Abstract: A drug delivery device for administration to a subject is provided. In some embodiments, the drug delivery device includes a reservoir containing an active pharmaceutical ingredient and a potential energy source. The drug delivery device also includes a trigger operatively associated with the potential energy source, where the trigger is configured to actuate at a predetermined location within the subject. The drug delivery device also includes a rupturable membrane disposed along a flow path extending between the reservoir and an outlet, where the membrane is configured to rupture when the trigger is actuated. Once the trigger is actuated, the potential energy from the potential energy source may be released to expel the active pharmaceutical ingredient in a jet through the outlet.

Abstract: A blood flow rate measurement system measures fluid flow rate in a blood vessel having a catheter-based heart pump inserted therein, without relying on measurements of electric current drawn by a motor that drives the heart pump. A turbine is disposed at or near a distal end of the heart pump catheter. Blood or other fluid flowing through the blood vessel urges blades of the turbine to rotate. The turbine is mechanically coupled to a signal generator, which generates a signal indicative of a rotational speed of the turbine, which is dependent, at least in part, on speed of the fluid flowing through the blood vessel. A tachometer, external to the body of the patient, calculates the blood flow rate from the rotational speed of the turbine. In some cases, the blades are collapsible, to reduce diameter of the turbine, thereby facilitating insertion of the system into the blood vessel.

Abstract: A method and apparatus to determine body composition of a subject is disclosed. Physical characteristics of a subject and water in a pool is determined. A body of the subject is completely submerged in the pool of water such that a head of the subject is just below a surface of the water in the pool. The subject completely exhales air into an air measuring device as the body of the subject is submerged just below the surface of the water. A semi-rigid strip or tab portion may be coupled to the air measuring device to indicate when air pressure within the air measuring device is between a predetermined range. The body composition is then determined based on the determined subject characteristics, water characteristics and the amount of air exhaled into the air measuring device when the air pressure is between the predetermined range.

Abstract: Disclosed are sensor devices, systems, and methods for performing electrochemical measurements. The sensor device includes a flexible orthodontic device substantially cylindrical in shape with a hole in an end configured to allow saliva to pass. The device further includes one or more valves to allow the saliva to pass in a forward direction through the flexible orthodontic device and not in a reverse direction, and one or more electrochemical electrodes configured to contact the saliva, wherein the one or more electrodes are configured to determine the presence of one or more chemical biomarkers in the saliva.

Abstract: A medical instrument having an aspiration needle, handle device and an actuation force limiter. The actuation force limiter provides an active or passive force release mechanism that keeps the force from overpowering operation of the needle.

Abstract: A portable sampler, the sampler including a sampler assembly having a housing that includes a receiver defined therein for interchangeably receiving a number of removable inlet assemblies, the removable inlet assemblies including a respirable inlet assembly and a thoracic inlet assembly. The respirable inlet assembly includes a hybrid cyclone assembly, the hybrid cyclone assembly including an impaction stage and a cyclone in series. The thoracic inlet assembly includes an inlet slot configured to function as a size-selective inlet. Another thoracic inlet assembly includes a housing having a number of openings configured to receive a sample airflow; an inlet insert through which an inlet aperture is defined; a prequalification chamber defined between a lower surface of the housing and an upper surface of the inlet insert; and a protrusion extending downward from the lower surface of the housing into the inlet aperture of the inlet insert to from an inlet slot.

Abstract: A method of a processor for detecting a presence of Cheyne-Stokes respiration from a respiration signal includes accessing data representative of a respiration signal. Data is assessed to detect apnea and/or hypopnea events. A cycle length histogram is determined based on the events and an incident of Cheyne-Stokes respiration is detected based on the cycle length histogram.

Abstract: A method for detecting cancer involved lymph nodes. The method includes placing a pH-sensing paper inside a needle of an injection syringe, filling the injection syringe with a buffer solution, putting the pH-sensing paper in contact with lymphatic fluid of a lymph node by inserting the needle of the injection syringe inside the lymph node, putting the lymphatic fluid in interaction with the buffer solution by injecting the buffer solution into the lymph node utilizing the injection syringe, and detecting that the lymph node as a cancer involved lymph node if color of the pH-sensing paper is changed to an acidic-range pH color.

Abstract: A medical appliance for use in medical procedures to controllably advance a medical device through a sheath. The medical appliance features pneumatic action and connecting structures adapted to couple the appliance to a variety of types of catheters, tools, and instruments.

