Abstract: An assembly for modifying airflow into a nasopharyngeal airway or trachea of a patient. A valve assembly is adapted to attach to an airflow generator, wherein the airflow generator is a continuous blower of a type producing a constant head of pressurized air. One or more drive gears are attached to and powered by a servo motor. A valve seal within the feed tube is connected to and operable by the drive gears, the valve seal adapted to cycle within the feed tube across the outlet. A controller circuit is connected to the servo motor for operating the servo motor incrementally, wherein pressurized air from said airflow generator continuously enters said feed tube from said inlet but travels to said patient only when said servo motor causes said valve seal to move such that said pressurized air is converted into a single, repeatable burst.

Abstract: The present disclosure pertains to a system and method for managing a sleep session of a subject. Managing the sleep session is based on cardiac activity in the subject during the sleep session. Cardiac activity, as monitored via one or more sensors worn on an extremity of the subject and/or placed at a distance from the subject, is used to determine periods of slow wave sleep. Sensory stimulation is delivered to the subject during the periods of slow wave sleep to enhance slow wave activity. Wearing a sensor on an extremity, and/or placing a sensor at a distance from the subject during sleep, as opposed to the subject wearing an EEG cap, is more comfortable for the subject.

Abstract: A multiple side hole infusion apparatus is a device that is used to deliver and distribute medical fluid over a targeted area as well as facilitate the insertion of a guide wire or similar object into a patient's body. The device features a tubular infusion member that is inserted into and able to slide within a tubular sleeve member. A quantity of dynamic fluid is introduced into the tubular infusion member and is able to exit through a fluid-release port located on the tubular infusion member and into an annular clearance between the tubular infusion member and the tubular sleeve member. The quantity of dynamic fluid is then able to exit the tubular sleeve member through a plurality of fluid-distribution ports that is located along the length of the tubular sleeve member, enabling the quantity of dynamic fluid to spread over a targeted area within the patient's body.

Abstract: A catheter shaft (10) having improved guide wire accessibility, reduced deflation time, and increased push, having a first tube (11), which forms a first lumen, and a second tube (12), which forms a second lumen and is disposed at least partially within the first tube (11), wherein the second tube (12) is welded, via the outer surface thereof, to the inner surface of the first tube (11), at least in sections, and to a catheter having such a catheter shaft. A simple and cost-effective method for producing such a catheter shaft or catheter.

Abstract: An elongated medical device with a modified drive surface for use with the driving mechanism of a robotic system. The elongated medical device has a distal portion configured to navigate the lumen of a human body channel and a proximate portion with a surface different from that of the distal portion and adapted to better interact with the driving mechanism than the surface of the distal portion.

Abstract: This document relates to catheter-based therapeutic apparatus and methods for directing therapy within the body of a subject. This document also encompasses a control handle comprising a steering assembly and a delivery assembly suitable for use in conjunction with the catheter-based therapeutic apparatus to provide steering and fine positional control of the catheter tip.

Abstract: A medical device control handle or catheter includes deflection assembly and at least one of the following: a disk actuator, a lever actuator and a ring actuator for actuating additional puller wires in manipulation of multiple features of the medical device or catheter independently of each other. The disk actuator has a common rotational axis with but is rotationally independent of the deflection assembly. The lever actuator has a separate rotational axis. The ring is mounted outside of the control handle and rotatable relative to the control handle to actuate another puller wire for manipulating another feature of the catheter. Each of the disk, lever and ring actuators are of a design that allows existing control handles and catheters to be readily modified to include these actuators.

Abstract: Tension member seals and securing mechanisms for medical devices are described herein. An example embodiment of a tension member seal comprises an elongate member, a first plug, a second plug, a material disposed within a chamber defined by the elongate member, and a tension member. The elongate member has a first configuration and a second configuration and the material is configured to seal the chamber as the elongate member is moved between its first and second configurations.

