Abstract: Various embodiments of a system for priming a catheter assembly are disclosed herein. For example, the system can include a catheter assembly including an elongate body and an operative device coupled thereto. The system can also include a priming vessel configured to receive insertion of the operative device therein. The priming vessel can include a proximal portion secured to the distal portion of the elongate body such that the elongate body is in fluid communication with the priming vessel. The priming vessel can also include a distal end through which air is expelled when a fluid is channeled through the elongate body and into the priming vessel to expel air from within the catheter assembly.

Abstract: This patent document discloses perfusion catheters and related methods for treating blood vessel lesions and abnormalities. A perfusion catheter can include an inflatable balloon, an elongate shaft operably attached to the balloon, and an optional containment structure surrounding at least a portion of the balloon. The balloon can be inflated until its outer surface contacts a wall of a blood vessel. When inflated, the balloon's inner surface defines a passage for blood to flow. The balloon can be configured to release one or more substances formulated to treat a tissue at or near the wall of a blood vessel. In an example, the balloon can include a bioactive layer, which comprises the one or more substances, overlaying an optional base layer. In an example, the balloon can include multiple filars, at least one of which is configured to elute the one or more substances through a perforation or hole in the filar.

Abstract: Materials and methods for producing localized hypothermia in a patient (e.g., for treatment of acute pancreatitis and pancreatic cancer).

Abstract: A gastric calibration tube includes a flexible elongate member, a pushing member, and a balloon member. The flexible elongate member has a proximal end portion, a distal end portion, and an outer surface that extends between the proximal and distal end portions. The outer surface defines a side opening. The flexible elongate member defines a lumen that is in communication with the side opening. The pushing member has a proximal portion and a distal portion. The distal portion is advanceable through the lumen of the flexible elongate member and out of the side opening of the flexible elongate member. The balloon member is secured to one or both of the flexible elongate member and the pushing member. The balloon member is inflatable to fix the gastric calibration tube within a patient's stomach.

Abstract: Embodiments can provide an expandable nasogastric intubation assembly, comprising a tube subassembly and an expander subassembly, comprising an inflatable balloon comprising a proximal expander component section and a distal expander component section wherein the proximal expander component section is located between the proximal end of the intubation assembly and the distal expander component section; wherein the distal expander component section is located between the distal end of the intubation assembly and the proximal expander component section; wherein the inflatable balloon is coupled to the tube subassembly, the proximal expander component section is configured to be inflated from an injection of fluid into at least one first opening located in the second passageway, and the distal expander component section is configured to be inflated by the injection of fluid into at least one second opening located in the second passageway.

Abstract: Described here are delivery devices for delivering one or more implants to the body, and methods of using. The delivery devices may deliver implants to a variety of locations within the body, for a number of different uses. In some variations, the delivery devices have a cannula with one or more curved sections. In some variations, a pusher may be used to release one or more implants from the cannula. In some variations, one or more of the released implants may be a self-expanding device. Methods of delivering implants to one or more sinus cavities are also described here.

Abstract: Some embodiments provide a soft tissue device, such as a transverse carpal ligament cutting device having one or more balloons that are deflated when the device is in an inactive position and are inflated when the device is in an active position. Other embodiments provide a soft tissue cutting method, such as a method of cutting a transverse carpal ligament that uses a soft tissue cutting device.

Abstract: A device and method for dilating a Eustachian tube of a patient is disclosed. The device includes a guide catheter and a balloon dilation catheter. The balloon dilation catheter has an actuator that prevents injury to the middle ear. The balloon dilation catheter is slidably coupled with the guide catheter through the guide catheter lumen and is fully inserted into the guide catheter lumen when the distal side of the actuator is adjacent to the proximal end of the guide catheter. The method involves advancing the guide catheter and balloon dilation catheter through a nasal passage of the patient to dilate a portion of the Eustachian tube.

Abstract: Expandable intubation assemblies and methods for using and making the same are provided.

Abstract: A catheter system includes an elongate catheter having a lumen extending at least partially therethrough, and a leading catheter end segment, a guidewire positionable within the lumen of the catheter, and fastening structure supported adjacent the leading catheter end segment. The guidewire and the catheter are adapted for relative movement. The fastening structure is dimensioned to selectively engage the guidewire to secure the guidewire with respect to the leading catheter end segment such that movement of the guidewire causes deflection of the leading end segment with respect to the longitudinal axis.

