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: Apparatus and methods are provided for using catheters to increase the accuracy of anatomical maps in the setting of patient movement.

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: Apparatus and methods are provided for delivering fluids into a patient's body that includes a tubular member including a proximal end, a distal end sized for introduction into a patient's body, and a fluid delivery lumen extending between the proximal and distal ends; and a flexible pad on the distal end including a tissue contacting surface, a passage communicating with the fluid delivery lumen, and plurality of capillary channels in the tissue contact surface communicating with the passage, the capillary channels configured to deliver fluid from the fluid delivery lumen and passage to tissue contacted by the tissue contact surface.

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: A catheter system comprises an elongate catheter body including a distal end, a cannulation lumen extending through the catheter body and terminating at the distal end of the catheter body, and a steering element extending through the catheter body for steering the distal end. The catheter system also comprises an imaging element secured to a distal end portion of the catheter body and configured to obtain optical images of an area located distally of the distal end of the catheter body. The catheter body includes a ridge extending axially along an outer surface of the distal end portion, wherein a width of the ridge measured about a circumference of the catheter body is less than a length of the ridge measured along the longitudinal axis, and the imaging element is radially aligned with the ridge with at least a portion of the imaging element disposed within the ridge.

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: 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: System and methods are provided for treating a patient that include a delivery device sized for introduction into a target site within a patient's body, a source of one or more therapeutic and/or diagnostic agents coupled to the delivery device, and a tubular member sized for introduction into the patient's vasculature to isolate the thoracic duct. Once the thoracic duct is isolated, fluid may be removed from the thoracic duct, e.g., to prevent the agents that transit from the target site into the thoracic duct from entering the patient's vasculature, and/or to modulate flow through the thoracic duct to modulate concentration and/or resident time of the agents at the target site. The one or more agents may include particles sized for preferential transit into the lymphatic system.

Abstract: Systems and methods are provided for injecting one or more agents into tissue within a patient's body that includes a catheter. A needle guide extends from a distal end of the catheter and terminates at a distal tip, e.g., including a foot with an atraumatic contact surface, the needle guide having a cross-section smaller than the distal end and being biased to a curved shape. The needle guide includes a passage communicating from a lumen of the catheter to an outlet at the distal tip, and a needle device is disposed within the passage that may be deployed from the outlet to inject one or more agents into tissue. The catheter also includes an imaging assembly on the distal end configured to acquire images of tissue adjacent the needle guide distal tip.

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 is provided that includes an outer tubular member comprising a proximal end, a distal end sized for introduction into a patient's body, and a lumen extending between the proximal and distal ends; a relatively small cross-section needle tip extending distally beyond the distal end; and an internal pressure release member slidably disposed within the lumen between a distal position and a proximal position to prevent viscous injectate from expressing from the distal tip.

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: Systems and methods are provided for navigating within the heart and attaching to the wall of the heart for performing injection of one or more agents into tissue. The system includes an outer catheter, a mid catheter slidably disposed within a lumen of the outer catheter, and a needle catheter slidably disposed within a lumen of the mid catheter. The mid catheter includes a vacuum hood attached to a mid catheter distal end such that a radiopaque distal tip of the mid catheter extends into the vacuum hood. The vacuum hood includes at least two radiopaque features, the spatial relationship of which visibly changes under fluoroscopy when the vacuum hood is under sealed vacuum.

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: System and methods are provided for treating a patient that include a delivery device sized for introduction into a target site within a patient's body, a source of one or more therapeutic and/or diagnostic agents coupled to the delivery device, and a tubular member sized for introduction into the patient's vasculature to isolate the thoracic duct. Once the thoracic duct is isolated, fluid may be removed from the thoracic duct, e.g., to prevent the agents that transit from the target site into the thoracic duct from entering the patient's vasculature, and/or to modulate flow through the thoracic duct to modulate concentration and/or resident time of the agents at the target site. The one or more agents may include particles sized for preferential transit into the lymphatic system.

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 carrying a plurality of electrodes. The tubular device includes a primary lumen extending between the proximal and distal ends; a steering element lumen adjacent the primary lumen; a plurality of wires extending proximally from the electrodes, and 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 wires, and at least some of the windings surrounding the primary lumen and one or both of the steering element lumen and the wires. 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 navigating within the heart and attaching to the wall of the heart for performing injection of one or more agents into tissue. The system includes an outer catheter, a mid catheter slidably disposed within a lumen of the outer catheter, and a needle catheter slidably disposed within a lumen of the mid catheter. The mid catheter includes a vacuum hood attached to a mid catheter distal end such that a radiopaque distal tip of the mid catheter extends into the vacuum hood. The vacuum hood includes at least two radiopaque features, the spatial relationship of which visibly changes under fluoroscopy when the vacuum hood is under sealed vacuum.

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 is provided that includes an outer tubular member comprising a proximal end, a distal end sized for introduction into a patient's body, and a lumen extending between the proximal and distal ends; a relatively small cross-section needle tip extending distally beyond the distal end, and an internal pressure release member slidably disposed within the lumen between a distal position and a proximal position to prevent viscous injectate from expressing from the distal tip.

Abstract: A catheter system comprises an elongate catheter body including a distal end, a cannulation lumen extending through the catheter body and terminating at the distal end of the catheter body, and a steering element extending through the catheter body for steering the distal end. The catheter system also comprises an imaging element secured to a distal end portion of the catheter body and configured to obtain optical images of an area located distally of the distal end of the catheter body. The catheter body includes a ridge extending axially along an outer surface of the distal end portion, wherein a width of the ridge measured about a circumference of the catheter body is less than a length of the ridge measured along the longitudinal axis, and the imaging element is radially aligned with the ridge with at least a portion of the imaging element disposed within the ridge.