Abstract: An apparatus for preventing stroke by occluding blood flow through a right carotid artery and a left carotid artery of a patient is provided. The apparatus has a first occluding catheter that carries a first occluding balloon that has an inflated configuration that occludes either the right carotid artery or the left carotid artery. The apparatus also includes a second occluding catheter that carries a second occluding balloon that has an inflated configuration that occludes the other one of the right carotid artery or the left carotid artery that is not occluded by the first occluding balloon. An insertion device may also be present to allow for insertion of the first and second occluding catheters.

Abstract: An inflatable balloon includes a base balloon having a cylindrical section and a conical section and at least one circumferential fiber extending circumferentially around the conical section. The inflatable balloon includes a plurality of reinforcing strips in the conical section over the at least one circumferential fiber. Each reinforcing strip includes a plurality of fibers extending at an angle relative to the at least one fiber. Each reinforcing strip is positioned a set circumferential distance away from a neighboring reinforcing strip.

Abstract: A chest drainage system, including a circulation assembly having an intake for taking fluid into the system and an exhaust for exhausting fluid out of the system. An intake flow device is configured to selectively control fluid flow through the intake and an exhaust flow device is configured to selectively controlling fluid flow through the exhaust. The circulation assembly has a first configuration and a second configuration such that transitioning between the first and second configurations during operation of the circulation assembly displaces at least a portion of fluid within the system with fluid from outside the system via the intake and the exhaust. A sensor is arranged in fluid communication with the fluid within the system and configured to detect a concentration of a reference fluid in the fluid in the system.

Abstract: Systems, methods, and devices are provided for the treatment of edema. In one aspect a method for implanting an indwelling catheter within a vein of a patient is provided. The catheter can extend from a position upstream of at least one outflow port of a duct of the lymph system to a terminal position downstream of the at least one outflow port. In use, a first restriction can be created within the vein proximal to a distal region of the catheter. The first restriction can define a localized low pressure zone distal of the restriction and within a portion of the vein housing the catheter. The low pressure zone can be adjacent to the at least one outflow port to enable fluid to pass from the at least one lymph duct outflow port into the vein.

Abstract: The devices and methods described herein include an implantable body lumen fluid flow modulator including an upstream flow accelerator separated by a gap from a downstream flow decelerator. The gap is a pathway to entrain additional fluid from a branch lumen(s) into the fluid stream flowing from the upstream flow accelerator to the downstream flow decelerator.

Abstract: A ventricular catheter assembly including a proximal catheter and a cooperating cranial cover. The cranial cover includes a base plate having an opening aligned with a burr hole in the skull of a person. A guide extends upwardly from the base plate and receives the proximal catheter.

Abstract: Certain embodiments of the invention relates to a transdermal drug delivery system containing donepezil or a pharmaceutically acceptable salt thereof as an active ingredient, more specifically to a transdermal drug delivery system containing a drug-containing matrix layer comprising donepezil or its pharmaceutically acceptable salt, a styrene copolymer, a hydrogenated rosin glycerol ester, and optionally a hydrocarbon resin.

Abstract: Applicators for a microprojection array capable of multiple impacts and methods of using the applicators are described.

Abstract: The application discloses a method to fabricate microneedle patches, comprising a) casting (painting and pasting) an aqueous polymer solution on a mold of array of micro-holes which is made of porous materials; b) sucking the polymer solution into the micro-holes by applying vacuum at the back of the mold; d) freezing and thawing the casted polymer solution to induce gelation; and e) drying the gelled polymer solution. Specifically, the present invention describes a process and composition of polymeric microneedlepatch which overcomes the limitations of existing microneedles systems and may be used for transdermal delivery system for therapeutics and other applications.