Abstract: Various embodiments of an eccentric balloon catheter are disclosed. In some embodiments, an eccentric balloon catheter includes an eccentrically positioned guidewire tube, with an interior lumen, that extends at least a portion of the length of the catheter body. Optical fibers may extend the length of the catheter body and may also be eccentrically positioned within the catheter body. An inflatable balloon may be positioned within a window within the catheter body near the distal end of the catheter. When inflated, the balloon and catheter may slide relative to one another. When used within a vessel, an inflated balloon may press against a vessel wall and bias the catheter toward an opposite vessel wall.

Abstract: An intubation device having a main body portion defining a first longitudinal axis, a distal tip portion coupled to the main body portion and defining a second longitudinal axis, and a deflection system having a single drive member extending within at least the distal tip portion and coupled thereto. The deflection system is operable to exert a tensile force upon the distal tip portion to articulate the distal tip portion relative to the main body portion between a resting position and a positive incline position and a negative incline position.

Abstract: A safety balloon catheter includes a flexible, multi-lumen balloon catheter and a hollow barbell-shaped stretch valve. The balloon catheter has a proximal catheter end, a balloon defining a balloon interior to be inflated with an inflation fluid, a hollow inflation lumen extending through the catheter to the balloon interior and shaped to convey the inflation fluid to and from the balloon interior, and a hollow second lumen parallel to the inflation lumen; and a balloon drainage port fluidically connecting the balloon interior to the second lumen. The stretch valve is shaped to permit a fluid to pass therethrough and positioned in the second lumen to at least partially slide therein such that, in a steady state, a distal barbell end of the stretch valve prevents the inflation fluid from passing through the drainage port and, in an actuated state, the distal barbell end slides within the second lumen to permit the inflation fluid to pass through the drainage port and into the second lumen.

Abstract: A safety catheter includes a flexible, multi-lumen shaft having an outer diameter, a distal tip, a proximal catheter end with a drain end and a proximal inflation end. The multi-lumen shaft defines a drain lumen, a distal hollow balloon portion, at least one inflation lumen, and a drainage port. A hollow stretch valve is coaxially disposed in the drainage lumen and has a radially self-expandable proximal section fixedly connected within the drain lumen by self-expansion, a flexible intermediate section longitudinally movable within the drain lumen, and a distal plug movably positioned in the drain lumen to prevent fluid from passing through the drainage port in a steady state and being slidably disposed within the drain lumen such that, in a stretched state when the proximal catheter end is stretched, the distal plug slides within the drain lumen to permit the inflation fluid to pass through the drainage port.

Abstract: An apparatus is for performing a medical procedure using an inflation fluid. The apparatus includes a shaft with two inflation lumens for transmitting the inflation fluid. A balloon supported by the shaft has an interior capable of being inflated by the inflation fluid transmitted through the inflation lumens of the shaft. The tubes defining the inflation lumens provide two outlets for transmitting different flows of the inflation fluid to the interior of the balloon. A stent and related methods are also disclosed.

Abstract: A maneuverable feeding tube system can include: a feeding tube having an internal lumen and distal opening; a maneuverable tube having a flexible distal end being located within the internal lumen of the feeding tube such that the flexible distal end is associated with the distal opening of the feeding tube, wherein the flexible distal end includes one or more flex members; a control member operably coupled to a flexible distal end of the maneuverable tube and extending through the internal lumen of the feeding tube; and a port coupled to a proximal end of the feeding tube with the control member extending therethrough.

Abstract: A safety balloon catheter includes a flexible, multi-lumen balloon catheter and a hollow barbell-shaped stretch valve. The balloon catheter has a proximal catheter end, a balloon defining a balloon interior to be inflated with an inflation fluid, a hollow inflation lumen extending through the catheter to the balloon interior and shaped to convey the inflation fluid to and from the balloon interior, and a hollow second lumen parallel to the inflation lumen; and a balloon drainage port fluidically connecting the balloon interior to the second lumen. The stretch valve is shaped to permit a fluid to pass therethrough and positioned in the second lumen to at least partially slide therein such that, in a steady state, a distal barbell end of the stretch valve prevents the inflation fluid from passing through the drainage port and, in an actuated state, the distal barbell end slides within the second lumen to permit the inflation fluid to pass through the drainage port and into the second lumen.

Abstract: A safety balloon catheter includes a stretch valve and a balloon catheter having a proximal catheter end, a balloon defining an interior to be inflated with an inflation fluid, an inflation lumen extending through the shaft to the interior and shaped to convey inflation fluid thereto and from, a second lumen parallel to the inflation lumen, and a balloon drainage port fluidically connecting the balloon interior to the second lumen. The hollow stretch valve is shaped to permit a fluid to pass therethrough and is positioned in the second lumen to at least partially slide therein such that, in a steady state, the stretch valve prevents the inflation fluid from passing through the drainage port and, in an over-inflated state, the distal sliding portion slides within the second lumen to permit the inflation fluid to pass through the drainage port and into the second lumen.

