Abstract: 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.

Abstract: Embodiments relate to an insertion device that includes: a plunger coupled with a lock collar. The insertion device houses contents including: a striker including self-locking striker snap arm(s) where the striker is kept from firing by a striker spring captured between the plunger and the striker when the insertion device is in a cocked position; a sensor assembly; and a needle carrier that holds a piercing member, the needle carrier captured between the striker and a needle carrier spring where a self-releasing snap(s) keeps the needle carrier cocked, where the plunger prevents the self-releasing snap(s) from repositioning and releasing the needle carrier. The striker fires the needle carrier such that the self-locking striker snap arm(s) are positioned to allow the striker to snap down. The needle carrier is then retracted when the user releases the plunger and the piercing member is encapsulated within the insertion device.

Abstract: The disclosed invention includes sweat sensing devices configured to periodically measure sweat conductivity and galvanic skin response, devices to measure volumetric sweat flow rate, and devices that combine the three functions. The disclosure further includes methods for using a device configured to perform periodic sweat conductivity measurements, galvanic skin response measurements, and volumetric sweat rate measurements so that each sensor modality informs composite estimates of sweat onset, sweat cessation, sweat ion concentration, and sweat rate. The method uses those measurements to inform other sweat sensing device functions, such as determining the existence of a physiological condition, or performing measurements of concentrations, ratios, and trends of sweat analytes.

Abstract: An integrated system for the monitoring and treating diabetes is provided, including an integrated receiver/hand-held medicament injection pen, including electronics, for use with a continuous glucose sensor. In some embodiments, the receiver is configured to receive continuous glucose sensor data, to calculate a medicament therapy (e.g., via the integrated system electronics) and to automatically set a bolus dose of the integrated hand-held medicament injection pen, whereby the user can manually inject the bolus dose of medicament into the host. In some embodiments, the integrated receiver and hand-held medicament injection pen are integrally formed, while in other embodiments they are detachably connected and communicated via mutually engaging electrical contacts and/or via wireless communication.

Abstract: Disclosed is a biosensor needle including a light-transmissive main body having a width that is less than a length so as to be inserted into a testee, and a plurality of metal particles provided at at least a part of the main body and generating a surface enhanced Raman scattering (SERS) effect of light incident through the main body.

Abstract: A sweat sensing device includes a plurality of sweat collection pads communicating with a sensor. Each of the pads is activated by a timing circuit which allows one or more of the pads to be activated at a selected time and subsequent deactivated after a defined period of time. This allows for selective collection of sweat from a plurality of pads over a prolonged period of time. An impedance measuring circuit can be employed to determine if one or more of the pads becomes disconnected, in order to avoid irritation. Further, the devices can use a common microfluidic device which both transports sweat activating substance, such as pilocarpine, to the surface of the skin and directs sweat away from the skin to a sensing device.

Abstract: Systems and methods for analyte monitoring, particularly systems and methods for monitoring and managing life of a battery in an analyte sensor system worn by a user, are provided.

Abstract: Methods and apparatus for providing data processing and control for use in a medical communication system are provided.

Abstract: An implantable medical device is described. The implantable medical device includes a small molecule generator, a small molecule diffusor, and a cannula that connects the two. The small molecule generator includes an electrolyte reservoir and a set of electrodes. A first portion of the electrolyte reservoir is impermeable to a predetermined class of small molecules. A second portion of the electrolyte reservoir is permeable to the small molecules. The set of electrodes is disposed inside the electrolyte reservoir and is configured to facilitate electrolysis of the small molecules based on an electric power application to the set of electrodes and on presence of electrolyte inside the electrolyte reservoir. At least a portion of the small molecule diffusor is permeable to the small molecules.

Abstract: Disclosed herein is a sensor comprising a conduit; the conduit comprising an organic polymer; a working electrode; the working electrode being etched and decorated with a nanostructured material; a reference electrode; and a counter electrode; the working electrode, the reference electrode and the counter electrode being disposed in the conduit; the working electrode, the reference electrode and the counter electrode being separated from each other by an electrically insulating material; and wherein a cross-sectional area of the conduit that comprises a section of the working electrode, a section of the reference electrode and a section of the counter electrode is exposed to detect analytes.