Abstract: A tubing set includes a rigid medical fluid chamber, medical fluid tubing, and a cuff. The rigid medical fluid chamber includes a housing and a tubular fitting extending from the housing. The medical fluid tubing is connected to the tubular fitting such that the medical fluid tubing is in fluid communication with the medical fluid chamber. The cuff is positioned over a length of the medical fluid tubing to inhibit denting of a wall of a length of the medical fluid tubing connected to the tubular fitting and extending beyond the tubular fitting. The cuff inhibits denting when the medical fluid tubing is coiled.

Abstract: A capping device that includes a cap, a first member, a second member, and a living hinge is provided. The cap is for covering the top of a medical access connector. The first member is connected with the cap. The living hinge is located between the first member and the second member. Capping and uncapping the medical access connector with the cap is transparent to a user that is manipulating the medical access connector.

Abstract: A medical connector for use in a fluid pathway includes a substantially transparent housing having a proximal end with a proximal opening and a distal end with a distal opening, and a cavity extending therebetween. The connector provides a substantially visible fluid flow path extending through a substantial portion of the connector.

Abstract: A simply lockable quick coupling for releasably connecting a hose to an implantable apparatus, comprises a first attachment piece that can be connected to the hose and a second attachment piece that can be connected to the apparatus, wherein the attachment pieces can be rotated relative to each other in the locked state.

Abstract: Described is a priming device to prime a gas from a fluid delivery system by receiving the gas and a fluid used to push the gas into a chamber, the priming device including a cover body having a lid, and a housing having a chamber, an inlet port and an opening to release gas received into the chamber. The device has a priming-ready configuration where the medical connector and the housing are coupled with the cover body, and the fluid path of the medical connector and the passage of the housing remain sealed, a priming configuration where the medical connector is advanced in the cover body to fluidly couple with the housing, and a post-priming configuration where the housing is decoupled from the cover body and the lid closed to prevent contamination of the medical connector.

Abstract: An apparatus for substantially sterile connection of flexible tubing, including at least one tubing holder, which is adapted to receive one or more lengths of flexible tubing and which is also equipped with one or more sterilant applicators. The sterilant applicator is adapted to apply a sterilant to the length of tubing when the tubing length is received in the tubing holder. At least one cutter, which is movable in relation to the tubing holder and adapted to cut the length of tubing. A connector holder, which includes a compartment housing and a substantially sterile tubing connector. The connector holder is movable in relation to the tubing holder to a position where the length of tubing and the sterile tubing connector are aligned and can be urged together.

Abstract: The application relates to a connecting element, in particular for connecting vessels and for producing a fluidic connection between vessels or elements joined to the connecting element. The invention also relates to an elastic spring element as a valve element.

Abstract: A linearly actuated pinch clamp is provided, including a housing, a motor connected to the housing, a mechanical drive unit connected to the motor for converting a rotary motion of the motor to a linear motion and for introducing a mechanical advantage to the motion of the motor, and a pinching element having a body and a pinching surface. The pinching element body is coupled to the mechanical drive unit. In certain versions of the pinch clamp, the pinching element is slidably mounted to the housing such that the pinching element is linearly displaceable by the mechanical drive unit between a first position and a second position where the pinching surface cooperates with a fixed surface to pinch closed a flexible tube.

Abstract: An apparatus for neuromuscular electrical stimulation is provided. The apparatus may be a stimulation lead having an elongated member made up of at least one conductor and an insulative sheath surrounding at least a portion of the conductor. A distal portion of the elongated member may include one or more electrodes and at least one fixation element to secure the one or more electrodes in or adjacent to a desired anatomical site for providing stimulation thereto. The stimulation lead has a strain relief portion on the proximal side of the one or more electrodes, configured to reduce axial forces on the distal region of the elongated member, and the effects thereof, to reduce the risk of, or even prevent, displacement of the one or more electrodes and to accommodate localized flexural motion. The apparatus also may include at least one fixation element sized and configured to be deployed between muscle layers to maintain the electrode position at the stimulation site.

