Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of balloon counterpulsation catheters. The access route is through the femoral arteries and the iliac arteries into the aorta, where an intra-aortic balloon pump catheter is positioned to provide cardiac support. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device.

Abstract: A steerable balloon catheter including a balloon catheter supported by a steerable guidewire having a deflectable distal tip. The guidewire comprises a longitudinal hypotube and a spring coil attached to the distal end of the hypotube and includes a longitudinally movable deflection member which is attached to the distal end of the spring coil and a tip retaining member which extends from the distal end of the hypotube to the distal end of the spring coil for providing very precise deflection of the distal tip of the balloon catheter.

Abstract: A catheter includes a body having an outer surface defining a lumen and an expandable tip on a distal end thereof. The tip includes an opening axially extending therethrough. Upon insertion of a device having a larger outer diameter than the inner diameter of the expandable tip, the opening permits passage of the device therethrough. The tip expands commensurately with a difference between the outer diameter of the device and the inner diameter of the expandable tip. The expandable tip includes a tubular wall having an axially extending weakened portion formed from (1) at least two axially aligned slit segments and (2) at least two axially aligned segments that are strengthened when compared to the slit segments. One of the strengthened segments is positioned between two of the slit segments. Another of the strengthened segments is formed between a distal-most slit segment and a distal end of the expandable tip.

Abstract: An introducer assembly includes an outer sheath, and a dilator assembly that includes a dilator hub and a dilator sheath. The dilator sheath is disposed within the outer sheath passage, and a proximal end of the dilator sheath is movably disposed within the dilator hub. The dilator assembly further includes a needle disposed within the dilator sheath, and coupled with the dilator hub. The dilator sheath has a first position and a second position relative to the dilator hub, where in the first position the needle distal end extends out from the dilator sheath distal end, and in the second position the dilator sheath is extended over the needle distal end.

Abstract: A single operator exchange biliary catheter having a common distal lumen. The biliary catheter includes an elongate shaft having a proximal portion defining an ancillary lumen and a distal portion defining a common guidewire and ancillary lumen. The common distal lumen reduces the profile of the distal portion of the shaft. The elongate shaft also includes a proximal guidewire port disposed between the proximal end of the shaft and the distal end of the shaft to facilitate single operator use. A seal may be disposed adjacent the proximal guidewire port to thereby seal the port. Preferably, the shaft includes a single lumen distal portion and a bi-lumen proximal portion. The single lumen distal portion of the shaft may be curved and may include a tapered or spherically shaped distal tip.

Abstract: A multi-lumen catheter and method for inserting same in a patient is disclosed. The catheter includes an elongated, central, multi-lumen tube portion having a proximal end and a distal end. The central tube portion has a substantially cylindrical outer shape and is internally segmented into a plurality of lumens. A distal branch portion includes a plurality of single-lumen distal extension tubes. A proximal branch portion includes a plurality of single-lumen proximal extension tubes. Each proximal extension tube has a distal first end and a proximal second end. The distal first end of each proximal extension tube is connected to the proximal end of the central tube portion such that the single lumen of each distal extension tube is in fluid communication with one of the plurality of lumens of the central tube portion. Each lumen of the central tube portion and the lumens of the distal and proximal extension tubes in fluid communication therewith define a flow path through the catheter.

Abstract: Cannulas for surgical and medical use expand along their entire lengths. The cannulas are inserted through tissue when in an unexpanded condition and with a small diameter. The cannulas are then expanded radially outwardly to give a full-size instrument passage. Expansion of the cannulas occurs against the viscoelastic resistance of the surrounding tissue. The expandable cannulas do not require a full depth incision, or at most require only a needle-size entrance opening. In one embodiment of the invention, the cannula has a pointed end portion. In this embodiment of the invention, the cannula includes wires having cores which are enclosed by jackets. The jackets are integrally formed as one piece with a sheath of the cannula. The cannula may be expanded by inserting members or by fluid pressure. The cannula is advantageously utilized to expand a vessel, such as a blood vessel. An expandable chamber may be provided at the distal end of the cannula.

Abstract: Conduits are provided to direct blood flow from the left ventricle to a coronary artery at a location distal to a blockage in the coronary artery. Threaded and nonthreaded conduits are delivered using a guidewire delivered through the posterior and anterior walls of a coronary artery and into the heart wall. A dilator may be provided over the guidewire into the heart wall, and the conduit delivered over the dilator. An introducer sleeve may be provided over the dilator into the heart wall, the dilator removed, and the conduit delivered through the introducer sleeve. A hollow needle also may be inserted into the posterior and anterior walls of the coronary artery prior to inserting the guidewire. A depth measuring tool may determine the appropriate length of the conduit prior to delivery.

