Abstract: Methods and devices that provide enhanced delivery of a composition to a body region of a patient utilizing radiofrequency energy include directing a first electrode and a second electrode coupled to a radiofrequency energy source to a location proximate to the body region. Radiofrequency energy is provided in modulated pulses from the radiofrequency energy source to the body region from at least one of the first electrode and the second electrode to provide a delivery condition configured to enhance delivery of the composition. The composition is delivered proximate to the body region using a composition delivery element. Devices for enhance composition delivery are also disclosed.

Abstract: A neural interfacing device is disclosed. The neural interfacing device includes a microneedle electrode. The microneedle electrode includes a body having a void formed therein and a plurality of microneedles. The void surrounds the plurality of microneedles, and the plurality of microneedles are bent outward with respect to the body to form a three-dimensional microneedle electrode. Additionally, each of the plurality of microneedles is sized and shaped to penetrate a nerve epineurium.

Abstract: A “localizable” systemic gene therapy system is provided substantially increasing the transfection efficiency of the gene vectors into targeted tissue cells and substantially reducing the escape of the gene vectors from the targeted tissue volume, such as would waste the vectors, promote undesired immune reactions, and/or incur prohibitive costs for the required dose of gene-containing virus vectors. In this regard, the invention provides a means to simultaneously achieve local electroporation and gene-containing vector injection in a portion of a vascularized organ. It includes two double-balloon catheters that create contained volumes in parallel blood vessels for the introduction of vectors with reduced loss along with electrodes providing electroporation of the cells in the same location where the vectors are injected.

Abstract: A wearable medical device is provided for monitoring a cardiac condition of a patient, where the device is releasably mounted to the patient's chest and includes at least two skin-facing electrodes forming a first one or more ECG leads for ongoing monitoring of heart functioning and at least one touch electrode for intermittently obtaining additional circuit vectors for deriving additional metrics regarding the functioning of the patient's heart. Each touch electrode is configured to form an additional lead/vector that is a larger vector and/or separated by at least 15° from a corresponding first lead/vector formed from the first one or more ECG leads in a vector cardiogram representation of the first one or more ECG leads and the additional lead/vector.

Abstract: A wearable device 100 for managing alcohol-driven violence is disclosed. The device 100 comprises a capsule C1 adapted to sense sweat of wearer and detect a level of alcohol in the sweat, a capsule C3 adapted to convert a data detected by the capsule C1 to generate signal activating a capsule C4, a capsule C2 adapted to provide power to the capsule C3, and a capsule C5 adapted to detect a muscle activity of the wearer, wherein the capsule C4 is adapted to inject a drug into the body of the wearer, when activated, and wherein the capsule C5 alerts authorities when no muscle activity is detected.

Abstract: A method of forming a microneedle array can include forming a sheet of material having a plurality of layers and micromilling the sheet of material to form a microneedle array. At least one of the plurality of layers can include a bioactive component, and the microneedle array can include a base portion and plurality of microneedles extending from the base portion.

Abstract: Methods and systems for modulating intraosseous nerves (e.g., nerves within bone) are provided. For example, the methods and systems described herein may be used to modulate (e.g., denervate, ablate) basivertebral nerves within vertebrae. The modulation of the basivertebral nerves may facilitate treatment of chronic back pain. The modulation may be performed by a neuromodulation device (e.g., an energy delivery device).

Abstract: Proposed is a patch for the alleviation and prevention of acne, in which anti-acne activity of a biodegradable metal represented by MgaZnbXc (in which a, b and c are wt % of individual components, a+b+c=100 wt %, 0?a?100, 0?b?100, and 0?c?10, among which a or b is the greatest, and X is at least one selected from the group consisting of Ca, Fe, Mn, Si, Na, Zr, Ce, and P) is demonstrated, thus exhibiting novel use thereof as a patch for the alleviation and prevention of acne.