Abstract: A method and system for the diagnosis of anomalies in a lead attached to an implantable medical device, such as an implantable cardioverter defibrillator (ICD), including an insulation breach resulting in a short circuit of the high-voltage shock pulse. Determination that the defibrillation pathway is shorted may be made by initial analysis of a Reference EGM and Diagnostic EGM and subsequent analysis of Differential Diagnostic EGMs. Upon determining if a specific defibrillation pathway is shorted, the nonessential defibrillation electrode of that pathway may be excluded from the defibrillation circuit, delivering defibrillation current only between functioning defibrillation electrodes. Alternatively, the ICD system can confirm the presence of a lead anomaly with one or more alternative diagnostic approaches. Patient and remote-monitoring alerts may be initiated.

Abstract: A method and system for employing a medical device is disclosed. The medical device includes a housing, a processor disposed within the housing, a connector module, and a medical electrical epicardial lead connected to the processor through the connector module. The epicardial lead is used to sense a cardiac signal from tissue of a patient. The lead comprises an insulative lead body that includes a proximal end and a distal end, at least one conductor disposed in the lead body, and a side helical fixation member, disposed a distance from the distal end, the side helical fixation member. The side helical fixation member comprises a set of windings configured to wrap around the lead body circumference. The side helical fixation member includes a distal tip comprising a sharpened elongated flat free end that is perpendicular to the lead body and angled toward an inside of the set of windings.

Abstract: A delivery device for installing a medical device in a patient comprising a body portion having a proximal end and a distal end, the distal end having a chisel shaped tip, a receptacle disposed in the distal end of the body portion for receiving a medical device for implanting in the patient, a handle disposed at the proximal end of the body portion for facilitating advancement of the proximal end of the body portion into the patient.

Abstract: A multichannel clip device and methods of use that facilitate connection of multiple electrical components of a first device and a second device for testing and/or verification are provided herein. Such multichannel clip devices can include a spring-loaded clip having multiple electrical contacts for coupling with a contact portion of a first device and which are connected to a proximal connector through a flexible stimulation cable. The contacts can be included within a neurostimulation lead connector and the proximal connector adapted to couple with standard connectors on a clinician programmer, each contact being coupled to a corresponding contact of the proximal connector to define multiple separate channels.

Abstract: Methods, systems and devices are disclosed for treating a spinal disorder by applying a source of direct current to a spinal cord in animals, including humans. Trans-spinal direct current stimulation (tsDCS) uses direct current via cathodal and/or anodal stimulation to induce cell proliferation, cell differentiation, and/or cell migration at or near the area of the spinal cord being treated, and up-regulates or down-regulates protein expression by cells at or near the area of the spinal cord being treated.

Abstract: This application describes a miniature implantable neurostimulator system for sciatic nerves and their branches. The implanted miniature neurostimulator is implanted in the leg and stimulates these nerves for the treatment of urinary or bowel incontinence. The miniature implantable neurostimulator has a low duty cycle permitting a small size with medically-acceptable longevity. The system includes a wireless programmer and patient-activated key fob.

Abstract: An oral appliance provides electrical stimulation to a patient's tongue in a manner that prevents collapse of the tongue and/or soft palate during sleep. More specifically, the appliance may induce a reversible current or currents in a lateral direction across the tongue in a manner that shortens the patient's Palatoglossus muscle, which in turn pulls the patient's soft palate downward towards a base of the tongue, and/or decreases a volume of the tongue.

Abstract: An oral appliance is disclosed that provides electrical stimulation to a patient's tongue in a manner that prevents collapse of the tongue and/or soft palate during sleep. More specifically, the appliance may induce a reversible current or currents in a lateral direction across the tongue in a manner that shortens the patient's Palatoglossus muscle, which in turn pulls the patient's soft palate downward towards a base of the tongue and/or decreases a volume of the tongue.

Abstract: A removable oral device is disclosed. The removable oral device comprises a mounting retainer configured to align with a set of teeth. An electrical stimulator is coupled to the mounting retainer. A single lead is employed that has a first and a second end and lacking a mechanical connection to the mounting retainer. A first and a second electrode are positioned along the single lead. The lead is disposed perpendicular to a longitudinal axis of a patient's tongue such that the first electrode is proximate a first hypoglossal nerve and the second electrode is proximate a second hypoglossal nerve.

