Abstract: The present invention provides a kit for the delivery a therapeutic agent to an organ blood flow and the removal of the excess of said therapeutic agent from said organ blood flow, said kit comprises: (a) the therapeutic agent, (b) a first retrievable medical device (26), for delivering said therapeutic agent into the organ inflow, (c) a second retrievable medical device for isolating the organ outflow vessel and (d) a separation device (25) comprising at least one filter able to separate the therapeutic agent excess from the organ outflow, having an inlet (38) for the organ outflow having a therapeutic agent excess and an outlet (39) for filtered organ outflow.

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 medical lumen access device assembly includes a medical lumen access device holder including an elongate tube defining a lumen extending from a proximal opening of the elongate tube to a distal opening of the elongate tube. A check valve is positioned over an opening of the elongate tube and includes a valve member having a biased closed position wherein an internal volume defined by the lumen is fluidly blocked from an exterior of the elongate tube at the opening and an open position defining a fluid path from the exterior to the internal volume through the opening. The medical lumen access device assembly also includes a medical lumen access device disposed at least partially within the lumen and having a proximal segment extending beyond the distal opening. At least a portion of the medical lumen access device includes a hydrophilic coating.

Abstract: A transluminal device may include an elongate section extending between a proximal end and a distal end of the device. The elongate section may be configured to be inserted into a body cavity. The device may include a balloon within the elongate section between the proximal end and the distal end.

Abstract: An introducer sheath is provided with a sheath tube which is formed of a tubular member provided with a hollow portion through which an elongated body is freely inserted and includes a distal portion having a tapering outer diameter and a main body portion having a constant outer diameter. The distal portion of the sheath tube includes a concave portion which is bent radially inward from an end portion, through which an elongated body protrudes, in a concave shape in a cross section parallel to an axial direction, and a convex portion which is contiguous to the concave portion and is bent radially outward in a convex shape in a cross section parallel to the axial direction.

Abstract: The current invention provides this advance in infection control via its unique application of active sterilization to a catheter or implant. While most catheters, and many implants, are passive devices, the current invention will provide an active component as a integral part of the implanted catheter or device to continuously or intermittently sterilize the exposed surfaces/areas of the device. This active sterilization may be accomplished by a variety of mechanisms, including, application of heat, RF, microwave, ultrasound, ultraviolet radiation or other energy capable of sterilizing the device or dislodging any problematic Biofilm that may form. The active sterilization may also employ the pumping of a sterilizing chemical from all attached drug reservoir, the use of electricity or freezing temperatures or any other mechanism for either inhibiting, killing or dislodging any infectious material in contact with the implant.

Abstract: Devices for the local delivery of microdose amounts of one or more active agents, alone or in combination, in one or more dosages, to selected tissue of a patient are described. The devices generally include multiple microwells arranged on or within a support structure and contain one or more active agents, alone or in combination, in one or more dosages and/or release pharmacokinetics. In an exemplary embodiment, the device has a cylindrical shape, having symmetrical wells on the outside of the device, each well containing one or more drugs, at one or more concentrations, sized to permit placement using a catheter, cannula, or stylet. Optionally, the device has a guidewire, and fiber optics, sensors and/or interactive features such as remote accessibility to provide for in situ retrieval of information and modification of device release properties. In a preferred embodiment, the fiber optics and/or sensors are individually accessible to discrete wells.

Abstract: A catheter and method for draining a bladder and injecting a two part biologic adhesive is provided. The catheter has a tubular body extending between proximal and distal ends. A balloon is located adjacent the distal end with a first port extending between the proximal end and the balloon providing for inflation an deflation of the balloon. A second port extends substantially between the proximal end and the distal end for drainage. A pair of ports separate from one another and from the first and second ports extend between the proximal end and the balloon. The pair of ports are each arranged in fluid communication with separate openings located between the balloon and the proximal end to provide separate fluid flow paths for the separate components of the two part biologic adhesive between the proximal end and the openings.