Abstract: A method for thermal bonding of an inverted balloon neck on a catheter, including placing an inverted balloon neck (84) on a shaft (86) of a catheter, and characterized by applying heat at an internal hollow (85) of the shaft (86) where the inverted balloon neck (84) is placed, while applying internal pressure to attach an external surface of the shaft (86) to the inverted balloon neck (84).

Abstract: A subintimal recanalization catheter system for recanalizing a blood vessel. The system includes a support catheter and a balloon catheter configured to extend through the support catheter. The support catheter includes a tubular portion and an extension segment extending distal of the distal opening of the tubular portion. The balloon catheter, having a balloon secured to a distal portion thereof, is positionable through the tubular portion of the support catheter to position the balloon alongside the extension segment. The system is configured to be advanced into a subintimal space between a first tissue layer and a second tissue layer of a blood vessel wall where the balloon may be inflated against the extension segment to cause a distal portion of the catheter shaft of the balloon catheter to deflect toward the vessel lumen within the subintimal space to facilitate reentry into the vessel lumen.

Abstract: A catheter assembly with segmented or step-wise deployment stabilization system includes a base or handle, puncture needle extending from the handle, and a deployment mechanism or mechanisms to selectively extend from the distal end of the needle for first length a hollow stabilizing component and as a second step to a second further length a stabilizing guide wire element. The needle will gain sub-dermal access to the patient to the intended position for deployment of a catheter. Hollow stabilizing component provides for a first additional guide and support for a catheter sheath from the distal end of the needle. The stabilizing wire element provides additional length, guide and support for the catheter sheath. The hollow stabilizing component has some degree of flexibility as does the guide wire to minimize chance of damage to surrounding tissue.

Abstract: The present invention generally relates to double-ended wire guides for use in a percutaneous procedure within a body cavity and to methods of using such devices. In certain embodiments, the wire guide includes a break-away discontinuity near at least one end of the wire guide.

Abstract: The present invention relates to a balloon catheter having a catheter balloon with micro drillings and a metal mesh and particularly to balloon catheters for the cardiac field for minimizing or preventing restenosis. Active agent solutions may be administered through the micro drillings such as using an injection catheter.

Abstract: An indeflator for inflating a therapeutic balloon. A barrel has an interior chamber that receives fluid and an outlet in fluid communication with the interior chamber. A plunger sealingly engages the interior of the barrel. The plunger is selectively movable to dispense fluid through the outlet of the barrel. A coarse inflation control assembly includes a coarse inflation actuator that rotates about a coarse rotational axis to dispense fluid through the barrel at an inverse coarse inflation rate. A fine inflation control assembly includes a fine inflation actuator selectively rotatable about a fine rotational axis to dispense fluid through the outlet at an inverse fine inflation rate. The inverse fine inflation rate is greater than the inverse coarse inflation rate.

Abstract: A multi-lumen catheter assembly comprises an inner shaft, an outer shaft and one or more features. The inner shaft comprises an inner surface and an outer surface. The inner surface defines a first lumen. The outer shaft is coaxially disposed about the inner shaft and is deformable inwardly toward the outer surface of the inner shaft. The outer shaft comprises an inner surface and an outer surface. The outer shaft is radially space from the inner shaft such that the inner surface of the outer shaft and the outer surface of the inner shaft together define a second lumen. The one or more features are configured to maintain patency through the second lumen as the outer shaft deforms inwardly toward the outer surface of the inner shaft.

Abstract: Described are microneedle devices comprising an electron beam crosslinked or photocrosslinked polymer material, and methods of making and using them, such as for drug delivery or sampling biological fluids.

Abstract: Described herein are systems, devices, and methods for providing a metallized film electrode having a metallized film and an electrical connector. The metallized film has a base layer and a metal coating disposed on a bottom surface of the base layer. The metallized film has at least one metal-coated area and may be formed into various shapes for application of therapeutic electrical stimulation to a patient's tissue. The connector provides electrical communication to the first metal-coated area.

