Abstract: The present disclosure provides an apparatus including a catheter having a first end and a second end and defining a lumen extending from the first end to the second end. The apparatus also includes one or more openings positioned in a side wall of the catheter between the first end and the second end of the catheter. The apparatus also includes one or more coverings positioned over the one or more openings. A diverter is configured to contact a first covering of the one or more coverings to transition the first covering from a first position to a second position where the first covering projects away from a side wall of the catheter to at least partially obstruct the lumen of the catheter such that the first opening of the one or more openings is accessible via the lumen.

Abstract: A balloon catheter including a heating element disposed about a portion of an outer surface of a catheter shaft; a balloon mounted about the outer surface of the catheter shaft to coincide with the heating element; and thermally expandable material disposed inside the mounted balloon. The balloon catheter eliminating the need for pressurized liquid inflation media to be dispensed into/expelled from the balloon in order to inflate/deflate, respectively, the balloon.

Abstract: Inflatable devices are disclosed including a surface which has a network of polymer chains and is configured to be inflatable into a therapeutically or diagnostically useful shape, and at least one ultrashort laser pulse-formed modification in the surface. The network can, for example, include a network morphology that is substantially unchanged by modification with the ultrashort pulse laser. Ultrashort laser pulses can be laser pulses equal to or less than 1000 picoseconds in duration. Advantageously, the etching process uses a relatively low-heat laser to avoid significant heating of surrounding polymers while modifying the surface (and other structures) of the device. The process is configured so that the polymer chain morphology adjacent the modification is substantially unaffected by the low-heat laser. The resulting inflatable device has customized surface features while still retaining substantially homogenous polymer network morphology.

Abstract: A balloon guide catheter including a catheter shaft having a main lumen defined therein extending axially therethrough to receive a guidewire therein and an inflation lumen defined axially therein arranged semi-encircling the main lumen. The inflation lumen having an inlet port radially outward from the catheter shaft and an exhaust vent(s) disposed proximate the distal end of the catheter shaft. The exhaust vent(s) being disposed longitudinally through a distal terminating end of the inflation lumen or radially inward in fluid communication with the main lumen. A porous membrane is disposed at the exhaust vent(s) to permit only gas to pass therethrough. Secured about the outer surface proximate the distal end of the catheter shaft and coinciding with the inlet port is a balloon.

Abstract: A balloon guide catheter system including a balloon guide catheter having a catheter shaft that includes: (i) a main lumen; (ii) an inflation lumen; and (iii) an exhaust lumen. The terminating distal end of the inflation lumen and the terminating distal end of the exhaust lumen being in localized fluid communication with one another underneath the balloon while in a non-inflated state. A balloon is disposed about a distal region of an outer surface of the catheter shaft. The exhaust lumen is configured to purge the residual air in a proximal direction and out from a proximal region of the balloon guide catheter.

Abstract: A balloon catheter is described having a reinforced, co-axial, duel lumen design. In some embodiments, the balloon catheter includes a purging mechanism designed to purge air from the balloon.

Abstract: Disclosed is an implantable catheter for fluid passage, including a catheter tube, a catheter tip member including one or more apertures and an open proximal end, and a cleaning unit at least partially positioned within the catheter tip member. The catheter tip member is connected at the proximal end thereof to the catheter tube, thereby fluidly coupling the catheter tube to an exterior of the catheter. The cleaning unit is configured for movement within the catheter tip member such as to mechanically prevent, mitigate, and/or remove blockage in the one or more apertures when the catheter tip member is implanted in a body cavity. The catheter tip member further includes a stopper configured to be engaged by a tip portion of a mandrel, such as to prevent the mandrel from reaching and/or damaging the cleaning unit when using the mandrel to guide the catheter tip member into the body cavity.

Abstract: A dilation system and method for accessing a surgical target site to perform surgical procedures. In one version, the dilation system includes a dilation assembly and an actuating mechanism. The dilation assembly comprises plurality of dilator segments. The actuating mechanism is operably associated with the dilator segments so as to cause the dilator segments to move from a collapsed state to an expanded state.

