Abstract: A guidewire assembly may include a handle assembly including: a handle body; a shaft extending through the handle body; and an actuator. The guidewire assembly may further include a tube extending distally from the handle assembly and including a proximal portion and a distal portion; and an interior body extending from the handle assembly through the tube to the distal portion of the tube, wherein the interior body is coupled to the shaft. The shaft may be configured to move longitudinally through the handle body as the actuator is rotated to move interior body longitudinally through the tube.

Abstract: Medical devices and methods for delivering fluid. The medical devices include one or more needles for delivering fluid. The methods may optionally include expanding an expandable member such as an inflatable member to expand an expandable scaffold outward toward a lumen wall. The methods may include delivering a first fluid out of one or more needles, and delivering a secondary fluid (which may be the same type of fluid as the first fluid, or a different type of fluid) from the device without delivering the secondary fluid through a needle.

Abstract: Embodiments of the present disclosure comprise occlusion and drug delivery devices and methods. One aspect of the disclosure comprises a drug delivery device comprising an inner expansion member and an outer drug delivery component. Another aspect of the disclosure comprises bioabsorbable, lumen-occluding implants.

Abstract: The present invention provides a novel shunt device and methods of use, and in particular a cerebral shunt device. The cerebral shunt device includes an outer tube member forming a first lumen, the outer tube member having a drainage outlet and at least one opening to the first lumen in a distal region along the length of the outer tube member. The shunt also includes an inner tube member forming a second lumen, the inner tube member having at least one opening to the second lumen along the length of the inner tube member. The inner tube member is positioned within the first lumen and a pump unit fluidly connected to the second lumen to force fluid from the first lumen, which clears obstructions in the shunt.

Abstract: The invention relates to an adjustable implantable throttle for controlling a drainage rate in implantable drains for cerebrospinal fluid drainage. Despite the existence of proven valves, the invention has set itself the object of improving valves. It solves this by making at least one effective length of at least one channel adjustable.

Abstract: Techniques for treating subjects with an injected agent include applying vacuum pressure to tissue adjacent the injection and optionally electroporating said tissue. A device for applying such treatment includes a housing defining a receptacle and an opening into the receptacle. A port extends through the housing remote from the opening and is connectable to a vacuum source, such that the port can communicate vacuum pressure from the vacuum source to the receptacle. The device includes an insert that is receivable within the receptacle and that defines an internal chamber, which is in communication with the vacuum source when the insert resides in the receptacle. The insert includes at least one electrode positioned within the chamber and configured to deliver one or more electroporation pulses to a targeted portion of tissue extending through the at least one opening and at least momentarily held in the chamber responsive to the vacuum pressure.

Abstract: A transdermal double-layer microneedle based on hydrogen producing probiotics and its preparation method and application thereof are provided. The transdermal double-layer microneedle consists of a needle body and a backing layer. The raw material of the needle body includes hyaluronic acid and hyaluronidase. The raw material of the backing layer includes methacrylate anhydride gelatin and silk fibroin protein. The hydrogen producing bacteria are loaded in the microneedles, and the pore size of the matrix material is lower than the diameter of the probiotics, which will not lead to the leakage of bacteria and has high safety. Treatment of inflammatory skin diseases by gas has low side effects. The needle tip is loaded with hyaluronidase to increase the tissue space and improve the effect of gas treatment. It is expected to be used in psoriasis and other inflammatory skin diseases.

Abstract: The present invention provides a transdermally deliverable microneedle patch, a manufacturing mold therefor, and a manufacturing method therefor. The transdermally deliverable microneedle patch includes: a basal layer for attaching to an epidermis, and a microneedle array and a bump array arranged on the basal layer. The microneedle array includes a plurality of microneedles that protrude and extend away from the basal layer. The microneedles are made of a predetermined medicament and a first dissolvable carrier component, and diameters of ends of the microneedles opposite to the basal layer are less than 50 ?m. The bump array includes a plurality of bumps that protrude and extend away from the basal layer. Diameters of ends of the bumps opposite to the basal layer are greater than 50 ?m. The bumps are arranged at intervals along a periphery of the microneedle array, and heights by which the bumps protrude from the basal layer are less than heights by which the microneedles protrude from the basal layer.

