Abstract: Glucose monitoring devices and related systems and methods, the glucose monitoring devices including a sensor electronics unit having a housing and a printed circuit board disposed within the housing, a transcutaneous glucose sensor assembly, and a conductive sensor connector. The printed circuit board includes a first electrical contact, the transcutaneous glucose sensor assembly includes a distal portion having a working electrode and proximal portion having a working-electrode contact in electrical communication with the working electrode, and the conductive sensor connector electrically connects the working-electrode contact with the first electrical contact. Further, the conductive sensor connector extends through a hole in the proximal portion of the transcutaneous glucose sensor assembly and through a hole in the printed circuit board.

Abstract: A method for using a patch for pain relief, and the patch are provided. The method includes determining a location corresponding to source of pain in a body, and disposing a patch including a reactive capacitance material at one of a location corresponding to source of pain or a location between location corresponding to source of pain and a brain. The patch is disposed adjacent to the surface of the body. The reactive the capacitance material comprises conductive particles dispersed in a binder so that at least a majority of the conductive particles are adjacent to, but do not touch, one another. The patch includes a first outer layer, a reactive capacitance layer, and a second outer layer. The reactive capacitance layer is disposed between the first outer layer and the second outer layer. The reactive capacitance layer is formed of the reactive capacitance material.

Abstract: A system for a physiological characteristic sensor deployed with a sensor inserter includes an adhesive skin patch coupled to the physiological characteristic sensor. The adhesive patch is to couple the physiological characteristic sensor to an anatomy. The system includes a gravity resistance system coupled to the adhesive patch and to be coupled to the sensor inserter. The gravity resistance system maintains the adhesive patch substantially perpendicular to a longitudinal axis of the sensor inserter prior to deployment of the physiological characteristic sensor and the gravity resistance system is to be removable from the sensor inserter by the adhesive patch upon deployment of the physiological characteristic sensor.

Abstract: A device (250) for estimating the risk of a future hypoglycemic event for a subject with a standing insulin regimen (206), wherein the standing insulin regimen comprises one or more types of insulin medicament dosage regimen (208), wherein each of the one or more types of insulin medicament dosage regimen (208) comprises a type of insulin medicament (210) defining one or more types of insulin medicaments. Using the evaluation of a glucose concentration, a first time derivative and an insulin on board for the subject in a current metabolic state, and the evaluation of a glucose concentration, a first derivative and a historical insulin on board to estimate a hypoglycemic risk measure.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: A computer-implemented method and a system for analyzing glucose monitoring data indicative of a glucose level, comprising: presenting by a data processing device provided a graphical window on a display device wherein the graphical window comprises a time abscissa axis that defines time units, and a glucose ordinate axis that defines glucose units; receiving a plurality of glucose monitoring values associated with a monitoring time period by the data processing device; segmenting the plurality of glucose monitoring values into a plurality of glucose monitoring traces indicative of the glucose level; defining a reference trace segment; determining the reference trace segment for each of the plurality of glucose monitoring traces; and plotting, for a time window comprising the reference trace segment, the plurality of glucose monitoring traces within the graphical window. Furthermore, a non-transitory computer readable medium is disclosed.

Abstract: A sensor system detects a presence or concentration of an analyte in a medium. The sensor system contains a sensor having a sensor head with a chamber. The sensor head has a permeable area through which the analyte can pass into the chamber when the sensor head contacts the medium. A cross-linked hydrogel fills the chamber, the hydrogel is configured to undergo a change in volume when contacting the analyte passed into the chamber which leads to a change in pressure in the chamber. A pressure sensor is configured to measure the pressure in the chamber for detecting the presence or concentration of the analyte.

Abstract: The invention relates to a microneedle array and to the use thereof for intradermal delivery, comprising a plurality of microneedles on a carrier, wherein this microneedle array is suitable for penetrating the skin of humans or animals and includes at least one color change indicator.

Abstract: Methods and related systems are disclosed for determining a temperature of an indoor space with a plurality of onboard sensors of a device of a climate control system. In an embodiment, the method includes detecting raw temperatures with the plurality of sensors. In addition, the method includes determining a combined temperature offset for a first sensor of the plurality of sensors based on outputs of a plurality of models. The plurality of models are to determine a plurality of temperature offsets for the first sensor based on different airflow directions relative to the device. Further, the method includes adjusting the raw temperature detected by the first sensor with the combined temperature offset.

