Abstract: An earplug to be worn in the ear canal of a person has a thermochromic probe and stem portion that continuously monitors the core body temperature of the wearer and changes color reversibly upon detection of temperatures above or below a temperature range considered to be normal for tympanic temperature to visually indicate to the wearer or an observer that the wearer has an unsafe core body temperature. The earplug has an outer body formed of a soft resilient material configured to conform to the generally conical interior profile of the ear canal and become resiliently and removably engaged therein when pressed into the canal. The probe has a head portion and a radial flange configured to permit a desired insertion distance such that, when properly inserted, the head portion is near, but not in contact, with the tympanic membrane and engaged on the conical wall of the ear canal.

Abstract: Disclosed herein is a sample recovery and collection device comprising a tube, a cap, an insert, and an opening. The cap includes an O-ring and is removably secured to the tube for sealing the tube. The insert includes a first end having a ring that is adhered to the tube and second end opposite the first end. The insert also includes a first leg, a second leg, and a third leg, each coupled to and extending from the ring to the second end. The opening extends from the ring to the second end and the insert defines a diameter. Also disclosed herein is a kit comprising the sample recovery and collection device. Further disclosed herein is a method of collecting a sample from a subject.

Abstract: There is provided a personal fall detection system comprising a sensor module that is suitable for attachment to a user, the sensor module comprising an accelerometer for measuring accelerations acting on the sensor module; and a processor for analyzing the measured accelerations to determine if the sensor module has suffered an impact, and for estimating a vertical displacement of the sensor module during a time period immediately before the impact; wherein the processor estimates the vertical displacement of the sensor module by twice integrating the measurements from the accelerometer.

Abstract: Disclosed is an apparatus for facilitating access to the left atrium, and specifically the left atrial appendage. The apparatus may comprise a sheath with first and second curved sections that facilitate location of the fossa ovalis and left atrial appendage. The apparatus may further comprise tissue piercing and dilating structures. Methods are also disclosed.

Abstract: A medical device including a barrel having an open first end and capable of supporting a needle at a second end of the barrel is provided and includes a lid releasably adhered to and overlying the open first end of the barrel in a fluid tight manner; and a pad secured to a surface of the lid such that the pad is disposed within a cavity of the barrel when the lid is adhered to the barrel, wherein the pad comprises a disinfecting solution.

Abstract: A biopsy device includes a first cannula having a first aperture, a second cannula having a second aperture, and a driver unit. The second cannula is disposed co-axially with the first cannula. At least one of the first aperture and the second aperture has a cutting edge. The driver unit has a ratchet drive mechanism operatively coupled to the first cannula and the second cannula. The ratchet drive mechanism includes a first gear fixedly attached to the first cannula. A second gear is fixedly attached to the second cannula. A torsion spring has a first end portion connected to the first gear and a second end portion connected to the second gear. The torsion spring stores energy which when released drivably rotates one of the first gear and the second gear relative to the other of the first gear and the second gear.

Abstract: Embodiments of the invention are directed to a medical device and methods for collecting a tissue sample from a patient's body. The device may include a first tube defining a lumen and an aperture at a distal end of the first tube. A second tube extends within the lumen of the first tube and defines a lumen and slots, where at least some of the slots have sharp edges configured to shear tissue. The second tube is movable relative to the first tube such that the sharp edges cut a plurality of samples from tissue disposed within the aperture.

Abstract: A guidewire manipulation device includes a housing sized to be supported by a hand of a user, the housing having a distal end and a proximal end; a rotation member rotationally disposed within the housing; a locking assembly coupled to the rotation member, the locking assembly configured to selectively transfer rotational movement of the rotation member to rotational movement of a guidewire; a handle coupled to the housing and configured to be operable by the hand of the user; and a drive system coupled to the handle, the drive system configured to apply alternating clockwise motion and counter-clockwise motion to the guidewire by causing the rotation member to rotate.

Abstract: A computer-implemented method is provided for conducting a hearing assessment of a patient. The method includes: presenting a plurality of objects on a display of a computing device, where each object produces an audio output in response to a stimuli from the patient and the audio output by the objects varies in frequency and intensity amongst the plurality of objects; prompting a patient with a visual cue to classify objects producing sound; receiving an input from the patient for each object in the plurality of objects, where the input indicates whether the audio output by a given object was perceptible to the patient; and generating an audiogram for the patient using the input received from the patient.

Abstract: The compression measurement and feedback system measures the magnitude and the angle of manual CPR force applied to a patient and provides the measured magnitude and direction information as compression data feedback to the person applying CPR to the patient. Any variation in the magnitude or direction of the compression force applied may be calculated from the compression data measured by the compression sensor. A monitor receives the compression data and processes the compression data to generate feedback data to the CPR provider indicating the magnitude and direction of the applied CPR compression along with ideal CPR compression characteristics for comparison.