Abstract: A safety catheter includes a shaft. The shaft has a proximal shaft portion having a proximal end, a distal tip portion defining a junction with the proximal shaft portion, a fluid drain lumen, and a balloon inflation lumen. The fluid drain lumen defines a distal fluid drain opening at the distal tip portion distal of the junction and a proximal fluid drain opening adjacent the proximal end and fluidically connected to the distal fluid drain opening. A hollow zero-pressure balloon is disposed at the junction and has an interior fluidly connected to the balloon inflation lumen, a distal leg fixedly secured to the distal tip portion, and a proximal leg temporarily secured to the proximal shaft portion.

Abstract: An apparatus for direct gastric feeding via a gastrostomy tract formed in a patient. The apparatus includes a tube, an internal bolster, an external bolster, and a force-generating device. The force-generating device may include a pair of automatically adjustable spring members on the external bolster. The spring members are responsive to changes in the length of the gastrostomy tract and eliminate the need for periodic adjustment or replacement of the apparatus.

Abstract: The present invention relates compositions for delivering therapeutic agents from a medical device including an expandable and collapsible structure and methods employing them. A lipid coating including one or more fatty acids increases the amount of therapeutic agent released from the device at the delivery site. The therapeutic agent can be in a matrix including a hydrophilic polymer or an amphiphilic polymer. Release and adhesion coatings can also facilitate delivery of therapeutic agent.

Abstract: An apparatus including a cannula having a dimension suitable for insertion into a blood vessel and an expandable body coupled thereto, the expandable body comprising a first expandable member and a second expandable member to isolate a length of the vessel upon expansion within the blood vessel. The expandable body having an intermediate expandable member along a working length between the first expandable member and the second expandable. A method including introducing a cannula and an expandable body coupled thereto into a blood vessel at a point coextensive with a treatment site and expanding a first expandable member and a second expandable member of the expandable body to isolate a length of the vessel adjacent the treatment site. The method further including delivering a treatment agent to a vessel region between the first expandable member and the second expandable member while inflating and deflating an intermediate expandable member.

Abstract: Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel.

Abstract: Methods for forming a “coating gradient” on medical devices, such as a balloon catheter or guidewire are disclosed. The balloon portion of the catheter has a protective covering initially placed over it to prevent the balloon from receiving a first hydrophilic coating. After a first hydrophilic coating is applied, the protective covering is removed. A second hydrophilic coating could be applied to the catheter. A guidewire having less lubricity at the distal end portion also can be created. A first hydrophilic coating is applied to the elongated shaft and distal shaft section of the guidewire. After the first hydrophilic coating cures, the first hydrophilic coating is removed from a portion of the distal shaft section of the guidewire. A second hydrophillic coating can then be applied to the elongated shaft and distal shaft section of the guidewire. The second hydrophilic coating can be allowed to cure.

Abstract: A balloon catheter has an elongated flexible shaft made of a metal and at least one inflatable balloon mounted on a distal end area of the flexible shaft. A wall of the shaft providing the mechanical properties for flexibility and pushability is entirely made of metal, the wall has a sheet-like shape, and the wall has an outer diameter up to 0.5 mm and a wall thickness in a range from 0.02 mm to 0.1 mm.

Abstract: An applicator for delivering brachytherapy includes elongate members movable between collapsed and expanded configurations for delivering brachytherapy within a lumpectomy cavity, a vaginal cavity, or other target region. The elongate members may be expandable into a symmetrical or asymmetrical expanded configuration, e.g., into a generally spherical, pear-shaped, or planar configuration. A system for delivering brachytherapy includes the applicator and an access device for lining and/or dilating a body cavity and/or for receiving the applicator therein. The access device is advanced into a body cavity, an expandable member on the access device is inflated, the applicator is advanced into the access device, and the elongate members are expanded to deliver radiation to the target region.

Abstract: A medical device is provided for dilatation of a vessel and delivery of a therapeutic agent to a wall of the vessel. The medical device comprises a catheter, a balloon located at a distal end of the catheter, and a drug delivery extension. The drug delivery extension is configured to extend beyond an outer surface of the balloon when the balloon is in an expanded configuration in order to deliver the therapeutic agent to an area beyond the outer surface of the balloon. The drug delivery extension may be one or more tubes, elongate members and/or expandable structures. The drug delivery extension may include a sheath for drug delivery.

