Abstract: A pulmonary access device comprises an elongated shaft having a proximal shaft section, a bendable shaft section, a distal shaft section, and a channel. The pulmonary access device further comprises a profiled stylet configured for being disposed in the working channel of the elongated shaft, the profiled stylet having a proximal stylet section with a first lateral stiffness profile, an intermediate stylet section having a second lateral stiffness profile less than the first lateral stiffness profile, a distal stylet section, wherein, when the profiled stylet is disposed in the working channel of the elongated shaft, the intermediate stylet section axially aligns with the bendable shaft section. The pulmonary access device further comprises a pull wire affixed to the distal shaft section, such that, when the pull wire is tensioned, the bendable shaft section bends, thereby deflecting the distal shaft section relative to the proximal shaft section.

Abstract: An ablation catheter assembly comprises an outer ablation catheter comprising an elongated shaft having a proximal shaft section and a distal shaft section, an inner lumen extending through the proximal shaft section and the distal shaft section, a distal tip port in communication with the inner lumen, and at least one ablative element disposed on the distal shaft section. The ablation catheter assembly further comprises an inner ablation catheter slidably disposed within the inner lumen of the outer ablation catheter. The inner ablation catheter comprises an elongated inner member having a proximal member section and a distal member section, and ablative elements disposed along the distal member section. The distal member section is configured for being deployed from the distal tip port when the inner ablation catheter is distally slid within the inner lumen of the outer ablation catheter, thereby placing the distal member section into an expanded loop geometry.

Abstract: A steerable biopsy device comprises an outer sheath comprising a sheath body having a proximal sheath section and a distal sheath section. The outer sheath further comprises a distal sheath tip and a sheath lumen terminating at a distal port in the distal sheath tip. The biopsy device further comprises a biopsy needle integrated with the sheath body. The biopsy needle is slidably disposed in the sheath lumen. The biopsy needle comprises a needle shaft and a distal needle tip configured for being displaced between a stored position within the sheath lumen and a deployed position outside of the distal port of the distal sheath tip. The biopsy device further comprises an articulation control actuator configured for articulating the distal sheath section, and a needle actuator configured for distally advancing the distal needle tip from the stored position to the deployed position.

Abstract: A steerable biopsy device comprises an outer sheath comprising a sheath body having a proximal sheath section and a distal sheath section. The outer sheath further comprises a distal sheath tip and a sheath lumen terminating at a distal port in the distal sheath tip. The biopsy device further comprises a biopsy needle integrated with the sheath body. The biopsy needle is slidably disposed in the sheath lumen. The biopsy needle comprises a needle shaft and a distal needle tip configured for being displaced between a stored position within the sheath lumen and a deployed position outside of the distal port of the distal sheath tip. The biopsy device further comprises an articulation control actuator configured for articulating the distal sheath section, and a needle actuator configured for distally advancing the distal needle tip from the stored position to the deployed position.

Abstract: A pulmonary access device comprises an elongated shaft having a proximal shaft section, a bendable shaft section, a distal shaft section, and a distal tip. The pulmonary access device further comprises an elongated sheath having a proximal sheath section, a malleable distal sheath section, and working channel. The working channel is configured for slidably receiving the elongated shaft. The pulmonary access device further comprises a handle assembly including a handle body. The handle body is affixed to a proximal end of the elongated shaft. The handle body is removably affixed to a proximal end of the elongated sheath.

Abstract: A steerable biopsy device comprises an outer sheath comprising a sheath body having a proximal sheath section and a distal sheath section. The outer sheath further comprises a distal sheath tip and a sheath lumen terminating at a distal port in the distal sheath tip. The biopsy device further comprises a biopsy needle integrated with the sheath body. The biopsy needle is slidably disposed in the sheath lumen. The biopsy needle comprises a needle shaft and a distal needle tip configured for being displaced between a stored position within the sheath lumen and a deployed position outside of the distal port of the distal sheath tip. The biopsy device further comprises an articulation control actuator configured for articulating the distal sheath section, and a needle actuator configured for distally advancing the distal needle tip from the stored position to the deployed position.

