Abstract: Devices and methods to treat atrial fibrillation via inhibition of nerves which innervate the pulmonary vein are provided.

Abstract: A delivery catheter for delivery, then photo-activation of photo sensitive material has a photo-sensitive substance-delivery part and an activation part. The catheter delivers substances such as biomaterials to a target site, followed by illumination of the target using optics located at the distal tip of the catheter which are optically coupled to an extracorporeal light source. In another aspect a deployable light-delivery catheter is disclosed that can illuminate a large area of tissue.

Abstract: An irrigation ablation probe comprises a generally rigid probe body and a handle mounted to the proximal end of the probe body. The generally rigid probe body comprises an ablation electrode at its distal end having at least one irrigation opening through which fluid can pass. An infusion tube extends through the probe body for introducing fluid into the ablation electrode. The irrigation ablation probe is useful for treating atrial fibrillation during open heart surgery.

Abstract: Methods and systems for delivering toxin and toxin fragments to a patient's nasal cavity provide for both release of the toxin and delivery of energy which selectively porates target cells to enhance uptake of the toxin. The use of energy-mediated delivery is particularly advantageous with light chain fragment toxins which lack cell binding capacity.

Abstract: A subcutaneous drain, preferably for implantation into the skull of a patient comprises a basically hollow cap and a stem with an inside, central passageway passing from top of the cap through the stem. A lumen is provided through at least a portion of the inside, central passageway with the lumen preferably exiting the cap through a side slit in the cap and stem. The lumen is provided with a supporting ledge to reduce kinkage and promote an unimpeded fluid path. The side slit is resilient to allow for the selective removal of the lumen. The cap and stem are, as mentioned, substantially hollow and defines a chamber in communication with the subdural space, so that with the device in place, a physician can use a hypodermic needle to gain access to fluid in the subdural space by piercing the needle tip of the hypodermic syringe or needle through the thin wall of the cap of the device. A circumferential flange is provided to facilitate location of the device. Also, the stem is slightly inwardly tapered.

Abstract: Electromotive delivery of macromolecules can be provided using a delivery device including a first chamber for contacting a macromolecule delivery medium to a surface of a tissue or other anatomy of a patient; and a second chamber for contacting a receiving medium to the patient. A first electrode can be disposed in the first chamber so as to not directly contact the macromolecule delivery medium. A second medium having a buffering agent can be used to keep the first electrode from coming into direct contact with the macromolecule delivery medium. A second electrode can be disposed within the receiving medium in the second chamber such that the second electrode does not directly contact the patient. An electric field can be generated using the first and second electrodes in order to cause the macromolecule delivery medium to move into the tissue of interest from the first chamber of the delivery device.

Abstract: A method of generating bone or connective tissue in a subject in need thereof, the method comprising: (a) implanting a scaffold in a damaged region of the subject, the scaffold comprising a tissue growth promoting agent; and (b) enhancing uptake of the tissue growth promoting agent into cells located on the scaffold, wherein the enhancing is effected by induced poration of the cells thereby generating bone or connective tissue in the subject. Kits for generating bone or connective tissue are also provided.

Abstract: Apparatus for the delivery of an electrical field which facilitates the intracellular delivery of a therapeutic agent to a predetermined site within the tissue of a patient. The apparatus will comprise a plurality of penetrating electrodes arranged in a predetermined spatial relationship, each electrode with a cross sectional area contributing to the total cross sectional area of all electrodes, and structural means incorporating an inanimate source of energy operatively connected to the plurality of electrodes for deploying the electrodes, wherein the source of energy is sufficient to impart a force of at least 1000 pounds per square inch (0.7 kilogram per square millimeter) of total cross sectional area of all electrodes at the initiation of the deployment of the electrodes. The apparatus will also comprise means for generating an electrical field which facilitates the intracellular delivery of a therapeutic agent, which means is operatively connected to said electrodes at least in their deployed state.

Abstract: A system comprising: a hollow tube having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end; at least a portion of the tube comprising a porous membrane; and a gas-rich perfluorocarbon solution incorporated in the porous membrane; wherein the porous membrane has a porosity in the range of 0.001-200 microns, in order that: (i) the gas-rich perfluorocarbon solution is effectively incorporated into the porous membrane; and (ii) when the porous membrane is positioned in blood, the gas-rich perfluorocarbon solution elutes out of the porous membrane, in aggregations small enough to prevent the creation of embolisms in the blood, with the elution of the gas-rich perfluorocarbon solution into the blood varying between minutes and several hours, depending on the temperature and the hemodynamics of the blood.

