Abstract: A catheter for measuring a fractional flow reserve includes a proximal shaft, a distal shaft coupled to a distal portion of the proximal shaft, and a pressure sensor coupled to the distal shaft. The proximal shaft includes a distal portion configured to extend through a stenosis in a vessel. The distal portion of the proximal shaft includes a radially expanded configuration having a first diameter and a radially collapsed configuration having a second diameter, wherein the first diameter is larger than the second diameter. The distal shaft includes a guidewire lumen configured to receive therein.

Abstract: A catheter for measuring a fractional flow reserve includes a proximal shaft, a distal shaft coupled to the proximal shaft, a pressure sensor coupled to the distal shaft, and at least one pressure sensor wire operably connected to the pressure sensor. The proximal shaft includes a radially expanded configuration and a radially collapsed configuration, wherein the proximal shaft has a first outer diameter in the radially expanded configuration and a second outer diameter smaller than the first outer diameter in the radially collapsed configuration. The distal shaft defines a guidewire lumen configured to receive a guidewire therein.

Abstract: The present invention provides an optical irradiation apparatus including: a dual laser light source unit which simultaneously or selectively outputs multiple light sources created with different outputs; an optical fiber which is connected to the dual laser light source unit, receives the light outputted from the dual laser light source unit, and emits the received light through an embossed end surface; and an inflatable balloon catheter which is formed to surround the embossed end surface of the optical fiber and expands constricted tissue. With the present invention, it is possible to effectively treat constricted tissue during a procedure of performing an anticancer therapy on entire human bodies with various types of cancers, and it is possible to mitigate patient's pain by reducing a relapse rate of stenosis after the photothermal therapy.

Abstract: A balloon catheter comprises an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end. An inflatable balloon is supported along the distal end of the shaft, the balloon when inflated including a generally cylindrical barrel section forming a working surface, and generally conical end sections that do not form a part of the working surface. The balloon further includes at least one radiopaque identifier for indicating the relative position of the working surface, said identifier being provided on at least one of the conical end sections of the balloon so as to define the extent of the working surface. Related aspects are also disclosed.

Abstract: Disclosed herein are expandable introducer sheaths and methods of making and using the same. The sheaths minimize trauma to a patient's vasculature by allowing for temporary expansion of a portion of the sheath to accommodate passage of a delivery system for an implant, then return to a non-expanded state after the passage of the device. The sheath includes a foldable inner member having a detached flap structure at its distal tip that facilitates expansion of the sheath lumen to increased diameters, and an elastomeric distal end that reduces push and retrieval forces therethrough. The sheath can include a hemostasis seal on its proximal end to prevent the leakage of blood out of the sheath and prevent ballooning of outer layer of the sheath.

Abstract: A balloon for a balloon catheter includes a body section and cone sections. At least one of the cone sections defines a plurality of grooves spaced around the circumference of the cone section.

Abstract: An occlusion bypassing apparatus for re-entering the true lumen of a vessel after subintimally bypassing an occlusion in a vessel. The apparatus includes an outer shaft component having a needle lumen there-through. A proximal end of the outer shaft component is fixed within a handle of the apparatus at a first attachment point. A stabilization tube of the apparatus is disposed within the needle lumen. A proximal end of the stabilization tube is fixed within the handle at a second attachment point that is spaced apart from the first attachment point and an elongated body and a distal end of the stabilization tube are not attached to the outer shaft component. A needle component of the apparatus is configured to be slidably disposed within the stabilization tube and removable therefrom, and the stabilization tube minimizes resistive forces exerted onto the needle component by the outer shaft component.

Abstract: A multi-layered balloon is provided where each layer is formed such that each layer is made from tubing that optimizes the inner wall stretch thus providing maximum balloon strength. The high pressure, multi-layer balloon is provided with layers that allow for slipping, such that the balloon has a very high pressure rating and toughness, yet excellent folding characteristics. Methods for producing such multi-layer balloons using existing balloon forming equipment are also provided. The multi-layer balloons can have alternating structural and lubricating layers, or layers with low-friction surfaces. The multi-layer balloons are preferably manufactured using a variety of methods including nesting, co-extrusion, or a combination of nesting and co-extrusion. The multi-layer balloons have balloon layers having substantially similar, or the same, high degree of biaxial orientation of their polymer molecules such that each balloon layer of the multi-layer balloon will fail at approximately the same applied pressure.

