Abstract: Devices and methods are described for providing continuous measurement of an analyte concentration. In some embodiments, the devices include a membrane that has an interference domain designed to reduce the permeation of one or more interferents.

Abstract: Membrane systems incorporating silicone polymers are described for use in implantable analyte sensors. Some layers of the membrane system may comprise a blend of a silicone polymer with a hydrophilic polymer, for example, a triblock poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) polymer. Such polymeric blends provide for both high oxygen solubility and aqueous analyte solubility.

Abstract: Embodiments described herein relate to an analyte monitoring device having a user interface with a display and a plurality of actuators. The display is configured to render a plurality of display screens, including a home screen and an alert screen. The home screen is divided into a plurality of simultaneously displayed panels, with a first panel displays a rate of change of continuously monitored analyte levels in interstitial fluid, a second panel simultaneously displays a current analyte level and an analyte trend indicator, and a third panel displays status information of a plurality of components of the device. When an alarm condition is detected, the display renders the alert screen in place of the home screen, the alert screen displaying information corresponding to the detected alarm condition. Furthermore, the actuators are configured to affect further output of the analyte monitoring device corresponding to the detected condition.

Abstract: A parameter affecting the absorptivity or the concentration of blood in tissue is measured using a semiconductor light source (7) and a light detector (8). The semiconductor light source (7) is operated at several operating conditions, at which it has different temperatures and therefore different emission spectra. In particular, the operating conditions correspond to different time intervals after switching the light source (7) on, while the light source (7) has not yet reached thermal equilibrium. This allows to perform a spectroscopic measurement using one light source only, which increases accuracy and reduces device cost.

Abstract: Confidence in a physiological parameter is measured from physiological data responsive to the intensity of multiple wavelengths of optical radiation after tissue attenuation. The physiological parameter is estimated based upon the physiological data. Reference data clusters are stored according to known values of the physiological parameter. At least one of the data clusters is selected according to the estimated physiological parameter. The confidence measure is determined from a comparison of the selected data clusters and the physiological data.

Abstract: An electrochemical sensor system comprises an electrochemical sensor and a hydrogel composition. The electrochemical sensor has at least a counter electrode and a working electrode. The hydrogel composition contacts the working electrode. The hydrogel composition comprises a first monomer, a second monomer, a cross-linking agent, and a solvent. The first monomer has hydrophilic characteristics. The second monomer has hydrophobic characteristics. The ratio of the first monomer to the second monomer is from about 0.1:99.9 to about 99.9:0.1.

Abstract: A blood glucose sensing system includes a sensor and a sensor electronics device. The sensor includes a plurality of electrodes. The sensor electronics device includes stabilization circuitry. The stabilization circuitry causes a first voltage to be applied to one of the electrodes for a first timeframe and causes a second voltage to be applied to one of the electrodes for a second timeframe. The stabilization circuitry repeats the application of the first voltage and the second voltage to continue the anodic-cathodic cycle. The sensor electronics device may include a power supply, a regulator, and a voltage application device, where the voltage application device receives a regulated voltage from the regulator, applies a first voltage to an electrode for the first timeframe, and applies a second voltage to an electrode for the second timeframe.

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: A blood separation and testing system for a blood sample is disclosed. The blood separation and testing system includes a blood sampling transfer device adapted to receive a blood sample, a blood separation device, and a blood testing device. The blood separation device is adapted to receive a portion of the blood sampling transfer device such that with the blood sampling transfer device received within the blood separation device and a rotational force applied to the blood sampling transfer device, a plasma portion of the blood sample is separated from a cellular portion of the blood sample. The blood testing device is adapted to receive a portion of the blood sampling transfer device to analyze the plasma portion of the blood sample and obtain test results.

Abstract: A vent plug is disclosed that includes a body having a distal end, a proximal end, and a lumen extending through the distal and proximal ends. A membrane is disposed across the lumen, the membrane being hydrophobic and air permeable. A fluid chamber is formed within the lumen distal the membrane. A distal lumen opening being shaped and sized to retain blood within the lumen until the internal pressure of the lumen increases in response the a finger pressing against a proximal lumen opening.

