Abstract: The various embodiments of the subject invention included herein provide devices, systems and methods for aiding the regrooming or refolding of balloons upon deflation. The scope of the inventions in this specification includes methods and devices that reduce the profile of balloons after deflation, reduce or eliminate wings, high-points, irregularities, bunching, thickening, and the like, and facilitate passage of a deflated balloon through a body void or lumen, or through a medical device such as a guide catheter, guide sheath, femoral or radial introducer sheath, and the like.

Abstract: An apparatus for performing a medical procedure and, in particular, an aortic valvuloplasty, in a vessel for transmitting a flow of fluid. The apparatus includes an inflatable perfusion balloon including an internal passage for permitting the fluid flow in the vessel while the perfusion balloon is in an inflated condition, the balloon including a plurality of cells in a single cross section and a covering for at least partially covering the cells. A valve associated with the balloon controls the fluid flow within the passage, the valve being arranged external to the passage. The valve may form a tubular extension of the covering, or may be separate from the covering, and may comprise flaps. A spiral covering may also form the valve.

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

Abstract: A device and method for selectively applying a composition a treatment surface (e.g., skin) to impart an aesthetically pleasing appearance to the surface. The device may include a detector for obtaining image data corresponding to an image of an area of skin. The device may also include an applicator for selectively applying a fixed amount of the composition to the skin to a location within the area of skin as determined by the device. The fixed amount is selected to reduce the artifact magnitude by a predetermined coverage level when applied to the skin. The device may include a processing arrangement for receiving image data from the detector, determining an artifact magnitude of the location based on the image data, comparing the artifact magnitude to a threshold, and directing the applicator to apply the composition to the skin when the artifact magnitude is above the threshold.

Abstract: A device and a method are for application of a composition to a treatment surface (e.g., skin). The device may include an optical emitter projecting fiducials to skin; a detector obtaining image data corresponding to an image of an area of skin marked with the fiducials; an applicator applying the composition to a location within the skin area; and a processing arrangement. The processing arrangement is receiving the image data, analyzing the image data to determine a morphology of the skin area based on the fiducials captured within the image, identifying, based on the morphology, a region within the image corresponding to the location aimed by the applicator arrangement, analyzing the image data to determine whether the identified region corresponds to a skin artifact, and directing the applicator arrangement to selectively apply the composition to the location when the skin artifact is detected from the identified region.

Abstract: In the preferred embodiment of the present invention, a patch of dissolving microneedles loaded with active ingredients to be applied to skin for treating skin conditions is provided. As seen in FIG. 1, the dissolving microneedle patch (10) comprises a substrate (12) and a plurality of microneedles (14) which extends from the substrate. The dissolving microneedle patch (10) is made of a matrix material and at least one active ingredient such as a corticosteroid, namely triamcinolone (TAC). The matrix material is made of bio-compatible materials such as hyaluronic acid (HA), polyvinylpyrrolidone (PVP), or mixture of them, which dissolve rapidly when they are in contact with the inner skin. The active ingredient is loaded onto individual patches with the desirable dosage ranging from 0.01 mg-1.0 mg.

Abstract: A medical drug devices for transdermal drug delivery systems (TDDS) comprising a novel iontophoretic polymeric microneedle device and its use in administration of drugs.

Abstract: A first tube connector and a second tube connector are to be automatically and mechanically attached to and detached from each other. Provided is an attaching/detaching device (100) including: a fixing portion (104) configured to fix a first tube connector (105); a holding portion (107) configured to hold a second tube connector (106); a moving portion configured to move the holding portion (107), which holds the second tube connector (106), in a direction of approaching the first tube connector (105) to connect the second tube connector (106) to the first tube connector (105), and move the second tube connector (106) after the connection in a direction of separating from the first tube connector (105) to release the connection of the second tube connector (106) and the first tube connector (105).