Abstract: An acoustic tweezer is disclosed. The acoustic tweezer includes a function signal generator configured to generate a function signal for an ultrasound signal, a power amplifier configured to amplify the ultrasound signal based on the function signal, and an ultrasound transducer of a single channel in which a hologram thin film having different thin film thicknesses for each region is attached to an ultrasound oscillating surface of the ultrasound transducer, and the ultrasound transducer is configured to generate a plurality of ultrasound signals having different phase differences by allowing an oscillated ultrasound signal to pass through the hologram thin film.

Abstract: A system for treating a vascular region includes an elongate catheter shaft having a distal end region, with an inner lumen formed in the elongate shaft and a fluid delivery lumen formed in the elongate shaft adjacent to the inner lumen. A treatment core is disposable within the inner lumen, and has one or more ultrasound transducers disposable adjacent to the distal end region of the elongate catheter shaft, the one or more ultrasound transducers including a proximal-most ultrasound transducer. The fluid delivery lumen is adapted such that fluid passing through the fluid delivery lumen exits the fluid delivery lumen at a position proximal to the proximal-most ultrasound transducer.

Abstract: In some instances, an apparatus includes a hub that defines a cavity, a catheter that includes a lumen, and a core attached to the catheter. The core can include a valve actuation tip, and at least a portion of the core can be positioned within the cavity of the hub. The apparatus can further include a valving member that includes an attachment portion that is fixedly attached to the core and a valve positioned distal to a proximal end of the cavity and proximal to the valve actuation tip. The valve can be movable relative to the core such that as at least a portion of the valve moves distally, interaction between the valve and the valve actuation tip opens the valve to establish fluid communication between the cavity of the hub and the lumen of the catheter.

Abstract: A dialysis machine includes a leakage construction having a leakage collecting device and a leakage connector. The leakage connector is preferably a leakage adapter arranged between an opening of the leakage collecting device and a hose. The leakage connector has a main body to which a seal is attached, which can be brought into sealing contact with the leakage collecting device.

Abstract: Disclosed is a cap configured for removable attachment a medical device. The cap has a body with an opening, a bottom, and a chamber defined between the opening and the bottom. The cap has a wall of the chamber comprising a thread originating proximate the opening and extending into the chamber by a height. The height of the thread increases as a function of increasing distance from the opening. A liquid disinfectant is contained within the chamber.

Abstract: A fluid-fitting tool is disclosed that can align with and rotationally couple with a fluid fitting where the fluid-fitting tool can include a passage and an engagement feature for engaging against the fluid fitting such that when the fluid-fitting tool is spaced apart from the fluid fitting, the fluid-fitting tool can move in a longitudinal direction toward and away from the fluid fitting, and can rotate relative to the fluid fitting around a longitudinal axis of the passage, and when a portion of the fluid-fitting tool and the fluid fitting are rotationally aligned and longitudinally overlap, the fluid-fitting tool can move longitudinally relative to the fluid fitting, and the fluid fitting is rotated when the fluid-fitting tool is rotated around a longitudinal axis of the passage.

Abstract: A system and method for determining the proper dynamic strain profile of an elastomeric construct. The strain characteristics of a deficient heart are determined and compared to the normal strain characteristics of a healthy heart. A construct having elastomeric elements is provided that can expand along multiple axes. In an unloaded condition remote from the deficient heart, the elastomeric elements are pressurized to determine the pressure differential being experienced. Furthermore, optimal strain characteristics are calculated along a first axis and a second axis as a function of the pressure differential. The first optimal strain characteristic and the second optimal strain characteristic are used to estimate the dynamic strain characteristics that will be applied to the heart. The dynamic strain characteristics are compared to the optimal strain characteristics required by the heart to determine if the construct is proper using an automated drive.

Abstract: An impeller for a pump is disclosed herein. The impeller can include a hub having a fixed end and a free end. The impeller can also have a plurality of blades supported by the hub. Each blade can have a fixed end coupled to the hub and a free end. The impeller can have a stored configuration and a deployed configuration, the blades in the deployed configuration extending away from the hub, and the blades in the stored configuration being compressed against the hub.