Abstract: A protective catheter tip has a generally tubular body portion defining an interior cavity. The proximal end of a urinary catheter is at least partially received within the protective tip, with the protective tip being retained on the urinary catheter without the need for a sleeve connecting the protective tip and the catheter. The protective tip may include a projection received within a draining hole or eye at the proximal end of the catheter to retain the protective tip on the catheter. The protective tip may instead include one or more projections that apply a frictional force to an outer surface of the catheter to retain the protective tip on the catheter. The protective tip may instead be retained on the catheter by a tether extending between the protective tip and a distal end of the catheter. The protective tip may also be provided in two pieces.

Abstract: Multi-lumen catheters with improved tip configurations, including a triple-lumen catheter which may be useful for apheresis. In one variation, the catheter has three lumens with distal openings angularly spaced apart and staggered axially with respect to one another. In another variation, the catheter has two lumens exiting distally and one centrally positioned lumen exiting proximally. A third variation is a catheter with a single distal opening and two proximal openings. The staggered lumen openings along the axial length of the catheter may decrease recirculation while maximizing flow rates.

Abstract: A catheter has an entrance opening defined by the first end of a catheter body and non-smooth inner surface. The entrance opening intersects a longitudinal axis extending longitudinally through the center of a lumen adapted to drain urine from a bladder. The non-smooth inner surface can have dimples, channels, or grooves, all of which decrease frictional fluid forces against the inner surface as the urine drains. The catheter is free of any eyelets formed in the side wall of the catheter body. The catheter is further free from any hemispheric tip located at one end.

Abstract: For selective treatment of diseased tissue sections or organ parts, the surface of medical devices entering into contact with areas thereof under pressure is coated with lipophilic substantially water-insoluble medicaments binding to various tissue components with good adherence thereto, said medicaments having an effect thereupon a short time after entering into contact therewith without exerting a harmful influence upon adjacent healthy tissue.

Abstract: For selective treatment of diseased tissue sections or organ parts, the surface of medical devices entering into contact with areas thereof under pressure is coated with lipophilic substantially water-insoluble medicaments binding to various tissue components with good adherence thereto, said medicaments having an effect thereupon a short time after entering into contact therewith without exerting a harmful influence upon adjacent healthy tissue.

Abstract: For selective treatment of diseased tissue sections or organ parts, the surface of medical devices entering into contact with areas thereof under pressure is coated with lipophilic substantially water-insoluble medicaments binding to various tissue components with good adherence thereto, said medicaments having an effect thereupon a short time after entering into contact therewith without exerting a harmful influence upon adjacent healthy tissue.

Abstract: A balloon catheter having wires situated between an outer layer and a surface of a balloon is described. Each wire may be confined within an interior space of a pocket or encapsulated within a sheath. The pocket includes the outer layer and the balloon surface. The outer layer and balloon surface are unattached to allow the wire to slidably fit between therewithin. The pocket is selectively bonded to the balloon. The sheath includes a preformed shape that completely circumscribes the wire along the longitudinal and radial directions of the wire. The confined and encapsulated feature of the wires enable the wires to be atraumatic and remain spaced apart during treatment of calcification of a lesion.

Abstract: A balloon catheter having a shaft, a balloon, and an external delivery tube, as well as methods of use thereof. In one example, the balloon catheter is an agent delivery catheter including a catheter body extending between catheter proximal and distal portions. An inflatable balloon assembly is coupled with the catheter body. An agent delivery assembly, which is coupled with the catheter body and the inflatable balloon assembly, includes a delivery lumen extending through the catheter body and an agent delivery tube extending along an exterior balloon surface. The agent delivery tube includes at least one delivery orifice directed outside of the exterior balloon surface. The agent delivery assembly is isolated from fluid communication with the inflatable balloon assembly.

Abstract: Medical balloons are energetically treated to form regions that facilitate deflation to a desirable configuration.

Abstract: A method of manufacturing a balloon catheter involves applying a first application liquid, which contains a hydrophilic coating material, to the outer periphery of a balloon which is disposed on an elongated catheter and is held in an expanded state; folding the balloon; and applying a second application liquid, which contains the hydrophilic coating material, to the balloon with the balloon folded.