Abstract: Systems for applying a transcutaneous monitor to a person can include a telescoping assembly, a sensor, and a base with adhesive to couple the sensor to skin. The sensor can be located within the telescoping assembly while the base protrudes from a distal end of the system. The system can be configured to couple the sensor to the base by compressing the telescoping assembly.

Abstract: The present embodiments relate generally to applicators of on-skin sensor assemblies for measuring an analyte in a host, as well as their method of use and manufacture. In some aspects, an applicator for applying an on-skin sensor assembly to a skin of a host is provided. The applicator includes an applicator housing, a needle carrier assembly comprising an insertion element configured to insert a sensor of the on-skin sensor assembly into the skin of the host, a holder releasably coupled to the needle carrier assembly and configured to guide the on-skin sensor assembly while coupled to the needle carrier assembly, and a drive assembly configured to drive the insertion element from a proximal starting position to a distal insertion position, and from the distal insertion position to a proximal retraction position.

Abstract: Detection of placement of dental aligners in patient mouth on teeth for indication of wearing compliance. Described herein are apparatuses and methods for detecting wearing, including compliance. In some variations these apparatuses and methods may include a sensor configured to detect deflection of the one or more deflectable structures. In some variations, these apparatuses and methods may include a proximity sensor coupled to the appliance shell and configured to generate sensor data when in proximity with intraoral tissue.

Abstract: Systems and methods for extracting blood glucose patterns and suggesting a behavior may include receiving, at a computing device comprising a processor, temporal data including information regarding glucose readings; identifying, by the computing device, at least one pattern based on metabolite levels extracted from the temporal data the model including variables corresponding to each of the patterns; formulating, by the computing device, a model for predicting a metabolic response; and storing the model on a data storage device. Based on the model, the behavior may be suggested to maintain a blood glucose level within a desired range.

Abstract: There is provided a device arranged to couple electromagnetic radiation into or out of a biological material. The device comprises a first metamaterial comprising: a substrate component having a thickness no greater than a first wavelength of the electromagnetic radiation; and a plurality of elements supported by the substrate component, wherein each element has a first dimension no greater than a first wavelength of the electromagnetic radiation and at least two of the elements of the plurality of elements are non-identical.

Abstract: Embodiments of the present disclosure provide systems and methods for monitoring a patient to produce a signal representing a blood oxygen concentration. The signal may be analyzed to determine the presence of one or more sleep apnea events, and an integral of the signal may be calculated if the signal is outside of a set range or threshold. A practitioner may choose to be informed of the presence of sleep apnea events if the blood oxygen concentration is less then a preset limit, if an upper limit has been reached for an integral representing the severity of the oxygen deprivation over time, or anytime sleep apnea events may be present in the signal.

Abstract: Methods and apparatuses for determining an analyte value are disclosed.

Abstract: A method for detecting an interferent contribution in a biosensor is disclosed. Herein, the biosensor has a first electrode (112), a second electrode, and a third electrode (114), wherein the first electrode (112) and the second electrode are covered by a membrane, wherein the first electrode (112) further includes an enzyme or wherein the first electrode (112) is covered by an enzyme layer. Further, the first electrode (112), the second electrode, and the third electrode (114) are connected via a potentiostat, wherein, in a normal operational mode, via the potentiostat an electrical potential difference is applied between the first electrode (112) and the second electrode in a manner that the first electrode (112) allows for oxidative processes and the third electrode (114) allows for reductive processes.

Abstract: A catheter for measuring a fractional flow reserve includes a proximal shaft, a distal shaft coupled to a distal portion of the proximal shaft, and a pressure sensor coupled to the distal shaft. The distal shaft includes a middle wall portion configured to extend through a stenosis in a vessel. The middle wall portion of the distal shaft includes at least one skive reducing the cross-sectional profile of the middle wall portion. The middle wall portion may further include at least one stiffening wire for increasing columnar stiffness of the middle wall portion.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: Disclosed are analyte monitoring systems and methods for calibrating an analyte sensor using one or more reference measurements. These systems and methods may include using a conversion function and first sensor data to calculate a first sensor analyte level, weighting a first reference analyte measurement (RM1) and one or more previous reference analyte measurements according to a weighted average cost function, updating the conversion function using the weighted RM1 and the one or more weighted previous reference analyte measurements as calibration points, and using the updated conversion function and second sensor data to calculate a second sensor analyte level. In some aspects, the systems and methods may include updating one or more of lag parameters used to calculate the sensor analyte levels.