Abstract: A catheter assembly having a balloon disposed at the distal end thereof and a therapeutic substance delivery assembly, including a needle in fluid communication with a therapeutic substance delivery lumen for allowing a therapeutic substance to be injected into a diseased physiological lumen. A deflector is positioned along an inside wall of the delivery lumen, positioned, such that as a bend region forms caused by the movement of the delivery lumen, the deflector bends to rest on the outside curvature of the bend. As the needle is made to travel through the bend, the ribbon helps to bounce the needle tip off the wall of the delivery lumen, allowing the needle to travel through the bend without digging into and/or gouging the delivery lumen wall.

Abstract: A biological agent delivery device for delivering biological agents includes a sheath having a longitudinally extending wall surrounding an interior region, and a closed tip at a distal end. A flexible pouch formed in the sheath wall for containing a biological agent is capable of being displaced radially outwardly for radially displacing the biological agent.

Abstract: The invention relates to an apparatus and method for imaging and mapping various structures located at a target area within a patient's lumen using conventional IVUS technology. The mapped images are used to accurately determine and control the location of the device within the lumen relative to the target area and/or target site. Once the drug delivery device is properly positioned within the lumen, additional ultrasonic images are generated and used to control the position and depth of penetration of a retractable needle of the device. Needle position can be precisely determined, both in relationship to the device as well as the target site for drug delivery. This allows accurate delivery of drug to the target site and, thus, enhanced treatment capabilities.

Abstract: An atrial isolator comprising two tubular members, two lumens, drainage ports, and expandable occluders. The expandable occluders are adapted to engage an opening of the superior vena cava into the right atrium or the inferior vena cava and right tricuspid valve into the right atrium. The second tubular member is inserted into the lumen of the first tubular member to provide a displacement between the first expandable occluder and the second expandable occluder which is adjustable. A cardioplegia port is located between the two expandable occluders and in communication with a cardioplegic lumen. Methods of using such an atrial isolator are also disclosed, particularly to provide circulatory isolation of the heart and coronary blood vessels, and cardioplegia delivery.

Abstract: Apparatus, systems, methods, and kits are provided for isolating a target lung segment and treating that segment, usually by drug delivery or lavage. The systems include at least a lobar or sub-lobar isolation catheter which is introduced beyond a second lung bifurcation (i.e., beyond the first bifurcation in a lobe of the lung) and which can occlude a bronchial passage at that point. An inner catheter is usually introduced through the isolation catheter and used in cooperation with the isolation catheter for delivering and/or removing drugs or washing liquids from the isolated lung region. Optionally, the inner catheter will also have an occluding member near its distal end for further isolation of a target region within the lung.

Abstract: A single operator exchange biliary catheter having a common distal lumen. The biliary catheter includes an elongate shaft having a proximal portion defining an ancillary lumen and a distal portion defining a common guidewire and ancillary lumen. The common distal lumen reduces the profile of the distal portion of the shaft. The elongate shaft also includes a proximal guidewire port disposed between the proximal end of the shaft and the distal end of the shaft to facilitate single operator use. A seal may be disposed adjacent the proximal guidewire port to thereby seal the port. Preferably, the shaft includes a single lumen distal portion and a bi-lumen proximal portion. The single lumen distal portion of the shaft may be curved and may include a tapered or spherically shaped distal tip.

Abstract: A stent-delivery catheter system delivers and implants a self-expanding stent intraluminally into a human patient's body lumen. A self-expanding stent is removabaly attached to the distal end of an inner member so that attachment projections prevent axial movement of the stent on the inner member while the stent is being delivered and implanted in a patient's body lumen.

Abstract: A surgical tool (112, 410) for use in expanding a cannula (10, 150, 250) includes a first leg (114, 414) having a first end (118, 418) engageable with an inner surface (70, 212, 322) of the cannula. A second leg (114, 414) is connected with the first leg (114, 414). The second leg (114, 414) has a second end (118, 418) engageable with the inner surface (70, 212, 322) of the cannula (10, 150, 250). The first and second ends (118, 418) are movable away from each other to apply a radially outwardly directed force to the inner surface (70, 212, 322) of the cannula (10, 150, 250) and cause expansion of the cannula.