Abstract: A hub (14) for a triple lumen catheter (12) especially for use with a catheter assembly (10) such as for hemodialysis. The hub (14) has a body (40) with one distal opening (58) for insertion thereinto of a proximal end portion (26) of the catheter (12), and three proximal openings (52,54,56) for insertion thereinto of distal end portions (74,76,78) of three extension tubes (16,18,20) each associated with one of the catheter's three lumens (30,32,34). The hub provides three passageways (68,70,72) extending from respective proximal openings to respective interior openings (60,62,64) in communication with the one distal opening (58), for establishing fluid communication between each extension tube (16,18,20) and its associated catheter lumen (30,32,34). Preferably, the hub is insert molded to respective end portions of the catheter (12) and the extension tubes (16,18,20).

Abstract: The invention provides an applicator for skin treatment having one or more RF electrodes. An article is located between the electrodes, such as a roller or flexible belt containing one or more protruding pins electrically isolated from the RF electrodes. The invention also provides a system for skin treatment comprising the applicator of the invention and a control unit. The invention further provides a method of treating skin disorders in which a section of the skin is heated while, essentially simultaneously, piercing one or more holes in the heated section of the skin. The method of the invention may be used, for example, in collagen remodeling.

Abstract: An anesthetic nerve block catheter and methods of using the anesthetic nerve block catheter to perform a nerve block or continuous nerve block procedure are disclosed.

Abstract: Catheter systems include direction-sensitive, multi-polar tip electrode assemblies for electroporation-mediated therapy, electroporation-induced primary necrosis therapy and electric field-induced apoptosis therapy, including configurations for producing narrow, linear lesions as well as distributed, wide area lesions. A monitoring system for electroporation therapy includes a mechanism for delivering electrochromic dyes to a tissue site as well as a fiber optic arrangement to optically monitor the progress of the therapy as well as to confirm success post-therapy. A fiber optic temperature sensing electrode catheter includes a tip electrode having a cavity whose inner surface is impregnated or coated with thermochromic/thermotropic material that changes color with changes in temperature. An optic fiber/detector arrangement monitors the thermochromic or thermotropic materials, acquiring a light signal and generating an output signal indicative of the spectrum of the light signal.

Abstract: A vascular access device having a fluid chamber in which UV-C radiation is emitted to irradiate pathogens contained in an infusate flowing though the fluid chamber.

Abstract: An implantable cardiac therapeutic device having at least one implantable sensor arranged to sense at least one physiologic characteristic of a patient, an implantable therapeutic agent delivery assembly wherein the delivery assembly and a therapeutic agent to be delivered are configured for placement in a patient's pericardial space, and a controller in communication with the at least one implantable sensor and with the therapeutic agent delivery assembly wherein the controller evaluates the at least one physiologic characteristic for indications of a condition indicating administration of the therapeutic agent and wherein, upon detection of such indications, induces the therapeutic agent delivery assembly to deliver the agent.

Abstract: The invention relates to a medical device for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent and an additive. In certain embodiments, the additive has a hydrophilic part and a drug affinity part, wherein the drug affinity part is at least one of a hydrophobic part, a part that has an affinity to the therapeutic agent by hydrogen bonding, and a part that has an affinity to the therapeutic agent by van der Waals interactions. In embodiments, the additive is water-soluble. In further embodiments, the additive is at least one of a surfactant and a chemical compound, and the chemical compound has a molecular weight of from 80 to 750 or has more than four hydroxyl groups.

Abstract: Methods and apparatus are provided for applying an fragment of a neurotoxin such as the active light chain (LC) of the botulinum toxin (BoNT), such as one of the serotype A, B, C, D, E, F or G botulinum toxins, via permeabilization of targeted cell membranes to enable translocation of the botulinum neurotoxin light chain (BoNT-LC) molecule across the targeted cell membrane to the cell cytosol where a therapeutic response is produced in a mammalian system. The methods and apparatus include use of catheter based delivery systems, non-invasive delivery systems, and transdermal delivery systems.

Abstract: Method and apparatus for the reproducible, consistent and efficacious delivery of a therapeutic agent to a patient. The invention comprises means for the controlled administration of the therapeutic agent (30) through an orifice to the patient, a plurality of penetrating electrodes (56) arranged with a predetermined spatial relationship relative to the orifice (14), and means for generating an electrical signal operatively connected to the electrodes.