Abstract: Disclosed herein are embodiments of a connector system for releasably connecting together tubes, for example medical tubing, and methods of making and using such a connector system, whereby the connector system includes a female coupler having a first passageway; a male coupler having a second passageway; and a catch assembly comprising a catch movably coupled to the female coupler, a catch-biasing member which biases the catch, and a follower responsive to a cam, whereby the catch is responsive to the follower and correspondingly, the cam.

Abstract: An example of a method of enabling medical fluid transfer between a source container and a destination container can comprise the steps of providing a closed-system fluid transfer module comprising a first closeable, resealable medical connector and a second closeable, resealable medical connector, a multidirectional fluid control valve with a driving interface configured to interface with an electromechanical driver of an electronic medical fluid transfer device, and an intermediate container or an intermediate pumping region; and instructing a user to couple the closed-system fluid transfer module to the electronic medical fluid transfer device.

Abstract: A neck-hanging massaging device includes an elastic arm, a first handle, a second handle, an electrode assembly and an electric pulse generating device. The first handle and the second handle are fixedly connected to the two sides of the elastic arm. The electrode assembly is arranged on the elastic arm. The electric pulse generating device is electrically connected with the electrode assembly. The electric pulse generating device is arranged in the first handle.

Abstract: One aspect is forming a medical lead for implantation. The method includes forming a plurality of non-ground electrodes, at least one non-ground electrode having a plurality of segments. Overmold portions are formed for the at least one of the plurality of non-ground electrodes, including keys and tabs. One of a plurality of conductors is attached to one segment of the at least one non-ground electrode using the keys and tabs. The non-ground electrodes and plurality of conductors are assembled into electrode assembly and the overmold portions are reflowed. The reflowed electrode assembly is then ground to form the medical lead.

Abstract: Apparatus and methods for treating back pain are provided, in which an implantable stimulator is configured to communicate with an external control system, the implantable stimulator providing a neuromuscular electrical stimulation therapy designed to cause muscle contraction to rehabilitate the muscle, restore neural drive and restore spinal stability; the implantable stimulator further including one or more of a number of additional therapeutic modalities, including a module that provides analgesic stimulation; a module that monitors muscle performance and adjusts the muscle stimulation regime; and/or a module that provides longer term pain relief by selectively and repeatedly ablating nerve fibers. In an alternative embodiment, a standalone implantable effRF ablation system is described.

Abstract: A new class of peripheral nerve interfaces that combines microfluidics with microelectronics. A peripheral nerve interface that allows intraneural targeting through the combined use and sequential application of lysing agents and neurotrophic factors.

Abstract: A neuromodulator includes an electromagnetic (EM) wave generator configured to generate EM waves remote from a patient and to direct the EM waves to one or more target regions within the patient. Frequencies of the EM waves fall outside a range of frequencies that activates neurons. Intersection of the EM waves in each target region creates envelope-modulated electric and magnetic fields having one or more frequencies that fall within the range of frequencies that activates neurons. The neuromodulator includes control circuitry configured to control parameters of the EM waves produced by the EM wave generator. The neuromodulator may use feedback based on one or more of patient input and/or sensing of physiological signals in order to close the loop and control the EM waves.

Abstract: The invention relates generally to systems and devices for material delivery, energy delivery, and/or monitoring electrophysiological activity, and method of use thereof. In particular, the present invention provides devices and systems, and methods of use thereof, configured to deliver therapeutic compositions, to provide electroporation and/or sonoporation to increase therapeutic efficiency, and to monitor electrophysiological activity, for example, before and after treatment.

Abstract: A neural stimulator, suitable for implanting in a recipient, and configured to combine vagal nerve stimulation (VNS) with cochlear stimulation, to result in faster adaptation to new sounds and maps, and alleviation of tinnitus in the recipient.

Abstract: An electric current stimulation device includes a first electrode and a second electrode that are arranged in a body, and an output circuit that outputs an electric signal; wherein the electric signal by which the user feels no pain is output from the output circuit, and the electric signal is applied to a distal portion of extremities or near the same by the first electrode and the second electrode when arranging the body at the distal portion of the extremities of the user or near the same.

