Abstract: A vascular introducer for accessing a circulatory system of a patient includes a sheath and a dilator. The sheath includes a fitting attached at a proximal end, and includes a liner that is longer than a core tube. A proximal segment of the liner is attached to an inner surface of the core tube, but a distal segment of the liner is everted to cover an outer surface of a distal segment of the core tube. The dilator is positioned in the sheath and includes a tapered distal segment that extends beyond a distal end of the sheath. A handle is attached to the proximal end of the dilator and extends proximally from the fitting. During a procedure, a blood vessel may constrict and grip the sheath. During withdrawal of the sheath, the core tube is slid within a first portion of the everted distal segment of the liner while another portion of the liner is de-everting.

Abstract: Various methods employing transvascular access devices are described, including a method of placing a central catheter in a peripheral vein in an arm of a patient; a method of providing percutaneous access to the heart of a patient; a method of clearing a clotted arteriovenous dialysis graft; a method of creating multiple access points into a single blood vessel; a method of creating an AV fistula in a patient; and a method of providing a bypass to a blockage in a popliteal artery in a patient.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The distal end of the sheath is maintained in the first, low cross-sectional configuration and expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for diagnostic or therapeutic procedures such as ureteroscopy, cardiac electrophysiology, gastroenterology, and spinal access.

Abstract: A minimally invasive endovascular device for treating a blocked or obstructed biological lumen, such as a blood vessel fully or partially obstructed by deposits of biological matters in or non-biological matters. Certain embodiments of the present invention comprise two capture members that are configured to be placed on either side of the obstruction and enclose around the obstruction for removal. Embodiments of the present invention also provide methods for implementing an endovascular device according to aspects of the present invention.

Abstract: The methods, devices and systems described herein relate to accessing a hollow organ with increased accuracy and safety. In one example, they relate to transseptal crossings of the atrial septal wall, preferably from the right atrium into the left atrium. Numerous different devices are described for performing access methods, each of which can be used with a piercing stylet that transitions to an atraumatic configuration after piercing the intervening tissue.

Abstract: A renal flow system injects a volume of fluid agent into a location within an abdominal aorta in a manner that flows bi-laterally into each of two renal arteries via their respectively spaced ostia along the abdominal aorta wall. A local injection assembly includes two injection members, each having an injection port that couples to a source of fluid agent externally of the patient. The injection ports may be positioned with an outer region of blood flow along the abdominal aorta wall perfusing the two renal arteries. A flow isolation assembly may isolate flow of the injected agent within the outer region and into the renals. The injection members are delivered to the location in a first radially collapsed condition, and bifurcate across the aorta to inject into the spaced renal ostia. A delivery catheter for upstream interventions is used as a chassis to deliver a bilateral local renal injection assembly to the location within the abdominal aorta.

Abstract: Provided are devices and methods for reducing or preventing fluid flow through a catheter lumen. For example, the devices and methods can be used to reduce blood flow through a catheter. Optionally, the catheter is an intravenous catheter. Also provided are catheters.

Abstract: A catheter assembly comprising an elongated tubular structure having a distal end and a proximal end; a septum disposed within the interior of the tubular structure so as to define a first lumen and a second lumen, and a valve element disposed at the distal end of the tubular structure and configured to move longitudinally relative to the tubular structure between (i) a closed position in which the distal end of the tubular structure is closed off by the valve element, and (ii) an open position in which the distal end of the tubular structure is not closed off by the valve element; wherein the tubular structure, septum and valve element are configured so as to provide fluid communication between the first and second lumen when the valve element is disposed in its closed position.

Abstract: This invention is an air block for industrial, medical, and non-medical uses. For example, the air block is connected to the proximal end of a vascular access catheter. The air block is either removably connected to the proximal end of the catheter or it is integral to the proximal end of the catheter. The air block permits introduction of other catheters or instrumentation through its central lumen and on into a lumen of the catheter while minimizing fluid loss or gain into the catheter. The air block further prevents air from entering the catheter and provides for removal of the air or other gas from the central lumen before it can enter the catheter where it could cause harm to the patient. The air block can be attached to various standard proximal catheter terminations including Luer fittings and hemostasis valve outer barrels.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the performance of procedures in the left atrium. The access route is through the inferior vena cava to the right atrium, where a trans-septal puncture, followed by advancement of the catheter is completed. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the right atrium and through the atrial septum into the left atrium. The distal end of the sheath is subsequently expanded using a radial dilatation device.