Abstract: A device suitable for removing material from a living being is provided, featuring at least an aspiration pump, powered by a motor. The aspiration pump and any optional infusate pump preferably feature a helical pumping mechanism, and operate at a high rate of rotation, thereby ensuring adequate pumping performance and flexibility. The helical pumping mechanism may be a helical coiled wire about a central core tube. The helical coil wire, whether together with, or independent of, the core tube, may be rotated to cause a pumping action. Additionally, a narrow crossing profile is maintained, ensuring that the device may reach more tortuous regions of the vasculature. In one embodiment, the system comprises a wire-guided mono-rail catheter with a working head mounted on a flexible portion of the catheter that can laterally displace away from the guide wire to facilitate thrombus removal.

Abstract: A catheter tip designed to reduce the outflow velocity and/or directional momentum of fluid being infused by a catheter having such a tip. In one variation, a plurality of channels is provided at the distal portion of the catheter to increase the outflow cross-sectional area. In another variation, the diameter of the catheter at its distal portion where the fluid exits is increased. In yet another variation, a bullet-shaped nose is implemented which may decrease turbulence at the distal end of catheter tip. The low velocity outflow catheter tip may also be implemented on a dual lumen catheter, such as a hemodialysis catheter, to reduce recirculation rate. Various device configurations and methods for such implementations are also disclosed.

Abstract: An infusion system comprises an infusion set (30) with one or more advanced features including tube set strain relief (10), infusion pumps having heat exchange abilities and two-direction pumping abilities (100), Piezo pump devices (200), reservoirs (220, 240) made from expanded tubing, and oil impregnated pump plungers (302). An exemplary strain relief (10) includes an adhesive layer (12) such as pressure sensitive adhesive (PSA) secured to a base (14). The base (14) rotatably receives a pin (18) of a tube holder (16). The pin (18) is captured within an opening (22) of the base (14) to allow 360 degree rotation of the tube holder (16).

Abstract: Embodiments of the invention are directed towards a rapid exchange catheter configured for insertion into a subintimal space and crossing an occlusion in a subintimal space. The catheter includes a proximal end, a distal end, a first lumen configured to receive a first wire, the first lumen extending longitudinally through a least a lateral port of the catheter, and a second lumen having at least a portion distal of the lateral port and extending through at least the distal end of the catheter. The catheter also includes an exchange port arranged on a exterior portion of the catheter configured to the receive a second wire and second rapid exchange port in communication with the second lumen. Moreover, other embodiments of the invention are directed towards methods for using the rapid exchange catheter to cross an obstruction in a vessel, e.g., a total or partial occlusion, in a subintimal space.

Abstract: A cannula for preventing spraying of liquid is disclosed. The cannula includes a support tube partially inserted into a human body to guide a surgical instrument to an inside of the human body and a handle integrally formed with the support tube to allow the surgical instrument to be in and out of the human body, wherein the handle further includes a plurality of seal plates coupled to an inside thereof to prevent spraying of liquid onto an operator by an internal pressure of the human body and an outlet formed at a side surface thereof to reduce an internal pressure of the handle to atmospheric pressure.

Abstract: Catheters are disclosed that are configured for insertion into the vasculature connected to the prostate gland of a male patient or uterus of a female patient. Such catheters may comprise a conduit having one or more bends. Conduits with a general U-shaped bend and a compound curve are within the scope of this disclosure Methods related to the catheters, including methods of use and methods of manufacture, are also disclosed.

Abstract: An apparatus for determining a length of a portion of a steering wire disposed within a bendable medical device includes an electrical contact slidably coupled with a steering wire, an electrical source configured to transmit an electrical signal through a portion of the steering wire, and a processor configured to monitor a parameter of the electrical signal at or about the electrical contact and configured to determine a length of a portion of the steering wire using the monitored parameter.

Abstract: The present invention provides compositions for preventing growth and proliferation of biofilm embedded microorganisms on devices comprising: (a) a cationic polypeptide and (b) a bis-guanide or a salt thereof. The invention further provides methods for preparing medical devices with such compositions.

