Everting device and method for tracheostomy

Abstract

An integrated device and improved method for tracheostomy which includes the placement of an everted film sheath into a patent's trachea, through which the tracheal tube is inserted.

1 . A medical device for establishing an airway in a patient comprising:
 a guide, said guide defining a first end adapted to be placed on the outer skin of a patient's neck at an appropriate insertion location for a tracheal tube, and a second end opposite the first end;   a pushing means, defining a distal end, a proximal end, a storage space and an opening near the distal end of the pushing means in communication with the storage space; wherein said pushing means is held in moveable relation to the guide such that as the proximal end of the pushing means is moved toward the second end of the guide, the distal end of the pushing means moves away from the first end of the guide;   a first everting film sheath defining a distal end and a proximal end; wherein a portion of the first everting film sheath is stored within the storage space of the pushing means, a portion of the first everting film sheath near the distal end of the first everting film sheath extends from the opening and is attached near the first end of the guide; whereby as the proximal end of the pushing means is moved toward the first end of the guide, the first everting film sheath everts from the opening.   
     
     
         2 . The medical device of  claim 1  further comprising cutting means for cutting tissue of the patient. 
     
     
         3 . The medical device of  claim 1  wherein the pushing means comprises a separate pusher. 
     
     
         4 . The medical device of  claim 1  further comprising a needle defining a proximal end and a sharp distal end adapted for piercing the tissue of the patient, said needle held in movable relation to the guide such that as the proximal end of the needle is moved toward the second end of the guide, the sharp distal end of the needle moves away from the first end of the guide. 
     
     
         5 . The medical device of  claim 1  further comprising a tracheal tube defining a proximal end and a distal end, held in movable relation to the guide such that as the proximal end of the tracheal tube is moved toward the second end of the guide, the distal end of the tracheal tube moves away from the first end of the guide. 
     
     
         6 . The medical device of  claim 5  wherein the pushing means is positioned to lie inside the tracheal tube. 
     
     
         7 . The medical device of  claim 5  wherein the pushing means comprises the tracheal tube. 
     
     
         8 . The medical device of  claim 1  wherein the storage space is a lumen and further comprising a needle defining a proximal end and a sharp distal end adapted for piercing the tissue of the patient, said needle held in movable relation to the guide such that as the proximal end of the needle is moved toward the second end of the guide, the sharp distal end of the needle moves away from the first end of the guide, and further comprising a tracheal tube defining a proximal end and a distal end, held in movable relation to the guide such that as the proximal end of the tracheal tube is moved toward the first end of the guide, the distal end of the tracheal tube moves out of and away from the first end of the guide, and wherein the pushing means is positioned to lie inside the tracheal tube and the needle is positioned to lie inside the lumen. 
     
     
         9 . The medical device of  claim 1  wherein the storage space is a lumen and further comprising a cutting means defining a proximal end and a sharp distal end adapted for piercing the tissue of the patient, said cutting means held in movable relation to the guide such that as the proximal end of the cutting means is moved toward the second end of the guide, the sharp distal end of the cutting means moves away from the first end of the guide, and further comprising a tracheal tube defining a proximal end and a distal end, held in movable relation to the guide such that as the proximal end of the tracheal tube is moved toward the first end of the guide, the distal end of the tracheal tube moves out of and away from the first end of the guide. 
     
     
         10 . The medical device of  claim 9  wherein the pushing means comprises the tracheal tube. 
     
     
         11 . The medical device of  claim 5  further comprising:
 a hollow needle, said needle defining a proximal end and a distal end, said needle held in the lumen in movable relation to the pushing means such that as the proximal end of the needle is moved toward the distal end of the pushing means, the distal end of the needle moves away from the distal end of the pushing means; 
 a piercing wire defining a distal end and a proximal end adapted to pierce the skin of the patient; and 
 a second everting film sheath wherein the second everting film sheath defines a distal end and a proximal end; wherein a portion of the second everting film sheath is stored within the hollow needle, a portion of the second everting film sheath near the distal end of the second everting film sheath extends from the distal end of the hollow needle and is attached to the outside of the needle near the proximal end of the needle, whereby as the proximal end of the needle is moved toward the second end of the guide, the second everting film sheath everts from the distal end of the hollow needle. 
 