Abstract: The control of fluid introduction into and out of body conduits such as vessels, is of great concern in medicine. As the development of more particular treatments to vessels and organs continues it is apparent that controlled introduction and removal of fluids is necessary. Fluid delivery and removal from such sites, usually referred to as irrigation and aspiration, using fluid exchange devices that control also need to be considerate of potential volume and/or pressure in a vessel or organ are described together with catheter and lumen configurations to achieve the fluid exchange. The devices include several electrically or mechanically controlled embodiments and produce both controlled and localized flow with defined volume exchange ratios for fluid management. The applications in medicine include diagnostic, therapeutic, imaging, and uses for the introduction or removal of concentrations of emboli within body cavities.

Abstract: A variable infusion length catheter includes a tube assembly having a plurality of coaxial tubes each with a plurality of side ports formed therein, and having among the tubes a plurality of different rotational configurations each defining a different pattern of fluid communication among the side ports and a corresponding different infusion length of the catheter. Related methodology is also disclosed.

Abstract: A blood volume control method has been developed including: monitoring a condition of a patient (such as hematocrit (Hct)), wherein the condition is indicative of blood volume in the patient; automatically determining that the condition indicates a low blood volume in the patient; automatically infusing an infusion solution into the patient in response to the determination of a low blood volume, and automatically adjusting the infusion to maintain the monitored condition at a predetermined value.

Abstract: A method for modulating remodeling of an infarct region of a myocardium, the method including the controlled local delivery of therapeutic agent(s) employing microparticles as a carrier, and devices and compositions relating thereto.

Abstract: Embodiments of the present invention include methods of treating, preventing, or ameliorating a vascular disease and/or disorder in a diabetic or pre-diabetic patient. The methods include implanting a stent in a vascular region in a diabetic patient, and during the implantation procedure, delivering a drug formulation from a source other than the stent to the vascular region. The stent may be a bare metal stent, or a drug eluting stent, such as a metal stent having a coating including a drug. The drug may be everolimus, sirolimus, or a combination thereof. The drug formulation may include dexamethasone, paclitaxel, or a combination thereof.

Abstract: A medical practitioner can specify certain parameters for a procedure that involves delivering a therapeutic agent, while leaving other parameters open. The therapeutic agent can be sensitive to biomechanical forces (or other influences) associated with delivery. The procedure can involve regenerative medicine, for example delivering progenitor or stem cells to a diseased heart using a catheter, whereby unbridled transport in the catheter may compromise efficacy. The open parameters can influence efficacy of the agent and thus therapeutic outcome. A computer-based system can apply stored information, such as from databases, to narrow the possible values of the open parameters. From the narrowed possibilities, an optimization routine can determine suitable or optimized values for the open parameters. The determined values can manage biomechanical forces incurred by the therapeutic agent, thereby promoting efficacy and healing. The optimized parameters can guide the practitioner in the procedure.

Abstract: Clot disruption and dissolution are achieved using a catheter having the ability to infuse a thrombolytic agent, aspirate clot and fluid, and allow passage of a guidewire. Optionally, the catheter may also include a mechanical agitator for further disrupt clot in the presence of the thrombolytic agent. A flow resistor in the catheter provides for infusion and/or aspiration to be concentrated primarily at a clot treatment area in a blood vessel while also providing optional infusion and/or aspiration distal to the treatment area. In some embodiments, infusion, aspiration and guidewire passage occur through a common lumen. The thrombolytic agent, such as tPA, streptokinase, or urokinase, is directly released into the clot at the point where the agitator is engaging the clot. In this way, the thrombolytic activity of the agent is enhanced and the dissolution of the clot is improved.

Abstract: The invention generally relates to internal (e.g., implantable, insertable, etc.) drug delivery devices which contain the following: (a) one or more sources of one or more therapeutic agents; (b) one or more first electrodes, (c) one or more second electrodes and (d) one or more power sources for applying voltages across the first and second electrodes. The power sources may be adapted, for example, to promote electrically assisted therapeutic agent delivery within a subject, including electroporation and/or iontophoresis. In one aspect of the invention, the first and second electrodes are adapted to have tissue of a subject positioned between them upon deployment of the medical device within the subject, such that an electric field may be generated, which is directed into the tissue. Furthermore, the therapeutic agent sources are adapted to introduce the therapeutic agents into the electric field.

Abstract: Methods and systems for treating pleural disease comprising a providing a low dosage of a sclerosing agent over a period of time. Certain examples include catheter with a sclerosing agent that is inserted into the pleural space. The sclerosing agent is released in a sustained-release manner over a period of time to achieve diffuse pleurodesis of the pleural layers.