Abstract: An electrode lead comprises an electrically insulative cuff body and at least three axially aligned electrode contacts circumferentially disposed along the inner surface of the cuff body when in the furled state. The electrode contacts may be circumferentially disposed around a nerve, and an electrical pulse train may be delivered to the electrode contacts thereby stimulating the nerve to treat obstructive sleep apnea. The electrical pulse train may be one that pre-conditions peripherally located nerve fascicles to not be stimulated, while stimulating centrally located nerve fascicles. A feedback mechanism can be used to titrate electrode contacts and electrical pulse train to the patient. A sensor that is affixed to the case of a neurostimulator can be used to measure physiological artifacts of respiration, and a motion detector can be used to sense tapping of the neurostimulator to toggle the neurostimulator between an ON position and an OFF position.

Abstract: An apparatus is described comprising electrodes (22) configured to be placed upon a portion of a body of a subject, and a user interface device (26). A computer processor (24) applies a neuromodulation treatment to the subject, by driving electrical pulses into the portion of the subject's body via the electrodes, and generates an output on the user interface device that indicates to the subject a physiological effect that the neuromodulation treatment has upon the subject's body.

Abstract: At least one electrical brain signal is received from a patient and is demultiplexed into an efferent motor intention signal and at least one afferent sensory signal (such as an afferent touch sense signal and/or an afferent proprioception signal). A functional electrical stimulation (FES) device is controlled to apply FES to control a paralyzed portion of the patient that is paralyzed due to a spinal cord injury of the patient. The controlling of the FES device is based on at least the efferent motor intention signal. A demultiplexed afferent touch sense signal may be used to control a haptic device. The afferent sensory signal(s) may be used to adjust the FES control.

Abstract: The present invention improves control of currents in a multi-site direct current neurostimulation system. Precise control incorporates three constant current sources in a system consisting of spinal, polarizing and peripheral circuits. Constant current sources (sinks) are placed on the high side of the peripheral circuit and one sink in series on the low side of the spinal circuit in a four electrode configuration, for maintaining both predetermined currents, and current ratios, as the electrode/skin impedance and body impedance vary over the course of a treatment. Resistive steering is also implemented.

Abstract: An exemplary diagnostic system is configured to execute a diagnostic application, communicatively couple to a cochlear implant, receive, while communicatively coupled to the cochlear implant, input representative of an activation code, validate the activation code, link, in response to the validation, the activation code to a unique implant identifier associated with the cochlear implant, and enable, in response to the linking, a feature of the diagnostic application for use with the cochlear implant.

Abstract: An exemplary diagnostic system directs a cochlear implant to step through applying a sequence of stimulation events each having a different stimulation level to an electrode set disposed on an electrode lead, detects, while the cochlear implant is stepping through applying the sequence of stimulation events to the electrode set, user input indicating that a stapedial reflex state within the recipient changes from a first reflex state to a second reflex state, identifies a particular stimulation event that corresponds to the change in the stapedial reflex state from the first reflex state to the second reflex state, the particular stimulation event having a particular stimulation level, and graphically presents one or more graphical markers indicating that the stapedial reflex state is the second reflex state at the particular stimulation level.

Abstract: An exemplary scalar translocation detection system detects a first evoked response occurring in response to acoustic stimulation applied to a cochlear implant patient. The system detects the first evoked response by way of an electrode configuration disposed on an electrode lead while the electrode configuration is positioned at a first location along an insertion path of the electrode lead into a cochlea of the patient. The system further detects, by way of the electrode configuration while it is positioned at a second location along the insertion path, a second evoked response occurring in response to additional acoustic stimulation applied to the patient. The system further determines an amplitude change and/or a phase change between the first and second evoked responses, and then determines whether a scalar translocation of the electrode lead from one scala of the cochlea to another has occurred based on the amplitude change and/or the phase change.

Abstract: Disclosed are methods and systems for treating epilepsy by stimulating a main trunk of a vagus nerve, or a left vagus nerve, when the patient has had no seizure or a seizure that is not characterized by cardiac changes such as an increase in heart rate, and stimulating a cardiac branch of a vagus nerve, or a right vagus nerve, when the patient has had a seizure characterized by cardiac changes such as a heart rate increase.

