPLICATION

MEDICINE PRODUCT FOR THE ANALYTENÜBERWACHUNG AND DRUG DELIVERY

INTEGRATED LANZETTEN TESTSTREIFEN

DEVICE FOR COLLECTING LIQUIDS WITH INTEGRATED LANZETTE AND REACTION RANGE

ANALYTSENSOREN AND PROCEEDING TO THEIR PRODUCTION AND USE

SENSOR ARRAY

INSTRUMENT FOR THE MEASUREMENT OF A CONCENTRATION OF A COMPONENT IN A LIQUID SAMPLE

ANALYSIS DEVICE AND DURCHSTECHELEMENTINTEGRIERTE CONNECTION FOR A CONCENTRATION ANALYSIS DEVICE

INTEGRATED LANZETTE AND TESTSTREIFEN FOR ANALYTIC MEASUREMENT

DEVICE TO THE WITHDRAWAL OF BODY FLUIDS AND TO ANALYTENÜBERWACHUNG

BODY FLUID MEASURING INSTRUMENT WITH LANZETTE AND BUT UTILIZATION LANZETTENHALTER

VORRICHTUNG ZUR BESTIMMUNG DER KONZENTRATION ZUMINDEST EINER MEDIZINISCHEN SUBSTANZ IN LEBENDEN ORGANISMEN

DEVICE FOR THE DETERMINATION OF INTERESTING PARAMETERS IN LIVING ORGANISMS.

SMALL-VOLUMED SENSOR TO IN-VITRO REGULATION

BIO SENSOR, IONTOPHORETI SAMPLING SYSTEM, AND PROCEDURE FOR ITS APPLICATION

COLLECTING DEVICES FOR TRANSDERMALE SAMPLE SYSTEMS

FOR CHEMICAL SIGNALS IMPERMEABLE MASK

Ethylene receptor biosensor

The present disclosure relates to biosensors (10) having a receptor layer (5) and a mediator layer (6), the receptor layer including ethylene receptor molecules. The present disclosure also relates to sensor units (20) comprising one or more biosensors (10) and a controller (11). In some embodiments, one or more sensor units (20) may be in wireless communication with a receiver module or a network gateway.

Method and apparatus for obtaining blood for diagnostic tests

Analytical device with prediction module and related methods

Gated Voltammetry

A sensor system, device, and methods for determining the concentration of an analyte in a sample is described. Gated voltammetric pulse sequences including multiple duty cycles of sequential excitations and relaxations may provide a shorter analysis time and/or improve the accuracy and/or precision of the analysis. The disclosed pulse sequences may reduce analysis errors arising from the hematocrit effect, variance in cap-gap volumes, non-steady-state conditions, mediator background, a single set of calibration constants, under-fill, and changes in the active ionizing agent content of the sensor strip.

Test strip container with integrated meter having strip coding capability

A system for diagnostic testing may include a meter for performing a test on a sample applied to a test media and a selectively closable container configured to house test media compatible with the meter. The system may also provide mechanisms for removing a meter from a test container and reattaching it to a new one using one of several coding methods that recalibrate the meter for the new container of test strips. Alternatively, the system may include an auto-calibration system where data is provided individually on each individual test medium in a form readable by the test meter. The carried data may include an embedded code relating to data particular to that individual strip. The data is presented so as to be read by a meter associated with the diagnostic test strip in order to avoid manually inputting the information. In addition, the system may further provide mechanisms to reconfigure the meter to perform a new function when it has been determined that a triggering event has occurred ...

Transdermal analyte monitoring systems and methods for analyte detection

Medical devices and methods

Methods and devices to monitor an analyte in body fluid are provided Embodiments include continuous or discrete acquisition of analyte related data from a transcutaneously positioned in vivo analyte sensor automatically or upon request from a user Embodiments include wirelessly communicating analyte level information from on body electronics device to a second device such as a display device, and an analyte sensor compsing one or more storage devices such as non-volatile memory and other discrete components ...

Personal diagnostic devices and related methods

Body fluid sampling device

Medical device for analyte monitoring and drug delivery

MEDICAL DEVICE FOR ANALYTE MONITORING AND DELIVERY 5 Disicosed is an ingestible, implantable or wearable medical device comprising a microarray which comprises a bioactive agent capable of interacting with a disease marker biological analyte; a reservoir which comprises at least one therapeutic agent and is capable of releasing the therapeutic agent(s) from the medical device; and a plurality of microchips comprising a microarray scanning device capable of obtaining physical 10 parameter data of an interaction between the disease marker biological analyte with the bioactive agent; a biometric recognition device capable of comparing the physical parameter data with an analyte interaction profile; optionally a therapeutic agent releasing device capable of controlling release of the therapeutic agent from the reservoirs; an interface device capable of facilitating communications between the microarray scanning 15 device, biometric recognition device and the therapeutic agent releasing device ...

Method, apparatus, and computer-readable medium for generating a set of recommended orthotic products

In an embodiment, the present invention is an apparatus, comprising: a foot mat; a depth sensing camera; an elevated foot platform that reduces or prevents rotational movement of a foot; a processor in communication with the depth sensing camera, the processor further configured to calculate the circumference of a user's leg based on data from the depth sensing camera while the user has one foot on the foot mat and one foot on the elevated foot platform, the processor further configured to select a recommended product for the user's knee or ankle from among a set of pre-manufactured candidate products for knees or ankles based at least in part upon the leg circumference of the user; and an output device to display information received from the processor, the information identifying the recommended product to the user.

Electrode system for measuring an analyte concentration under in-vivo conditions

System, device and method of dynamic glucose profile response to physiological parameters

Method, device and system for providing consistent and reliable glucose response information to physiological changes and/or activities is provided to improve glycemic control and health management.

Electronic device for providing information regarding exercise state based on metabolite information and method thereof

An electronic device for providing exercise information and a method therefor are provided. The electronic device includes a first sensor module, a second sensor module, at least one output device, and at least one processor. The at least one processor is configured to detect an event relating to start of an exercise state, obtain motion information corresponding to the exercise state using the first sensor module, obtain metabolite information of a user using the second sensor module, and provide information regarding the exercise state to the user through the at least one output device, based on whether the metabolite information satisfies a specified condition.

Biointerface layer for analyte sensors

Disclosed are devices for determining an analyte concentration (e.g., glucose). The devices comprise a sensor configured to generate a signal associated with a concentration of an analyte and a sensing membrane located over the sensor. The sensing membrane comprises a biointerface layer which interfaces with a biological fluid containing the analyte to be measured. The biointerface layer comprises a biointerface polymer, wherein the biointerface polymer comprises polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The biointerface layer increases sensor longevity and decrease sensor inaccuracy by inhibiting accumulation of cells, proteins, and other biological species on the outermost layers of the sensor.

Remote monitoring of analyte measurements

Methods and apparatus, including computer program products, are provided for remote monitoring. In some example implementations, there is provided a method. The method may include receiving, at a remote monitor, a notification message representative of an event detected, by a server, from analyte sensor data obtained from a receiver monitoring an analyte state of a host; presenting, at the remote monitor, the notification message to activate the remote monitor, wherein the remote monitor is configured by the server to receive the notification message to augment the receiver monitoring of the analyte state of the host; accessing, by the remote monitor, the server, in response to the presenting of the notification message; and receiving, in response to the accessing, information including at least the analyte sensor data. Related systems, methods, and articles of manufacture are also disclosed. 0i Ls L ... 0 F- z z z 4' %S ui0 i0 ui0 z z x x x Ir l) ...

Enzyme immobilized adhesive layer for analyte sensors

Disclosed are devices for determining an analyte concentration (e.g., glucose). The devices comprise a sensor configured to generate a signal associated with a concentration of an analyte and a sensing membrane located over the sensor. The sensing membrane comprises an enzyme layer, wherein the enzyme layer comprises an enzyme and a polymer comprising polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The enzyme layer protects the enzyme and prevents it from leaching from the sensing membrane into a host or deactivating.

Physiological signal monitoring device

A physiological signal monitoring device includes a base, a biosensor mounted to the base, a transmitter, and a sealing unit. The base is adapted to be mounted 5 to a skin surface of a host. The biosensor includes a mounting seat and a sensing member that is mounted to the mounting seat. The sensing member is adapted to be partially inserted underneath the skin surface of the host for measuring an analyte of the host and to send 10 a corresponding physiological signal. The transmitter is for receiving and transmitting the physiological signal, and has a bottom portion. The transmitter covers the base while the bottom portion faces the base. The sensing member is coupled to the transmitter. The 15 sealingunitis used to sealpaths throughwhichaliquid possibly penetrates into an interior of the physiological signal monitoring device so as to avoid damage of the device.

Method and apparatus for signal transmission and detection using a contact device

Percutaneous biological fluid sampling and analyte measurement devices and methods

Method and apparatus for signal transmission and detection using a contact device

Blood analyte monitoring through subcutaneous measurement

Analyte monitoring device and methods of use

PERCUTANEOUS BIOLOGICAL FLUID SAMPLING AND ANALYTE MEASUREMENT DEVICES AND METHODS

A device for sampling a biological fluid and measuring at least one target constituent within the biological fluid. The device has at least one electrochemical cell having an inner electrode and an outer electrode in a concentrically-spaced relationship. In a preferred embodiment, the outer electrode has a cylindrical configuration having an open distal end and the inner electrode has an elongated configuration positioned co-axially within the outer electrode and a distal end configured to penetrate the skin. The spacing between the electrodes exerts a capillary force on biological fluid present at the open distal end of the outer electrode. A system is also provided which includes a control unit in electrical communication with the electrochemical cell for controlling the selection and measurement of the target constituent. Methods of sampling of biological fluids within the skin and measuring the sampled fluids are also provided, as well as kits comprising one or more of the inventive ...

AGENTS AND METHODS FOR ENHANCEMENT OF TRANSDERMAL TRANSPORT

The invention according to an exemplary embodiment relates to a method for transporting a substance across a biological membrane comprising the steps of applying a delipidation agent to a portion of the biological membrane, applying a hydration agent to the portion of the biological membrane, sonicating the portion of the biological membrane, and transporting the substance across the biological membrane. The step of applying the delipidation agent may be carried out prior to or simultaneously with the step of applying the hydration agent. The hydration agent may be applied before, during, or after the sonication step. The methods according to exemplary embodiments of the invention can provide improved transdermal transport in applications such as continuous analyte extraction and analysis and transdermal delivery of drugs and vaccines.

BIOLOGICAL FLUID SAMPLING AND ANALYTE MEASUREMENT DEVICES AND METHODS

A device for sampling a biological fluid and measuring a target analyte within the biological fluid is provided. The device has at least one micro-piercing member used to penetrate the skin to a selected depth and access biological fluid, a sampling means and a measuring means. The sampling means comprises a fluid transfer medium, such as a hydrophilic porous material, by which sampled biological fluid is transferred from the micro-piercing member to the measuring means. The measuring means includes an electrochemical cell having at least one porous electrode and, typically, a reagent material, where the electrochemical cell is configured so as to make an electrochemical measurement of a target analyte in accessed biological fluid present therein. Methods of sampling biological fluids within the skin and measuring the sampled fluids are also provided, as well as kits comprising one or more of the inventive devices.

BODY FLUID SAMPLING SEVICE

... ²²²Body fluid sampling device comprising a sampling element (10) having a fluid ²pathway (11) for receiving body fluid, at least a portion of said fluid ²pathway is open to the environment and further comprising a fluid receiving ²means (40) being spaced from said fluid pathway so that fluid in said pathway ²will not contact the fluid receiving means initially. Said fluid receiving ²means has two or more test zones (45) for performing analytical reactions. ²Fluid from said channel is contacted with said fluid receiving means either by ²bringing the fluid receiving means and the fluid into mechanical contact or by ²electrically transporting fluid from the channel onto the fluid receiving ²means.² ...

SYSTEMS AND METHODS FOR MONITORING HEALTH AND DELIVERING DRUGS TRANSDERMALLY

The present invention pertains to a system and method for transdermal sampling, comprising: at least one sampler for retrieving and transferring at least one analyte obtained transdermally from the skin of a subject; at least one detector system for identifying and quantifying said at least one analyte; and at least one logic module for: (i) receiving and storing input data from said at least one detector, (ii) relating the input data to other data obtained from the subject, (iii) displaying output information, (iv) transmitting the output information to another system, and (v) controlling the operation of said at least one sampler and at least one detector.

SYSTEMS AND METHODS FOR MONITORING HEALTH AND DELIVERING DRUGS TRANSDERMALLY

The present invention pertains to a system and method for transdermal sampling, comprising: at least one sampler for retrieving and transferring at least one analyte obtained transdermally from the skin of a subject; at least one detector system for identifying and quantifying said at least one analyte; and at least one logic module for: (i) receiving and storing input data from said at least one detector, (ii) relating the input data to other data obtained from the subject, (iii) displaying output information, (iv) transmitting the output information to another system, and (v) controlling the operation of said at least one sampler and at least one detector.

ACCESS DISCONNECT DETECTION USING GLUCOSE

An access disconnect sensor for a patient undergoing extracorporeal blood processing includes an electrochemical fuel cell or sensor to detect blood leakage. The fuel cell includes circuitry for oxidizing glucose in the blood. The sensor also includes a transmitter to send a signal to a remote receiver that the sensor indicates the presence of blood. The circuitry may include a battery or may use electricity generated by the sensor to send a signal indicating a leak of blood or disconnection of the access needle.

HANDHELD PERSONAL DATA ASSISTANT (PDA) WITH A MEDICAL DEVICE AND METHOD OF USING THE SAME

A medical device module for use in a system with a personal data assistant (PDA) with at least one medical device includes a housing, at least one medical device and a processor. The housing is adapted to couple with the PDA. The at least one medical device interface is coupled to the housing for interfacing with the at least one medical device. The processor is coupled to the at least one medical device interface to process data from the at least one medical device. The processor is also capable of interfacing with the PDA.

METHOD FOR MANUFACTURING A STERILIZED AND CALIBRATED BIOSENSOR-BASED MEDICAL DEVICE

A method for manufacturing a sterilized and calibrated biosensor-based medical device (e.g., an integrated biosensor and lancet medical device) includes sterilizing a biosensor-based medical device that contains a biosensor reagent composition (e.g., an analyte specific enzyme and mediator biosensor reagent composition). The sterilizing can be accomplished using, for example, a gamma radiation based technique. Thereafter, the biosensor reagent composition of the sterilized biosensor- based medical device is calibrated. Another method for manufacturing a sterilized and calibrated biosensor-based medical device includes first assembling and packaging a plurality of biosensor-based medical devices that include a biosensor reagent composition. The packaged biosensor-based medical devices are then sterilized using a radiation- based sterilization technique, to create a plurality of sterilized, packaged biosensor-based medical devices. Thereafter, the sterilized and packaged biosensor-based medical ...

PORTABLE INTERSTITIAL FLUID MONITORING SYSTEM

A strip-like microneedle device is provided that includes an array of hollow microneedles, a diaphragm pump to extract interstitial fluid from skin, and a sensor that detects the concentration of the fluid. The microneedle device can be interfaced to an external sensor to produce a reading, or can be self- contained. One version uses an attachable/detachable microneedle array as a single-use, disposable unit. The device is portable, and is used by placing one finger on the microneedle array, and actuating the diaphragm pump with another finger, thereby obtaining the fluid sample. Solid coated or transparent microneedles could instead be used as an in-situ sensor, with either electrodes or an optical sensor.

LACTATE SENSORS AND ASSOCIATED METHODS

A lactate-responsive enzyme may form the basis for lactate detection and quantification using an electrochemical analyte sensor. Various features may be incorporated within an analyte sensor containing a lactate-responsive enzyme, particularly lactate oxidase, to improve sensitivity and response stability of the analyte sensor. Such analyte sensors may comprise: a working electrode having an active area disposed thereon, and a mass transport limiting membrane overcoating at least the active area upon the working electrode. The active area comprises at least a polymer, an albumin, and a lactate-responsive enzyme that is covalently bonded to the polymer. The mass transport limiting membrane may comprise at least a crosslinked polyvinylpyridine homopolymer or copolymer. The analyte sensors may determine a lactate concentration in a biological fluid, particularly in vivo, which may be correlated to various physiological conditions.