Abstract: A clot removal system includes an elongated tubular sheath and an elongated tubular catheter received within the sheath. A distal segment of the catheter is split into a plurality of catheter wall segments, with each wall segment having a pre-shaped curved configuration. Each wall segment defines at least one scraping edge and has a distal tip that is less stiff than a remaining portion of the wall segment. The clot removal system has a transport configuration in which the distal segment of the catheter is axially aligned with a distal segment of the sheath and the wall segments are urged against the pre-shaped curved configuration by the sheath. The clot removal system also has a deployed configuration in which the distal segment of the catheter is advanced distally beyond the distal segment of the sheath and the wall segments conform to the pre-shaped curved configuration.

Abstract: A pressure activated valve comprises a valve housing defining a linen for receiving bodily fluids therein and a flexible membrane disposed in the valve housing. The flexible membrane includes a slit extending therethrough so that the flexible membrane may be moved between an open and a dosed configuration based on fluid pressure within the lumen. A nonthrombogenic coating may be formed on fluid contacting surfaces of the flexible membrane.

Abstract: A dual lumen introducer sheath provides access to at least one renal artery and at least one peripheral blood vessel of a patient. The introducer sheath includes a proximal hub comprising first and second ports, a first lumen, and a second lumen. The first lumen extends from the first port to a first distal aperture and has sufficient length such that when the first port is positioned outside the patient the first distal aperture is positionable in the abdominal aorta at or near origins of the patient's renal arteries. The second lumen extends from the second port to a second distal aperture, has a shorter length than the length of the first lumen, and is configured to allow passage of a catheter device through the second lumen and into or through an iliac artery contralateral to an insertion point of the introducer sheath into the patient.

Abstract: A catheter assembly comprises a catheter including a catheter wall and a lumen extending lengthwise of the wall. The wall has inner and outer surfaces. The wall includes plural openings that extend through the wall and communicate with the lumen. An elongated hollow needle includes a proximal end portion and a distal end portion. The needle is movable in the lumen to move the distal end portion between the openings. The distal end portion is directed radially outward so as to extend into an adjacent opening. The distal end portion has a configuration that stores potential energy when in the lumen. The potential energy is converted to kinetic energy to produce movement of the proximal end portion as the distal end portion moves from the inner surface of the catheter wall across an edge of an opening. The movement of the proximal end portion is haptically perceptible.

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: A pumping device that can be used with currently-available pressure bag infusers is disclosed. The pumping device is hand-held and lightweight. The device is controlled by a microprocessor. Thus constant pressure to the bag is maintained through automatic adjustment of pumping and venting functions. In addition, a novel, new pressure bag infuser and a modified Luer Lock fitting for use with the pumping device are described.

Abstract: Provided herein is a method of delivering nucleic acid molecules to a compartmentalized tissue or organ of a subject. Also provided herein are uses and processes for delivering a nucleic acid molecule to the parenchyma of a compartmentalized tissue or organ. The methods and uses can be used in the treatment of diseases and conditions and in industrial, agricultural and veterinary applications. Also provided herein are compositions containing an adenovirus or adeno-associated virus or other recombinant virus formulated for administration to the parenchyma of a tissue or organ.

Abstract: An automatic pump relay system includes controllers coupled to drivers for sequentially discharging fluid from a plurality of medication containers into a coupler having a reflux barrier from which fluid is administered to a patient. The internal fluid pressure of the coupler is determined by a pressure sensing device or devices that provide signals to the controllers that, based at least on the sensor signals, cause the drivers to operate in reverse and forward directions so as to rapidly decrease and raise the fluid pressure within the coupler during a relay from an empty syringe to a filled syringe, thereby avoiding bolus formation and an interruption in infusion therapy. Independently operable syringes pumps are contemplated to be connected in relay fashion to form a modular system. An associated method is also disclosed wherein a fluid administration pressure is stored for use as a reference during a syringe changeover.

Abstract: A method is described for decreasing activity of at least one sympathetic nerve, nerve fiber or neuron innervating at least one blood vessel in the pulmonary vasculature of a patient to ameliorate pulmonary hypertension. In one embodiment, the method may involve advancing an intravascular treatment device to a target location in a target blood vessel within the pulmonary vasculature of the patient and using the treatment device to decrease activity of at least one sympathetic nerve, nerve fiber or neuron innervating the target blood vessel at or near the target location to ameliorate pulmonary hypertension.