Abstract: The invention relates to skin tape stripping methods to identify a subject at risk of having atopic dermatitis, or a subject having atopic dermatitis who is at risk of developing a food allergy, or a subject at risk of developing a food allergy in the absence of the subject having atopic dermatitis.

Abstract: Apparatus, methods, and systems for detecting alcohol concentrations of an individual, and in particular in vivo alcohol concentrations of an individual. Alcohol sensing compositions include at least one alcohol-responsive active area comprising a concerted enzyme system having at least a first enzyme and second enzyme capable of acting in concert to facilitate the detection of alcohol. At least one of the enzymes in the concerted enzyme system is a ketoreductase.

Abstract: An apparatus and method for examining an organism surface includes a pliable member including a contact layer, a plurality of channels, and a reaction layer, wherein the plurality of channels are disposed between the contact layer and the reaction layer; each of the channels having a size in the range of micrometers and formed of biocompatibility materials, and the contact layer including a plurality of spherical projections having a size in the range of micrometers and formed of biocompatible materials, and the reaction layer including examining molecules and a reaction unit.

Abstract: 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.

Abstract: Handheld steering devices for use with intravascular devices and associated systems and methods are disclosed. In some instances, the handheld steering device includes a housing sized and shaped for grasping by a hand of a user; a steering controller coupled to the housing; a processor in communication with the steering controller, the processor configured to translate inputs from the steering controller into actuation signals based on a code architecture that includes a script for at least one of a return home function, a return to stored position function, a store current position function, or an automated mapping function; and an actuator positioned within the housing and configured to interface with the intravascular device based on the actuation signals to the steer the intravascular device. Associated systems and methods are also disclosed.

Abstract: A method for evaluating a gastrointestinal tract may include receiving an electrical signal that includes data pertaining to motility in the gastrointestinal tract of a patient and analyzing one or more characteristics of the electrical signal relative to one or more respective thresholds indicative of an occurrence or an imminence of a condition of the gastrointestinal tract.

Abstract: The invention refers to a method of determining an indicator that is representative for a patient's volume responsiveness, comprising the following steps: (i) measuring a sequence of pulse signals of a patient; (ii) determining an envelope(signal)-curve based on the sequence of measured pulse signals; (iii) determining a fit(envelope(signal))-function based on the previously determined envelope(signal)-curve, the fit(envelope(signal))-function representing an idealised curve progression of the envelope(signal)-curve without comprising pulse variations caused by ventilation or respiration induced heart-lung interaction; (iv) determining respiratory pulse variation signals corresponding to the pulse variations caused by ventilation or respiration induced heart-lung interaction; (v) determining an envelope(respiration)-curve based on the previously determined respiratory pulse variation signals; (vi) determining a fit(envelope(respiration))-function based on the previously determined envelope(respiration)-curve,

Abstract: Electrochemical Impedance Spectroscopy (EIS) is used in conjunction with continuous glucose monitors and continuous glucose monitoring (CGM) to enable in-vivo sensor calibration, gross (sensor) failure analysis, and intelligent sensor diagnostics and fault detection. An equivalent circuit model is defined, and circuit elements are used to characterize sensor behavior.

Abstract: Provided herein are devices, systems, and methods for assessing, treating, and for developing new treatments for pulmonary arterial hypertension (PAH) using pulmonary artery pressure (PAP) values and/or cardiac output (CO) estimates.

Abstract: An apparatus for estimating a biological substance in a user using a unit spectrum for the biological substance acquired using a biological tissue simulation solution is provided. The apparatus may include a spectrometer configured to emit a light to a skin of a user, detect the light returned from the skin, and measure a skin spectrum of the user from the detected light and a processor configured to estimate a biological substance in the user based on the measured skin spectrum and a unit spectrum acquired using a biological tissue simulation solution.

Abstract: A wearable breath analysis device is disclosed that may be worn, for example, around the neck or wrist of a user. The wearable device may be a stand-along device (in which case it may include a display that provides a user interface), or may operate in conjunction with a smartphone or other command device. The wearable device may include auditory and/or vibratory notice and communications features or capabilities, for example, such as a reminder or notice to conduct a breath analyte measurement, instructions to the user in the course of conducting the measurement, and notice of the breath analyte measurement results. The auditory or vibratory notice may be provided at the wearable, and/or at the command device where a command device is used. Related methods also are provided.