Abstract: An example system includes a collar; a first stimulating electrode array positioned on the collar and configured to delivery stimulation therapy to a patient; a second stimulating electrode array being positioned on the collar and configured to deliver stimulation therapy to the patient; a sensor array being positioned on the collar and configured to detect one or more features indicative of laryngeal muscle activity of the patient; and a controller configured to control stimulation therapy to be delivered via the first stimulating electrode array and the second stimulating electrode array.

Abstract: An implantable electrode system includes a controller device to treat apply electric field therapy (EFT) to a target structure according to specific anatomical properties of the target structure. The system enables selective association of contacts of the implantable electrode system with one or more target locations of varying tissue types within the body for application and measurement of EFT. The one or more target locations are associated with one or more anticipated tissue parameters that the implantable electrode system uses to apply and update waveform parameters to modulate EFT application from each respective contact to the one or more target locations.

Abstract: A neural implant for a brain area is provided. The neural implant has at least one stimulation section for generating stimulation signals for the brain area, an electrode section with at least one electrode, which is coupled to the stimulation section via a DC connection and can be arranged in the brain area and is designed to apply the stimulation signals to the brain area, and at least one first protection structure section, which is designed to monitor the stimulation section. The first protection structure section is powered by a first energy supply and the protective structure section is powered by a second energy supply, and the first energy supply is galvanically isolated from the second energy supply.

Abstract: An apparatus for fastening around a cranial burr hole includes a substantially flat core and a shell encapsulating a ring portion of the core. The shell defines an orifice substantially centered within the ring portion, and has a contoured lower surface to match the cranial curvature. Pliable arms of the core extend laterally from the ring portion, each being terminated by a fastener member. A central portion of a placement tool for the apparatus has a lower part configured to extend through the apparatus orifice, and an upper part from which first and second arms of the tool extend laterally. Each tool arm is terminated with a receptacle to hold a bone screw, and, when the tool central portion lower part extends through the apparatus orifice, each receptacle aligns with a corresponding fastener member, and lower openings of the receptacles are generally oriented along the contoured lower surface.

Abstract: It is disclosed an electrical interconnection system comprising: i) an interconnection board comprising an intrinsically non elastic substrate, said substrate having a first face and an opposed second face, and at least one conductive track on and/or within at least a portion of said substrate; ii) a stretchable interconnect comprising an intrinsically elastic substrate, said substrate comprising at least one well or groove comprising at least one compliant conductive element therein, said at least one well or groove being configured to accommodate said at least one conductive track of said interconnection board; and iii) at least one bolus of an electrically conductive paste located within said at least one well or groove, configured to electrically connect said at least one compliant conductive element with said at least one conductive track.

Abstract: Stimulation lead includes an elongated lead body having distal and proximal ends and wire conductors extending therebetween. The stimulation lead also includes a lead paddle having a multi-dimensional array of electrodes positioned along a contact side of the lead paddle. The electrodes are electrically coupled to the wire conductors. The lead paddle includes a paddle body and a conductor organizer disposed within the paddle body. The conductor organizer has multiple channels extending along the lead paddle. The channels receive the wire conductors and retain the wire conductors in a designated arrangement with respect to the lead paddle. The conductor organizer has openings to the channels. The wire conductors extend through the openings and are terminated to the respective electrodes.

Abstract: The embodiments described herein relate to a self-positioning, quick-deployment low profile transvenous electrode system for sequentially pacing both the atrium and ventricle of the heart in the “dual chamber” mode, and methods for deploying the same.

Abstract: A system for improving cognitive function is disclosed. The system comprises a non-invasive brain stimulation device (150); a human computer interface; and a computer (101) configured to control the non-invasive brain stimulation device (150) and the human computer interface. The computer (101) controls the brain stimulation device (150) and the human computer interface to assess a subject's baseline cognitive function by interaction with the subject using the human computer interface. If the subject's baseline cognitive function is impaired, the computer (101) uses the human computer interface to provide the subject with a strategy for improving performance in a cognitive function test and stimulates the subjects brain with the non-invasive brain stimulation device (150) while training the subjects cognitive function.

