Abstract: Catheter balloons (10) for delivering a bioactive (260) to a body vessel in a greater amount and/or more quickly are provided, as well as related methods of treatment. The catheter balloon may include a dual balloon assembly at the distal portion (300) of the catheter having an inner balloon (44), an outer balloon (42) with apertures (43) concentrically arrayed around the inner balloon, and a catheter shaft (30) adapted to deliver a carrier (270) through the apertures of the outer balloon. The bioactive is disposed on a portion of at least one of the inner and outer balloon surfaces. Radial outward expansion of the inner balloon urges the outer balloon into contact with the wall of the body vessel. The carrier is introducible within the catheter shaft to pass through the annular lumen (242) between the balloons and through the apertures of the outer balloon. The carrier interacts with the bioactive in order to release a therapeutically effective amount of drug to the wall of the body vessel.

Abstract: A catheter includes a flexible braided shaft having a length sufficient to access a target vessel of the body, such as a renal artery. An electrode at the catheter's distal tip is configured to ablate extravascular target tissue, such as perivascular renal nerve tissue. An electrical conductor coupled to the electrode extends along a first lumen of the shaft. A second lumen of the shaft terminates at a port arrangement on an outer surface of the shaft near the electrode. The second lumen transports a contrast media from the catheter's proximal end and through the port arrangement. The catheter may include a steering arrangement and a lubricious coating on an outer surface of the shaft, allowing a clinician to navigate the catheter through vasculature and into the target vessel without use of a separate delivery sheath or guiding catheter.

Abstract: The assembly comprises two or more catheter tubes fused together to form a fused catheter bundle. Each tube has at least one lumen extending longitudinally through the catheter from its distal end to its proximal end and at least one of said tubes comprises a pressure resistant lumen. The tubes are fused together by use of heat & pressure generated by heat shrinkable tube slides positioned over a segment of the catheter tubes while mandrels are positioned within each tube lumen. After cooling, the heat shrinkable tube may be removed and the mandrels removed such that and the fused catheter bundle is formed. One or more of the tubes may be of a different hardness, material and/or color. A distal end of the fused catheter bundle can be split free floating, stepped or tapered tipped. A non fused portion may form catheter extension legs.

Abstract: The present invention comprises methods, compositions, devices and systems for determining the status of, or treating, a body structure or conduit. An embodiment of the invention comprises a fluid pressure control device for pressure control of fluid introduced into a body structure or conduit.

Abstract: Systems, devices and methods for eluting an agent at a treatment site are disclosed. The devices include an expandable frame and at least one membrane. The membrane may carry an agent to elute at the treatment site. The membrane may allow blood flow at the treatment site during agent delivery.

Abstract: A guidewire can include a shaft or core wire that has a distal section configured for access to a vascular treatment site and a proximal section configured for intervention at a vascular treatment site. At least a portion of the distal section of the shaft or core wire can have a diameter that is greater than a diameter of the proximal section.

Abstract: Apparatus and methods are provided for delivering fluid into a body lumen during a medical procedure. A distal end of an apparatus may be introduced into a body lumen, and a valve on the distal end may be opened to deliver fluid through a first lumen into the body lumen, e.g., contrast and/or other diagnostic or therapeutic agents. The valve may be closed, and a procedure may be performed within the body lumen, e.g., using a treatment element carried on the distal end. For example, the treatment element may include a balloon that may be inflated when fluid is delivered through the first lumen with the valve closed. Optionally, a prosthesis, energy source, drug platform, and the like may be carried by the balloon for treating the body lumen. In various embodiments, the valve may be located proximal or distal to the treatment element.

Abstract: A catheter tip device and methods for manufacturing a catheter tip device are disclosed, the device comprising a transducer module attached to a capsule, wherein the transducer module comprises a carrier including a recessed die-attach area, a transducer die located in the recessed die-attach area, and at least one conductive lead deposited onto the carrier and interconnected to the transducer die. The recessed die-attach area has an outer perimeter greater than the outer perimeter of the transducer die forming a groove between at least one edge of the transducer die and the outer perimeter in which an adhesive agent is located to attach the transducer die to the recessed die-attach area. The methods of manufacturing the catheter tip device involve the use of an array of carriers.

