Abstract: The present invention refers to medical devices comprising a modified Co-Polymer or to the modified Co-Polymer itself having high flexibility and high stress resistance, especially tensile strength or tear resistance, in addition to the good physical characteristics of a Block-Co-Polymers of a polyamide and a polycarbonate, either polycarbonate diol or polycarbonate diamine.

Abstract: A system comprising a catheter having an expandable element, which when expanded, has an annular shape surrounding a passageway. The expandable element in the expanded state is rollable along at least a portion of the shaft of the catheter without slipping. The system may be used for delivering an object to a site in the body, retrieving an object from a body, removing debris and/or other particulate matter from a blood vessel, and distending and/or expanding a pathologically-involved region of a blood vessel wall.

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: Embodiments of handheld devices for dilating tissue along the paranasal sinuses include a handle assembly that includes a grip portion, an inflation mechanism, and a digital actuation member configured to actuate the inflation mechanism. The handheld devices also include a rigid cannula that includes a distal end and a proximal end, where the rigid cannula is coupled to the handle assembly along the proximal end. The handheld devices further include an inflatable balloon coupled to an outside of the rigid cannula proximate to the distal end, an inflation lumen at least partially disposed along the rigid cannula and in fluid communication with the inflatable balloon and the inflation mechanism, and an aspiration lumen at least partially disposed along the rigid cannula and includes an aspiration port proximate to the distal end.

Abstract: A catheter-based/intravascular fluid injection system with application to renal denervation includes a multiplicity of needles which expand open around a central axis to engage the wall of a blood vessel, or the wall of the left atrium, allowing the injection of a cytotoxic and/or neurotoxic solution for ablating conducting tissue, or nerve fibers around the ostium of the pulmonary vein, or circumferentially in or just beyond the outer layer of the renal artery. The expandable delivery system includes expandable components that facilitate positioning of a multiplicity of injection needles against the inside wall of a blood vessel from where they can be advanced. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into the tissue of the wall of the targeted blood vessel.

Abstract: Devices, systems, and methods for delivery of therapeutics, in particular thrombolytic agents, in particular plasmin, are provided. The devices, systems, and methods also provide for occlusion of a vessel or graft distal and/or proximal to a treatment zone. Also provided are devices, systems, and methods that trap emboli.

Abstract: A catheter having an elongated shaft with a tubular member which forms at least a portion of the shaft and which is formed of a biaxially oriented thermoplastic polymeric material, and a method of forming the catheter shaft by radially and longitudinally expanding the tubular member to biaxially orient the polymeric material, and, in one embodiment, tapering the tubular member to form a bending stiffness transition. A catheter of the invention has an improved combination of low bending stiffness, high rupture pressure, and high tensile strength, for improved catheter performance.

Abstract: A method of reducing the risk of clinical sequelae to catheter induced vascular injuries may include introducing a guide wire into a vascular sheath residing in a blood vessel, proximally retracting the vascular sheath while leaving the wire in place, and observing indicia of the presence or absence of a vascular injury caused to the blood vessel by the vascular sheath or a procedural catheter previously advanced through the vascular sheath. If indicia of a vascular injury are observed, the method may further involve proximally retracting the guide wire to position the inflatable balloon adjacent the injury and inflating the balloon to reduce blood flow past the injury, while leaving the guide wire in place to provide subsequent access to the injury.

Abstract: Methods and intravascular treatment devices for treating atherosclerosis are provided.

Abstract: A method for delivering a therapeutic substance to a treatment site within a body lumen includes advancing a balloon catheter to the treatment site. A balloon of the balloon catheter is inflated and while the balloon is inflated, a primer that coats the treatment site and attracts the therapeutic substance thereto is delivered through a first fluid delivery lumen of the balloon catheter. The balloon of the balloon catheter is deflated for a predetermined period of time. The balloon of the balloon catheter is reinflated and while the balloon is reinflated, the therapeutic substance is delivered through a second fluid delivery lumen of the balloon catheter. The primer improves adherence of the therapeutic substance to the treatment site.

Abstract: An angioplasty assembly having a guidewire device for use in peripheral vascular and coronary angioplasty applications. The guidewire invention has one or more angioplasty devices mounted directly on the distal tip of the guidewire. In one embodiment the angioplasty device includes an angioplasty balloon. In another embodiment, the device includes a stent balloon with expandable stent, or a self-expanding stent, or combinations of these. Preferably, the guidewire is housed within a hypotube. Optionally, the hypotube may house a retractable piercing element with a distal loop 3 suitable for piercing a vessel wall. The guidewire allows an angioplasty procedure to be completed using a single device.