Abstract: A device (10,210) for treatment of a canal associated with an orifice includes a flexible stem portion (20, 220) adapted for insertion along the canal and having an expandable member (24, 224) carried by the stem portion (20, 220) at or adjacent the distal end. The expandable member (24, 224) is for occlusion of an inner end region of the canal. A cap (40, 240, 340) mounted on the stem portion (20, 220), configured as a receptacle (42, 242), to close an outer end of the canal and to accommodate the surface(s) about the outer end of the canal. The cap (40, 240) thereby de-fines with the expandable member (24, 224), a treatment zone, wherein the receptacle (42, 242) is adapted to receive and store treatment fluid for contact with the surface(s) about the outer end of the canal.

Abstract: A catheter has a balloon electrode assembly with at least one compliant balloon member and at least one electrode carried on an outer surface of the balloon member for accomplishing circumferential sensing or ablation in a tubular region of the heart, including a pulmonary vein or ostium. The catheter may also include an electrode assembly with a tip and/or ring electrode distal of the balloon electrode assembly adapted for focal contact.

Abstract: An optogenetic system and method for preventing or halting seizures. The system and method use a sensor for monitoring the activity of a neural network containing a group of target neurons, and generating an input signal indicative of said activity, the target neurons being excitatory neurons. Excitatory stimulation is delivered in the form of an optical signal by an optical stimulator to the target neurons, the optical signal being determined based on the input signal, to reduce the overall activity of the target neurons.

Abstract: Tissue may be cut and extracted from an interior location in a patient's body using a probe or tool which both effects cutting and causes vaporization of a liquid or other fluid to propel the cut tissue through an extraction lumen of the cutting device. The cutting may be achieved using an electrosurgical electrode assembly, including a first electrode on a cutting member and a second electrode within a cutting probe or tool.

Abstract: A system for infusing medication into a mammalian subject is provided. The system includes an injection system for controlling a flow of fluid from a fluid reservoir to a needle. A sensor is provided that detects a characteristic indicative of the fluid pressure in the needle. The injection system controls the flow of fluid to the needle in response to the characteristic detected by the sensor and the sensor continuously detects the characteristic as the needle is inserted into the subject. The system further includes a conductive element for providing electric nerve stimulation, wherein the system provides electric nerve stimulation in response to the sensor detecting a pressure exceeding an upper limit.

Abstract: A dermal delivery device includes a film having first and second outwardly facing major surfaces; at least one liquid reservoir contained within the film; at least one microfluidic channel having a transverse dimension between about 100 nm and 0.5 mm disposed within the film and in fluid communication with the at least one liquid reservoir; and at least one outlet port operatively connected to the first outwardly facing major surface of the film in fluid communication with the at least one microfluidic channel.

Abstract: The present invention provides systems, methods, and devices for electroporation-based therapies (EBTs). Embodiments provide patient-specific treatment protocols derived by the numerical modeling of 3D reconstructions of target tissue from images taken of the tissue, and optionally accounting for one or more of physical constraints or dynamic tissue properties. The present invention further relates to systems, methods, and devices for delivering bipolar electric pulses for irreversible electroporation exhibiting reduced or no damage to tissue typically associated with an EBT-induced excessive charge delivered to the tissue.

Abstract: A transdermal delivery device includes a film having first and second outwardly facing major surfaces; at least one liquid reservoir contained within the film; at least one microfluidic channel having a transverse dimension between about 100 nm and 0.5 mm disposed within the film and in fluid communication with the at least one liquid reservoir; and at least one outlet port associated with at least one microneedle operatively connected to the first outwardly facing major surface of the film in fluid communication with the at least one microfluidic channel.

Abstract: Methods and apparatus for the reproducible, consistent and efficacious delivery of an HBV vaccine to a subject. The disclosure comprises apparatus for the controlled administration of the HBV vaccine through an orifice to the subject, a plurality of penetrating electrodes arranged with a predetermined spatial relationship relative to the orifice, and an electrical signal generator operatively connected to the electrodes.

Abstract: Described is a device and method for administration of molecules to tissue in vivo for various medical applications, the device comprising a single hypodermic injection needle and at least two spaced elongate electrodes which provide for the ability, when the needle is inserted into tissue, such as skin or muscle, to pulse tissue with a non-uniform electric field sufficient to cause reversible poration of cells lying along or in close proximity to the track made by the needle upon its insertion into said tissue.