Abstract: Glucose monitoring devices and related systems and methods, the glucose monitoring devices including a sensor electronics unit having a housing and a printed circuit board disposed within the housing, a transcutaneous glucose sensor assembly, and a conductive sensor connector. The printed circuit board includes a first electrical contact, the transcutaneous glucose sensor assembly includes a distal portion having a working electrode and proximal portion having a working-electrode contact in electrical communication with the working electrode, and the conductive sensor connector electrically connects the working-electrode contact with the first electrical contact. Further, the conductive sensor connector extends through a hole in the proximal portion of the transcutaneous glucose sensor assembly and through a hole in the printed circuit board.

Abstract: An automatic sensor inserter is disclosed for placing a transcutaneous sensor into the skin of a living body. According to aspects of the invention, characteristics of the insertion such as sensor insertion speed may be varied by a user. In some embodiments, insertion speed may be varied by changing an amount of drive spring compression. The amount of spring compression may be selected from a continuous range of settings and/or it may be selected from a finite number of discrete settings. Methods associated with the use of the automatic inserter are also covered.

Abstract: The ingestible event marker data framework provides a uniform, comprehensive framework to enable various functions and utilities related to ingestible event marker data (IEM data). The functions and utilities include data and/or information having an aspect of data derived from, collected by, aggregated by, or otherwise associated with, an ingestion event.

Abstract: The present disclosure is directed to a shuttle apparatus for detachably joining a catheter to a guidewire so that the joined catheter, extending alongside the guidewire, is in sliding engagement with the guidewire without extending around the guidewire. The apparatus comprises a collar member sized for mounting in sliding engagement around a length of the guidewire, the collar member having a longitudinal axis that approximately aligns along the length, when mounted thereabout, the length being defined between a proximal-most point of the guidewire and a distal point of the guidewire, the distal point being offset proximally from a distal-most point of the guidewire. The apparatus further comprises a plug member coupled to the collar member, the plug member having a longitudinal axis, and the plug member being sized to fit within an opening of the catheter for detachable engagement therewith.

Abstract: Devices are provided to automatically access blood from beneath or within skin. These devices include a plurality of injectors configured to drive needles into the skin and draw samples of blood into the device. These devices additionally include a plurality of sensors which can detect a target analyte in the blood samples received by the device. These devices further include a user interface, which may prompt the user to self-administer a dose of a substance, or accept a user input which could affect or otherwise influence the activation of the device (i.e., the firing of needles to draw blood samples into the device and detect an analyte). These devices can be wearable and configured to automatically access blood from skin, for example, to access blood from the skin at one or more points in time after the user has self-administered a dose of a substance.

Abstract: A method of detection of an analyte includes using a detector array having at least two detector elements that can emit electromagnetic waves, and selectively connecting a transmit circuit to any one or more of the at least two detector elements of the detector array. At least one transmit signal is generated using the transmit circuit, where the at least one transmit signal is in a radio or microwave frequency or visible range of the electromagnetic spectrum. The at least one transmit signal is transmitted into a target containing at least one analyte of interest using the one or more of the at least two detector elements connected to the transmit circuit.

Abstract: A catheter for measuring a pressure distal of a stenosis includes a shaft including a housing in a distal portion of the shaft. A flexible printed circuit board is coupled to the housing. A pressure sensor is coupled to the flexible printed circuit board and is suspended within the housing. An aperture enables blood flow into the housing and into contact with the pressure sensor.

Abstract: A system and method for continuous glucose monitoring (CGM) of blood in a blood vessel of a patient using a non-invasive sensor composed of a patch antenna operating in the Industrial, Scientific and Medical (ISM) Radio band (5.725 GHz-5.875 GHz). The device determines the blood glucose concentration of the blood in the blood vessel based on the measured shift of the resonant frequency of the non-invasive antenna patch sensor. A radio frequency (RF) synthesizer is used to drive the patch antenna with a fraction of its output coupled to both the antenna and receiver through a directional coupler. In this approach both the transmitted (FWD) and received (REV) power are processed, by demodulating logarithmic amplifiers, which convert the RF signals to corresponding voltages for downstream processing. The resulting voltages are then fed into a microcontroller and the measured shift in resonant frequency is converted to a real-time glucose concentration.