Abstract: An implantable pulse generator (IPG) that generates spinal cord stimulation signals for a human body has a programmable signal generator that can generate the signals based on stored signal parameters without any intervention from a processor that controls the overall operation of the IPG. While the signal generator is generating the signals the processor can be in a standby mode to substantially save battery power.

Abstract: The present invention provides systems and methods for modulating the plasticity and/or memory of the autonomic nervous system.

Abstract: A method of detecting catheter movement includes positioning a first sensor in a first body cavity, monitoring a first parameter profile of the first body cavity, positioning a second sensor in a second body cavity, monitoring a second parameter profile of the second body cavity, the second parameter profile different than the first parameter profile at a first time, and, when the second parameter profile is the same as the first parameter profile at a second time after the first time, taking a catheter movement action.

Abstract: A method of treating a patient having a blood pressure comprises delivering neuromodulation therapy to sustain or increase the blood pressure. The neuromodulation therapy includes placing a sympathetic therapy electrode in a posterior portion of a blood vessel and stimulating at least one extravascular cardiac sympathetic nerve fiber using said electrode.

Abstract: A stimulation protocol determination system includes an input module and a selector module. The input module is provided to receive an indication of an upper airway flow limitation via sensed respiratory effort information. The selection module is provided to automatically select, based on the indicated upper airway flow limitation, a stimulation protocol.

Abstract: An optoelectronic electrode element includes an electrode module (40) having at least a first and second electrodes (41, 42) each having an electrode surface (41s, 42s). An an optoelectronic module (20) is provided and having a photovoltaic cell (21a) suitable for transforming optical energy into electrical energy. A feeding fibre optic (31a) is also provided. A coupling module (10) is provided and having a circuit receiving portion (12) for inserting, positioning, and rigidly fixing the optoelectronic module (20) to the coupling module (10); and a feeding fibre cavity (11a) for inserting and coupling the feeding fibre optic to bring it in optimal optical communication with the photovoltaic cell. The coupling module (10) is coupled directly to a fixing area of the electrode module (40), such that the photovoltaic cell be in electrical contact with the first and second electrodes (41, 42).

Abstract: Leadless, implantable microstimulators for treating chronic inflammation. These devices can include a static magnetic field detector (e.g., non-Hall effect sensors/detectors, including those based on a Wiegand effect or generating pulses at a predetermined frequency range and using a detection circuit to determine the decay rate of the pulses), to trigger an emergency shut off of the micro stimulator. Also described are methods and apparatuses for regulating the temperature of an implant based applied power from a charger (e.g., voltage across the charger when unloaded and when loaded by the implant) to yield a power control loop correlated with the power drawn by the implant to determine temperature of the implant. A negotiation protocol can exchange data between the charger and the implant (e.g., type of charger, type of implant, nature of the coupling between the two, etc.) to set target power control loop parameters to estimate and regulate implant temperature.

Abstract: A system and method for powering a medical device that includes a fixture configured for periodic patient proximity; external electrical coupling device integrated into the fixture wherein the external electrical coupling device comprises at least one external energy coupler and is configured to detect presence of an electrical medical device implant in a transmission zone of the external electrical coupling device; an electrical medical device implant, wherein the electrical medical device implant comprises at least one implant energy coupler; and wherein the external electrical coupling device is configured to couple to the implantable medical device through a wireless energy transmission between the external energy coupler and the implant energy coupler when presence of the implantable medical device is within a transmission zone.

Abstract: A system for providing clinical decision support during a clinical encounter with a patient includes a mobile computing device and a remote computing device communicatively coupled to and remotely located from the mobile computing device, the remote computing device configured to receive clinical data during the clinical encounter from a medical device associated with the patient, provide a first interactive display including the clinical data, enable the mobile computing device to access the clinical data, receive user input based on the clinical data from the mobile computing device, and provide the user input and the clinical data at the first interactive display, where the mobile computing device is configured to access the clinical data, provide the clinical data at a second interactive display, prompt a user for the user input based on the clinical data via the second interactive display, and transmit the user input to the remote computing device.