Abstract: Disclosed herein are therapeutic compositions for treating and preventing diseases such as neointimal hyperplasia (NIH), where the compositions comprise a therapeutic particle that has a localized association with a blood vessel and a therapeutic agent, such as an anti-NIH agent. Methods of use of the therapeutic compositions are also disclosed.

Abstract: A catheter tunneling adapter including a generally elongated body having a proximal end, a distal end and a through passageway. The proximal end of the adapter is connectable both to a proximal hub of a stylet and subsequently to the distal end of a tunneler. The distal end of the adapter comprises a connector for connecting a plurality of proximal catheter tubes thereto, wherein the proximal end of one tube is affixed within the passageway at the adapter's distal end and the proximal end of the second tube is plugged by a plug extending distally from a free end of an elongate flexible arm that also extends distally of the adapter's distal end, such that the plug is offset laterally therefrom. The flexible arm and the affixed second tube end are deflectable toward the first tube to reduce the profile of the assembly during tunneling.

Abstract: In the treatment method, a surgeon introduces a catheter assembly into a blood vessel in an arm, and delivers a distal portion of the catheter assembly to a predetermined position of a lower limb through the blood vessel in the body. Moreover, in the treatment method, the surgeon pulls an inner catheter out of an outer catheter, causes a treatment device to advance to the treatment target through the inside of the outer catheter, and treats the treatment target by the treatment device.

Abstract: Devices and methods for facilitating access to the pancreaticobiliary system are disclosed. In particular, the methods include bending a device having an elongate body with a first lumen, a second lumen, and respective first and second exit openings. The methods include inserting a first guidewire through the first lumen and out of the first exit opening to cannulate a pancreatic duct, and inserting a second guidewire through the second lumen and out of the second exit opening to cannulate a biliary duct.

Abstract: Apparatus and methods are provided for making catheters having intermediate layers that minimize or eliminate gaps during layup.

Abstract: Medical devices and methods for making and using the same. A medical device may include an elongate tubular member. The tubular member may include a first circumferential tube segment, a second circumferential tube segment disposed next to the first circumferential tube segment, and a third circumferential tube segment disposed next to the second circumferential tube segment. The first tube segment and the second tube segment may be separated by a first set of slots formed in the tubular member. The second tube segment and the third tube segment may be separated by a second set of slots formed in the tubular member. The second tube segment may be connected to the first tube segment with a proximally-extending beam formed in the tubular member. The second tube segment may also be connected to the third tube segment with a distally-extending beam formed in the tubular member. A ring may be defined in the second tube segment between the proximally-extending beam and the distally-extending beam.

Abstract: A method and apparatus for diverting the path of an object moving within a catheter sheath so that the object exits the catheter sheath at an angle greater than 0° and less than 90° is disclosed. The subject matter of this application more specifically pertains to catheter sheaths and catheter sheath portions that comprise a lateral opening and an deflection means such that objects moving along the longitudinal axis of a catheter are diverted from the longitudinal axis so that they exit the catheter through a lateral opening in the catheter sheath or catheter sheath portion.

Abstract: The herein disclosed invention is directed to methods of treating difficult to treat refractory or recalcitrant rhinosinusitis involving the steps of (1) topical application of antimicrobials/antibiotics and corticosteroids, (2) endoscopic debridement and cleansing to remove debris and biofilm, (3) endoscopic instillation of antimicrobials/antibiotics plus corticosteroids to the sinuses, and (4) hydrotherapy to disrupt/inhibit bacterial/fungal biofilm attachment to the sinus mucosa. Also disclosed is a kit of components for carrying out the treatment of this invention.