Abstract: A single or multi layered device (hereinafter alternately referred to as a “capsule”) of non-digestible material encapsulating an ingestible drug solution capable of slow solution release of stable solubilized drugs in water, saline, a buffer or lipophilic acceptable carriers. Methods for preparing the same and for safe, nearly constant dispensing of drugs following capsule swallowing. A safe, controlled flow release mechanism for the capsule's drug to the gastric system is disclosed.

Abstract: A microneedle array assembly includes a microneedle array that has a plurality of microneedles. A distribution manifold includes a fluid supply channel that is coupled in flow communication to a plurality of resistance channels. Each of the resistance channels are coupled in flow communication to a respective one of the microneedles of the microneedle array. The resistance channels have a resistance value to a fluid flow through each resistance channel that is in the range between about 5 times greater to about 100 times greater than a resistance to the fluid flow through the supply channel.

Abstract: Microneedle arrays and methods of forming the same can include one or more bioactive components bonded to a biocompatible material such that the one or more bioactive components are cleavable in vivo to release the bioactive component from the biocompatible material.

Abstract: An access port for transporting fluids into a patient's body utilizing a multiple seals in parallel is disclosed. The access port 100 includes a flanged base 102, a receptacle 106 with multiple seals 108 and 110, and a cannula 104. The access port may also include a guide needle for installation purposes, and a sanitary adaptor that seals the receptacle for long term usage. Adhesives or bandaging may utilize the flanged base to secure the access port to the patient. The flanged base may also be installed beneath the patient's skin so secure the access port. The receptacle utilizes a multitude of sealing mechanism, including but not limited to O-ring seals and screw-lock seals. The receptacle additionally contains and outlet flow path leading to the cannula. The cannula connects from the receptacle into the patient's body. The cannula is installed perpendicular to the plane of the flanged base and protrudes on the side of the access port facing into the patient's body while the receptacle faces outward.

Abstract: Certain aspects are directed to a housing and cap to provide protection of medical devices having one or more percutaneous connection (e.g., a three-way stopcock or catheter port).

Abstract: Systems, apparatus, and methods are described for delivering a therapeutic substance, such as an anesthetic, to a tympanic membrane of a subject. Such systems can include an earset with a valve configured to control flow of a fluid, such as air, into and out of a reservoir. In some embodiments, systems, apparatus, and methods described herein can include additional valves and features for relieving negative pressure within the reservoir.

Abstract: A plurality of individually addressable electrodes is supported by a housing. The individually addressable electrodes are for at least one of applying stimulation electrical signals to skin of a user and detecting biometric electrical signals from the skin of the user. At least one of a signal detector is provided for detecting the biometric electrical signals and a signal generator is provided for generating the stimulation electrical signals. An electrode multiplex circuit is provided for addressing the plurality of individually addressable electrodes by at least one of routing the biometric electrical signals from the skin of the user through more than one of the plurality of individually addressable electrodes to the signal detector and routing the stimulation electrical signals from the signal generator through more than one of the plurality of individually addressable electrode to the skin of the user.

Abstract: Methods and devices for stimulating a nerve in a patient include positioning a device adjacent an outer skin surface of the patient and emitting an electrical field near the vagus nerve within the patient. The electric field is varied to create burst periods and constant periods. The charge of the electric field emitted during the burst periods alternates between positive and negative. The charge of the electric field emitted during the constant periods has a magnitude of zero.

Abstract: Guidewires and methods for transmitting electrical stimuli to a heart and for guiding and supporting the delivery of elongate treatment devices within the heart are disclosed. A guidewire can comprise an elongate body, including first and second elongate conductors, and at least first and second electrodes. A distal end portion of the elongate body can include a preformed bias shape, such as a pigtail-shaped region, on which the first and second electrodes can be located. The preformed bias shape can optionally be non-coplanar relative to an intermediate portion of the elongate body. The first and second elongate conductors can be formed of a single structure or two or more electrically connected structures. The conductors can extend from proximal end portions to distal end portions that electrically connect to the first and second electrodes.

