Abstract: A single pass, large bore transseptal crossing catheter system is disclosed. An elongate, flexible tubular body has a proximal end, a distal end and an electrically conductive sidewall defining a central lumen. An insulation layer surrounds the sidewall and leaves exposed a first distal electrode tip. An inner conductive wire is provided, having a second distal electrode tip. The inner wire is axially movably extendable through the central lumen. A tubular insulation layer is provided in between the wire and the electrically conductive sidewall.

Abstract: A flexible guide tube having a deflectable distal end is disclosed with at least first and second tensioning lines coupled to a deflectable distal end of the flexible guide tube. The first tensioning line is configured to deflect the distal end of the flexible guide tube in a first direction and the second tensioning line is configured to deflect the distal end of the flexible guide tube in a second direction that is opposite the first direction. A handle is coupled to flexible tube, the handle having a medial portion with a longitudinal axis substantially parallel with at least a portion of the flexible guide tube, a first actuator disposed proximal the medial section, and a second actuator disposed distal the medial section.

Abstract: Provided is a method for creating an atraumatic tip using a laser, the method comprising positioning a puncture device distal end relative to the laser, wherein the device is configured to rotate around a longitudinal axis to intersect the laser beam; directing the laser beam to the distal end to create a desired shape of the distal end of the body defining a first tip profile; directing the laser beam towards the first tip profile to create a fillet on the distal end of the body, wherein creating the fillet may comprise at least one tip profile, wherein each tip profile comprises a diameter ablation profile; and directing the laser beam to the fillet to smooth the distal end of the body, wherein the smoothing of the distal end of the body comprises at least one tip profile comprising a diameter and a power level.

Abstract: An instrument port includes an elongated shaft, a bendable shaft, a steerable tip, an offset balloon, and a handle. The bendable shaft has a proximal end attached to the distal end of the elongated shaft along a shaft axis, the bendable shaft configured to bend only within a pivot plane that is defined by the shaft axis and a pivot axis that is orthogonal to the shaft axis. The steerable tip is attached to a distal end of the bendable shaft and includes a camera and a light emitter. The offset balloon is attached to the external surface of the elongated shaft and has an internal volume in fluid communication with a fluid port in the elongated shaft. The handle includes at least one lever in mechanical communication with the bendable shaft to adjust a customizable angle of the steerable tip measured between the shaft axis and the tip axis.

Abstract: A method can include engaging the pericardium of a patient at two engagement positions of the pericardium. The method can further include moving the two engagement positions of the pericardium away from each other to tension a portion of the pericardium. The method can further include advancing an access device through the tensioned portion of the pericardium to introduce the access device into the pericardial space of the patient. Other and further methods are also disclosed.

Abstract: A medical device comprising a handle comprising a first actuator coupled to a first set of articulation cables; and a second actuator coupled. The device may include a shaft comprising a distal articulation section configured to bend with a distal articulation deflection angle and a distal articulation radius, wherein actuation of the first articulation member is configured to induce the distal articulation deflection angle in the distal articulation section. The device may further include a balloon configurable in a deflated state and an inflated state.

Abstract: Disclosed are methods of transseptal crossing to permit introduction of large bore catheters into to the left atrium, such as to deploy left atrial appendage closure devices or to repair or replace a mitral valve. The method may include the steps of providing a single pass, large bore transseptal crossing system, having a tubular access cannula and an energy delivery wire movably extending through the tubular access cannula. A first electrode tip on the energy delivery wire is brought into contact with a fossa ovalis and energized. The energy delivery wire and cannula are advanced into the left atrium. A large bore sheath is advanced directly over the access cannula and into the left atrium. The cannula and energy delivery wire are removed, and a large bore index procedure catheter may be advanced through the large bore sheath and into the left atrium.

Abstract: An embodiment of a tissue engagement device having a sheath, a first arm, a second arm, a first tissue engaging member, a second tissue engaging member, and an actuation cannula. At least a proximal portion of each arm is within the sheath and the tissue engaging members may be positioned on a distal end of each arm. The actuation cannula is also within the sheath, and can move within the sheath between a retracted position and an extended position. The actuation cannula moves at least a portion of each of the first and second arms into a region between an exterior surface of the actuation cannula and an interior surface of the sheath as the actuation cannula moves to the extended position. The engaging members are configured to pierce a desired tissue and anchor to the desired tissue layer when the actuation cannula is in the extended position.

Abstract: A single pass, large bore transseptal crossing catheter system is disclosed. An elongate, flexible tubular body has a proximal end, a distal end and an electrically conductive sidewall defining a central lumen. An insulation layer surrounds the sidewall and leaves exposed a first distal electrode tip. An inner conductive wire is provided, having a second distal electrode tip. The inner wire is axially movably extendable through the central lumen. A tubular insulation layer is provided in between the wire and the electrically conductive sidewall.

Abstract: A transseptal crossing system can have a sheath and an elongate tubular body. The tubular body can include an electrically conductive sidewall defining a central lumen and a distal end section. The central lumen may be configured to receive a guidewire and to permit at least a portion of the guidewire to extend through a distal opening of the electrically conductive sidewall. The distal end section can comprise a distal end surface in electrical communication with the electrically conductive sidewall. The distal end surface includes a first section being positioned generally perpendicular to a longitudinal axis of the elongate tubular body and a second section being positioned at a non-orthogonal angle relative to the longitudinal axis of the elongate tubular body. At least one of the first section or the second section may be configured to deliver energy to a target tissue.

