Abstract: A patient's physiological parameters, ascertained using intravascular ultrasound (IVUS) in combination with virtual histology (VH), are evaluated to predict whether the patient's physiology has an increased risk of producing a Clinical Event or a Silent Clinical Event. In one embodiment, one or more physiological parameters, such as Plaque Burden, Minimum Lumen Area, and whether or multiple VH-TCFAs are present, are compared to target values and/or ranges. A concurrence of the values for the physiological parameters to the target ranges indicates that a patient's physiology has an increased risk of producing a Clinical Event or a Silent Clinical Event.

Abstract: An eye monitor is disclosed for monitoring the size of a pupil of a monitored subject. The eye monitor includes a tracking device for tracking movement of the user's pupil and a monitoring device for monitoring the size of the user's pupil. The eye monitor provides for a continuous and real time analysis of the subject's eye and in particular the pupil of the eye, to determine whether the subject has been exposed to harmful chemicals and without requiring the subject to actively participate in the monitoring.

Abstract: Provided is a holder which comprises at least two probe mount portions and is to be put on the head of a subject by inserting a light-transmitting probe for emitting light from the tip thereof or a light-receiving probe for receiving light through the tip thereof in the probe mount portion, the holder characterized by being provided with a linear backbone portion extending in a first direction, at least two linear branch portions extending in a second direction different from the first direction, and a disposition reference point disposed so as to match a first specific point, the first specific point being set in the head of the subject.

Abstract: Exemplary apparatus and process can be provided for imaging information associated with at least one portion of a sample. For example, (i) first different wavelengths of at least one first electro-magnetic radiation can be provided within a first wavelength range provided on the portion of the sample so as to determine at least one first transverse location of the portion, and (ii) second different wavelengths of at least one second electro-magnetic radiation within a second wavelength range can be provided on the portion so as to determine at least one second transverse location of the portion. The first and second ranges can east partially overlap on the portion. Further, a relative phase between at least one third electro-magnetic radiation electro-magnetic radiation being returned from the sample and at least one fourth electro-magnetic radiation returned from a reference can be obtained to determine a relative depth location of the portion.

Abstract: The present invention relates to a device for examining nerve function. In order to examine the function of a nerve of the human body, the device for examining nerve function of the present invention includes: at least one stimulator for stimulating the human body; and a stimulator-fixing member having a form corresponding to the hands or feet of the human body, wherein the stimulator is located at one side of the simulator-fixing member so as to fix the stimulator to the hands or feet of the human body. The device for examining nerve function of the present invention further includes at least one blood-circulation detection sensor fixed at the stimulator-fixing member. According to the present invention, since the degree of hypoesthesia is examined through the stimulation of the stimulator, test accuracy and reliability may be greatly improved and it is possible to systematically and actively determine a diagnosis and course of treatment for a patient having diabetes or spinal nerve damage, e.g.

Abstract: A main body of a sphygmomanometer includes an air duct having an end connected to a tube extending from the cuff and another end connected to the inflation bulb. The main body also includes a pressure sensor that measures a pressure in the air duct, a display unit, a controller that controls display operation of the display unit in accordance with a measurement obtained using the pressure sensor, and a determination button. In the sphygmomanometer, the cuff, the tube, the air duct and the inflation bulb communicate with one another so as to have a uniform inner pressure, and the controller causes the pressure value measured when the determination button is pressed to be continuously displayed in the display unit.

Abstract: A pulse measurement apparatus and a method of obtaining pulse information using the same are provided. The pulse measurement apparatus includes a frame, a first arm and a second arm installed in the frame so that the first and the second arms are rotated, and a sensor unit formed at one end of each of the first arm and the second arm, brought in contact with an inner wall within an ear of a user, and configured to detect pulse waves transferred through a blood vessel. The pulse measurement apparatus mounted on an ear and reduced in size can be provided, and a continuous and stable pulse wave signal can be measured using the pulse measurement apparatus.