Abstract: Systems, methods, and articles for delivering an antimicrobial composition to the proximal elements of a trans-dermal catheter and into the lumen of the transdermal catheter are disclosed. In an embodiment, an antimicrobial composition placed on an interior surface a cap element, and transfers antimicrobial to the exterior of the proximal end of the transdermal catheter. The system comprises an elongate member configured for insertion into a lumen of a catheter, the elongate member containing an antimicrobial.

Abstract: A fluid delivery mechanism that has a substantially cylindrical sleeve and an actuator coupled to the sleeve for controlling a circumference of the sleeve.

Abstract: Removable cardiac implants, applicators for inserting, repositioning and/or removing them, and methods of using them are described. In particular, removable or repositionable ventricular partitioning devices are described. Systems including removable implants and applicators for inserting and/or removing them are also described.

Abstract: Removable cardiac implants, applicators for inserting, repositioning and/or removing them, and methods of using them are described. In particular, removable or repositionable ventricular partitioning devices are described. Systems including removable implants and applicators for inserting and/or removing them are also described.

Abstract: This invention provides methods of preventing or treating cardiac ischemia-reperfusion injury in a mammalian subject. The methods comprise administering to the subject an effective amount of an aromatic-cationic peptide to a subject in need thereof, wherein the peptide is D-Arg-2 6-Dmt-Lys-Phe-NH2 (SS-31).

Abstract: Catheters used for medical treatment, e.g., hemodialysis are filled with a locking solution, usually heparin between treatments. To prevent infections, antimicrobial or antibiotic substances have been used as locking solution alone or in combination with antithrombotic substances. It has been found that these locking solutions are rapidly washed out from the catheter tip. The invention describes a thixotropic gel that can be used as locking solution. Beneficial substances, e.g., antimicrobial or antibiotic substances can be added to the gel. A preferred antimicrobial substance is taurolidin alone or in combination with salicylic acid or one of its salts.

Abstract: A system, method, and article for delivering an antimicrobial agent into the lumen of a trans-dermal catheter are disclosed. In an embodiment, the system comprises an elongate member configured for insertion into a lumen of a catheter, and the elongate member containing an antimicrobial. In the alternative an antimicrobial agent can be placed on an interior surface of a retaining ring.

Abstract: A needle catheter configured for injecting an agent into a wall of a patient's body cavity, which directs a needle from the distal tip of the catheter into the wall of the body cavity at an angle relative to the axis of the shaft. The resulting angled injection pathway improves the retention of the agent in the body cavity wall, while keeping a distal section of the catheter substantially perpendicular to the body cavity wall for optimal push against the tissue at the injection site.

Abstract: Described herein are methods and devices for selectively applying fluids (particularly anesthetics) to a target tissue from within a blood vessel while minimizing the amount of fluid applied to non-target tissue. The injection catheters described herein may include an elongate body, a directional injector, and one or more holdfasts for securing the catheter before extending the injector. The methods of selectively applying anesthetic to a target structure generally include the steps of inserting an injection catheter into a body vessel, positioning the injection catheter within the body vessel near the target structure, anchoring the injection catheter before extending a directional injector from the injection catheter, and applying anesthetic from the injection catheter to the target structure.

Abstract: Distal access aspiration guide catheter system and methods for delivering implantable devices, catheters, or substances in or near and/or restoring flow through body lumens, such as blood vessel lumens are described. A distal access aspiration guide catheter having a proximal, medial, and distal possessing high flexibility, high resistance to kinking and a large lumen to wall thickness ratio.

Abstract: A system for applying shear stress ex-situ to a fluid. A method of preparing a fluid for intravenous administration to a patient. In some embodiments, the system comprises a shear device; and at least one device configured for intravenous administration of the fluid to a patient, the devices defining a fluid passage configured to be sterilized and maintained sterile during use, the fluid comprising at least one therapeutic fluid, blood, or a combination thereof. The shear device of the system is in fluid communication with the at least one device configured for intravenous administration of the fluid to a patient.

Abstract: The present disclosed subject matter is directed to a less invasive surgical system, apparatus and method including a guidable catheter for providing electroporation therapy to a subject suffering from heart or kidney disease. The system includes an electrical generator and an apparatus for denervating an artery. The apparatus includes a catheter having a proximal end, a distal end, a first lumen with a first exit port, a second lumen having a second exit port. The apparatus also includes a first needle including a first electrode. The apparatus also includes a displacement mechanism engaged to the catheter near the proximal end such that the displacement mechanism controls the linear position and angular position of the catheter.