Abstract: The present invention relates to a device for carrying out a tVNS treatment with at least one electrode for generating a stimulation pulse. The device has at least one detection means which is designed to detect a patient movement, and the device has an open-loop or closed-loop control unit, designed to initiate the output of stimulation pulses through the electrode if a patient movement detected by the detection device reaches or exceeds a predetermined threshold value.

Abstract: A system comprising a control module; a neuro-stimulation unit operationally controlled by the control module and configured to generate an electrical stimulation signal at a frequency of between 40-50 Hz; and at least two electrodes configured to be positioned in simultaneous dermal contact with an inner surface of the wrist of a subject, proximately to a median nerve of the subject, wherein each of the at least two electrodes is connected to the neuro-stimulation unit for delivering the generated electrical stimulation signal from the neuro-stimulation unit to the subject, wherein the electrical stimulation signal is configured to apply a neuromodulation treatment to the subject, to reduce occurrences of an arrhythmia-related condition in the subject.

Abstract: A method and apparatus for treating a patient by generating a first series of pulses having a frequency in a range from about 1 Hz to about 5 kHz, a voltage range from about 0 (zero) volts to about 100 (one hundred) volts, and a duty cycle of about 1% to about 90%; generating a second series of pulses having a frequency in a range from about 5 kHz to about 50 kHz, a voltage range from about 0 (zero) volts to about 100 (one hundred) volts, and a duty cycle of about 1% to about 90%; modulating the first series of pulses and the second series of pulses into a combined waveform of pulses; and delivering the combined waveform of pulses to the skin of the patient via an electrical circuit.

Abstract: An earpiece including a frame with an over ear portion and a lower portion including an upper arm including at least a first electrode and a lower arm including at least a second electrode, wherein the upper arm and the lower arm are flexible and resilient to mount the earpiece in a user's ear.

Abstract: Systems, devices, and methods for neurostimulation via vestibular stimulation are described. One example is a device for administering thermal stimulation to an ear canal of a subject. The device may include an earpiece configured to be at least partially insertable into the ear canal of the subject; a thermoelectric device thermally coupled to the earpiece and configured to heat and/or cool the earpiece to thereby heat and/or cool the ear canal of the subject; and a controller configured to administer a selected treatment plan including administering a caloric vestibular stimulation (CVS) stimulus to the ear canal of the subject in a condition-treatment effective amount during a first treatment interval. The treatment plan may be effective to produce a durable improvement in at least one symptom of the condition for a time of at least 1 week following cessation of the administering.

Abstract: Provided are systems and methods for treating pain in the head and neck, including headache pain. The systems and methods may be used to deliver electrical stimulation to the occipital nerve(s). The systems and methods may be used relieve pain in the region innervated by the targeted occipital nerves as well as one or more regions of referred pain that occur outside the innervation region of the occipital nerves. Due to the complex structures and anatomy around the occipital nerve(s), precise placement of the lead is achieved by the described systems and methods.

Abstract: An implantable stimulation system having a stimulation unit coupled to a programmable controller, a stimulation circuit and an array of electrodes disposed on a pair of flexible paddles is provided for selectively stimulating at least one pelvic (e.g., cavernous) nerve. The programmable controller is pre-programmed to run an excitation electrode routine that selectively scans the electrode arrays with a series of directional current flows to optimize electrode selection for use in stimulating a nerve. The implantable stimulation system may be programmed to run a first stimulation pulse sequence corresponding to a first mode for invoking a rapid erectile response, a second nerve rehabilitation stimulation mode for rehabilitating neural transmission in a cavernous nerve, a third penile rehabilitation mode for reducing penile fibrosis, and/or a fourth bladder nerve rehabilitation mode for rehabilitating neural transmission in nerves that control the lower urinary tract.

Abstract: Systems, devices, and techniques for adjusting electrical stimulation based on sensed ECAP signals. For example, processing circuitry is configured to control delivery of a first train of electrical stimulation pulses at a first frequency to a first target tissue and control delivery of a second train of electrical stimulation pulses at a second frequency to a second target tissue different from the first target tissue. The processing circuitry can also receive an ECAP signal elicited by a pulse of the second train of electrical stimulation pulses, adjust, based on the ECAP signal, a first value of a parameter that at least partially defines the first tram of electrical stimulation pulses to a second value, and, responsive to adjusting the first value of the parameter to the second value, control delivery of subsequent pulses of the first tram of electrical stimulation pulses according to the second value of the parameter.