Abstract: The invention relates to a data communication system (100) and a method that can particularly be applied for communicating data from a medical instrument like a catheter or a guide-wire via a high-speedlink (101). The system (100) comprises (in-vivo) a slave component (150) with a controllable slave clock (153) and a transmitter (151) for transmitting a data signal (ds) that is clocked by the slave clock signal (clk). Moreover, it comprises (ex-vivo) a master component (110) with a clock controller (114,115,116) that receives a master clock signal (ref_clk) and the data signal (ds) and that generates a clock control signal (ccs) for adjusting the slave clock (153) to the master clock (113). The slave clock (153) may thus be realized with low space and energy requirements, e.g. by a voltage controlled oscillator (VCO). Moreover, the link (101) via which the data signal (ds) and the clock control signal (ccs) are exchanged may be realized by just two signal wires.

Abstract: A rapid exchange catheter comprises a guide wire lumen including a substantially sealed portion in which a lumen wall extends around an entire periphery thereof and a channel portion including a channel opening the lumen to an exterior of the catheter, wherein a width of the channel is less than a maximum width of the channel portion. A guide wire ramp extends into the channel portion, with the ramp extending further into the lumen of the channel portion as a distal end of the ramp is approached.

Abstract: A bi-directional perfusion cannula is provided that includes an elongate tube for insertion into an artery. The elongate tube has a first aperture at a distal end of the tube which is forward during insertion and configured so that blood can flow into the artery in the direction of insertion, an elbow formed in the elongate tube, and a second aperture formed in or slightly rearward of the elbow and configured for supplying blood into the artery in a second direction which is generally opposite to the insertion direction.

Abstract: Single filter and multi-filter endolumenal methods and systems for filtering fluids within the body. In some embodiments a blood filtering system captures and removes particulates dislodged or generated during a surgical procedure and circulating in a patient's vasculature. In some embodiments a filter system protects the cerebral vasculature during a cardiac valve repair or replacement procedure.

Abstract: A tube can include an elongated cannulated member that has an external wall. The tube can be navigated during a selected procedure. The tube can be shaped to selected configurations.

Abstract: A delivery system for delivering a therapeutic agent to a patient includes a catheter, a stop feature, a container and a bar. The catheter has a proximal end and a distal end and includes a body defining a lumen that extends to the distal end of the catheter. The stop feature is in proximity to the distal end of the catheter. The container is configured to house the therapeutic agent and is insertable and slidably disposable in the lumen of the catheter. The container is also configured to engage the stop feature of the catheter. The bar is slidably disposable in the lumen of the catheter. Sliding of the bar distally in the lumen forces the therapeutic agent out of the container and out of the lumen when the container is engaged with the stop feature. The stop feature is configured to inhibit the container from exiting the lumen.

Abstract: A device for maintaining an aseptic catheter environment is provided. The device includes a first housing and a second housing. The first housing and the second housing are coupled to one another by way of at least one coupler. The first housing and the second housing are configured to engage one another when in a closed configuration and to define an interior space when in the closed configuration. At least one aperture and/or notch is defined within at least one of the first housing and the second housing. The at least one aperture and/or notch is sized and shaped to allow at least part of a catheter to be positioned therethrough.

Abstract: The present invention is directed to a novel device and method for providing a disposable endotracheal intubation device for use with an auxiliary passageway serving as a guide for the placement of an orogastric or other enterally directed device in a patient. The present invention pertains to a medical catheter device, removably attachable to an endotracheal tube, for guiding the path of an enteral tube into the esophagus of a patient. The catheter device preferably employs an adjustable clamp to fix the position of the catheter relative to the endotracheal tube. The present invention also pertains to a combination medical intubation device comprising an endotracheal tube and a catheter proximate the endotracheal tube to guide the path of an enteral tube. The present invention also pertains to a method of intubating a patient using this combination medical intubation device.

Abstract: A catheter shaft and methods for making and using the same. The catheter shaft may include a core portion, a cap portion, and one or more lumens. The cap portion may be disposed on or over a section of the core portion and define a region with a different exterior or interior surface characteristic. For example, the cap portion may define a lubricious region along the catheter shaft. Manufacturing the catheter shaft may include a modified co-extrusion process that incorporates a flow valve on at least one of the material supply lines so that the supply line can be regulated by a user.

