Abstract: A system for facilitating fluid connection between cannulae and a blood pump. The system includes a cannula having a distal end adapted to be in fluid communication with the circulatory system and a proximal end configured to couple to an inlet of the blood pump. Further included is a tunneling device configured to be inserted into a body of a patient to direct the proximal end of the cannula adjacent to the inlet and including a second connecting structure. Further included is a plug which has a first plug part and a second plug part. The first plug part includes a second connecting structure, the first and second connecting structures being selectively engageable. The second plug part is configured to be inserted in the proximal end of the cannula. The first and second plug parts are selectively disengageable to allow in situ disconnection between the cannula and tunneling device.

Abstract: The invention relates to a balloon catheter comprising a catheter tube, an inflatable balloon, the ends of which are attached to the catheter tube, and a stent attached around the balloon. The stent extends at least partly along the length of the balloon. In an uninflated state, at least the outside surface of the balloon not covered by the stent is provided with a relief structure which is substantially disappeared in an inflated state of the balloon. The invention also relates to a method for manufacturing such a balloon catheter.

Abstract: An embolic protection device comprising an expandable structure and a catheter. The catheter has a distal region and a working channel dimensioned to slideably receive an interventional device. The expandable structure is attached to the distal region of the catheter. The expandable structure has an expandable working channel extension and a working channel opening, the expandable working channel extension has a proximal end and a distal end, the proximal end of the working channel extension is attached to a distal end of the working channel, and the distal end of the working channel extension forms the working channel opening. The working channel opening is disposed proximate an exterior surface of the expandable structure when the expandable structure is expanded. The working channel, working channel extension, and the working channel opening form a continuous lumen.

Abstract: An intravascular catheter is positionable within a blood vessel for use in transvenous stimulation of targets external to the wall of the blood vessel. The catheter includes a catheter body, a support at the distal end of the catheter body, and a plurality of electrodes carried by the support. At least a portion of the support being inflatable within the blood vessel to bias at least a portion of the plurality of electrodes into contact with the blood vessel wall.

Abstract: A method for dilating a stenotic region in an airway of a patient may include advancing a balloon catheter through the airway of the patient to position an inflatable balloon of the catheter within at least a portion of the stenotic region, maintaining a position of the catheter relative to the patient, and inflating the balloon of the catheter to dilate the stenotic region of the airway. A system for dilating a stenotic region in an airway of a patient may include a catheter shaft having an overall length of less than 70 cm, an inflatable balloon disposed along a distal portion of the catheter shaft, and a stylet.

Abstract: The present invention provides insertable medical devices having elastic surfaces associated with bioactive agent-containing microparticulates and a coating material. Upon expansion of the elastic surfaces the microparticulates can be released to a subject.

Abstract: A medical device includes an expandable element for location in a blood vessel. The expandable element is movable between a collapsed configuration and an expanded configuration. In the expanded configuration, at least a part of a longitudinal axis of the expandable element is curved in three-dimensional space. The medical device can be stent deployment device which includes an elongate catheter shaft and an inflatable balloon.

Abstract: A thrombectomy catheter includes a catheter body having first and second lumens formed therein, and a flow directing mechanism upon a distal body end forming a channel for conveying fluid between an outlet and an inlet fluidly connected with the first and second lumens. The channel axially and circumferentially advances about the catheter body, and is positioned between the outlet and inlet such that fluid conveyed by the channel enters a suction stream flowing to the inlet and entraining material of disrupted thrombus.

Abstract: A drug coating layer which is a drug coating layer having a morphological form including a plurality of elongated bodies having long axes that each crystal of a water-insoluble drug independently has on a substrate surface, in which the long axes of the elongated bodies are nearly linear in shape, and the long axes of the elongated bodies form an angle in a predetermined range with respect to a substrate plane with which the long axis of the elongated body intersects. The drug coating layer can provide low toxicity and a high intravascular stenosis inhibitory effect.

Abstract: A device, system, and method for enhancing cooling uniformity and efficiency of cryogenic fluids and providing a treatment element the shape of which can be adjusted for multiple purposes. The device may include a balloon catheter and fluid dispersion element, the fluid dispersion element directing the flow of coolant from a fluid injection element the interior wall of the balloon. The method of changing the shape of the treatment element may include retracting and extending a shaft to which the distal neck of a balloon is coupled, so that the balloon goes from a first shape to a second shape.