Abstract: A gastro-intestinal tube placement device for percutaneously placing gastro-intestinal tubes into the gastric cavity. The gastro-intestinal tube placement device of the present invention includes a containment element, such as an overtube, through which a gastro-intestinal tube can pass, and a displacing element assembly for pushing a gastro-intestinal tube through the containment element. The present invention also includes a gastro-intestinal tube having a collapsible internal bolster at its distal end, which bolster is capable of being manipulated to have a reduced lateral extent that allows the tube to be placed within the containment element.

Abstract: Systems and methods for delivering material into bone deploy a cannula through soft tissue to establish a subcutaneous path into bone. A material is introduced into bone through the cannula. The systems and methods advance a tamping instrument through the cannula to urge material residing in the cannula into bone. The introducing step delivers material at a pressure no greater than about 360 psi.

Abstract: A venous drainage catheter comprising a cannula and a lumen, wherein the proximal end is adapted for attachment to a bypass machine and the distal end has a drainage port in fluid communication with the cannula lumen. Expanding members, having an actuating mechanism which expand the members from a collapsed condition, are disposed circumferentially about the drainage port. Methods for using the devices are also disclosed.

Abstract: A catheter for injecting medication to a specific point within a patient comprises a drug delivery lumen extending from a proximal end of the catheter to an injection port. The catheter comprises a mechanism for angularly pushing the injection port outwardly away from the body of the catheter into an artery wall so that medication can be injected directly into the artery wall.

Abstract: Methods, systems, and kits for subcutaneously implanting articles, such as drug inserts and reservoirs. The methods rely on percutaneously forming a tissue tract and radially dilating the tract to a diameter which permits introduction of the article. By fully expanding the lumenal diameter of the tissue tract prior to introduction of the article, damage to the article resulting from passage through a partially expanded tissue tract can be avoided. In the exemplary embodiment, a radially expandable sleeve is first percutaneously introduced to the subcutaneous target site. An assembly of a cannula and dilator is then passed through the sleeve, effecting radial expansion. The dilator is removed and the article is then introduced through a lumen of the cannula.

Abstract: A vascular access device is provided which can be used for chronic venous or organ access. When implanted, the device facilitates repeated intermittent infusions of medical treatment while reducing the risk of infection at the implant site. The vascular access device comprises an elongated body and a delivery tube coupled to the elongated body for delivering the medical treatment to a preselected site in a patient's body, which permits subcutaneous implanting of the device with a minimally invasive procedure. A sheath and a dilator are adapted to form an access tunnel in the patient's body commensurate in configuration with the elongated body of the device. A guide wire is provided to guide the sheath and dilator from a first opening to a second opening in the patient's body. The introduction of the sheath eases the placement of the device and reduces access site trauma to the vein, organ, or any other location in the body to which the medicine or therapy is to be applied.

Abstract: The present invention comprises a method and device for providing an expandable introducer sheath. The method of employing the inventive device comprises inserting an elongate flexible tubular sheath into a vessel (with a proximal end of the sheath extending proximally outward through the skin), to slidably receive intravascular devices. When a larger size introducer sheath is desired, the sheath is manipulated while still in the vessel to expand its inner diameter to a larger size. In one embodiment, the sheath is made of a shape-memory polymer and is manipulated by inserting a heated mandrel (with an outer diameter larger than the inner diameter of the sheath) within the sheath to cause the sheath to expand to an inner diameter at least approximately equal to an outer diameter of the mandrel. The shape-memory polymer material ensures that the sheath will retain its expanded inner diameter. Alternatively, the sheath is formed from a telescoping multi-tubular arrangement of progressively larger tubes.

Abstract: An active cannula or sleeve which does more than merely maintain a channel or passage is usable to create and/or enlarge a channel or passage, to position a scope or instrument, to move or locate tissue, etc. The cannula can vary in size or shape as needed, intraoperatively. Because a cannula of the present invention is expandable, the surgeon can make a small relatively small incision, stretch the tissue with the expandable cannula, contract the cannula and remove it, allowing the skin to come back to its unstretched condition. Thus, a smaller incision can be made to fit the same size instrument. This results in less trauma and scarring and an easier operation. The cannulas are or can assume such a non-circular shape, to fit into a natural skin opening and cause less trauma. The devices can be used to seal off a space; to expand an existing space or a potential space for working or visualization; to move tissue (for example, to stretch an incision) or to protect it.