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 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 the patient's body, and a lumen extending between the proximal end and the distal end; 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 needle tip.

Abstract: An ablation catheter is disclosed, comprising an elongate body having a fluid lumen extending therethrough. The catheter includes a distal electrode assembly featuring a central insert electrode and an outer electrode that surrounds it at the distal end. The insert electrode has a non-circular cross-sectional shape. Fluid passages are formed between portions of the insert electrode and an inner surface of the outer electrode. The fluid passages are in fluid communication with the lumen and are configured to deliver fluid to a tissue-contacting surface of the catheter, enhancing ablation safety and efficiency. Also disclosed are related systems and methods of using the catheter for therapeutic ablation.

Abstract: An ablation catheter is disclosed, comprising a handle, an elongate body coupled to the handle and comprising a fluid lumen extending therethrough, an electrode coupled to the elongate body, a high voltage conductor electrically coupled to the electrode, a fluid conduit at least partially positioned within the handle, and an isolation manifold. The isolation manifold includes a first inlet port, a second inlet port, and an outlet port. The high voltage conductor is positioned within the first inlet port, the fluid conduit is coupled to the second inlet port, and the outlet port is coupled to the fluid lumen. The high voltage conductor extends through the outlet port and into the fluid lumen. Also disclosed are related systems and methods of using the catheter for therapeutic ablation.

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: Apparatus, systems, and methods are provided for placing pacing leads or other devices within a patient's heart. In an exemplary embodiment, the apparatus includes a tubular member comprising a flexible distal portion defining a curvilinear shape in a relaxed state including a curved first region defining a first radius lying within a first plane, a substantially straight second region extending from the first curved region defining a first length, and a curved third region extending from the second region defining a second radius smaller than the first radius.

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 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: 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: A pass-through electrode device includes a tubular member including a proximal end, a distal end sized for introduction into a patient's body, a lumen extending between the proximal end and the distal end, and one or more pass-through electrodes on the distal end. Each pass-through electrode includes an outer portion on an outer wall of the tubular member, an inner portion exposed within an inner wall of the lumen, and is passive, e.g., electrically isolated and/or unconnected to other electrodes or components of the device. A system is also provided that includes an outer tubular member including one or more pass-through electrodes and a procedure device introducible through and deployable from the tubular member for performing a procedure, e.g., mapping and/or ablation. The procedure device includes one or more active electrodes that may be aligned with pass-through electrodes when the device is at least partially positioned within the outer 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 is provided that includes an outer tubular member comprising a proximal end, a distal end sized for introduction into the 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 needle tip.

Abstract: Catheters, sheaths, or other tubular devices are provided, e.g., steerable tubular devices, including braided or other reinforcement configurations and/or including one or more steering elements for deflecting a distal portion, and/or to methods for making such catheters, sheaths, or other tubular devices. The devices and methods described herein may involve simplified, e.g., single-piece, construction of catheter shafts, which may save space and/or provide more robust construction of the resulting devices compared to conventional manufacturing methods.

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 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: 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 the patient's body, and a lumen extending between the proximal end and the distal end; 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 needle tip.

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.