Abstract: A motion analysis system includes: at least one orientation sensor configured to detect three-dimensional torso motion over time, the at least one orientation sensor including: a multiaxial accelerometer configured to detect acceleration in at least three orthogonal directions, and a gyroscope; and a controller configured to receive data from the at least one orientation sensor, the controller programmed to process the data to: determine at least one of a state and a transition of the torso; identify normal parameters for the determined at least one of the state and transition; and determine whether motion of the torso is outside the normal parameters. The controller is configured to identify, in real-time, the occurrence of a fall in progress of an individual from at least one of a standing state, a standing-to-seated transition, and a seated-to-standing transition.

Abstract: A biopsy device having a cannula and a translating and rotating cutter with respect to the cannula is disclosed. The biopsy device may have a programmable memory for use in operating the cutter. The biopsy device may also include a reservoir, and may be functional to provide a flow of pressurized liquid through the cutter.

Abstract: The invention is directed to tissue cutting members and biopsy devices with such tissue cutting member for separating a tissue specimen from a patient's body at a target site. The tissue cutting member is slidably disposed within an inner lumen of an elongated probe member of the biopsy device to cut a tissue specimen drawn into the interior of an outer cannula of the biopsy device through a tissue receiving aperture in the probe. The tissue cutting member has a tubular distal portion with a distal tip having an outer tissue cutting edge, an inner tissue receiving aperture, and a longitudinally oriented opening with a closed proximal end and open distal end which opens to the inner tissue receiving aperture to facilitate flaring of the distal tubular portion. The cutting member has at least one opening in a wall of the tubular portion to maintain a vacuum during use.

Abstract: A medical device for collecting cells includes a perforated tube and a brush disposed therein for collecting cells from tissue adjacent the tube. The tube includes a perforated portion and tissue can be drawn into the perforations in response to a vacuum applied to the tube. The brush can be inserted into the tube with the head portion of the brush aligned with the perforated portion to collect cells form the tissue that has been drawn into the perforations by the vacuum. The brush can be removed from the tube and another brush can be inserted to increase cell collection amounts.

Abstract: A body fluid sampling system for use on a tissue site includes a single drive force generator. A plurality of penetrating members are operatively coupled to the force generator. The force generator moves each of the members along a path out of a housing with a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. A flexible support member couples the penetrating members to define a linear array. The support member is movable and configured to move each of the penetrating members to a launch position associated with the force generator.

Abstract: A system for mapping a tissue surface includes a probe for mapping a tissue surface, a localization system to measure a location data point indicative of the probe's location, a memory in which to store the location data point, a servo mechanism to move the probe along at least a portion of the tissue surface, a controller to move the probe to a plurality of locations and to record in the memory a plurality of location data points, and a contact-sensing processor to analyze the plurality of location data points and to identify a subset thereof on the tissue surface. A modeling processor generates a model of the tissue surface using the subset of location data points. The contact-sensing processor utilizes probe velocity, or a rate of change in the distance moved by the probe, to determine contact between the probe and the tissue surface.

Abstract: The present disclosure relates to signal processing and, more particularly, to determining the value of a physiological parameter, such as the blood oxygen saturation (SpO2) of a subject. In an embodiment, a first baseline for a first waveform and a second baseline for a second waveform are determined. In this embodiment, the first and second waveforms are indicative of the physiological parameter of the subject. The first and second waveforms are filtered to obtain a first direct-current (DC) component for the first waveform and a second DC component for the second waveform. A measured value for the physiological parameter is derived from the first and second baseline signals, and the first and second DC components. In an embodiment, the measured value for the physiological parameter is determined based on a ratio of the normalized difference between the DC component and the baseline signal for the first waveform with respect to same for the second waveform.

Abstract: The described invention provides a disposable handheld biopsy device for taking biopsies, the biopsy device comprising a tissue cutting assembly which has features to control the tissue length that will be severed by the cutting assembly; and a vacuum assembly which has features to control the vacuum level. The disposable handheld biopsy device of the described invention is simple, lightweight, portable, and cost effective to manufacture and dispose of.

Abstract: This invention relates to a device (10) for taking at least one sample of soft tissue from an organ, said device comprising a body (11) and a needle (12) arranged in the body and extending at least partly outside the body through the front end of the body, the needle is formed by a stylet and a cannula coaxial with said stylet. The device comprises a mechanism for arming the needle, designed for sequentially moving the stylet and then the cannula from a rest position to a shooting position wherein the stylet and the cannula are retracted towards the rear end of the body, and a triggering mechanism designed to release the stylet then the cannula and to allow their displacement from the shooting position to the rest position. The cannula is coupled to a cannula slider (24) comprising at least one retaining element (26) for maintaining the cannula slider in a shooting position.

Abstract: A sample collection tool comprises a collection end configured for collecting a sample. Optionally, the sample is collected from within a body cavity of an animal without causing significant discomfort or injury to the animal. A first handle portion has a first end connected to the collection end and a second end. A second handle portion is connected to the second end of the first handle portion by a breakable connection. The second end of the first handle portion has at least one winglet. The at least one winglet is compliant in a preferential direction. The breakable connection is ruptured at least in part when the at least one winglet is forced in the preferential direction.