Abstract: A catheter having an elongate shaft including a plurality of apertures disposed along at least a length of the shaft to facilitate bending. The catheter includes an inflatable balloon, wherein a subset of the plurality of apertures provides fluid communication from an inflation lumen to the inflatable balloon.

Abstract: A balloon catheter assembly includes a first tubular member with a proximal portion and a distal portion and a lumen extending between the proximal portion and the distal portion. A balloon has a proximal waist length, a distal waist length and an expandable region therebetween disposed about the distal portion. A tie layer is disposed between the proximal waist length or distal waist length and the first tubular member. The tie layer comprises a polyester polymer and a polyamide polymer.

Abstract: A safety catheter includes a multi-lumen shaft. The shaft has a proximal shaft portion with a distal end having a given outer diameter and a distal tip portion having an outer diameter less than the given outer diameter. A hollow balloon is disposed at a junction of the proximal shaft portion and the distal tip portion. The balloon has a distal leg fixedly secured to the distal tip portion and a proximal leg removably secured to the proximal shaft portion.

Abstract: Methods to size a gastric pouch. In at least one embodiment for measuring the size of a gastric pouch of the present disclosure, the method comprises the steps of introducing a catheter into an esophagus, the catheter comprising an outer elongate tube, an inner elongate tube disposed within the outer elongate tube, a proximal balloon attached to the outer elongate tube, a distal balloon having a first end attached to the outer elongate tube and a second end attached to the inner elongate tube, at least two detection electrodes positioned on the outer elongate tube between at least two excitation electrodes, and a pressure transducer positioned on the outer elongate tube, locating the gastroesophageal junction using the proximal balloon, adjusting the distal balloon axially to a desired balloon length, injecting a fluid into the distal balloon to extend the distal balloon circumferentially, and determining a size variable of the gastric pouch.

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: The invention relates to a balloon for medical devices, in particular for catheters used in angioplasty, comprising a polyamide copolymer material characterized in that said polyamide copolymer material is represented by the general formula (I): HO—(PF—OOC—PA-COO—PF—COO—PA)n-COOH in which PA is a polyamide segment and PF is a diol segment comprising dimer diols and/or corresponding OH-terminating diol polyesters and n is a number between 5 and 20.

Abstract: A medical device, at least a portion of which is formed from a polymer composition including at least one liquid crystal block copolymer having at least one A block and at least one B block wherein the A block is formed of mesogenic repeat units and the B block is a soft block.

Abstract: Dilation catheters including a mechanism used in, for example, removing gas or air from the catheters are disclosed. A dilation catheter may include an elongated tubular member having a distal end and a proximal end, a proximal handle proximate the proximal end of the tubular member, and an inflatable balloon proximate the distal end of the tubular member with inflatable balloon being in fluid communication with a fluid port to supply inflation liquid to the inflatable balloon. The inflatable balloon may include an opening for permitting gas to exit the inflatable balloon. In the proximate location of the opening, an expandable material or a barrier material that permits gas to exit through the opening, while retaining inflation liquid in the inflatable balloon.

Abstract: A retention device for use in a human or mammalian body includes superelastic wires that expand when they are released from a confined state. The retention device may have the outer form of a Foley catheter. One or more superelastic wires within the balloon of a Foley catheter help to insure retention within the body, such as within a urinary bladder.

Abstract: A collateral ventilation bypass trap system directly linked with a patient's lung or lungs may be utilized to increase the expiratory flow from the diseased lung or lungs, thereby treating one aspect of chronic obstructive pulmonary disease. The system includes a trap, a filter/one-way valve and an air carrying conduit. The system also includes a retention device for securing system elements in position.

Abstract: A catheter is disclosed providing a balloon catheter having a distal tip that is flexible while additionally incorporating high column strength. The present invention additionally provides a distal tip region that accommodates for various sized guidewires. In preferred embodiments, the distal tip region is initially configured for accommodating the passage of 0.12-inch guidewires only. Through specific manufacturing processes, however, the distal tip is modified so that it also may be expanded to accommodate the passage of 0.14-inch guidewires. In additional preferred embodiments, an elastomeric sleeve is disposed over the modified distal tip to allow the tip to return to the initial 0.12 -inch accommodating profile when the larger 0.14-inch guidewire is withdrawn from the catheter.

