Methods and apparatus are provided for applying an fragment of a neurotoxin such as the active light chain (LC) of the botulinum toxin (BoNT), such as one of the serotype A, B, C, D, E, F or G botulinum toxins, via permeabilization of targeted cell membranes to enable translocation of the botulinum neurotoxin light chain (BoNT-LC) molecule across the targeted cell membrane to the cell cytosol where a therapeutic response is produced in a mammalian system. The methods and apparatus include use of catheter based delivery systems, non-invasive delivery systems, and transdermal delivery systems.

A catheter assembly for navigation including a flexible catheter having a proximal portion adjacent a proximal end and a distal portion adjacent a distal end and defining a longitudinal axis, the flexible catheter defining a lumen extending therethrough along a longitudinal axis and configured to enable translation of an instrument from the proximal end to the distal end. The flexible catheter defines a compound curve formed on the distal portion, wherein the compound curve includes an elbow bend and a radially curved portion. The elbow bend deflecting the distal portion of the flexible catheter from the longitudinal axis, while the radially curved portion extends from the elbow bend farther deflecting the distal portion about a center point. The catheter guide assembly for navigation includes a control handle disposed at the proximal end of the flexible catheter and is configured to advance and rotate the flexible catheter within a luminal structure.

Methods, systems, and devices for accessing tissue outside a bronchus and marking the location of a biopsy are provided. The method includes loading a navigation plan into a navigation system with the navigation plan including a CT volume generated from a plurality of CT images, inserting an extended working channel (EWC) including a location sensor into a patient's airways, registering a sensed location of the EWC with the CT volume of the navigation plan, and selecting a target in the navigation plan located outside the periphery of a patient's airways. The method further includes navigating the EWC and location sensor proximate the target, inserting a piercing catheter into the EWC, piercing through an airway wall to reach the target, storing a position of the location sensor in the navigation system as a biopsy location, and performing a biopsy at the stored biopsy location.

A control of an artificial intelligence medical suction device may be embodied by a controller through the steps of: setting a suction pressure of a suction pump connected to the catheter to be a predetermined reference suction pressure, moving the catheter forward so that a suction end portion of the catheter is inserted into the respiratory organ, and analyzing a state of the suction end portion of the catheter based on a variation value of an actual suction pressure measured from the catheter. The medical suction device is capable of determining whether the suction end portion thereof is adsorbed to an inner wall of bronchial tubes on its own.

Methods and apparatus are provided for applying an fragment of a neurotoxin such as the active light chain (LC) of the botulinum toxin (BoNT), such as one of the serotype A, B, C, D, E, F or G botulinum toxins, via permeabilization of targeted cell membranes to enable translocation of the botulinum neurotoxin light chain (BoNT-LC) molecule across the targeted cell membrane to the cell cytosol where a therapeutic response is produced in a mammalian system. The methods and apparatus include use of catheter based delivery systems, non-invasive delivery systems, and transdermal delivery systems.

An intra-tumoral agent deployment apparatus for diagnosing and delivering targeted, sequential deployment of agents to an endo-bronchial and, or an intra-parenchymal tumor, said apparatus formed of, among other things, an elongated shaft assembly including: at least one lumen; an intra-tumoral probe wire for tumor traversal, slidably interposed there between or slidably disposed between any one of, or combination of the at least one lumen; and wherein the displacement of the intra-tumoral probe wire causes disruption of an endo-bronchial and, or an intra-parenchymal tumor tissue, and, or creating an inlet for deployment of at least a first agent comprising any one of a therapeutic agent and, or a delivery vehicle from the first lumen, and a subsequent second agent comprising any one of a therapeutic agent and, or a binding agent from any one of the first lumen, second lumen, and, or the delivery vehicle.

A bronchial piercing catheter assembly used to navigate to target tissue in a patient under EMN guidance includes a handle, a shaft, and a catheter tip. The shaft extends from the handle and includes a proximal end and a distal end. The catheter tip is located on the distal end of the shaft and is designed to penetrate tissue. The catheter tip further includes a base member defined along a central longitudinal axis of the bronchial piercing catheter and a trailing tip member adjacent to the base member. The trailing tip member tapers relative to the base member and a leading tip member adjacent to the trailing tip member. The leading tip member further tapers to a distal end.

A catheter assembly for navigation including a flexible catheter having a proximal portion adjacent a proximal end and a distal portion adjacent a distal end and defining a longitudinal axis, the flexible catheter defining a lumen extending therethrough along a longitudinal axis and configured to enable translation of an instrument from the proximal end to the distal end. The flexible catheter defines a compound curve formed on the distal portion, wherein the compound curve includes an elbow bend and a radially curved portion. The elbow bend deflecting the distal portion of the flexible catheter from the longitudinal axis, while the radially curved portion extends from the elbow bend farther deflecting the distal portion about a center point. The catheter guide assembly for navigation includes a control handle disposed at the proximal end of the flexible catheter and is configured to advance and rotate the flexible catheter within a luminal structure.

A drug delivery system is described. The system has a first fluid delivery reservoir and a second fluid delivery reservoir. The first reservoir is separately controllable from the second reservoir. The first reservoir and second reservoir are attached to a manifold having a first solution channel in fluid communication with the first reservoir and a second solution channel in fluid communication with the second reservoir. The manifold is connected to a catheter having a first lumen in fluid communication with the first solution channel and a second lumen in fluid communication with the second solution channel. The catheter has a first balloon in fluid communication with the first lumen and a second balloon in fluid communication with the second lumen. The first balloon is located within the second balloon. The first balloon is not in fluid communication with the second balloon and the second balloon is perforated. A method for using the system and a kit containing the system are also described.

A drug delivery system is described. The system has a first fluid delivery reservoir and a second fluid delivery reservoir. The first reservoir is separately controllable from the second reservoir. The first reservoir and second reservoir are attached to a manifold having a first solution channel in fluid communication with the first reservoir and a second solution channel in fluid communication with the second reservoir. The manifold is connected to a catheter having a first lumen in fluid communication with the first solution channel and a second lumen in fluid communication with the second solution channel. The catheter has a first balloon in fluid communication with the first lumen and a second balloon in fluid communication with the second lumen. The first balloon is located within the second balloon. The first balloon is not in fluid communication with the second balloon and the second balloon is perforated. A method for using the system and a kit containing the system are also described.