Abstract: The methods, systems, and devices disclosed herein generally involve convection-enhanced delivery of drugs to a target region within a patient. Microfluidic catheter devices are disclosed that are particularly suitable for targeted delivery of drugs via convection, including devices capable of multi-directional drug delivery, devices that control fluid pressure and velocity using the venturi effect, and devices that include conformable balloons. Methods of treating various diseases using such devices are also disclosed, including methods of treating cerebral and spinal cavernous malformations, cavernomas, and hemangiomas, methods of treating neurological diseases, methods of treatment using multiple microfluidic delivery devices, methods of treating hearing disorders, methods of spinal drug delivery using microfluidic devices, and methods of delivering stem cells and therapeutics during fetal surgery. Methods of manufacturing such devices are also disclosed.

Abstract: A method of increasing blood flow through an obstructed blood vessel includes providing an expandable member substantially made of a mesh having a plurality of interstices. The expandable member is inserted into the blood vessel, positioned within the blood vessel with the proximal member end upstream of the distal member end and the member body located radially adjacent at least a portion of an obstruction, and expanded to bring at least a portion of the member body into contact with the obstruction. An outward radial force is exerted on the obstruction to dislodge at least one fragment from the obstruction and to enhance blood flow through the blood vessel past the obstruction. The at least one fragment is passed through at least one interstice of the member body in the radial direction, and is selectively retained within the expandable member.

Abstract: A catheter for delivery of sclerosant to a tubular member or vein of the body to cause ablation. The catheter has one or more balloons located near the distal end to enhance effectiveness of the sclerosant and prevent its delivery to the deep venous system. The catheter has an orifice located near the distal end of the catheter to direct the sclerosant into the vessel and one or more effluent openings to provide for removal of the sclerosant fluid. A heating member such as an electrical resistance element, a Laser probe, or an RF electrode located within the catheter lumen or on the outside of the catheter shaft heats the sclerosant fluid to improve its ablation effectiveness.

Abstract: A catheter is provided that includes an external sheath, a rotatable conduit housed within the external sheath, and a fluid rotary joint having a rotatable insert that places an inner lumen of the rotatable conduit in fluid communication with an external port under rotation of the rotatable conduit. The rotatable insert may include a channel structure including an external annular channel. The rotatable conduit is received within the channel structure such that the inner lumen is in fluid communication with the external port through the annular channel under rotation. The external sheath may define an outer lumen that may be in fluid communication with the inner lumen at a location remote from a proximal portion of the catheter, and the outer lumen may be in fluid communication with a secondary port. The rotatable conduit may be housed within a torque cable that is connected to the rotatable insert.

Abstract: An angioplasty catheter assembly having an anchoring catheter within a guide catheter such that the anchoring catheter anchors to the guide catheter and the inner wall of a coronary artery; the anchoring catheter has an opening in its tubular wall such that a guide wire and balloon dilatation catheter can be disposed therethrough and extending through the length of the anchoring catheter.

Abstract: There are disclosed apparatus and methods for treating tissue by delivering at least one therapeutic agent into the tissue. In one embodiment, the apparatus comprises a catheter (30, 40) and a balloon member (150) disposed on a distal region of the catheter. A plurality of pockets (164) are disposed on the balloon member (150), and a plurality of needles (180) are associated with each of the plurality of pockets. The plurality of needles (180) are configured to engage tissue when the balloon (150) is in the inflated state, and further are configured to disperse a therapeutic agent from an associated pocket (164) into the tissue when the balloon (150) is in the inflated state. A first needle (180a) of the plurality of needles may comprise a length that is different than a second needle (180b), permitting the delivery of first and second therapeutic agents to different depths within the tissue.

Abstract: The invention generally relates to method and apparatus for crossing an obstruction in a tubular member, and more particularly to a medical device method for crossing of a chronic occlusion in a subintimal or interstitial space of an artery.

Abstract: A hydrophilic, lubricious coating for a substrate includes a first coating layer having a cross-linked polyurethane or polyurea complexed with poly(ethylene oxide) formed by reacting a mixture of an isocyanate, a polyol or polyamine, and a poly(ethylene oxide), and a second coating layer having a cross-linked polyurethane or polyurea complexed with polyvinylpyrrolidone formed by reacting a mixture of an isocyanate, a polyol or polyamine, and a polyvinylpyrrolidone. The first layer is substantially covered by the second layer and the second layer at least partially interpenetrates the first layer. The coating is provided by applying the first coating layer, curing to provide a cross-linked polyurethane or polyurea/poly(ethylene oxide) coating, applying the second layer, and curing to provide a cross-linked polyurethane or polyurea/polyvinylpyrrolidone coating.

