Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: The invention relates to a general composite compartmental model and a compartmental analysis procedure to extract non-invasively the concentration (Cp) of the imaging agent in plasma (301), in metabolites (304, 504) and in blood elements (303) (like red cells, platelets, plasma protein etc.) from time signal curves measured within a reference tissue region (200). This is made possible by deploying an injection function (SINJ(t)) as input which models the amount of imaging agent administered to the patient as a function of time. The invention allows the presentation of the plasma input function to the medical practitioner without the need for invasively drawing blood samples.

Abstract: Systems and methods for treating a lung of a patient. One embodiment of a method comprises positioning a leadless marker in the lung of the patient relative to the target, and collecting position data of the marker. This method further comprises determining the location of the marker in an external reference frame outside of the patient based on the collected position data, and providing an objective output in the external reference frame that is responsive to movement of the marker. The objective output is provided at a frequency (i.e., periodicity) that results in a clinically acceptable tracking error. In addition, the objective output can also be provided at least substantially contemporaneously with collecting the position data used to determine the location of the marker.

Abstract: A medical connector and method of using the medical connector are provided. In one form, the medical connector includes an elongate main body having a longitudinal axis and a lumen extending axially therethrough, proximal and distal end portions of the elongate main body with the distal end portion being configured to be connected to a first tubular medical device, an auxiliary connection device having a port for being connected to a second tubular medical device, and an adjustable connection between the auxiliary connection device and the elongate main body that allows positioning of the port of the auxiliary connection device relative to the elongate main body to be adjustably selected by a user for ease in connecting the second tubular medical device to the auxiliary connection device.

Abstract: A catheter system adapted for navigating, guiding and implanting a catheter or a plurality of catheters in a spatially-defined implantation within the tissue of a patient is provided. The system can include a tissue navigation system and a probe to inform the navigation system to guide emplacement of the catheters within a target tissue. The probe can provide images, such as fiberoptic visual images, or ultrasound images, or can provide radiolocation data, to guide the catheter emplacement. The catheters supply a pressurized liquid including a bioactive agent, such as can be used in the treatment of cancer, for example 123I- or 125I-IUDR. The system and methods provided can be used in the treatment of locally advanced tumors, such as cancers of the brain, head or neck, esophagus, prostate, ovary, liver, pancreas, bladder or rectum.

Abstract: A blood vessel embolization method includes inserting a balloon catheter into a blood vessel of a human or an animal having a lesion site and disposing a balloon of the balloon catheter at a portion located at a proximal side of the blood vessel and in a neighborhood of the lesion site thereof; shutting off a blood flow in the blood vessel by expanding the balloon; discharging a glucose solution from a distal end of the balloon catheter in a state in which the blood flow in the blood vessel is shut off; discharging a cyanoacrylate-based embolization substance-containing liquid from the distal end of the balloon catheter after the glucose solution injection step; hardening an embolization substance by maintaining a blood flow shut-off state of the blood vessel after the embolization substance injection step; and removing the balloon catheter from the blood vessel after the embolization substance-hardening step.

Abstract: Catheter apparatus comprises a coaxial cable having proximal and distal ends. The cable includes a hollow center conductor, an outer conductor and an electrically insulating layer between the conductors. An antenna is at the distal end of the cable, and a diplexer is connected to the cable, the diplexer including a transmit path for connecting the antenna to a transmitter which transmits first frequency signals and a receive path for connecting the antenna to a receiver which detects second frequency signals the diplexer isolating the signals on the two paths from one another. A transmission line connects the cable to the diplexer, the transmission line having a segment with a tubular inner conductor one end of which is connected to the center conductor and a second end of which is adapted for connection to a coolant source, the center and inner conductors forming a continuous coolant pathway.

Abstract: Medical devices and methods for manufacturing and using medical devices. An example medical device includes a core member, a tubular member coupled to the core member, and a tip member coupled to the tubular member. The tubular member may have a plurality of slots formed therein. The tip member may include a polymeric material. An intermediate member may be disposed between the tubular member and the core member that aids the bonding of the tip member thereto.