Abstract: In some examples, a tether head assembly of a delivery system includes an inner retainer and an outer retainer that defines an aperture comprising a receptacle configured to receive an attachment member of a medical device, a passageway, and a groove. The inner retainer is movable within the groove between a second position in which the passageway is dimensioned to receive the attachment member and a first position in which the passageway is dimensioned to prevent passage of the attachment member. In some examples, a tether handle assembly defines a channel, a force transmitter within the channel, a slidable member partially received within a first end of the channel and a button partially received within a second end of the channel. Distally-directed force applied to the button may cause the force transmitter to apply proximally-directed force to the slidable member, moving the slidable member and an attached pull wire proximally.

Abstract: In some examples, a tether head assembly of a delivery system includes an inner retainer and an outer retainer that defines an aperture comprising a receptacle configured to receive an attachment member of a medical device, a passageway, and a groove. The inner retainer is movable within the groove between a second position in which the passageway is dimensioned to receive the attachment member and a first position in which the passageway is dimensioned to prevent passage of the attachment member. In some examples, a tether handle assembly defines a channel, a force transmitter within the channel, a slidable member partially received within a first end of the channel and a button partially received within a second end of the channel. Distally-directed force applied to the button may cause the force transmitter to apply proximally-directed force to the slidable member, moving the slidable member and an attached pull wire proximally.

Abstract: [Problem] To provide a cosmetic mask which imparts effective stimulation to the appropriate position and has a tightening effect. [Solution] This cosmetic mask is worn on the face of a user, is able to cover at least the cheeks, and is equipped with a pair of simulators which impart electric or ultrasonic stimulation to a location corresponding to either the zygomatic muscle or masseter muscle of the user. The cosmetic mask may be equipped with a stimulator fitting unit for fitting the stimulators to a cheek position, and maybe constituted so that at least some of the stimulators are detachable. The cosmetic mask may also be equipped with a nosepiece which matches the protruding shape of the nose, a left-right fitting portion which is fitted while applying tensile force to the left and right sides of the face, and a vertical fitting portion which is fitted while applying tensile force from the lower surface of the mandible over both sides of the face to the top of the head.

Abstract: An apparatus for delivering a plurality of electromagnetic fields to a body of an individual. The apparatus includes a plurality of electrode elements and a control device coupled with the plurality of electrode elements. The control device is configured to detect temperatures of the plurality of electrode elements, determine alternate firing sequences of the plurality of electrode elements, and implement the determined alternate firing sequences for delivering the plurality of electromagnetic fields for treating tumors in the body of the individual and reducing temperatures of the plurality of electrode elements.

Abstract: The present invention relates to a skin attachment connecting device and, more specifically, to a skin attachment connecting device for applying a micro-electric current for a cell movement of the skin, wherein a protrusion part comes into contact with a skin attachment while the connecting device formed in a tong shape picks up the attachment formable in various shapes, such that a micro-electric current is applied to the skin attachment. In order to achieve the purpose as described above, a connecting device for applying power transferred from a power supply device to a skin attachment, according to the present invention, is formed in a tong shape and comprises, therein, a connection part for applying power transferred from the power supply device to the skin attachment while contacting the skin attachment.

Abstract: The present disclosure relates to neural electrode technology for measuring a biosignal of a human or applying a neural signal to the human, and a neural electrode assembly includes a body that is inserted into a uterus in a non-invasive manner, a recording neural electrode formed to measure a uterine contraction-evoked neural signal, the recording neural electrode being coupled to the body, and a stimulating neural electrode formed to stimulate a nerve entering the uterus to suppress the uterine contraction, the stimulating neural electrode being coupled to the body.

Abstract: An implant unit configured for implantation into a body of a subject is provided. The implant unit may include a flexible carrier unit including a central portion and two elongated arms extending from the central portion, an antenna, located on the central portion, configured to receive a signal, at least one pair of electrodes arranged on a first elongated arm of the two elongated arms. The at least one pair of electrodes may be adapted to modulate a first nerve. The elongated arms of the flexible carrier may be configured to form an open ended curvature around a muscle with the nerve to be stimulated within an arc of the curvature.