Abstract: Method and system for determining real time analyte concentration including an analyte sensor having a portion in fluid contact with an interstitial fluid under a skin layer, an on-body electronics including a housing coupled to the analyte sensor and configured for positioning on the skin layer, the on-body electronics housing including a plurality of electrical contacts, on the housing; and a data analysis unit having a data analysis unit housing and a plurality of probes, on the housing. Each of the probes configured to electrically couple to a respective electrical contact when the data analysis unit is positioned in physical contact with the on-body electronics. The one or more signals on the probes correspond to one or more of a substantially real time monitored analyte concentration level (MACL), MACL over a predetermined time period, or a rate of change of the MACL, or combinations thereof, are provided.

Abstract: Correction for initial variation in thickness of a polymer layer and for changes in the coating thickness that occur after implantation of a biosensor and therefore provides substantial increase in the accuracy and lifetime of implantable sensors is done using a factor derived from the decay of potential.

Abstract: A contact lens for lens-to-lens communication includes blink detection circuitry, one or more electrodes, a logic engine, and data transmission circuitry. The blink detection circuitry is configured to generate a blink signal in response to a blinking of an eye. The logic engine is coupled to receive the blink signal from the blink detection circuitry. The data transmission circuitry is coupled between the one or more electrodes and the logic engine. The logic engine causes the data transmission circuitry to drive electrical data signals onto the one or more electrodes in response to the blink signal reaching a pre-determined threshold.

Abstract: Systems, devices, and methods are provided for changing the power state of a sensor control device in an in vivo analyte monitoring system in various manners, such as through the use of external stimuli (light, magnetics) and RF transmissions.

Abstract: A system for transdermal alcohol sensing to be worn near a skin surface of a user, including: an alcohol sensor; a microporous membrane; a housing coupled to the alcohol sensor and the membrane, defining a volume between the alcohol sensor and a first membrane side, and fluidly isolating the volume from a second membrane side opposing the first membrane side; an electronics subsystem electrically coupled to the alcohol sensor, operable to power and receive signals from the alcohol sensor; and a fastener operable to position the second membrane side proximal the skin surface.

Abstract: A puncture device includes a housing unit including an attachment surface configured to be attached to a body surface of a user; a puncture needle including an outer needle and an inner catheter located in the outer needle, the puncture needle being configured to be projected from the attachment surface to be punctured into a body of the user; a puncture mechanism configured to project the puncture needle from the attachment surface to be punctured into the body of the user, and pull back only the outer needle of the puncture needle into the housing unit with the inner catheter of the puncture needle indwelled in the body; and a puncture angle adjustment mechanism configured to adjust a puncture angle of the puncture needle, which is an angle of the puncture needle with respect to the attachment surface.

Abstract: A sweat sensing device includes a plurality of sweat collection pads communicating with a sensor. Each of the pads is activated by a timing circuit which allows one or more of the pads to be activated at a selected time and subsequent deactivated after a defined period of time. This allows for selective collection of sweat from a plurality of pads over a prolonged period of time. An impedance measuring circuit can be employed to determine if one or more of the pads becomes disconnected, in order to avoid irritation. Further, the devices can use a common microfluidic device which both transports sweat activating substance, such as pilocarpine, to the surface of the skin and directs sweat away from the skin to a sensing device.

Abstract: A deformable closed-loop multi-layered microelectronic device is provided. A top layer, a bottom layer and a middle layer of the microelectronic device each have at least a first section and a second section pivotable with respect to each other. A pivot is provided to a terminal end of the first section of the middle layer, for allowing the first section to rotate about the pivot. The pivot is vertically sandwiched between and connected to a terminal end of the first section of the top layer and a terminal end of the first section of the bottom layer. The first sections of the bottom layer and the top layer are pivotable in a substantially synchronized manner to deform the bottom layer and the top layer in a substantially synchronized manner.

Abstract: 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.

Abstract: Methods, structures, and systems are disclosed for biosensing and drug delivery techniques. In one aspect, a device for detecting an analyte and/or releasing a biochemical into a biological fluid can include an array of hollowed needles, in which each needle includes a protruded needle structure including an exterior wall forming a hollow interior and an opening at a terminal end of the protruded needle structure that exposes the hollow interior, and a probe inside the exterior wall to interact with one or more chemical or biological substances that come in contact with the probe via the opening to produce a probe sensing signal, and an array of wires that are coupled to probes of the array of hollowed needles, respectively, each wire being electrically conductive to transmit the probe sensing signal produced by a respective probe.