Abstract: System and methods for providing a patient with arrhythmia treatment are described. For example, a system includes an arrhythmia monitoring and treatment assembly configured to be worn on the torso of the patient. The assembly has a housing discreetly extending from a skin surface of the patient. The assembly is configured to provide therapy on detecting one or more arrhythmia conditions of the patient. A first at least one user response button is disposed on the assembly at a first location on the torso concealed under clothing, and a second at least one user response button is configured to be worn on a second location of the patient's body, a location other than the torso that is accessible to the patient. The system suspends an impending therapy upon receiving a user input from either one of the first or second at least one user response buttons.

Abstract: Methods and systems are provided that comprise: sensing cardiac events of a heart; utilizing one or more processors to perform: declaring a ventricular fibrillation (VF) episode based on the cardiac events charging a single charge storage capacitor; delivering a multi-phase VF therapy that includes phase I and phase II therapies, wherein: a) during the phase I therapy, a combination of two or more medium voltage (MV) shocks are delivered entirely from the single charge storage capacitor; and b) during the phase II therapy, a low voltage pulse train is delivered at least partially from the single charge storage capacitor.

Abstract: A method of determining whether rapid pulse indicative of ventricular tachycardia (VT) or ventricular fibrillation (VF) requires electric shock to defibrillate the rapid pulse using blood flow as a robust indicator of blood pressure stability. Preferably, the blood flow monitor is an optical sensor capable of monitoring blood flow change the moment VT or VF has begun its onset.

Abstract: A lens or eye mask for treating an eye of a patient includes a flexible printed circuit board (PCB) that is configured to fit over at least a portion of a surface of the eye and a plurality of electrode pairs that are arranged on the flexible PCB. An electrical source is configured to provide electrical energy to each electrode pair to create a near electromagnetic field within the eye and thereby therapeutically treat target tissue within the eye. A spacing between electrodes of each electrode pair is controlled to achieve a predetermined penetration depth of the near electromagnetic field within the eye.

Abstract: A proximity sensor for a transcranial magnetic stimulation (TMS) system detects the proximity of a TMS coil assembly to a position at which the coil is to receive pulses during TMS treatment and provides feedback to the operator so that the operator may adjust the TMS coil assembly to maintain optimal positioning during treatment. A flexible substrate containing a sensor or sensor array is disposed between the TMS coil assembly and the position such that the coupling of the TMS coil assembly to the position may be detected by the sensor(s). Sensor outputs are processed by signal processing circuitry to provide an indication of whether the TMS coil assembly is properly disposed with respect to the position during TMS treatment. A display provides an indication of how to adjust the TMS coil assembly to improve the positioning of the TMS coil assembly.

Abstract: Described herein are high-power pulsed electromagnetic field (PEMF) applicator systems. The systems can comprise a base housing including a controller configured to generate a low-power control signal and one or more applicators coupled to the base. Each applicator can include a drive circuitry comprising a generator configured to receive the low-power control signal and to produce, in the applicator, a high-power, pulsed electromagnetic field signal based on the low-power control signal. The high-power pulsed electromagnetic field signal can has a power of greater than 40 W. Each applicator can further include a coil, circuit configured to emit the high-power pulsed electromagnetic field signal, and an electromagnetic energy shield disposed between the drive circuitry and the coil circuit.

Abstract: A device for treating living tissue with a magnetic field. The device includes one or more coil applicators; and a generator configured to drive a stimulation coil that is housed within the coil applicator that faces a tissue being treated. The device provides a magnetic field in a range of 0.1T to 3T at a distance of 1 cm or less from the face of the coil applicator.

Abstract: An implant system for photodynamic therapy with a light source for radiating light which is implantable in a resection cavity, and with an autonomous control unit which is connectable via a supply line to the light source.