Abstract: A method for performing an in-vivo calibration of a blood pressure sensor that is associated with a balloon of an in-vivo balloon system, the sensor and balloon being associated such that the sensor is in-vivo when the balloon is in-vivo. The balloon is inflated so that a gas pressure in the balloon system is indicative of a patient's blood pressure. The patient's blood pressure is monitored through two channels, the gas pressure and the sensor. The blood pressure measurements obtained by monitoring the gas pressure are used as reference, or “true,” blood pressure measurements to determine a mathematical relationship between blood pressure measurements obtained through the sensor and the reference blood pressure measurements. In this manner, future blood pressure measurements obtained through the sensor can be modified according to the mathematical relationship to generate calibrated blood pressure measurements.

Abstract: An apparatus for percutaneously implanting a localization wire into a tissue mass comprises a cannula with a preloaded localization wire. An actuator is provided to effect the relative movement of the cannula and localization wire such that a distal end of the localization wire is exposed to the tissue mass. A method for implanting a localization wire includes inserting a cannula with a preloaded localization wire into a tissue mass and relatively moving the cannula and localization wire to expose a portion of the localization wire to the tissue mass.

Abstract: The invention relates to a medical system for introducing a catheter into a blood vessel of a patient, having a computer and control unit, a means for creating a transparent general view of the position of the vessel, a catheter with a reversible inflatable balloon located in the front area, to the outside of which a stent can be fitted for implanting into the vessel, a position locating system for the catheter with position and location sensors that can determine the position and location of the catheter, the system with at least one OCT (optical coherence tomography) sensor at a catheter end for the close-up area, with at least one IVUS (intravascular ultrasound) imaging sensor at a catheter end for the remote area and the computer and control unit having image processing and image display functions for the image sensors.

Abstract: A rotating cutting head catheter for passage through chronic total occlusions or other refractory atherosclerotic plaque from diseased arteries is disclosed. The catheter's rotating cutting head is designed to reside safely within an outer protective sheath when not in use. The outer protective sheath contains one or more helical grooves or slots, and the cutting head contains protruding blades or projections that fit into these helical grooves or slots. Application of torque to an inner catheter or wire attached to the cutting head applies spin to the cutting head, and the force of the sheath's helical grooves or slots against the cutting head's protruding blades or projections advances the cutting head outward from the protective sheath. Once extended, the cutting head may now rotate freely. The device may use a guidewire to direct the cutting head to the desired position.

Abstract: A treatment device is provided including a catheter having a lumen that is opened to a distal end of the catheter; a wire passing through the lumen so that the wire is inserted into or retracted from the lumen; and a piece disposed at a distal end of the wire and having the maximum width when the piece is protruded from the distal end of the catheter is set larger than the diameter of the lumen, wherein the piece body is formed of a deformable material having a broad curved surface shape that distributes concentration of pressure acting on tissues, and when the wire is pulled in toward the catheter, the piece being extended in the axial direction by the lumen and reduced in its outer diameter so as to be pulled into the lumen.

Abstract: A catheter device comprising a chamber containing an opacity enhancing substance is disclosed. The opacity enhancing substance is in a dried or semi-dried form within the chamber of the device. Release of a liquid into the chamber suspends the substance and forms an opacity enhancing solution that is released into the lumen of the device in order to enhance the opacity of the device for imaging.

Abstract: An angiographic injector system and a method of controllably delivering medical fluid to a patient from an angiographic injector system are disclosed. A multiple processor control system is used to actively control the injection process and to monitor sensed functions of the system. The multiple processors provide dual redundancy safety circuits for critical control functions such as syringe motor drive speed and current. A motor/servo-amplifier nested control function is also disclosed. A unique method and apparatus are disclosed for establishing injection parameter default values just prior to an injection procedure that are based on physiological values of the patient to be treated. The injector system uses an interactive display panel that presents sequenced set-up screens to the user and which enables the user to select injection procedures, parameters and other modes of operation directly through the interactive panel.

