Abstract: Systems and methods are provided for performing a medical procedure within a patient's body that involves a thoracic duct including an ostium communicating with the patient's venous system. An apparatus is provided that includes a catheter including proximal and distal ends and a lumen extending therebetween. An expandable sealing member is carried beyond the distal end that is expandable from a delivery condition to a deployed condition in which the sealing member defines a concave contact surface shaped for engaging a vessel wall surrounding the outlet of the thoracic duct. The sealing member includes an aspiration port in the contact surface communicating with the catheter lumen for removing fluid from the thoracic duct.

Abstract: Deflectable apparatus and methods for performing a procedure within a patient's body using such apparatus are provided. Generally, the apparatus includes an elongate tubular member including a proximal end, a distal end, a longitudinal axis extending between the proximal and distal ends, a deflectable distal portion including first and second lumens spaced apart from one another on generally opposite sides of the longitudinal axis, and a handle coupled to the proximal end of the tubular member. A pull wire includes a loop disposed within the handle and first and second segments extending from the loop and slidably received in the first and second lumens, respectively, and coupled to the distal end. An actuator is provided on the handle for applying tension to either the first or the second segment to cause a distal portion of the tubular member to deflect, e.g., in opposite directions.

Abstract: Catheters, sheaths, or other tubular devices are provided that include a proximal end, a distal end sized for introduction into a patient's body, and a steerable distal portion. The tubular device includes a primary lumen extending between the proximal and distal ends; an auxiliary lumen adjacent the primary lumen; and one or more reinforcement members including windings extending helically along at least the distal portion, at least some of the windings passing between the primary and steering element lumens and at least some of the windings surrounding both the primary and steering element lumens. In one embodiment, a steering element is slidably disposed within the auxiliary lumen. Apparatus and methods for making such tubular devices are also provided.

Abstract: Systems and methods are provided for performing a medical procedure within a patient's body that involves a thoracic duct including an ostium communicating with the patient's venous system. A distal end of a catheter is introduced through the patient's venous system into a body lumen adjacent the ostium of the thoracic duct. An expandable member on the distal end of the tubular member may be expanded adjacent the ostium, e.g., within the body lumen or the thoracic duct itself, and used to isolate the thoracic duct from the body lumen, whereupon a medical procedure may be performed via the thoracic duct. For example, lymphatic fluid may be removed from the thoracic duct through a lumen of the tubular member and/or one or more agents may be introduced into the thoracic duct through the tubular member.

Abstract: Tubular devices are provided that include a proximal end, a distal end sized for introduction into a patient's body, a central lumen, a conductor extending between the proximal and distal ends adjacent the central lumen, reinforcement members including windings extending helically around the central lumen, and an outer jacket. The tubular device includes a first portion in which the conductor extends helically around the central lumen, and a second portion in which the conductor extends longitudinally and either a) all of the windings surround the central lumen and the conductor remains outside the windings, b) at least some of the windings pass between the central lumen and the conductor and at least some of the windings surround both the central lumen and the conductor, and c) all of the windings surround both the central lumen and the conductor. Methods for making such tubular devices are also provided.

Abstract: Apparatus and methods are provided for creating tubular devices, e.g., as components for catheters, sheaths, and or other devices sized for introduction into a patient. In one embodiment, a method is provided for making a tubular device using a sheet of material including a coated first surface. The sheet is rolled around a mandrel until longitudinal edges of the sheet are disposed near or adjacent one another, e.g., without attaching the longitudinal edges together. A tubular braid is positioned over the sheet-wrapped mandrel, one or more tubular segments are positioned over the tubular braid, and heat shrink tubing is positioned over the tubular segments. The resulting assembly is heated to cause the tubular segments to at least partially reflow and/or otherwise laminate the tubular segments to the tubular braid and sheet. The heat shrink tubing and mandrel are then removed to create the tubular device.