Abstract: Embodiments of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such embodiments can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some embodiments can include a sheath with inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer and a portion of the outer layer overlaps the folded portion of the inner layer. Some embodiments include an elastic outer cover positioned outside the outer layer. Embodiments of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths.

Abstract: The present invention relates to balloon catheters for treating a luminal system of a patient. Specifically, the invention relates to catheters having a flexible membrane positioned at a distal portion of the catheter, the flexible membrane retained in a substantially unexposed conformation prior to deployment. Preferably the flexible membrane is capable of delivering a therapeutic agent to a localized environment when deployed to an exposed conformation.

Abstract: This disclosure relates to medical devices and related methods. In some embodiments, the methods include applying a material to the balloon and then removing the material from one or more regions of the balloon.

Abstract: The present invention relates to balloon catheters for treating a luminal system of a patient. Specifically, the invention relates to catheters having a flexible membrane positioned at a distal portion of the catheter, the flexible membrane retained in a substantially unexposed conformation prior to deployment. Preferably the flexible membrane is capable of delivering a therapeutic agent to a localized environment when deployed to an exposed conformation.

Abstract: A catheter system suitable for the retrieval of debris and other solid or liquid matter from body passages, and the removal of said matter from the body. More particularly, a catheter system including two or more concentrically-arranged conduits and an inflatable element connected therebetween, wherein the inflatable element is arranged such that it may entrap solid or liquid matter in an internal annular cavity.

Abstract: Endoluminally delivered tissue patches and related systems and methods for delivering the tissue patches for treating lesions of the alimentary tract are disclosed. A system for delivering a tissue implant includes a catheter having an expandable member at a distal end portion, a carrier placed around the expandable member, and the carrier configured to expand from a contracted state to an expanded state and to receive the tissue implant. The tissue implant contacts the lesion of the alimentary tract when the expandable member expands the carrier to the expandable state.

Abstract: Apparatus and methods are disclosed for medical treatment comprising bone, tissue or duct dilatation using inflatable dilatation elements together with apparatus and techniques for tensioning, stretching, folding, and/or wrapping the dilatation elements externally as well as in situ to facilitate insertion, positioning and withdrawal procedures.

Abstract: A balloon catheter comprising a catheter tube, an inflatable and deflatable balloon fixed to the catheter tube and a refolding device for folding the balloon onto the catheter tube during balloon deflation, wherein the refolding device includes at least one flap arrangement being fixed on the catheter tube and being disposed within the balloon.

Abstract: A multi-layer inflatable balloon cuff may be adapted to seal a patient's trachea when associated with an endotracheal tube. The outer layer and the inner layer of the balloon cuff may have different material properties that may enhance a cuff's mechanical pressure seal by reducing wrinkles or folds that may form against a patient's tracheal walls.

Abstract: Apparatus and methods are disclosed for medical treatment comprising bone, tissue or duct dilatation using inflatable dilatation elements together with apparatus and techniques for tensioning, stretching, folding, and/or wrapping the dilatation elements externally as well as in situ to facilitate insertion, positioning and withdrawal procedures.

Abstract: Apparatus and methods are disclosed for medical treatment comprising bone, tissue or duct dilatation using inflatable dilatation elements together with apparatus and techniques for tensioning, stretching, folding, and/or wrapping the dilatation elements externally as well as in situ to facilitate insertion, positioning and withdrawal procedures.

Abstract: A catheter balloon is configured to improve its fold-in or collapsing behavior. The catheter balloon has a balloon body portion, a first tapered end portion and a second tapered end portion. The balloon body portion has a substantially cylindrical shape in an expanded state. The first tapered end portion is formed at a first end of the balloon body portion. The first tapered end portion includes a first predetermined embossment. The second tapered end portion is formed at a second end of the balloon body portion. The second tapered end portion includes a second predetermined embossment. The balloon body portion is formed free of a predetermined embossment. In other words, the balloon body portion is formed without folds so that there is only predetermined folding on the conical end portions for inducing the folding of the balloon body portion in a predetermined direction upon collapsing.

Abstract: A method and device that addresses the problem of an incompetent aortic valve by using a simple cardioplegia catheter that can deliver cardioplegia solution to the coronary arteries through the usual aortic cannulation site even in the presence of aortic valve incompetence. The device includes a cardioplegia cannula (32) with an additional lumen containing a nitinol wire (34) inside it that allows advancement of a folded nitinol umbrella (36) with a non-porous membrane or a compressed nitinol ring that covers the aortic valve when opened. During installation, after puncture of the aorta by the coaxial needle and removal of the coaxial needle but before installation of the cardioplegia solution through the central lumen of the catheter, the nitinol umbrella (in folded position) or nitinol ring (in compressed position) is advanced through the second lumen into the aorta just above the aortic valve.