Abstract: Device and method are provided for diagnosing and treating diseases and injuries to the spine by injecting drugs into the diseased or injured area. The device and method of the subject invention provide improvements to patient and operator safety, along with ease-of-use and convenience improvements over conventional techniques.

Abstract: An integrated catheter system for performing angiography on a human patient, the integrated catheter system consisting of an angiographic catheter onto which a thin-walled sheath is co-axially mounted. The angiographic catheter having an essentially straight and elongated proximal section in the form of a cylindrical shaft that is surrounded for less than one-half of its length by the thin-walled sheath that has an outer diameter that is less than 0.25 mm greater than the outside diameter of the angiography catheter. The strength to prevent buckling of the thin-walled sheath being provided by the shaft of the angiographic catheter. The integrated catheter system also being ideal for the placement of stents using small diameter stent delivery systems such as the stent-on-a-wire system.

Abstract: Devices and methods are described herein for engraftment of stem cells into a pancreas using an endovascular approach. Targeted intra-arterial injection of stem cells selectively in a splenic artery can achieve engraftment of insulin producing cells in the tail of the pancreas with high efficiency and without systemic circulation of these cells to other organs. In one embodiment, a catheter device includes expandable occlusion elements in the form of inflatable balloons that can be used to isolate a proximal and distal end of a pancreatic portion of the splenic artery. In another embodiment, the occlusion elements include a filter element instead of a balloon. In some embodiments, targeted delivery of stem cells to the pancreatic tail can be achieved for treatment of, for example, diabetes. In some embodiments, an arterial section of the splenic artery can be isolated for selective perfusion of therapeutic cells/drugs to the tail of the pancreas.

Abstract: An angiographic catheter having an elongated flexible insertion tube having a cylindrical inflatable sheath circumferentially mounted thereon. The sheath contains a series of discharge ports at its distal end. A fluid is introduced into the proximal end of the sheath under sufficient pressure so that the sheath is fully inflated and fluid is discharged into a desired target area within the patients body.

Abstract: A drug delivery catheter suited for cardiac procedures. The catheter includes a distal helical coil or other fixation and penetrating element which can be operated from the proximal end of the catheter to engage and penetrate the myocardium. Once delivered to the inside of the heart, the catheter can be used to inject small doses of therapeutic agents to the myocardium. The drug delivery system of the catheter allows for precise control of the dose injected into the heart wall.

Abstract: An apparatus for targeting a desired target site on a body tissue that separates a first body cavity from a second body cavity of a patient includes a catheter having a longitudinally extending catheter lumen and adapted to provide access to the first body cavity. A framing member has a collapsed condition in which the framing member is adapted for insertion into the first body cavity through the catheter lumen and an expanded condition in which the framing member is adapted for placement within the first body cavity. The framing member has a framing member body. At least one target point is carried by the framing member and is adapted for placement adjacent the desired target site. At least one target wire is attached to at least one target point. At least a portion of the target wire extends through the catheter lumen. The target wire is substantially spaced apart from the framing member body. A method of using the apparatus is also described.

Abstract: A method and device for preparing an implant from an implant material are provided. A defect image of the defect which has a defect contour is made available, in which a first calibration member arranged in or adjacent to the defect is displayed. A second calibration member is arranged on or adjacent to the implant material to be processed, this second calibration member corresponding to the first calibration member. A real-time image of the implant material is displayed on a display device. The defect image is displayed on the display device and superimposed on the real-time image so that the first and the second calibration members are displayed one on top of the other. A processing tool is displayed on the display device in the real-time image and moved over the implant material so that it follows the defect contour displayed in the defect image.