Abstract: Tubing made of two or more polymers circumferentially arranged around the perimeter of the tubing in a single layer may be useful as medical tubing. Specifically, such tubing may be useful in catheters, sheaths, sheath introducers, implant delivery systems, and other medical devices having elongated tubular components. Selection of the two or more polymers based on the durometer and melting temperature permits optimization of axial strength and flexibility for particular applications. Such tubing may be extruded as a single layer tubing or a multi-layer tubing where the additional layers may be single material layers or more multi-polymer layers.

Abstract: Lung conditions are diagnosed and optionally treated using a functional assessment catheter or a functional lung assessment and treatment catheter. A flow restrictive component is initially placed in a bronchus or lung passageway upstream from a diseased lung region. The isolated lung region is then functionally assessed through the catheter, while the flow restrictive component remains in place. If the patient is a good candidate for treatment by occlusive or restrictive treatment techniques, the flow resistive component may be left in place. If the patient is not suitable for such treatment, the flow resistive component may be removed.

Abstract: A catheter assembly includes an elongated main body defining two or more longitudinal lumens including distally positioned openings. One or more side-ports are defined in the main body communicating with at least one of the two or more longitudinal lumens. The catheter assembly also includes an inflatable balloon disposed around a portion of the main body. The inflatable balloon includes a distal end disposed substantially adjacent to a proximal side of one or more side-ports. The inflatable balloon in the inflated state is adapted to extend at partially over the one or more side-ports.

Abstract: A method of producing a balloon of a balloon catheter includes the following method steps: providing a balloon body coupled to a proximal sleeve and a distal sleeve by transitional sections extending between the balloon body and the sleeves; creating folds in at least the distal sleeve; and stabilizing at least a distal section of the folds of the distal sleeve.

Abstract: A catheter assembly includes a catheter shaft, a balloon and a pair of collars. The collars may be fixed or rotatable about a catheter shaft prior to exposure to an electric current. Where the collars are fixed to the shaft, the balloon is rotatable about the collars. When exposed to the electric current the collars expand to engage the waists of the balloon thereby sealing the balloon. Where the collars are rotatable about the shaft, each waist of the balloon is engaged to a respective collar. When the rotatable collars are exposed to the electric current the collars expand to engage the shaft of the catheter thereby sealing the balloon.

Abstract: A medical guidewire assembly comprises a guidewire having a flexible tip. A medical device such as a collapsible filter for use as an embolic protection device is mounted on the guidewire. The filter is advanced through a body lumen with the guidewire tip extending distally. A variable thickness guidewire (having a recess or thinner segment between thicker segments) can be employed. At a first location the filter is advanced relative to the tip to a location which is distally advanced from the first location. Placement of the filter in an optimal distal location is thereby achieved.

Abstract: An abdominal cavity balloon for preventing a haemorrhage in a patient's pelvic region, comprising an inflatable balloon, wherein the balloon is provided with a smooth surface and with a strip that is flexurally stiff and formed to follow the balloon's shape for positioning the balloon.

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 woven fabric layer composed of at least two woven fabric fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: A catheter includes an outer tube, and an inner tube which is disposed inside the outer tube and through which a guide wire is passed via a distal-side opening and a proximal-side opening. The outer tube has, in the axial direction thereof, at least: a first region on the distal side; a second region disposed on the proximal side and higher in rigidity than the first region; and a transition region which is provided between the first region and the second region and of which rigidity varies from the same rigidity as that of the first rigidity to the same rigidity as that of the second rigidity. The outer tube is configured with an opening, to which the proximal-side opening of the inner tube is connected, being provided in the second region.

Abstract: The invention is drawn to a method and apparatus for providing a pressure relief system for a catheter in the form of a fitting, which, when incorporated into the tubing comprising the inflation lumen, will hold the tubing in place while the pressure is below a predetermined level, but will slide out of the tubing, allowing the tubing to separate and releasing the pressure, provided the pressure exceeds that level. Once the pressure has been released, the fitting may be reattached, the conditions which caused the unsafe overpressure may be corrected, and the procedure continued without removal or replacement of the catheter or any of its components.