Abstract: An implantable electrical line including a lead, wherein the lead includes at least one helically wound electrical conductor. The at least one helically wound electrical conductor is surrounded by a fiber braid, which is formed by at least two fibers or fiber bundles, and wherein the at least two fibers or fiber bundles are interwoven and wound around the electrical conductor in opposite winding directions.

Abstract: The present disclosure provides neurostimulation methods and system for deep brain stimulation. A neurostimulation apparatus includes a plug configured to be mounted to a burr hole formed in a skull of a subject, a plurality of cable conductors configured to be coupled to the plug, and a lead configured to be coupled to the plurality of cable conductors, the lead comprising at least one electrode configured to apply stimulation to the subject, wherein the plug is configured to generate and supply electrical stimulation pulses to the lead through the plurality of cable conductors.

Abstract: Anchoring devices and methods for affixing an implanted lead of a neurostimulation system at a target location in a patient are provided herein. Such anchoring devices includes a helical body having a plurality of tines extending laterally outward from the lead when deployed that engage tissue to inhibit axial movement of the implanted lead. The plurality of tines are biased towards the laterally extended deployed configuration and fold inward towards the lead to a delivery configuration to facilitate delivery of the lead through a sheath. The tines may be angled in a proximal direction or in both proximal and distal directions and may include various features to assist in visualization and delivery of the lead. The anchor may be formed according to various methods, including laser cutting of a tubular section along with heat or reflow to set the material with the anchor in the deployed configuration and injection molding.

Abstract: An implantable device including a proximal end, a distal end, an elongate electrically conductive component arranged between the proximal end and the distal end, and a contact pole electrically connected to the elongate electrically conductive component. The contact pole is arranged in a region of the distal end to electrically contact bodily tissue adjacent to the contact pole during operation of the implantable device. The elongate electrically conductive component includes a sub-component connected in series with remaining portions of the elongate electrically conductive component. The sub-component includes a capacitive component, an inductive component and a magneto-resistive component, which are arranged to cause a reduction of a resistivity of the magneto-resistive component that leads to a shift of a resonance frequency of the sub-component.

Abstract: The invention contemplates, inter alia, the use of remote ischemic conditioning in the treatment of cancer, neurodegenerative disorders, and gastrointestinal disorders, among others.

Abstract: One aspect of the present disclosure relates to a closed-loop therapy system for treating autonomic instability or a medical condition associated therewith in a subject. The therapy delivery system can include a sensing component, a delivery component, and a controller. The sensing component can be configured to detect at least one physiological parameter associated with autonomic instability or a medical condition associated therewith. The delivery component can be configured for implantation on or about an autonomic nervous tissue target or a spinal nervous tissue target. The controller can be configured to automatically coordinate operation of the sensing and delivery components. The controller can also be configured to deliver an electrical signal to the delivery component to modulate activity at the autonomic nervous tissue target or a spinal nervous tissue target and effectively treat autonomic instability or a medical condition associated therewith.

Abstract: One aspect of the present disclosure relates to a therapy delivery device for treating an obstetric or gynecological disorder other than urinary incontinence in a subject. The therapy delivery device can include a housing, at least one electrode, and a power source. The housing can be configured for implantation in a reproductive system of the subject. The at least one electrode can be connected to the housing and be configured to delivery an electrical signal to an autonomic nervous system nerve target. The power source can be in electrical communication with the at least one electrode.

Abstract: A method of optimizing the electrical stimulation of a bladder of a patient including selecting a first subset of electrodes from a set of electrodes positioned adjacent to a set of nerves associated with the bladder. The set of electrodes may include one or more electrodes, each of which may be configured to deliver electrical stimulation pulses generated by a stimulator device to the nerves. The method may further include delivering an electrical stimulation pulse through the selected first subset of electrodes and recording at least one parameter of the electrical stimulation pulse after receiving patient feedback.