Abstract: A method for producing a computational flow dynamics model for assessing the efficacy of the deployment of a flow-diverting device in a blood vessel of a patient is provided. Image data of the patient is acquired with a medical imaging system, from which images depicting the blood vessel are reconstructed. A pre-treatment blood vessel model is generated by segmenting the reconstructed images. This pre-treatment blood vessel model is then used to generate a post-treatment, or post-deployment, model of the blood vessel. A post-deployment model of the flow-diverting device is generated and used together with the post-treatment blood vessel model to generate a computational flow dynamics model.

Abstract: Systems, methods, and devices allow percutaneous mapping, orientation and/or ablation in bodily cavities or lumens. Such may include a structure that is percutaneously positionable in a cavity, such as an intra-cardiac cavity of a heart. Transducers carried by the structure are responsive to blood flow. For example, the transducers may sense temperature, temperature being related to convective cooling caused by blood flow. A controller discerns positional information or location, based on signals from the transducers. For example, blood flow may be greater and/or faster proximate a port in cardiac tissue than proximate tissue spaced from the port. Position information may allow precise ablation of selected tissue, for example tissue surround a port in the intra-cardiac cavity.

Abstract: A method of identifying potential driver sites for cardiac arrhythmias includes acquiring a plurality of electrograms from a plurality of locations on at least a portion of a patient's heart. Using the acquired electrograms, at least one electrical activity map is generated. Desirable electrical activity maps include complex fractionated electrogram standard deviation and mean maps, dominant frequency maps, peak-to-peak voltage maps, and activation sequence maps. Using one or more of these maps (e.g., by analyzing one or more electrogram morphological characteristics represented by these maps), at least one potential driver site can be detected.

Abstract: A device senses cardioelectrical signals using a right atrial (RA) lead, which might include far-field R-waves as well as near-field P-waves. The device concurrently senses events using a proximal electrode of an LV lead, which can sense both P-waves and R-waves as substantially near-field events. Suitable templates are then applied to the signals sensed via the proximal LV electrode to identify the origin of the signals (e.g. atrial vs. ventricular) so as to properly classify the corresponding events sensed in the RA as near-field or far-field events. In this manner, far-field oversensing is conveniently detected.

Abstract: A drug interlock for vehicles based on exhaled breath directed onto said SERS-active substrate, wherein a detected drug substance in exhaled breath of a subject locks said vehicle from use for at least a pre-determined time or a repeated exhaled breath test where no drugs are detected. A collecting surface has a Surface Enhanced Raman Spectroscopy (SERS)-active layer that comprises at least one SERS-active material. The collecting surface is arranged as an outer surface of a waveguide for contact with exhaled breath, such that at least traces of said at least one drug substance in said exhaled breath can contact said SERS-active layer for read-out of a Raman shift spectrum that is detected in-situ for said detecting the presence or determining the quantitative amount of said at least one drug substance from said exhaled breath.

Abstract: Methods are disclosed for distinguishing whether an animal is experiencing a bacterial infection or a viral infection. One monitors breath taken from the animal over time to measure the relative amount of a first breath stable isotope to a second breath stable isotope therein over time. A quick change in the isotope ratios within several hours from the likely infection is indicative of a bacterial infection. A delayed change in the isotope ratios, followed by periodic repeated alterations in the ratios, is indicative of viral infection. The methods are particularly efficient when using cavity ringdown spectroscopy for the monitoring. They may be used for monitoring a patient already admitted to a hospital, or for monitoring a patient initially complaining of adverse symptoms, or for triage, or for collectively monitoring a population of animals.

Abstract: Systems and methods for monitoring incentive spirometry are disclosed. A patient measuring unit measures inhalation and/or exhalation flow and/or volume. The patient is instructed to follow a prescribed program of repeated inhalations and/or exhalations using the patient measuring unit. Feedback is provided to the patient to facilitate compliance with the prescribed program. All usage of the patient measuring unit is recorded and displays are provided for both the patient and an attending clinician. Prescribed performance targets are programmed, and alarms are set to indicate when prescribed targets are not met. Alarms can be set for minimum and maximum flow rates, minimum inhalation volume, minimum repeat count per set, maximum interval between sets, and maximum performance degradation compared to a recent average.