Abstract: Some embodiments are directed to a needle assembly including at least N injection needles where N is at least four and a multiple of two. The needle assembly also includes a first liquid port adapted to be connected to an injection device, and N second liquid ports connected to one of the N injection needles. N/2 main liquid pathways each have an entrance connected to the first liquid port and an exit, further including N/2 secondary liquid pathways that have two extremities each opening on one of the N second liquid ports, and a mid portion connected to the exit of one of the main liquid pathways. The main liquid pathways and the secondary liquid pathways define N liquid flow paths between the first liquid port and the N second liquid ports dimensioned so a pressure drop between them is similar.

Abstract: A suction/irrigation medical device valve system comprises a first valve plunger configured for insertion into a first valve plunger channel. The first valve plunger has a first latch member disposed at a distal end with a first sealing member and a first valve opening disposed proximally from the first latch member. The system also comprises a second valve plunger configured for insertion into a second valve plunger channel. The second valve plunger includes a second valve opening that is longer than the first valve opening. The system also comprises a valve body having the first and second valve plunger channels. The first and second valve plunger channels are configured to receive the first and second valve plungers, respectively.

Abstract: Embodiments of the present invention provide an electroporation system comprising an electroporation probe having at least two contiguous electrodes configured to be inserted into biological tissue for electroporation treatment, and a pulse generator electrically connected to the probe and configured to drive the electroporation probe using a sequence of one or more electric pulses to cause current transmission through the probe and induce a non-uniform electric field in the biological tissue proximate the probe electrodes. Treatment tissue can be targeted by controlling the probe configuration, carrier solution characteristics and parameters of the electroporation pulse sequence to achieve predictable electroporation outcomes. This electroporation control method can also reduce potentially toxic effects of electroporation treatment.

Abstract: Disclosed is a microneedle including at least one tip portion that is capable of penetrating the skin and includes a liquid medicine melted in the skin; a base portion supporting the at least one tip portion; and at least one guide portion that is provided between the at least one tip portion and the base portion, is made of a non-soluble material, and is protruded in a direction in which the at least one tip portion penetrates the skin to couple with the at least one tip portion. In accordance with such a configuration, the at least one tip portion may be instantly separated in a short time, whereby superior liquid medicine supplyability is exhibited.

Abstract: An ultrasonic surgical instrument is disclosed including a handle including a pivoting handle portion, an end effector configured to treat tissue, a waveguide extending to the end effector, a battery and a vibration generating system selectively operable in a plurality of energizing operating states. The plurality of energizing operating states consists of a first operating state in which a first power is supplied to the end effector and a second operating state in which a second power is supplied to the end effector. The first power is different than the second power. The vibration generating system includes a transducer selectively attachable to the handle and a switch configured to operably switch the vibration generating system between the first operating state and the second operating state. The switch is further configured to operably switch the vibration generating system between the plurality of energizing operating states and a non-energizing operating state.

Abstract: An apparatus for manufacturing a multilayer microneedle patch and a method to manufacture a multilayer microneedle patch is disclosed along with multilayer microneedle patches.

Abstract: According to the invention, there is provided a probe applicator (10) disposed for receiving flexible probes (11) that are intended for endoscopic use and can be made accessible with the probe applicator for laparoscopic use. The control of the device supplying the probes (11) occurs via control elements (32, 33) of the probe applicator (10). Preferably, the probe (11) is supplied via a connecting device (38) provided on the probe applicator (10).

Abstract: Systems and methods are disclosed herein for monitoring the status of an ambulatory medical device and the health condition of a subject that receives therapy from the ambulatory medical device. The ambulatory medical device can have a touchscreen display user interface to receive input signals from a user and display alarm conditions associated with the status of an ambulatory medical device or health condition of a subject. The disclosed methods and systems can determine whether status information received from a monitoring system interface satisfies an alarm condition for the ambulatory medicament device or for the subject. If the status information satisfies an alarm condition, the touchscreen user interface can display one or more alarm status indicators corresponding to the alarm condition. The user can activate a therapy change interface on the touchscreen display and modify a control parameter of the ambulatory medical device that controls the therapy delivery to the subject.