Abstract: Methods and apparatus are described for a bidirectional introducer. An apparatus includes a bidirectional introducer, comprising a catheter including: a sheath; and a dilator located within and substantially coaxially with the sheath, the dilator having a distal end portion that includes at first section having a proximal first section end and a distal first section end and a second section having a proximal second section end and a distal second section end, wherein a) the distal first section end is coupled to the proximal second section end and b) at least a portion of the first section is characterized by a first rigidity and at least a portion of the second section is characterized by a second rigidity that is higher than the second rigidity.

Abstract: The present invention provides a cardiac vascular occlusion system which includes inner and outer guide catheters and an occluding member disposed on the inner catheter. The occluding member may be deployed from a compressed to an expanded position to limit retrograde blood flow in a body lumen. The occluding member may be used when injecting a contrast agent into the body lumen.

Abstract: A method of extravasated drug delivery is disclosed, including inserting a catheter with a first balloon, a second balloon, and a third balloon positioned between the first and second balloons and having a wall with an abrasive outer surface, into a bodily cavity, inflating the first and second balloons to create a chamber therebetween, stimulating a flow of blood cells by inflating the third balloon until the abrasive outer surface abrades tissue, and delivering the agent to the chamber. A balloon catheter system is also provided including a balloon having a wall with an abrasive outer surface for abrading tissue, a catheter having a first lumen for supplying fluid to the balloon to inflate the balloon such that the abrasive surface stimulates a flow of blood cells, and a second lumen for supplying an agent to tissue.

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

Abstract: An infusion media delivery device includes a housing having a base adapted to be secured to a user's skin. An infusion media reservoir is supported by the housing. A moveable hollow needle is selectively engageable with the reservoir to communicate infusion media from the reservoir. The needle is supported for movement relative to the housing base between a first position and a second position. The needle is spaced apart from a user's skin when in the first position and the base is secured to the user's skin, and the needle is arranged to pierce the user's skin when in the second position and the base is secured to the user's skin.

Abstract: Methods for determining the size, pathology, and volume of embolic debris captured in an embolic protection filtering device. The methods may include providing an embolic protection filtering device and scanning the filtering device with a computed tomography scanner. The methods may also include analyzing digital images produced during the scanning step.

Abstract: A medical device at least partially insertable into a patient. The device comprises a catheter portion comprising a flexible tube that is at least partially insertable into the patient, and a valve portion proximal to the catheter portion. The valve portion comprises a planar flexible member comprising first and second valve portions separated from one another by an internal slit. The thickness of the planar flexible member at the internal slit is less than the thickness of the planar flexible member at any other location.

Abstract: A catheter for medical procedures comprises a shaft portion having a distal end insertable into a body lumen, the shaft portion having a wall defining a working lumen extending therewithin and a first strengthening element coupled to the wall to increase a burst pressure of the shaft portion, wherein the first strengthening element cooperates with a base material of the wall to define a flexible region of the shaft portion allowing the shaft portion to be atraumatically inserted into the body lumen.

Abstract: The present invention relates to contrast agents for optical imaging of oesophageal cancer and Barrett's oesophagus in patients. The contrast agents are esters of 5-aminolevulinic acid (5-ALA). They are useful in the diagnosis of oesophageal cancer and Barrett's oesophagus, for follow up of progress in disease development, and for follow up of treatment of oesophageal cancer and Barrett's oesophagus. The contrast agents are delivered by particular routes of administration.

Abstract: A medical device with improved flexibility characteristics and methods of using the same. The medical device may include a proximal end, a distal end, and an intermediate region. In at least some embodiments, the column strength or flexibility of the intermediate portion is generally greater than the column strength or flexibility at the distal end.

Abstract: Systems and methods for separating pericardial tissue from the epicardium of the heart are disclosed. The apparatus includes a catheter comprising an elongated body, including a proximal end and a distal end and a lumen extending therebetween. The apparatus further comprises a needle carried at the distal end of the catheter. The needle includes a proximal end, a distal end, and a lumen extending between the proximal and distal ends, and is in fluid communication with the catheter lumen. The needle is of a length sufficient to penetrate myocardial tissue of the heart, from the endocardium to and through the epicardium. A coupling on the catheter is provided for communication with a fluid source, to facilitate flow of fluid through the catheter lumen and needle lumen. Fluid can thereby flow through the catheter and needle lumens to a location between the epicardium and pericardial tissue.