Abstract: A method and system for designing a therapy or for treating a condition associated with excess weight in a subject comprising applying a neural conduction block to the vagus nerve at a blocking site with the neural conduction block selected to at least partially block nerve impulses on the vagus nerve at the blocking site and administering a composition comprising an effective amount of an agent that alters the energy balance of the subject.

Abstract: Transcutaneous electrical and magnetic nerve stimulation devices are disclosed, along with methods of treating lower urinary tract disorders using energy that is delivered noninvasively by the devices. The disorders comprise overactive bladder, urge incontinence, stress, incontinence, urge frequency, non-obstructive urinary retention and interstitial cystitis/painful bladder syndrome. In embodiments of the disclosed methods, a posterior tibial nerve of a patient is stimulated non-invasively. Methods are disclosed for selecting protocol parameters for a nerve stimulation session for treating each individual patient, wherein modules of the bladder of the patient are represented as coupled non-linear oscillators.

Abstract: Systems, methods, and interfaces are described herein for assisting in a user in configuring cardiac therapy. A projection of a phrenic nerve stimulation map may be projected on a graphical depiction of a portion of a patient's heart. The phrenic nerve stimulation map may indicate to a user the regions of the patient's heart that may have a likelihood of stimulating the patient's phrenic nerve.

Abstract: A device and method are provided for altering body mass composition in a human subject by applying galvanic vestibular stimulation (GVS) using electrodes placed in electrical contact with the subject's scalp at a location corresponding to each of the subject's left and right vestibular systems. The current source include a feedback loop for measuring a resistance across the subject's scalp and adjusting a voltage output to maintain a constant current across the subject's scalp. GVS may be applied for a predetermined period of time at regular intervals.

Abstract: The present invention is generally directed to visual neural stimulation and more specifically to improved usability of a visual prosthesis, and a visual prosthesis structure easily adaptable to the eye or the brain. They system includes a pattern recognition component, and zoom component combined with an indication component for indicating the location of the pattern, such as a face, in a zoomed out image.

Abstract: An electronic stimulation device is adapted for electrically stimulating a target zone of an organism with relative low pain sensations without generating relative much sensations of paresthesia. The electronic stimulation device comprises at least one electronic stimulation unit. The electronic stimulation unit includes at least one first electrode and at least one second electrode. The electronic stimulation unit receives a high-frequency electrical stimulation signal to impel the first electrode and the second electrode to generate an electric field. The range of the electric field covers the target zone, and the electric field strength ranges from 100 V/m to 1000 V/m. The frequency of the high-frequency electrical stimulation signal ranges from 200 KHz to 1000 KHz.

Abstract: Method for operating a pacemaker comprising the procedures of building a database of a cardiac cycle of a patient suffering from bundle branch block and artificially pacing a ventricle of the patient using the pacemaker according to anticipative atrioventricular (AV) delays in the database which are based on measured P-P intervals in the database.

Abstract: Systems and methods are described herein for assisting a user in identification of interventricular (V-V) delay for cardiac therapy. The systems and methods may monitor electrical activity of a patient using external electrode apparatus to provide electrical heterogeneity information for a plurality of different V-V intervals and may identify a V-V interval based on the electrical heterogeneity information.

Abstract: Systems and methods are described herein for assisting a user in identification and/or optimization of an atrioventricular (A-V) interval for use in cardiac therapy. The systems and methods may monitor electrical activity of a patient using external electrode apparatus to provide electrical heterogeneity information for a plurality of different A-V intervals and may identify an A-V interval based on the electrical heterogeneity information.

Abstract: One aspect of the present disclosure related to a closed-loop therapy system for treating an anxiety or anxiety-associated disorder in a subject. The therapy delivery system can include a sensing component, a delivery component, and a controller. The sensing component can be configured to detect at least one physiological parameter associated with the anxiety or anxiety-associated disorder. The delivery component can be configured for implantation on or about an autonomic nervous tissure target or a spinal nervous tissue target. The controller can be configured to automatically coordinate operation of the sensing and delivery components. The controller can also be configured to deliver an electrical signal to the delivery component to modulate activity at the autonomic nervous tissue target or a spinal nervous tissue target and effectively treat the anxiety or anxiety- associated disorder.