Abstract: Systems and methods for His bundle pacing and classifying response to pacing impulses include applying, using a pulse generator, an impulse through a stimulating electrode to induce a response from a patient heart. A response to the impulse is measured using at least one sensing electrode and frequency characteristics of the response are analyzed to determine whether His bundle capture has occurred and, if so, what type of capture has occurred. To facilitate analysis, the response measured from the patient heart may also be filtered to pass or stop frequencies indicative of certain capture types.

Abstract: An adaptive treatment management system includes a sensor system, a treatment optimization system, and a treatment delivery system. The treatment optimization system may update a treatment regimen multiple times between physician visits to facilitate optimization of treatment. The treatment optimization system may determine a treatment regimen based on at least one of patient data, treatment compliance data, and related treatment data. Patient data may be provided by the sensor system. Treatment compliance data may be provided by the treatment delivery system. Related treatment data may be provided by a remote system.

Abstract: Devices and methods to deliver microcurrent stimulation therapy to the human body, when connected to a micro-stimulation current-generating apparatus. The method of applying microcurrent stimulation therapy to key points around the eye for treatment of problems such as macular degeneration, retinitis pigmentosa, glaucoma, optic neuritis and other eye-related or nerve-related conditions, as well as other diseases, such as Bell's Palsy, requiring localized stimulation to the eyes and/or on other body parts.

Abstract: Devices and methods to deliver microcurrent stimulation therapy to the human body, when connected to a micro-stimulation current-generating apparatus. The method of applying microcurrent stimulation therapy to key points around the eye for treatment of problems such as macular degeneration, retinitis pigmentosa, glaucoma, optic neuritis and other eye-related or nerve-related conditions, as well as other diseases, such as Bell's Palsy, requiring localized stimulation to the eyes and/or on other body parts.

Abstract: High frequency stimulation for treating sensory and/or motor deficits in patients with spinal cord injuries and/or peripheral polyneuropathy, and associated systems and methods. A representative method includes addressing the patient's somatosensory dysfunction and/or motor dysfunction, resulting from neuropathy and/or spinal cord injury, by directing an electrical therapy signal to the patient's spinal cord region, the therapy signal having a frequency in a frequency range from 1.5 kHz to 100 kHz.

Abstract: A gait management apparatus applies stimulation to a user suffering from a neurological disease (such as Parkinson's Disease) gait dysfunction. Motion sensors are arranged to be worn by a patient, and electrical stimulation electrodes are on the legs for stimulation. A controller receives motion sensing signals, and processes these signals to generate stimulation signals for operation of the electrodes to stimulate limb movement upon detection of a gait abnormality. There may be a user actuator for user actuation of electrical stimulation, and the inputs may be a series of taps. The controller may provide signals to prevent occurrence of freezing of gait when it senses that a patient is walking or has an intention to walk. Also, it may apply stimulation at an intensity level which is insufficient for functional muscle stimulation but sufficiently high to trigger activation of efferent nerves.

Abstract: This application is generally related to identifying or otherwise programming one or more cycling parameters for operation of an implantable pulse generator to provide a neurostimulation therapy to a patient using a non-paresthesia stimulation pattern. in some embodiments, the cycling parameter is selected by measuring physiological signals during trial stimulation. In other embodiments, multiple cycling parameters are identified for use by the patient using a patient controller device.

Abstract: Apparatus and methods for managing pain uses a multiplexed modulation/stimulation signal to provide pain relief during spinal cord stimulation or peripheral nerve stimulation.

Abstract: Embodiments of the present invention provide systems and methods for the treatment of pain through activation of select neural fibers. The neural fibers may comprise one or more afferent neural fibers and/or one or more efferent neural fibers. If afferent fibers are stimulated, alone or in combination with efferent fibers, a therapeutically effective amount of electrical stimulation is applied to activate afferent pathways in a manner approximating natural afferent activity. The afferent fibers may be associated with primary receptors of muscle spindles, golgi tendon organs, secondary receptors of muscle spindles, joint receptors, touch receptors, and other types of mechanoreceptors and/or proprioceptors. If efferent fibers are stimulated, alone or in combination with afferent fibers, a therapeutically effective amount of electrical stimulation is applied to activate intrafusal and/or extrafusal muscle fibers, which results in an indirect activation of afferent fibers associated therewith.