Abstract: The present invention relates to a treatment device and a method for controlling the same, and provides a treatment device comprising: an insertion unit formed to be insertable in tissue after penetrating through a surface of the tissue; a displacement measuring unit for measuring displacement of the surface of the tissue, caused by an insertion of the insertion unit; and a control unit for controlling an insertion motion of the insertion unit on the basis of the displacement measured by the displacement measuring unit. According to the present invention, the device allows medical treatment in a state in which the insertion unit has been inserted to reach a precise position of a target, so as to improve an effect of medical treatment.

Abstract: Disclosed is a skin treatment device, including: a support main body; a rotating part mounted on one surface of the support main body to be rotatable about a rotating shaft; a plurality of elastic parts which have one ends fixed to the support main body and inserted into the rotating part and are disposed to correspond to a rotation direction of the rotating part, and a needle holder coupled to tip ends of the elastic parts. When the rotating part rotates, the plurality of elastic parts are bent in the rotation direction so that relative positions of tip ends of the elastic parts vary.

Abstract: A surgical robotic system has a tool drive coupled to a distal end of a robotic arm that has a plurality of actuators. The tool drive has a docking interface to receive a trocar. One or more sensors in the docking interface sense a magnetic field generated by the trocar. One or more processors are configured to determine a position and orientation of the trocar based on the sensed magnetic field, and then drive the actuators to orient the docking interface to the determined orientation of the trocar, or otherwise guide the robotic arm toward the determined position of the trocar. Other aspects are also described and claimed.

Abstract: A method has been invented for intravenously inserting a tumor reduction radiation emitter into the body of a patient suffering from a cancerous tumor. The emitter is very small, yet detectable by medical imaging techniques and guidable by use of magnetism. The emitter is guided through the body by use of a magnet until it is adjacent or in in the tumor itself. The emitter can be oriented in various desired directions by the magnet. The emitter is then wirelessly powered by electrical induction, causing the radiation of a desired wavelength to be directed to tumor cells, causing tumor reduction.

Abstract: Microneedle arrays for introducing an active ingredient through a skin surface of a subject can include a base layer, a plurality of microneedles projecting from the base layer, and an active ingredient. Each of the microneedles comprises an elongate body having a proximal portion and a distal portion, in which the proximal portion is attached to the base layer. Each of the microneedles comprises at least one dissolvable polymer. The active ingredient is incorporated in the elongate body, and the active ingredient is present only in the distal portion and at least internally in the distal portion.

Abstract: An ultrasound therapy system and method is provided that provides directional, focused ultrasound to localized regions of tissue within body joints, such as spinal joints. An ultrasound emitter or transducer is delivered to a location within the body associated with the joint and heats the target region of tissue associated with the joint from the location. Such locations for ultrasound transducer placement may include for example in or around the intervertebral discs, or the bony structures such as vertebral bodies or posterior vertebral elements such as facet joints. Various modes of operation provide for selective, controlled heating at different temperature ranges to provide different intended results in the target tissue, which ranges are significantly affected by pre-stressed tissues such as in-vivo intervertebral discs. In particular, treatments above 70 degrees C., and in particular 75 degrees C.

Abstract: Systems and methods are provided for anesthetizing a tympanic membrane of an ear. The systems are personalizable to ensure proper anesthetizing solution administration. The systems and methods may also be useful for administering a solution to the ear canal of a human patient and for maintaining the solution therein.

Abstract: This invention concerns treating apparently normal tissue surrounding sites of cancerous tumors so as to reduce both the probability of a recurrence of cancer at and near the site of a cancerous tissue, and to reduce the amount of apparently healthy tissue that is usually excised along with the tumor, thereby providing a substantial benefit to the cancer patient by eliminating or delaying tumor recurrence and sparing normal tissue for its functionality and for avoiding unnecessary disfigurement.