Abstract: A host-client data sharing system manages diabetes care data. A host database, preferably web or internet based, is implemented for storing diabetes care data relating to multiple diabetics. A client or local database stores the diabetes care data relating to multiple diabetics on a personal appliance such as a PC, or a portable or handheld microprocessor-based computing device. The host database uses multiple servers for handling client interactions with the system.

Abstract: The present invention generally relates to systems and methods for monitoring and/or providing feedback for drugs or other pharmaceuticals taken by a subject. In one aspect, the present invention is directed to devices and methods for determining a species within the skin of a subject; and producing feedback to a subject based on the determination of the species. The feedback may be, for example, visual, audible, tactile, a change in temperature, etc. In some cases, information regarding the determination of the species may be transmitted to another entity, e.g., a health care provider, a computer, a relative, etc., which may then provide feedback to the subject in some fashion. In some cases, the feedback may be directly indicative of the species. However, the feedback may also be indirect in some embodiments.

Abstract: The present disclosure includes methods, devices and systems for establishing a connection between a medical device and a remote computing device, receiving an upgrade command at the medical device, storing a current version of persistent data and a current version of executable code in a first storage area of the medical device, transmitting at least the current version of the persistent data to the remote computing device, receiving a second format of the current version of the persistent data and an upgraded version of executable code at the medical device, storing the second format of the current version of the persistent data and the upgraded version of the executable code in a second storage area of the medical device, and executing the upgraded version of the executable code with the second format of the current version of the persistent data.

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: Ultraviolet irradiation of fluids for the purposes of disinfection, sterilization and modification of a target organic compound found within the fluids. The target compound in the fluids can have an absorption spectra with an ultraviolet wavelength ranging from 230 nm to 360 nm. The absorption spectra includes a first and second set of wavelengths corresponding to absorption peaks and absorption valleys in the absorption spectra, respectively. A-set of ultraviolet radiation sources irradiate the fluids. The set of ultraviolet radiation sources operate at a set of peak wavelengths ranging from 230 nm to 360 nm with a peak full width at half maximum that is less than 20 nm. The set of peak wavelengths are proximate to at least one wavelength in the second set of wavelengths corresponding to the absorption valleys in the absorption spectra with a variation of a full width half maximum of the absorption valley.

Abstract: A device for inserting needles of a microneedle patch into a skin includes a housing. The housing includes a support portion for supporting a microneedle patch, a pressure-receiving portion to which the user applies a force to press the microneedle patch against the skin, and a plurality of leg portions each having at its one end a connecting portion connected to the pressure-receiving portion and having at its other end a tip portion coming into contact with the skin. The housing is designed to deform when a force is applied to the pressure-receiving portion, to cause a tension in a portion of the skin facing the support portion.

Abstract: A subcutaneous sensor system includes a sensor, a plurality of reservoirs, a plurality of pumps, a mixer provided with a plurality of mixer inlets and a mixer outlet, and a controller having an input coupled to the sensor output and a plurality of control outputs coupled to the plurality of pumps and the mixer. In certain embodiments, the system further includes an enclosure for the reservoirs, the pumps, the mixer and the controller, e.g. in the form of a skin patch or in the form of an implantable enclosure. In certain embodiments, the sensor is external to the enclosure and implanted beneath the skin tissue.

Abstract: Methods of manufacturing a biocompatible, hermetic feedthrough monolithically integrated with a biocompatible ribbon cable are described, as well as the resulting devices themselves. The hermetic feedthrough is created by placing glass over a mold of doped silicon or other material with a higher melting temperature than the glass and heating it to reflow the glass into the mold. The glass is then ground or otherwise removed to reveal a flat surface, and tiny pillars that were in the mold are isolated in the glass to form electrically conductive vias. The flat surface is used to cast a polymer and build up a ribbon cable, photolithographically or otherwise, that is monolithically attached to the vias.

Abstract: The present disclosure relates to devices and methods for non-invasive measuring of analytes. At least one embodiment relates to a wearable system for non-invasive measuring of a concentration of an analyte in skin tissue. The wearable system includes an integrated circuit that includes a first optical unit. The first optical unit includes a Raman spectrometer. The first optical unit also includes an OCT spectrometer and an interferometer optically coupled to the OCT spectrometer or an infrared (IR) spectrometer. The first optical unit additionally includes a light coupler. The wearable system further includes a first light source for performing Raman spectroscopy. The wearable system additionally includes a second light source for performing OCT spectroscopy or IR spectroscopy. Still further, the wearable system includes read-out electronics to determine an optical model of the skin tissue based on the spectroscopic data and to determine the concentration of the analyte.