Abstract: Catheter having an elongate tubular shaft including an inflation lumen and a guidewire lumen defined therein, the guidewire lumen extending along at least a distal length of an inner tubular member of the elongate tubular shaft. The catheter includes a distal tip member having a proximal end and a distal end, wherein the distal tip member is monolithic and the proximal end of the distal tip member is secured to a distal end of the inner tubular member. The catheter includes a balloon having a proximal portion and a distal portion, the proximal portion of the balloon sealingly coupled to the distal portion of the elongate tubular shaft. The distal portion of the balloon is sealingly coupled to the distal tip member and the balloon defines an inner chamber in communication with the inflation lumen, wherein the proximal end of the distal tip member is disposed within the inner chamber.

Abstract: System and components for inducing pleurodesis. A tube device is provided that is generally inert in a first state. The device includes a second state that is configured to provide one or both of mechanical and chemical stimulation to induce pleurodesis. Different sheath and tube configurations are provided for the actuatable features of the device.

Abstract: An interspinous process spacer diagnostic balloon catheter and method. The balloon catheter has a main expandable member, a distal expandable member and a proximal expandable member that all can be expanded from a collapsed configuration to an expanded configuration and then collapsed again to a collapsed configuration. The device can be used to determine whether a particular patient is a candidate for implantation of an interspinous process spacer to treat the symptoms of lumbar spinal stenosis and the size of such a spacer if indicated.

Abstract: A method of increasing blood flow through an obstructed blood vessel includes providing an expandable member substantially made of a mesh having a plurality of interstices. The expandable member is inserted into the blood vessel, positioned within the blood vessel with the proximal member end upstream of the distal member end and the member body located radially adjacent at least a portion of an obstruction, and expanded to bring at least a portion of the member body into contact with the obstruction. An outward radial force is exerted on the obstruction to dislodge at least one fragment from the obstruction and to enhance blood flow through the blood vessel past the obstruction. The at least one fragment is passed through at least one interstice of the member body in the radial direction, and is selectively retained within the expandable member.

Abstract: The present invention comprises systems, methods and devices for the delivery of compositions for occluding or of means for opening conduits. The implantable occlusive material may be delivered pre-formed or in situ cured and, may be a resorbable material that supports tissue ingrowth that eventually replaces the material leaving little or no original material in place. The delivery system is positioned to allow for placement of the occlusive material into the body conduit. Use of delivery systems, methods and devices for re-opening an occluded body conduit are also included.

Abstract: A catheter having shaft segments which are joined together by a strong bond providing a low profile shaft section with a flexibility transition and/or a compositional transition. A balloon catheter embodying features of the invention has a distal tip member and a coupling band member surrounding a junction of an inner tubular member of the shaft, and has a gradual change in bending stiffness along a distal end section of the shaft which extends distally from a location within the balloon interior. Another catheter embodying features of the invention has shaft segments joined together by a diagonal seam.

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

Abstract: Devices and methods for altering gaseous flow within a lung to improve the expiration cycle of an individual, particularly individuals having chronic obstructive pulmonary disease. The methods and devices create channels in lung tissue and maintain the patency of these surgically created channels in tissue. Maintaining the patency of the channels allows air to pass directly out of the lung tissue which facilitates the exchange of oxygen ultimately into the blood and/or decompresses hyper-inflated lungs.

Abstract: A catheter tubing is disclosed having a cross-sectional profile that takes the characteristics of a structural beam, such as an “I”-beam, and in so doing possesses the bending moment and stiffness of the beam profile. The tubing can be made from existing polymers and existing manufacturing techniques, and multi-lumen configurations are possible. In the example of the I-beam profile, the catheter tubing will have two lumens while a double I-beam configuration will possess four lumens.

Abstract: The present invention is directed to distal tip designs for catheter, wherein distal tip material is positioned about an inner shaft. The distal tip material may also be used as a tie layer for thermally bonding two incompatible materials together, such as a waist portion of a balloon to the inner shaft.

Abstract: Medical device polymeric tubing segments suitable for forming catheter shafts or as balloon parisons are formed with discrete regions having different orientation relative to each other. Wall thickness may also be varied of the length of the segment.