Abstract: Method and system for providing continuous calibration of analyte sensors includes calibrating a first sensor, receiving data associated with detected analyte levels from the first sensor, and calibrating a second sensor based on a predetermined scaling factor and data associated with detected analyte levels from the first sensor, is disclosed.

Abstract: A method of manufacturing a detection/stimulation lead for implantation into a venous, arterial, or lymphatic network is shown and described. The method includes providing a microcable comprising a sheath of insulating material covering an electrically conductive core. The method further includes surrounding a portion of the microcable with an electrically conductive metal ring. The method also includes crimping the ring such that the thickness of the sheath is penetrated by a portion of the metal ring and such that an electrical connection is formed between the metal ring and the electrically conductive core.

Abstract: Systems and methods of use involving sensors having a particle-containing domain 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.

Abstract: A method of making a sensor includes depositing a layer of hydrogel over a substrate, the hydrogel configured to change thickness or volume in response to a selected condition and including a plurality of magnetic particles disposed in the hydrogel so that a magnetic property of the hydrogel changes with changes of thickness or volume of the hydrogel. The hydrogel is sacrificed in selected region(s) of the layer so that the hydrogel outside the selected region(s) forms a plurality of spaced-apart islands of the hydrogel. The islands of the hydrogel are enclosed in an enclosure at least partly permeable to a selected fluid. A sensor for detecting a condition includes the substrate, islands, and a device coil arranged with respect to the hydrogel so that changes in the magnetic property modulate an electrical property of the sensor. A system includes the substrate, islands, and a magnetic-field detector.

Abstract: Biointerface membranes are provided which can be utilized with implantable devices, such as devices for the detection of analyte concentrations in a biological sample. More particularly, methods for monitoring glucose levels in a biological fluid sample using an implantable analyte detection device incorporating such membranes are provided.

Abstract: A biomarker monitoring method and system in one embodiment includes a communications network, a portable wellness device configured to form a communication link with the communications network, the portable wellness device including a detector configured to detect at least one biomarker in a biologic sample, a first memory, a plurality of program instructions stored in the first memory, and a processing circuit operably connected to the first memory and configured to execute the program instructions to generate wellness data based upon detection of the at least one biomarker in the biologic sample, and a remote user interface operably connected to the communications network and configured to render the wellness data.

Abstract: Systems and methods for multiple analyte analysis are provided. In one embodiment, a method includes determining concentrations of first and second analytes in a sample. The first and second analytes may be, for example, glucose and hydroxybutyrate. In this form, an indication related to the measured concentration of hydroxybutyrate is provided in response to determining that the concentration of hydroxybutyrate is above a predetermined value. In a further aspect of this form, a quantitative indication representative of the measured glucose concentration is automatically provided regardless of the value of the measured glucose concentration. In another embodiment, a system includes a meter configured to interact with a test element to assess first and second analytes in a sample. Further embodiments, forms, objects, features, advantages, aspects, and benefits shall become apparent from the description and drawings.

Abstract: 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.

Abstract: An approach for detecting a transient error in a body fluid sample based on the shape of a response curve of a sensor is provided. The response curve is represented by an equation including at least one coefficient describing a curvature or slope of the response curve. The approach includes comparing the coefficient to a range of coefficients which includes coefficients of response curves corresponding to known analyte concentrations. The approach further includes detecting a transient error based on the comparison. In some examples of the approach, the comparison and detection are performed by a processing transient error detector executing computer readable instructions embodied in a non-transitory computer-readable medium. Other examples of the approach determine a concentration of the analyte based on the equation. Advantageously, various examples of the approach can expedite detection of transient errors at the time of measuring and before reporting sample result.

Abstract: A sensor cartridge comprising a sterile capsule. The sensor cartridge further comprises a sensor within the sterile capsule. The sensor cartridge further comprises a sensor connector connected to the sensor in an initial position. The sensor cartridge further comprises an insertion needle for inserting the sensor into a subject. The insertion needle is within the sterile capsule. The sensor cartridge further comprises a sensor mounting unit for receiving the sensor connector at a mounted position. The sensor mounting unit comprises an adhesive surface for attaching to an exterior surface of the subject. The sensor cartridge further comprises an insertion mechanism operable for actuating the insertion needle and moving the sensor connector from the initial position to the mounted position.