NOVEL BIOSENSOR AND RELATED WOUND DRESSING SYSTEM

A biosensor for detecting a biomarker in a bodily fluid, secretion or exudation is disclosed. The biosensor essentially comprising a first electrode (100a), a second electrode (100b), an electrode coating (200) and a mechanical electrode stabilizer (300). The biomarker is an enzyme catalyzing a chemical reaction in which a singularity or plurality of constituents of the electrode coating (200) are chemically altered by the breaking of covalent chemical bonds when being in contact with the same. The electrode coating comprises a natural or synthetic substrate of the biomarker. The first electrode and the second electrode are electrically conductive and are kept in a substantially constant and uniform distance from each other by means of the mechanical electrode stabilizer (300). The exposed electrically conductive surface of at least one of the first electrode and the second electrode are substantially fully covered by the electrode coating (200). The biosensor exists in at least one state ...

BIOINTERFACE LAYER FOR ANALYTE SENSORS

Disclosed are devices for determining an analyte concentration (e.g., glucose). The devices comprise a sensor configured to generate a signal associated with a concentration of an analyte and a sensing membrane located over the sensor. The sensing membrane comprises a biointerface layer which interfaces with a biological fluid containing the analyte to be measured. The biointerface layer comprises a biointerface polymer, wherein the biointerface polymer comprises polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The biointerface layer increases sensor longevity and decrease sensor inaccuracy by inhibiting accumulation of cells, proteins, and other biological species on the outermost layers of the sensor.

METHOD FOR MEASURING BLOOD COMPONENTS AND BIOSENSOR AND MEASURING INSTRUMENT FOR USE THEREIN

A method for measuring blood components in which the amount of blood cells and the amount of disturbance substances in blood are measured with high precision and high reliability and the amount of blood components can be corrected accurately based on the measurements. In a sensor for measuring blood components, a first working electrode (13) measures a current flowing at the time of oxidation-reduction reaction of blood components, a second working electrode (17) measures the amount of blood cells, and a third working electrode (12) measures the amount of disturbance substances. The amount of an objective blood component is then corrected based on the measurements. The amount of blood components is thereby measured with higher precision and accuracy.

INTEGRATED LANCE AND STRIP FOR ANALYTE MEASUREMENT

The present invention relates, in general, to lancing elements for use in drawing bodily fluids out of a patient and, more particularly, to an improved lancing element including first and second elements positioned relative to each other such that an incision formed by the first element is held open by the second element and bodily fluids are pulled up the lancing element by surface tension on the first and second lancing elements.

CLOSED-LOOP DRUG DELIVERY SYSTEM

A delivery system for a drug or bioactive agent includes an implantable pump and a delivery conduit that may be implanted in an organ or other tissue (e.g., the central ox the peripheral nervous system) of a subject. A sensor is also implanted, and a controller unit receives the sensor output and directs drug delivery from within the patient pump accordingly. The sensor directly measures a primary biochemical material or state in the tissue or organ system, and the monitoring unit effects closed loop feedback control of the pump to achieve a desired end. The end may be the regulation of metabolism or maintenance of a stable metabolic or other state, or may be treatment regimen, e.g., by delivery of a dosage level or distribution of a drug in specific brain or nervous system tissue. The sensed material may be the agent itself, a metabolite, or a related native material, tissue state or condition.

FULLY INTEGRATED WEARABLE OR HANDHELD MONITOR

An arrangement comprises a housing containing one or more components configured for at least one of body fluid sampling and analysis. The arrangement includes a housing containing one or more components configured for at least one of body fluid sampling and analysis, and a body attachment element. The housing and the body attachment element are connected by a quick- release mechanism configured to facilitate removal of the housing from the body attachment element.

AN AUTOMATED SYSTEM FOR CONTINUOUSLY AND AUTOMATICALLY CALIBRATING ELECTROCHEMICAL SENSORS

METHOD FOR MEASURING BLOOD COMPONENTS AND BIOSENSOR AND MEASURING INSTRUMENT FOR USE THEREIN

The present invention provides a method of measuring a component in blood, by which the amounts of blood cells and an interfering substance can be measured with high accuracy and high reliability and the amount of the component can be corrected accurately based on the amounts of the blood cells and the interfering substance. In a sensor for measuring a blood component, a first working electrode 13 measures a current that flows during a redox reaction of a blood component, a second working electrode 17 measures the amount of blood cells, and a third working electrode 12 measures the amount of an interfering substance. Next, based on the measurement results, the amount of the blood component to be measured is corrected. Thus, more accurate and precise measurement of the amount of the blood component can be realized.

BLOOD SENSOR AND BLOOD EXAMINING INSTRUMENT INCLUDING SAME

A blood sensor (20a) comprises a substrate (21); a spacer (22) attached t o the top of the substrate (21); a cover (23) attached to the top of the spa cer (22); a blood reservoir portion (24) defined by a substrate hole (21a) f ormed in the substrate (21), a part of a spacer hole (22a) formed in the spa cer (22) and connected to the substrate hole (21a), and a cover hole (23a) f ormed in the cover (23) and connected to the spacer hole (22a); a supply pas sage (25) defined by another part of the spacer hole (22a) and communicating with the blood reservoir portion (24); and detection electrodes formed in t he supply passage (25). The cover (23) projects from the supply passage (25) toward the inside of the blood reservoir portion (24) farther than the subs trate (21) and the spacer (22).

METHODS OF USING INFORMATION FROM RECOVERY PULSES IN ELECTROCHEMICAL ANALYTE MEASUREMENTS AS WELL AS DEVICES, APPARATUSES AND SYSTEMS INCORPORATING THE SAME

Methods are disclosed for measuring an analyte concentration in a fluidic sample. Such methods allow one to correct and/or compensate for confounding variables such as temperature before providing an analyte concentration. The measurement methods use response information from a test sequence having at least one DC block, where the DC block includes at least one excitation pulse and at least one recovery pulse, and where a closed circuit condition of an electrode system is maintained during the at least one recovery pulse. Information encoded in the at least one recovery pulse is used to correct/compensate for temperature effects on the analyte concentration. Also disclosed are devices, apparatuses and systems incorporating the various measurement methods.

METHODS AND SYSTEMS FOR OPTIMIZING SENSOR FUNCTION BY THE APPLICATION OF VOLTAGE

A method is provided for initializing an analyte sensor, such as a glucose sensor. Where a sensor has been disconnected and reconnected, a disconnection time is determined and a sensor initialization protocol is selected based upon the disconnection time. The sensor initialization protocol may include applying a first series of voltage pulses to the sensor. A method for detecting hydration of a sensor is also provided.

ANALYTE TESTING METHODS AND DEVICE FOR CALCULATING BASAL INUSLIN THERAPY

... ²²Described herein are various methods to ensure safety and the compliance of ²therapeutic ²diabetes protocols. The method can be achieved by performing safeguards ²against ²hypoglycemia of the user prior to any change in basal insulin dosage based on ²the ²plurality of data.² ...

GATED AMPEROMETRY

... ²A sensor system, device, and methods for determining the concentration of an ²analyte in a sample is described. Gated amperometric pulse sequences including ²²multiple duty cycles of sequential excitations and relaxations may provide a ²shorter ²analysis time and/or improve the accuracy and/or precision of the analysis. ²The ²disclosed gated amperometric pulse sequences may reduce analysis errors ²arising from ²the hematocrit effect, variance in cap-gap volumes, non-steady-state ²conditions, mediator ²background, under-fill, temperature changes in the sample, and a single set of ²calibration ²constants.² ...

ENCAPSULATED ELECTRONICS

An eye-mountable device includes an electrochemical sensor embedded in a polymeric material configured for mounting to a surface of an eye. The electrochemical sensor includes a working electrode and a reference electrode that reacts with an analyte to generate a sensor measurement related to a concentration of the analyte in a fluid to which the eye-mountable device is exposed. An example assembly process includes: forming a sacrificial layer on a working substrate; forming a first layer of a bio-compatible material on the sacrificial layer; providing an electronics module on the first layer of the bio-compatible material, forming a second layer of the bio-compatible material to cover the electronics module; and annealing the first and second layers of the bio-compatible material together to form an encapsulated structure having the electronics module fully encapsulated by the bio-compatible material.

BIOSENSING METER WITH PLUGGABLE MEMORY KEY

A biosensing meter (10) is enabled to receive a sample strip (18) that includes a sample well (20) with an analyte reactant therein and electrodes (24, 26) in contact therewith. The biosensing meter (10) includes an excitation supply (44) for supplying potentials to a sample strip electrode (24). A sense amplifier (50) is also provided for connection to another electrode (26) of an inserted sample strip (18) and produces an output signal indicative of sensed currents when an analyte containing fluid is present in the strip's sample well. A pluggable memory key (30) is insertable into the meter (10) and includes a plurality of stored parameter values and procedure routines that control operations of the meter. A microprocessor (59) is responsive to a procedure routine and parameter values accessed from the pluggable memory key (30) to cause the excitation supply to apply a plurality of potentials for preset durations, both the values of the potentials and the time duration of their application ...

Biosensing Meter with Pluggable Memory Key

A TONOMETER SYSTEM FOR MEASURING INTRAOCULAR PRESSURE BY APPLANATION AND/OR INDENTATION

A tonometer system for measuring intraocular pressure by accurately providing a predetermined amount of applanation of the cornea, and detecting the amount of force required to achieve the predetermined amount of applanation. The system is also capable of measuring intraocular pressure by identing the cornea using a predetermined force applied using an indenting element, and detecting the distance the indenting element (16) moves into the cornea when the predetermined force is applied, the distance being inversely proportional to intraocular pressure. Also provided is a method of using a tonometer system to measure hydrodynamic characteristics of the eye, especially outflow facility. The tonometer system includes a contact device for placement in contact with the cornea and an actuation apparatus (6) for actuating the contact device so that a portion thereof projects inwardly against the cornea to provide a predetermined amount of applanation. The system further includes a detecting arrangement ...

METHOD AND APPARATUS FOR OBTAINING BLOOD FOR DIAGNOSTIC TESTS

Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and (b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises: (a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and (b) a vacuum pump. Preferably, the apparatus also includes a housing. In a further aspect of the invention, a pneumatic lancing assembly is provided. The pneumatic lancing assembly uses differential gas pressure to thrust a lancet into skin tissue. In another aspect of this invention ...

BIOSENSOR, IONTOPHORETIC SAMPLING SYSTEM, AND METHODS OF USE THEREOF

An automated system for continual transdermal extraction of analytes present in a biological system is provided. The system can be used for detecting and/or measuring the concentration of the analyte using an electrochemical biosensor detection means. The system optionally uses reverse iontophoresis to carry out the continual transdermal extraction of the analytes.

GLUCOSE MEASURING INSTRUMENT.

Described is a device for measuring and displaying the concentration of glucose in the blood. The device consists of a display unit (2) into which disposable sensor units (1) with a biomembrane (9) can be inserted. The display unit (2) has a built-in processor (3) in whose store (7) a glucose-concentration curve (5) is stored and which can analyse the measurement result provided by a sensor (1). The processor has a time-measuring device (4) whose zero setting has a fixed correlation with the date of manufacture of the disposable sensor (1). Before the device is handed over to a patient, the glucose-concentration curve is irreversibly calibrated, the curve corresponding to the characteristics of the sensor biomembrane (9) at the time of manufacture. Using the time-measurement device (4), the glucose-concentration curve is automatically and irreversibly corrected, taking into consideration the time-dependent characteristics of the sensor biomembrane (9).

ТЕСТ-СИСТЕМА ДЛЯ ОПРЕДЕЛЕНИЯ КОНЦЕНТРАЦИИ АНАЛИЗИРУЕМОГО ВЕЩЕСТВА В ФИЗИОЛОГИЧЕСКОЙ ИЛИ ВОДНОЙ ЖИДКОСТИ

В заявке описан тест-элемент для определения концентрации по меньшей мере одного анализируемого вещества в пробе физиологической жидкости, имеющий расположенные на определенном расстоянии друг против друга первую и вторую поверхности, которые имеют два, по существу, одинаковых и в основном конгруэнтно совмещенных участка, образующих на первой и второй поверхностях участки с высокой и низкой поверхностной энергией, формирующие систему распределения пробы по меньшей мере с двумя чувствительными участками для измерений, отличающийся тем, что чувствительные участки для измерений первой и второй поверхностей имеют два соответствующих участка с рабочими и контрольными электродами электрохимического детектора. Расположенная внутри предлагаемого в изобретении тест-элемента система распределения пробы не имеет никаких механических и/или конструктивных признаков стенок, канавок или каналов, предназначенных для направления физиологической жидкости к чувствительным участкам, и обеспечивает возможность ...

Method for distributing contact information between applications

A method and system for distributing contacting information between applications is provided. The system preferably uses an ENUM-type protocol and a middleware tool kit to associate telephone numbers to other identifying information, such as e-mail addresses or URLs for web sites. The system enables the associated contacting information to be shared across multiple applications that may be implemented on a computer or a mobile telephony device. Information is shared only after verification that a requester is authorized to receive the requested contacting information.

Biosensor unit and biosensor system

The biosensor unit has a substrate composed of a subcutaneously retained part that is retained under the skin and a base part that is placed on the skin surface. The biosensor unit comprises a sensor part detecting numerical information regarding a substance to be measured as electric signals, a signal amplifying part amplifying the electric signals, a CPU including a calculation part A/D converting the amplified electric signals and processing them to create transmittable data, a storage storing electric signals and data, a transmission part transmitting data to an external device through optical communication, and a battery part for drive. The sensor part is provided on the subcutaneously retained part and the transmission part is provided on the base part.

Medical device for glucose monitoring or regulation

A medical device comprising a pressure generating means adapted to displace a liquid, a sensor adapted to measure a flow resistance, and an implantable member comprising an analyte responsive porous membrane which reversibly changes its porosity subject to changes in analyte concentration occurring in the solution surrounding the implantable member. The analyte may in particular be glucose. The medical device may also be used for drug administration.

Lancet integrated test element tape dispenser

A lancet integrated test element tape includes a plurality of lancet integrated test elements. The lancet integrated test elements each include a lancet configured to form an incision in tissue and a test element configured to analyze body fluid from the incision in the tissue. A cartridge includes a supply compartment configured to store an unused section of the tape. The tape is folded within the supply compartment to limit damage to the lancet integrated test elements. The cartridge can further include a waste compartment in which a used section of the tape is stored. An indexing mechanism moves the tape between the supply and waste compartments.

Electrochemical sensor having symmetrically distributed analyte sensitive areas

The present invention provides an electrochemical sensor that employs multiple electrode areas that are exposed for contact with a body fluid, e.g., when the sensor is inserted subcutaneously into a patient's skin. The exposed electrode areas are arranged symmetrically, such that a symmetrical potential distribution is produced when an AC signal is applied to the sensor. The sensors in accordance with these teachings can advantageously be used with AC signals to determine characteristics of the sensor and thus improve sensor performance. These teachings also provide a biocompatible sensor with multiple reference electrode areas that are exposed for contact with body fluid.

Analyte Monitoring Devices and Methods

Methods and devices for providing application specific integrated circuit architecture for a two electrode analyte sensor or a three electrode analyte sensor are provided. Systems and kits employing the same are also provided.

System and/or method for glucose sensor calibration

The subject matter disclosed herein relates to systems, methods and/or devices for calibrating sensor data to be used in estimating a blood glucose concentration. A relationship between sensor signal values and reference readings may be used to estimate a relationship between sensor signal values and measurements of blood glucose concentration.

Real-time self-calibrating sensor system and method

A system and method for calibrating a sensor of a characteristic monitoring system in real time utilizes a self-calibration module for periodic determination of, and compensation for, the IR drop across unwanted resistances in a cell. A current-interrupt switch is used to open the self-calibration module circuit and either measure the IR drop using a high-frequency (MHz) ADC module, or estimate it through linear regression of acquired samples of the voltage across the sensor's working and reference electrodes (Vmeasured) over time. The IR drop is then subtracted from the closed-circuit value of Vmeasured to calculate the overpotential that exists in the cell (Vimportant). Vimportant may be further optimized by subtracting the value of the open-circuit voltage (Voc) across the sensor's working and reference electrodes. The values of Vmeasured and Vimportant are then controlled by respective first and second control units to compensate for the IR drop.

Analyte sensor

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Transdermal Sampling and Analysis Device

Transdermal sampling and analysis device, method and system are provided for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples. The transdermal sampling and analysis device, method and system may cause disruption to the skin cells to create capillary-like channels from which biological samples may flow to the transdermal sampling and analysis device. The transdermal sampling and analysis device, method and system may collect the biological samples in a reservoir where the biological sample may chemically react with a biologically reactive element. A sensor may convert the produced electrons (ions) into measured electrical signals. The converted signals may be measured and the levels of an analyte may be determined based on the measured signals.