Abstract: In one general aspect, various embodiments are directed to an ultrasonic surgical instrument that comprises a transducer configured to produce vibrations along a longitudinal axis at a predetermined frequency. In various embodiments, an ultrasonic blade extends along the longitudinal axis and is coupled to the transducer. In various embodiments, the ultrasonic blade includes a body having a proximal end and a distal end, wherein the distal end is movable relative to the longitudinal axis by the vibrations produced by the transducer.

Abstract: Embodiments of the invention include methods of tissue/wound treatment and associated devices and systems, including devices for breaching bio-films contained in and around wounds, devices for maximizing moisture vapor transmission rate, and tissue dressings with added barrier features for permeable surfaces.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a catheter shaft. An expandable balloon may be coupled to the catheter shaft. The balloon may be capable of shifting between a folded configuration and an expanded configuration. A plurality of elongate electrode assemblies may be disposed on the balloon. A cover layer may be deposited on the electrode assemblies. Portions of the electrode assemblies may be free of the cover layer.

Abstract: The devices 400, 500 include microneedles 450, 550 that may be separable from the drug delivery devices, control drug release rate and/or direction, or a combination thereof. When the microneedles are separable, a force applied to the drug delivery devices may be effective to penetrate a biological tissue with the microneedles and then to separate the microneedles from the drug delivery devices. The drug delivery devices may be capable of achieving discrete periods of drug release.

Abstract: An electroporation device for injecting a product into a ciliary muscle of an eye, said device comprising: a support having a support contact surface extending along a virtual sphere having a radius between 10 and 15 mm, so as to match the outside surface of the eye, a first electrode comprising an invasive electrode needle, a second electrode having an electrically conductive electrode contact surface, optionally an injection needle, wherein the support comprises an insertion guide configured to guide a sliding of said electrode needle and/or injection needle along a respective insertion axis, so that the angle between said insertion axis and a plane tangential to the virtual sphere at the insertion point is less than 40°, the insertion point being the point where said insertion axis crosses said virtual sphere.

Abstract: Disclosed herein are systems and methods involving the use of magnetic resonance imaging and optogenetic neural stimulation. Aspects of the disclosure include modifying a target neural cell population in a first region of a brain to express light-responsive molecules. Using a light pulse, the light-responsive molecules in the target neural cell population are stimulated. Multiple regions of the brain are scanned via magnetic resonance imaging. The scans allow for observation of a neural reaction in response to the stimulation in at least one of the multiple regions of the brain.

Abstract: A method of treating and managing diseased ocular tissue in the bulbar conjunctiva comprises providing a device comprising a plurality of microneedles arranged on a substrate contacting the device with a diseased ocular tissue region formed in the bulbar conjunctiva stroma to form a plurality of micro-injury sites therein. A device comprises a contact lens substrate comprising a substantially elliptical corneal portion and a limbus portion located radially about the corneal portion. A scleral portion is located radially about the substrate. The device is at least partially degradable and/or comprises a therapeutic compound. At least a portion of the scleral portion is configured to overlay, and deliver the therapeutic compound to a diseased ocular tissue located adjacent to the cornea of a patient.

Abstract: An apparatus includes a rigid body, a flexible sealing element, a nozzle assembly, and an electrode. The rigid body defines a channel, a reservoir, and a vent path. The reservoir is in fluid communication with the channel. The vent path is in fluid communication with the reservoir. The reservoir is configured to provide spacing between the channel and the vent path. The sealing element is positioned distal to the rigid body. The nozzle assembly includes a nozzle head and a post. The post extends distally through the channel of the rigid body. The nozzle head projects distally from a distal end of the post. The electrode is disposed within the channel of the rigid body. The reservoir extends laterally from a longitudinal axis defined by the electrode.