Abstract: A medical tube includes a distal portion provided on one end side having a first outer diameter, a first inner diameter, and a first thickness; a proximal portion provided on the other end side having a second outer diameter greater than the first outer diameter, a second inner diameter greater than the first inner diameter, and a second thickness greater than the first thickness; and an intermediate portion provided between the distal portion and the proximal portion and having an outer diameter, an inner diameter, and a thickness which gradually vary. Thus, a medical tube is provided having improved operability and which reduces the likelihood of bending during an operation.

Abstract: A catheter shaft with an improved manifold bond and methods for making and using the same. The catheter shaft may include a sleeve disposed, for example, near its proximal end. The sleeve may include a first layer that is attached to the catheter shaft and a second layer to which a hub or manifold may be attached.

Abstract: Catheter ultrasound systems including a sheath, a handle, a sheath lumen, and an ultrasound catheter disposed within the lumen of the sheath with ultrasound elements capable of visualizing anatomical regions. The handle allowing the ultrasound catheter to rotate with respect to the sheath using a rotation adjustment knob within the handle or alternatively an separate manipulation handle attached to the proximal end of the ultrasound catheter. The sheath, ultrasound catheter, or both may also include one or more electrodes or other location sensor for both orienting the ultrasound element as well as for diagnostic purposes.

Abstract: Devices and methods are disclosed for less invasive surgery. More particularly, methods and devices described herein permit improved access within a body cavity when performing a minimally invasive procedure, typically through a small opening, a surgical port, or during an open surgical procedure.

Abstract: It is an object of the present invention to provide a catheter, whereby a tunnel infection route is closed such that infection can be prevented, by improving adhesiveness between a medical catheter and a biologically-derived adhesive (fibrin adhesive), cells, or biological tissue. The present invention provides a medical catheter which is composed of material selected from the group consisting of silicone, polyurethane, polypropylene and polytetrafluoroethylene (PTFE), at least a portion of the surface of which is modified by plasma ion implantation.

Abstract: Embodiments of the invention include a medical device for accessing a patient's body portion and used for diagnosis and treatment of medical conditions. Embodiments of the invention may include a particular endoscopic positioning mechanism for placing an endoscope and an additional treatment device within desired body portions in order to assist in diagnosis and treatment of anatomical diseases and disorders. In particular, a medical device according to an embodiment of the invention includes a positioning mechanism configured for movement through at least two degrees of freedom.

Abstract: A male connector for a sensor guide wire for intravascular measurements of physiological variables in a living body, and a method for producing said male connector. The male connector comprises a plurality of spaced apart conductive members, extending at least partially along the length of the male connector, and a plurality of conductive areas separated from each other by insulating areas, disposed along the male connector, wherein each of the conductive members are connected to a respective conductive area.

Abstract: A penis erection stimulation system comprises a fully implantable drug delivery device for delivering a drug in relation to a penis to achieve erection of the penis. The drug delivery device may comprise a catheter adapted to be implanted in the corpora cavernosa of a penis or in close proximity thereto in order to deliver drugs through said catheter. Alternatively, one or more infusion needles may be disposed within and implanted along with one or more housings adjacent the patient's left and right corpora cavernosa. A reservoir and a pump may also be implanted inside the patient's body to supply the infusion needle with infusion liquid.

Abstract: The present invention provides catheter compositions that provide anti-thrombogenic properties while not adversely impacting mechanical properties. All embodiments of the present invention comprise a catheter that comprises a fluoropolymer additive with specific compositions and/or purity levels.

Abstract: Embodiments provide adjustable vascular catheter systems suitable for use in radial access procedures. In embodiments, the adjustable catheter includes an elongated tubular member having a wall defining a proximal end, a distal end, and a main lumen extending therebetween; a first micro-lumen having a proximal end, a distal end, and a hollow lumen extending therebetween, wherein the first micro-lumen extends substantially outwardly from the catheter wall and runs in parallel with the main lumen; and a first shape wire adapted to pass within the first micro-lumen, wherein the first shape wire has a shape memory function sufficient to deflect a deflectable distal portion of the elongated tubular member. In various embodiments, the shape of the deflected distal portion may allow a user to navigate the catheter past one or more tortuosities and reach normally positioned and anomalous positioned vascular ostia. Some embodiments include second and third shape wires, each having a different shape memory function.

