Abstract: A skin-adorned physiological or biochemical sensing device is disclosed herein. The device preferably comprises a first substrate and a second substrate. The first substrate comprises an array of solid microneedles designed to penetrate a biological interface to access a physiological fluid or tissue. Each microneedle is capable of electrical interface with the physiological fluid or tissue. The second substrate comprises integrated circuitry designed to transduce at least one signal produced by an electrophysiological or electrochemical reaction. A sensing device is formed that is capable of interpreting the signal arising from the electrophysiological or electrochemical reaction to ascertain the level of some physiological or biochemical entity.

Abstract: A wearable respiration monitoring system having a transmitter coil that is adapted to generate and transmit multi-frequency AC magnetic fields, two receiver coils adapted to detect variable strengths in two of the AC magnetic fields and generate AC magnetic field strength signals representing anatomical displacements of a monitored subject, and at least one accelerometer that is configured to detect and monitor anatomical positions and movement of the subject, and generate and transmit accelerometer signals representing same. The wearable monitoring system further includes an electronics module that is adapted to receive the AC magnetic field strength signals and accelerometer signals, and determine at least one respiratory disorder as a function of the AC magnetic field strength signals and at least one anatomical position of the subject as a function of the accelerometer signals.

Abstract: An apparatus for estimating bio-information, includes a pulse wave sensor configured to measure a pulse wave signal from a user, and a processor configured to obtain two or more parameters among a maximum point, an average point, and an onset point, from a waveform of the measured pulse wave signal, and combine the obtained two or more parameters to generate a pulse wave analysis result.

Abstract: A medical device for detecting at least one analyte in a body fluid, a method for assembling the medical device and a method of using the medical device are disclosed. The medical device comprises: an analyte sensor having an insertable portion; an insertion cannula receiving the insertable portion of the analyte sensor; an electronics unit connected with the analyte sensor; and a housing comprising an electronics compartment receiving the electronics unit and a sensor compartment receiving the analyte sensor, the sensor compartment forming a sealed compartment receiving the insertable portion of the analyte sensor, the sealed compartment comprising detachable upper and lower caps, the lower cap configured for detachment before insertion, the insertion cannula being attached to the upper cap, wherein detaching the upper cap after insertion removes the insertion cannula, wherein the electronics compartment at least partially surrounds the sensor compartment.

Abstract: A method for determining lung function in a patient is disclosed, in which a multi-lumen catheter with an expandable occluding element at its end is used to isolate a targeted lung compartment, and respiratory characteristics at the targeted lung compartment are measured over multiple respiratory cycles. The relation between various characteristics of the respiratory cycle is used to determine compliance of lung tissue within the targeted lung compartment.

Abstract: A device for generating alerts for Hypo and Hyperglycemia Prevention from Continuous Glucose Monitoring (CGM) determines a dynamic risk based on both information of glucose level and a trend obtainable from a CGM signals. The device includes a display whose color depends on the DR (for example, red for high DR, green for low risk). When DR exceeds a certain threshold, alerts are generated to suggest the patient to pay attention to the current glucose reading and to its trend, both of which are shown on the display in numbers and symbols (e.g. an arrow with different slope or color).

Abstract: A biosensor for determining an analyte is disclosed. The sensor has a sensor module covered at least partially by a biocompatibility layer. The biocompatibility layer has a polymer having —CO—NR1R2 side groups, wherein R1 and R2 are independently selected from —H and C1 to C6 alkyl. A method for producing the biosensor, as well as to uses and methods of using related to the biosensor, are also disclosed.

Abstract: A single smart health device able to monitor all physiological aspects of a human body includes a body fluid detection module, a temperature detection module, an electrocardiogram detection module, and a control module. The body fluid detection module tests and detects amounts of biological substances in body fluids. The temperature detection module detects a temperature of the human body. The electrocardiogram detection module detects a heart rate of the human body. The control module is electrically connected to the body fluid detection module, the temperature detection module, and the electrocardiogram detection module, and obtains the detected amounts of biological substances, the detected temperature, and the detected heart rate.

Abstract: An eye implantation device has a body including a support system adapted to engage at three points with an iridocorneal angle of an anterior chamber of an eye into which the device is implanted.

Abstract: A sensor implanted in tissues and including a sensing enzyme takes an electrical measurement and compares it to reference curves for the voltage current relationship. The sensor determines whether molecular compounds are present which interfere with the detection of the molecule of interest. If interfering species are found, the measurement voltage is set in a low range to reduce errors, while if the interfering species are not found, the measurement voltage is set in a high range to increase the detected signal.

Abstract: The present invention is directed to a cuff-like medical device that may analyze and report the concentrations of various biomarkers in a subject's bodily fluids, samples of which may be extracted by the device in the field and analyzed on the spot using the cuff-like medical device. For example, extracellular fluid (commonly known as “tissue fluid”) of a patient may be analyzed by the present invention, and in particular, the constituent interstitial fluid—the known main component of extracellular fluid—may be analyzed for concentrations of one or more specific types of proteins. A sensor component within the device may include one or more aptamers that permit chemical binding of at least one biomarker of interest. When the aptamer-protein binding complex is complete, an electronic component of the device may employ nanoscale weighing using frequency differential analysis through quartz crystal microbalances to determine the presence and concentration of biomarkers.