Abstract: A wake-to-sleep transition for a subject is detected based on responsiveness to breathing cues provided to the subject. A pressurized flow of breathable gas to the airway of subject having one or more gas parameters that are adjusted to provide breathing cues to the subject. Based on a detected conformance of the respiration of the subject to the breathing cues, a determination is made as to whether the subject is awake or asleep.

Abstract: This invention relates to a breathing sensing device, comprising a diaphragm (100) having a first pressure chamber (120) on one side and a second pressure chamber (121) on a second side, wherein said first and second pressure chambers (120, 121) are connected to a system pressure (L1) by means of flow passages (143, 153) having different cross sectional passage area (Ar, Af) arranged to facilitate detection of a pressure drop due to breathing, wherein the relation of cross sectional passage area between the cross sectional passage area (Ar) providing a restricted flow passages (143) to and/or from the second pressure chamber (121) is in the range of 1/50- 1/200 in relation to the cross sectional passage area (A f) providing a flow passage to and/or from the first pressure chamber (120).

Abstract: A medical implant component including a fiber Bragg grating sensor is described. The sensor may be located so as to be at a leading end of the implant when the implant is being inserted, allowing feedback to be provided to a surgeon of the force being applied to the leading end of the implant during implantation. An interrogator for a sensor fiber Bragg grating is also described. The interrogator includes a matched fiber Bragg grating to the sensor fiber Bragg grating, which passes a proportion of the return light signal from the sensor fiber Bragg grating, the intensity of which can be related to the strain/force applied to the sensor Bragg grating.

Abstract: Embodiments presented herein provide apparatus and methods for imaging-assisted determination of pressure gradient of blood flow across a valve orifice in a cardiovascular circuit without the use of velocity data measured at the valve orifice. An embodiment of the methods comprise creating an image of a valve orifice, creating a planimeter slice from the image of the valve orifice including a trace of the perimeter of the valve orifice, determining the valve orifice area by determining the area contained within the trace, determining the instantaneous flow rate through the valve orifice based on bulk flow data away from the valve, and determining the instantaneous pressure gradient across the valve orifice from the valve orifice area and the instantaneous flow rate.

Abstract: Single piece biopsy forceps having jaws that are caused to open and close in response to longitudinal movement of an actuation rod. The single piece forceps are formed from a single metal blank with opposing jaw sections connected via a self-hinge. The metal blank includes a self-hinge portion, a channel section on either end of the hinge portion and a jaw section on distal ends of the channel sections. The jaws are formed from the jaw section of the metal blank and the channel sections are bent to provide generally U-shaped channel sections. The hinge portion is bent so that the jaws are oriented in opposed aligned relation. A fixed and a movable pin are disposed through slots in the channel sections. Movement of the movable pin with respect to the fixed pin via an actuator rod or wire causes the jaws of the biopsy forceps to open and close.

Abstract: A biopsy device includes a cannula and an inner divider wall disposed in the cannula. The inner divider wall defines a plurality of cannula fluid openings. The outer wall of the cannula and the inner divider wall together define a cutter receiving lumen and a cannula vacuum lumen. The cannula fluid openings provide fluid communication between the cutter receiving lumen and the cannula vacuum lumen. A cutter is translatable with respect to the cannula for severing tissue drawn into the cannula. The cutter is operable to cover and/or uncover the cannula fluid openings. A proximal portion of the cutter is spaced away from the inner divider wall. A distal portion of the cutter is configured to slide adjacent to the inner divider wall.

Abstract: A medical trajectory guide includes a base a configured for alignment with a coordinate system of an imaging device, first and second guide members rotatably attached to the base, a guide sleeve in contact with the first and second guide members, and a locking mechanism attached to the guide sleeve and configured to allow separate movement of the first guide member and the second guide member. The first and second guide members are rotatable about a first and second axis, respectively. The guide sleeve includes a longitudinal axis about which the guide sleeve is prevented from rotating.

Abstract: A device, a kit, and a method of use thereof, for self-administration and collection of cervical cell tissue samples such as for Pap smear testing. The device comprises an insertion tube, within which is carried a movable cervical aligning tool with an aligning probe, and a cellular sampling tool with a cellular adhesion surface. The aligning probe and cellular adhesion surface can be selectively movable relative to the insertion tube to improve accuracy of the testing and user safety.