Abstract: Deflectable apparatus and methods for performing a procedure within a patient's body using such apparatus are provided. Generally, the apparatus includes an elongate tubular member including a proximal end, a distal end, a longitudinal axis extending between the proximal and distal ends, a deflectable distal portion including first and second lumens spaced apart from one another on generally opposite sides of the longitudinal axis, and a handle coupled to the proximal end of the tubular member. A pull wire includes a loop disposed within the handle and first and second segments extending from the loop and slidably received in the first and second lumens, respectively, and coupled to the distal end. An actuator is provided on the handle for applying tension to either the first or the second segment to cause a distal portion of the tubular member to deflect, e.g., in opposite directions.

Abstract: Apparatus, systems, and methods are provided for delivering a lead or other instrument into a patient's body using a tubular device including a proximal end, a distal end sized for introduction into a body lumen, and a lumen extending therebetween, thereby defining a longitudinal axis. The tubular device includes a sidewall surrounding the lumen including a reinforcing layer embedded in one or more layers of base material, and a slittable seam in the sidewall extending from the proximal end partially towards the distal end substantially parallel to the longitudinal axis. In addition, slitter devices are for slitting, splitting, or opening the slittable seam. Methods are also provided for making catheters or other tubular devices including slittable, e.g., re-welded longitudinal seams that may be preferentially slit, split, or otherwise opened.

Abstract: Devices and methods are provided for performing a medical procedure using a trans-septal approach. The device includes a dilator including a proximal end, a distal end terminating in a distal tip, and a lumen extending between the dilator proximal and distal ends, and a needle device including a proximal end, a distal end sized for introduction into the dilator lumen and terminating in a sharpened distal tip. The needle is movable relative to the dilator to selectively expose the needle device distal tip distally from the dilator lumen and advance the dilator relative to the needle device. The dilator may have a complex tapered shape on its distal tip, e.g., including first and second tapered regions. The needle device may include an inner needle including the sharpened distal tip and an outer tube including a substantially blunt distal end that slidably receives the inner needle.

Abstract: An apparatus includes a first catheter defining a first longitudinal axis and a first lumen. A first actuator can be coupled to the first catheter and configured to rotate about the first longitudinal axis to deflect a distal end of the first catheter relative to the first longitudinal axis. A second catheter can define a second longitudinal axis and a second lumen. At least a portion of the second catheter can be configured to slide within the first lumen. A magnetic member can be coupled to a distal end of the second catheter. The magnetic member can define a third lumen. The third lumen can be in fluid communication with the second lumen. A second actuator can be coupled to the second catheter and configured to move linearly along the second longitudinal axis so as to vary a spacing between the magnetic member and the first catheter.

Abstract: Devices and methods are provided for inhibiting mouth breathing and/or improving nasal breathing, e.g., for PAP users or users with other sleeping problems. In an exemplary embodiment, an adhesive device is provided that includes an elongate membrane comprising first and second ends and side edges extending between the first and second ends, a first surface comprising an adhesive layer. The adhesive layer may be a low tack adhesive that is adherent to skin, yet is also easily removable without leaving significant residue. Optionally, the device may include one or more valves to provide one-way flow across the membrane, one or more weakened regions in the membrane, and/or one or more tabs to facilitate removal of the membrane from over a user's mouth.

Abstract: Systems and methods are provided for performing a medical procedure within a patient's body that involves a thoracic duct including an ostium communicating with the patient's venous system. A distal end of a catheter is introduced through the patient's venous system into a body lumen adjacent the ostium of the thoracic duct. An expandable member on the distal end of the tubular member may be expanded adjacent the ostium, e.g., within the body lumen or the thoracic duct itself, and used to isolate the thoracic duct from the body lumen, whereupon a medical procedure may be performed via the thoracic duct. For example, lymphatic fluid may be removed from the thoracic duct through a lumen of the tubular member and/or one or more agents may be introduced into the thoracic duct through the tubular member.

