Abstract: Sinusitis, mucocysts, tumors, infections, hearing disorders, choanal atresia, fractures and other disorders of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat and mouth structures are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies and endoscopic studies.

Abstract: The present invention relates to pharmaceutical compositions comprising a chemotactic hematopoietic stem cell product comprising an enriched population of CD34+ cells containing a subpopulation of CD34+/CXCR-4+ cells having CXCR-4-mediated chemotactic activity, methods of preparing these compositions and use of these compositions to treat or repair vascular injury, including infarcted myocardium.

Abstract: A medical device, the medical device formed at least in part from a melt blend of at least one polymer comprising hydrolysable groups and a carbodiimide.

Abstract: The invention provides a device for filtering emboli from blood flowing through a lumen defined by the walls of a vessel in a patient's body including a filter element. The filter element is expandable from a collapsed configuration to an expanded configuration. When the filter element is in the expanded configuration, the average pore size is from 30 to 300 microns and the standard deviation of the pore size is less than 20 percent of the average pore size. The filter element has two or more filtering layers, each filtering layer having pores, and each filtering layer being adjacent to at least one other filtering layer.

Abstract: An activation circuit for selectively providing an electrical current to one or more electroactive polymers (EAPs) in a medical device is disclosed. The activation circuit may include a sensor for sensing a measure related to a parameter of an elongated member and/or a balloon of the medical device. The electrical current may be provided to the one or more EAPs according to the sensed parameter of the elongated member and/or the balloon of the medical device. In some cases, the activation circuit may include a comparator for comparing the sensed measure to a threshold to determine when the electrical current is applied to the EAPs. The parameter may be a pressure, a fluid flow, a temperature, and/or other suitable parameter.

Abstract: The invention generally relates to carbon nanotube based drug delivery methods, devices, and compositions. More particularly, the invention relates to controlled drug delivery using anchored carbon nanotube arrays.

Abstract: A kit of parts comprises a system and instructions for use for controlling patient temperature which uses a central venous line catheter having a heat exchange element. The central venous line catheter is provided with one or more lumens for providing access to the central blood supply of the patient, and with additional lumens for communicating heat exchange fluid to the heat exchange element. Heat exchange fluid temperature is controlled through a feed back loop in which patient temperature is sensed and used to control a temperature control unit comprising a heating device and/or a cooling device in heat exchange relationship with the heat exchange fluid. A tubing set transports the heat exchange fluid between the central venous line and the temperature control unit, with a pump serving to circulate the fluid in a closed fluid circuit in the system.

Abstract: An infusion catheter and method, with an elongated shaft having a guidewire lumen which has a proximal section and a common distal section extending to a distal port at a distal end of the shaft, and an infusion lumen which is in fluid communication with the distal port of the guidewire lumen and which joins the common distal section of the guidewire lumen at a location distal to the guidewire proximal port. A restricted passage from the infusion lumen to the common distal section of the guidewire lumen has a smaller transverse dimension than the guidewire lumen and a guidewire slidably disposed in the guidewire lumen.

Abstract: Methods and devices incorporating a guidewire entry port subassembly for use in rapid exchange catheters. The use of a subassembly allows for stronger quality control and simpler fabrication of a rapid exchange device. In several embodiments, methods of making a molded guidewire entry port using a mold, often in conjunction with one or more mandrels, are disclosed. Several device embodiments include a separate molded guidewire port as well as molded guidewire ports which are attached, during a molding step, to segments of a catheter.

Abstract: Sinusitis, mucocysts, tumors, infections, hearing disorders, choanal atresia, fractures and other disorders of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat and mouth structures are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies and endoscopic studies.

Abstract: The present invention relates to a catheter comprising an outer tube; an inner tube; and a balloon fixed at its proximal sleeve to the outer tube and at its distal sleeve to the inner tube, wherein the inner tube comprises an elastic segment.

Abstract: Catheter devices having an expandable balloon for delivering a therapeutic agent to a body site. The balloon has one or more folds which serve as a reservoir for containing the therapeutic agent. The fold may have any of various configurations to hold the therapeutic agent. In some cases, the balloon comprises one or more lobes that forms the fold(s). The therapeutic agent may be provided in various ways. For example, the therapeutic agent may be contained in packets that rupture upon expansion of the balloon, or as a plurality of discrete bulk masses, or sealed within compartments.