Abstract: A biological fluid collection device (10) that receives a sample (12) and provides flow-through blood stabilization technology and a precise sample dispensing function for point-of-care and near patient testing applications is disclosed. A biological fluid collection device of the present disclosure is able to effectuate distributed mixing of a sample stabilizer within a blood sample and dispense the stabilized sample in a controlled manner. In this manner, a biological fluid collection device of the present disclosure enables blood micro-sample management, e.g., passive mixing with a sample stabilizer and controlled dispensing, for point-of-care and near patient testing applications. Advantageously, a biological fluid collection device of the present disclosure includes an internal vacuum (28). In this manner, a biological fluid collection device of the present disclosure eliminates the need for additional vacuum creating components that must be connected to the biological fluid collection device during use.

Abstract: Disclosed here are devices, systems, and methods for continuous monitoring of biomarkers using a wearable, non-intrusive microneedle sensor patch platform. In some aspects, a wearable, non-intrusive microneedle sensor device includes a microneedle sensor unit couplable to an electronics unit, where the microneedle sensor unit comprises a substrate, an array of spiked microneedle structures configured as electrochemical sensor electrodes, an array of base structures that encase a lower portion of spiked microneedle structures, and electrical interconnections that electrically couple the electrodes to the electronics unit for processing of detectable signals associated with one or multiple biomarkers in a biofluid.

Abstract: A medical device includes an antenna external to a case, package, or encapsulant for the electronic systems of the medical device. In one embodiment, a diabetes infusion pump is enclosed within a metal case, the pump including a processor and a communication module for wireless communications. An antenna is disposed in the delivery tubing of the pump outside the case with an antenna feed interconnecting the external antenna with the internal communication module. In another aspect, a thin film antenna is formed on the outer surface of the case in which a physiological parameter sensor, such as a glucose sensor, is enclosed. Multiple antennas may be used for communications on different frequencies.

Abstract: A system, apparatus, and device estimate the state of the glucose metabolism of the subject based on a correlation between a blood glucose level of the subject acquired in advance and an index which is based on the pulse wave of the subject associated with the blood glucose level.

Abstract: Fault detection and diagnostics for a microneedle array based continuous analyte monitoring device are provided. The electrochemical sensors, including the electrodes of the analyte monitoring device configured for measuring one or more target analytes, may experience various faults during use of the analyte monitoring device. By modeling the sensors as an electrical network, measurements of the electrical network may be correlated with operational parameters of the sensor. The voltage at the counter electrode provides an indication of the resistance or impedance between the working electrode and the counter electrode and is used to identify the occurrence of faults occurring at the continuous analyte monitoring device.

Abstract: A cuff for monitoring physiological cycles has an exterior and interior surface and securing means. The cuff consists of a body having an upper curve, a lower curve and a height (CH) therebetween. A sensor adhered with a flexible protective overlay to the interior surface is in communication with a microprocessor storage means. The microprocessor storage means can be within the cuff or separate therefrom with communication between the sensor and the storage means being wireless or through a communication member. A locking tab, having a width less than the body, extends from one side of the body. A slot retaining area extends from the body on a side opposite the locking tab and contains a slot dimensioned to receive the locking tab. A pull tab is adjacent the slot retaining area opposite the body. The pull tab shares a base with the slot retaining area and has a top line and an end width less than the width of the body.

Abstract: A catheter system and a method for performing body obstruction destruction are disclosed. The catheter comprises a catheter shaft comprising a proximal end and a distal end, including an outer tubular member and at least one inner tubular member disposed within the outer tubular member; a first fluid lumen defined between the inner tubular member and the outer tubular member and at least one second lumen defined by the inner tubular member; one or more fluid exit openings located at a distal end region of the catheter configured to permit fluid to exit the catheter from the first fluid lumen; fluid pressure means located external of the catheter ahead from the proximal end for delivering said fluid in the first fluid lumen at a pressure range predetermined to cause destruction of said obstruction.

Abstract: A subcutaneous sensor for use with a continuous glucose monitor includes a reference electrode, a working electrode, and a composition for releasing nitric oxide (NO). The reference electrode includes a reference substrate and an ion limiting layer over the reference substrate. The working electrode includes a conductive substrate, an interference layer over the conductive substrate, an enzyme layer over the interference layer, and a glucose limiting layer. The enzyme layer has an enzyme for reacting with in-vivo glucose in body fluid of a patient. The glucose limiting layer is over the enzyme layer and limits an amount of the in-vivo glucose from the body fluid of the patient that passes to the enzyme layer. The composition for releasing nitric oxide (NO) includes a NO release compound, a hydrophilic material and a hydrophobic material. The composition is on the reference electrode.

Abstract: There is provided a glucose sensor system comprising: a transmitter (2) for containing a battery (212), the transmitter being for placement on top of patient skin; a transcutaneous connector (3) comprising at least one conductive path; and an implantable monolithic integrated circuit (I) for placement beneath the patient skin, wherein the implantable monolithic integrated circuit comprises a potentiostat and an electrochemical sensing element; wherein the potentiostat is electrically coupled to the transmitter (2) via the transcutaneous connector (3), and the electrochemical sensing element is configured to sense glucose concentration and generate an electrical signal representative of the glucose concentration, and wherein the potentiostat is electrically connected to the electrochemical sensing element.