Abstract: Systems and methods for delivering to and/or receiving fluids or other materials, such as blood or interstitial fluid, from subjects, e.g., from the skin. Beading disruptors and/or capillaries may be used for facilitating the transport of fluids from a subject into a device. Beading disruptors may disrupt the “pooling” of bodily fluids such as blood on the surface of the skin and help influence flow in a desired way. A capillary may conduct flow of fluid in the device, e.g., to an inlet of a channel or other flow path that leads to a storage chamber. A vacuum (reduced pressure relative to ambient) may be used to receive fluid into the device, e.g., by using relatively low pressure to draw fluid into the inlet of a channel leading to a storage chamber. The vacuum source may be part of the device and have a volume that is larger than a recess of the fluid transporter that receives fluid from a surface.

Abstract: A port-a-cath needle adapted for determining the position of the needle prior to dispensing medical treatments is disclosed. Disclosed embodiments of the port-a-cath needle comprises a cannula, a hollow needle, and an inflatable balloon. The balloon is disposed at the distal end of the port-a-cath needle such that when the needle is inserted into a patient, the balloon may be inflated and the resistance pressure used to determine if the needle is inserted into the port chamber or a port-a-cath device or is surrounded by soft tissue. In certain embodiments, the balloon may be maintained in the inflated configuration in order to help retain the port-a-cath needle within the port chamber while treatment is delivered to the patient.

Abstract: An apparatus includes a body, a needle, a catheter, and an actuator assembly. The needle extends distally from the body. The needle has an inner wall defining a needle lumen. The needle lumen is in fluid communication with a fluid port of the body. The catheter is slidably disposed in the needle lumen. The catheter has a catheter lumen. The first actuator assembly is configured to translate the catheter within and relative to the needle. The apparatus may also include an actuator assembly that is configured to rotate the needle relative to the body. The apparatus may be used to first deliver a leading bleb of fluid to the subretinal space in a patient's eye via the needle. The apparatus may then be used to deliver a therapeutic agent to the subretinal space in the patient's eye via the catheter.

Abstract: The present disclosure provides devices and uses thereof. A devices disclosed herein comprises a plurality of microneedles adapted to protrude from the device. In some embodiments, a device is dimensioned and constructed to carry a payload, so that the payload can be delivered to an internal tissue of a subject or through a wall of a vessel after interaction with microneedles. In some embodiments, devices can be used for oral or intravenous administration. In some embodiments, devices can be used for implantation such as vaginal, rectal, urethral or bladder suppository or pessary.

Abstract: Disclosed are compositions, devices, systems, kits, and methods for neural ablation.

Abstract: Retrieval of material from vessel lumens can be improved by electrically enhancing attachment of the material to the removal device. The removal device can have a core assembly that includes a hypotube coupled to a first electrical terminal and a pushwire coupled to a second electrical terminal, the pushwire extending through the hypotube lumen. An insulating layer separates the hypotube and the pushwire, and an interventional element is coupled to a distal end of the pushwire. The interventional element can be disposed adjacent to a thrombus. An electrical signal is delivered to the interventional element to promote adhesion of the thrombus to the interventional element. The electrical signal can optionally be a periodic waveform, and the total energy delivered can be between 0.75-24,000 mJ and the peak current delivered via the electrical signal can be between 0.5-5 mA.

Abstract: A microneedle includes a substrate, and projections which extend from a surface of the substrate. Each of the projections includes layers separated from each other in a direction in which the projection extends. The layers include a first layer which contains a polymer which is soluble in water and poorly soluble in oil and a second layer which contains a polymer that is soluble in oil. The first layer and the second layer are adjacent to each other and are formed in the order of the first layer and the second layer from the projection to the substrate.

Abstract: Tissue may be cut and extracted from an interior location in a patient's body using a probe or tool which both effects cutting and causes vaporization of a liquid or other fluid to propel the cut tissue through an extraction lumen of the cutting device. The cutting may be achieved using an electrosurgical electrode assembly, including a first electrode on a cutting member and a second electrode within a cutting probe or tool. Thus, over a first cutting portion, radio frequency current may help cut the tissue and over a second or over transition region, the RF current may initiate vaporization of the fluid or other liquid to propel the tissue from the cutting device.