Abstract: A method for positioning an intravascular catheter may include inserting the intravascular catheter into a venous system of a patient, wherein the catheter includes a plurality of electrodes, and multiple electrodes of the plurality of electrodes are configured to emit electrical signals; positioning a distal portion of the catheter in a first position; using one or more electrodes of the plurality of electrodes to acquire an ECG signal; based on the acquired ECG signal, adjusting the distal portion of the catheter to a second position different from the first position; identifying at least one first electrode of the plurality of electrodes to stimulate a first nerve; identifying at least one second electrode of the plurality of electrodes to stimulate a second nerve; and stimulating at least one of the first and second nerves to cause a contraction of a respiratory muscle.

Abstract: A device for the treatment of the body of a wearer comprising an orthopedic brace combined with at least one electrically active zone to stimulate the body of the wearer of the brace.

Abstract: A method of providing electrical stimulation to the sole of a patient's foot is disclosed. An assembly is disclosed that comprises a non-conductive mat having an aperture and a piezoelectric device positioned to fill at least a portion of the aperture. A flexible conductive material is positioned to be in electrical contact with a first and a second primary surface of the piezoelectric device, and with the surface of the skin, providing an electric current to the skin when the piezoelectric is mechanically compressed.

Abstract: Systems and methods for performing non-obtrusive, automatic adjustment of an auditory prosthesis are disclosed. A control expression can be detected during a conversation. Upon detection of the control expression, an audio setting adjustment can be selected and applied to the auditory prosthesis. Multiple adjustments can be made in response to identifying multiple control expressions during a conversation.

Abstract: Selective high-frequency spinal cord modulation for inhibiting pain with reduced side affects and associated systems and methods are disclosed. In particular embodiments, a programmer has instructions that, in response to an input, select between at least first and second sets of therapy signal parameters, the first set including a frequency of less than 1.2 kHz and generating a paresthesia-inducing electrical therapy signal, and the second set including a frequency in a range from 1.5 kHz to 50 kHz and generating a non-paresthesia-inducing electrical therapy signal.

Abstract: Described herein are systems and methods for the treatment of pain using electrical nerve conduction block (ENCB). Contrary to other methods of pain treatment, the ENCB can establish a direct block of neural activity, thereby eliminating the pain. Additionally, the ENCB can be administered without causing electrochemical damage. An example method can include: placing at least one electrode contact in electrical communication with a region of a subject's spinal cord; applying an electrical nerve conduction block (ENCB) to a nerve in the region through the at least one electrode contact; and blocking neural activity with the ENCB to reduce the pain or other unwanted sensation in the subject.

Abstract: The present disclosure relates to methods, devices, and systems used for the treatment of mood, anxiety, cognitive, and behavioral disorders (collectively, neuropsychiatric disorders) via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive systems, devices and methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infraorbital, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein.

Abstract: A system for controlling a position of a patient's tongue includes attaching at least one electrode to the patient's Hypoglossal nerve and applying an electric signal through the electrode to at least one targeted motor efferent located within the Hypoglossal nerve to stimulate at least one muscle of the tongue. The system may also include the use of more than one contact to target more than one motor efferent and stimulating more than one muscle. The stimulation load to maintain the position of the tongue may be shared by each muscle. The position of the patient's tongue may be controlled in order to prevent obstructive sleep apnea.

Abstract: An implantable neurostimulator-implemented method for managing tachyarrhythmias through vagus nerve stimulation is provided. An implantable neurostimulator, including a pulse generator, is configured to deliver electrical therapeutic stimulation in a manner that results in creation and propagation (in both afferent and efferent directions) of action potentials within neuronal fibers of a patient's cervical vagus nerve. Operating modes of the pulse generator are stored. A maintenance dose of the electrical therapeutic stimulation is delivered to the vagus nerve via the pulse generator to restore cardiac autonomic balance through continuously-cycling, intermittent and periodic electrical pulses. A restorative dose of the electrical therapeutic stimulation is delivered to prevent initiation of or disrupt tachyarrhythmia through periodic electrical pulses delivered at higher intensity than the maintenance dose.