Compositions, methods, and systems comprising fluorous-soluble polymers

The present invention generally relates to compositions, methods, and systems comprising polymers that are fluorous-soluble and/or organize at interfaces between a fluorous phase and a non-fluorous phase. In some embodiments, emulsions or films are provided comprising a polymer. The polymers, emulsions, and films can be used in many applications, including for determining, treating, and/or imaging a condition and/or disease in a subject. The polymer may also be incorporated into various optoelectronic device such as photovoltaic cells, organic light-emitting diodes, organic field effect transistors, or the like. In some embodiments, the polymers comprise pi-conjugated backbones, and in some cases, are highly emissive.

Method of Calibrating an Analyte-Measurement Device, and Associated Methods, Devices and Systems

The invention relates to a method for calibrating an analyte-measurement device that is used to evaluate a concentration of analyte in bodily fluid at or from a measurement site in a body. The method involves measuring a concentration, or calibration concentration, of an analyte in blood from an “off-finger” calibration site, and calibrating the analyte-measurement device based on that calibration concentration. The invention also relates to a device, system, or kit for measuring a concentration of an analyte in a body, which employs a calibration device for adjusting analyte concentration measured in bodily fluid based on an analyte concentration measured in blood from an “off-finger” calibration site.

Analyzing Device, Sensor Testing Device, Testing Method and Computer-Readable Storage Medium

There is provided a sensor testing method including: applying at least one of a first voltage that obtains a response caused by a substance and a second voltage that either obtains no response or substantially no response caused by the substance across a first electrode and a second electrode of a sensor; measuring current flowing between the first electrode and the second electrode; and determining whether or not there is a defect present in the sensor based on a quantity related to an amount of change per specific period of time of a current measured when the first voltage and/or the second voltage have been applied.

Glucose sensor product and related manufacturing and packaging methods

A glucose sensor product is manufactured by a process that maintains the sterility of the glucose sensor while allowing gaseous manufacturing by-products to be vented from the inside of the glucose sensor package. The method begins by placing a glucose sensor assembly into a plastic package tray having a sealing surface surrounding an opening. The method continues by covering the opening with a microbial barrier material such that the microbial barrier material overlies the sealing surface, forming a seal between the sealing surface and the microbial barrier material, resulting in a sealed package tray containing the glucose sensor assembly, and sterilizing the glucose sensor assembly inside the sealed package tray. The microbial barrier material maintains sterility of the glucose sensor assembly while allowing volatile by-products outgassed from the glucose sensor assembly and the plastic package tray to pass therethrough.

Bodily fluid composition analyzer with disposable cassette

Disclosed is an apparatus for analyzing the composition of bodily fluid. The apparatus can include a fluid handling network including a patient end configured to maintain fluid communication with a bodily fluid in a patient and a pump unit in operative engagement with the fluid handling network. The pump unit can have an infusion mode, in which the pump unit is operable to deliver infusion fluid to the patient through the patient end, and a sample draw mode, in which the pump unit is operable to draw a sample of the bodily fluid from the patient through the patient end. The apparatus can include a spectroscopic analyzer positioned to analyze at least a portion of the sample; a processor in communication with or incorporated into the spectroscopic analyzer; and stored program instructions executable by the processor to obtain measurements of two or more properties of the sample.

System and methods for determination of analyte concentration using time resolved amperometry

A method for determining a concentration of an analyte is disclosed. The method includes applying a potential excitation to a fluid sample containing an analyte and determining if a current decay curve associated with the fluid sample has entered an analyte depletion stage. The method also includes measuring a plurality of current values associated with the fluid sample during the analyte depletion stage and calculating an analyte concentration based on at least one of the plurality of current values.

Method for detecting a malfunction of a sensor for measuring an analyte concentration in vivo

The invention relates to a method for detecting a malfunction of a sensor for measuring an analyte concentration in vivo, wherein a series of measurement signals is produced by means of the sensor, and a value of a noise parameter is continually determined from the measuring signals, the noise parameter indicating how severely the measurement is impaired by interference signals. According to the invention, continually determined values of the noise parameter are used to determine how quickly the noise parameter changes, and the rate of change of the noise parameter is evaluated to detect a malfunction.

Transdermal systems, devices, and methods for biological analysis

A transdermal test sensor includes a test chamber including a liquid, a reagent system in contact with the liquid, a housing containing the liquid, and a semipermeable membrane. The housing includes an opening, the semipermeable membrane is connected to the housing and covers the opening, and the housing and the semipermeable membrane enclose the liquid and the reagent system. The transdermal test sensor also includes an analyzer in communication with the liquid. When porated tissue is contacted with the semipermeable membrane and sufficient time is allowed for a fluid sample to traverse the porated tissue and for an analyte in the fluid sample to enter the liquid in the transdermal sensor through the semipermeable membrane, a change in at least one optical property or at least one electrical property of the liquid is detected. The change detected is then correlated with the analyte concentration in the fluid sample.

Advanced analyte sensor calibration and error detection

Systems and methods for processing sensor data and self-calibration are provided. In some embodiments, systems and methods are provided which are capable of calibrating a continuous analyte sensor based on an initial sensitivity, and then continuously performing self-calibration without using, or with reduced use of, reference measurements. In certain embodiments, a sensitivity of the analyte sensor is determined by applying an estimative algorithm that is a function of certain parameters. Also described herein are systems and methods for determining a property of an analyte sensor using a stimulus signal. The sensor property can be used to compensate sensor data for sensitivity drift, or determine another property associated with the sensor, such as temperature, sensor membrane damage, moisture ingress in sensor electronics, and scaling factors.

Determining Analyte Concentrations in Biological Fluids with Abnormal Output Detection

A biosensor has an abnormal output detection system that determines whether an output signal from the redox reaction of an analyte has a normal or abnormal shape or configuration. The abnormal output detection system improves the accuracy and precision of the biosensor in determining whether an output signal has a shape or configuration that may not provide an accurate and/or precise analysis of a biological fluid. The biosensor generates an output signal in response to the redox reaction of the analyte. The biosensor normalizes the output signal and compares the normalized output signal with one or more control limits. The biosensor may generate an error signal when the normalized output signal is not within the control limits.

Manufacturing electrochemical sensor module

Certain processes for manufacturing an electrochemical sensor module include assembly first and second housing portions of sensor modules; dispensing a sensor fiber across multiple first housing portions; joining the first and second housing portions; and separating the sensor modules by cutting the sensor fiber.

Method for preparing a catheter assembly including a sensing element having an adhesive backing

The present invention is directed to a sensing element that comprises a flexible substrate having first and second opposite surfaces; at least one sensor disposed on the first surface of the flexible substrate; an adhesive layer substantially covering the second surface of the flexible substrate; and a release liner releasably adhered to the adhesive layer so that upon removal of the release liner the adhesive layer is exposed for securing the sensing element to the catheter. The release liner permits the sensing element to be positioned at a desired location within the catheter after which the release liner can be removed to expose the adhesive layer. The adhesive layer can then be used to attach and secure the sensing element at a desired location on the catheter. As a result, the need for additional adhesives can be reduced or eliminated.

Integrated delivery device for continuous glucose sensor

Systems and methods for integrating a continuous glucose sensor, including a receiver, a medicament delivery device, and optionally a single point glucose monitor are provided. Manual integrations provide for a physical association between the devices wherein a user (for example, patient or doctor) manually selects the amount, type, and/or time of delivery. Semi-automated integration of the devices includes integrations wherein an operable connection between the integrated components aids the user (for example, patient or doctor) in selecting, inputting, calculating, or validating the amount, type, or time of medicament delivery of glucose values, for example, by transmitting data to another component and thereby reducing the amount of user input required. Automated integration between the devices includes integrations wherein an operable connection between the integrated components provides for full control of the system without required user interaction.

Systems and methods for replacing signal artifacts in a glucose sensor data stream

Systems and methods for minimizing or eliminating transient non-glucose related signal noise due to non-glucose rate limiting phenomenon such as interfering species, ischemia, pH changes, temperatures changes, known or unknown sources of mechanical, electrical and/or biochemical noise, and the like. The system monitors a data stream from a glucose sensor and detects signal artifacts that have higher amplitude than electronic or diffusion-related system noise. The system processes some or the entire data stream continually or intermittently based at least in part on whether the signal artifact event has occurred.

Reference Electrodes Having an Extended Lifetime for use in Long Term Amperometric Sensors

The present application provides Ag/AgCl based reference electrodes having an extended lifetime that are suitable for use in long term amperometric sensors. Electrochemical sensors equipped with reference electrodes described herein demonstrate considerable stability and extended lifetime in a variety of conditions.

System for In Vivo Biosensing Based on the Optical Response of Electronic Polymers

A system for continuous in vivo biosensing of specific analyte molecule concentrations based on the dynamic optical properties of electronic polymers is disclosed. The biosensor system includes at least one implant member subcutaneously exposed to the interstitial fluid of the subject, and a reader member at least temporarily positioned over the implant member to probe it with light of specific wavelengths through the skin. The system has many potential applications, including the real-time monitoring of blood glucose levels in diabetics as a method to supplement or replace conventional capillary blood testing.

Method and/or system for multicompartment analyte monitoring

Subject matter disclosed herein relates to monitoring and/or controlling levels of an analyte in bodily fluid. In particular, estimation of a concentration of the analyte in a first physiological compartment based upon observations of a concentration of the analyte in a second physiological compartment may account for a latency in transporting the analyte between the first and second physiological compartments.

Polar plot to represent glucose sensor performance

Disclosed are methods, apparatuses, etc. for providing a visual expression of the performance of one or more blood glucose sensors. In one particular example, a relative comparison of a rate of change sensor blood glucose and a rate of change in reference blood glucose may be expressed in a polar plot or graph. The polar plot or graph may then be generated onto a visual medium.

HOLLOW MICRONEEDLE HAVING A VARIABLE APPEARANCE

The present invention relates to a method for fabricating a hollow microneedle having a variable appearance. The method makes it possible to vary the length of the microneedle, the outer and inner diameters of the upper and lower parts thereof, the aspect ratio, the sharpness, and the structural bending rate thereof, in accordance with the purposes of the same. Accordingly, the appearance of the hollow microneedles according to the present invention can be varied with flexibility according to various purposes, such as the transferring of medication and the taking of a blood sample, and to various factors, such as the target part for the medication transfer, the depth of the medication transfer, and the amount and viscosity of the medication. Thus, the microneedle can be used as a multi-purpose device for transferring medication. 1. A method of manufacturing a hollow microneedle having a varied appearance , comprising:coating a solution of a viscous material on a surface of a substrate;bringing the solution of the viscous material into contact with a frame;lifting the substrate, the frame, or the substrate and the frame for the contacted frame and substrate to be spaced apart from each other to thereby manufacture a solid microstructure;depositing metal on the solid microstructure;protecting an upper portion of the metal-deposited solid microstructure, and plating metal on a surface of the microstructure; andremoving the solid microstructure to obtain a hollow microneedle,wherein a coating thickness of the viscous material, a diameter of the frame, a temperature of the viscous material, a lifting speed, a plating thickness, or combination thereof is adjusted.2. The method of claim 1 , wherein in said coating a solution of a viscous material claim 1 , the viscous material is a polymer compound which is removed by an organic solvent.3. The method of claim 2 , wherein the polymer compound is one of acrylonitrile styrene (AS) claim 2 , polyamide claim 2 , polyethylene ...

Aqueous radiation protecting formulations and methods for making and using them

Medical devices are typically sterilized in processes used to manufacture such products and their sterilization by exposure to radiation is a common practice. Radiation has a number of advantages over other sterilization processes including a high penetrating ability, relatively low chemical reactivity, and instantaneous effects without the need to control temperature, pressure, vacuum, or humidity. Unfortunately, radiation sterilization can compromise the function of certain components of medical devices. For example, radiation sterilization can lead to loss of protein activity and/or lead to bleaching of various dye compounds. Embodiments of the invention provide methods and materials that can be used to protect medical devices from unwanted effects of radiation sterilization.

Medical device comprising a multipart housing

A medical device for carrying out at least one medical function, comprising at least one element that can be at least partially inserted into a body tissue of a user and further comprising at least one housing that can be placed on a skin surface of the user. The housing has a multipart design and comprises at least one functional component. The functional component can be connected to the insertable element. The housing further comprises at least one protective component. The protective component is designed to at least partially enclose the functional component. The protective component can be connected to the functional component, particularly after insertion of the insertable element.

ANALYTE SENSORS HAVING A SIGNAL-TO-NOISE RATIO SUBSTANTIALLY UNAFFECTED BY NON-CONSTANT NOISE

Systems and methods of use involving sensors having a signal-to-noise ratio that is substantially unaffected by non-constant noise are provided for continuous analyte measurement in a host. In some embodiments, a continuous analyte measurement system is configured to be wholly, transcutaneously, intravascularly or extracorporeally implanted. 1. An electrochemical continuous glucose sensor configured for implantation in a host , the glucose sensor comprising:an electrode configured to measure a signal indicative of a glucose concentration of a host, wherein the signal comprises a glucose-related component and a non-glucose related component; anda membrane covering at least a portion of the electrode, wherein the membrane is configured to reduce passage of an interfering species therethrough, whereby the non-glucose-related component of the signal is less than about 20% of the signal over a period of at least one day;wherein the glucose sensor has a sensitivity to glucose of from about 25 pA/mg/dL to about 500 pA/mg/dL.2. The glucose sensor of claim 1 , wherein the interfering species has an oxidation potential that overlaps with an oxidation potential of a measured species indicative of the concentration of the analyte.3. The glucose sensor of claim 1 , wherein the measured species is a product of an enzymatic reaction between glucose and an enzyme and is measured by the electrode.4. The glucose sensor of claim 1 , wherein the membrane comprises a silicone-containing polymer.5. The glucose sensor of claim 4 , wherein the silicone-containing polymer is a polysiloxanes.6. The glucose sensor of claim 4 , wherein the silicone-containing polymer is a polycarbosiloxane.7. The glucose sensor of wherein the silicone-containing polymer is a copolymer comprising a silicone segment and a polyurethane segment.8. The glucose sensor of claim 1 , wherein the membrane comprises a fluorocarbon-based material.9. The glucose sensor of claim 1 , wherein the non-glucose-related component ...

Delivering and/or receiving fluids

The present invention generally relates to receiving bodily fluid through a device opening. In one aspect, the device includes a flow activator arranged to cause fluid to be released from a subject. A deployment actuator may actuate the flow activator in a deployment direction, which may in turn cause fluid release from a subject. The flow activator may also be moved in a retraction direction by a retraction actuator. In one aspect, the device may include a vacuum source that may help facilitate fluid flow into the opening of the device and/or may help facilitate fluid flow from the opening to a storage chamber. In one aspect, a device actuator may enable fluid communication between the opening and the vacuum source and the flow activator may be actuated after the enablement of fluid communication.

FLUX LIMITING MEMBRANE FOR INTRAVENOUS AMPEROMETRIC BIOSENSOR

A flux limiting layer for an intravenous amperometric biosensor is formed on a substrate to limit a diffusion rate of an analyte from blood to an enzyme electrode. The layer may be formed from ethylene vinylacetate (EVA) dissolved in a solvent such as paraxylene, spray-coated to cover a portion of the electrode, and cured to seal the electrode to the substrate. In a glucose sensor having glucose oxidase disposed on the electrode, thickness and concentration of the EVA layer are optimized to promote a linear output of electrode current as a function of blood glucose concentration. 1. A flux limiting membrane for an intravenous amperometric biosensor , comprising:an ethylene vinylacetate (EVA) polymer at least partially coating a reagent disposed on an electrode of the biosensor to limit a rate at which a reactant from blood diffuses to the reagent.2. The flux limiting membrane of claim 1 , wherein the reactant comprises glucose.3. The flux limiting membrane of claim 1 , wherein the EVA polymer is deposited from a solution comprising EVA dissolved in a solvent.4. The flux limiting membrane of claim 3 , wherein the solution comprises between about 0.5 wt % and about 6.0 wt % of an EVA composition.5. The flux limiting membrane of claim 4 , wherein the EVA composition has a vinyl acetate content between about 9 wt % and about 50 wt %.6. The flux limiting membrane of claim 3 , wherein the solvent is selected from the group comprising cyclohexanone claim 3 , paraxylene claim 3 , and tetrahydrofuran.7. The flux limiting membrane of claim 1 , wherein the EVA polymer comprises an average diffusion layer thickness between about 0.5 microns and about 10 microns.8. The flux limiting membrane of claim 1 , further comprising a biocompatibility layer.9. The flux limiting membrane of claim 8 , wherein the biocompatibility layer comprises heparin.10. The flux limiting membrane of claim 1 , further comprising poly(methylmethacrylate-co-butyl methacrylate) blended with the EVA polymer. ...