Abstract: The present invention relates to a vessel for withdrawing blood, the vessel containing a solution which comprises a guanidinium salt, a buffer substance, a reducing agent, and/or a detergent as components. The vessel is particularly suited for withdrawing blood which is to be analyzed with respect to nucleic acids.

Abstract: A decorative device for use with a medical instrument having a tubing structure, the decorative device including at least one connector configured to removably couple to the tubing structure on the medical instrument, the connector having a face plate engaging structure configured to attachably engage at least tone decorative face plate member.

Abstract: A mouthguard apparatus is disclosed herein. In various aspects, the mouthguard apparatus includes an electronics package adapted to attach removably to a dental appliance. The dental appliance may be configured to be secured within the mouth of a user. At least portions of the electronics package adapted to extend external to a mouth of the user when the electronics package is attached to the dental appliance and the dental appliance is secured within the mouth of the user, in various aspects. Related methods are disclosed herein. This Abstract is presented to meet requirements of 37 C.F.R. §1.72(b) only. This Abstract is not intended to identify key elements of the apparatus and methods disclosed herein or to delineate the scope thereof.

Abstract: Methods and devices are disclosed for controlled mediation and/or improvement of inflammation, inflammation associated with pain, and pain by delivering non-ablative thermal tissue damage to portions of a region of tissue including a volume of inflamed tissue, thereby activating the immune systems pain relief response to the tissue damage.

Abstract: A high-frequency operation apparatus includes a grasping portion for grasping a treatment target living tissue, an electrode for supplying a high-frequency current to the living tissue, a high-frequency current supplying section that generates the high-frequency current necessary for treatment, a cable section that transmits the high-frequency current, an impedance measuring section for measuring an impedance value of the living tissue, a detecting section that detects that the impedance value reaches an impedance threshold at a time when moisture in the living tissue starts to evaporate, a measuring section that measures an output time of the high-frequency current after the detection, a storing section that stores a set time, and an output control section that performs control for stopping an output when the output time of the high-frequency current reaches the stored set time.

Abstract: Disclosed are methods and systems for non-invasive ultrasound neuromodulation of superficial cortex of the brain or stimulation of nerve roots or peripheral nerves. Such stimulation is used for such purposes as determination of motor threshold, demonstrating whether connectivity to peripheral nerves or motor neurons exists and performing nerve conduction-speed studies. Neuromodulation of the brain allows treatment of conditions such as depression via stimulating superficial neural structures that have connections to deeper involved centers. Imaging is optional.

Abstract: In order to provide heating means for an ultrasonic application setup, adapted for heating a sample (20) gently and fast and saving costs and space, an ultrasound transducer (10) capable of being driven at multiple frequencies including a main frequency for efficient production of ultrasound waves and at least one alternative frequency, at which almost no ultrasound is generated, a system for sample analysis comprising such an ultrasound transducer (10) and a method for controlling such an ultrasound transducer (10) are proposed, wherein the ultrasound transducer (10) is driven either at the main frequency for generating ultrasonic waves or at the alternative frequency for generating heat in the ultrasound transducer (10), if the sample (20) is to be heated.

Abstract: A device and method for the treatment of mouth sores or ulcers, such as canker sores. The device includes a vacuum bulb connected to a treatment tip via a fluid-tight conduit. The device allows for a vacuum to be applied to the area of a canker sore by positioning of the tip and actuation of the vacuum bulb. Through gentle application of a vacuum to the area afflicted with a canker sore, the sensitivity of the afflicted area is diminished and the healing process is significantly improved. The device preferably includes disposable applicator tips.

Abstract: The invention is a manual CPR or CCC continuous chest compression assist device for use on a person suffering cardiac arrest. The assist device has a compressible body structure and an audible signal element, visual signal assembly or both. The audio signal element is interposed in the body structure to announce or generate an audible sound or “click” at a predetermined deflection of the compressible portions. The visual signal assembly is interposed in the body structure to announce or generate a visible light at a predetermined deflection of the compressible portions. The activation of the visual or audio signal corresponds to a predetermined deflection of the compressible portions pressing against the breastbone and alerts the person administering to initiate decompressing to relax the body structure for the next compression, upon relaxation the device decompresses and a second audible or visual signal or both indicates a reset of the device.