Abstract: An apparatus is provided that is operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including proximal and distal ends, a lumen extending there between, and a balloon on the distal end. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The valve may be biased to be closed, e.g., by a spring element disposed within the balloon. Optionally, the apparatus also includes an actuator for expanding a helical member within the balloon interior, e.g., either before or after expanding the balloon, such that the helical member and balloon may adopt an expanded helical shape for removing material within a body lumen.

Abstract: Interventional procedures on the carotid arteries are performed through a transcervical access while retrograde blood flow is established from the internal carotid artery to a venous or external location. A system for use in accessing and treating a carotid artery includes an arterial access device, a shunt fluidly connected to the arterial access device, and a flow control assembly coupled to the shunt and adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state. The flow control assembly includes one or more components that interact with the blood flow through the shunt.

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 device for fracturing calcifications in heart valves including a catheter (12, 22, 42) configured for percutaneous delivery to a heart valve, an fracture-producing element (14, 26, 46, 64, 66,82, 124, 152) disposed at a distal portion of the catheter and operative to vibrate and mechanically fracture calcifications when brought into contact with a calcification at a leaflet of the heart valve, and an energy source (34, 47, 79, 98, 152) operative to vibrate the fracture-producing element so that the fracture-producing element fractures the calcification without necessarily removing the calcification from the leaflet. The device may further comprise a valvuloplasty balloon (30), an embolic protection net (56) and a protective sleeve (110, 130).

Abstract: Systems and methods are adapted for treating the carotid artery. The systems include interventional catheters and blood vessel access devices that are adapted for transcervical insertion into the carotid artery. Embodiments of the systems and methods can be used in combination with embolic protection systems including blood flow reversal mechanisms, arterial filters, and arterial occlusion devices.

Abstract: A balloon catheter is provided that may be used to dilate hardened regions of a stenosis. The balloon catheter is provided with one or more dilation elements that extend along a surface of a balloon. Each dilation element is connected to an outer surface of the balloon by a connector. The connector is sufficiently sized and designed to undergo stress-induced plastic deformation incurred during blow molding so that a significant portion of each of the dilation elements does not become absorbed into the wall of the final blow molded balloon, thereby maintaining the structural integrity of each of the dilation elements.

Abstract: A medical device having an elongate support structure and an inflatable balloon including a first-end portion secured to the support structure at a first location, a second-end portion secured to the support structure at a second location distal to the first location, and a middle-body portion. The first-end portion has a wall thickness greater than a wall thickness of the middle-body portion; the balloon defines a sealed interior through which the support structure extends. The balloon being stretch-mounted to the support structure in tension relative to the support structure; the balloon is formed in a diamond-like configuration that transitions to a substantially spherical configuration when the balloon is inflated to a inflation pressure that is at least about ten percent greater than atmospheric pressure, such that when inflated to the inflation pressure and anchored in an anatomical body region, resists movement of the support structure relative to the balloon.

Abstract: A medical device for treating a heart valve insufficiency, with an endoprosthesis which can be introduced into a patient's body and expanded to secure a heart valve prosthesis in the patient's aorta with a catheter. In an embodiment, the endoprosthesis has a plurality of positioning arches configured to be positioned with respect to a patient's aorta and a plurality of retaining arches to support a heart valve prosthesis. The endoprosthesis includes a collapsed mode during the process of introducing it into the patient's body and an expanded mode when it is implanted. The endoprosthesis may be introduced into a patient's body and expanded via a catheter. In an embodiment, the catheter has first and second slide mechanisms configured to independently manipulate first and second sleeve elements to sequentially expand the endoprosthesis from the collapsed mode to the expanded mode.

Abstract: A device for treating pulmonary hypertension includes an inflatable balloon structure (1), an implantable port (9), and a conduit (2) connecting the balloon (1) and the implantable port in a sealed manner. The balloon, the port and the conduit are filled with a gas, and the pressure is such that the balloon (1) is normally inflated but is capable of being compressed during systole. The inflatable balloon (1) has first and second segments sized to extend into the left branch and the right branch of the pulmonary artery bifurcation respectively. The conduit (2) may connected in a T-junction to a middle portion of the balloon (1) or may be bifurcated into first and second branches (12a,12b) which are connected to the first and second balloon segments (13a,13b), respectively. The device may also have guide tubes opening at the longitudinal ends of the balloon (1) and guide wires (4, 6) engaged and capable of sliding in said guide tubes.

