Endotracheal tube with aerosol delivery apparatus II

Abstract

Current methods of drug administration to the lungs are inefficient. ‘Endotracheal Tube with Aerosol Delivery Apparatus II’ is specifically designed for uniform intrapulmonary delivery of aerosolized medication in patients on mechanical ventilation. As opposed to the current methods of drug delivery where aerosol particles are generated at the proximal end of the ETT, with majority of the particles adhering to the endotracheal tube during delivery, this invention bypasses the endotracheal tube by generating aerosol particles at its distal end. This invention incorporates 1 to 6 (preferably 4 to 6) secondary cannulations in the wall of the ETT with pinhole terminal orifices at the distal tip of the ETT arranged symmetrically. The secondary cannulations continue proximally as semi-flexible tubules that terminate as MDI adapters to fit the nozzle of MDI canister. This device generates 1-6 aerosol plumes. Numerous variations in the ID, shape, trajectory and location of the secondary cannulations and distal orifices in the wall of the ETT generate aerosol plumes with velocity, geometry, particle size and orientation that ensures effective aerosol delivery to the respiratory system.

What is claimed is:  
     
         1 . An improved method of drug delivery to patient's respiratory system comprising: 
 an endotrcheal tube (ETT) having a main tube with provision for a connector at the proximal end; the said connector may be connected to a ventilator, ambu bag, T-piece or any breathing apparatus or gas source (gas cylinder or wall source); a main lumen extending through the main tube; a wall surrounding the main lumen; the said tube with or without an expandable balloon cuff at the distal end; a primary cannulation formed in the wall of the ETT for inflation and deflation of the balloon cuff with a coupling adapted to connect to a syringe;    an ETT with secondary cannulation/cannulations (1 to 6 or more) in its' wall; the said cannulation(s) terminating with a orifice at the distal tip of ETT; the said cannulation's distal orifice preferably not in communication with the main lumen of the ETT; the said distal orifice of the secondary cannulation not extending beyond the main tip of the ETT; the said cannulation with a proximal exit port on the outer wall of the ETT; the said exit port makes a connection with a semi-flexible tubule outside the main structure of the ETT; the said flexible tubule terminating at the proximal end as MDI adapter or rigid cylindrical tubule that fuses or mates with MDI adapter; the said MDI adapter with a provision for fitting the nozzle of MDI canister;    an ETT with six or more orifices at the distal tip which may or may not be equidistant from each other, preferably in 1, 3, 5, 7, 9, 11 o'clock positions, but may have an alternative arrangement anywhere along the circular distal edge of the ETT;    a pressurized canister that contains a suspension of pulverized medication in a liquid propellant (for example CFC) or a solution of medication in a liquid propellant (for example HFA); the said canister with a nozzle; the aerosol particles of medication and liquid propellant exiting from the said nozzle on actuation of the canister; the propellant evaporating and the said medication particles delivered to the respiratory sytem; the said pressurized canister, the time of actuation of which can be varied with inspiratory and/or expiratory phase of respiratory cycle of a patient who is breathing spontaneously or mechanically through a ventilator; the said “medication” or “drug” should be considered to include any substance or agent that can be delivered to the tracheobronchial tree/respiratory system for diagnostic or therapeutic purposes in the form of solid, liquid or gas;    an ETT, the wall of which may be of variable thickness, durometer, flexibility, lumen ID, lumen OD, terminal end (curved or straight), curvature (convexity/concavity), secondary orifices (Murphy's eye 1 or 2), and lumen shape (round or oval);    an ETT with provision for the flow of humidified or non-humidified air at controlled temperature to the patient's respiratory system;    an ETT such that 1 to 6 (or more) aerosol plumes can be generated at its distal tip to deliver aerosol medication to each lung individually (via a single port) as well as a uniform distribution to both lungs via multiple ports;    an ETT with multiple secondary carmulations and terminal orifices which may be identical or different from each other in shapes, ID's, trajectories and orientations to generate multiple same or different aerosol plumes having velocity, geometry, orientation and particle sizes in order to maximize uniform drug delivery to tracheobronchial tree of both lungs; the said plumes may be eccentric, narrow and fast; eccentric, narrow and slow; eccentric, wide and slow; eccentric, wide and fast;    intubating the patient with the said ETT;    
     