Abstract: A system for an neurostimulator coupled to electrodes. The system comprises a input device configured for generating directional control signals, and memory storing ideal multipole configurations.

Abstract: A system for treating cardiac arrhythmias comprising a generator including: a sensing circuitry configured to evaluate one or more identified signals representative of electrical activity of the heart and detect an arrhythmia, a control circuitry that is configured to control delivery of a therapy in response to the detected arrhythmia, the therapy including a first stage of electrical pulses delivered via at least a first electrode, wherein the first set of electrical pulses is configured to destabilize and/or terminate a reentry associated with the arrhythmia, and a first lead coupled to the generator, wherein the first lead includes the first electrode. The therapy further includes a second stage of electrical pulses delivered via the first electrode and/or a second electrode, wherein the second stage of pulses is configured to terminate the reentry; and an inter-stage delay separating the first and second stages of electrical pulses.

Abstract: A controller for a pacing device, configured to; receive sensor data comprising respiratory data; determine a respiratory sinus arrhythmia, RSA, factor of a pacing signal based on the sensor data; determine a cardio-respiratory phase synchronisation, CRPS, factor of the pacing signal based on the sensor data; and provide the pacing signal for pacing a heart of a patient in accordance with the RSA factor and the CRPS factor.

Abstract: Certain medical devices, such as auditory prostheses, have an implantable portion and an external portion. The implantable portion and external portion each include a transmission/receiver coil that communicates signals between the two portions. The implanted coil is implanted about the ear canal while the external coil is disposed about the pinna or in the ear canal itself. The proximity of the two coils allows for signal transmission between the implantable and external portions.

Abstract: Devices, systems, and methods for providing patient wear compliance information are provided. For example, a medical device includes a plurality of electrodes configured to be continuously coupled externally to a patient and to monitor electrical activity on the skin of the patient. The system also includes at least one motion sensor configured to generate a motion signal based upon movement of the patient. The system further includes a processor configured to receive an electrical signal based on the monitored electrical activity, record a wear onset event based on the electrical signal and the motion signal, record a wear offset event based on one or more of the electrical signal and the motion signal indicating that the patient is not wearing the medical device, and output a graphical representation including information regarding the patient's wear compliance based on the recorded wear onset event and the recorded wear offset event.

Abstract: Wearable devices are provided herein including wearable defibrillators, wearable devices for diagnosing symptoms associated with sleep apnea, and wearable devices for diagnosing symptoms associated with heart failure. The wearable external defibrillators can include a plurality of ECG sensing electrodes and a first defibrillator electrode pad and a second defibrillator electrode pad. The ECG sensing electrodes and the defibrillator electrode pads are configured for long term wear. Methods are also provided for using the wearable external defibrillators to analyze cardiac signals of the wearer and to provide an electrical shock if a treatable arrhythmia is detected. Methods are also disclosed for refurbishing wearable defibrillators. Methods of using wearable devices for diagnosing symptoms associated with sleep apnea and for diagnosing symptoms associated with heart failure are also provided.

Abstract: Various systems, methods, and devices related to modifying views of a multi-lead electrocardiogram (ECG), as well as identifying notations associated with the multi-lead ECG, are described. An example method includes displaying graphical elements in a first arrangement. The graphical elements respectively depict electrical signals indicative of an electrical activity of a heart. The example method further includes detecting a signal indicative of a display selection, and, based on the display selection, rearranging the graphical elements from the first arrangement to a second arrangement.

Abstract: An unattended approach can increase the reproducibility and safety of the treatment as the chance of over/under treating of a certain area is significantly decreased. On the other hand, unattended treatment of uneven or rugged areas can be challenging in terms of maintaining proper distance or contact with the treated tissue, mostly on areas which tend to differ from patient to patient (e.g. facial area). Delivering energy via a system of active elements embedded in a flexible pad adhesively attached to the skin offers a possible solution. The unattended approach may include delivering of multiple energies to enhance a visual appearance.