Abstract: A medical toilet with fingerprint reading handles is disclosed. The handles extend from a side surface of a seat on the medical toilet allowing a toilet seat user to use the fingerprint reader while sitting on the medical toilet. The handles enable authentication of a user and loading of specific medical toilet functionality associated with the authenticated user. The fingerprint readers are also used to determine cardiac functions of the user in addition to authentication of the user. The handles may be retractable and may include UV sanitation.

Abstract: In a method of recalibrating continuous glucose monitoring data from a user, operable on a digital processor, an indication from the user that the user has taken a meal is received (806). A self-monitored of blood glucose levels from the user (810) at two separate times during a day corresponding to when the user has taken a meal. A glucose signal is received from a continuous glucose monitoring sensor (818) at times corresponding to the two separate times that the user has taken a meal. Two reconstructed blood glucose values based on the glucose signal from the continuous monitoring sensor at times when the at least two self-monitored of blood glucose levels are received from the user. A linear regression is performed (822) using y=ax+b, wherein x corresponds to the two reconstructed blood glucose values and y corresponds to the two self-monitored of blood glucose levels thereby generating an estimation of a and b.

Abstract: This document provides methods and materials involved in differentiating analytes detected using a FSCV method. For example, methods and materials for using paired pulse voltammetry to discriminate analytes based on their adsorption characteristics to an electrode (e.g., a carbon fiber electrode) are provided.

Abstract: 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.

Abstract: Method and apparatus for providing an integrated analyte sensor and data processing unit assembly is provided.

Abstract: 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.

Abstract: Methods and systems for controlling an insulin pump in response to glucose measurements are responsive to a base insulin delivery profile and a temporary insulin delivery profile. These can be used, e.g., to control blood glucose level of a subject using a continuous glucose monitor and an insulin infusion pump. During a selected time range, an insulin amount for the pump to supply is determined using the temporary insulin delivery profile. Outside that time range, the insulin amount is determined using the base insulin delivery profile. The temporary insulin delivery profile can specify an exact amount to be supplied (a “hard” profile), a nominal amount to be supplied if doing so does not drive glucose out of a desired zone (“soft”), or a soft profile with a minimum amount of insulin to be delivered (“semi-soft”).

Abstract: An implantable medical device is described. The implantable medical device includes a small molecule generator, a small molecule diffusor, and a cannula that connects the two. The small molecule generator includes an electrolyte reservoir and a set of electrodes. A first portion of the electrolyte reservoir is impermeable to a predetermined class of small molecules. A second portion of the electrolyte reservoir is permeable to the small molecules. The set of electrodes is disposed inside the electrolyte reservoir and is configured to facilitate electrolysis of the small molecules based on an electric power application to the set of electrodes and on presence of electrolyte inside the electrolyte reservoir. At least a portion of the small molecule diffusor is permeable to the small molecules.

Abstract: An analyte sensor and a method for making the analyte sensor are disclosed. In one aspect, the analyte sensor includes a crosslinked, hydrophilic copolymer in contact with a surface of an electrode, and an analyte sensing component embedded within the crosslinked, hydrophilic copolymer. The method of making the analyte sensor includes depositing a precursor mixture containing monomers and an analyte sensing component onto an electrode, exposing the deposited precursor mixture to a controlled environment for a specified period of time, and photopolymerizing the deposited exposed precursor mixture into a copolymer layer in contact with a surface of the electrode. Exposing the deposited precursor mixture to a controlled environment can increase the sensitivity of the sensor by reducing the thickness of the copolymer layer and/or by causing the analyte sensitive component within the copolymer layer to have a non-uniform concentration within the layer.

Abstract: An integrated system for the monitoring and treating diabetes is provided, including an integrated receiver/hand-held medicament injection pen, including electronics, for use with a continuous glucose sensor. In some embodiments, the receiver is configured to receive continuous glucose sensor data, to calculate a medicament therapy (e.g., via the integrated system electronics) and to automatically set a bolus dose of the integrated hand-held medicament injection pen, whereby the user can manually inject the bolus dose of medicament into the host. In some embodiments, the integrated receiver and hand-held medicament injection pen are integrally formed, while in other embodiments they are detachably connected and communicated via mutually engaging electrical contacts and/or via wireless communication.