Abstract: A system includes one or more optical sensors for the measuring and monitoring of physiological information of a motorized system operator. The system is configured to determine an incapacitation state of the motorized system operator based upon the measured physiological information. When the measured physiological information indicates an incapacitation state (intoxication level, stress level, and so forth), the system is configured to provide a response thereto including, but not limited to: lock out operation of the motorized system, provide a warning on a display, transmit a message from the motorized system, assume automatic control of the motorized system, and so forth. The system includes a plurality of light sources (e.g., light-emitting diodes (LEDs)), one or more photodetectors, and control circuitry coupled to the plurality of light sources and/or photodetectors to non-invasively measure physiological information (e.g., blood alcohol concentration, stress levels, and so forth).

Abstract: Devices and methods for profiling microbiota of skin are described which include a hand-held microbe profiling device including a housing defining an opening, the housing including at least one rotatable component at least partially disposed in the opening defined by the housing, an elongated flexible strip disposed on an outer surface of the at least one rotatable component, the outer surface of the elongated flexible strip positioned to contact one or more regions of a skin surface of an individual through the opening defined by the housing, a location-capture component to detect a location of one or more regions of the skin surface as the elongated flexible strip contacts said one or more regions, at least one sensor component to detect one or more signals emitted or reflected from the elongated flexible strip, and a computing component to associate the location of said one or more regions of the skin surface and the detected one or more signals.

Abstract: Embodiments of neural interfaces according to the present invention comprise sensor modules for sensing environmental attributes beyond the natural sensory capability of a subject, and communicating the attributes wirelessly to an external (ex-vivo) portable module attached to the subject. The ex-vivo module encodes and communicates the attributes via a transcutaneous inductively coupled link to an internal (in-vivo) module implanted within the subject. The in-vivo module converts the attribute information into electrical neural stimuli that are delivered to a peripheral nerve bundle within the subject, via an implanted electrode. Methods and apparatus according to the invention incorporate implantable batteries to power the in-vivo module allowing for transcutaneous bidirectional communication of low voltage (e.g. on the order of 5 volts) encoded signals as stimuli commands and neural responses, in a robust, low-error rate, communication channel with minimal effects to the subjects' skin.

Abstract: A person monitoring system is operable to predict the onset of an adverse condition of a person. The system receives first information corresponding to a feature of a person support apparatus and second information corresponding to a physiological characteristic of the person. The system calculates a condition score as a function of the first and second information. In some instances, the system alerts a caregiver if the condition score exceeds a predetermined threshold. Alternatively or additionally, the person monitoring system alerts a caregiver when a person supported on a person support apparatus is regaining consciousness by monitoring one or more of a change in position, a heart rate, and a respiration rate. A person monitoring system that monitors a person's quality of sleep and presents information concerning the quality of sleep to one or more interested parties is also disclosed.

Abstract: A cradle drive mechanism, a table and a patient imaging and carrying apparatus are provided. The cradle drive mechanism includes: a first portion, which is arranged on a main base and has a belt drive structure, wherein the belt drive structure is used to connect a cradle and drive the cradle to make a reciprocating motion; a second portion, which is arranged on a secondary base and has a secondary supporting and rotating member, wherein the second portion and the first portion form a gap therebetween, and the secondary supporting and rotating member is used to support the cradle; and two guiding and rotating members, which are arranged on the second portion and/or the first portion for guiding the cradle to move linearly. The present application can simplify the structure by adoption of the belt drive structure. Further, the gap between the second portion and the first portion does not attenuate the X-ray additionally, so the dose of the X-ray emitted can be decreased.

Abstract: A system orientates and displays intra-vascular ultrasound imaging data using an acquisition processor and an image data processor. The acquisition processor acquires, during navigation of an ultrasound catheter through a vessel, for multiple individual intra-vascular ultrasound images comprising an image sequence, data representing an individual image and orientation data associated with the individual image indicating orientation of the catheter and individual image with respect to a reference position external to patient anatomy. The image data processor aligns the multiple individual intra-vascular ultrasound images with respect to the external reference position by rotating individual images of the image sequence as necessary to have substantially the same orientation with respect to the external reference position in response to the orientation data.