Abstract: A feeding tube for insertion into the jejunum of a patient. An elongated tubular member has a proximal portion, a distal portion, a lumen extending between the proximal and distal portions, and at least one aperture at the distal portion. The aperture is sized for passage of fluid material from the lumen into the jejunum. An inflatable balloon is disposed about a length of the elongated tubular member distal portion. The balloon is sized and configured such that upon inflation via water or saline inflation media, the balloon projects outwardly from the tubular member distal portion so as to be engageable with an interior wall of the body passageway. An echogenic material is disposed along the tubular member distal portion in conjunction with the balloon to provide an echogenic capability, so that the tubular member length is visible under ultrasound imaging.

Abstract: The dilation balloon of the subject invention preferably comprises a balloon portion mounted about a shaft that, when inflated, produces a configuration comprising a tapered distal end and a proximal end or butt that is substantially flat (preferably truncated) and is adapted to generally conform with the outer contours of an endoscope through which it is introduced when the balloon is pulled back against the endoscope face. The close engagement of the subject balloon catheter and endoscope, when forming a balloon-scope train, enables the scope to more readily navigate strictures and tortuous body lumen, as well as allows the balloon to act as a lens for viewing anatomical structure within the body lumen, such as tumors, strictures, and the inner luminal wall surface itself.

Abstract: A collapsing clip including a plurality of collapsed self expanding wire frame segments is contained within the distal end of a catheter. The clip can be delivered to the neck of an aneurysm within the neurovascular system using a catheter. The collapsing clip impinges the distal and proximal framed wire segments onto the neck of the aneurysm. The framed wire segments are inter positioned so that the diamond shaped spaces between the wires are substantially blocked. The neck of the aneurysm is blocked by the distal and proximal framed wire segments forming a barrier.

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: A method for treating an occlusion in a coronary artery of a patient includes percutaneously advancing an occlusion treatment tool (such as an angioplasty balloon or stent delivery device) through the vasculature of the patient and into a coronary artery to a site of the occlusion. Following the treatment of the occlusion, a therapeutic agent is admitted into the first coronary artery. The therapeutic agent is selected to treat microvasculature obstructions at a target cardiac tissue site distal to the site of the occlusion.

Abstract: A balloon catheter includes a balloon support member having a hollow axial lumen and open distal end for allowing passage of a guidewire therethrough, a balloon disposed around the balloon support member, and an annular balloon seal disposed proximate to a distal end of the balloon catheter. The seal defines a central passageway for allowing passage therethrough of a guidewire extending out the distal end of the balloon support member, and is configured to form a substantially fluid tight seal around each of a plurality of guidewires having different outer diameters.

Abstract: A noncircular inner lumen guiding catheter with assisted variable support has an inner wall defining a noncircular cross-sectional shaped lumen for use in delivery of multiple microcatheters or other devices for treatment of neurovascular defects, such as for treatment of aneurysms. The noncircular inner lumen guiding catheter with assisted variable support includes torque transmittal guidance walls that are flexible linearly but not circumferentially, and that are neither collapsible nor kinkable. The noncircular shaped cross-section of the inner lumen may extend along the entire length of the catheter or a portion thereof, including distal or proximal.

Abstract: A catheter configured for performing reperfusion by alternatively occluding a vessel so as to prevent fluid flow and removing that occlusion to allow fluid flow is described. A first catheter includes an outer member and a retractable valve to allow and prevent fluid flow in the vessel. A second catheter includes a sheathed expansion member that can be deployed and recaptured to prevent and allow, respectively, fluid flow. A third catheter includes an angioplasty balloon to open a vessel occlusion, in which an occlusion balloon is used to allow and disallow fluid flow. A fourth catheter includes an expandable member for providing mechanical plunging action to urge thrombotic material to a more distal location. A fifth catheter includes an accessory catheter that can be used to perform reperfusion with another catheter. A sixth catheter includes an inner balloon within an outer balloon configured to perform reperfusion.

Abstract: There is provided a microcatheter having a proximal solution lumen and a distal tip portion with a guidewire lumen. The microcatheter and methods of use thereof allows for introduction of solution into a vessel while manipulating the guidewire and/or the microcatheter itself. The solution may be a contrast solution, for viewing of the vessel, a therapeutic or diagnostic solution, or any other type of solution.

Abstract: A catheter system can include a first catheter having an elongated body that defines a lumen, and a second catheter slidably disposed within the lumen of the first catheter. The lumen of the first catheter can also include a key joint component that corresponds to a key joint component on the second catheter. The distal end portion of the second catheter can include a pre-formed bend that extends at a non-zero angle relative to a longitudinal axis of the first catheter. In some embodiments, the second catheter can be used to aspirate a substance from a body lumen.