Abstract: Apparatus, systems and methods employing contact lens sensors are provided. In some aspects, a contact lens includes a substrate that forms at least a portion of the body of the contact lens; an optical communication device disposed on or within the substrate; and a photodetector disposed on or within the substrate, wherein the photodetector harvests light emitted from a device and generates power from the harvested light. In some aspects, an apparatus comprises a tag having a circuit including: an optical communication device; and a photodetector that harvests light received and generates power from the harvested light. The tag can be disposed on or within a contact lens in various aspects.

Abstract: A system and process for determining and analyzing surface property parameters of a substance based on kinetic method is provided. The system comprises a sample processing system and a detection system. The sample processing system includes a reactor (3), a collector for liquid to be tested (5), and a container for liquid to be tested (6). The detection system includes a detecting electrode (13), a concentration and activity operator, a kinetic data processor, a surface property operation module, and a result output module. The process comprises: having the substance to be tested to be treated with an electrolyte solution, measuring activity of liquid to be tested upon reaction at a pre-set time interval, and processing with the kinetic data processor and the surface property operation module, so as to obtain surface property parameters of the substance to be tested.

Abstract: Methods, devices, and computer programs are presented for creating a unified data stream from multiple data streams acquired from multiple devices. One method includes an operation for receiving activity data streams from the devices, each activity data stream being associated with physical activity data of a user. Further, the method includes an operation for assembling the unified activity data stream for a period of time. The unified activity data stream includes data segments from the data streams of at least two devices, and the data segments are organized time-wise over the period of time.

Abstract: A method and data processing device for automatically generating a user-specific measuring data recording routine for discontinuous blood glucose measurement with a blood glucose measuring device in a data processing device. The method comprises the steps of providing of process data indicating an expected continuous course of the blood glucose value of a user, in the calculation unit based on blood glucose measuring values from continuous blood glucose measurement, generating of user-specific measuring routine data, which indicate a measuring routine with user-specific measuring events for discontinuous blood glucose measurement with a blood glucose meter taking into account the process data by means of the calculation unit, and providing of the user-specific measuring routine data to the data output interface for data transmission.

Abstract: Systems and methods for applying time-dependent algorithmic compensation functions to data output from a continuous analyte sensor. Some embodiments determine a time since sensor implantation and/or whether a newly initialized sensor has been used previously.

Abstract: 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.

Abstract: Apparatuses and methods for corrective guidance of eating behavior of a patient equipped with a gastric restriction device. The apparatus provides continuous monitoring or one or more parameters related to food passing through the gastric restriction device. Each monitored parameter is processed to provide a visual indication of the current eating behavior. The visual indication is used as input to the patient or a caregiver to modify the eating behavior. In some embodiments, the apparatus includes an emergency relief mechanism that automatically relieves excess pressure developing in the gastric restriction device. In some embodiments, the apparatus is enabled to deliver an appetite suppressant to modify the eating behavior.

Abstract: An electrochemical sensor system is adapted to assist in determining an analyte concentration of a fluid. The electrochemical sensor system comprises a substrate, conductive material and a hydrogel or liquid. The substrate having porosity therethrough. The conductive material includes at least one electrode. The at least one electrode is coupled to the substrate. The at least one electrode has a first surface and an opposing second surface. The hydrogel or liquid is adapted to assist in carrying the analyte of the fluid to the first and second surfaces of the at least one electrode.

Abstract: A body-mountable device may include a first polymer layer, a second polymer layer, and a structure that includes a sensor between the first and second polymer layers. Forming the body-mountable device may involve positioning the structure on the first polymer layer and then forming, in a molding piece, the second polymer layer over the structure positioned on the first polymer layer. The molding piece includes a surface that supports the second polymer layer as the second polymer layer is being formed and a protrusion that extends from the surface to the sensor through the second polymer layer as the second polymer layer is being formed. The body-mountable device that is removed from the molding piece has a channel to the sensor formed by the protrusion.

Abstract: Provided are devices and methods suitable for immobilizing tissue and for use in non-invasive methods of assessing lower urinary tract symptoms as well as in surgical application.