Abstract: One aspect of the present disclosure relates to a tissue imaging device that includes a catheter body, a hood, and a visualization assembly. The catheter body includes a distal end portion, a proximal end portion, and at least one lumen extending between the distal and proximal end portions. The catheter body includes at least one drainage port having a first opening and at least one infusion port having a second opening. The first and second openings are located about a lateral aspect of the catheter body. The hood projects distally from the distal end portion and is configured to self-expand into an expanded deployment state that defines an open area therein. The visualization assembly is disposed within the open area and extends distally from the distal end portion of the catheter body.

Abstract: A catheter is disclosed having a flexible tubing with a proximal end and a distal end. The catheter comprising at least one movable magnet provided within the distal end of the flexible tubing. A control mechanism is operable to selectively activate the at least one movable magnet from the proximal end of the flexible tubing. The at least one movable magnet is responsive to an external magnetic field to position and guide the distal end of the flexible tubing within a body of a patient.

Abstract: A method, including constructing a simulated surface of a body cavity, and pressing a distal end of a probe against a wall of the body cavity. While pressing the distal end against the wall, position measurements are accepted from the probe indicating a position of the probe within the body cavity, and force measurements are accepted from the probe indicating a force between the distal end and the wall. A distortion in the simulated surface is created at the position indicated by the position measurements, so as to form a distorted surface, upon detecting that the force measurements exceed a predefined amount. The distorted surface is then displayed.

Abstract: An implantable lead includes a lead body having a proximal end portion and a distal end portion with a connector located at the proximal end and an electrode located at the distal end. The implantable lead further includes a coil conductor that has spiral sections wound within a lumen of the lead body and couples the lead connector to the electrode. The coil conductor has an insulation material provided on at least a segment of the coil conductor. The insulation material has a dielectric constant set such that the coil conductor forms a distributed band stop filter when exposed to a known RF magnetic field. The coil conductor comprises a filar wound into the spiral sections. The filar of the coil conductor has an insulation coating provided thereon with the insulation coating forming a dielectric layer between adjacent spiral sections of the filar.

Abstract: The invention features catheters, hydrogel compositions, and methods that useful for the treatment of various conditions and diseases. The invention also provides kits and instructions for use.

Abstract: The invention relates to an ultrasound catheter comprising a device arranged in the area of the catheter tip for ultra-sound image recording, with at least one lumen routed into the area of the catheter tip open at this end and ending adjacent to the ultrasound image recording device for issuing an ultrasound contrast means being provided.

Abstract: The present invention is generally directed towards an imaging transducer assembly. Generally, the imaging transducer assembly is combined with a sensor of a medical positioning system. In one aspect, the transducer assembly and the sensor share the same voltage source. In another aspect of the invention, the sensor surrounds a portion of the imaging transducer assembly, forming a housing that reinforces the assembly.

Abstract: Sympathetic nerves run through the adventitia surrounding renal arteries and are critical in the modulation of systemic hypertension. Hyperactivity of these nerves can cause renal hypertension, a disease prevalent in 30-40% of the adult population. Hypertension can be treated with neuromodulating agents (such as angiotensin converting enzyme inhibitors, angiotensin II inhibitors, or aldosterone receptor blockers), but requires adherence to strict regimens and often does not reach target blood pressure threshold to reduce risk of major cardiovascular events. A minimally invasive solution is presented here to reduce the activity of the sympathetic nerves surrounding the renal artery by locally delivering neurotoxic or sympathetic nerve-blocking agents into the adventitia. Extended elution of these agents may also be accomplished in order to tailor the therapy to the patient.

Abstract: The invention relates to a coated medical device for rapid delivery of a therapeutic agent to a tissue in seconds to minutes. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent, a contrast agent, and an additive.