Abstract: Methods and devices for increasing oxygenation levels in the blood supply and thereby treating the condition of hypoxemia. Multiple approaches such as pressure reduction in the pulmonary circulatory system, reducing triggering mechanisms in the main pulmonary artery and restricting flow in the pulmonary circulatory system are disclosed. Interventions associated with those approaches can including shunting, restrictors, compliance devices, pharmacologic substances, etc.

Abstract: Methods of analyte monitoring management are provided. The methods include indicating on a user interface a plurality of analyte management procedures available for user-selection, where the plurality of analyte management procedures relate to analyte management parameters. Embodiments include receiving an indication to initiate a first procedure of the plurality of analyte management procedures, where the first procedure is for determining a first analyte management parameter. The methods may further include outputting user-instructions associated with the first procedure; receiving analyte measurement data for the first procedure; estimating the first analyte management parameter based on the analyte measurement data; calculating a degree of certainty for the estimation of the first analyte management parameter; and, initiating an action in response to an event associated with a status of the estimation of the first analyte management parameter or the degree of certainty.

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: A method includes obtaining blood glucose measurements and blood glucose times of a patient from a blood glucose meter and executing a patient management program configured to display on a screen a graphical user interface having a trend window of the blood glucose measurements on the time line. The patient management program is configured to receive, in the trend window magnifying inputs for a magnification window superimposed on a segment of the timeline to specify a date range for a magnified window. The patient management program is further configured to display the magnified window including the blood glucose measurements of the patient from the specified date range and display a first information window including quantitative information associated with the blood glucose measurements from the specified date range.

Abstract: A multi-lumen catheter for monitoring intra-abdominal pressure, the catheter including an expandable outer balloon and an expandable inner balloon positioned within the outer balloon. A first lumen communicates with the inner balloon and the inner balloon and first lumen are filled with gas to form a gas filled chamber to monitor pressure within the bladder to thereby monitor pressure within an abdomen of the patient. A second lumen communicates with the bladder to remove fluid from the bladder. The catheter is configured for attachment of an external pressure transducer communicating with the gas filled chamber for measuring bladder pressure based on gas compression caused by deformation of the expanded inner balloon deformed by the expanded outer balloon.

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: 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: A biological information detection device includes: a needle body configured to pierce the living body; and a sensor that has an elongated shape and is configured to detect biological information using a distal end portion of the sensor that is configured to indwell inside a living body. The distal end portion of the sensor is insertable into the living body by moving along the needle body after the needle body has pierced the living body.

Abstract: The invention disclosed herein includes sensors having three dimensional configurations that allow expansive “360°” sensing (i.e. sensing analyte from multiple directions) in the environments in which such sensors are disposed. Embodiments of the invention provide analyte sensors having foldable substrates adapted to produce optimized configurations of electrode elements as well as methods for making and using such sensors. Typical embodiments of the invention include glucose sensors used in the management of diabetes.

Abstract: An analyte monitoring system and methods for extending the life of a sensor in an analyte monitoring system. The analyte sensor may include an analyte sensor and a transceiver. The analyte sensor may include an indicator, a detector, and an amplifier. The indicator may be configured to exhibit one or more detectable properties based on an amount or concentration of an analyte in proximity to the indicator. The detector may be configured to detect one or more of the detectable properties and output an analyte signal indicative of the amount or concentration of the analyte in proximity to the indicator. The amplifier may be configured to amplify the analyte signal. The transceiver may be configured to adjust a gain of the amplifier. The transceiver may be configured to additionally or alternatively adjust a drive current of a light source of the analyte sensor.

Abstract: 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.

Abstract: A catheter has extruded length of tubing and an injection molded tip that facilitates insertion of the catheter into the body. The catheter is fabricated by the steps of providing the tubing, for example, by extruding the tubing from a thermoplastic resin cutting the tubing to the desired length, inserting a plug into the tubing, inserting one end of the tubing into an injection mold cavity, creating and forming a tip in an injection molding step, and demolding the tubing with the formed tip.

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.