Abstract: Described herein are microelectrode array devices, and methods of fabrication, assembly and use of the same, to provide highly localized neural recording and/or neural stimulation to a neurological target. The device includes multiple microelectrode elements arranged protruding shafts. The protruding shafts are enclosed within an elongated probe shaft, and can be expanded from their enclosure. The microelectrode elements, and elongated probe shafts, are dimensioned in order to target small volumes of neurons located within the nervous system, such as in the deep brain region. Beneficially, the probe can be used to quickly identify the location of a neurological target, and remain implanted for long-term monitoring and/or stimulation.

Abstract: A system for multi-mode breast x-ray Imaging which comprises a compression arm assembly for compressing and immobilizing a breast for x-ray imaging, an x-ray tube assembly, and an x-ray image receptor is provided. The system is configured for a plurality of imaging protocols and modes.

Abstract: Methods for updating a 2D/3D registration between a three-dimensional image data set corresponding to a target area subjected to a movement and a plurality of two-dimensional projection images of the target area include: selecting a plurality of contour points along a contour, the contour being visible in a first projection image and a three-dimensional image data set registered therewith, the plurality of contour points being associated with a rigid object in the target area; determining a displacement of each contour point of the plurality of contour points between the first projection image and a successively captured second projection image; obtaining movement information for each contour point of the plurality of contour points based on the determined displacement, the movement information describing a movement of the rigid object; and updating the registration based on the obtained movement information.

Abstract: A system for detecting lymphedema comprising a dual energy x-ray absorptiometry system and one or more spacer pads disposed within a field of view of the dual energy x-ray absorptiometry system. The dual energy x-ray absorptiometry system comprises an x-ray source and a patient support platform, wherein the patient support platform is configured to receive a patient in a supine position with the x-ray source disposed above the patient support platform. The one or more spacer pads are configured to be positioned between body parts of the patient.

Abstract: A method and apparatus for correcting a focus of a CT device are provided. The method includes: calculating a total focus shift according to scanning data; and correcting, when the CT device is running, a deflection of an electron beam emitted from a ray source of the CT device, based on the total focus shift. The device includes: a shift calculation module, configured to calculate a total focus shift according to scanning data; and a shift correction module, configured to correct, when the CT device is running, a deflection of an electron beam emitted from a ray source of the CT device, based on the total focus shift.

Abstract: A method of evaluating at least one tissue type includes providing a tissue classifier comprising multiple detector arrays for each of multiple tissue types. Each detector array comprises multiple detectors and each detector comprises multiple tissue type-assigned intravascular ultrasound (IVUS) spectra. For each of the detector arrays, an input IVUS spectrum of the tissue region is compared to the tissue type-assigned IVUS spectra of each of the detectors in the detector array and it is determined whether the input spectrum corresponds to the tissue type of the detector. The results for the detector. The results for the detector arrays are combined to provide a tissue characterization of the tissue region from the multiple tissue types. One or more IVUS images can be displayed with the tissue characterization and an indication of the size of at least one of the tissue types in a selected portion of the image that is displayed.

Abstract: A non-invasive endometrial sample collector has an outer body of absorbent material configured for insertion into a vaginal cavity of a patient such that a distal end of the body is positioned proximate a uterine cervix of the patient. The collector has an internal collection assembly disposed within the outer body of absorbent material. The internal collection assembly includes a funnel having an opening at the distal end of the outer body configured to face the uterine cervix when the outer body is positioned in the vaginal cavity, and a reservoir in fluid communication with the funnel. During a menstruation cycle of the patient when endometrial tissue cells are shed within menstrual fluid that passes through the uterine cervix, or during any type of normal or abnormal bleeding episode, at least a portion of said fluid is directed to the reservoir via the funnel under the force of gravity.

Abstract: Disclosed is a device useful for preserving tissue samples after extraction from human or animal patients. The device includes a circular blade for taking a tissue sample, the blade being coupled to a sealing cap which mates to one end of a container. A retrieval port is also disclosed for extracting fluids from the container. Methods are also disclosed by which tissue samples may be taken and prepared for storage, processing, culture, or other analysis.

