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 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 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: 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: System and methods are provided for harvesting one or more organs, e.g., a lung from a donor body. In one embodiment, a distal end of a tubular member is introduced into the donor body's vasculature via a percutaneous access site, and the tubular member is manipulated until the distal end of the tubular member is disposed within the thoracic duct. Fluid is removed from the thoracic duct through the tubular member to a location exterior to the patient's body, and one or more organs are removed from the donor body. Optionally, one or more parameters within the thoracic duct or other parameters of the donor body may be monitored and fluid removal may be adjusted to reduce fluid accumulation within the one or more organs.

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

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 imaging cardiac tissue using fluorescent dyes delivered into tissue. A distal end of an imaging device may be introduced into a chamber of the heart, and fluorescent dye may be delivered into one or more body lumens in the heart such that the dye is absorbed by cardiac tissue adjacent the chamber. Images of the cardiac tissue adjacent the chamber may be acquired using the imaging device, the dye enhancing identifying cardiac electrical activity within the cardiac tissue. Optionally, based on the identified cardiac electrical activity, tissue within the heart may be ablated or otherwise treated.

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: 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: 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: A catheter system comprises an elongate catheter body including a distal end. The catheter system also comprises a cannulation lumen extending through the elongate catheter body and terminating at the distal end of the elongate catheter body. The catheter system also comprises a steering element extending through the elongate catheter body for steering the distal end of the elongate catheter body and an imaging element extending within the elongate catheter body. The imaging element is configured to obtain optical images of an area located distally of the distal end of the elongate catheter body.

Abstract: Telescoping catheters are provided that include an outer tubular member and an inner member slidably received within a lumen of the outer member. The outer and inner members include cooperating magnetic elements on their distal ends. The magnetic elements may be mounted at locations to secure the inner member at a first axial position, e.g., a retracted position, using a magnetic attraction between the magnetic elements. The inner member may be moved axially from the first position by overcoming the magnetic attraction such that a predetermined axial force may disengage the magnetic elements to allow the first elongate member to directed from the first position to one or more other axial positions.

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 accessing a region within a patient's body and performing a procedure therein that includes a catheter including a tubular member comprising a proximal end, a distal end sized for introduction into a patient's body, an imaging assembly on the distal end, and a substantially transparent expandable member attached to the tubular member distal end such the imaging assembly is disposed within an interior of the expandable member, the imaging assembly imaging through a surface of the expandable member. The tubular member includes a drainage lumen communicating one or more drainage ports on the tubular member distal end proximal to the balloon for aspirating fluid from the patient's body. The catheter may be used to access a pericardial space and an ablation probe may be introduced through the catheter to treat heart tissue while fluid is infused and/or aspirated via the drainage ports.

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: A system for delivering a lead comprises an imaging device comprising a proximal end and an expandable distal end having an inner balloon and an outer balloon. The outer balloon is concentric with the inner balloon. The expandable distal end includes a channel defined between the inner balloon and the outer balloon. The imaging device further comprises a lumen extending between the proximal and distal ends and an imaging assembly for imaging through the expandable distal end. The system further comprises an elongate rail comprising a proximal end and a distal end positionable through the lumen of the imaging device and the channel. The elongate rail comprises a fixation element on the distal end. The system also comprises a lead comprising a proximal end, a distal end introduced through the lumen of the imaging device guided by the elongated rail, and one or more electrodes on the distal end.

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: 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 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.