Abstract: Medical balloons are described that have modified regions that enhance folding of the balloon.

Abstract: The present invention provides apparatus and methods for facilitating folding of a balloon before, during or after a medical procedure. In a first embodiment, the apparatus generally comprises at least one catheter shaft member, a balloon disposed on a distal region of the catheter shaft member, and at least one folding member disposed along at least a proximal region of the balloon. The folding member may comprise at least one radially-outward projecting member integrally formed with or attached to the balloon, or an internally-formed groove in the balloon, which is adapted to promote twisting of the balloon to reduce the profile of the balloon in the deflated state. Optionally, biasing members may be disposed between the folding member and an adjacent portion of the balloon to promote folding of the balloon in a clockwise or counter-clockwise direction.

Abstract: A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon. The non-compliant medical balloon is composed of a matted fabric layer composed of at least two matted fabric fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: A perfusion guidewire is disclosed. The perfusion guidewire includes an elongate core member and a collapsible sheath tightly wrapped around at least the distal portion of the elongate core member such that the wrapped sheath is folded upon itself, forming a plurality of layers of material in a radial direction from the longitudinal axis of the elongate core member. The wrapped sheath is tightly wrapped about the elongate core member such that the wrapped sheath and elongate core member travel as a unit during navigation within the blood vessel of the body of a patient. The wrapped sheath is expandable to a larger diameter in order to allow a perfusate to pass through the lumen of the sheath.

Abstract: A device for folding a balloon of a balloon catheter onto a catheter tube during a balloon deflation includes a first band positioned on the catheter tube distal to the balloon and a second band positioned on the catheter tube proximal to the balloon. One or more elastic member(s) are attached to and extend between the bands for interaction with the outer surface of the balloon. During a balloon deflation, the elastic members cooperate to fold the balloon into pleats. When used on a cutting balloon, each elastic member is formed with a slot to allow a respective blade of the cutting balloon to extend through the elastic member. The elastic members fold the cutting balloon into a configuration in which each blade becomes nestled within a pair of adjacent balloon pleats to prevent the blade from inadvertently incising tissue during an in-vivo movement of the balloon catheter.

Abstract: An outer balloon is provided in the interior thereof with a coil conductor for a local endo coil for intracorporeal placement for recording magnetic resonance signals, which can be deployed for the purpose of receiving signals. In addition to the coil, a filling medium is fed into the balloon, so that the deployed coil conductor is surrounded at least in sections by at least one material having a dielectric constant ?r>1.

Abstract: An injection needle assembly including an injection needle, which can pierce body tissue, and a needle guide, which can be placed on the body tissue and axially stabilizes the injection needle against flexure and cracking.

Abstract: An actuator for an interventional surgical procedure is described. The actuator may include an actuator body having a distal end and a proximal end. A central expandable section is located between the distal end and the proximal end. The expandable section is operable between an unactuated condition in which the expandable section is in a furled state and an actuated condition in which the expandable section is in an unfurled state. A needle is located at the expandable section. The needle is moveable in an approximately perpendicular direction relative to a central longitudinal axis of the actuator body from a position within the actuator body to a position outside of the actuator body.

Abstract: An actuator for an interventional surgical procedure is described. The actuator may include an actuator body having a distal end and a proximal end. A central expandable section is located between the distal end and the proximal end. The expandable section is operable between an unactuated condition in which the expandable section is in a furled state and an actuated condition in which the expandable section is in an unfurled state. A needle is located at the expandable section. The needle is moveable in an approximately perpendicular direction relative to a central longitudinal axis of the actuator body from a position within the actuator body to a position outside of the actuator body.

Abstract: Apparatus and methods for ablating tissue surrounding a tubular anatomical structure such as the wall of a blood vessel or prostatic tissue surrounding the urethra. The apparatus includes an ultrasonic emitter such as a cylindrical emitter and an inflatable annular lens balloon surrounding the ultrasonic emitter. The lens balloon is inflated with a liquid having acoustic velocity different than that of the surrounding medium, so as to form an annular refracting surface. The acoustic energy from the emitter is focused into an annular focal region.

