Atraumatic introducer for nasal endotracheal tubes and its method of use

Abstract

The present invention provides an intubation device including a nasal endotracheal tube having a proximal, relative to a person inserting the nasal endotracheal tube, end and a distal end; and an introducer including an elongated member having a proximal open end and a distal blunt end, the introducer proximal open end including a hollow mouth having sidewalls for receiving and holding the distal end of the endotracheal tube. The dilator/introducer is simply a tube, solid or hollow having a hollow proximal end that will hold a distal end of a nasal endotracheal tube in place. It will act as a dilator, and once the distal end of the endotracheal tube is past the nasopharynx and is visualized in the oropharynx, the “dilator” is removed and typically discarded. A method of use of the intubation device is also disclosed.

1 . A device comprising:
 a nasal dilator/introducer comprising an elongated member having a proximal open end and a distal blunt end, wherein the distal end of the elongated member does not have an opening and is unopenable, wherein the distal end of the elongated member comprises a distal-most end wall, and wherein the proximal end of the elongated member comprises a proximal-most side edge, the proximal-most side edge defining the only opening for receiving a endotracheal tube,   the elongated member proximal open end comprising a hollow mouth having sidewalls for receiving the distal end of the endotracheal tube only through the proximal-most side edge and holding the distal end of the endotracheal tube,   wherein a distal end portion of the dilator/introducer has tapered sidewalls and comprises the distal end of the elongated member,   wherein the tapered sidewalls increase in effective diameter at least 10% from a first distal location to a first proximal location,   wherein the first distal location is within 1 inch of the distal end of the dilator/introducer,   wherein the longitudinal distance from the first distal location to the first proximal location is at least 0.5 inches, and   wherein the tapered sidewalls increase in effective diameter at least 10% from the first proximal location to a second proximal location which is more proximal than the first proximal location to the proximal end of the dilator/introducer,   wherein the longitudinal distance from the first proximal location to the second proximal location is at least 0.5 inches, and   wherein the hollow mouth is at the proximal-most side edge of the dilator introducer,   wherein the hollow mouth sidewalls for receiving and holding the distal end of the endotracheal tube has a continuous transverse perimeter along the entire perimeter for surrounding the distal end of the endotracheal tube.   
     
     
         2 . The device of  claim 1 ,
 wherein the tapered sidewalls increase in effective diameter at least 15% from the first distal location to the second proximal location,   wherein the first distal location is within 0.5 inches of the distal end of the dilator/introducer,   wherein the longitudinal distance from the first distal location to the first proximal location is at least 1 inch, and   wherein the tapered sidewalls increase in effective diameter at least 15% from the first proximal location to the second proximal location,   wherein the longitudinal distance from the first proximal location to the second proximal location is at least 1 inch.   
     
     
         3 . The device of  claim 1 ,
 wherein the tapered sidewalls increase in effective diameter at least 15% from the first distal location to the second proximal location,   wherein the first distal location is within 0.25 inches of the distal end of the dilator/introducer,   wherein the longitudinal distance from the first distal location to the first proximal location is at least 5% of the length of the dilator/introducer, and   the tapered sidewalls increase in effective diameter at least 15% from the first proximal location distal location to the second proximal location,   wherein the longitudinal distance from the first proximal location to the second proximal location is at least 5% of the length of the dilator/introducer.   
     
     
         4 . The device of  claim 1 , wherein the dilator/introducer is bendable but sufficiently stiff to be self supporting; the dilator/introducer having closed sidewalls extending from the distal end to the proximal end. 
     
     
         5 . The device of  claim 1 , wherein the tapered longitudinal contour progressively decreases from the distal end to the proximal end and has an absence of step changes in contour over 30 degrees relative to a longitudinal axis of the introducer. 
     
     
         6 . The device of  claim 1 , wherein the hollow mouth is sufficiently elastic to expand upon insertion of the distal end of the nasal endotracheal tube thereinto. 
     