Abstract: A method for capturing dislodged vegetative growth during a surgical procedure is provided. The method includes maneuvering, into a circulatory system, a first cannula having a distal end and an opposing proximal end, such that the first cannula is positioned to capture the vegetative growth en bloc. A second cannula is positioned in fluid communication with the first cannula, such that a distal end of the second cannula is situated in spaced relation to the distal end of the cannula. A suction force is provided through the distal end of the first cannula so as to capture the vegetative growth. Fluid removed by the suction force is reinfused through the distal end of the second cannula. Subsequent to becoming dislodged, the vegetative growth is captured by the first cannula. A method for capturing a vegetative growth during removal of a pacemaker lead is also provided.

Abstract: A device for occluding a target body lumen, comprises a wire structure defining a wire structure lumen extending therethrough and movable between a reduced diameter insertion configuration and an expanded diameter deployed configuration and a basket structure extending across the wire structure lumen and including therein a cell growth promoting agent to promote cell growth across the wire structure lumen to occlude the target body lumen.

Abstract: The present invention provides minimally invasive devices and methods for accessing the sinuses and their surrounding structures for surgery and other treatments. The anterior ethmoid and maxillary sinuses are accessed and treated under minimal anesthesia with little or no postoperative limitation of activity or adverse symptoms. Direct visual verification of the sinuses and their natural ostia is utilized. Other paranasal sinuses may be treated by this method as well. The sinuses, in particular the maxillary and anterior ethmoid, are accessed via a direct anterior to posterior axis and the natural ostia of those sinuses is directly visualized for placement of a guide-free dilator, in the desired location within the natural ostia. That access to the maxillary ostium is accomplished by the anterior transuncinate “keyhole” approach in which a hole is punched in the uncinate process with the described devices according to the described methods.

Abstract: Systems and methods are adapted for treating the carotid artery. The systems include interventional catheters and blood vessel access devices that are adapted for transcervical insertion into the carotid artery. Embodiments of the systems and methods can be used in combination with embolic protection systems including blood flow reversal mechanisms, arterial filters, and arterial occlusion devices.

Abstract: A catheter is described herein, having a catheter shaft including a proximal end and a distal end, a tip attached to the distal end, including first and second legs spaced apart to form a slot therebetween, the slot in fluid communication with a lumen of the catheter shaft, and a bladder inflatable element positioned over an outer surface of at least one of the first and second legs.

Abstract: A system for performing angioplasty and a method of utilizing same are provided. The system includes a balloon mounted on a catheter shaft and an expandable constraining structure mounted over the balloon. The expandable constraining structure includes a plurality of axial struts crossing a plurality of radially-expandable rings being for constraining said balloon such that isolated balloon regions protrude through openings in said constraining structure when the balloon is inflated.

Abstract: A balloon catheter is provided that may be used to dilate hardened regions of a stenosis. The balloon catheter is provided with dilation elements that extend along a surface of a balloon. The dilation elements may comprise a coil and dilation wire. The coil and wire may be configured in various ways such that inflation of the balloon creates a concentration of forces along the dilating wires which are thereafter transmitted to stenosed regions of a vessel wall. The force exerted by the dilation elements against the stenosed region is sufficient to fracture plaque from the vessel wall.

Abstract: A constraining structure for use with a balloon catheter can include multiple longitudinal struts and multiple, sinusoidal shaped radial rings. The constraining structure can expand to form a pattern of channels including substantially square windows. The constraining structure can modify, restrict, and control a shape and/or size of the balloon when inflated. Inflating the balloon catheter within the constraining structure can provide nonuniform pressure on a vessel wall adjacent the balloon.

Abstract: An inflatable balloon includes a base balloon having a cylindrical section and a conical section and at least one circumferential fiber extending circumferentially around the conical section. The inflatable balloon includes a plurality of reinforcing strips in the conical section over the at least one circumferential fiber. Each reinforcing strip includes a plurality of fibers extending at an angle relative to the at least one fiber. Each reinforcing strip is positioned a set circumferential distance away from a neighboring reinforcing strip.