Analyte Sensor

Systems and methods of use for continuous analyte measurement of a host's vascular system are provided. In some embodiments, a continuous glucose measurement system includes a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host's circulatory system. 1. A method for measuring an analyte in a host , comprising:exposing a continuous analyte detection system to a sample, wherein the continuous analyte detection system comprises a continuous analyte sensor configured for contact with a sample from a circulatory system of a host in vivo and configured to generate a first signal associated with a test analyte and a second signal associated with a reference analyte, and a reference sensor configured to generate a reference signal associated with the reference analyte;receiving the first signal, the second signal, and the reference signal;calculating a calibration factor associated with a sensitivity of the continuous analyte sensor; andcalibrating the first signal, wherein calibrating comprises using the calibration factor.2. The method of claim 1 , wherein the exposing step further comprises simultaneously exposing the continuous analyte sensor and the reference sensor to the sample.3. The method of claim 1 , wherein the receiving step further comprises receiving the first signal from a first working electrode disposed under an enzymatic portion of a membrane system.4. The method of claim 3 , wherein the receiving step further comprises receiving the second signal from the first working electrode.5. The method of claim 3 , wherein the receiving step further comprises receiving the second signal from a second working electrode disposed under the membrane system.7. The method of claim 5 , wherein the receiving step further comprises receiving a non-analyte-related signal from a third working electrode disposed under a non-enzymatic portion of the membrane system.8. The method of claim 1 , wherein ...

Enzyme co-factor enhancement of biosensor performance

The present invention is broadly concerned with the crafting and manufacturability of an implantable enzymatic-based sensor characterized by a small size, optimum geometry, linearity of response over the concentration range of interest, extended shelf-life, selectivity for the analyte in question, and the ability to exclude bioactive interferents. More particularly, it is preferably concerned with a general approach to optimize the performance of the biorecognition elements required to produce biosensors of the type designed to provide, and in conjunction with a suitable signal processing unit, a current which is proportional to the concentration of the analyte of interest. The biosensors described herein may be implanted in vivo, including intra-cerebral, sub-cutaneous, intra-muscular, inter-peritoneal oral, serum, and vascular implantation, the majority of which may act as a surrogate for systemic monitoring and used to monitor analytes of interest in real-time. Multiple biosensors can be joined together to allow for the simultaneous recording of multiple analytes of interest. In addition to the in vivo applications, sensors of the design described herein may also find use in medical monitoring, industrial processes, fermentation, environmental monitoring, and waste water stream monitoring. The present invention offers co-factor enhancement of the biorecognition element, providing access to a range of biorecognition elements heretofore difficult to incorporate into a manufacturing process for the large-scale production of biosensors.

Hand-held test meter with signal recovery block

A hand-held test meter (“HHTM”) for use with an analytical test strip in the determination of an analyte in a bodily fluid sample includes a housing, an electrical signal receiving block, a signal recovery block and a microcontroller block, all of which are disposed in the housing. The electrical signal receiving block is configured to receive an electrical signal from an analytical test strip inserted in the HHTM that has been distorted into a distorted electrical signal. In addition, the signal recovery block and microcontroller block are configured to recover the electrical signal from the distorted electrical signal by generating a recovered electrical signal based on a predetermined recovered electrical signal frequency, a recovered electrical signal amplitude estimated from the distorted electrical signal, a recovered electrical signal offset estimated from distorted electrical signal and a recovered electrical signal phase determined using a least sum squares calculation.

High energy radiation insensitive analyte sensors

Enzyme based analyte sensors having radiation stabilizing agents are disclosed and described. More particularly, devices comprising a radiation stabilizing agent and methods for stabilizing sensors to high energy radiation sterilization are disclosed and described.

ANALYTE SENSOR

The present disclosure relates generally to an electrochemical sensor comprising a membrane layer comprising one or both of an active enzymatic portion and an inactive-enzymatic or non-enzymatic portion, at least one electrode disposed beneath the membrane and either at least one pH sensor or a hematocrit sensor. The present disclosure also relates to methods of adjusting analyte concentration values using a correction factor based on measured pH values and/or measured hematocrit levels. 1. An analyte sensor comprising:a membrane comprising an active enzymatic portion and an inactive-enzymatic or non-enzymatic portion;at least two electrodes disposed beneath the membrane; andat least one pH sensor disposed beneath the membrane and in proximity to the at least two electrodes.2. The sensor of claim 1 , wherein the at least one pH sensor is disposed beneath the membrane.3. The sensor of any one of the previous claims claim 1 , wherein the at least two electrodes comprises a working electrode and a blank electrode claim 1 , and the membrane is partitioned over the working electrode and the blank electrode.4. The sensor of claim 2 , wherein the working electrode is disposed under the active enzymatic portion of the membrane and the blank electrode is disposed under the inactive-enzymatic or non-enzymatic portion of the membrane.5. The sensor of claim 2 , wherein the membrane is partitioned over the working electrode associated with the active enzymatic portion and the blank electrode associated with the inactive-enzymatic or non-enzymatic portion.6. The sensor of claim 2 , wherein the at least one pH sensor is positioned in closer proximity to the working electrode than the blank electrode.7. The sensor of claim 2 , wherein at least one pH sensor is positioned in closer proximity to the blank electrode than the working electrode.8. The sensor of claim 2 , wherein the at least one pH sensor is positioned at an equal distance from the working electrode and the blank ...

Implantable Biosensor Device and Methods of Use Thereof

Sensor devices and methods are provided for detecting the presence or concentration of an analyte in fluid. The device has a reservoir; a working electrode located within the reservoir, a catalyst covering at least part of the working electrode; an oxygen-generating auxiliary electrode in the reservoir; and a reservoir cap to isolate the working and auxiliary electrodes within the reservoir. The device further includes means for selectively rupturing the cap to permit analyte from outside the reservoir to contact the catalyst. The methods may include in vivo glucose monitoring and may include implanting the device in a patient; disintegrating a reservoir cap to permit glucose to enter the reservoir; generating oxygen using the oxygen-generating auxiliary electrode; and using a working electrode to oxidize hydrogen peroxide produced by the reaction of the oxygen with glucose in the presence of glucose oxidase, and thereby detecting endogenous glucose in the patient. 1. A sensor device for detecting the presence or concentration of an analyte in a fluid comprising:a structural body which comprises a first reservoir that has a first opening in the structural body;a working electrode located within the first reservoir;a catalyst covering at least a portion of the working electrode;an oxygen-generating auxiliary electrode located within the first reservoir; andat least one reservoir cap closing the first opening to isolate the working electrode and the auxiliary electrode within the first reservoir and to prevent an analyte outside of the first reservoir from contacting the catalyst.2. The sensor device of claim 1 , further comprising a means for rupturing or displacing the at least one reservoir cap to permit the analyte from outside of the first reservoir to contact the catalyst.3. The sensor device of claim 1 , further comprising a reference electrode.4. The sensor device of claim 3 , wherein the reference electrode is located within the first reservoir.5. The sensor ...

CONTROL OF BIOFOULING IN IMPLANTABLE BIOSENSORS

Disclosed herein is a device comprising a biosensor having disposed upon it a coating; the coating comprising a polymer matrix; where the polymer matrix is operative to facilitate the inwards and outwards diffusion of analytes and byproducts to and from the sensing element of the biosensor; and a sacrificial moiety; the sacrificial moiety being dispersed in the polymer matrix, where the sacrificial moiety erodes with time and increases the porosity of the polymer matrix thus offsetting decreases in analyte permeability as a result of biofouling. 1. A device comprising: a polymer matrix; where the polymer matrix is operative to facilitate an inwards and outwards diffusion of analytes, byproducts and other water soluble entities towards a sensing element of the biosensor; and', 'a sacrificial moiety; the sacrificial moiety being dispersed in the polymer matrix, where the sacrificial moiety erodes with time and increases the porosity of the polymer matrix thus offsetting decreases in analyte permeability as a result of biofouling., 'a biosensor having disposed upon it a coating; the coating comprising2. The device of claim 1 , where the erosion of sacrificial moieties creates a new implantable device-tissue interface; the new implantable device-tissue interface presenting a fresh surface to biofouling media to re-establish analyte transport within the polymeric matrix.3. The device of claim 1 , where the polymer matrix comprises hydrogels claim 1 , xerogels claim 1 , organogels claim 1 , absorbent polymers claim 1 , dip-coated or layer-by-layer coated polyelectrolytes claim 1 , electropolymerized polymers claim 1 , or combinations thereof.4. The device of claim 1 , where the polymeric matrix experiences a ‘partial’ or ‘no’ collapse following the erosion of the sacrificial moieties.5. The device of claim 1 , where the sacrificial moieties comprise a biodegradable polymer.6. The device of claim 5 , where the biodegradable polymer is a polyanhydride claim 5 , polyaspirin ...

Tubular Sensor, Constituent Measuring Device, and Tubular Sensor Manufacturing Method

A tubular sensor includes a tubular body having a longitudinally extending cavity, an insulation layer formed on the inner wall surface of the tubular body; and a plurality of longitudinally extending electrodes formed on the insulation layer and extending continuously from one end to the other end of the tubular body. The tubular sensor can be employed in a constituent measuring device. The tubular sensor can be manufactured by forming the insulation layer on a thin metal sheet, forming the plurality of electrodes on the insulation layer in stripes, cutting the thin metal sheet with the insulation layer and the electrodes formed thereon to produce a plate-shaped body having a development shape of the tubular body, and press working the plate-shaped body to form the tubular body. 1. A tubular sensor comprising:a tubular body possessing a distal end portion terminating at a distal-most end, a proximal end portion terminating at a proximal-most end, and a cavity extending throughout the tubular body which opens at both the distal-most end and the proximal-most end of the tubular body, the tubular body possessing an inner wall surface facing towards and surrounding the cavity;the distal end portion of the tubular body being beveled and pointed to puncture a patient's skin so that a blood sample from the patient's body enters the cavity at the distal end portion of the tubular body;an insulation layer fixed on the tubular body and directly in contact with the inner wall surface of the tubular body, the insulation layer being made of an insulating material which is different from material forming the tubular body, the insulating layer possessing an inner surface; anda plurality of separate and circumferentially spaced apart electrodes immovably fixed in place on the tubular body and directly in contact with the inner surface of the insulation layer, each of the plurality of electrodes being electrically conductive and extending continuously from adjacent the distal end ...

Gated Voltammetry Devices

A sensor system, device, and methods for determining the concentration of an analyte in a sample is described. Gated voltammetric pulse sequences including multiple duty cycles of sequential excitations and relaxations may provide a shorter analysis time and/or improve the accuracy and/or precision of the analysis. The disclosed pulse sequences may reduce analysis errors arising from the hematocrit effect, variance in cap-gap volumes, non-steady-state conditions, mediator background, a single set of calibration constants, under-fill, and changes in the active ionizing agent content of the sensor strip.

DUAL ELECTRODE SYSTEM FOR A CONTINUOUS ANALYTE SENSOR

Disclosed herein are systems and methods for a continuous analyte sensor, such as a continuous glucose sensor. One such system utilizes first and second working electrodes to measure additional analyte or non-analyte related signal. Such measurements may provide a background and/or sensitivity measurement(s) for use in processing sensor data and may be used to trigger events such as digital filtering of data or suspending display of data. 1. A continuous glucose sensor configured and arranged for insertion into a host for and detecting glucose in the host , the sensor comprising:a first working electrode comprising a first resistance domain, wherein the first working electrode is configured to generate a first signal having a first noise component related to a noise-causing species;a second working electrode comprising a second resistance domain, wherein the second working electrode is configured to generate a second signal having a second noise component related to the noise-causing species; anda third resistance domain disposed continuously over the first resistance domain and the second resistance domain.2. The sensor of claim 1 , wherein the noise-causing species comprises at least one member selected from the group consisting of externally produced HO claim 1 , urea claim 1 , lactic acid claim 1 , phosphates claim 1 , citrates claim 1 , peroxides claim 1 , amino acids claim 1 , amino acid precursors claim 1 , amino acid break-down products claim 1 , nitric oxide claim 1 , NO-donors claim 1 , NO-precursors claim 1 , reactive oxygen species claim 1 , compounds having electroactive acidic claim 1 , amine or sulfhydryl groups claim 1 , acetaminophen claim 1 , ascorbic acid claim 1 , dopamine claim 1 , ephedrine claim 1 , ibuprofen claim 1 , L-dopa claim 1 , methyldopa claim 1 , salicylate claim 1 , tetracycline claim 1 , tolazamide claim 1 , tolbutamide claim 1 , and triglycerides.3. The sensor of claim 1 , wherein the noise-causing species is non-constant.4. The ...

System and methods for processing analyte sensor data

Systems and methods for processing sensor analyte data, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. During initial calibration, the analyte sensor data is evaluated over a period of time to determine stability of the sensor. The sensor may be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. The calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and analyte data and quality of sensor calibration. Algorithms provide for optimized prospective and retrospective analysis of estimated blood analyte data from an analyte sensor.

ANALYTE SENSOR WITH INCREASED REFERENCE CAPACITY

Systems and methods of use for continuous analyte measurement of a host's vascular system are provided. In some embodiments, a continuous glucose measurement system includes an electrochemical sensor incorporating a silver/silver chloride reference electrode, wherein a capacity of the reference electrode is controlled. 1. An implantable electrochemical sensor for measuring an analyte concentration in a host , comprising:a working electrode configured to measure a concentration of an analyte; anda silver/silver chloride reference electrode, wherein at least a portion of the silver/silver chloride reference electrode is covered with an enzyme layer, wherein the enzyme layer is configured, in vivo, to generate hydrogen peroxide upon exposure to a substrate, whereby the hydrogen peroxide regenerates silver chloride of the reference electrode such that a reference capacity of the reference electrode is increased.2. The implantable electrochemical sensor of claim 1 , wherein the enzyme is an oxidase enzyme.3. The implantable electrochemical sensor of claim 2 , wherein the substrate is selected from the group consisting of glucose claim 2 , urate claim 2 , ascorbate claim 2 , citrate claim 2 , L-lactate claim 2 , succinate claim 2 , D-glucose claim 2 , and ethanol.4. The implantable electrochemical sensor of claim 1 , wherein the analyte is glucose.5. The implantable electrochemical sensor of claim 1 , wherein the reference electrode comprises a chloridized elongated silver body.6. The implantable electrochemical sensor of claim 1 , further comprising a diffusion barrier configured to substantially block diffusion of hydrogen peroxide between the silver/silver chloride reference electrode and the working electrode.7. The implantable electrochemical sensor of claim 1 , wherein the enzyme layer has a thickness from about 0.01 microns to about 12 microns thick.8. The implantable electrochemical sensor of claim 1 , wherein a percentage of a surface area of the reference ...

Method and fuel cell for electrochemical measurement of analyte concentration in vivo

The invention relates to a method for the electrochemical measurement of an analyte concentration in vivo, comprising a fuel cell with which the analyte to be measured is reacted catalytically with an enzyme contained in an enzyme layer and which supplies an electrical voltage, dependent on the analyte concentration to be measured, beween an anode and a cathode, which voltage is measured. In the catalytic reaction of the analyte to be measured in the enzyme layer, a product is generated which, as fuel of the fuel cell, oxidizes on the anode and is reduced on the cathode. The invention further relates to a fuel cell for such a method.

MEMBRANE PHASE ELECTRODE USING PRINTING AND BIO-MOLECULE DETECTION USING SAME

A membrane electrode includes a novel sensor combining a filtering function of a membrane and a signal measuring ability of an electrode. A target material may be measured by filtration through the membrane. A small amount of target materials may be detected with high sensitivity using an amplified electrical signal by increasing electrical conductivity by reducing metal ions on the membrane, and thus the target material may be subject to quantitative analysis. In addition, only a target material selectively binding to a receptor may be filtrated by passing a sample through the membrane after a receptor material is fixed to the electrode, and thus may be used to detect an electrical signal. In addition, the sensor may measure a signal in various methods such as electrical conductivity, impedance, etc. 1. A sensor , comprising:an electrode printed on a filtering membrane,wherein an electrical signal is generated in the electrode by passing a reaction solution prepared by mixing a ligand-fixed enzyme or ligand-fixed metal nanoparticle and a sample containing a target material through the filtering membrane.2. The sensor according to claim 1 , wherein the filtering membrane is a filter selected from the group consisting of nitrocellulose claim 1 , polycarbonate claim 1 , nylon claim 1 , polyester claim 1 , cellulose acetate claim 1 , polysulfone claim 1 , and polyethanesulfone.3. The sensor according to claim 1 , wherein the electrode is printed by a screen printing process.4. The sensor according to claim 3 , wherein the electrode is an interdigitated electrode having a gap of 10 to 1000 μm.5. The sensor according to claim 1 , wherein the ligand is an antibody claim 1 , an antigen claim 1 , an enzyme claim 1 , a peptide claim 1 , a protein claim 1 , DNA claim 1 , RNA claim 1 , PNA claim 1 , or an aptamer.6. The sensor according to claim 1 , wherein the enzyme is a peroxidase claim 1 , an alkali phosphatase claim 1 , a galactosidase claim 1 , or a glucose oxidase.7. ...