Abstract: A system and method for applying a low strength, low frequency magnetic field therapy to biological tissues. A coil is excited with a low frequency oscillating current, e.g., 10-1000 Hz. The coil is, e.g., 5-200 turns, having a diameter of 2-20 mm, and produces a magnetic field strength of about 0.01-5mTelsa at a distance of 1 cm from the coil, or a cover over the coil, into the tissue. The current is preferably controlled by a smartphone or other programmable device controlled by a downloadable app in accordance with a PEMF program which may be separately downloaded or updated, and provided through an audio jack. Alternately, a digital interface and/or wireless interface may control the current. An app on the smartphone may be used to control the frequency, amplitude/envelope modulation, waveform, duration, etc. of the oscillation. The coil may be in mineral housing with a simple filter, and TRRS-type audio jack.

Abstract: A wearable repelling magnet assembly comprising a plurality of magnetic components and a retaining member, the retaining member forms a physical linkage between the magnetic components. The magnetic components each project a magnetic field and form a repelling sequence in which each magnetic component exerts a repelling force against the adjacent magnetic components within the sequence, creating a separation interval between the magnetic components and further redirecting the magnetic fields outwardly away from a magnetic axis. The retaining member may be configured as a loop to be worn about a wearer's body.

Abstract: A mouthpiece-type treatment device is capable of treating inflammation in the oral cavity such as in the gums by having a light irradiating means inside the mouthpiece, and has a plurality of modules that can be detached from the mouthpiece so as to be usable by both children and adults regardless of the size of the oral cavity. The device further includes: a main body having a mouthpiece which is inserted into the oral cavity, and a connection part; a cell regeneration lamp provided inside the mouthpiece; and a plurality of coupling modules which are coupled to the respective ends of the mouthpiece, wherein the cell regeneration lamp can output near-infrared rays, can be used by all patients of various oral cavity sizes, and can treat stomatitis occurring not only on the gums but also the palate, the membrane lining the cheek, etc.

Abstract: Described herein are light therapy devices for treating pain. The devices generally include a plurality of light sources configured to stimulate photobiomodulation in tissue, and may be equipped with a safety mechanism configured to stabilize power and current distribution. Methods for treating pain using the light therapy devices are also described herein.

Abstract: Systems and methods for phototherapeutic modulation of nitric oxide in mammalian tissue include use of a first wavelength and first radiant flux of light to stimulate enzymatic generation of nitric oxide, and use of a second wavelength and second radiant flux of light to stimulate release of nitric oxide from endogenous stores of nitric oxide. Pulsed light and/or partially non-overlapping light impingement windows may be used. Non-coherent light impinged on tissue may include a peak wavelength in a range of from 410 nm to 440 nm in the absence of light emissions having a peak wavelength of from 600 nm to 900 nm.

Abstract: A laser device can provide a prompt, precise, and stable laser therapy in that it can: (i) minimize post-treatment adverse reactions, such as hyperpigmentation, erythema, etc.

Abstract: Provided herein are systems and methods and for a beta converter to treat Alzheimer's disease and increase patience adherence.

Abstract: Methods of treating a subject are provided, involving providing a first region of biological material coupled to the subject; initiating a change in a cellular environment of the cells in the first region; and due to a change in biological or chemical activity of the cells in the first region, inducing a biological change in a second region inside the subject, along with various biophoton collectors and biophoton bypasses useful for implementing a variety of the method embodiments.

Abstract: A transcranial device for irradiating a cranium of a user includes a power source, and a headset configured to receive power from the power source. The headset includes a positioning structure including one or more irradiation sources and a control module located on a substrate structure. The control module is configured to modify operational characteristics of the one or more irradiation sources. The substrate structure includes a central segment, and one or more ribs extending from the central segment. The one or more ribs include one or more respective expanded portions at one or more respective distal ends of the one or more respective ribs. The one or more ribs are pliable, such that, the one or more ribs are configured to be bent for locating and fastening the headset onto a head of a user, using one or more first fastening structures, and a second fastening structure.

Abstract: A design, quality assurance, and clinical use procedures are provided for real-time tracking of a custom MRI/CT-compatible brachytherapy applicators. A real-time tracking system is used for applicator implantation, repositioning and tracking during treatment delivery.