Abstract: A balloon catheter for delivering a therapeutic and/or diagnostic agent to tissue is described including an outer balloon having a wall with an opening therethrough and an inner surface, an inner balloon disposed in the outer balloon, enclosing an inflation chamber and having an outer surface defining a space between the outer surface of the inner balloon and the inner surface of the outer balloon, a catheter having a first lumen in fluid communication with the space between the inner balloon and the outer balloon for supplying the agent thereto, and a second lumen through which fluid is supplied to the inflation chamber for inflating the inner balloon to urge the agent out of the opening in the outer balloon, wherein the outer balloon and/or the inner balloon comprise at least one protrusion for directing the agent formed by an inner balloon wall and/or the outer balloon wall.

Abstract: A hybrid microguide catheter and method for making and using the same. The catheter may include a first tubular member and a second tubular member. The tubular members may be arranged so that the second tubular member extends distally beyond the first tubular member. Alternatively, the catheter may include a tubular body having a first opening and a second opening. The first opening may be positioned along the tubular body a distance from the second opening.

Abstract: Dual chamber, conforming, irradiation balloons with independent filling means can be filled with water or air in either chamber and allow fine control over dosimetry.

Abstract: A method of puncturing an interatrial septum between a right atrium and a left atrium may include introducing a distal end of a catheter endoluminally into the right atrium. The method also may include introducing a distal end of a cannula into the right atrium. The cannula may include a proximal first segment and a distal second segment. The distal second segment may be deflectable away from a linear configuration relative to the proximal first segment. A needle tip may be provided at a distal end of the distal second segment. At least a portion of the cannula may be received within a lumen of the catheter. The method also may include deflecting the distal second segment in the right atrium to a deflected configuration by actuating a mechanism at a proximal end of the cannula to align the needle tip with a target point on the interatrial septum.

Abstract: The present invention relates to a balloon catheter system for draining and/or supplying fluid from/into hollow organs, body cavities or cysts, comprising a conduit catheter with an open distal end, a hollow needle guided in a separate guide conduit and a balloon surrounding the catheter stem at the distal end of the conduit catheter. The conduit catheter with the hollow needle can be inserted from outside into the hollow organ via a guide catheter, into the body cavity or cyst, the balloon can be filled with filling medium via the hollow needle through an opening formed in the guided duct and provided in the lumen of the balloon, and it can be fixed in the hollow organ, body cavity or cyst. The hollow needle can be removed from the guide duct after filling the balloon. The balloon and the conduit catheter remain in the hollow organ, body cavity or cyst.

Abstract: A catheterization device that may be designed by use of an adaptive genetic algorithm computational fluid dynamics approach, as well as other Global Optimization methods that may include simulated annealing, multistart and interval methods, continuous branch and bound methods, evolutionary algorithms, and tabu search and scatter search methods, as well as other available Global Optimization methods that is able to maximize/optimize the dwell time of an infused agent in the vicinity of a vascular lesion. The device may have an internal by-pass channel that allows the blood upstream of the lesion to continue its pulsatile flow through the vessel in the part of it occluded by the lesion, while simultaneously allowing the disbursement and maximal dwell time of an antithrombolytic or other diagnostic or therapeutic agent needed to treat the lesion.

Abstract: A method and apparatus for introducing a cardiac lead to an implantation site that includes a catheter body having an outer wall and a distal leader and having a proximal portion extending from the first proximal end to a second distal end. An inner member is positioned within an outer lumen of the catheter body and is spaced from the outer wall to form a first inner lumen for receiving a guide tool inserted therein and a second lumen for receiving the cardiac lead while the guide tool is positioned within the first inner lumen. A distal end of the inner member forms a first opening at a distal end of the first inner lumen and a second opening at a distal end of the second inner lumen, the first opening and the second opening positioned proximal the distal leader.

Abstract: A balloon catheter assembly (10) includes a balloon (20) at a distal end (18) of a balloon catheter (14). The balloon (20) is inflated with a fluid (44) which has suspended therein a plurality of particles (46) which may be microcapsules or pellets. The particles (46) are echogenic and/or radiopaque, in the preferred embodiment to provide Rayleigh scattering of ultrasonic waves directed to the balloon (20). The balloon (20) thus becomes visible under ultrasonic imaging and by use of an inflation fluid (44) which can be of low viscosity and low toxicity.