TRANSCUTANEOUS ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 1. A system for measuring an analyte in a host , comprising: an electronics unit;', 'a mounting unit releasably matable to the electronics unit; and', ["an in vivo portion adapted for insertion through an exit port of the mounting unit and through an exit site of the host's skin; and", "an ex vivo portion adapted to remain above the host's skin after insertion of the in vivo portion and to operably connect to the electronics unit,"], 'a sensor comprising], 'an on-skin assembly comprising{'sup': 3', '3, 'wherein the electronics unit, when releasably mated to the mounting unit, together comprise a subassembly that has a volume of less about 8 cmand a thickness of less than about 10 mm, whereby motion artifacts cased by motion of the subassembly translating to the sensor in vivo is reduced as compared to a subassembly that has a volume of greater than about 8 cmand a thickness of greater than about 10 mm.'}2. The system of claim 1 , wherein the electronics unit claim 1 , when releasably mated to the mounting unit claim 1 , together comprise a subassembly that has a volume of less about 6 cmand a thickness of less than about 9 mm claim 1 , whereby motion artifacts caused by motion of the subassembly translating to the sensor in vivo is reduced as compared to a subassembly that has a volume of greater than about 6 cmand a thickness of greater than about 9 mm.3. The system of claim 1 , wherein the electronics unit and housing each comprise a mutually engaging electrical contact.4. The system of claim 1 , wherein the mounting unit comprises an elastomeric sealing member for sealing the operable connection of the sensor with the electronics unit.5. The system of claim 1 , wherein the sensor exits the mounting unit at an edge or near an edge of the device ...

ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 1. An analyte measuring system , the system comprising:a mounting unit adapted for mounting on a skin of a host;an electronics unit detachably connectable to the mounting unit;a sensor for measuring a level of the analyte, the sensor comprising an in vivo portion for insertion through the skin at an exit site of the host and an ex vivo portion connected to the mounting unit, wherein the sensor is operably connected to the electronics unit when the electronics unit is detachably connected to the mounting unit; anda communication station for receiving and processing analyte measurements received from the electronics unit, wherein the mounting unit comprises an opening configured to releasably receive the electronics unit therein, and wherein the electronics unit and the mounting unit each comprise at least one electrical contact, and wherein each of the at least one electrical contacts is protected from moisture by an elastomeric sealing member that fits within the mounting unit.2. The system of claim 1 , wherein the communication station comprises a hand-held receiver.3. The system of claim 1 , wherein the electronics unit body is designed to be used with a plurality of sensors.4. The system of claim 1 , wherein at least one electrical contact comprises a conductive elastomer.5. The system of claim 4 , wherein the sensor is disposed adjacent to the electrical contact or within the electrical contact.6. The system of claim 1 , wherein the elastomeric sealing member forms an interference fit with the electronics unit.7. The system of claim 1 , wherein the elastomeric sealing member is integral with the mounting unit.8. The system of claim 1 , wherein the sealing member forms a raised portion surrounding the at least one electrical contact.9. The ...

Electrochemical Transdermal Glucose Measurement System Including Microheaters and Process For Forming

A device contains individually controllable sites for electrochemically monitoring an analyte in interstitial fluid of a user. The sites include a conductive pattern attached at a first and second ends thereof to electrode material in a closed-circuit configuration for receiving a first predetermined voltage applied thereto in order to thermally ablate a stratum corneum of a user's skin to access the interstitial fluid and form an open-circuit configuration including first and second portions of the electrode material that are electrically isolated from each other; a sensing area deposited on at least one of the first and second portions of the electrode material; and a measuring component for receiving individual measurement data from the sensing area in response to a second predetermined voltage applied to the open circuit configuration. The individual measurement data is indicative of an amount of the analyte in the interstitial fluid.

SYSTEM AND METHODS FOR PROCESSING ANALYTE SENSOR DATA FOR SENSOR CALIBRATION

Systems and methods for processing sensor analyte data are disclosed, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. The sensor can be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. Reference data resulting from benchtop testing an analyte sensor prior to its insertion can be used to provide initial calibration of the sensor data. Reference data from a short term continuous analyte sensor implanted in a user can be used to initially calibrate or update sensor data from a long term continuous analyte sensor. 1. A method for calibrating a continuous analyte sensor , comprising:receiving sensor data from a continuous analyte sensor, wherein the sensor data comprises at least one sensor data point indicative of a glucose concentration in a host's interstitial fluid;receiving reference data from a reference analyte monitor, wherein the reference data comprises at least one reference data point indicative of a glucose concentration in the host's blood;determining a conversion function for converting the sensor data into estimated blood glucose values, using electronic circuitry, based on a most probable set of parameters that correlates with calibration data, wherein the most probable set of parameters is determined based on a probability analysis; andconverting the sensor data using the conversion function.2. The method of claim 1 , wherein one or more matched data pairs are inputs into the probability analysis claim 1 , wherein the matched data pairs comprise at least one sensor data point matched with at least one reference data point.3. The method of claim 1 , wherein the probability analysis is based on a probability distribution.4. The method of claim 3 , wherein the probability analysis comprises determining a maximum joint probability based on the probability distribution.5. The ...

Vented dispensing device and method

Disclosed is a fluid dispensing device that includes at least one reservoir to hold the therapeutic fluid, at least one other unit requiring communication with ambient air, at least partly, to operate, and at least one housing defining an interior to retain the at least one reservoir and the at least one other unit. The at least one housing has at least one vent port formed on one or more of its walls. The at least one vent port is adapted to direct or communicate air to maintain pressure equilibrium between the air pressure in the interior of the at least one housing and the ambient air pressure outside the at least one housing, and provide communication with the ambient air to the at least one other unit requiring air to enable operation of the at least one other unit.

TISSUE IMPLANTABLE MICROBIOSENSOR

A biosensor system comprises a capillary substrate, conductive electrode, and a plurality of nanoparticles having an enzyme deposited thereon formed in a cavity at one end of the capillary substrate. The substrate may have an optional reinforcing layer (which may be conductive or non-conductive) and optional insulating layer thereon. A cannula having an optional conductive layer, insulating layer, and reference electrode may also form part of the system. 1. A tissue implantable biosensor system comprising:a capillary substrate;a conductive electrode within said capillary substrate, said capillary substrate having a cavity at one end;a plurality of nanoparticles having an enzyme immobilized thereon deposited in said cavity; anda reference electrode.2. The tissue implantable biosensor system of claim 1 , wherein said capillary substrate has an exterior surface coated with a reinforcing material coating.3. The tissue implantable biosensor system of claim 2 , wherein said reinforcing material coating selected from the group consisting of a para-aramid polymer coating claim 2 , carbon nanotube coating claim 2 , and graphene coating.4. The tissue implantable biosensor system of claim 3 , wherein said reinforcing material forms an electric shield around said capillary substrate which reduces electrical noise and dielectric absorption effects in said system.5. The tissue implantable biosensor system of claim 2 , wherein said reinforcing material coating has a thickness from about 2 nm to about 100 nm.6. The tissue implantable biosensor system of claim 2 , wherein said reinforcing material coating has an overlying insulating layer.7. The tissue implantable biosensor system of claim 1 , wherein said conductive electrode comprises a metal or metal alloy wire which is sealed in the capillary substrate and etched to a depth to form said cavity.8. The tissue implantable biosensor system of claim 7 , wherein a resin seals said wire in said capillary substrate.9. The tissue ...

Devices, systems, and methods to compensate for effects of temperature on implantable sensors

Systems and methods for compensating for effects of temperature on implantable sensors are provided. In some embodiments, systems and methods are provided for measuring a temperature to determine a change in temperature in a sensor environment. In certain embodiments, a temperature compensation factor is determined based on a change in temperature of the sensor environment. The temperature compensation factor can be used in processing raw data of an analyte signal to report a more accurate analyte concentration.

Method and Device for Providing Offset Model Based Calibration for Analyte Sensor

Methods and devices to detect analyte in body fluid are provided. Embodiments include processing sampled data from analyte sensor, determining a single, fixed, normal sensitivity value associated with the analyte sensor, estimating a windowed offset value associated with the analyte sensor for each available sampled data cluster, computing a time varying offset based on the estimated windowed offset value, and applying the time varying offset and the determined normal sensitivity value to the processed sampled data to estimate an analyte level for the sensor.

Diffusion layer for an enzymatic in vivo sensor

Electrode systems are disclosed for measuring the concentration of an analyte under in vivo conditions, where the systems includes an electrode with immobilized enzyme molecules and an improved diffusion barrier that controls diffusion of the analyte from body fluid surrounding the electrode system to the enzyme molecules. Methods of making and using the system also are disclosed.

Sensor module with enhanced capillary flow

A sensor module is disclosed herein. The sensor module includes a main housing defining an analysis zone within the housing. The sensor module also includes a skin piercing member mounted within the main housing. The skin piercing member is movable relative to the main housing between a retracted position and an extended position. The main housing of the sensor module defines a fluid sample flow passage that extends from a sampling end of the main housing to the analysis zone. The fluid sample flow passage includes a funnel structure through which the skin piecing member extends when in the extended position. The fluid sample flow passage also includes capillary flow enhancing slots that extend outwardly from opposite sides of the funnel structure.

Analyte sensor

Devices and methods are provided for continuous measurement of an analyte concentration. The device can include a sensor having a plurality of sensor elements, each having at least one characteristic that is different from other sensor(s) of the device. In some embodiments, the plurality of sensor elements are each tuned to measure a different range of analyte concentration, thereby providing the device with the capability of achieving a substantially consistent level of measurement accuracy across a physiologically relevant range. In other embodiments, the device includes a plurality of sensor elements each tuned to measure during different time periods after insertion or implantation, thereby providing the sensor with the capability to continuously and accurately measure analyte concentrations across a wide range of time periods. For example, a sensor system 180 is provided having a first working electrode 150 comprising a first sensor element 102 and a second working electrode 160 comprising a second sensor element 104 , and a reference electrode 108 for providing a reference value for measuring the working electrode potential of the sensor elements 102, 104.

Collagen scaffolds, medical implants with same and methods of use

The subject invention concerns non-degradable three dimensional porous collagen scaffolds and coatings. These scaffolds can be prepared around sensors for implantation into a body. A specific embodiment of the invention concerns implantable glucose sensors. Sensors comprising a collagen scaffold of the invention have improved biocompatibility by minimizing tissue reactions while stimulating angiogenesis. The subject invention also concerns methods for preparing collagen scaffolds of the invention. The subject invention also concerns sensors that have a collagen scaffold of the invention around the exterior of the sensor.

Method and Apparatus for Providing Glycemic Control

Methods to provide glycemic control and therapy management based on monitored glucose data, and current and/or target HblAC levels are provided. Systems to provide glycemic control and therapy management based on monitored glucose data, and current and/or target HblAC levels are provided. Kits to provide glycemic control and therapy management based on monitored glucose data, and current and/or target HblAC levels are provided. 1. A method implemented using one or more processors , comprising:determining a correlation between a mean glucose value information and an HbAlC level associated with a subject;determining a rate of glycation of the subject based at least in part on the determined correlation between the mean glucose value information and the HbAlC level;applying one or more subject specific parameters to the determined correlation between the mean glucose value information and the HbAlC level; and 'wherein the one or more subject specific parameters includes an age of the subject, an activity level of the subject, a medication intake information of the subject, or a living condition of the subject.', 'determining a target HbAlC level based on determining the rate of glycation of the subject and applying the one or more subject specific parameters to the determined correlation;'}2. The method of claim 1 , wherein the mean glucose value information includes applying a weighting function to monitored glucose level information over a predetermined time period.3. The method of claim 2 , wherein the weighting function is based on a time of day information associated with the monitored glucose level information.4. The method of claim 2 , wherein the weighting function is based on a time period associated with the monitored glucose level information.5. The method of claim 2 , wherein the predetermined time period includes one of approximately 30 days claim 2 , approximately 45 days claim 2 , or approximately 90 days.6. The method of claim 1 , further including ...

BIOSENSOR

A biosensor having a hollow coil having wires coiled in parallel and an electronic circuit component operably connected to the coil, wherein the wires include at least a first coiled wire which may be used as a counter electrode, a second coiled wire which may be used as a working electrode and a third coiled wire which may be used as a reference electrode, wherein the second coiled wire is provided with a biocompatible layer having a bioreceptor, wherein the electronic circuit component is capable of generating an input signal for a transceiver based upon the activity of the bioreceptor and wirelessly sending the input signal to the transceiver, wherein the electronic circuit component is encapsulated in a biocompatible resin. 1. A biosensor , comprising: a hollow coil comprising wires coiled in parallel and an electronic circuit component operably connected to the coil ,wherein the wires include at least a first coiled wire which is used as a counter electrode, a second coiled wire which is used as a working electrode and a third coiled wire which is used as a reference electrode,wherein the second coiled wire is provided with a biocompatible layer comprising a bioreceptor,wherein the electronic circuit component is capable of generating an input signal for a transceiver based upon the activity of the bioreceptor and wirelessly sending the input signal to the transceiver andwherein the electronic circuit component is encapsulated in a biocompatible resin.2. The sensor according to claim 1 , wherein the second coiled wire has a Pt surface.3. The sensor according to claim 1 , wherein the biocompatible layer comprising the bioreceptor is electroconductive.5. The sensor according to claim 1 , wherein the coil is encapsulated in a top layer of a biocompatible material.6. The sensor according to claim 5 , wherein the biocompatible material is a hydrophilic material.7. The sensor according to claim 6 , wherein the hydrophilic material is chosen from the group consisting ...

System and apparatus for determining temperatures in a fluid analyte system

A test sensor includes a body, a first conductive trace, a second conductive trace, and a third conductive trace. The body includes a first region that has a fluid-receiving area, a second region separate from the first region, and a first temperature sensing interface disposed at or adjacent to the fluid-receiving area. The fluid-receiving area receives a sample. The first trace is disposed on the body, and at least a portion of the first trace is disposed in the first region. The second and third traces are disposed on the body. The third trace extends from the first to the second regions. The third trace is connected to the first trace at the first temperature sensing interface. The third trace includes a different material than the first trace. A first thermocouple is formed at the first temperature sensing interface. The thermocouple provides temperature data to determine an analyte concentration.

MULTIPLE ELECTRODE SYSTEM FOR A CONTINUOUS ANALYTE SENSOR, AND RELATED METHODS

In one embodiment, a continuous analyte sensor having more than one working electrode, and configured to reduce or eliminate crosstalk between the working electrodes. In another embodiment, a continuous analyte sensor having more than one working electrode, and configured so that a membrane system has equal thicknesses over each of the electrodes, despite having differing numbers of layers over each of the electrodes. In another embodiment, a configuration for connecting a continuous analyte sensor to sensor electronics. In another embodiment, methods for forming precise windows in an insulator material on a multi-electrode assembly. In another embodiment, a contact assembly for a continuous analyte sensor having more than one working electrode. 1. A continuous analyte sensor , comprising:a first working electrode;a second working electrode; anda membrane overlying at least a portion of the sensor, including the first and second working electrodes, the membrane being continuous, but for a first portion located between the first and second working electrodes that has properties that differ from properties of other portions of the membrane.2. The continuous analyte sensor of claim 1 , wherein at least one of the properties is permeability.3. The continuous analyte sensor of claim 2 , wherein the first portion is cross-linked.4. The continuous analyte sensor of claim 2 , wherein the other portions are cross-linked claim 2 , and the first portion is cross-linked by an amount different from the other portions.5. The continuous analyte sensor of claim 2 , wherein the first portion has a lower content of a hydrophilic species than the other portions.6. The continuous analyte sensor of claim 5 , wherein the hydrophilic species is removed by a secondary removal process claim 5 , a leaching process claim 5 , or a precipitation process involving heat claim 5 , pH claim 5 , or solvents.7. The continuous analyte sensor of claim 1 , wherein the first portion comprises a ...