Abstract: A system and method for vessel catheterization is provided, having an introducer sheath and a catheter. The introducer sheath can include a handle and a sheath body extending from the handle. An access lumen is provided in the introducer sheath, and can include a tapered portion that is sized to receive a tapered outer surface of the catheter. The catheter may be a central venous catheter, such as a peripherally inserted central catheter, including a hub, a catheter body with at least one lumen extending distally from the hub, and at least one tube extending proximally from the hub. The introducer sheath is preferably a splittable sheath. The catheter can be inserted into the access lumen, and translated until confronting surfaces of the tapered outer surface of the catheter body and the tapered portion of the introducer sheath contact one another. This arrangement can inhibit buckling and/or kinking of the catheter during insertion, and improve initial catheter tip positioning.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: A catheter including a tube having at least one lumen, at least one elongate element, the at least one elongate element having a bendable portion at a predetermined bendable portion location therealong forward of a distal end of the tube and at least one selectably inflatable balloon communicating with at least one of the at least one lumen, the at least one selectably inflatable balloon having a forward end and a rearward end, the rearward end of the balloon being located rearwardly of the predetermined bendable portion location.

Abstract: Methods for selective cooling or heating of a target site in the human body include a catheter having a supply elongated element and a delivery elongated element, with inlet and exit ports. Blood is withdrawn from the supply elongated element and cooled or heated in a control unit. The treated blood is sent to the targeted area via delivery elongated element. The supply elongated element can act as an insulator for the treated blood in the delivery elongated element.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: A catheter is configured to prevent kinking of a catheter during handling or mounting of a pressure device. The catheter has a proximal end of its catheter shaft that is provided with a bending section having a flexibility greater than that of the section of the catheter shaft joining the proximal end.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: A collateral ventilation bypass trap system directly linked with a patient's lung or lungs may be utilized to increase the expiratory flow from the diseased lung or lungs, thereby treating one aspect of chronic obstructive pulmonary disease. The system includes a trap, a filter/one-way valve and an air carrying conduit. The system also includes a retention device for securing system elements in position.

Abstract: A catheter is disclosed providing a balloon catheter having a distal tip that is flexible while additionally incorporating high column strength. The present invention additionally provides a distal tip region that accommodates for various sized guidewires. In preferred embodiments, the distal tip region is initially configured for accommodating the passage of 0.12-inch guidewires only. Through specific manufacturing processes, however, the distal tip is modified so that it also may be expanded to accommodate the passage of 0.14-inch guidewires. In additional preferred embodiments, an elastomeric sleeve is disposed over the modified distal tip to allow the tip to return to the initial 0.12 -inch accommodating profile when the larger 0.14-inch guidewire is withdrawn from the catheter.

Abstract: Compliant coatings for insertable medical articles are provided. In some aspects, the coating includes a diene polymer-containing layer, and a second coated layer that includes another polymer. The coating can be formed by coupling the polymer of the second coated layer to the first coated layer via latent reactive groups, such as photoreactive groups. In other aspects, the insertable medical article has a coating that provides different functional features to different surfaces of the article. The medical article can have a cylindrical shape with an interior surface having a first coating, and an exterior surface with a second coating, wherein the article also includes a plurality of openings.

Abstract: Drainage belongs to medical equipment, particularly to medical tools and is specified for drainage of cavities. Drainage comprises a first tube, an additional tube, which is fixed upon it, a unit of the clot's splitter and the splitter's fixing element. The additional tube has a smaller diameter with an opening, inside which the conductor is mounted, a unit of clots splitter is installed on the working end of the drainage, it comprises a cylinder, a tube with an opening, placed on it, which is the continuation of the additional tube of the drainage and a spring with a cutter inside the cylinder. A cutter is located diametrically inside the working head, while in the end of the wall of the first tube and the splitter's unit comprises a channel, inside which splitter's fixing element was led, its working end is inside the unit's cylinder and fixes the splitter.

Abstract: To accomplish isolation and removal of a substance from a vasculature, a catheter is employed to occlude a vessel of the vasculature. The substance is thus isolated in the vasculature and can be removed. In this way, the substance is removed before entering other parts of the circulatory system. This method is applicable to removal of contrast from the coronary sinus shortly after injection of the coronary arteries with the contrast. The method substantially minimizes or avoids renal dysfunction caused by angiographic procedures in which contrast must be injected. Such angiographic procedures are often performed during intervention procedures. This method substantially prevents circulation of the contrast to the kidneys where it could otherwise cause renal dysfunction or failure. The apparatus for implementation of the method is also disclosed.