Abstract: A control system for allowing a physician to control the orientation of a medical device or a medical instrument in a variety of directions with one hand. An actuator selectively tensions one or more control cables having ends secured at or adjacent a distal tip of the medical device in order to bend the distal tip in a desired direction. In one embodiment, a physician can adjust the movement of the distal tip in a desired direction without affecting the orientation of the medical device in other directions.

Abstract: A voice controlled surgical system including a wireless command microphone receiving audio input, a voice control module for generating commands from the audio input received by said wireless command microphone, a detection module for generating signals indicative of a proximity of said wireless command microphone, a switch module for disabling the commands in response to one or more of the signals, and an alarm module activated in response to the one or more of the signals.

Abstract: A catheter for removing tissue from a body lumen includes a rotatable cutter. The cutter includes an annular cutting tip at the distal end portion of the cutter for removing tissue from the body lumen. An axial cavity is defined by an interior surface of the cutter and extends proximally from the annular cutting tip toward the proximal end portion of the cutter. An eccentric opening extends from the central cavity through the cutter to allow tissue removed from the body lumen by the annular cutting tip to pass proximally through the eccentric opening toward an interior passage of the catheter body. The offset opening is offset from the longitudinal axis of the cutter.

Abstract: A system for positioning an interchangeable tool in a body cavity includes a channel having a lumen in direct communication with the body cavity, a tool introducer having a longitudinal axis and a distal end, and a tool holder covering at least a portion of the interchangeable tool that is pivotally connected to the tool introducer allowing angular positioning of the interchangeable tool after the tool holder emerges from the channel into the body cavity. A method for engaging an interchangeable tool with a distal portion of a tool manipulator in a body cavity includes inserting a tool introducer into a channel, orienting the distal portion of the tool manipulator in the body cavity, emerging the interchangeable tool from the channel into the body cavity, and positioning the interchangeable tool eccentrically to the lumen of the channel.

Abstract: A device for establishing an access channel to a target location is presented. The device includes a plurality of cylindrical segments. A plurality of backbones each extends through a backbone channel of each segment to join the plurality of segments together. When joined together, the central bore of each of the plurality of cylindrical segments align to form an access channel. A distal segment is fixedly attached to each of the plurality of backbones such that an orientation of the distal segment can be adjusted by linear movement of one or more of the plurality of backbones through the plurality of cylindrical segments. Furthermore, when linear movement of the plurality of backbones is restricted, the shape of the access channel can be adjusted by external forces while maintaining the orientation of the distal segment.

Abstract: A surgical retractor comprising a retractor body having a site portion and handle portion, and an impactor body on the retractor body. The impactor body is positioned and configured for use in impacting the site portion of the surgical site. An impaction axis of the impaction body is preferably substantially aligned with an axis of the site portion of the impactor body. The impactor body is preferably attached to the retractor body at a junction between the site portion and the handle portion of the retractor body. In one embodiment, the impactor portion is configured to selectively mate with an impactor extension member to thereby optionally receive direct impaction on the impactor portion or indirect impaction through the impactor extension member.

Abstract: A surgical access device includes a body having a first member and a second member relatively movable between open and closed configurations. Each member is positionable within an opening in tissue to provide access to an interior space of a patient. Each member includes a top surface, a bottom surface, a leading end, and a trailing end. The top surfaces are positioned in close cooperative alignment when the first and second members are in the closed configuration. The trailing ends are positioned in close cooperative alignment when the first and second members are in the open configuration. In the open position, the first and second members define a passage therethrough to permit access to the interior space for passage of a surgical instrument therethrough.

Abstract: A surgical instrument includes a first member having an inner surface and an outer surface. A second member has an inner surface and an outer surface. At least one of the inner surfaces defines at least one mating element and the outer surfaces are engageable with tissue. The members are relatively movable between a first configuration and a second configuration to space the tissue and define an opening between the members. At least one third member defines at least one mating element engageable with the at least one mating element of the inner surface such that the at least one third member is disposed within the opening. Systems and methods are disclosed.

Abstract: An adaptor for removably engaging surgical retractor blades to a retractor frame has a recess with a latch mechanism at its proximal end for removably securing the adaptor to the rail of a retractor frame, and a spring-loaded locking jaw mechanism at its distal end for removably engaging a retractor blade.