Abstract: Systems and methods are provided for delivering neurostimulation therapies to patients for treating chronic heart failure. A neural fulcrum zone is identified and ongoing neurostimulation therapy is delivered within the neural fulcrum zone. The implanted stimulation device includes a physiological sensor for recording the patient's response to the neurostimulation therapy on an ambulatory basis over extended periods of time.

Abstract: An example of a system for programming a neurostimulator may include a storage device and a pattern generator. The storage device may store a pattern library and one or more neuronal network models. The pattern library may include fields and waveforms of neuromodulation. The one or more neuronal network models may each be configured to allow for evaluating effects of one or more fields in combination with one or more waveforms in treating one or more indications for neuromodulation. The pattern generator may be configured to construct and approximately optimize a spatio-temporal pattern of neurostimulation and/or its building blocks using at least one neuronal network model.

Abstract: A system for use with a neurostimulator coupled to one or more electrodes implanted adjacent neural tissue of a patient. The system comprises a user input device configured for allowing a user to select different nerve fiber diameters and to select a set of stimulation parameters. The system further comprises processing circuitry configured estimating regions of activation within the neural tissue of the patient based on the selected nerve fiber diameters and the selected stimulation parameter set. The system further comprises a display device configured for displaying the estimated regions of tissue activation. The user input device may further be configured for allowing the user to select different tissue regions of therapy, in which case, the display device may display the different tissue region on a human body map, and different indicia associating the displayed tissue regions for therapy to displayed estimated regions of tissue activation.

Abstract: Systems and methods are provided for optimizing hemodynamics within a patient's heart, e.g., to improve the patient's exercise capacity. In one embodiment, a system is configured to be implanted in a patient's body to monitor and/or treat the patient that includes at least one sensor configured to provide sensor data that corresponds to a blood pressure within or near the patient's heart; at least one adjustable component designed to cause blood to flow in a direction opposite to the normal direction (regurgitation) within the patient's heart; and a controller configured for adjusting the function of the at least one adjustable component based at least in part on sensor data from the at least one sensor.

Abstract: Systems and methods for determining multiple sites for multi-site cardiac stimulation are disclosed. The system can comprise an electrostimulation circuit that can deliver electrostimulation to one or more candidate sites in at least one chamber of the heart, such as a left ventricle of the heart, within the same cardiac cycle. The system can sense a physiologic signal during the electrostimulation of the heart, determine activation timings from first and second sets of physiologic signals respectively sensed at the plurality of candidate sites when the heart undergoes specified intrinsic activities or stimulation, and determine at least first and second selected sites, among a plurality of candidate sites, using the respective activation timings. The system can deliver multi-site stimulation such as to the first and second selected sites during a same cardiac cycle, simultaneously or separated by a specified temporal offset.

Abstract: Approaches to rank potential left ventricular (LV) pacing vectors are described. Early elimination tests are performed to determine the viability of LV cathode electrodes. Some LV cathodes are eliminated from further testing based on the early elimination tests. LV cathodes identified as viable cathodes are tested further. Viable LV cathode electrodes are tested for hemodynamic efficacy. Cardiac capture and phrenic nerve activation thresholds are then measured for potential LV pacing vectors comprising a viable LV cathode electrode and an anode electrode. The potential LV pacing vectors are ranked based on one or more of the hemodynamic efficacy of the LV cathodes, the cardiac capture thresholds, and the phrenic nerve activation thresholds.

Abstract: Hearing assistance apparatus, systems and methods that involve the use of distributed power.