Method and System for Powering an Electronic Device

Methods and apparatus for providing a power supply to a device, including an inductive rechargeable power supply for a data monitoring and management system in which a high frequency magnetic field is generated to provide power supply to a rechargeable power source such as a battery of a transmitter unit in the data monitoring and management system are provided.

Analyte Sensor

Systems and methods of use for continuous analyte measurement of a host's vascular system are provided. In some embodiments, a continuous glucose measurement system includes a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host's circulatory system. 1. An integrated sensor system for measuring an analyte in a sample of a host and for fluid infusion into the host , comprising:an analyte sensor configured and arranged for measuring an analyte concentration in a biological sample of a circulatory system of a host;a vascular access device;tubing assembly comprising tubing; anda flow control device configured to regulate exposure of the analyte sensor to a biological sample and to a reference solution according to a flow profile, wherein the flow control device comprises a valve, and wherein the valve is configured and arranged with a gravity flow position and a controlled flow position.2. The system of claim 1 , wherein the system is configured such that the analyte sensor is flushed by the reference solution when the valve is in the gravity flow position.3. The system of claim 2 , wherein the gravity flow position comprises a first flow rate of the solution claim 2 , wherein the controlled flow position comprises a second flow rate of the solution claim 2 , and wherein a ratio of the first flow rate to the second flow rate is at least about 10:1.4. The system of claim 3 , wherein the gravity flow position has a flow rate of at least about 600 ml/hr.5. The system of claim 3 , wherein the controlled flow position has a flow rate of from about 0.5 ml/hr to about 4.0 ml/hour.6. The system of claim 1 , wherein the valve is configured and arranged to receive the tubing in a substantially linear configuration.7. The system of claim 6 , wherein the valve and the tubing assembly are configured and arranged such that the tubing is in a stretched state after installation of the tubing in the valve.8. ...

ZWITTERION SURFACE MODIFICATIONS FOR CONTINUOUS SENSORS

Devices are provided for measurement of an analyte concentration, e.g., glucose in a host. The device can include a sensor configured to generate a signal associated with a concentration of an analyte; and a sensing membrane located over the sensor. The sensing membrane comprises a diffusion resistance domain configured to control a flux of the analyte therethrough. The diffusion resistance domain comprises one or more zwitterionic compounds and a base polymer comprising both hydrophilic and hydrophobic regions. 1. A device for measurement of an analyte concentration , the device comprising:a sensor configured to generate a signal associated with a concentration of an analyte; anda sensing membrane located over the sensor, the sensing membrane comprising a diffusion resistance domain configured to control a flux of the analyte therethrough, wherein the diffusion resistance domain comprises a base polymer and one or more zwitterionic compounds, and wherein the base polymer comprises both hydrophilic and hydrophobic regions.2. The device of claim 1 , wherein an amount of the one or more zwitterionic compounds in the diffusion resistance domain is less than about 10% wt. of the resistance domain.3. The device of claim 1 , wherein an amount of the one or more zwitterionic compounds in the diffusion resistance domain is less than about 5% wt. of the resistance domain.4. The device of claim 1 , wherein the one or more zwitterionic compounds comprise a betaine compound or derivative thereof.5. The device of claim 1 , wherein the one or more zwitterionic compounds comprise at least one compound selected from the group consisting of a carboxyl betaine compound claim 1 , a sulfo betaine compound claim 1 , a phosphor betaine compound claim 1 , and derivatives thereof.6. The device of claim 1 , wherein the one or more zwitterionic compounds comprise at least one compound selected from the group consisting of cocamidopropyl betaine claim 1 , oleamidopropyl betaine claim 1 , ...

IN-BODY SENSOR HEALTH DIAGNOSTICS USING VSET BASED METHODS

Vset-based systems and methods for performing sensor health diagnostics are disclosed. Methods and systems for in-body glucose sensor health diagnostics may use steady-state Isig characterization under full-range operating Vsets, transient Isig response characterization after Vset alternations, transient Vset characterization, and open circuit potential measurements for estimating sensor health and for monitoring sensor properties. 1. A real-time diagnostic method for a glucose sensor used for measuring the level of glucose in the body of a user , said sensor including physical sensor electronics , a microcontroller , and a working electrode , the method comprising:periodically measuring, by the physical sensor electronics, electrode current (Isig) signals for the working electrode for a plurality of Vset values within a range of Vset values, wherein Vset is the operating potential for said sensor, and wherein each said measured Isig signal includes a steady-state signal component and a transient signal component;generating, by the microcontroller, a set of Isig-Vset pairs over time, each said pair comprising the steady-state signal component of one of said periodically measured Isig signals and its corresponding Vset value;generating, by the microcontroller, an Isig-Vset plot based on a plurality of said Isig-Vset pairs;determining, by the microcontroller, based on said Isig-Vset plot, whether the sensor is healthy; andwhen it is determined that the sensor is not healthy, blanking glucose sensor measurements to the user.2. The method of claim 1 , wherein said range of Vset values is determined by said sensor's specific design.3. The method of claim 1 , wherein said plurality of Vset values are uniformly distributed between a minimum Vset value and a maximum Vset value.4. The method of claim 3 , wherein said uniform distribution further includes a step resolution parameter.5. The method of claim 1 , wherein said plurality of Vset values are non-uniformly distributed ...

Near-ir glucose sensors

Glucose-sensing luminescent dyes, polymers, and sensors are provided. Additionally, systems including the sensors and methods of using these sensors and systems are provided.

Apparatus and methods for analyte sensor spatial mismatch mitigation and correction

Apparatus and methods for reducing error due to spatial arrangement of sensor elements in a parameter sensor such as a physiologic analyte sensor. In one exemplary embodiment, the analyte sensor is configured to measure an analyte of a living being (e.g., blood glucose), and the apparatus and methods employ determination of a blood analyte concentration based on a prescribed relationship of N1/N2—i.e., N1 analyte modulated sensing elements (e.g., glucose electrodes) associated with and proximate to N2 background sensing elements of the sensor—in order to compensate for response differences due to spatial arrangement of the sensor elements or “spatial mismatch.” This configuration of sensor elements and method of determining blood analyte concentration (based on multiple background signal electrodes) enables increased accuracy of the sensor.

PROTECTIVE FILM MATERIAL FOR BIOSENSOR PROBE

The present disclosure provides, as a film structure useful for a probe of a biosensor, a film structure comprising a detection layer including an analyte-responsive enzyme; and a protection film formed on the detection layer, in which the protection film includes a copolymer mixture including poly(styrene-ran-4-vinylpyridine-ran-propyleneglycol methacrylate); and poly(4-vinylpyridine)-block-poly(Calkyl methacrylate), or poly(4-vinylpyridine-ran-2-hydroxyethyl methacrylate). 13-. (canceled)5. The protection film according to claim 4 , wherein in Formula 1 R is an alkyl group having 3 to 6 carbon atoms.6. The protection film according to claim 5 , wherein the polymer represented by Formula 1 is crosslinked with polyethylene glycol diglycidyl ether (PEGDGE).7. The protection film according to claim 4 , wherein the protection film further includes poly(2-methoxyethylacrylate).8. The protection film according to claim 5 , wherein the protection film further includes poly(2-methoxyethylacrylate).9. The protection film according to claim 6 , wherein the protection film further includes poly(2-methoxyethylacrylate).11. The protection probe according to claim 10 , wherein the protection film covers the working electrode claim 10 , the reference electrode claim 10 , the counter electrode claim 10 , and the detection layer.12. The protection probe according to claim 10 , wherein in Formula 1 R is an alkyl group having 3 to 6 carbon atoms.13. The protection probe according to claim 10 , wherein the polymer represented by Formula 1 is crosslinked with polyethylene glycol diglycidyl ether (PEGDGE).14. The protection probe according to claim 10 , wherein the protection film further includes poly(2-methoxyethylacrylate).15. The protection probe according to claim 11 , wherein the protection film further includes poly(2-methoxyethylacrylate).16. The protection probe according to claim 12 , wherein the protection film further includes poly(2-methoxyethylacrylate).17. The protection ...

Advanced analyte sensor calibration and error detection

Systems and methods for processing sensor data and self-calibration are provided. In some embodiments, systems and methods are provided which are capable of calibrating a continuous analyte sensor based on an initial sensitivity, and then continuously performing self-calibration without using, or with reduced use of, reference measurements. In certain embodiments, a sensitivity of the analyte sensor is determined by applying an estimative algorithm that is a function of certain parameters. Also described herein are systems and methods for determining a property of an analyte sensor using a stimulus signal. The sensor property can be used to compensate sensor data for sensitivity drift, or determine another property associated with the sensor, such as temperature, sensor membrane damage, moisture ingress in sensor electronics, and scaling factors.

Health Management Devices and Methods

Methods and devices and systems including a communication module operatively coupled to a data collection module for communicating the stored analyte related data after the analyte related data is stored in the data collection module over a predetermined time period, and a user interface unit configured to communicate with the communication module to receive from the communication module the stored analyte related data in the data collection module over the predetermined time period, and to output information associated with the monitored analyte level, where the user interface unit is configured to operate in a prospective analysis mode including substantially real time output of information associated with the monitored analyte level, or a retrospective analysis mode including limited output of information during the predetermined time period wherein no information related to the monitored analyte level is output during the predetermined time period, are provided. 1. An analyte monitoring system , comprising:a transcutaneous analyte sensor configured to be positioned at least in part in contact with a fluid under a skin layer and to generate analyte data over a predetermined time period;a data collection module operatively coupled to the transcutaneous analyte sensor for receiving and storing the analyte data over the predetermined time period;a control unit operatively coupled to the data collection module and configured to control, at least in part the operation of the data collection module;a communication module operatively coupled to the control unit, the communication module configured to communicate the analyte data; anda receiver unit operatively coupled to the communication module and configured to receive the analyte data,wherein the receiver unit is configured to display information related to the analyte monitoring system and is configured to not display the analyte data.2. The system of claim 1 , wherein the communication module is configured to ...

ANALYTE SENSORS AND METHODS OF MANUFACTURING SAME

Analyte sensors and methods of manufacturing same are provided, including analyte sensors comprising multi-axis flexibility. For example, a multi-electrode sensor system comprising two working electrodes and at least one reference/counter electrode is provided. The sensor system comprises first and second elongated bodies E, E, each formed of a conductive core or of a core with a conductive layer deposited thereon, insulating layer that separates the conductive layer from the elongated body, a membrane layer deposited on top of the elongated bodies E, E, and working electrodes ″ formed by removing portions of the conductive layer and the insulating layer , thereby exposing electroactive surface of the elongated bodies E, E 1. A continuous analyte sensor configured for in vivo use , the continuous analyte sensor comprising:an elongated conductive body comprising a working electrode; anda membrane covering at least a portion of the working electrode;wherein the continuous analyte sensor has a fatigue life of at least 20 cycles of flexing of from about 45° to about −45° at a bend radius of about 0.031-inches.2. The continuous analyte sensor of claim 1 , wherein the elongated conductive body comprises an elongated core claim 1 , an insulating layer covering at least a portion of the elongated core claim 1 , a conductive layer comprising a reference electrode or a counter electrode and covering at least a portion of the insulating layer claim 1 , and a membrane covering at least a portion the working electrode.3. The continuous analyte sensor of claim 2 , wherein the elongated core comprises an elongated body and a layer of conductive material covering at least a portion of the elongated body.4. The continuous analyte sensor of claim 3 , wherein the elongated body comprises at least one material selected from the group consisting of stainless steel claim 3 , titanium claim 3 , tantalum claim 3 , and a polymer.5. The continuous analyte sensor of claim 3 , wherein the ...

Analyte Sensor Calibration Management

Methods and devices to detect analyte in body fluid are provided. Embodiments include positioning an analyte sensor in fluid contact with an analyte, detecting an attenuation in a signal from an analyte sensor after positioning during a predetermined time period, categorizing the detected attenuation in the analyte sensor signal based, at least in part, on one or more characteristics of the signal, performing signal processing to generate a reportable data associated with the detected analyte sensor signal during the predetermined time period, managing if and when to request additional reference signal measurements, and managing if and when to temporarily not display results. 1positioning an analyte sensor in fluid contact with an analyte;detecting an attenuation in a signal from an analyte sensor after positioning during a predetermined time period;categorizing the detected attenuation in the analyte sensor signal based, at least in part, on one or more characteristics of the signal; andperforming signal processing to generate a reportable data associated with the detected analyte sensor signal during the predetermined time period.. A method, comprising: The present application is a continuation of U.S. patent application Ser. No. 15/017,568 filed Feb. 5, 2016, now U.S. Pat. No. 9,730,623, which is a continuation of U.S. patent application Ser. No. 14/270,332 filed May 5, 2014, which is a continuation of U.S. patent application Ser. No. 13/729,075 filed Dec. 28, 2012, now U.S. Pat. No. 8,718,739, which is a continuation of U.S. patent application Ser. No. 12/363,712 filed Jan. 30, 2009, now U.S. Pat. No. 8,346,335, which claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 61/040,633 filed Mar. 28, 2008 entitled “Analyte Sensor Calibration Management,” and assigned to the assignee of the present application, Abbott Diabetes Care Inc. of Alameda, Calif., the disclosures of each of which are incorporated herein by reference for all purposes.The ...

THERMOSENSITIVE NANOSENSOR FOR INSTANTANEOUS TRANSCUTANEOUS BIOLOGICAL MEASUREMENT

A thermosensitive nanosensor includes a substrate having a plurality of vertically standing nanostructures attached thereto, the plurality of vertically standing nanostructure being covered with a conductive material to form conductive coated nanostructures; a thermosensitive hydrogel adjacent to the plurality of conductive coated nanostructures; and a cover layer on top of the thermosensitive hydrogel to prevent loss of moisture and mechanical stress. 1. A thermosensitive nanosensor comprising:a substrate having a plurality of vertically standing nanostructures attached thereto, the plurality of vertically standing nanostructure being covered with a conductive material to form conductive coated nanostructures;a thermosensitive hydrogel adjacent to the plurality of conductive coated nanostructures;a cover layer on top of the thermosensitive hydrogel to prevent loss of moisture and mechanical stress.2. The thermosensitive nanosensor of claim 1 , wherein the substrate includes a fabric sandwiched between an insulating layer and conductive layer.3. The thermosensitive nanosensor of claim 1 , wherein the cover layer encases the thermosensitive hydrogel4. The thermosensitive nanosensor of wherein the cover layer is provided as coating over the thermosensitive hydrogel.5. The thermosensitive nanosensor of claim 1 , wherein each of the plurality of the conductive coated nanostructures are coated with the hydrogel claim 1 , and the hydrogel is coated with the cover layer.6. The thermosensitive nanosensor of claim 1 , wherein the thermosensitive hydrogel is interdispersed among the conductive coated nanostructures.7. The thermosensitive nanosensor of claim 6 , wherein the thermosensitive hydrogel includes a plurality of hydrogel strips.8. The thermosensitive nanosensor of claim 1 , wherein the thermosensitive hydrogel surrounds the plurality of the conductive coated nanostructures.9. The thermosensitive nanosensor of claim 1 , wherein the thermosensitive hydrogel and cover ...

BIO-ADAPTABLE IMPLANTABLE SENSOR APPARATUS AND METHODS

Biocompatible implantable sensor apparatus and methods of implantation and use. In one embodiment, the sensor apparatus is an oxygen-based glucose sensor having biocompatibility features that mitigate the host tissue response. In one variant, these features include use of a non-enzymatic membrane over each of the individual analyte detectors so as to preclude contact of the surrounding tissue with the underlying enzyme or other matrix, and mitigate vascularization, and insulation of the various electrodes and associated electrolytic processes of the sensor from the surrounding tissue. In one implementation, the sensor region of the implanted apparatus is configured to interlock or imprint the surrounding tissue so as to promote a high degree of glucose molecule diffusion into the individual detectors, and a constant and predictable sensor to blood vessel interface, yet preclude the tissue from bonding to the sensor, especially over extended periods of implant. 1. An implantable analyte sensor , comprising:a biocompatible housing having a size and shape suitable for implantation in a body;a plurality of analyte detectors;circuitry operatively connected to the plurality of detectors and configured to process at least a portion of signals generated by one or more of the detectors to produce processed signals;data transmission apparatus configured to transmit at least a portion of said processed signals to a receiver when the implanted sensor is disposed in a tissue environment within said body; andan electrical power source operatively coupled to at least the circuitry and data transmission apparatus and configured to provide electrical power thereto; andwherein said sensor further comprises apparatus configured to promote interlock of at least a portion of said plurality of detectors with biological tissue of the body proximate thereto without substantive blood vessel ingrowth.2. The sensor of claim 1 , wherein the analyte comprises blood glucose claim 1 , and the ...