Abstract: A method of sealing a network of veins which provide drainage to the testes, comprising: (a) inserting a catheter into a main vein of said network; and (b) causing said vein to seal over at least a length, with a single application of vein irritant such that no forward movement of the catheter is required.

Abstract: A vascular access catheter having a catheter shaft configured for insertion into a vein of a patient. The catheter has an exterior surface, which has a plurality of openings defined in the distal end portion of the catheter shaft, and can have respective first and second lumens. The first lumen is in fluid communication with at least one opening of the plurality of openings and is in communication with a first extension tube. The catheter has a first extension tube and a second extension tube. The first extension tube is positioned in fluid communication with the first lumen, and the second extension tube is positioned in fluid communication with the second lumen. The second extension tube is configured for high pressure CT injections, and the first extension tube is longer in length than the second extension tube.

Abstract: In one aspect, the present invention provides a biomaterial having at least one biocompatible surface. The biocompatible surface comprises a plurality of immobilized Notch ligand molecules, wherein the plurality of immobilized Notch ligand molecules are capable of promoting differentiation in one or more epithelial cells. In another aspect, the present invention provides an implantable medical device comprising a layer of a biomaterial. Another aspect of the invention provides methods for promoting epithelial cell differentiation. The methods of this aspect of the invention include the step of contacting one or more epithelial cells with a biomaterial comprising an amount of immobilized Notch ligand molecules sufficient to promote differentiation in the one or more epithelial cells.

Abstract: A medical device includes a body, a member in the body, and a contrast agent in the member. The device can be visible by magnetic resonance imaging.

Abstract: A medical instrument such as a guidewire that is designed to have controlled torque transmission along its length. Specially treated areas are placed in selected and equal areas along the entire length of the elongated shaft of the medical instrument, and are separated from one another by untreated areas. This process ensures that any torque is transmitted distally, in a smooth manner, regardless of the guidewire position, thus resulting in a substantial reduction in whipping. In one embodiment, a stainless steel guidewire is utilized, and is subjected to annealing heat treatment in selected areas. This annealing process creates a mandrel that has repeated temper properties along its length. Torque applied at one end of this mandrel is transmitted to the opposite end in an even and controlled manner, even when the mandrel is formed into a loop.

Abstract: The arrangement (10) is suited for transmitting an informative signal (S1), generated by suitable signal generator (1) at a first electrical site (7a) to a second electrical site (7b). The first electrical site (7a) is electrically connected to the second electrical site (7b) by means of a capacitively coupled transmission line (5a, 5b). In order to enable such capacitively coupled transmission line distributed or lumped capacitors (4a, 4b, 4c, 4d) can be used. The arrangement is connectable to an accessory device (6), which may comprise a spectrometer, a further signal generator, tuning means, etc. The further signal (S2) is generated by the accessory device (6) and transported via the capacitively coupled transmission line (5a, 5b) in a direction from the second electrical site (7b) to the first electrical site (7a). The further signal (S2) can be used for feeding an amplifier (2), or for carrying the signal (S1).

Abstract: Catheters such as guide catheters can be configured for delivery of devices to vasculature portions such as intracranial spaces while retaining a desired level of flexibility. A catheter having an elongate shaft can include removable support means that can provide column support to the elongate shaft. The elongate shaft can include anchoring means that releasably secure the removable support means. The catheter can be deployed within a patient's vasculature, followed by deploying the removable support means.

Abstract: A method for performing an in-vivo calibration of a blood pressure sensor that is associated with a balloon of an in-vivo balloon system, the sensor and balloon being associated such that the sensor is in-vivo when the balloon is in-vivo. The balloon is inflated so that a gas pressure in the balloon system is indicative of a patient's blood pressure. The patient's blood pressure is monitored through two channels, the gas pressure and the sensor. The blood pressure measurements obtained by monitoring the gas pressure are used as reference, or “true,” blood pressure measurements to determine a mathematical relationship between blood pressure measurements obtained through the sensor and the reference blood pressure measurements. In this manner, future blood pressure measurements obtained through the sensor can be modified according to the mathematical relationship to generate calibrated blood pressure measurements.