Abstract: A balloon catheter includes 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 first and second spaced conical end sections and a working surface between the conical sections. The balloon further includes at least one radiopaque marking identifying the transition from the conical end section to the working surface. Related aspects are also disclosed.

Abstract: The invention relates to a balloon catheter comprising a catheter tube and an inflatable balloon. The ends of the balloon are attached to the catheter tube. The outside surface of the balloon in an uninflated state is provided with a relief structure which in an inflated state of the balloon is substantially disappeared. The invention also relates to a method for producing such a balloon catheter.

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: An apparatus for dilating an upper esophageal sphincter. The apparatus includes an elongated expandable member having a cross-section shaped to support a natural shape of an upper esophageal sphincter. A catheter extends from the elongated inflatable member.

Abstract: A dilatation balloon is fabricated according to a process that forms cavities and indentations in the balloon and/or catheter sections. A length of tubing is axially elongated and radially expanded in a form to provide the requisite biaxial orientation and strength. Then, an excimer laser or another type of laser or mechanical material removal tool is used to remove the polymeric material, virtually without thermal effects. Cavities in the sleeve sections of the balloon are defined and if desired, indentations in the cone sections are defined. Material removal, particularly near the balloon sleeves enables a thinner, more flexible bonding area between the catheter shaft and the balloon. Further, the indentations along the cone sections enables tighter wrapping of the balloon for a reduced delivery profile. Rigidity near the sleeves is reduced for better maneuverability of the catheter in tortuous passageways.

Abstract: Reinforced angioplasty balloon having an external elastic sheath. The elastic sheath maintains, along its length, a substantially uniform circular cross-section during balloon inflation and forces a deflated balloon into a compacted, substantially circular, wingless profile.

Abstract: A medical device system with pressurized balloon having a radial wrap configuration yields improved withdrawal force, and has pre-stressed struts for reinforcing at fold points for ease of inflation, deflation, and heightened radiopacity.

Abstract: A reinforced composite balloon may comprise a body layer and a reinforcing layer. The reinforcing layer may comprise a single-layer structural network having a plurality of apertures. The reinforcing layer may be molded from a reinforcing tube having a plurality of apertures or aperture precursor holes.

Abstract: An apparatus is presented for use with a biologically-compatible-fluid pressure source.

Abstract: A method of treating early papillomavirus infection of an orifice of a human or animal body including any canal associated with an orifice, comprising applying a viral inactivation agent to the orifice and/or canal in an amount effective to inactivate a portion of the virus infecting the orifice or canal. Apparatus is also disclosed.

Abstract: A controlled volume inflation-deflation device to inflate a balloon to occlude a blood vessel by dialing a knob that locks at rotational positions to locate a plunger at equally spaced locations within a syringe of the inflation-deflation device. The inflation-deflation device includes a releasable latch to lock the proximal and distal housings together to hold the plunger forward for occlusion, and to separate and hold the proximal and distal housings to retract the plunger for perfusion. When the inflation-deflation device is returned to the latched position, the balloon is re-inflated to its previous occlusive diameter. Also, an extension tube made of a lower modulus outer material co-extruded over and miscible with a higher modulus inner material may be used to produce a suitably low compliance extension tube for the inflation-deflation device.

Abstract: An insertion portion rigidity changeable catheter with a balloon has an insertion portion including a coil-shaped member which is extensible and contractible, with a compression length set to be a predetermined length, and a sheath which is a tube body with flexibility having a fluid conduit, includes a sheath main body surrounded by the coil-shaped member, and a sheath end portion provided at one end side of the sheath main body, and having a contact surface which one end surface of the coil-shaped member contacts, has one opening of the fluid conduit in the sheath end portion and has another opening of the fluid conduit at another end side of the sheath main body, an inflatable/deflatable balloon which is inflated by being supplied with a fluid via the one opening of the fluid conduit to expand to a diameter larger than an outside diameter of the sheath end portion, and is deflated by the fluid being discharged via the one opening to be brought into close contact with an outer circumferential face of the sh

Abstract: Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The first balloon may have various configurations including being tapered relative to the second balloon. The second balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.