Abstract: Methods are provided to treat a neurological disorder in a patient by adjusting connectivity between network nodes in a brain of patient using electrical stimulation. Electrical stimulation including a carrier wave component is employed to adjust connectivity using infraslow frequencies of less than 1 Hz.

Abstract: A nerve stimulator and a manufacturing method thereof. The nerve stimulator includes a glass substrate, and a plurality of metal pins provided on the substrate, wherein the metal pins form stimulation portions on one side of the substrate, and the density of the metal pins is greater than 15 Pin/mm2. The stimulation portions in the present nerve stimulator have a high density and a good stimulation effect. The processing method thereof is to cut out a high-density metal pin array first by using a metal underlayer, then the manufacturing method overcomes the deficiency in the prior art that it is rather difficult to manufacture a high density of nerve stimulation electrodes by using other substrates such as ceramics and the like.

Abstract: Methods of providing neuromodulation therapy to a patient are disclosed herein. In particular, methods of applying deep brain stimulation (DBS) for the treatment of Parkinson's disease (PD) and related disorders are disclosed. Aspects of the methods involve using stimulation waveforms having a first polarity (e.g., cathodic stimulation) to determine an optimum arrangement of electrodes for providing the therapy (i.e., identifying a sweet-spot for stimulation). Therapy is then provided using the optimum arrangement of electrodes to deliver stimulation waveforms having the opposite polarity (e.g., anodic stimulation).

Abstract: A method and system are provided for determining a relation between stimulation settings for a brain stimulation probe and a corresponding V-field. The brain stimulation probe comprises multiple stimulation electrodes. The V-field is an electrical field in brain tissue surrounding the stimulation electrodes.

Abstract: Deep Brain Stimulation (DBS) electrodes are positioned within (or adjacent to) white matter fiber tracts in a brain of patient. The DBS electrodes may be positioned near one or more stimulation sites within the white matter fiber tracts. The stimulation sites may be selected based on the disorder of the patient. In some examples, the stimulation sites may be selected based on one or more symptoms of the patient. In some examples, additional electrodes may be positioned in another area to collect bioelectrical brain signals. The area in which the additional electrodes are placed is an area that is different from the stimulation site but is targeted by stimulation therapy provided at the stimulation site.

Abstract: System and methods for detecting impedance changes and for adjusting electrical therapy based on impedance changes are disclosed herein. A method in accordance with a particular embodiment includes applying a therapeutic, paresthesia-less electrical signal to a patient via a patient modulation system that includes a signal delivery device in electrical communication with a target neural population of the patient. The method can include monitoring on a periodic basis an impedance of an electrical circuit that includes the signal delivery device. The method can further include detecting a change in the impedance that indicates a fault and providing an indication that the fault exists.

Abstract: An example of a system may include a processor; and a memory device comprising instructions, which when executed by the processor, cause the processor to access at least one of: patient input, clinician input, or automatic input; use the patient input, clinician input, or automatic input in a search method, the search method designed to evaluate a plurality of candidate neuromodulation parameter sets to identify an optimal neuromodulation parameter set; and program a neuromodulator using the optimal neuromodulation parameter set to stimulate a patient.

Abstract: Systems and methods may monitor electrical activity of a patient's heart using electrodes during delivery of cardiac conduction system pacing therapy, generate electrical heterogeneity information (EHI) based on the monitored electrical activity during delivery of cardiac conduction system pacing therapy, and determine whether the cardiac conduction system pacing therapy would benefit from supplemental cardiac pacing therapy based on the generated EHI.

Abstract: Systems and methods for His bundle pacing and classifying response to pacing impulses include applying, using a pulse generator, an impulse through a stimulating electrode to induce a response from a patient heart. A response to the impulse is measured using at least one sensing electrode and time-domain based characteristics of the response are analyzed to determine whether His bundle capture has occurred and, if so, what type of capture has occurred.