Abstract: Markers that are visible under magnetic resonance imaging (MRI) and fluoroscopy and related medical devices are disclosed.

Abstract: A medical device having a segmented construction. In at least some embodiments, a medical device including a plurality of conductive elongated members that are of such a length and are connected together in such a manner to impart a degree of MRI compatibility to the device. In some embodiments, the elongated members can include a series of solid elongate members and tubular elongate members, which construction provides one way to control at least some properties of the device, for example, stiffness, torque transmission, flexibility, shape retention, and the like. In yet some additional embodiments, at least one of the elongated members has a recess into which a protrusion of another elongated member may fit.

Abstract: Alternative designs, materials and manufacturing methods for guidewires. Some embodiments pertain to a composite guidewire having proximal and distal section, and a connector adapted and configured for permanently joining the proximal section to the distal section. In some embodiments, at least one of the sections is made of a linear-elastic nickel-titanium alloy. Several alternative guidewire tip designs including coiled safety/shaping structures are also disclosed.

Abstract: The present invention provides systems and methods of use for catheters and electrophysiological devices. In particular, the present invention provides coronary catheters within which an extendable electrode array is housed.

Abstract: This document provides methods and materials that can be used to reduce or prevent contrast agent-induced toxicity. For example, devices for capturing contrast agents from blood are provided.

Abstract: A guide wire (1) to assist percutaneous endovascular deployment which has zones of varying stiffness. An elongate central zone (3) of high stiffness, a proximal zone (4) of transition from high stiffness to semi-stiffness and a distal zone (5) of transition from high stiffness to being relatively flexible. The distal zone (5) has three zones, a semi stiff zone (11) adjacent the central zone, a transition zone (13) being of flexibility of from semi-stiff extending to flexible and a tip zone (15) being of high flexibility. The distal tip has a small J curve (16) to ensure that it is atraumatic in vessels and to prevent damage to the aortic heart valve. The distal zone (5) can also have a large curve to assist with anchoring the guide wire into the aortic arch.

Abstract: A catheter, particularly an intra-vascular catheter, has at least one magnetic field-generating element arranged in the catheter envelope in the region of the catheter tip, characterized in that the magnetic field of which is variable while the catheter is inserted into a patient.

Abstract: A catheter device for providing visualization as well as support and/or stability for blood vessels during procedures for inserting electrical leads. The catheter device comprises a longitudinal member having a distal end and a proximal end, an expandable element near the distal end of the longitudinal member for providing support to the blood vessel, and a contrast release port near the distal end of the longitudinal member for releasing a contrast medium into the blood vessel to visualize the blood vessel. The expandable element may comprise an inflatable balloon, or a plurality of compressible elements that expand to a balloon like shape, or a compressible coil housed in a protective sheath that retracts to allow the coil to expand. The catheter device comprises two inflatable balloons. At its proximal end, the catheter device comprises one or more inflation ports for inflating the one or more balloons.

Abstract: Apparatuses and methods for implanting objects, such as a marker, in the lungs of patients. In one embodiment, a bronchoscopic catheter assembly for implanting an object in the lung of a patient includes a handle, a delivery catheter projecting outwardly from the handle, and a push wire contained within the catheter In one aspect of this embodiment, the catheter can be configured to releasably hold a plurality of markers at a distal end. In another aspect of this embodiment, the push wire can be operably connected to the handle and axially moveable within the delivery catheter to eject the marker out of the catheter within the bronchi of the patient. In a further aspect of this embodiment, the marker can further include an anti-migration device associated with the marker for holding the marker in place once the marker is deployed in the bronchi. The anti-migration device can be integral with the marker or positioned proximate to the marker to prevent migration of the marker.