Abstract: A perfusion guidewire is disclosed. The perfusion guidewire includes an elongate core member and a collapsible sheath tightly wrapped around at least the distal portion of the elongate core member such that the wrapped sheath is folded upon itself, forming a plurality of layers of material in a radial direction from the longitudinal axis of the elongate core member. The wrapped sheath is tightly wrapped about the elongate core member such that the wrapped sheath and elongate core member travel as a unit during navigation within the blood vessel of the body of a patient. The wrapped sheath is expandable to a larger diameter in order to allow a perfusate to pass through the lumen of the sheath.

Abstract: Apparatus and method are provided for treatment of a bifurcation of a body lumen. The apparatus includes an elongated catheter body having a proximal end and a distal end. A balloon is associated with the distal end of the balloon catheter. The balloon includes a main vessel balloon for treating a main vessel of the bifurcation, and a branch vessel balloon for treating a branch vessel of the bifurcation. The branch vessel balloon includes an accordion configuration capable of being expanded from an unexpanded collapsed accordion configuration to an expanded accordion configuration extending into the branch vessel.

Abstract: The present invention provides balloon dissection apparatus and methods of use in which an elongate balloon is utilized to dissect along a region that follows a naturally existing path alongside a vessel or structure, such as an artery, a vein, a lymphatic, the trachea, the esophagus or even a nerve bundle.

Abstract: A device for folding a balloon of a balloon catheter during balloon deflation includes a band and a plurality of elongated fingers that are attached to the band. The band includes a midsection and a pair of overlaps with each overlap extending from the midsection to a respective end of the band. The band is folded into an annulus wherein the overlaps are juxtaposed and can be joined together by soldering, welding or adhesive bonding. The annulus is attached to the catheter tube of the balloon catheter with the fingers extending over the balloon in a substantially same axial direction. In operation, the fingers are moveable between an unstressed configuration, when the balloon is deflated, and a stressed configuration, when the balloon is inflated. In a stressed configuration, the fingers urge against the balloon and are biased toward the stressed configuration to return to an unstressed configuration.

Abstract: A method and apparatus for protecting a balloon of a balloon catheter from damage prior to inserting the balloon catheter into a body lumen. The balloon protector comprising a tube of synthetic material having a reduced inside diameter which is drawn about the catheter balloon. The balloon protector retaining the catheter in a reduced configuration. The material of the balloon protector including a kinked portion which provides the protector with an area that will draw inward toward and against the catheter when the ends of the protector are drawn longitudinally in opposite directions.

Abstract: The present invention relates to a tracheal ventilating device, especially a tracheal tube or tracheal cannula which obturates the trachea as hermetically as possible for ventilating a patient, the device comprising a cuffed balloon which blocks the trachea below the glottis and through which a ventilating cannula is passed, with the cuffed balloon when filled or inflated and freely unfolded without any limitation, being larger than when placed in the trachea in an inflated state, and being made from a soft flexible foil material. To intubate a patient with said device as gently as possible at low pressures over a long period of time and with a low risk of infection, the invention suggests that the draped fold of the cuffed balloon should rest on the trachea and be designed in such a way that the loop created at the dead end of a fold has a small diameter which inhibits the free flow of secretion through the loop of said fold.

Abstract: A retention member and a feeding tube having a feeding lumen and an inflation lumen. The retention member including a sleeve section, an expandable section, and a shoulder section of decreasing wall thickness therebetween. The sleeve section sealingly engages the feeding tube distal end and the expandable section everts about the shoulder section to sealingly engage the feeding tube and define an expandable lumen in communication with the inflation lumen.

Abstract: A vascular introducer is disclosed which includes an elongated primary sheath defining an interior lumen and having opposed proximal and distal end portions, and at least an elongated secondary sheath disposed within the interior lumen of the primary sheath and adapted for movement from a collapsed condition to an open condition in response to insertion of a dilator through an interior lumen thereof.

Abstract: A balloon catheter for dilating a stenotic region of a patient's body lumen such as an artery or for the implantation of an expandable stent within a patient's body lumen. The balloon of the catheter has a plurality of canted wings which are inclined at an angle of about 15° to about 75°, preferably about 30° to about 60° from a line tangent to an inner tubular member extending within the interior of the balloon.