Abstract: The present disclosure relates to a device and method for inducing improvement of cerebral circulation by using light energy, i.e., photo-innervated neuro-stimulation (PINS), and stimulating nerve endings distributed in the epidermis or dermis located below a skin surface in an area corresponding to the carotid artery or an area corresponding to the vertebral artery of the cervix so that blood vessels (vascular muscles) in the brain are relaxed. The present disclosure can be utilized in treating or preventing vascular dementia and Alzheimer's disease, which are caused by the lack of cerebral circulation, and various other brain-related diseases, such as stroke, migraine, depression, and Parkinson's disease, and improving learning ability, memory, and concentration.

Abstract: A circadian lighting apparatus includes a housing, two light sources, and a control logic. The first light source has a higher color temperature (e.g. 5000K) and the second light source has a lower color temperature (e.g., 1900K). The control logic can clamp operation color temperature to a mixed high color temperature (e.g., 4000K) and a mixed low color temperature (e.g., 2700K), and operate the apparatus according to a circadian schedule such that the mixed high color temperature is used for a daytime circadian state and the mixed low color temperature is used for a nighttime circadian state, and the color temperature of the apparatus is bound by the mixed high color temperature and the mixed low color temperature. This apparatus enables a personalize-able circadian light where each user can set his/her own circadian color temperature range.

Abstract: An improved laser-therapy device for the treatment of acupuncture points, which comprises: a control unit; laser emitting means associated to said control unit; means for generating an emission signal, which are functionally associated to said control unit and to said laser emitting means; and means for modulating said emission signal, which are designed to generate a modulated signal, wherein said modulated signal derives from a first square-wave modulation at a frequency of 100 Hz combined with a second square-wave modulation at a frequency of between 1 and 2 Hz, characterized in that a third square-wave modulation at a frequency of between 50 and 200 Hz is provided, combined, respectively, with said first and second modulations, characterized in that a third square-wave modulation at a frequency of between 5 and 20 Hz is provided, combined, respectively, with said first and second modulations.

Abstract: Methods and apparatus for the inactivation of infectious agents in, on or around a catheter residing in a patient's body cavity. The method comprises a coupling adapter for facilitating the transmission of non-ultraviolet sterilizing electromagnetic radiation (EMR) substantially axially along an optical element into the catheter body. Through delivery of the sterilizing EMR to particular areas of highest infection, the present disclosure is able to inactivate the major sources of infection in catheters.

Abstract: A radiation source that simultaneously produces two radiation frequencies of combined radiation, in order to break apart a mutated DNA base pair. The radiation source produces combined radiation, the combined radiation being for a thymine base and a cytosine base in a thymine and cytosine base pair. The radiation source produces combined radiation, the combined radiation being for a guanine base and a thymine base in a guanine and thymine base pair. The radiation source produces combined radiation, the combined radiation being for an adonine base and a guanine base in an adonine and guanine base pair. The radiation source produces combined radiation, the combined radiation being for an adonine base and a cytosine base in an adonine and cytosine base pair.

Abstract: Methods of treatment trajectory optimization for radiotherapy treatment of multiple targets include determining beam's eye view (BEV) regions and a BEV region connectivity manifold for each target group of a plurality of target groups separately. The information contained in the BEV regions and the BEV region connectivity manifolds for all target groups is used to guide an optimizer to find optimal treatment trajectories. To improve the visibility of insufficiently exposed voxels of planning target volumes (PTVs), a post-processing step may be performed to enlarge certain BEV regions, which are considered for exposing during treatment trajectory optimization.

Abstract: A treatment planning apparatus include: a quality metric generator configured to electronically generate a first quality metric based on input received via a user interface; an optimizer configured to determine treatment parameters for a treatment plan that is executable by a processing unit of a treatment machine to operate the treatment machine, wherein the optimizer is configured to determine the treatment parameters for the treatment plan based on the first quality metric; and a controller configured to influence how the optimizer performs optimization, wherein the controller is configured to provide a first continuous function for the first quality metric.