Abstract: Techniques associated with an implant system for imparting vibratory massage to tissue within a body is disclosed. Methods include placing an implant device near a surface of a stomach, the implant device configured to produce and communicate a vibration to stomach tissue, the implant device including a case forming a portion of an exterior of the implant device and defining an interior of the implant device, a vibration generator mounted on the case to vibrate the implant device, and a tissue engaging structure located on the exterior surface of the case to engage the stomach tissue, securing the implant device to the stomach, and activating the vibration generator of the implant device to cause the implant device to vibrate against the stomach, wherein the vibration stimulates a nerve to suppress an appetite.

Abstract: Techniques associated with an implant system for imparting vibratory massage to tissue within a body is disclosed. Methods include placing an implant device near a surface of a bladder, the implant device configured to produce and communicate a vibration to bladder tissue, the implant device including a case forming a portion of an exterior of the implant device and defining an interior of the implant device, a vibration generator mounted on the case to vibrate the implant device, and a tissue engaging structure located on the exterior surface of the case to engage the stomach tissue, securing the implant device to the bladder, and activating the vibration generator of the implant device to cause the implant device to vibrate against the bladder, wherein the vibration stimulates a nerve to induce urination.

Abstract: A massage device comprises a body having a body-contacting head adjacent one end and a handle adjacent the other end, the body shaped to permit the user to reach the back of his/her body with the head when the handle is at the user's front or side; and having a rest pivot extending from the body and terminating at a distal end in a support-contacting face, the rest pivot being positioned so that when the device is between a support surface and the user with the head in contact with the user's body and the handle positioned for contact by the user's hand, (a) the user's bodyweight stabilizes the rest pivot against sliding movement on the support and (b) any pivoting force about the rest pivot applied by the user's hand to the handle is substantially less than the force exerted against the user's body by the head.

Abstract: The present disclosure relates to a support apparatus for use on a leg, ankle, and foot cast. The support apparatus attaches to the bottom of the cast and has a first sole and a second sole. The first sole is removable from the second sole providing the cast with both an aggressive tread on the second sole and a moderate tread on the first sole.

Abstract: An ankle walker including an ankle shell, an inner lining, at least one bladder and at least one strap is provided. The ankle shell includes a base, a lower foot portion, a first and second side panel and a back panel. The lower foot portion extends upward from the base. The first side panel and second side panel extend from respective first and second portions of the lower foot portion. The back panel extends from a third portion of the lower foot portion and is positioned between the first and second side panels. The ankle shell has a first slot separating the first side panel from the back panel and a second slot separating the second side panel from the back panel. At least one of the first and second slots has a height that is at least one half the height of the ankle walker.

Abstract: An orthosis for supination and/or pronation of a forearm of a wearer, the orthosis including a base, an upper arm support coupled to the base and configured to secure an upper arm of the wearer, a rotation assembly coupled to the base and including an output member rotatable relative to the base within a rotation plane, and a forearm support member coupled to the output member of the rotation assembly and configured to releasably engage a wrist and the forearm of the wearer.

Abstract: An arch support used by an athlete practicing his or her sport in bare feet, which consists of a metatarsal elastic compressive strap and an elastic calcaneal strap originating and terminating on the metatarsal strap using a crossing pattern on the plantar surface of the foot. Design is minimal in structure allowing the athlete to maximize contact of plantar surface of foot with the floor, or other surface, while maintaining support of foot structure.

Abstract: A wound care product is a nonwoven fabric made of filaments bulked from a tow and fixed into a 3-dimensional structure.

Abstract: A multiple-use blotting device for blotting blood from a fingertip includes a substrate, and a blood absorbing pad secured to the substrate. The blood absorbing pad has a plurality of blood absorbing sections that are evenly spaced from one another. The blotting device includes a protective cover overlying the blood absorbing pad, the protective cover having a window formed therein for exposing the blood absorbing pad. The cover is coupled with the substrate and is adapted to rotate relative to the substrate and the blood absorbing pad for sequentially aligning the window of the cover with each of the blood absorbing sections for exposing, one at a time, each of the blood absorbing sections. After one section of the pad has been used to blot blood, the cover is rotated for exposing a clean, unused section of the pad, while covering the used, blood-soaked section of the pad.