     
         7 . The device of  claim 1 , wherein the mouth section has a greater outer diameter than the remainder of the dilator/introducer. 
     
     
         8 . The device of  claim 1 , wherein the dilator/introducer has a length of 5 to 30 inches. 
     
     
         9 . The device of  claim 1 , wherein the dilator/introducer has an outer diameter of 12 french to 46 french from the first proximal location to the proximal end of the dilator/introducer and the mouth section has an inner diameter of 3 mm to 11.5 mm. 
     
     
         10 . The device of  claim 8 , wherein the dilator/introducer is solid until the proximal-most 10 to 50 mm. 
     
     
         11 . The device of  claim 1 , wherein the dilator/introducer is hollow and self-supporting and has a wall thickness of about 0.02 inches to 0.14 inches and a Shore A durometer rating of about 30 to about 80. 
     
     
         12 . The device of  claim 1 , wherein the dilator/introducer is hollow and self-supporting and has a wall thickness of about 0.067 inches to 0.106 inches and a Shore A durometer rating of about 40 to about 60. 
     
     
         13 . The device of  claim 1 , wherein the dilator/introducer is solid, but for its mouth, and self-supporting and has an outer diameter of 12 french to 46 french and a Shore A durometer rating of about 20 to about 60. 
     
     
         14 . The device of  claim 1 , wherein the dilator/introducer is solid, but for its mouth, and self-supporting and has an outer diameter of 12 french to 46 french of at least 90% of the dilator/introducer, with the proviso that the distal end of the length of the introducer, has a diameter in this range or smaller; and a Shore A durometer rating of about 30 to about 50. 
     
     
         15 . The device of  claim 1 , wherein the dilator/introducer has at least one member of the group consisting of a distal grasping area for grasping with forceps and a proximal grasping area for grasping with forceps. 
     
     
         16 . The device of  claim 1 , wherein the blunt end is closed. 
     
     
         17 . The device of  claim 1 , wherein the proximal open end defines the only open end of the dilator/introducer. 
     
     
         18 . The device of  claim 1 , wherein the endotracheal tube has an external circumferential groove which can mate with a raised internal circumferential rib of the dilator/introducer. 
     
     
         19 . The device of  claim 1 , wherein the dilator/introducer has a tapered longitudinal contour, wherein the diameter of the introducer increases from the distal end to the proximal end, and the dilator/introducer has an absence of step changes in longitudinal contour over 30 degrees relative to a longitudinal axis of the introducer. 
     
     
         20 . The device of  claim 1 , wherein the dilator/introducer proximal-most end is rounded or beveled. 
     
     
         21 . A method for using the device of  claim 1 , comprising:
 providing the dilator/introducer;   inserting the dilator/introducer into a patient's nose distal end first and advancing the introducer manually until the introducer is visualized in the oropharynx;   grasping the dilator/introducer and advancing the introducer on through until the proximal end of the dilator/introducer is visible.   
     
     
         22 . A device comprising:
 a nasal endotracheal tube having a proximal end, relative to a person inserting the nasal endotracheal tube, and a distal end; and   an introducer comprising an elongated member having a proximal open end and a distal blunt end,   the introducer proximal open end comprising a hollow mouth having sidewalls for receiving and holding the distal end of the endotracheal tube, wherein the distal end of the elongated member does not have an opening and is unopenable, wherein the distal end of the elongated member comprises a distal-most end wall, and wherein the proximal end of the elongated member comprises a proximal-most side edge, the proximal-most side edge defining the only opening for receiving the endotracheal tube;   wherein the distal end does not have an opening and is unopenable,   wherein the hollow mouth sidewalls for receiving and holding the distal end of the endotracheal tube has a continuous perimeter for surrounding the distal end of the endotracheal tube,   wherein the dilator/introducer is bendable but sufficiently stiff to be self-supporting.   
     
