Abstract: The disclosure is directed to a device for electroporating and delivering one or more antigens and a method of electroporating and delivering one or more antigens to cells of epidermal tissues using the device. The device comprises a housing, a plurality of electrode arrays projecting from the housing, each electrode array including at least one electrode, a pulse generator electrically coupled to the electrodes, a programmable microcontroller electrically coupled to the pulse generator, and an electrical power source coupled to the pulse generator and the microcontroller. The electrode arrays define spatially separate sites.

Abstract: Microarray applicator (10000) including a microarray carrier (8000), which is retained within a housing (2000) by virtue of microarray carrier (8100) being engaged withholder (2400). Microarray patch (8200) and flexible backing (8220) are positioned such that the central portion (8210) has microneedles (8211) protrude in the direction opposite from the bottom (7200) of plunger (7000). Plunger (7000) is in a first position, having first notch (7310) engaged with ridge (2320). After activation, wherein plunger (7000) is in a second position such that second notch (7320) is engaged with ridge (2320). Here, bottom (7200) of plunger (7000) extends below first major surface (2100) of housing (2000) and has ejected microarray patch (8200).

Abstract: Disclosed herein are embodiments of a conductive polymer doped with silica nanoparticles. In several embodiments, a coated electrode comprising a coating of the conductive polymer on a conductive surface of the electrode is provided. In some embodiments, the silica nanoparticles of the conductive polymer are mesoporous and are loaded with a pharmaceutical agent. Methods of using the conductive polymer doped with silica nanoparticles are also provided, including methods of recording or stimulating a bioelectric signal and methods of administering a pharmaceutical agent to a subject.

Abstract: According to one embodiment, a guidance system is described for assisting in an advancement of a medical component within a body of a patient. The guidance system features a probe and a console. The console is communicatively coupled to the probe and features AI-based visualization controls and AI-based guidance assistance logic. The AI-based visualization controls are configured to generate, position, and reposition a visualization area between the medical component and a targeted vasculature of the patient. The visualization area is a sub-region of a total imaging area rendered by the console. The AI-based guidance assistance logic is configured to monitor for a presence of the medical component within the visualization area, provide a feedback for generating a notification that the medical component is within the visualization area, and apply an imaging enhancement to at least a portion of imaged data within the visualization area to assist in the advancement.

Abstract: Structures for treating tissue with high-frequency energy, methods of making a structure for treating tissue with high-frequency energy, and methods of treating tissue with high-frequency energy. A structure for use in treating tissue may include multiple microblades composed of an electrical conductor. Each of the microblades may include a shaft and a tip arranged adjacent to an end of the shaft. The tip includes multiple surfaces that surround a solid core of the tip and at least two of the surfaces may taper toward the end of the shaft.

Abstract: The disclosed embodiments are directed to a wearable automatic drug delivery device configured to provide basal-only dosing of insulin. In a primary embodiment, the wearable drug delivery device is configured to provide automatic operation and provides audible alerts and visual status indicators to the patient. In other embodiments, the patient may have some degree of control over the operation of the device by providing tapping gestures on housing of the device. In yet another embodiment, the patient may provide input and receive status from the device via an application executing on a portable computing device in wireless communication with the wearable drug delivery device.

Abstract: The present invention is directed to compositions and methods targeting tissue resident cells, such as fibroblasts, in a subject harboring conditions or at risk for conditions that would benefit from anti-fibroblastic therapy. The present invention relates to the use of fluorochemical compositions and methods of delivery that result in retention of the fluorochemical composition and any bioactive agent delivered in combination with the fluorochemical composition.

Abstract: A sensor device, such as a biosensor, may comprise a polymer substrate, which is structured so as to form sets of microneedles and respective vias. The microneedles extend, each, from a base surface of the substrate. Each of the vias extends through a thickness of the substrate, thereby forming a corresponding set of apertures on the base surface. Each of the apertures is adjacent to a respective one of the microneedles. The device further may comprise two or more electrodes, these including a sensing electrode and a reference electrode. Each electrode may comprise an electrically conductive material layer that coats a region of the substrate, so as to coat at least some of the microneedles and neighboring portions of said base surface. Related devices, apparatuses, and methods of fabrication and use of such devices may be provided.

Abstract: An apparatus for reducing ventilation induced diaphragm disuse in a patient receiving ventilation support from a mechanical ventilator (MV), including: an electrode array of first and second types and comprising a plurality of electrodes configured to stimulate a phrenic nerve of the patient; and at least one controller configured to: identify a type of electrode array from at least two different types, generate a stimulus signal for stimulating a phrenic nerve of the patient based upon the identity of the electrode type.

Abstract: An injector is disclosed for injecting an injectable substance into at least one of the epidermal tissue and the dermal tissue of a subject. The injector includes an outer housing and a control member disposed within the outer housing. A needle head, which is configured to support a plurality of needles, is operatively coupled to the control member. First means are provided in communication with the control member and are configured to be driven by the control member for converting a movement of the control member into a movement of the needle head along an injection direction and toward an injecting position of the needle head. Second means are configured to move the needle head in a direction having a component that is normal to the injection direction and absent movement of the outer housing relative to the skin of the subject.

Abstract: A jet injection and electroporation device for use with an agent cartridge defining a volume containing a pre-measured dose of agent therein, the electroporation device including a housing having an axis extend therethrough, a nozzle at least partially positioned within the housing, and a cavity sized to receive at least a portion of the agent cartridge therein. The device also includes an array having a plurality of electrodes extending therefrom, a propulsion cartridge configured to operatively engage the cartridge when the agent cartridge is positioned within the cavity; and a power supply in electrical communication with the array.

Abstract: Provided are a micro-needle patch and a manufacturing method thereof. The micro-needle patch includes: a support on one surface of which grooves are formed; a gel membrane for delivery of a transmitter to be transferred in which the grooves are filled with a mixture of the transmitter with a biodradable resin, the mixture being in a gel phase; a plurality of micro-needles projected on the other surface of the support and for penetrating the skin; a first protective film that covers the gel membrane and is adhered on the support; and a second protective film that covers the plurality of micro-needles and is adhered on the other surface, wherein passages are formed by being penetrated from the support to each of the plurality of micro-needles or formed by penetrating the support between the plurality of micro-needles, so that the transmitter of the gel membrane is transferred to the skin.

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: 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: 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: 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.