Abstract: The present disclosure provides systems and methods for assembling a subassembly for use in manufacturing an implantable device header. A method includes placing a first split web into a top platen, placing a second split web into a bottom platen, placing a conductor assembly and an antenna assembly in the bottom platen on top of the second split web, compressing the top and bottom platens together, heating the top and bottom platens until a predetermined temperature and a predetermined pressure are reached, such that first split web is fused to the second split web to form the subassembly, separating the top and bottom platens, and removing the formed subassembly.

Abstract: The present invention relates to the field of medical devices, and specifically to a packaging structure and a packaging method for a retinal prosthesis implanted chip, including a high-density stimulation electrode component processed by a glass substrate, wherein the stimulation electrode component comprises the glass substrate, and a plurality of stimulation electrodes and a pad structure provided on the glass substrate; the stimulation electrodes are formed through cutting out metal pins on the metal and then pouring with glass; the stimulation electrode component is connected to an ASIC chip; a glass packaging cover is covered on the ASIC chip, the glass packaging cover is provided with a metal feedthrough structure for communicating with the stimulation chip; and the packaging cover covers and encapsulates the pad structure.

Abstract: This application is generally related to identifying or otherwise programming one or more cycling parameters for operation of an implantable pulse generator to provide a neurostimulation therapy to a patient using a non-paresthesia stimulation pattern. In some embodiments, the cycling parameter is selected by measuring physiological signals during trial stimulation. In other embodiments, multiple cycling parameters are identified for use by the patient using a patient controller device.

Abstract: The present invention relates to the field of medical appliances, more particularly to a communication system of an implantable device, comprising an external unit and an implantable unit, wherein the external unit and the implantable unit realize charging and bidirectional signal transmission of the external unit to the implantable unit by a wireless signal, two coupling coils are disposed outside the body, one for transmitting the forward signal, and one for receiving the reverse signal, and one coupling coil is disposed in the body for receiving and feeding back the signal, wherein the setting of the shape and position of the two coupling coils outside the body avoids the reverse signal fed back from inside of the body to be disturbed, thereby achieving effective transmission of the bidirectional signal, and overcoming the problem that the signal has weak signal strength and tends to be interfered when the traditional implantable device transmits the signal in a reverse direction.

Abstract: Techniques are disclosed for monitoring a patient for the occurrence of a cardiac arrhythmia. A computing system generates sample probability values by applying a machine learning model to sample patient data. The machine learning model determines a respective probability value that indicates a probability that the cardiac arrhythmia occurred during each respective temporal window. The computing system outputs a user interface comprising graphical data based on the sample probability values and receives, via the user interface, an indication of user input to select a probability threshold for a patient. The computing system receives patient data for the patient and applies the machine learning model to the patient data to determine a current probability value. In response to the determination that the current probability exceeds the probability threshold for the patient, the computing system generates an alert indicating the patient has likely experienced the occurrence of the cardiac arrhythmia.

Abstract: Systems, methods, and devices are disclosed for administering a therapeutic agent to a patient and improving therapeutic effects of such agents on a patient. A stimulation is applied to a portion of a patient's spine, and the therapeutic agent is administered to the patient intrathecally and proximal to the portion of the patient's spine. In some embodiments, a second stimulation is applied to the patient at a second portion of the patient's spine and concurrently with administering the therapeutic agent. Concerted stimulation of the patient's spine administering a therapeutic agent synergistically improves treatment outcome.

Abstract: A method for reducing visceral body fat in humans involving the steps of a user utilizing a pulsed electromagnetic field generating device for a recommended period of time; the user then laying in an LED therapy bed with a light chamber having an LED array configured to emit multiple wavelengths of light at differing output percentages, the LED array of the LED therapy bed producing a chamber spectrum combination of at least three different light wavelengths for a preferred length of time; and the user then utilizing a vibration platform for a preferred length of time. The method may be achieved through the use of custom designed equipment and methods.

Abstract: The present specification discloses a pulsed electromagnetic field system having planar microcoil arrays integrated into clothing. Each of the planar microcoil arrays has two or more planar microcoils positioned on a flexible substrate. The planar microcoil arrays are connected to a controller configured to generate an electrical current and transmit that electrical current, in accordance with a particular stimulation protocol, to each of the planar microcoil arrays.