Abstract: A laboratory specimen sealed within a chamber on an animal holder may be injected or otherwise administered material such as drugs and radioactive imagining materials from the ambient, or outside the chamber, through a sealed catheter assembly. The animal holder can be mounted on imaging machines such as MRI, X-ray, PET, CT and like imaging machines. Biologically contaminated animals are isolated within the chamber from the ambient, yet may be injected from outside the chamber thereby protecting lab technicians from contamination and isolating the animal from additional contamination from an ambient environment, such as an imaging laboratory.

Abstract: A device for inserting a catheter into a blood vessel that uses fluid flow to aid the insertion of the catheter into a patient is described herein. The device includes a catheter retention device that houses a catheter and is configured to attach to an angiocatheter or other blood vessel access device. The catheter retention device receives fluid and guides the catheter into the blood vessel using the flow of fluid to carry the catheter into the blood vessel.

Abstract: Apparatus for driving current in a power circuit of a medical device inserted into a body of a subject includes a power transmitter, which is adapted to generate, in a vicinity of the body, an electromagnetic field having a predetermined frequency capable of inductively driving the current in the power circuit. A passive energy transfer amplifier, having a resonant response at the frequency of the electromagnetic field is placed in proximity to the medical device so as to enhance the current driven in the power circuit by the electromagnetic field.

Abstract: The present invention relates to a measuring device including a sensor catheter, an evaluation unit, and means for receiving a magnetic field and converting the magnetic field to an electrical measurement signal which are situated in the sensor catheter and connected to the evaluation unit. The evaluation unit is designed to evaluate the electrical measurement signal.

Abstract: Described herein is an apparatus that includes an endotracheal tube or airway device having a proximal end and a distal end and an occlusion cuff. The occlusion cuff includes a sensor for helping determine proper endotracheal or airway device placement.

Abstract: A medical device including, e.g., an implantable medical lead or drug pump catheter, a guide member, or a sheath is delivered to a target location within a patient via a catheter capable of subselecting vessels or other cavities, passages, or the like within the patient's body. The catheter employs an inflatable member that, when actuated, acts to deflect a medical device to direct the device into a vessel or other cavity, passage, or the like branching off of, e.g., a vessel in which the catheter is arranged. In some examples, the inflatable member acts to deflect the delivery catheter, which in turn necessarily deflects the implantable medical device arranged therein. In other examples, the inflatable member acts to deflect the medical device to turn the device into a vessel or other cavity, passage, or the like branching off of the vessel in which the catheter is arranged.

Abstract: A medical device comprises a cannula for insertion to a target location in a body and at least one resonator situated on a surface of the cannula. The resonator resonates in response to an ultrasonic frequency applied to the target location to indicate the location of the cannula in the body. The ultrasonic frequency is generated by a transducer located external to the body. The medical device also comprises a device converting resonated frequencies into an image.

Abstract: A method and device for delineating structures includes a catheter for insertion at the structure, an expandable component operatively having proximal, distal and intermediate segments shiftable between a collapsed state and an expanded state, with the intermediate segment shiftable independently of the proximal and distal segments. A marking medium is carried by a portion of the intermediate segment, and the marking medium detectable using a selected imaging device. The marking medium is arranged to be transferable from the intermediate segment to portions of the cardiovascular structure upon shifting the intermediate segment to the expanded position with the intermediate segment in the desired position.

Abstract: A balloon catheter is provided with three lumens. The first lumen may be used as a guide wire lumen. The second lumen may be used as an inflation lumen. The third lumen may be used to provide various treatments to a vessel. Methods of using the balloon catheter to treat a patient are also provided.