Abstract: The invention discloses a balloon catheter comprising a catheter shaft, at the distal end of which an inflatable balloon is arranged and at the proximal end of which a connecting piece is arranged, comprising a guiding wire which can be passed through a guiding wire lumen of the catheter shaft from the proximal end to the distal end and through the balloon and an inflation or deflation lumen extending from the proximal end of the catheter shaft to the balloon, wherein a portion of the catheter shaft having a selectable length and extending from the proximal end is provided with a metal reinforcing pipe.

Abstract: To accomplish isolation and removal of a substance from a vasculature, a catheter is employed to occlude a vessel of the vasculature. The substance is thus isolated in the vasculature and can be removed. In this way, the substance is removed before entering other parts of the circulatory system. This method is applicable to removal of contrast from the coronary sinus shortly after injection of the coronary arteries with the contrast. The method substantially minimizes or avoids renal dysfunction caused by angiographic procedures in which contrast must be injected. Such angiographic procedures are often performed during intervention procedures. This method substantially prevents circulation of the contrast to the kidneys where it could otherwise cause renal dysfunction or failure. The apparatus for implementation of the method is also disclosed.

Abstract: Under one aspect, an interventional device includes a balloon having a flexible wall. The flexible wall includes a composition including between 0.005 wt. % and 0.20 wt. % of carbon nanotubes dispersed in a polymer. Under another aspect, a method of making an interventional device includes contacting a plurality of polymer particles with a plurality of nanotubes; extruding the polymer particles and the nanotubes to form a composition comprising the polymer and the nanotubes; and blow-casting the composition into a balloon.

Abstract: A feeding tube and method for introducing a feeding tube within the gastrointestinal tract of a patient, whereby the feeding tube is introduced by using a variation of the Ponsky “pull” method of feeding tube placement. The feeding tube comprises an elongate shaft having a distal end and proximal end. The feeding tube also comprises a coupling structure for coupling the feeding tube to a pull wire, the coupling structure be proximal of the distal end of the feeding tube shaft. The feeding tube further comprises a guiding structure for aligning the pull wire with the distal end of the shaft. The feeding tube is introduced within the patient by attaching the previously placed pull wire to the coupling and guiding structures of the feeding tube, and then pulling the pull wire so as to pull the feeding tube into and through the gastrointestinal tract of the patient.

Abstract: A miniaturized drug pump can actively dispense fluid at a controlled (or controllable) flow rate emerging at or near the distal tip of a catheter.

Abstract: A vascular introducer sheath includes a sheath body having an interior lumen for accommodating a dilator. The vascular introducer further includes a guidewire positioning means operatively associated with the interior lumen of the sheath body for directing a guidewire in either a vascular direction or an arterial direction within a venous system.

Abstract: The present invention relates to implantable medical devices and methods that employ these medical devices to treat heart valves. In one embodiment, a medical device is provided comprising a body. The body may have a portion thereof including therapeutic agent and can be configured to support the device proximate a heart valve. Methods in accordance with embodiments of the present invention may also include providing a medical device having a body with at least a portion thereof including a therapeutic agent. These methods may also include positioning the medical device in a location proximate to a downstream surface of the heart valve and securing the device. The therapeutic agent released may then be delivered to the heart valve.

Abstract: A reduced pressure delivery system for applying reduced pressure tissue treatment to a tissue site is provided. The system includes a manifold delivery tube and a balloon having an inner space. The balloon is capable of assuming collapsed and expanded positions. The system further includes a manifold having a plurality of flow channels. The manifold is disposed within the inner space of the balloon. A sharp tip is configured to be delivered within the manifold delivery tube to puncture the balloon.

Abstract: A tool for removing a discrete object from the body of a human or animal patient includes a single length of Nitinol tubing and a sheath. The tubing includes a tool head section at a distal end of the tubing and a shaft section extending from a proximal end of the tubing to the tool head section. The tool head section includes a slitted section and a non-slitted section. The non-slitted section is disposed at a distal most end of the tubing. The slitted section includes a plurality of longitudinal slits forming a plurality of strands.