     
         2 . The method of  claim 1  further comprising: 
 the secondary cannulation in the wall of the ETT; the said secondary cannulation in the same plane throughout its course in the wall of the ETT or with a change in the plane in its course; the said cannulation with course (tract) near the inner wall throughout; or near the outer wall throughout; or partly near the outer wall and partly near the inner wall in a variable ratio; the said cannulation may be on the outer surface of the wall of the ETT; the said cannulation may be on the inner surface of the wall of the ETT within the main lumen of the ETT; the said cannulation with the point of exit on the outer surface of the wall of the ETT at a level higher or lower than the point of entry of the primary cannulation; the said cannulation with tracts which may be straight, curvilinear, spiral or have any other trajectory or combinations of the same; the said cannulation with its distal tip splitting into greater than one tubules within the wall of the ETT to terminate as multiple orifices in the distal tip of the ETT.  
 the secondary cannulation with variations in the ID; the said cannulation may be uniform throughout the entire length or tapered throughout the entire length or both uniform and tapered in a variable ratio in the proximal and/or distal parts of ETT;  
 the secondary cannulations with variable shapes; the said cannulation preferably cylindrical but may be of alternative shapes; the said cannulation with a proximal cylindrical part that may become splayed, horn-shaped or an alternative shape at the distal end to generate slower and wider plume;  
 the secondary cannulations may be manufactured of the same material as the main ETT or coextruded with a material different from the one used to manufacture the main ETT; the said coextrusion done to change the physical properties of the lumen of the secondary cannulations; the said coextrusion facilitating maximum aerosol drug delivery to the tracheobronchial tree;  
 
     
     
         3 . Methods of  claim 1  further comprising: 
 terminal orifice(s) at the tip of the ETT; the said orifice maybe of different ID's (same, smaller or larger than secondary cannulations); different geometrical shapes (circular, semi-circular, lunar etc.); different locations (near the outer wall, inner wall, center, on the outer surface of the ETT, or on the inner surface of the ETT)  
 
     
     
         4 . The methods of  claim 1  further comprising: 
 the flexible tubule(s) (preferably 1 to 6 but could be more); the said tubules packaged in a larger hollow tube; the said tubules with variable length, flexibility, ID, OD, thickness, durometer, and shape; the said tubules terminating as MDI adapters or mating with MDI adapters at the proximal end; the proximal end of the said tubules terminating on the ventral surface of a circular plate in the center of the plate (if single)and at the peripheral rim of the plate (if multiple);  
 
     
     
         5 . The method of  claim 1  further comprising: 
 two circular plates; the said plates attached through a central connector; the lower plate preferably fixed; the upper plate which can rotate in a circular fashion or up and down along the circular and perpendicular grooves of the central connector; the assembly permitting fusion or mating of the proximal end of flexible tubules on the lower circular plate with the distal end of MDI adapter on the upper plate in six (or more) different positions; the said arrangement permitting flow of aerosol medication from MDI to the distal tip of the ETT via MDI adapter, flexible tubule and secondary cannulation;  
 a singular circular plate with flexible tubules terminating as MDI adapters on the peripheral rim of the plate; the nozzle of MDI fitting into the said six MDI adapters one at a time in six different positions by manually moving the MDI canister;  
 
     
     
         6 . The method of claims  1 - 5  with an improved system on delivery of medication to patient's respiratory system comprising: 
 an ETT with MDI adapter, flexible tubules, secondary cannulation, and distal orifices with two coaxial lumens; the said inner and outer coaxial lumens with variable ID's, OD's, shapes, lengths, trajectories, orientation, thickness of their walls and distance from each other; the said coaxial lumens may be coextruded with different materials; the said inner lumen for liquid or liquid aerosol flow and the said outer lumen for gas or vapor flow;  
 
     
     
         7 . The method of claims  1 - 6  with an improved system of delivery of aerosol medication to both lungs comprising: 
 a suction catheter incorporating all the principles of our device to serve dual purpose; a suction catheter that can be inserted through the ventilator lumen of ETT; the said catheter can aspirate respiratory secretions and then deliver multiple aerosol plumes (1 to 6 or more) via multiple orifices in the distal tip of the said catheter; the said catheter may be disposable or retained in a sterile sheet connected to the proximal end of the ETT so that it could be reinserted.