     
     
         12 . The medical device of  claim 11  wherein the pushing means comprises a pusher and is positioned to lie inside the tracheal tube. 
     
     
         13 . The medical device of  claim 4  wherein the first everting film sheath is wrapped in an axial spiral around the needle. 
     
     
         14 . The medical device of  claim 8  wherein the first everting film sheath is wrapped in an axial spiral around the needle. 
     
     
         15 . The medical device of  claim 9  wherein the first everting film sheath is wrapped in an axial spiral around the cutting means. 
     
     
         16 . The medical device of  claim 4  wherein the first everting film sheath is rolled around the needle. 
     
     
         17 . The medical device of  claim 8  wherein the first everting film sheath is rolled around the needle. 
     
     
         18 . The medical device of  claim 9  wherein the first everting film sheath is rolled around the cutting means. 
     
     
         19 . The medical device of  claim 16  wherein the first everting film sheath is defines a first longitudinal edge and a second longitudinal edge and wherein at least a portion of the first longitudinal edge overlaps the second longitudinal edge. 
     
     
         20 . The medical device of  claim 17  wherein the first everting film sheath is defines a first longitudinal edge and a second longitudinal edge and wherein at least a portion of the first longitudinal edge overlaps the second longitudinal edge. 
     
     
         21 . The medical device of  claim 18  wherein the first everting film sheath is defines a first longitudinal edge and a second longitudinal edge and wherein at least a portion of the first longitudinal edge overlaps the second longitudinal edge. 
     
     
         22 . The medical device of  claim 1  wherein an outwardly facing portion of the first everting film sheath has a textured surface. 
     
     
         23 . The medical device of  claim 1  wherein the pushing means is flexible and defines a preformed shape of a curve, and wherein a portion of the pushing means is held in a straight position by the guide. 
     
     
         24 . The medical device of  claim 5  wherein the pushing means is flexible and defines a preformed shape of a curve, and wherein a portion of the pushing means is held in a straight position by the guide; and wherein the tracheal tube defines a preformed shape of a curve, and wherein a portion of the tracheal tube is held in a straight position by the guide. 
     
     
         25 . A medical device for establishing an airway in a patient comprising:
 a pushing means, defining a distal end adapted to be pushed into an incision formed on a patient's neck, a proximal end, a storage space and an opening near the distal end of the pushing means in communication with the storage space;   an everting film sheath defining a distal end and a proximal end; wherein a portion of the first everting film sheath is stored within the storage space of the pushing means, a portion of the everting film sheath near the distal end of the everting film sheath extends from the opening and is attached near the first end of the guide; wherein as the distal end of the pushing means is pushed into the incision, the everting film sheath everts from the opening.   
     
     
         26 . A method of establishing an airway in a patient comprising the steps of:
 everting a film sheath into a patient's trachea through an incision;   inserting a tracheal tube into the film sheath.   
     
     
         27 . The method of  claim 26  further comprising the step of:
 making an incision at a predetermined location on the patient's neck. 
 
     
     
         28 . The method of  claim 27  further comprising, before the step of making an incision:
 predetermining the location at a point between the patient's first and second tracheal rings. 
 
     
     
         29 . The method of  claim 27  further comprising, before the step of making an incision:
 predetermining the location at a point between the patient's second and third tracheal rings. 
 
     
     
         30 . The method of  claim 27  wherein the everting step further comprises:
 dilating the patient's skin and pre-tracheal tissue by blunt dissection. 
 
     
     
         31 . The method of  claim 26  further comprising the steps of:
 inserting a guide wire into the incision; and 
 
       the step of inserting the tracheal tube further comprises advancing the tracheal tube over the guide wire. 
     
     
         32 . The medical device of  claim 1  wherein the first everting film sheath is wrapped in an axial spiral in the storage space. 
     
     
         33 . The medical device of  claim 1  wherein the first everting film sheath is rolled in the storage space.