Abstract: A single pass, large bore transseptal crossing catheter system is disclosed. An elongate, flexible tubular body has a proximal end, a distal end and an electrically conductive sidewall defining a central lumen. An insulation layer surrounds the sidewall and leaves exposed a first distal electrode tip. An inner conductive wire is provided, having a second distal electrode tip. The inner wire is axially movably extendable through the central lumen. A tubular insulation layer is provided in between the wire and the electrically conductive sidewall.

Abstract: An esophageal monitoring device includes a camera and, optionally, one or more lights to enable visualization of an interior of a subject's esophagus. Visualization of the interior of the subject's esophagus before and after a left atrial ablation procedure may enable a healthcare provider to determine whether or not the left atrial ablation procedure has damaged the subject's esophagus before the subject experiences any symptoms of such damage. An esophageal monitoring device may also include sensors and/or markers that enable a determination of its location within a subject's esophagus. Such an esophageal monitoring device may be configured for three-dimensional mapping, and enable the generation of an accurate three-dimensional map of the physical relationship between a subject's esophagus and the left atrium of his or her heart. Methods of monitoring a subject's esophagus while a left atrial ablation procedure is being conducted on the subject's hear are also disclosed.

Abstract: A temperature probe for monitoring temperatures of a surface of a tissue or organ within the body of a subject includes a section with a substantially two-dimensional arrangement and a plurality of temperature sensors positioned across an area defined by the substantially two-dimensional arrangement. Such an apparatus may be used in conjunction with procedures in which thermal techniques are used to diagnose a disease state or treat diseased tissue. Specifically, a temperature probe may be used to monitor temperatures across an area of a surface of a tissue or organ located close to the treated tissue to prevent subjection of the monitored tissue or organ to potentially damaging temperatures.

Abstract: A flexible guide tube having a deflectable distal end is disclosed with at least first and second tensioning lines coupled to a deflectable distal end of the flexible guide tube. The first tensioning line is configured to deflect the distal end of the flexible guide tube in a first direction and the second tensioning line is configured to deflect the distal end of the flexible guide tube in a second direction that is opposite the first direction. A handle is coupled to flexible tube, the handle having a medial portion with a longitudinal axis substantially parallel with at least a portion of the flexible guide tube, a first actuator disposed proximal the medial section, and a second actuator disposed distal the medial section.

Abstract: A method can include engaging the pericardium of a patient at two engagement positions of the pericardium. The method can further include moving the two engagement positions of the pericardium away from each other to tension a portion of the pericardium. The method can further include advancing an access device through the tensioned portion of the pericardium to introduce the access device into the pericardial space of the patient. Other and further methods are also disclosed.

Abstract: An esophageal monitoring device includes a camera and, optionally, one or more lights to enable visualization of an interior of a subject's esophagus. Visualization of the interior of the subject's esophagus before and after a left atrial ablation procedure may enable a healthcare provider to determine whether or not the left atrial ablation procedure has damaged the subject's esophagus before the subject experiences any symptoms of such damage. An esophageal monitoring device may also include sensors and/or markers that enable a determination of its location within a subject's esophagus. Such an esophageal monitoring device may be configured for three-dimensional mapping, and enable the generation of an accurate three-dimensional map of the physical relationship between a subject's esophagus and the left atrium of his or her heart. Methods of monitoring a subject's esophagus while a left atrial ablation procedure is being conducted on the subject's heart are also disclosed.

Abstract: A method can include engaging the pericardium of a patient at two engagement positions of the pericardium. The method can further include moving the two engagement positions of the pericardium away from each other to tension a portion of the pericardium. The method can further include advancing an access device through the tensioned portion of the pericardium to introduce the access device into the pericardial space of the patient. Other and further methods are also disclosed.

Abstract: A temperature probe for monitoring temperatures of a surface of a tissue or organ within the body of a subject includes a section with a substantially two-dimensional arrangement and a plurality of temperature sensors positioned across an area defined by the substantially two-dimensional arrangement. Such an apparatus may be used in conjunction with procedures in which thermal techniques are used to diagnose a disease state or treat diseased tissue. Specifically, a temperature probe may be used to monitor temperatures across an area of a surface of a tissue or organ located close to the treated tissue to prevent subjection of the monitored tissue or organ to potentially damaging temperatures.

Abstract: An esophageal monitoring device includes a camera and, optionally, one or more lights to enable visualization of an interior of a subject's esophagus. Visualization of the interior of the subject's esophagus before and after a left atrial ablation procedure may enable a healthcare provider to determine whether or not the left atrial ablation procedure has damaged the subject's esophagus before the subject experiences any symptoms of such damage. An esophageal monitoring device may also include sensors and/or markers that enable a determination of its location within a subject's esophagus. Such an esophageal monitoring device may be configured for three-dimensional mapping, and enable the generation of an accurate three-dimensional map of the physical relationship between a subject's esophagus and the left atrium of his or her heart. Methods of monitoring a subject's esophagus while a left atrial ablation procedure is being conducted on the subject's heart are also disclosed.