Abstract: Medical device comprising a hydrophilic coating, sterilised while in contact with a swelling medium comprising a low molecular polyol; and a separate buffer selected from the group consisting of carboxylic acids, amino acids, aminosulphonic acids and inorganic acids. The swelling media provides a stable pH after sterilisation and maintain the low friction of the coating.

Abstract: An insertable anti-occlude strip includes a strip made of a material that is flexible, sturdy, durable and compression resistant. The strip has a cross-sectional shape such that when the strip is inserted into a hollow, flexible tube, there are open longitudinal apertures formed between the strip and the inner wall of the tube, allowing bi-directional flow of air or fluids through the tube. The insertable and tubal anti-occlude strip, when inserted into a hollow and flexible tube, provides resistance to occlusion of the tube lumen when the tube is under compressive or shear forces, which would otherwise significantly reduce or halt flow of air or fluids through the tube.

Abstract: The aspiration catheters, systems and methods include a catheter having an elongated body with a cross-section having a flat side and a curve near the distal end. The first side of the cross-section can contact a first side of a delivery lumen in a first orientation, and a second side of the cross-section contacts the first side of the delivery lumen in a second orientation rotated 180° from the first orientation. The curve can be directed 90° relative to a normal of the flat side. The systems and methods can utilize two catheters, and a key joint formed with the two catheters which can rotationally fix the catheters with respect to each other, and the first and second catheters each include at least one pre-formed curve near the distal end. The two catheters can be moved proximally and distally for positioning in the right and left bronchi.

Abstract: Alcohol resistant aromatic polycarbonate urethanes including their use in catheters. In one embodiment, a power injectable central venous access device is provided comprising a single or multilumen catheter shaft, junction, and extension leg(s), all of which may comprise aromatic polycarbonate polyurethane that is configured to withstand direct and prolonged exposure to alcohol.

Abstract: Method for fabricating a catheter including providing an inner tubular member formed from a first polymeric material, the inner tubular member having a distal section, a distal end, and a lumen defined therein by a first inner diameter; necking down at least a portion of the distal section of the inner tubular member to form a necked tip having a second inner diameter; and removing a portion of polymeric material from an inner surface along the necked tip to define a third inner diameter for the necked tip. The method can include positioning the distal section of the inner tubular member in a balloon having a working length, a distal neck, and a distal leg, with the distal end of the inner tubular member extending distally beyond a distal end of the distal leg, and coupling the distal leg of the balloon to at least a portion of the distal section of the inner tubular member.

Abstract: Elongate, flexible catheter includes an elongated shaft having a proximal end, a distal end, and a lumen defined therein. The shaft includes a tubular member having an outer layer and an inner layer. The outer layer includes a first polymer selected from the group consisting of nylon 12, polyether block amide, and combinations thereof. The inner layer includes a second polymer having a heat deflection temperature greater than about 53° C. selected from the group consisting of nylon 11, nylon 6, nylon 6,6, nylon 6,12, polyamide-imide, polyetherimide, polypropylene, polyethylene terephthalate, polybutylene terephthalate, polyethereetherketone, and combinations thereof. Method of making an elongate, flexible catheter is also provided.

Abstract: A medical device and method are provided for accessing a side branch in an artery. The device includes a catheter having a sidewall, an internal lumen, and a side port formed through the sidewall. A perforating guide wire has a proximal portion within the internal lumen and a distal portion arranged to be movable out of the side port. The guide wire can be delivered through the side port to a side branch artery when the catheter is deployed to a location with the side port aligned with the side branch artery. In another embodiment, the catheter has inner and outer telescoping tubes with offset exit ports formed therein. The telescoping tubes can be used to change the degree of deflection of the perforating guide wire by changing the relative positions of the offset exit ports.