Abstract: A device for use in a removing fluids and debris from a surgical wound and for location of nerves adjacent to the surgical wound comprises a hollow electrically conductive tube which has a lumen extending from the distal end thereof to the proximal end thereof. Openings are located at the distal end of the tube for suction removal of the fluid and debris. A handle located at the proximal end of the tube is provided for attachment of a second tube which is connected to a vacuum source. Also extending from or located within the handle is attachment means for connecting the conductive tube to an electrical nerve stimulation module. An electrically conductive ball is attached at the distal end of the conductive tube and distal to the openings in the tube. The openings are sized so that at least one dimension thereof is less then the diameter of the lumen to prevent the lumen from becoming clogged with debris having a size greater then the diameter of the lumen which is removed from the surgical wound.

Abstract: A robotic catheter system includes a controller including a master input device and instrument driver in communication with the controller. An elongate flexible guide instrument is operatively coupled to the instrument driver. A fluid injection needle may be advanced from, or retracted into, a distal portion of the guide instrument.

Abstract: A device for assisting recovery from dysphagia, and a method of preventing and/or treating dysphagia. The device includes a catheter suitable for insertion into the body of a patient, for the introduction of nutrients to the stomach of said patient, and electrodes located on a surface of the catheter, the electrodes being positioned such that when the catheter is inserted into a patient the electrodes are in a suitable position for applying electrical pharyngeal stimulation.

Abstract: The perivascular leak repair system, and method of using the same, of the present invention provides a sealant reservoir 102 with a repair catheter 104 operably attached; a flow control device 106 disposed between the sealant reservoir 102 and the repair catheter 104, and the flow control device 106 responsive to a flow control signal 108; a heart phase detector 114 generating a diastole phase signal 112; an injection switch 122 generating a injection signal 120; and a flow controller 110 responsive to the diastole phase signal 112 and the injection signal 120, and generating the flow control signal 108. A method of sealing a perivascular leak comprises identifying the perivascular leak 140; inserting a repair catheter to the perivascular leak 142; injecting sealant at the perivascular leak 144; and removing the repair catheter 146. The sealant can be injected when the heart is in diastole to sweep the sealant into the perivascular leak.

Abstract: The present disclosure relates to devices, systems, and methods associated with a catheter device for delivering energy to a vein. One or more catheter devices include a cooling device, an infusion device, and an energy delivery device for delivering energy to a vein to treat incompetent valves.

Abstract: The present invention relates to the field of optical imaging and therapeutics. More particularly, embodiments of the present invention provide minimally-invasive Fiberoptic Microneedle Devices (FMDs) for light-based therapeutics, which physically penetrate tissue and deliver light directly into the target area below the skin surface (FIG. 1). A preferred embodiment of the invention is a fiberoptic microneedle device comprising: (a) one or more silica-based needles capable of guiding light and comprising a length of about 0.5-6 mm, a base having an outer diameter in the range of about 100-150 micron, and a tip having an outer diameter in the range of about 5-20 micron; (b) a support member to which the needles are secured; (c) a ferrule comprising one or more holes for each of the needles, wherein the ferrule is operably configured to provide mechanical support to each needle at all or some portion of the length of the needle.

Abstract: In an apparatus for storing and administering active substances, at least one transfer mechanism is provided, and a first reservoir that contains an active substance in dissolved form is also provided, the active substance being administered by way of the transfer mechanism. A second reservoir having the active substance in solid form is additionally provided in the apparatus.

Abstract: A surgical device is provided for both ablating a channel in a patient's tissue and also delivering a therapeutic agent. The device includes an elongated multi-lumen tube, an elongated tissue ablating assembly, and a therapeutic agent delivery assembly. The therapeutic agent is capable of being delivered into the channel and/or to the surrounding tissue. The device may further include a second multi-lumen tube also capable of delivering therapeutic agents. A method is also provided for using such a surgical device to ablate a channel in a patient's tissue and also deliver a therapeutic agent to the tissue, for example, for transmyocardial revascularization or other procedures.

Abstract: An implantable drug-delivery sleeve for an elongate component of an implantable medical device. The sleeve includes a tubular substrate having a lumen configured to receive the elongate component so as to allow relative displacement of the substrate and the elongate component, wherein the substrate is shaped so as to be retained stationary at a desired position along the elongate component, and a drug releasably carried by the substrate.