Abstract: The present disclosure relates to a tissue repair device. The device includes a handle, a knob coupled to the handle, and a needle coupled to the handle. The needle includes a proximal end and a distal end, the distal end including a slot, wherein a first anchor is housed within the distal end and a second anchor is housed within the slot and located proximal to the first anchor. An actuator disposed within the needle and operatively coupled to the knob, wherein advancement of the knob allows for engagement of the actuator with the first anchor and subsequent advancement of the first anchor via the actuator. A method of tissue repair is also disclosed.

Abstract: A threaded suture anchor with an eyelet shield transversely molded at a distal end of the anchor body, over which one or more strands of suture is looped. The anchor body is threaded and has a tapered distal portion. The proximal end portion of the suture anchor body has a polygonally shaped opening to accept a polygonal drive head, preferably hexagonal or square. The peripheral surface defining polygonally shaped opening is rounded and smooth to prevent abrading sutures placed in contact therewith. In another embodiment, a push-in anchor is provided with an eyelet shield at the proximal end of the anchor.

Abstract: An apparatus including a flexible length of cord and three tissue connectors positioned at the opposite ends of the cord and at an intermediate position of the cord is designed to be laparoscopically inserted through the abdominal wall and into the abdominal cavity, and used to move a first internal organ to a position away from a second internal organ where the apparatus holds the first internal organ in the position without further manual input, thereby providing surgical access to the second internal organ.

Abstract: A suturing instrument for placing multiple sutures include an elongate body engaged to a handle. A suturing head extends from a distal end of the elongate body, and the suturing head is articulable relative to the elongate body. Both a first needle carrier and a second needle carrier are movable into and out of the suturing head. A first actuator allows controlled movement of the first needle carrier, and this first actuator extends from a proximal end of the handle. A second actuator allows controlled movement of the second needle carrier, and this second actuator also extends from the proximal end of the handle. The suturing head can be articulated within a range of about 0 degrees to about 30 degrees, as measured from a longitudinal axis running along the length of the elongate body, and this variable articulation angle of the head allows deployment of the first needle carrier and the second needle carrier at various orientations with respect to the longitudinal axis.

Abstract: A system includes a tool and a suture connected to a needle. The tool includes a bore formed in a tube, and a suture slide communicating with the bore. The suture slide has a curved surface formed between an exterior surface of the tube and the bore of the tube. The needle is disposed in the bore. A segment of the suture is disposed within the bore and alongside the needle. The suture is in contact with the suture slide, and a proximal portion of the suture extends out of the bore at the suture slide. The suture slide is located forward of the back end the needle. Tension applied to the suture ejects a pointed distal end of the needle out of the distal end of the tube.

Abstract: Suture clip deployment devices for applying suture clips to sutures are described. Some embodiments can include a generally tubular main body and a vacuum port located at the distal end, a hollow inner body longitudinally slidable within the main body and extending from the main body at its distal end, and a suture recess located in the generally tubular main body. At least one suture clip configured to frictionally fit on an outer surface of the inner body is deployed during use. Clip deployment can occur after a vacuum source is applied to the device so as to draw the suture into the device. The suture lines can be retrieved through the suture recess, and the device can be actuated so as to deliver the suture clip off the delivery device and onto the suture, locking the suture in place.

Abstract: A surgical staple, comprising a backspan, a first leg member extending from the backspan, a second leg member extending from the backspan, and at least one substantially continuous channel extending along at least one of an inner surface and an outer surface of the first leg member and the second leg member.

Abstract: In various embodiments, a surgical stapler is disclosed. The stapler comprises a handle, a shaft, and a surgical end effector extending from the shaft. The stapler further comprises a firing member configured to move through a plurality of positions during a firing stroke, an electric motor configured to drive the firing member during the firing stroke, and a control system for controlling the electric motor. The control system comprises a battery and a pulse frequency modulation circuit configured to control the frequency of pulses supplied from the battery to the electric motor, wherein the pulse frequency modulation circuit is configured to optimize the speed applied to the firing member.