Abstract: A valvuloplasty catheter has a dog-bone shaped balloon with semi-compliant smaller diameter waist and non-compliant larger diameter bulbous end regions. The balloon centers across the valve with the waist adjacent to the annulus. One bulbous region serves to hyperextend the valve leaflets and the other assists in stabilizing the balloon position to reduce migration. The semi-compliant waist increases in diameter as fluid enters the balloon until it comes into contact with the valve annulus. The pressure within the balloon per unit of volume delivery has a greater slope after contact with the annulus than before resulting in a change in slope for the pressure versus volume curve. The diameter of the balloon and annulus are determined at this inflection point when the balloon contacts the annulus.

Abstract: A device for transanally introducing an infusion into the rectum of a patient, the device comprising an inflatable balloon having a waisted shape, two terminal sections of larger radius and, a middle section of a reduced radius, and is placed transanally, the distally adjoining radially enlarged balloon section being placed intrarectally and the proximally adjoining radially enlarged balloon section extracorporeally, wherein both balloon ends taper to the dimension of a shaft supporting the balloon and are fixed on the surface of the shaft such that as the balloon is filled, the two enlarged balloon sections move toward each other in opposite axial directions, and wherein the two radially enlarged balloon sections are enlarged relative to the middle balloon section, such that when the balloon is placed transanally, during the filling process the two radially enlarged balloon sections draw down over the middle, balloon section and contact each other, and to a method for filling the catheter balloon.

Abstract: A device and method for minimizing exposure of soft mucosa tissues to radiation, the device including a low-volume intracavity balloon catheter having multiple expansion portions, including an isometrically expanding portion and a substantially planar anterior portion.

Abstract: A process for forming a catheter balloon includes subjecting a tubular parison in a mold to molding fluid pressure. The resulting catheter balloon includes a balloon portion having two ends and tubular leg portions extending from either end. The ends of the balloon portion are tapered to the tubular leg portions. The tapered ends have alternating elongate areas of greater and lesser resistance to deformation displaced circumferentially about the tapered ends. The elongate areas of greater and lesser resistance to deformation can include ridges which are either longitudinal or spiraled or rods imbedded in the body of the balloon. While in the mold, the tubular legs are drawn axially sufficiently to form permanent creases in the tapered ends. This drawing may be sufficient to cause the material of the tapered ends to exceed the yield strength, particularly with the balloon material in a malleable state.

Abstract: An expandable balloon for insertion in a fluid conduit of a human or animal body is movable between a collapsed condition and an expanded condition. The balloon has, when in the expanded condition, a center line which follows a substantially helical path. The balloon can be combined with a stent such that the stent is expandable by the balloon from a collapsed condition to an expanded condition.

Abstract: A balloon and method of making a balloon catheter is provided. The balloon for the balloon catheter may be made by slicing through an integral dilation element on a parison (10). The parison may then be stretched to spread the slices to form wider gaps (20). The gaps define separate dilation element segments (14), which may make the balloon more flexible.

Abstract: A balloon or balloon cover comprising a composite material having a least one expanded fluoropolymer material and an elastomer is provided. The expanded fluoropolymer material can contain serpentine fibrils. In exemplary embodiments, the fluoropolymer is polytetrafluoroethylene. The composite material may be axially, helically, and/or circumferentially wrapped to form a balloon or balloon cover. The balloon or balloon cover exhibits a sharp increase in stiffness at a predetermined diameter. The balloon or balloon cover can be designed to have a stop point in either a radial or axial direction.

Abstract: A method for capturing dislodged vegetative growth during a surgical procedure is provided. The method includes maneuvering, into a circulatory system, a first cannula having a distal end and an opposing proximal end, such that the first cannula is positioned to capture the vegetative growth en bloc. A second cannula is positioned in fluid communication with the first cannula, such that a distal end of the second cannula is situated in spaced relation to the distal end of the first cannula. A suction force is provided through the distal end of the first cannula so as to capture the vegetative growth. Fluid removed by the suction force is reinfused through the distal end of the second cannula. Subsequent to becoming dislodged, the vegetative growth is caputred by the first cannula. A method for capturing a vegetative growth during removal of a pacemaker lead is also provided.

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.