Abstract: The system for removing blood containing contrast dye includes an inner catheter having a fixed proximal end and a distal free end, and an outer catheter coaxially disposed around a portion of the inner catheter, defining an inner channel and an annular outer channel. The fixed end of the inner catheter is coincident with the proximal end of the outer catheter, and the distal end of the inner catheter extends outward from the outer catheter. An annular suction orifice is defined between the distal end of the outer catheter and the inner catheter. First and second balloons are mounted adjacent the distal ends of the outer and inner catheters. The distal free end of the inner catheter extends beyond the second balloon. In use, the first and second balloons are inflated in the coronary sinus and blood containing contrast dye is then removed from between the first and second balloons.

Abstract: Catheter assemblies are generally discussed herein with particular discussions extended to catheter assemblies having a tip protector, a valve, a valve opener, and optionally a needle wiper. The valve opener is disposed inside a catheter hub and is configured to be pushed by an IV set luer connector to open a valve following successful catheterization to pass fluids or other solutions through the catheter. A tip protector is incorporated to block the needle tip and prevent the same from accidental needle stick. A wiper is optionally included to wipe blood deposits on the needle when the same is retracted from the catheter.

Abstract: Devices, systems, and methods are provided for controlling an inflammatory response in a subject. Devices, systems, and methods are provided that alter the functional structure of one or more inflammatory mediators in the peripheral blood of the subject. The device or system is useful in a method for treating an inflammatory disease or condition in the subject.

Abstract: A pressure activated valve comprises a valve housing defining a lumen for receiving bodily fluids therein and a flexible membrane disposed in the valve housing. The flexible membrane includes a slit extending therethrough so that the flexible membrane may be moved between an open and a closed configuration based on fluid pressure within the lumen. A nonthrombogenic coating may be formed on fluid contacting surfaces of the flexible membrane.

Abstract: A liquid embolic delivery system is provided for trapping an injected liquid embolic composition to prevent the liquid embolic from solidifying or otherwise passing outside of an embolization area. The delivery system includes a catheter for delivery of a liquid embolic composition and a containment member positioned at a distal end of the catheter which is shaped to trap the liquid embolic composition delivered through the lumen of the catheter. The containment member is formed as a brush, nest, sponge, swab, flexible sack, or other shape into and around which the liquid embolic composition is injected. The liquid embolic composition is trapped or meshes with the containment member during solidification containing the liquid embolic and preventing the embolic composition from passing into the blood stream.

Abstract: Medical systems and devices adapted to deliver a fluid agent to target tissue within a patient.

Abstract: A medical article is configured to provide access to a patient's vasculature. The medical article includes an elongated body and a pair of stabilizing wings that extend from the elongated body and are configured to stabilize the medical article on a patient. The stabilizing wings are configured to rotate together or independently about the longitudinal axis of the elongated body between at least a first configuration and a second configuration. The elongated body can include a one-way valve disposed therein. The medical article can also one or more adhesive layers configured to releasably attach at least a portion of the wings to a patient.

Abstract: The present invention is directed to a method of treating a respiratory or pulmonary condition by transvascular neuromodulation of a target site adjacent to an adrenal gland. A method for treating a respiratory or pulmonary condition via transvascular neuromodulation incorporating a closed-loop feedback system is also provided.

Abstract: A peripherally inserted central venous catheter having a position indicator is used in a method of detecting movement of a catheter tip within a patient's superior vena cava. The PICC comprises a catheter having a proximal end with distance marks at measured intervals, an anchor wing system secured to the catheter's proximal end, at least one extension leg secured to the anchor wing system and the position indicator attached to the extension leg. The position indicator has an area for marking a distance signifying an initial external length of catheter which extends from the point the catheter enters the patient to the point it is attached to the anchor wing and/or marking an initial full length or the internal length of catheter which is fully within the patient. Any movement of the catheter's tip is detected by comparing the current external distance mark with the initial external distance mark.

Abstract: A system and method of treating urinary incontinence including a catheter and injection guide operatively disposed together. At least one needle is operatively disposed within at least one lumen and at least one channel extending through the catheter and injection guide respectively. The injection guide is transformable from a pre-injection configuration for placement in the bladder to an injection configuration for injection of a pharmaceutical such as botulinum toxin into the bladder tissue. Upon introduction of the pharmaceutical to the bladder tissue, symptoms of incontinence are alleviated.