Abstract: An obturator with an elongated shaft, a proximal end, a substantially closed distal end and a MRI detectable distal shaft portion, which does not interfere with magnetic resonance imaging of tissue proximate thereto. Preferably, the distal shaft portion has an effective MRI detectable mass so as to provide a clear, T1-weighted image within an outline of the distal shaft portion upon magnetic resonance imaging.

Abstract: A method of medical imaging includes creating an anatomical map of an inner wall of a cavity in a body of a subject by inserting a probe into the body and collecting data using the probe. A three dimensional (3-D) contour is delineated in a 3-D image of the cavity based on the map.

Abstract: A system to minimize fluid turbulence inside a tissue cavity during endoscopic procedures. A body tissue cavity of a subject is distended by continuous flow irrigation using a solenoid operated pump on the inflow side and a positive displacement pump, such as a peristaltic pump, on the outflow side, such that the amplitude of the pressure pulsations created by the outflow positive displacement pump inside the said tissue cavity is substantially dampened to almost negligible levels. The present invention also provides a method for accurately determining the rate of fluid loss into the subject's body system during any endoscopic procedure without utilizing any deficit weight or fluid volume calculation, the same being accomplished by using two fluid flow rate sensors. The present invention also provides a system of creating and maintaining any desired pressure in a body tissue cavity for any desired cavity outflow rate.

Abstract: Closed loop heat exchange catheter systems and methods for preparing and using such systems wherein a reservoir or fluid bag is connected to the catheter system and used for at least priming of the system with a heat exchange fluid.

Abstract: Apparatus for use in deploying medical devices. The apparatus includes a wire having a diameter such that the wire can appropriately be used with either a corresponding over-the-wire configured catheter or a rapid-exchange configured catheter. The wire has a location at which it can be easily fractured, when desired, in order to convert the length of the wire from a length for use in an over-the-wire configuration to a rapid-exchange configuration.

Abstract: The invention provides a balloon catheter formed with a plurality of depressions. The balloon is coated with a matrix incorporating a therapeutic substance, which fills the depressions. When the balloon is expanded within a body lumen, the therapeutic substance may diffuse into the lumen wall, or all or a portion of the coating transfers to the lumen wall. A lattice frame may surround the balloon, applied prior to coating if the coating is to transfer, operative to maintain a more linear balloon profile during inflation, promoting more even transfer pressure. A contrast dye is incorporated into the transferred coating, enabling ready location and inspection of the treated lumen area.

Abstract: A first catheter is dimensioned for deployment within a renal artery. A second catheter has a shaft with an outer diameter smaller than an inner diameter of the first catheter's open lumen. A gap is formed between the shaft and the first catheter when the second catheter is situated within the first catheter. The gap facilitates transport of a fluid, such as imaging contrast media, along the first catheter. An electrode arrangement at the distal end of the shaft is configured to deliver ablative energy to perivascular renal nerves, and has an outer diameter about the same size as the inner diameter of the first catheter such that a fit therebetween substantially blocks fluid flow within the gap yet provides for relative movement between the electrode arrangement and the luminal wall. A conductor extends between the proximal and distal ends of the shaft and is coupled to electrode arrangement.

Abstract: A balloon catheter with delivery probe and method of use for delivering a therapeutic agent and/or diagnostic agent to tissue is provided. The catheter has a balloon, a first lumen and a probe movably disposed in the first lumen of said catheter. The probe has a lumen for delivering a diagnostic and/or therapeutic agent to tissue. The catheter has a third lumen through which fluid is supplied to the balloon. The catheter with delivery probe may be inserted into a bodily cavity such that the distal end of the probe extends out of an opening in the catheter. When the balloon is inflated the probe is captured between an outer wall of the balloon and the tissue so that therapeutic and/or diagnostic agent may be delivered to the tissue through the probe lumen via the distal end of the probe.

Abstract: There is provided a microcatheter having a proximal solution lumen and a distal tip portion with a guidewire lumen. The microcatheter and methods of use thereof allows for introduction of solution into a vessel while manipulating the guidewire and/or the microcatheter itself. The solution may be a contrast solution, for viewing of the vessel, a therapeutic or diagnostic solution, or any other type of solution.