Abstract: A pulmonary access device comprises an elongated shaft having a proximal shaft section, a bendable shaft section, a distal shaft section, and a channel. The pulmonary access device further comprises a profiled stylet configured for being disposed in the working channel of the elongated shaft, the profiled stylet having a proximal stylet section with a first lateral stiffness profile, an intermediate stylet section having a second lateral stiffness profile less than the first lateral stiffness profile, a distal stylet section, wherein, when the profiled stylet is disposed in the working channel of the elongated shaft, the intermediate stylet section axially aligns with the bendable shaft section. The pulmonary access device further comprises a pull wire affixed to the distal shaft section, such that, when the pull wire is tensioned, the bendable shaft section bends, thereby deflecting the distal shaft section relative to the proximal shaft section.

Abstract: An ablation catheter assembly comprises an outer ablation catheter comprising an elongated shaft having a proximal shaft section and a distal shaft section, an inner lumen extending through the proximal shaft section and the distal shaft section, a distal tip port in communication with the inner lumen, and at least one ablative element disposed on the distal shaft section. The ablation catheter assembly further comprises an inner ablation catheter slidably disposed within the inner lumen of the outer ablation catheter. The inner ablation catheter comprises an elongated inner member having a proximal member section and a distal member section, and ablative elements disposed along the distal member section. The distal member section is configured for being deployed from the distal tip port when the inner ablation catheter is distally slid within the inner lumen of the outer ablation catheter, thereby placing the distal member section into an expanded loop geometry.

Abstract: A pulmonary access device comprises an elongated shaft having a proximal shaft section, a bendable shaft section, a distal shaft section, and a channel. The pulmonary access device further comprises a profiled stylet configured for being disposed in the working channel of the elongated shaft, the profiled stylet having a proximal stylet section with a first lateral stiffness profile, an intermediate stylet section having a second lateral stiffness profile less than the first lateral stiffness profile, a distal stylet section, wherein, when the profiled stylet is disposed in the working channel of the elongated shaft, the intermediate stylet section axially aligns with the bendable shaft section. The pulmonary access device further comprises a pull wire affixed to the distal shaft section, such that, when the pull wire is tensioned, the bendable shaft section bends, thereby deflecting the distal shaft section relative to the proximal shaft section.

Abstract: A pulmonary access device comprises an elongated shaft having a proximal shaft section, a bendable shaft section, a distal shaft section, and a distal tip. The pulmonary access device further comprises an elongated sheath having a proximal sheath section, a malleable distal sheath section, and working channel. The working channel is configured for slidably receiving the elongated shaft. The pulmonary access device further comprises a handle assembly including a handle body. The handle body is affixed to a proximal end of the elongated shaft. The handle body is removably affixed to a proximal end of the elongated sheath.

Abstract: A medical device system includes an elongated body with a distal end that is configured and arranged for insertion into a patient. A housing is disposed in the distal end of the body. A rotatable magnet is disposed in the housing. At least one magnetic field winding is configured and arranged to generate a magnetic field at the location of the magnet. The magnetic field causes rotation of the magnet at a target frequency. An array of magnetic field sensors is disposed external to the patient. The magnetic field sensors are configured and arranged to sense the location and orientation of the magnet in relation to the array of magnetic field sensors.

Abstract: Discloses herein are ablative catheters and methods of use. The catheters can include a cooling chamber for circulating cooling fluid within the catheter tip to reduce hot spots within the catheter tip and/or to reduce the formation of coagulum. A proximal cooling chamber can be positioned proximally to a thermal mass for cooling a proximal portion of the catheter. In addition, or alternatively, a distal cooling chamber can be positioned for cooling a distal portion of the catheter tip. The cooling fluid can flow the ablative catheter in an open, closed, or open and closed loop.

Abstract: Disclosed herein, among other things, are methods and apparatus related to radio frequency (RF) ablation catheters. The present subject matter provides a method for forming an ablation catheter having a balloon at a distal end of the catheter. The method includes applying a band of conductive material to an outer surface of the balloon. The band of conductive material is adapted to provide one or more electrodes for radio frequency ablation therapy. A distal end of a lead is connected to the band of conductive material. The balloon is inverted, so that the inverted balloon includes the band of conductive material on an inside surface. According to various embodiments, the balloon includes a semi-permeable or hydro-able membrane.