Abstract: The invention relates to a method for diagnosis of multiple sclerosis (MS) wherein, presence or absence of an anti-AT1 receptor antibody is determined in a sample from a patient to be diagnosed and wherein, the presence of an anti-AT1-receptor antibody is indicative of the disease.

Abstract: An implantable medical device is disclosed that includes a valve seat and a valve member movable with respect to the valve seat. An adjustment circuit assembly includes a resistive element that is coupled to the valve member and operable to position the valve member relative to the valve seat so as to alter the pressure setting in response to a current applied to the resistive element.

Abstract: A tampon applicator barrel includes an insertion tip at a forward end of the barrel, a main body section that extends from the insertion tip, and a reverse taper section that is joined to the main body section so that the main body section is between the insertion tip and the reverse taper section. The main body section tapers toward the insertion tip section. The reverse taper section tapers in a direction away from the insertion tip section. A finger grip section extends from the reverse taper section to a plunger receiving end of the barrel opposite the forward end. The barrel is straight from the forward end to the plunger receiving end that receives a plunger.

Abstract: The present disclosure relates to an iontophoretic device having a delivery portion and a control portion that are located on a common base layer but separated from one another so as to provide increased flexibility and interface with a wearer.

Abstract: The invention provides use of a photosensitiser, which is a derivative (e.g., an ester) of 5-aminolevulinic acid (5-ALA) or a pharmaceutically acceptable salt thereof, in the manufacture of a medicament for use in the prevention or treatment of acne.

Abstract: A medical balloon assembly including an inflatable balloon and at least one cutting element extending from the balloon is disclosed. The inflatable balloon includes an outer wall facing outward and an inner wall facing outward. The cutting element comprises a plurality of openings therein including a first opening and a second opening. The first opening is closed off by a portion of the outer wall. The cutting element further includes a passageway extending from the first opening to the second opening. The passageway is defined by the cutting element and the portion of the outer wall which closes off the passageway. The passageway may contain a therapeutic agent.

Abstract: In accordance with at least one exemplary embodiment, a syringe, method and system for delivering a therapeutic amount of ozone are disclosed. An exemplary syringe can have a gas chamber and one or more electrodes. A portion of at least one electrode can be within the gas chamber. Alternatively, singularly or in conjunction, one or both electrodes can be attached to the outside of an exemplary syringe. One or more electrical contact points can be outside the gas chamber. Each electrical contact point can be connected to an electrode. Oxygen gas can provided within the gas chamber of the exemplary syringe. A medical ozone generator can be connected to the syringe via the electrical contact points. Corona discharge can be effectuated via the electrodes, which can result in an amount of ozone gas can being produced from the oxygen gas.

Abstract: The present invention provides a highly effective device and method for performing human colon irrigation. It comprises a bypass line having a non-return valve connected to a warm water supply line where in the non-return valve operates in proportion to back pressure as it develops in the colon thereby allowing gentler filling of colon and limiting pressure in the colon to a maximum safe level. Benefits include patient comfort and a safeguard against damaging the intestine. The present invention also provides a novel housing for a colon irrigation device which provides easy access to the internal part of the device without the need for disconnecting water or electrical supply lines.

Abstract: An enteral fluid delivery and reflux collection system and method are disclosed. A fluid nutrient source container and administration tube are joined to an enteral feeding tube, and a gastric reflux tube connects a vented reflux collection syringe to selectively permit or prevent reflux collection, and/or to aspirate or flush the associated fluid lines.

Abstract: A medical/surgical irrigator with a handpiece for discharging a lavage solution. There is reservoir in which a therapeutic agent is stored. The therapeutic agent can be selectively mixed with the lavage solution to form a blended solution. The mixing can be performed selectively so as to make it possible to sequentially apply the blended solution or a basic (lavage only) solution.