Abstract: One aspect of the present disclosure relates to a closed loop therapy system for treating post-traumatic stress disorder (PTSD) in a subject. The therapy delivery system can include a sensing component, a delivery component, and a controller. The sensing can be configured to detect at least one physiological parameter associated with PTSD. The delivery component can be configured for implantation on or about a pre-determined spinal simulation site. The pre-determined spinal stimulation site can include a spinal cord segment, or spinal nervous tissue associated therewith, other than a C1-C3 spinal cord segment or spinal nervous tissue associated therewith. The controller can be configured to automatically coordinate operation of the sensing and delivery components. The controller can also be configured to deliver an electrical signal to the delivery component to modulate activity at the pre-determined spinal stimulation site to effectively treat PTSD in the subject.

Abstract: Systems and methods are provided for delivering vagus nerve stimulation and carotid baroreceptor stimulation to patients for treating chronic heart failure and hypertension. The vagus nerve stimulation and carotid baroreceptor stimulation therapies may be provided using a single implantable pulse generator, which can coordinate delivery of the therapies.

Abstract: Systems and methods are provided for delivering neurostimulation therapies to patients for treating chronic heart failure. A titration process is used to gradually increase the stimulation intensity to a desired therapeutic level. This titration process can minimize the amount of time required to complete titration so as to begin delivery of the stimulation at therapeutically desirable levels.

Abstract: An apparatus and method for electrical charge balancing when generating a stimulus during functional neural stimulation is presented. A stimulus pulse is generated (cathodic or anodic), and after a selected delay a charge compensating pulse is generated of an opposite polarity. The electrode circuit discontinuously examines electrode voltage after termination of the stimulus pulse, and utilizes this voltage to determine how long to extend the width of the charge compensating pulse. The electrode circuit thus performs accurate electrical charge cancellation to remove residual charges from the electrode by precisely controlling pulse width for an opposing polarity compensating pulse that need not have the same current level as the stimulus pulse.

Abstract: Systems and methods are described herein for assisting a user in evaluation of cardiac therapy. The systems and methods may monitor electrical activity of a patient using external electrode apparatus to provide baseline electrical heterogeneity information and therapy electrical heterogeneity information. The electrical heterogeneity information may be used to generate surrogate hemodynamic information.

Abstract: Systems and methods for providing a trial neurostimulation to a patient for assessing suitability of a permanently implanted neurostimulation are provided herein. In one aspect, a trial neurostimulation system includes an EPG patch adhered to a skin surface of a patient and connected to a lead extending through a percutaneous incision to a target tissue location. The EPG may be a modified version of the IPG used in the permanent system, the EPG may be smaller and/or lighter than the corresponding IPG device. The EPG and a lead extension may be sealed to allow improved patient mobility and reduced risk of infection. The EPG may be compatible with wireless systems used to control and monitor the IPG such that operation and control of the EPG is substantially the same in each system to allow seemless conversion to the permanently implanted system.

Abstract: An integrated electromyography (EMG) and signal/stimulation generation clinician programmer may be coupled with an implantable temporary or permanent lead in a patient and at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient. Generally, the integrated clinician programmer may comprise a portable housing, a signal/stimulation generator, and EMG signal processor, and a graphical user interface. The housing has an external surface and encloses circuitry at least partially disposed within the housing. The signal/stimulation generator may be disposed within the housing and configured to deliver test stimulation to a nerve tissue of the patient via the implantable lead. The EMG signal processor may be disposed within the housing and configured to record a stimulation-induced EMG motor response for each test stimulation via the at least one EMG sensing electrode.