Abstract: A low profile surgical access device includes an elongated cannula having an opening defined at a proximal end thereof including an inner peripheral surface dimensioned to facilitate passage of instrumentation therethrough and an outer peripheral surface configured to operatively engage and removably secure to tissue via, e.g., fixation ribs, adhesive, anchors, clips, suction elements, expandable materials and/or combinations thereof. A valve is operatively coupled to the elongated cannula and provides a substantially fluid tight seal when instrumentation is inserted through the cannula. A seal housing is included which is positionable relative to the cannula and which is configured to operatively engage and removably secure to tissue. The instrument seal in the seal housing is positioned in vertical registry with the valve in the elongated cannula.

Abstract: Sinusitis, mucocysts, tumors, infections, hearing disorders, choanal atresia, fractures and other disorders of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat and mouth structures are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies and endoscopic studies.

Abstract: The present invention provides a dilatation and stent delivery device which tracks over two guidewires. One guidewire is disposed in each branch vessel of a bifurcation. The present invention provides a dilatation and stent delivery device which enables efficient and accurate stent deployment and dilatation of bifurcation lesions.

Abstract: A catheter system comprises a catheter and a reinforced catheter balloon. The catheter balloon has at least one cone portion and a working portion. The catheter balloon has in cross section the at least one cone portion has a polygonal shape with sides and corners. The balloon is disposed about a longitudinal axis and has an inflated state and an uninflated state. In the uninflated state the working portion of the balloon forms wings which have tips that are circumferentially aligned with the corners of the cone portion.

Abstract: A cannula having a proximal end, a distal end, and a lumen extending between the proximal and distal ends is provided. The diameter of the lumen of the cannula can be varied to take into account differences in the diameter of access and target vessels during cannulation. The cannula is further characterized by at least one mechanism that, upon actuation, serves to alter the conformation of the cannula between a normal profile conformation and a low profile conformation. The normal profile conformation is characterized by the cannula having a lumen diameter at the point of insertion, which is smaller than the lumen diameter both proximal and distal to the point of insertion, with the lumen diameter distal to the point of insertion also expandable to the diameter of the cannulated vessel of the patient. The low profile conformation is characterized by the cannula having a lumen diameter at the point of insertion that is greater than the lumen diameter distal to the point of insertion.

Abstract: A system and method for localized delivery of a therapeutic or diagnostic agent within a vessel is provided. The system and method provide for adjustability of the length of the treatment area. A catheter system includes an inner elongated element and an outer elongated element positioned coaxially with respect to the inner elongated element. A proximal occlusion element is positioned at the distal end of the outer elongated element, proximal to an outlet port. A distal occlusion element is positioned at a distal end of the inner elongated element. The distal end of the inner elongated element is distal to and movable with respect to the outer elongated element distal end.

Abstract: A transvascular system for delivering a drug to a tissue region from a blood vessel includes a catheter having a distal portion with puncturing, orientation, drug delivery, and imaging elements. The puncturing element is deployable for penetrating the vessel wall to access the tissue region. The orientation element has a predetermined relationship with the puncturing element, the imaging element detecting the location of the orientation element with respect to the tissue region to orient the puncturing element. The catheter is percutaneously introduced into the vessel, the puncturing element is oriented towards the tissue region, the puncturing element is deployed to access the tissue region, and the drug is delivered to the tissue region. An ablation device may also be deployed to create a cavity or fluid reservoir in the tissue region for receiving the drug therein, or an indwelling catheter may be advanced into and left in the tissue region.

Abstract: A device for interventional surgical or medical procedures is presented. The device is generally in the form of a balloon and is used to position itself or other working elements up against or through lumen walls in the body. The balloon is comprised of at least two materials of different elastic modulus, which allows for a flexible but relatively non-distensible, unfolding component of the balloon as well as an elastomeric, inflatable component of the balloon. The elastomeric component is fixedly attached to the flexible but relatively non-distensible component and together they form a pressure vessel that can be inflated within the lumens of the body.