Abstract: A catheter enabling an increase in operability when the catheter is inserted from the outside to the inside of a body and capable of remarkably reducing the risk of damage to shafts even in an unforeseen accident without complicating steps and increasing production cost. The catheter comprises at least the distal side shaft formed of a resin tube, the rear end side shaft with a higher rigidity than that of the distal side shaft, and a guide wire lumen. The catheter is characterized in that a core wire is disposed therein to adjust a flexibility so that the rear end portion of the distal side shaft is harder than the distal end portion of the distal side shaft and softer than the rear end side shaft, and the core wire is fixed to the distal side shaft near the rear end side opening part of the guide wire lumen and at a part of the rear end side portion of the distal end shaft.

Abstract: The disclosure is directed to tubular bodies for catheters. An inner tubular catheter body has an inner layer, a braided portion over the inner layer and an outer layer. The outer layer is fused to the braided portion for a selected length or lengths of the inner tubular body and is unfused for a selected length or lengths to achieve the desired combination of stiffness and flexibility.

Abstract: A catheter having an elongate shaft including a plurality of apertures disposed along at least a length of the shaft to facilitate bending. The catheter includes an inflatable balloon, wherein a subset of the plurality of apertures provides fluid communication from an inflation lumen to the inflatable balloon.

Abstract: Methods for cardiac ventricular restoration include delivering an implantable expandable device into the ventricle via a catheter. The expandable device is anchored either to the wall of the left ventricle or to the inter-ventricular septum and then expanded. When expanded, the device assumes a size and shape which fills the lower portion of the ventricular cavity restoring the normal volume and ellipsoid shape of the remaining portion of the cavity and favorably altering myocardial oxygen demand and wall stress.

Abstract: Devices, methods, and systems for measuring the size of gastric pouches. At least some embodiments include a catheter comprising an outer elongate tube, an inner elongate tube disposed within the outer elongate tube, a proximal balloon attached to the outer elongate tube, a distal balloon having a first end attached to the outer elongate tube and a second end attached to the inner elongate tube, at least two detection electrodes positioned on the outer elongate tube relative to at least two excitation electrodes, and a pressure transducer positioned on the outer elongate tube.

Abstract: A balloon catheter assembly includes a first tubular member with a proximal portion and a distal portion and a lumen extending between the proximal portion and the distal portion. A balloon has a proximal waist length, a distal waist length and an expandable region therebetween disposed about the distal portion. A tie layer is disposed between the proximal waist length or distal waist length and the first tubular member. The tie layer comprises a polyester polymer and a polyamide polymer.

Abstract: A process for producing a dilatation balloon by extruding a multiblock copolymer composition to form an extrudate comprising phase-separated glassy, rubber, and semicrystalline microdomains that are macroscopically ordered in a perpendicular alignment. The balloon formed by the process demonstrates, during inflation, a true stress vs. nominal strain response curve comprising a first zone representative of a low modulus balloon, a second zone representative of a high strength balloon, and a sharp transition from the first zone to the second zone.

Abstract: The present invention may include a medical device having a handle, a catheter coupled to the handle, and an expandable element coupled to the catheter. The medical device may also include first and second elongate bodies that traverse a length of the handle and catheter. A housing may be disposed within the handle, wherein the housing defines a first opening able to receive a portion of the first elongate body, a second opening able to receive a portion of the second elongate body, and a third opening opposite the first and second openings able to receive a portion of both the first and second elongate bodies. A separation element may be disposed within the housing, with the separation element defining a path able to receive a portion of the second elongate body, and whereby a portion of the first elongate body forms a loop around the separation element.

Abstract: A system and method for inflating and deflating a catheter balloon using osmosis. An elongate catheter shaft has a proximally disposed osmotic membrane in fluid communication with a distally mounted balloon through a fluid-filled catheter lumen. The balloon is inflated by exposing the exterior of the membrane to a solution that is hypotonic relative to the solution within the catheter lumen. The balloon is deflated by exposing the exterior of the membrane to a solution that is hypertonic in relation to the solution within the catheter lumen.

Abstract: An intravascular balloon catheter having an ultra soft tip. The catheter includes a braided reinforcement member extending substantially the length of the elongate shaft. A balloon is disposed at the distal end of the elongate shaft. An ultra soft tip is formed from a distal portion of balloon material extending distal of the distal end of the elongate shaft.

Abstract: This is directed to methods and devices suited for maintaining an opening in a wall of a body organ for an extended period. More particularly devices and methods are directed maintaining patency of channels that alter gaseous flow within a lung to improve the expiration cycle of, for instance, an individual having chronic obstructive pulmonary disease.

Abstract: An indwelling urinary catheter assembly is disclosed having an indwelling catheter and a sheath enclosing an insertable portion of the indwelling catheter.