Abstract: An implantable medical device can include a device housing including a circuitry module and a header including a header core defining a bore configured to receive a distal end of a lead, an antenna, and a header shell disposed around the header core and the antenna. The antenna can be a closed loop antenna and arranged such that the antenna is positioned within two planes to maximize the area within the closed loop to increase the radiation characteristics of the antenna.

Abstract: An operating room cable assembly for electrically coupling at least one implantable electrical stimulation lead to a trial stimulator includes an elongated body; a trial stimulator connector disposed at one end of the elongated body; and a lead connector disposed at another end of the elongated body. The lead connector can include one or more buttons that can be pushed to load a lead into the lead connector and released to retain the lead. Alternatively, the lead connector can include a lever that can be operated to load the lead. A further alternative is a slider with a lead engagement element that can be slid between positions allowing loading of a lead and engagement of the lead. Other alternatives include a lead connector with doors that can swing open to allow loading of a lead or a collet/sleeve that can be tightened on the lead.

Abstract: A method of electrostimulation of a group of one or more target muscles of a subject is provided, the method comprising in a first step applying to the subject an electrical pulse having a duration of at least 0.5 milliseconds and an intensity below that effective in stimulating contraction of the target muscles of the subject; and in a second step applying one or more electrical pulses at an intensity sufficient to stimulate contraction of the target muscles of the subject. An apparatus for the electrostimulation of the muscles of a subject employing the aforementioned method is also provided.

Abstract: Implantable medical devices include connector enclosure assemblies that utilize conductors that are electrically coupled to feedthrough pins and that extend into a can where electrical circuitry is housed. The conductors may be coupled to the feedthrough pins and to capacitor plates within a filter capacitor by an electrically conductive bonding material and as a single bonding event during manufacturing. The base plate of the connector enclosure assembly may also include a ground pin. Ground capacitor plates may be present at a ground aperture of the filter capacitor where the ground pin passes through so that the ground pin, a ground conductor, and the ground capacitor plate may be coupled. A protective cover may be provided for the connector enclosure assembly to enclose the conductors intended to extend into the can prior to the assembly being joined to the can. Conductors may be attached to a common tab that is subsequently removed.

Abstract: A housing for a medical implant that includes a housing wall made of an electrically insulating material with an inner face and an outer face and an electrical transmission through the housing wall. The electrical transmission includes an electrically conductive first terminal contact surface disposed on the inner face of the housing wall, an electrically conductive second terminal contact surface disposed on the outer face of the housing wall, a capacitor integrated into the housing wall and that includes a first capacitor electrode and a second capacitor electrode, a first connection line that electrically connects the first terminal contact surface to the first capacitor electrode, and a second connection line that electrically connects the second terminal contact surface to the second capacitor electrode. No continuously electrically conductive connection exists between the first terminal contact surface and the second terminal contact surface.

Abstract: A controller (20) for an advanced defibrillator (10) employs a therapy manager (30), a monitor manager (40), and a profile manager (50). In operation, the profile manager (50) manages a compilation of clinical usage profiles (60), each clinical usage profile (60) being derived from a different clinical usage of the advanced defibrillator (10) for the patient, and configures the therapy manager (30) and the monitor manager (40) responsive to a selection by a user of the advanced defibrillator (10) of one of the plurality of clinical usage profiles (60). Each clinical usage profile (60) includes a therapy profile (61) specifying a configuration of the therapy manager (30) for a delivery of an electric therapy to the patient. Each clinical usage profile (60) further includes a monitoring profile (62) specifying a configuration of the monitor manager (40) for a measuring of vital parameter(s) of the patient.

Abstract: A medical device for caring for a patient includes a patient utility for measuring a patient parameter or administering a therapy to the patient and an alarm system that has a receiver to accept status information about the medical device. A use detector of the alarm system is structured to determine when the medical device is being prepared for use and a status detector of the alarm system is adapted to determine from the status information that the medical device is in a ready state. The alarm system further includes an alarm that is activated when the medical device is both being prepared for use and not in the ready state. This description also includes methods of generating an alarm when the medical device is both being prepared for use and not in the ready state.