AMPEROMETRIC SENSOR AND METHOD FOR ITS MANUFACTURING

An in vivo amperometric sensor is provided for measuring the concentration of an analyte in a body fluid. The sensor comprises a counter electrode and a working electrode, and the working electrode comprises a sensing layer which is generally water permeable and arranged on a support member adjacent to a contact pad. The sensing layer comprises an immobilized enzyme capable of acting catalytically in the presence of the analyte to cause an electrical signal. The sensing layer has an upper surface facing the body fluid and a lower surface facing away from the body fluid, and the immobilized enzyme is distributed within the sensing layer in such a way that the enzyme concentration in the middle between the upper and lower surfaces is at least as high as on the upper surface of the sensing layer. 132-. (canceled)33. A method of using an in vivo amperometric biosensor of the type having working and counter electrodes arranged on a support member , the working electrode having a sensing layer with immobilized enzyme distributed therein , the method comprising:implanting the sensor into a body part to bring the sensing layer into contact with body fluid having an analyte; andcontrolling the rate of analyte diffusion through the sensor so that diffusion of the analyte in the sensing layer is the rate-limiting step in generating a signal corresponding to analyte concentration.34. The method of claim 33 , further comprising providing the sensing layer with an effective diffusion coefficient Dof analyte through the sensing layer of about 10-times to about 1000-times lower than the coefficient D of the analyte in water.35. The method of claim 33 , further comprising providing a diffusion barrier above the sensing layer claim 33 , wherein the diffusion barrier inhibits diffusion of analyte into the sensor to the extent that analyte concentration at the upper surface of the sensing layer is at most about ten times lower than in the body fluid surrounding the implanted sensor.36. ...

Temperature-Insensitive Membrane Materials and Analyte Sensors Containing the Same

Membranes permeable to an analyte may overlay the active sensing region of a sensor to limit the analyte flux and improve the response linearity of the sensor. Temperature variation of the analyte permeability can be problematic in some instances. Polymeric membrane compositions having limited variation in analyte permeability as a function of temperature may comprise: a polymer backbone comprising one or more side chains that comprise a heterocycle; and an amine-free polyether arm appended, via an alkyl spacer or a hydroxy-functionalized alkyl spacer, to the heterocycle of at least a portion of the one or more side chains. 1. A polymeric membrane composition comprising:a polymer backbone comprising one or more side chains that comprise a heterocycle; andan amine-free polyether arm appended, via an alkyl spacer or a hydroxy-functionalized alkyl spacer, to the heterocycle of at least a portion of the one or more side chains.2. The polymeric membrane composition of claim 1 , wherein the polymer backbone comprises a polyvinylpyridine or a polyvinylimidazole.3. The polymeric membrane composition of claim 2 , wherein the polymer backbone comprises a copolymer of vinylpyridine and styrene.4. The polymeric membrane composition of claim 1 , wherein the amine-free polyether arm comprises at least one polyethylene oxide block and at least one polypropylene oxide block claim 1 , the amine-free polyether arm being bound to a heterocyclic or heteroaromatic nitrogen atom in a side chain of the polymer backbone.6. The polymeric membrane composition of claim 5 , wherein x ranges between about 8 and about 16 claim 5 , y ranges between about 10 and about 32 claim 5 , and z ranges between about 10 and about 20.7. The polymeric membrane composition of claim 5 , wherein x≤z.8. The polymeric membrane composition of claim 5 , wherein a ratio of (x+z):y is at least about 1.7:1.9. The polymeric membrane composition of claim 5 , wherein a ratio of (x+z):y ranges between about 1.7:1 and about ...

Layered sensors and methods of using

Layered implantable sensors are described herein. Layered sensors described herein may include one or more analyte sensing populations. The one or more analyte sensing populations may detect different analytes, or different concentrations of the same analyte, for example. The layered sensors may include a reference population. The reference population may, or may not, be analyte sensing. As described herein, the first sensing population may be separated from a second sensing population (and/or a reference population) by a passive layer.

ANALYTE SENSORS FEATURING ENHANCEMENTS FOR DECREASING INTERFERENT SIGNAL

Analyte sensors are being increasingly employed for monitoring various analytes in vivo. Analyte sensors may feature enhancements to address signals obtained from interferent species. Some analyte sensors may comprise a working electrode comprising an active area disposed thereon and electrode asperities laser planed therefrom. Some analyte sensors may comprise an interferent-reactant species incorporated therewith. Some analyte sensors may comprise an interferent scrubbing electrode. Combinations of these enhancements may additionally be employed. 1. An analyte sensor comprising:a working electrode comprising an active area disposed thereon, the active area including an analyte-responsive enzyme; anda scrubbing electrode, wherein the scrubbing electrode is (1) positioned in a facing relationship to the working electrode and the working electrode and scrubbing electrode are spatially offset or (2) positioned above the working electrode and is permeable to an analyte of interest for diffusion of the analyte of interest to the active area.2. The analyte sensor of claim 1 , wherein the scrubbing electrode is positioned in a facing relationship to the working electrode and the working electrode and scrubbing electrode are spatially offset claim 1 , the offset being a thin layer in the range of about 1 μm to about 200 μm.3. The analyte sensor of claim 1 , wherein the scrubbing electrode has a width of about 200 μm to about 8000 μm.4. The analyte sensor of claim 1 , wherein the scrubbing electrode is positioned in a facing relationship to the working electrode and the working electrode and scrubbing electrode are spatially offset claim 1 , and the width of the scrubbing electrode to the working electrode is in the range of about 2:1 to about 50:1.5. The analyte sensor of claim 1 , wherein the scrubbing electrode has a potential in the range of about −2000 mV to about +2000 mV.6. The analyte sensor of claim 1 , wherein the scrubbing electrode is positioned above the ...

COMPOSITIONS AND METHODS FOR MEASURING BLOOD GLUCOSE LEVELS

In some embodiments, the present invention a mutated FAD-GDHa protein, wherein the mutated FAD-GDHa protein is mutated from a wild-type first species to contain at least one point mutation, wherein the mutated FAD-GDHα protein comprises: P(X)X4(X)V(X)RN(X)YDXRPXCXGXNNCMP(X)CP(X)A(X)Y(X)G(X)A(X)AG(X)AVV(X)E(X)A(X)Y(X)D(X)HRV(X)V(X)A(X)E(X)K(X)S(X)P(X)G(X)N(X)GRN(X)MDH(X)V(X)F(XW(X)GRGP(X)RDGXXR(X)T(X)L(X)X(X)X(X)E(X)P(X)NR(X)S(X)D(X)G(X)Y(X)Y(X), wherein each X represents a wild-type amino acid residue of the first species and n indicates the number of the wild-type amino acid residues of the first species represented by a respective parenthetical at that position, wherein: a) Xis selected from the group consisting of X, S, C, T, M, V, Y, N, P, L, G, Q, A, I, D, W, H, and E, wherein if Xis L, H or V, then Xis D; b) Xis selected from the group consisting of G, H, D, Y, S, and X; c) Xis selected from the group consisting of S and X; and d) Xis selected from the group consisting of S and X. 1. A mutated FAD-GDH protein , wherein the mutated FAD-GDHα protein is mutated from a wild-type first species to contain at least one point mutation , wherein the mutated FAD-GDHα protein comprises: P(X)X(X)V(X)RN(X)YDXRPXCXGXNNCMP(X)CP(X)A(X)Y(X)G(X)A(X)AG(X)AVV(X)E(X)A(X)Y(X)D(X)HRV(X)V(X)A(X)E(X)K(X)S(X)P(X)G(X)N(X)GRN(X)MDH(X)V(X)F(X)W(X)GRGP(X)RDGXXR(X)T(X)L(X)X(X)(X)E(X)P(X)NR(X)S(X)D(X)G(X)Y(X)Y(X) , wherein each X represents a wild-type amino acid residue of the first species and n indicates the number of the wild-type amino acid residues of the first species represented by a respective parenthetical at that position , wherein:{'sup': 1', '1', '2, 'a) Xis selected from the group consisting of X, S, C, T, M, V, Y, N, P, L, G, Q, A, I, D, W, H, and E, wherein if Xis L, H or V, then Xis D;'}{'sup': '3', 'b) Xis selected from the group consisting of G, H, D, Y, S, and X;'}{'sup': '4', 'c) Xis selected from the group consisting of S and X; and'}{'sup': '5', 'd) Xis selected from ...

METHOD AND APPARATUS FOR ANALYTE DETECTION USING AN ELECTROCHEMICAL BIOSENSOR

A method for sensing an analyte utilizing a sensor having a working electrode, the method includes providing the working electrode with an analyte-specific enzyme and a redox mediator, providing the working electrode to the analyte, accumulating charge derived from the analyte reacting with the analyte-specific enzyme and the redox mediator for a set period of time, connecting the working electrode to circuit after the set period of time, and measuring the signal from the accumulated charge. 1. A method for sensing an analyte utilizing a sensor , the sensor including a working electrode , the method comprising:providing the working electrode with an analyte-specific enzyme and a redox mediator;providing the working electrode to the analyte;accumulating charge derived from the analyte reacting with the analyte-specific enzyme and the redox mediator for a set period of time;connecting the working electrode to a circuit after the set period of time; andmeasuring a signal from the accumulated charge.2. The method of claim 1 , wherein prior to providing the working electrode to an analyte claim 1 , the method further comprises connecting the working electrode to the circuit claim 1 , and prior to providing the working electrode to the analyte claim 1 , the method further comprises disconnecting the working electrode from the circuit.3. The method of claim 1 , wherein the working electrode is connected to the circuit prior to providing the working electrode to the analyte claim 1 , the method further comprises disconnecting the working electrode from the circuit prior to providing the working electrode to the analyte.4. The method of claim 1 , wherein the sensor is an enzymatic electrochemical biosensor.5. The method of claim 1 , wherein the redox mediator is an immobilized redox polymer.6. The method of claim 1 , wherein the analyte is selected from the group consisting of cortisol claim 1 , glucose claim 1 , lactate claim 1 , 3-hydroxy butyrate claim 1 , alcohol claim 1 ...

Porous Polymeric Formulation Prepared Using Porogens

An analyte sensor for the continuous or semi-continuous monitoring of physiological parameters and a method for making the analyte sensor are disclosed. The analyte sensor includes a crosslinked copolymer network in contact with a surface of an electrode. The copolymer network has voids formed by the removal of a porogen, and an analyte sensing component is immobilized within the network. The method involves forming a solution of the precursors of the copolymer, depositing the mixture on a surface of an electrode, and curing the deposited mixture to provide the analyte sensor.

DIFFUSION BARRIERS AND SPACER MEMBRANES FOR ENZYMATIC IN-VIVO SENSORS

An electrode system is disclosed for measuring a concentration or presence of an analyte under in-vivo conditions, where the electrode system includes at least one electrode with immobilized enzyme molecules and an improved diffusion barrier that controls diffusion of the analyte from body fluid surrounding the electrode system to the enzyme molecules. The diffusion barrier includes a hydrophilic polyurethane or a block copolymer having at least one hydrophilic block and at least one hydrophobic block. The electrode system also can include a spacer membrane that includes a hydrophilic copolymer of acrylic and/or methacrylic monomers. 1. An electrode system for measuring a concentration or presence of an analyte under in-vivo conditions , the electrode system comprising:an electrode having immobilized enzyme molecules thereupon;an optional diffusion barrier that controls diffusion of the analyte from an exterior of the electrode system to the immobilized enzyme molecules; anda spacer membrane that forms at least a portion of an outer layer of the electrode system, wherein the spacer membrane comprises a hydrophilic copolymer of acrylic and/or methacrylic monomers, and wherein the hydrophilic copolymer comprises more than 50 mol-% hydrophilic monomers.2. The electrode system of claim 1 , wherein the spacer membrane is a hydrophilic copolymer from at least two or three acrylic and/or methacrylic monomers.3. The electrode system of claim 1 , wherein the hydrophilic monomers are hydrophilic (meth)acrylesters with a polar group claim 1 , hydrophilic (meth)acrylamides claim 1 , (meth)acrylic acid claim 1 , or combinations thereof.4. The electrode system of claim 3 , wherein the hydrophilic monomers are selected from the group consisting of 2-hydroxyethyl acrylate claim 3 , 2-hydroxyethyl methacrylate (HEMA) claim 3 , 2-methoxyethyl acrylate claim 3 , 2-methoxyethyl methacrylate claim 3 , 2-ethoxyethyl acrylate claim 3 , 2-ethoxyethyl methacrylate claim 3 , 2- or 3- ...

VIRTUAL REALITY BIOFEEDBACK SYSTEMS AND METHODS

A biofeedback virtual reality (VR) system and methods are provided for improving, optimizing, or minimizing the physiological or psychological effects of a medical condition, such as a physiological or psychological condition of a patient. The biofeedback VR System monitors one or more physiological parameters while presenting an immersive VR environment. The system and method comprise a closed-loop biofeedback system where a user (i.e., patient) observes a VR Experience provided by the VR System. The VR System monitors one or more physiological parameters while guiding the user to an improved (or optimized) physiological state through improvement of one or more of the physiological parameters. In some embodiments, a social experience is included in the VR, where the user engages with one or more other users in the VR Experience. 117-. (canceled)18. A method of treating a patient using a virtual reality biofeedback experience , the method comprising:providing the patient with a first virtual reality computing and display system operative to present a shared virtual reality experience that depicts a first virtual object in a first state, wherein the first virtual object does not represent the patient and does not represent a symptom the patient is experiencing;providing another patient with a second virtual reality computing and display system operative to present the shared virtual reality experience that depicts a second virtual object in the first state, wherein the second virtual object does not represent the patient and does not represent a symptom the patient is experiencing;receiving physiological data that represents modulation of the mind or body of the patient and the another patient while the shared virtual reality experience is provided to the patient;altering the shared virtual reality experience by causing the first virtual object to transition from the first state to a second state in response to processing the received physiological data of the ...

POLYMER MEMBRANES FOR CONTINUOUS ANALYTE SENSORS

Devices and methods are described for providing continuous measurement of an analyte concentration. In some embodiments, the device has a sensing mechanism and a sensing membrane that includes at least one surface-active group-containing polymer and that is located over the sensing mechanism. The sensing membrane may have a bioprotective layer configured to substantially block the effect and/or influence of non-constant noise-causing species. 120-. (canceled)21. A device for continuous in vivo measurement of a glucose concentration , the device comprising:an implantable sensor configured to continuously measure a signal indicative of a glucose concentration in a host, wherein the implantable sensor comprises an electroactive surface; a polymer comprising a hydrophilic segment, wherein the molecular weight of the polymer is from about 25,000 daltons to about 5,000,000 daltons, and', 'a polyurethaneurea,', 'wherein the blend of the polymer and the polyurethaneurea comprises both hydrophilic and hydrophobic regions; and, 'a membrane located over the sensor, wherein the membrane comprises a first domain comprising an enzyme configured to react with glucose to produce a measured species configured to be oxidized at the sensor, wherein the membrane comprises a second domain comprising a blend comprisingsensor electronics operably connected to the sensor, wherein the sensor electronics are configured to measure a current flow produced by the sensor to generate sensor data indicative of glucose concentration.221. The device of claim , wherein the hydrophilic segment comprises acrylate.231. The device of claim , wherein the membrane comprises a third domain configured to reduce permeation therethrough of an interfering species.241. The device of claim , wherein the third domain is located between the sensor and the first domain.251. The device of claim , wherein the third domain comprises a polymer comprising ionic components.261. The device of claim , wherein the third ...

ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 134-. (canceled)35. An applicator system configured to insert a transcutaneous analyte sensor into a host , the applicator system comprising:a housing configured for placement against a skin of the host;a sensor configured for transcutaneous placement through the skin of a host; andan applicator comprising an applicator component, a needle, a trigger, and a spring, wherein the applicator is configured to insert the needle and the sensor into the host, wherein the applicator component is configured to rotate with a continuous torque to insert the sensor into the host, wherein the sensor is inserted automatically into the host to a predetermined depth responsive to actuation of the trigger.36. The system of claim 35 , further comprising sensor electronics configured to be releasably electrically connected to the sensor.37. The system of claim 36 , further comprising a sealing member configured to seal the electrical connection of the sensor with the sensor electronics from external moisture when the sensor electronics are releasably electrically connected to the sensor.38. The system of claim 35 , wherein the applicator is releasably connected to the housing.39. The system of claim 38 , wherein the releasable connection is automatic.40. The system of claim 35 , wherein the housing comprises a body and an adhesive configured for adhering the body to the skin of the host.41. The system of claim 40 , further comprising a vent hole located between the body and the adhesive.42. The system of claim 40 , wherein the body is flexible.43. The system of claim 35 , wherein the sensor comprises a wire.44. The system of claim 35 , wherein the sensor comprises a planar substrate.45. An applicator system configured to insert a transcutaneous analyte sensor into a ...