     
         23 . The device of  claim 22 , wherein the dilator/introducer has an outer diameter of 12 french to 46 french and the mouth section has an inner diameter of 3 mm to 11.5 mm. 
     
     
         24 . The device of  claim 22 , wherein the introducer has a length of 5 to 30 inches. 
     
     
         25 . The device of  claim 22 , wherein the introducer is solid until the proximal-most 10 to 50 mm. 
     
     
         26 . The device of  claim 22 , wherein the introducer is hollow. 
     
     
         27 . (canceled) 
     
     
         28 . The device of  claim 22 , wherein the dilator/introducer has at least one member of the group consisting of a distal grasping area for grasping with forceps and a proximal grasping area for grasping with forceps. 
     
     
         29 . The device of  claim 22 , wherein the, wherein the proximal open end defines the only opening of the introducer. 
     
     
         30 . The device of  claim 22 , wherein the endotracheal tube has an external circumferential groove which can mate with a raised internal circumferential rib of the dilator/introducer. 
     
     
         31 - 32 . (canceled) 
     
     
         33 . The device of  claim 22 , wherein
 a hollow mouth section,   the elongated member has a length of 5 to 30 inches from the first end to the second end for insertion thereof past the nasopharyngeal region into the oropharyngeal region,   wherein the introducer has an outer diameter of 12 french to 46 french and the mouth section has an inner diameter of 3 mm to 11.5 mm,   wherein a distal end portion of the introducer has tapered sidewalls,   wherein the tapered sidewalls increase in effective diameter at least 10% from a first distal location to a first proximal location,   wherein the first distal location is within 1 inch of the distal end of the dilator/introducer,   wherein the longitudinal distance from the first distal location to the first proximal location is at least 0.5 inches.   
     
     
         34 . (canceled) 
     
     
         35 . The device of  claim 22 , wherein the distal-most end of the device is the distal end of the elongated member and the proximal-most end of the device is the proximal end of the elongated member and the hollow mouth sidewalls for receiving and holding the distal end of the endotracheal tube which has the continuous perimeter for surrounding the distal end of the endotracheal tube is at the proximal-most end of the device. 
     
     
         36 . The device of  claim 22 , wherein a distal three quarters of the dilator/introducer is solid with the hollow mouth at the proximal end. 
     
     
         37 . The device of  claim 22 , wherein the dilator/introducer consists of a tube having a progressive, tapering external effective diameter, the tube being solid or hollow and having a proximal open end for holding the distal end of the nasal endotracheal tube, wherein the dilator/introducer distal end has an effective diameter and the proximal end the dilator/introducer distal end has an effective diameter, wherein the dilator/introducer distal end effective diameter is smaller than the proximal end the dilator/introducer distal end effective diameter. 
     
     
         38 . A method for using the device of  claim 22 , comprising inserting the introducer into a patient's nose and advancing the introducer manually until the introducer is visualized in the oropharynx, and grasping the introducer after the introducer is visualized. 
     
     
         39 . The device of  claim 1 , wherein the dilator/introducer is self-supporting and has a naturally curved longitudinal axis forming an arc. 
     
     
         40 . The device of  claim 1 , wherein the endotracheal tube has a Murphy eye and inflatable cuff and the dilator/introducer proximal open end hollow mouth having sidewalls for receiving and holding the distal end of the endotracheal tube at the proximal end of the dilator/introducer to attach distal to the cuff to not cover the cuff. 
     
     
         41 . The device of  claim 1 , wherein the distal end of the introducer has a continuous transverse end wall which has no opening and is unopenable. 
     
     
         42 . The device of  claim 22 , wherein the distal end of the introducer has a continuous transverse end wall which has no opening and is unopenable. 
     
     
         43 . The device of  claim 1 , wherein the distal end of the dilator/introducer is a hemispherical or convex end wall. 
     
     
         44 . The device of  claim 22 , wherein the distal end of the dilator/introducer is a hemispherical or convex end wall.