Abstract: Apparatus for accessing a bodily passageway, the apparatus comprising: a flexible tube having a distal end and a proximal end, a longitudinal axis extending between the distal end and the proximal end, and a lumen extending from the distal end to the proximal end, the lumen being sized to receive matter to be transported through the bodily passageway; and an external thread disposed over the distal end of the tube, the external thread having a sufficient structural integrity, and a sufficient surface profile, such that when the tube is disposed in a bodily passageway, rotation of the tube about the longitudinal axis will result in longitudinal motion of the tube along said bodily passageway.

Abstract: The invention provides a medical device having a catheter and one or more expandable constricting/occluding members. The catheter is adapted for use with therapeutic or diagnostic devices, including an angioplasty/stent catheter and an atherectomy catheter. The constrictor/occluder is mounted at the distal end of the catheter. Manometers may be mounted distal to one or more constrictors for measuring pressure distal to the constrictor(s). Methods of using the devices are disclosed for preventing distal embolization during extracranial or intracranial carotid artery, vertebral artery, or coronary artery procedures, or procedures involving any vessel having collateral flow by reversing flow in the diseased vessel.

Abstract: An intraluminal catheter device having an expandable member formed of a matrix of fiber elements with a therapeutic agent incorporated therein. The therapeutic agent can be coated on the fiber elements in a co-axial configuration. The fiber elements may also have a second coating including a protective substance surrounding the therapeutic agent. The matrix of fiber elements can be formed by electrospinning. A process of delivering a therapeutic agent to a target site includes providing an intraluminal catheter device having an expandable member formed of a matrix of fiber elements, the expandable member having a therapeutic agent dispersed therein, and advancing the catheter device at a desired treatment site. Once at the desired treatment site, fluid is introduced into the inflation lumen to expand the expandable member from a first profile to a second profile, and the therapeutic agent is delivered to the desired treatment site.

Abstract: A catheter for delivering an agent to an injection site in a wall of a patient's body lumen, with an elongated shaft having a needle-through lumen slidably containing a needle therein, and an expandable member on the distal shaft section which has a collapsed configuration and a radially expanded configuration. In the radially expanded configuration, the expandable member supports the shaft in a position spaced away from the body lumen wall, and the needle slidably exits the needle-through lumen in the extended configuration through the port spaced away from the body lumen wall as a portion of the expandable member maintains the position of the port section of the shaft in the body lumen. The expandable member typically has an open-walled, helical, or lobed configuration providing a perfusion path along the expandable member.

Abstract: A catheter having an elongated shaft which has a multilayered distal tip with a first layer formed of a polyimide first material and a second layer formed of a polymeric second material. In one embodiment the multilayered distal tip is a separate member, distal to the distal end of a proximal portion of the shaft. In another embodiment, the shaft has an outer tubular member, and a multilayered inner tubular member with a distal end which forms the multilayered distal tip of the shaft. In a presently preferred embodiment, the polyimide material is a thermoset polyimide. In one embodiment, the polymeric second material is a polyamide material.

Abstract: A fluid control device is attached to tubes carrying irrigation solution to form the system. The control device splits the flow through a fiber optic scope and a fluid control unit. The fluid control unit controls rate of flow and direction. The operator utilizing a fluid rate and flow direction control device easily controls the flow of fluid into the joint, out of the joint, or no flow. The increased flow prevents collapse of a joint space and maintains clear visualization. The fluid flow solely relies on a gravity feed by having a fluid reservoir positioned at a high point in the system. It contains no fluid pump, vacuum or electronic controller while safely and reliably performing the functions of more complex devices.

Abstract: Balloon catheter comprises a shaft having a proximal end, a distal end, and an inflation lumen extending therein, and a balloon on the shaft which has an interior in fluid communication with the inflation lumen. The balloon is formed of a blend of polymeric materials comprising a transparent amorphous nylon having a Shore D duromcter hardness of not less than 77D and being not more than about 40% by weight of the blend, and a polyamide or a polyether block amide having a Shore D duromcter hardness of no more than 73D. An increase in radial diameter of the balloon above nominal pressure for one atmosphere of pressure is no greater than 0.025 mm/atm. A guidewire catheter is also provided.

Abstract: A bladder catheter for transurethral introduction into the urinary bladder by the urethrae, includes an elastic catheter shank with a fillable balloon element secured thereto and connected to a filling channel incorporated into the wall of the catheter shank. The balloon element and the catheter shank are made of polyurethane, a polyurethane-polyvinylchloride mixture or similar polyurethane-based material.