Abstract: Methods, systems and other embodiments associated with administering ionotophoretic medicines are presented. A method of administering ionotophoretic medicines includes applying a voltage across a body tissue and an iontophoretic solution including medicine. At least some of the iontophoretic solution including medicine is then injected into the body tissue without requiring the iontophoretic transportation of the iontophoretic solution including medicine through the skin. The iontophoretic solution is typically injected while the voltage is applied. The voltage causes an ionic current of iontophoretic medicine to flow which disperses the medicine within the body tissue toward body tissue connected to the voltage.

Abstract: A delivery apparatus for delivering a cargo to a target site of internal body tissue is provided. The delivery apparatus comprises a flexible tubular member having a distal end adapted for insertion proximate to the target site. A first electrode is configured for insertion within the flexible tubular member such that the first electrode is capable of being disposed proximate to the target site. A second electrode is configured to cooperate with the first electrode to form an electric field. A delivery component has a cargo carried thereby and is coupled with the first electrode. The delivery component is configured to degrade when exposed to the electric field such that the cargo is released to the target site upon degradation thereof. An associated method is also provided.

Abstract: Described herein generally are catheter systems used to deliver cells and other bioactive materials to a target location within the vascular system of the human body, and methods of delivering cells and other bioactive materials to such target locations.

Abstract: A method for maintaining clear passageways in an extracorporeal blood flow system. The method comprises intermittently providing one or more anti-clotting agents to a passageway of the extracorporeal blood flow system. Also disclosed is an extracorporeal blood flow system. The system comprises a passageway, and a device operatively connected to provide one or more anti-clotting agents to a least a portion of said passageway.

Abstract: Devices for photo-dynamic therapy of a living organism's tissues comprising an optical light exposure system (I) containing at least one source of light (2) selected from a group including light sources of high power and a large range of wavelength, single LEDs, LEDs in a matrix-arrangement, halogen light sources, laser diodes and laser light sources, a suspension supply system (II) and a system (III) for simultaneous delivery and irradiation of a suspension of a photosensitizer, wherein a central control system (1) is connected to suspension supply system (II) and to a control unit (3) of at least one source of light (2) of the optical light exposure system (I) and enables a simultaneous or a separate operation of both systems (I) and (II).

Abstract: A medical device for injecting a liquid medicine into an organism. The device comprises a needle, an injection tube attached to the posterior end of the needle and a housing having a conduit at the distal end. The needle being placed inside the housing in such a way that the needle can move from a position where entire length of needle is situated within the housing and the conduit to a position where the needle is protruded out of the housing. The device allows an anesthesia provider to perform a nerve block more safely and efficiently. In one embodiment of the device, an injection pad is used to single handedly inject syringes of liquid medicine into the injection tube.

Abstract: A robotic catheter system includes a controller including a master input device and instrument driver in communication with the controller. An elongate flexible guide instrument is operatively coupled to the instrument driver. A fluid injection needle may be advanced from, or retracted into, a distal portion of the guide instrument.

Abstract: An apparatus for delivery of a substance to an anatomical region in a body can include a catheter comprising a catheter body, and one or more electrically conductive elements supported by the catheter body and in electrical communication with one or more sources of electrical stimulus. The catheter body can comprise a lumen therein, a substantially closed distal end, and an infusion section configured to permit fluid to pass through the catheter body and that can have a length that is less than or equal to the length of the catheter body. In some embodiments, the apparatus can comprise a coiled member positioned within the lumen of the catheter body. The coiled member can comprise adjacent coils and can permit the uniform flow of the substance through one or more holes formed in the catheter body.

Abstract: Systems and methods for photodynamic ablation of cardiac tissue via an esophagus are disclosed. An exemplary system includes an ablation catheter having an expandable distal end for securing the ablation catheter in the esophagus. The distal end of the ablation catheter contains at least one light source operable to activate a photodynamic substance delivered to the target area of the cardiac tissue to be ablated and form a lesion. The system also includes at least one feedback device contained in the distal end of the ablation catheter. The at least one feedback device provides feedback for at least one of: positioning a distal end of an ablation catheter in a desired position in the esophagus adjacent a target area of the cardiac tissue to be ablated, forming an adequate lesion, and assessing lesion formation.