Abstract: The present invention provides improved methods for positioning of an implantable lead in a patient with an integrated EMG and stimulation clinician programmer. The integrated clinician programmer is coupled to the implantable lead, wherein the implantable lead comprises at least four electrodes, and to at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient. The method comprises delivering a test stimulation at a stimulation amplitude level from the integrated clinician programmer to a nerve tissue of the patient with a principal electrode of the implantable lead. Test stimulations are delivered at a same stimulation amplitude level for a same period of time sequentially to each of the four electrodes of the implantable lead.

Abstract: The present invention relates to a system (10) for planning and/or providing a therapy for neural applications, especially a neurostimulation and/or neurorecording applications, comprising at least one lead (300), the lead (300) having a plurality of electrodes (132) being capable to provide at least one stimulation field (F; F1; F2), further comprising at least one adjustment means (400), the adjustment means (400) being configured such that at least one characteristic parameter of the stimulation field (F; F1; F2) is directly and/or indirectly adjusted in order to establish at least one stimulation field (F; F1; F2) with at least one user defined maximal stimulation field characteristic at at least one user defined radial distance away from the lead (300).

Abstract: A method and system for fitting and adjusting the operation of an acoustic hearing prosthesis or a hybrid electric and acoustic hearing prosthesis. A graphic user interface allows for the acoustic and electric fitting parameters to be viewed and adjusted in a comparable way. The method further allows for the parameters for acoustic stimulation of the acoustic channels to be adjusted in response to behavioral or objective measurement of response to known stimuli, so as to achieve a desired response curve.

Abstract: A method of visualizing a user interaction with a clinician programmer is disclosed. A user engagement with respect to a screen of the clinician programmer is detected via one or more sensors associated with the screen of the clinician programmer. One or more locations on the screen of the clinician programmer corresponding to the user engagement is determined. An external monitor is communicatively coupled to the clinician programmer. The external monitor displays one or more cursors that graphically represent the one or more locations on the screen of the clinician programmer corresponding to the user engagement, respectively.

Abstract: Methods and systems for obtaining and analyzing electromyography responses of electrodes of an implanted neurostimulation lead for use neurostimulation programming are provided herein. System setups for neural localization and/or programming include a clinician programmer coupleable with a temporary or permanent lead implantable in a patient and at least one pair of EMG sensing electrodes minimally invasively positioned on a skin surface or within the patient. The clinician programmer is configured to determine a plurality of recommended electrode configurations based on thresholds and EMG responses of the plurality of electrodes and rank the electrode configuration according to pre-determined criteria.

Abstract: Devices, systems, and methods are disclosed that identify a type of cable coupled to a receptacle of a defibrillator and that activate one or both of an ECG monitoring module and an energy storage circuit based at least in part on the identified cable type. The cable-type identification may allow a defibrillator to, for example, operate in either or both of an ECG monitoring mode and/or a therapy mode, based on the type of cable that is coupled to the defibrillator. The disclosed devices, systems, and methods can monitor an ECG of a patient and deliver defibrillation therapy to the patient, depending on the type of cable coupled to the defibrillator and/or the type of detected ECG signal of the patient.

Abstract: A defibrillator (100) and method (300) are described having an improved automatic activation feature. The improvement comprises sensing a pattern of events which indicates that repeated activations are inadvertent, and thus are unnecessarily depleting the battery. The defibrillator then disables the automatic activation circuit (210) feature. Then, the sensing of a manual defibrillator operation may trigger a re-enablement of the automatic activation feature.

Abstract: Systems and methods are provided for delivering vagus nerve stimulation and cardioversion/defibrillation therapies to patients for treating chronic heart failure. The vagus nerve stimulation and cardioversion/defibrillation therapies may be provided using a single implantable pulse generator, which can coordinate delivery of the therapies to provide an acute vagus nerve stimulation therapy in advance of delivering cardioversion-defibrillation energy.