Abstract: Devices and methods are provided for performing a medical procedure using a trans-septal approach. The device includes a dilator including a proximal end, a distal end terminating in a distal tip, and a lumen extending between the dilator proximal and distal ends, and a needle device including a proximal end, a distal end sized for introduction into the dilator lumen and terminating in a sharpened distal tip. The needle is movable relative to the dilator to selectively expose the needle device distal tip distally from the dilator lumen and advance the dilator relative to the needle device. The dilator may have a complex tapered shape on its distal tip, e.g., including first and second tapered regions. The needle device may include an inner needle including the sharpened distal tip and an outer tube including a substantially blunt distal end that slidably receives the inner needle.

Abstract: Catheters, sheaths, or other tubular devices are provided that include a proximal end, a distal end sized for introduction into a patient's body, and a steerable distal portion. The tubular device includes a primary lumen extending between the proximal and distal ends; an auxiliary lumen adjacent the primary lumen; and one or more reinforcement members including windings extending helically along at least the distal portion, at least some of the windings passing between the primary and steering element lumens and at least some of the windings surrounding both the primary and steering element lumens. In one embodiment, a steering element is slidably disposed within the auxiliary lumen. Apparatus and methods for making such tubular devices are also provided.

Abstract: Systems and methods are provided for performing a medical procedure within a patient's body that involves a thoracic duct including an ostium communicating with the patient's venous system. A distal end of a catheter is introduced through the patient's venous system into a body lumen adjacent the ostium of the thoracic duct. An expandable member on the distal end of the tubular may be expanded adjacent the ostium, e.g., within the body lumen or the thoracic duct itself, and used to isolate the thoracic duct from the body lumen, whereupon a medical procedure may be performed via the thoracic duct. For example, lymphatic fluid may be removed from the thoracic duct through a lumen of the tubular member and/or one or more agents may be introduced into the thoracic duct through the tubular member.

Abstract: Systems and methods are provided for injecting one or more agents into tissue within a patient's body. In one embodiment, an injection device includes a substantially axially incompressible elongate member including a lumen extending between proximal and distal ends thereof. A distal stop is provided on the distal end and a needle tip extends distally beyond the distal stop, the needle tip having a cross-section smaller than the distal end. The needle tip includes a passage communicating between the lumen and an outlet in the distal tip that has having a cross-section smaller than the lumen. In an exemplary embodiment, the elongate member includes a coil extending between the proximal and distal ends, and a sleeve disposed within an interior region of the coil extending between the proximal and distal ends. The sleeve defines the lumen and may be free-floating within at least a portion of the coil.

Abstract: Apparatus and methods are provided for making catheters having intermediate layers that minimize or eliminate gaps during layup.

Abstract: A hub for a sheath, catheter, or other tubular device includes a first hub portion including a first hub lumen sized for receiving a medical device therethrough, and a second hub portion including a second hub lumen, the second hub portion coupled to the first hub portion such that the first and second hub lumens are aligned with one another and the first and second hub portions are spaced apart from one another to define a gap. A valve is secured within the gap between the first and second hub portions that includes a valve passage therethrough, e.g., for accommodating receiving a medical device through the first and second hub lumens into the tubular device, while providing a substantially fluid tight seal.

Abstract: Catheters, sheaths, or other tubular devices are provided that include a proximal end, a distal end sized for introduction into a patient's body, and a steerable distal portion. The tubular device includes a primary lumen extending between the proximal and distal ends; an auxiliary lumen adjacent the primary lumen; and one or more reinforcement members including windings extending helically along at least the distal portion, at least some of the windings passing between the primary and steering element lumens and at least some of the windings surrounding both the primary and steering element lumens. In one embodiment, a steering element is slidably disposed within the auxiliary lumen. Apparatus and methods for making such tubular devices are also provided.

Abstract: Catheters, sheaths, or other tubular devices are provided that include a proximal end, a distal end sized for introduction into a patient's body, and a steerable distal portion. The tubular device includes a primary lumen extending between the proximal and distal ends; an auxiliary lumen adjacent the primary lumen; and one or more reinforcement members including windings extending helically along at least the distal portion, at least some of the windings passing between the primary and steering element lumens and at least some of the windings surrounding both the primary and steering element lumens. In one embodiment, a steering element is slidably disposed within the auxiliary lumen. Apparatus and methods for making such tubular devices are also provided.