Abstract: A method of dilating a paranasal sinus ostium of a patient, which includes inserting a catheter having at least one balloon into a sinus ostium having an ostial wall, inflating the balloon by supplying fluid thereto such that the balloon exerts a force on the ostial wall, determining at least one parameter of the balloon, establishing an amount the balloon can be inflated without fracturing the sinus ostium based at least in part on the determined parameter of the balloon, and dilating the sinus ostium by inflating the balloon to an amount that does not exceed the established amount.

Abstract: A method and apparatus for delivering a therapeutic and/or diagnostic agent to tissue within a bodily cavity is provided herein. The apparatus may include a catheter assembly including a catheter and a delivery balloon having an expandable material disposed thereon, wherein the expandable material may be an absorbent at least partially charged with a therapeutic and/or diagnostic agent. The method may include the step of delivering a therapeutic and/or diagnostic agent to tissue by inflating the delivery balloon by supplying fluid thereto until the expandable material adopts an expanded state in which the expandable material contacts the tissue and is implanted in a bodily cavity.

Abstract: An adjustable balloon catheter for extravasated drug delivery is disclosed generally including an outer catheter with a first balloon and an inner catheter with a second balloon. The inner catheter is moveably disposed in a lumen of the outer catheter such that the inner catheter moves relative to the outer catheter, changing the distance between the balloons. A fluid source supplies air to the catheters via lumens therein to inflate the balloons to create a chamber between them, and at least one of the catheters has a lumen for delivering a therapeutic and/or diagnostic agent to the chamber. The inner catheter is then moved relative to the outer catheter to decrease the size of the chamber between the balloons and decrease the fluid pressure therein such that the therapeutic and/or diagnostic agent is extravasated into the surrounding tissue.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an elongate inner member having a guidewire lumen extending therethrough. An outer member may be disposed about the inner member. An inflation lumen may be formed between the inner member and the outer member. The medical device may be configured to have a first stiffness when the inflation lumen is free of inflation media and a second stiffness different from the first stiffness when inflation media is disposed within the inflation lumen. In addition, the inner member may include a collapsible region that is configured to deflect radially inward when inflation media is disposed within the inflation lumen.

Abstract: A system and method of integrating electromagnetic microsensors into interventional endovascular devices such as guidewires for tracking guidewires within vessels of the body with the use of a surgical navigation system.

Abstract: Embolic protection devices and methods for capturing embolic debris. An embolic protection device includes a pigtail catheter having a lumen for housing a guidewire. The distal portion of the catheter has one or more apertures in fluid communication with the lumen and one or more radiopaque markers on the distal-most section. The device includes a self-expanding filter coupled to a side of the catheter and a movable outer sheath surrounding the catheter. The outer sheath holds the filter in a collapsed configuration when surrounding the filter. The outer sheath is proximally retracted to deploy the filter. A method of capturing embolic debris includes inserting a guidewire into a body lumen, tracking the device over the guidewire, retracting the guidewire, positioning the device using the radiopaque marker, retracting the outer sheath and deploying the filter, performing a procedure, and advancing the outer sheath to recapture the filter.

Abstract: A ureteral bypass device and procedure suitable for performing internal urinary diversions within patients, including patients such as humans and veterinary animals (cats and dogs). The device includes a nephrostomy catheter having a proximal end, an oppositely-disposed distal end, and means for securing the distal end within the renal pelvis of a kidney of a patient, a cystostomy catheter having a proximal end, an oppositely-disposed distal end, and means for securing the distal end of the cystostomy catheter within the urinary bladder of the patient, and an adaptor fluidically connected to the proximal ends of the nephrostomy and cystostomy catheters so as to fluidically connect the nephrostomy and cystostomy catheters together through the adaptor. If implanted subcutaneously, the adaptor may include an entry site that has a self-sealing septum that can be accessed with a needle while the device remains implanted and secured under the skin to subcutaneous tissue.