Abstract: An exemplary surgical apparatus for treating tissue may include an anvil; a jaw pivotally connected to the anvil; and a first cartridge detachably connected to the anvil, holding staples of a first size; where a first clamp gap between the anvil and first cartridge is set by the connection between the first cartridge and jaw. An exemplary cartridge for a surgical stapler may include a cartridge housing; a plurality of staples held within the cartridge housing; and a sled slidable within, and retained by, the cartridge housing, including a central platform, at least one wedge connected to the central platform, and a knife rotatable relative to the central platform.

Abstract: A material-fastening device and related fastener and methods for use, and more particularly, a device with segments of the fastener capable of being independently attached to different sides of a gap in the material.

Abstract: A fastener cartridge can comprise a cartridge body including a plurality of fastener cavities and a plurality of fasteners removably stored therein. The fastener cartridge can further comprise a firing member including a first ramp surface and a second ramp surface which can be configured to co-operatively lift and eject the fasteners from the fastener cavities. The first ramp surface can initially lift the fasteners. The second ramp surface can then complete the lift of the fasteners. In such circumstances, the fasteners can be transferred from the first ramp surface to the second ramp surface of the firing member. In various circumstances, the first ramp surface and/or the second ramp surface can directly engage the fasteners. In other circumstances, the fastener cartridge can include fastener drivers which are directly lifted by the first ramp surface and/or the second ramp surface. The fastener cartridge can further include an anvil.

Abstract: The present invention resides in a sutureless wound closure device for external use. The device comprises a base layer for fixing the device to skin and an upper layer. The base layer includes an aperture therein. The upper layer has a first end anchored to the base layer and a second, opposite end that includes fixing means to attach the end to the base layer and close the aperture in the base layer.

Abstract: A gastroplasty method involves a staple line that terminates prior to reaching the gastroesophageal junction such that the bypassed portion of the stomach does not require resection. Additionally, bougies are taught that assist a physician in following the improved staple line of the present invention.

Abstract: A surgical instrument includes a body, a pivotable trigger, and a ratcheting assembly. The ratcheting assembly may include a rotary ratchet coupled to the trigger and a pawl coupled to the body. The rotary ratchet may further include a ramp that disengages the ratchet from the pawl. A release feature may be included to selectively disengage a second member of the ratcheting assembly from a first member. In some versions, the release feature may include a rotation knob or a slidable handle. In another configuration, the ratcheting assembly may have a first member coupled to an actuator and a second member coupled to the body. The assembly may include a lock member coupled to the body that selectively engages a plurality of teeth disposed on the actuator. Alternatively, the assembly may include a pivotable pawl coupled to the actuator that engages one or more notches formed in the body.

Abstract: Devices, systems and methods for compressing, cutting, incising, reconfiguring, remodeling, attaching, repositioning, supporting, dislocating or altering the composition of tissues or anatomical structures to alter their positional or force relationship to other tissues or anatomical structures. In some applications, the invention may be used to improve patency or fluid flow through a body lumen or cavity (e.g., to limit constriction of the urethra by an enlarged prostate gland).

Abstract: The invention relates generally to embolic agents and embolic delivery systems more specifically it relates to a device and method for filling of aneurysm or body cavity. In various embodiments, segmented and monolithic embolic agents provide the operator with the ability to select and detach the length of embolic agent, either extracorporeally or intracorporeally as desired by the operator, for implantation into the aneurysm or body cavity. Linking elements and detachment elements may be utilized by the operator to connect and detach variable lengths of embolic agents either extracorporeally or intracorporeally utilizing electrolytic, chemical, and mechanical detachment mechanisms. Embolic delivery systems are disclosed providing for constant and steady propulsion of the embolic agent.

Abstract: Surgical clip appliers are provided and includes a channel assembly extending distally from a housing; a clip carrier disposed within said channel assembly and defining a channel and a plurality of windows therein; a plurality of clips slidably disposed within said channel of said clip carrier; a wedge plate reciprocally disposed within said channel assembly, said wedge plate being operatively connected to said handles and including a plurality of apertures formed along a length thereof; and a clip follower slidably disposed within said channel of said clip carrier and disposed proximally of said plurality of clips, said clip follower being configured and adapted for selective engagement with said windows of said clip carrier and said apertures of said wedge plate. The clip follower is configured and adapted to urge said plurality of clips, in a distal direction relative to said clip carrier, upon reciprocal movement of said wedge plate.