Abstract: An embodiment of a mapping probe assembly includes a body frame with a lumen therein. The body frame includes a catheter shaft region, a loop section and a transition region between the catheter shaft region and a loop section. A plurality of mapping electrodes are attached around the loop section. Electrical conductors extend through the lumen of the body frame to the mapping electrodes. In some embodiments, the loop section is skived, where a portion of the body frame is removed toward the interior of the loop section. The loop section has a generally planar loop, and further has a loop center. In some embodiments, the catheter shaft has an alignment generally perpendicular to the loop section where the alignment of the catheter shaft is along a line that intersects the planar loop proximate to the loop center.

Abstract: An embodiment of an open-irrigated catheter system comprises a tip section, a distal insert, and mapping electrodes. The tip section has an exterior wall that defines an open interior region within the tip section. The exterior wall includes mapping electrode openings and irrigation ports. The exterior wall is conductive for delivering radio frequency (RF) energy for an RF ablation procedure. The irrigation ports are in fluid communication with the open interior region to allow fluid to flow from the open interior region through the irrigation ports. The distal insert is positioned within the tip section to separate the open region into a distal fluid reservoir and a proximal fluid reservoir. The mapping electrodes are positioned in the mapping electrode openings in the tip section.

Abstract: A mapping catheter includes an elongated body for inserting into patient vasculature. A distal end of the elongated body includes a distal portion that includes a plurality of electrodes, a proximal portion disposed proximal to the distal portion, and a reduced-dimension portion disposed between the proximal and distal portions. The distal end is formed, at least in part, from a memory shape material that bends into a preformed shape upon release from a confined space. The preformed shape includes a first loop formed, at least in part, by the distal portion. The first loop is transverse to a longitudinal axis of the proximal portion. The reduced-dimension portion is configured and arranged to bend such that the reduced-dimension section advances distally through the first loop when the first loop is held in a fixed position and a force is applied distally along the longitudinal axis of the proximal portion.

Abstract: Disclosed herein, among other things, are methods and apparatus related to radio frequency (RF) ablation catheters. The present subject matter provides a method for forming an ablation catheter having a balloon at a distal end of the catheter. The method includes applying a band of conductive material to an outer surface of the balloon. The band of conductive material is adapted to provide one or more electrodes for radio frequency ablation therapy. A distal end of a lead is connected to the band of conductive material. The balloon is inverted, so that the inverted balloon includes the band of conductive material on an inside surface. According to various embodiments, the balloon includes a semi-permeable or hydro-able membrane.

Abstract: Disclosed herein, among other things, are methods and apparatus related to radio frequency (RF) ablation catheters. The present subject matter provides an ablation catheter system including a catheter body with a distal tip, and a thermocouple component at the distal tip. The thermocouple component is adapted to sense temperature of bodily fluid and/or tissue. The system includes a non-conductive insert configured to physically separate and thermally insulate the thermocouple component from the catheter body. Various embodiments include an open-irrigated ablation catheter system, the system further including at least one fluid chamber and a plurality of irrigation ports within the catheter body, where the plurality of irrigation ports enable fluid to exit from the at least one fluid chamber. The non-conductive insert is further configured to physically separate and thermally insulate the thermocouple component from the plurality of fluid flow channels and irrigation ports.

Abstract: A medical device system includes an elongated body with a distal end that is configured and arranged for insertion into a patient. A housing is disposed in the distal end of the body. A rotatable magnet is disposed in the housing. At least one magnetic field winding is configured and arranged to generate a magnetic field at the location of the magnet. The magnetic field causes rotation of the magnet at a target frequency. An array of magnetic field sensors is disposed external to the patient. The magnetic field sensors are configured and arranged to sense the location and orientation of the magnet in relation to the array of magnetic field sensors.

Abstract: A mapping catheter includes an elongated body for inserting into patient vasculature. A distal end of the elongated body includes a distal portion that includes a plurality of electrodes, a proximal portion disposed proximal to the distal portion, and a reduced-dimension portion disposed between the proximal and distal portions. The distal end is formed, at least in part, from a memory shape material that bends into a preformed shape upon release from a confined space. The preformed shape includes a first loop formed, at least in part, by the distal portion. The first loop is transverse to a longitudinal axis of the proximal portion. The reduced-dimension portion is configured and arranged to bend such that the reduced-dimension section advances distally through the first loop when the first loop is held in a fixed position and a force is applied distally along the longitudinal axis of the proximal portion.