SYSTEMS AND METHODS FOR DISPLAY DEVICE AND SENSOR ELECTRONICS UNIT COMMUNICATION

Methods and apparatus are provided for communication among display devices and sensor electronics unit in an analyte monitoring system. The analyte monitoring system may include a sensor that is configured to perform measurements indicative of analyte levels. The sensor may be communicatively coupled to the sensor electronics unit. The sensor electronics unit may be configured to transmit data indicative of analyte levels to the display devices using one or more communication protocols. Furthermore, the sensor electronics unit may be configured to operate in multiple modes, and switch between the modes in response to commands received from the display devices. Related systems, methods, and articles of manufacture are also described. 1a transcutaneous glucose sensor comprising an in vivo portion, wherein the transcutaneous sensor is an electrochemical sensor, wherein the transcutaneous glucose sensor comprises a membrane and at least one electrode, wherein the at least one electrode is a working electrode;a sensor electronics unit operatively connected to the transcutaneous glucose sensor, wherein the sensor electronics unit comprises circuitry associated with measuring and processing sensor data received from the transcutaneous glucose sensor; anda display device operatively connected to the sensor electronics unit, wherein the display device is configured to display a glucose value.. A transcutaneous glucose sensor system, the system comprising: Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57. This application is a continuation of U.S. application Ser. No. 16/556,144, filed Aug. 29, 2019, which is a continuation of U.S. application Ser. No. 15/471,374, filed Mar. 28, 2017, now U.S. Pat. No. 10,561,349, which claims the benefit of U.S. Provisional Application No. 62/315,976, filed on Mar. 31, 2016. Each of the aforementioned applications is incorporated by ...

Advanced analyte sensor calibration and error detection

Systems and methods for processing sensor data and self-calibration are provided. In some embodiments, systems and methods are provided which are capable of calibrating a continuous analyte sensor based on an initial sensitivity, and then continuously performing self-calibration without using, or with reduced use of, reference measurements. In certain embodiments, a sensitivity of the analyte sensor is determined by applying an estimative algorithm that is a function of certain parameters. Also described herein are systems and methods for determining a property of an analyte sensor using a stimulus signal. The sensor property can be used to compensate sensor data for sensitivity drift, or determine another property associated with the sensor, such as temperature, sensor membrane damage, moisture ingress in sensor electronics, and scaling factors.

Analyte sensing biointerface

Disclosed herein is an analyte sensing biointerface that comprises a sensing electrode incorporated within a non-conductive matrix comprising a plurality of passageways extending through the matrix to the sensing electrode. Also disclosed herein are methods of manufacturing a sensing biointerface and methods of detecting an analyte within tissue of a host using an analyte sensing biointerface.

METHOD OF OPTIMIZING EFFICACY OF THERAPEUTIC AGENT

Method and device for outputting one or more signals associated with a monitored analyte level of an individual, the one or more signals including a substantially real time monitored analyte level and a rate of change information associated with the monitored analyte level, outputting a carbohydrate intake event indication, determining one or more data associated with one or more therapy information related to the monitored analyte level and the meal event indication, and outputting the determined one or more data over the outputted one or more signals associated with the monitored analyte level and the carbohydrate intake event indication are provided. 1. A management device comprising:an analyte sensor configured for insertion into a body fluid of a user, the analyte sensor configured to monitor an analyte level;a display device; and determine an initial insulin dose;', 'determine a rate of change of the analyte level; and', 'based on the determined rate of change, propose an adjusted insulin dose that is increased or decreased relative to the initial insulin dose., 'a processor operatively coupled to the analyte sensor and the display device, the processor configured to2. The management device of claim 1 , wherein the processor is configured to display on the display device the rate of change of the analyte level.3. The management device of claim 1 , wherein the adjusted insulin dose is increased by a percentage of the initial insulin dose if the rate of change of the analyte level is rising.4. The management device of claim 1 , wherein the adjusted insulin dose is increased by 10% to 20% of the initial insulin dose if the rate of change of the analyte level is rising.5. The management device of claim 1 , wherein the adjusted insulin dose is decreased by a percentage of the initial insulin dose if the rate of change of the analyte level is falling.6. The management device of claim 1 , wherein the adjusted insulin dose is decreased by 10% to 20% of the initial ...

Multiplexed Transdermal Extraction and Detection Devices for Non-Invasive Monitoring of Substances and Methods of Use

Multiplexed transdermal extraction and detection devices and systems for non-invasive monitoring of substances, such as glucose, are disclosed, as are methods of using these devices for substance monitoring in subjects. 1. A multiplexed , transdermal extraction and detection device for non-invasive monitoring of one or more substances in a subject , the device comprising an array of sensor pixels , each sensor pixel comprising:(a) a substrate comprising a set of electrodes for applying a current to the subject's skin for transdermally extracting one or more substances from the interstitial fluid by electro-migration and/or by electro-osmosis;(b) a reservoir associated with the sensor pixel, the reservoir containing a volume of gel for receiving the transdermally extracted substances from the sensor pixel;(c) a set of detection electrodes for electrochemical detection of the concentration of the one or more transdermally extracted substances present in the reservoir associated with the sensor pixel;wherein the array of sensor pixels is configured so that at least one of the sensor pixels is capable of extracting the one or more substances via a preferential pathway on the subject's skin.2. A multiplexed , transdermal extraction and detection system for non-invasive monitoring of one or more substances in a subject , the system comprising: ["(a) a substrate comprising a set of electrodes for applying a current to the subject's skin for transdermally extracting one or more substances from the interstitial fluid by electro-migration and/or by electro-osmosis;", '(b) a reservoir associated with the sensor pixel, the reservoir containing a volume of gel for receiving the transdermally extracted substances from the sensor pixel; and', '(c) a set of detection electrodes for electrochemical detection of the concentration of the one or more transdermally extracted substances present in the reservoir associated with the sensor pixel;', "wherein the array of sensor pixels is ...

ANALYTE SENSORS AND METHODS OF MANUFACTURING ANALYTE SENSORS

A method of manufacturing laminate structure including the steps of providing a waveguide structure having a plurality of waveguide cores and including a first surface, creating an oxygen sensing polymer cavity in the first surface of the waveguide structure to receive an oxygen sensing polymer, filling the oxygen sensing polymer cavity with the oxygen sensing polymer and curing the oxygen sensing polymer, adding a first layer material on top of the first surface of the waveguide structure, where the first layer material includes a reaction chamber cavity that is contiguous with the oxygen sensing polymer, filling the reaction chamber cavity with an enzymatic hydrogel and curing the enzymatic hydrogel; adding a second layer material on top of the first layer material, where the second layer material includes a conduit cavity to receive a conduit hydrogel, filling the conduit cavity with a conduit hydrogel and curing the conduit hydrogel, and adding a top cap on top of the second layer of material. 1141.-. (canceled)142. A dispensable , reversible oxygen binding molecule-albumin nanogel solution , configured to form a hydrogel upon curing , the dispensable , reversible oxygen binding molecule-albumin nanogel comprising: reversible oxygen binding molecule-albumin nanoparticles , wherein the reversible oxygen binding molecule and albumin are interconnected with a bifunctional linkers , wherein the reversible oxygen binding molecule-albumin nanoparticles are coupled to poly(ethylene glycol) (PEG) through a thio-linkage , and wherein the reversible oxygen binding molecule-albumin nanoparticles are functionalized to a nanogel matrix via a PEG-based linker.144. The dispensable claim 142 , reversible oxygen binding molecule-albumin nanogel solution of claim 142 , wherein the homobifunctional linker or heterobifunctional linker (L) is selected from a group consisting of amino acids claim 142 , peptides claim 142 , nucleotides claim 142 , nucleic acids claim 142 , organic ...

Systems and methods for display device and sensor electronics unit communication

Methods and apparatus are provided for communication among display devices and sensor electronics unit in an analyte monitoring system. The analyte monitoring system may include a sensor that is configured to perform measurements indicative of analyte levels. The sensor may be communicatively coupled to the sensor electronics unit. The sensor electronics unit may be configured to transmit data indicative of analyte levels to the display devices using one or more communication protocols. Furthermore, the sensor electronics unit may be configured to operate in multiple modes, and switch between the modes in response to commands received from the display devices. Related systems, methods, and articles of manufacture are also described.

ULTRALOW CONCENTRATION SENSING OF BIO-MATTER WITH PEROVSKITE NICKELATE DEVICES AND ARRAYS

Disclosed herein is an ultralow concentration sensor of biomarkers, and the use thereof to help heath industry, medical centers and food industry to sense biomarkers by catalyst assisted charge transfer from the biomarkers to the sensor device, resulting increased electrical resistance of the sensor. Specifically, perovskite nickelate RNiOis used to sense biological material facilitated by specific enzymatic activity in the proximity. 1. An ultrasensitive device for detecting low concentration of biomarker in a biological fluid , comprising:a perovskite nickelate film comprising RNiO3 or strongly correlated transition metal oxide (eg. NiO, FeOx), wherein said perovskite nickelate film is configured as a lattice or with micro-fluidic channels, wherein R is selected from the group consisting of Sm, Nd, Eu, Gd, Dy, Y, Lu, Pr, and La; andan enzyme or other catalyst conjugated to a conductive material, wherein said conductive material is associated with said perovskite nickelate film or in close proximity to said perovskite nickelate film, wherein said enzyme or other catalyst facilitates hydrogen transfer from said biomarker to said perovskite nickelate film and reduces conductivity at the interface between the perovskite nickelate film and said biomarker.2. The ultrasensitive device according to further comprising an electrode claim 1 , wherein said electrode captures increased resistivity in said perovskite nickelate film.3. The ultrasensitive device according to wherein said conductive material is Au electrode.4. The ultrasensitive device according to claim 1 , wherein said enzyme is glucose oxidase and the biomarker is glucose in body fluid.5. The ultrasensitive device according to claim 4 , wherein the body fluid is blood claim 4 , sweat or urine.6. The ultrasensitive device according to claim 1 , wherein said enzyme is horseradish peroxidase (HRP) and the biomarker is dopamine in cerebrospinal fluid.7. The ultrasensitive device according to wherein said enzyme is ...

Methods and systems for sleep management

A processing system includes methods to promote sleep. The system may include a monitor such as a non-contact motion sensor from which sleep information may be determined. User sleep information, such as sleep stages, hypnograms, sleep scores, mind recharge scores and body scores, may be recorded, evaluated and/or displayed for a user. The system may further monitor ambient and/or environmental conditions corresponding to sleep sessions. Sleep advice may be generated based on the sleep information, user queries and/or environmental conditions from one or more sleep sessions. Communicated sleep advice may include content to promote good sleep habits and/or detect risky sleep conditions. In some versions of the system, any one or more of a bedside unit 3000 sensor module, a smart processing device, such as a smart phone or smart device 3002 , and network servers may be implemented to perform the methodologies of the system.

MEMBRANE PHASE ELECTRODE USING PRINTING AND BIO-MOLECULE DETECTION USING SAME

A membrane electrode includes a novel sensor combining a filtering function of a membrane and a signal measuring ability of an electrode. A target material may be measured by filtration through the membrane. A small amount of target materials may be detected with high sensitivity using an amplified electrical signal by increasing electrical conductivity by reducing metal ions on the membrane, and thus the target material may be subject to quantitative analysis. In addition, only a target material selectively binding to a receptor may be filtrated by passing a sample through the membrane after a receptor material is fixed to the electrode, and thus may be used to detect an electrical signal. In addition, the sensor may measure a signal in various methods such as electrical conductivity, impedance, etc. 1. A sensor , comprising:a filtering membrane for filtering a reaction solution; andan electrode placed on the filtering membrane;wherein the reaction solution is prepared by mixing a ligand-fixed enzyme or ligand-fixed metal nanoparticle and a sample containing a target material,wherein the ligand-fixed enzyme or the ligand-fixed metal nanoparticles bound with the target material remain on the filtering membrane,wherein the electrode generates an electrical signal by the ligand-fixed enzyme or the ligand-fixed metal nanoparticles bound with the target material.2. The sensor according to claim 1 ,wherein the filtering membrane is a filter formed of one selected from the group consisting of nitrocellulose, polycarbonate, nylon, polyester, cellulose acetate, polysulfone, and polyethanesulfone.3. The sensor according to claim 1 ,wherein the electrode is printed by a screen printing process.4. The sensor according to claim 3 ,wherein the electrode is an interdigitated electrode having a gap of 10 to 1000 μm.5. The sensor according to claim 1 ,wherein the ligand is an antibody, an antigen, an enzyme, a peptide, a protein, DNA, RNA, PNA, or an aptamer.6. The sensor according ...

CONTINUOUS ANALYTE MONITORING SYSTEM WITH MICRONEEDLE ARRAY

Described herein are variations of an analyte monitoring system, including an analyte monitoring device. For example, an analyte monitoring device may include an implantable microneedle array for use in measuring one or more analytes (e.g., glucose), such as in a continuous manner. The microneedle array may include, for example, at least one microneedle including a tapered distal portion having an insulated distal apex, and an electrode on a surface of the tapered distal portion located proximal to the insulated distal apex. At least some of the microneedles may be electrically isolated such that one or more electrodes is individually addressable. 1. A microneedle array for use in sensing an analyte , comprising: a tapered distal portion having an insulated distal apex; and', 'an electrode on a surface of the tapered distal portion, wherein the electrode is located proximal to the insulated distal apex., 'a plurality of solid microneedles, wherein at least one microneedle is configured to sense an analyte in dermal interstitial fluid of a user and comprises2. The microneedle array of claim 1 , wherein the electrode is a working electrode configured to sense at least one analyte and the at least one microneedle comprises a biorecognition layer arranged over the working electrode claim 1 , wherein the biorecognition layer comprises a biorecognition element.3. The microneedle array of claim 2 , wherein the biorecognition element comprises glucose oxidase.4. The microneedle array of claim 2 , wherein the microneedle array comprises at least one microneedle comprising a counter electrode configured to source or sink current to sustain an electrochemical reaction on the working electrode.5. The microneedle array of claim 2 , wherein the microneedle array comprises at least one microneedle comprising a reference electrode configured to provide a reference potential for the working electrode.6. The microneedle array of claim 1 , wherein a distal end of the electrode is ...

GLUCOSE-SENSING DEVICE WITH MALTOSE BLOCKING LAYER

This disclosure relates to a glucose-sensing electrode including a nanoporous metal layer and a maltose-blocking layer formed over the nanoporous metal layer. The nanoporous metal layer is capable of oxidizing both glucose and maltose without an enzyme specific to glucose or maltose in the glucose-sensing electrode. The maltose-blocking layer has porosity that permits glucose to pass therethrough and inhibits maltose from passing therethrough toward the nanoporous metal layer. 1. A glucose-sensing electrode comprising:a substrate;a glucose oxidation layer formed over the substrate and capable of oxidizing both glucose and maltose; anda polymer layer formed over the glucose oxidation layer and comprising poly-phenylenediamine (poly-PD),wherein the polymer layer has porosity adjusted for passing glucose therethrough while blocking some of maltose from passing therethrough toward the glucose oxidation layer such that oxidation of glucose alone is substantially higher than oxidation of maltose alone in the glucose oxidation layer and the oxidation of maltose does not interfere determining a glucose level in a liquid containing glucose in a concentration of 4-20 mM and maltose in a concentration of 4-20 mM.2. The electrode of claim 1 , wherein the glucose oxidation layer comprises a deposit of irregularly shaped bodies that are formed of numerous nanoparticles having a generally oval or spherical shape with a length ranging between about 2 nm and about 5 nm claim 1 ,wherein adjacent ones of the irregularly shaped bodies abut one another while forming unoccupied spaces between non-abutting surfaces or portions of the adjacent ones of the irregularly shaped bodies,wherein abutments between adjacent ones of the irregularly shaped bodies connect the adjacent ones with one another, which forms a three-dimensional interconnected network of irregularly shaped bodies inside the glucose oxidation layer,wherein the unoccupied spaces between non-abutting surfaces of the adjacent ...