Abstract: An intravaginal treatment device (ITD) provides therapeutic light and fluid treatments. Vision systems throughout supporting networks and devices allow for directed control of the treatment processes. The ITD uses illumination to gather various types of imager data that is used to identify and conditions, monitor the treatment process, and evaluate treatment efficacy. Specific frequency light emissions and associated fluids are used to reduce overabundant flora, at least assist in elimination of fungal, viral and bacterial invaders, and enhance the detection process. Several configurations and sizes of ITDs with light and fluid therapy, also have a built in optics assembly (camera, light sources, etc.) for capturing intravaginal still images and video of vaginal channels, cervix, cervical channels, uterus and fallopian tubes. Some ITD configurations are also wearable and include full fluid delivery infrastructure unlike some other ITDs with external components.

Abstract: Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

Abstract: A PDT treatment system designed to treat all types of human inflammatory disorders. A suitable drug delivery system is developed to target proliferating cells, at inflamed sites, populated with macrophages and other inflammatory mediators. The hydrophobic photosensitizer is loaded into the liposomal bilayer formed of synthetic phospholipids; at least one of the synthetic phospholipids is conjugated to polyethylene glycol (PEG) molecules, to prevent accumulation in the liver and spleen. Further, (PEG) formulated photosensitizer increases the circulatory half-life of the drug, enhances solubility, and modifies pharmacokinetic and pharmacodynamic properties. The formulation, thus, leads to a higher amount of delivered drug to the diseased target synovial tissue, increasing clinical effectiveness. In one embodiment, pegylated liposomes loaded with mTHPC are administered to diseased synovial joints, followed by light irradiation.

Abstract: Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

Abstract: Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

Abstract: An injection device for injecting a product into an eye, said device comprising an injection needle and a support on which the injection needle is fixed, said device being characterized in that it comprises a locating mark disposed in such a way that the latter can be placed in contact with a defined bearing region of the surface of the eye, before any contact of the injection needle with said surface, and can then be kept in contact with said bearing region during a stage of penetration of said injection needle through said surface of the eye.

Abstract: Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

Abstract: Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

Abstract: A method for enhancing an immune response in a vertebrate subject is described. The method includes providing at least one energy stimulus configured to modulate one or more nervous system components of the vertebrate subject, and administering one or more immunogen to the vertebrate subject, wherein the at least one energy stimulus and the one or more immunogen are provided in a combination and in a temporal sequence sufficient to enhance an immune response in the vertebrate subject.

Abstract: Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

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

Abstract: A high-intensity pulsed-electrical-field (HIPEF) apparatus chemically induces lysis of ocular tissue within a localized portion of an eye. Instead of broadly applying a lysis affecting solution (e.g., plasmin) to the eye, the apparatus delivers solution to only a portion of the eye. The apparatus then alters the effectiveness of at least some of the solution delivered by applying a HIPEF to that solution. In some embodiments, for example, the apparatus delivers a solution that does not substantially affect lysis of ocular tissue and then enhances the solution's effectiveness by applying a HIPEF. As the apparatus applies the HIPEF with high precision, the HIPEF only enhances the effectiveness of the solution within select and localized portions of the eye. The apparatus is especially advantageous for vitreoretinal surgery, whereby the apparatus may selectively induce lysis of vitreous tissue within a localized portion of the vitreous cavity, without significantly affecting adjacent retinal tissue.

Abstract: An electrosurgical apparatus for coagulating tissue used in combination with an endoscope which includes an elongated flexible tube having a plurality of side-ports located therethrough. The tube extends through a working channel of the endoscope and an ionizable gas is supplied to the tube at or near the proximal end of the tube. A diffusing member directs the ionizable gas from the proximal end of the tube through each of the side-ports towards the tissue. An electrode is used for ionizing the gas prior to the gas exiting the side-ports.

Abstract: A photopolymerization system includes a catheter having a proximal inflatable member, a distal inflatable member, a fluid delivery lumen, and a fluid drainage lumen. The fluid delivery lumen includes at least one delivery port and the fluid drainage lumen at least one drainage port. The ports are positioned between the proximal inflatable member and the distal inflatable member. A light emission member is positioned adjacent the catheter. In a method of treating a vascular condition, the catheter is delivered to a treatment site within a vessel. The first and second inflatable members are expanded to form an enclosed treatment space within the vessel. Fluid is delivered to the treatment space through fluid delivery lumen. Excess fluid is removed from the treatment space through the fluid drainage lumen. The treatment space is exposed to light. A portion of the fluid is polymerized within the treatment space upon exposure to the light.