Flanged cylindrical implant and method of insertion

Abstract

A device for insertion into a puncture in a tracheoesophageal wall includes a cylindrical body and a flexible first flange provided on an outside surface of the body. The flange has a use orientation in which it projects generally outwardly from the outside surface of the body and an insertion orientation in which it is resiliently folded toward the axis of the body. A retainer constructed of a material soluble in fluids present in the tracheoesophageal wall and esophagus retains the flange in its resiliently folded orientation. A method for inserting the device into the puncture comprises the steps of resiliently deflecting the flange toward the axis of the body, placing the retainer over the resiliently folded flange, and either pushing the body, resiliently folded flange first, into the puncture so that the resiliently folded flange lies on the esophageal side of the tracheoesophageal wall, or pulling the body, resiliently folded flange first, into the puncture so that the resiliently folded flange lies on the tracheal side of the tracheoesophageal wall.A device for insertion into an opening in a wall in a human body includes a cylindrical device body having a longitudinal axis and a flexible first flange provided on an outside surface of the device body. The flange has a use orientation in which it projects generally outwardly from the outside surface of the device body and an insertion orientation in which it is resiliently folded toward the axis of the device body. A retainer retains the flange in its resiliently folded orientation. The retainer is constructed of a material soluble in fluids present adjacent the wall. A method for inserting the device into the opening comprises resiliently deflecting the flange toward the axis of the device body and placing over the resiliently folded flange a retainer of a material soluble in fluids present adjacent the wall.

1. In combination, a device for insertion into a puncture in a tracheoesophageal wall, the device including a cylindrical body having a longitudinal axis and a flexible first flange provided on an outside surface of the body, the flange extending radially outward from the axis of the body and being continuous radially outward from the body to a radially outer edge of the flange, the flange having a use orientation in which it projects generally outwardly from the outside surface of the body and an insertion orientation in which it is resiliently folded toward the axis of the body, and means for retaining the flange in its resiliently folded orientation, the retaining means being constructed of a material soluble in fluids present in the tracheoesophageal wall and an esophagus partially bounded by the tracheoesophageal wall. 
     
     
       2. The apparatus of  claim 1  wherein the first flange is positioned adjacent a first end of the body which is inserted  insertable through the puncture. 
     
     
       3. The apparatus of  claim 2  and further comprising a second flange spaced along the body from the first flange toward a second end of the body. 
     
     
       4. The apparatus of  claim 3  wherein the second flange is a flexible flange. 
     
     
       5. A method for inserting into a puncture  an opening in a tracheoesophageal  wall in a human body a device including a cylindrical device body having a longitudinal axis and a flexible flange provided on an outside surface of the device body and having a use orientation in which it projects generally outwardly from the outside surface of the device body comprising the steps of resiliently deflecting the flange toward the axis of the device body and , placing over the resiliently folded flange a retainer of a material soluble in fluids present in  adjacent the tracheoesophageal  wall and an esophagus partially bounded by the tracheoesophageal wall  inserting the device into the opening. 
     
     
       6. The method of  claim 5  wherein the wall has a first side and a second side, and further comprising the step of pushing the device body, resiliently folded flange first, from the first side into the puncture  opening so that the resiliently folded flange lies on an esophageal  the second side of the tracheoesophageal  wall. 
     
     
       7. The method of  claim 5   A method for inserting into an opening in a wall in a human body a device including a cylindrical device body having a longitudinal axis and a flexible flange provided on an outside surface of the device body and having a use orientation in which it projects generally outwardly from the outside surface of the device body comprising the steps of resiliently deflecting the flange toward the axis of the device body and placing over the resiliently folded flange a retainer of a material soluble in fluids present adjacent the wall, the wall having a first side and a second side, and further comprising the step of pulling the device body, resiliently folded flange first, from the second side into the puncture to  opening so that the resiliently folded flange lies on a tracheal  the first side of the tracheoesophageal  wall. 
     
     
       8. The method of  claim 5  wherein  A method for inserting into an opening in a wall in a human body a device including a cylindrical device body having a longitudinal axis and a flexible flange provided on an outside surface of the device body and having a use orientation in which it projects generally outwardly from the outside surface of the device body comprising the steps of resiliently deflecting the flange toward the axis of the device body and placing over the resiliently folded flange a retainer of a material soluble in fluids present adjacent the wall, the steps of resiliently deflecting the flange toward the axis of the device body and placing over the resiliently folded flange a retainer comprise  comprising the steps of inserting the device body in a first direction into an opening of an instrument having a cross section slightly larger than a cross section of the device body transverse to its longitudinal axis far enough that contact with a wall of the opening of the instrument collapses the flange, placing the retainer over the collapsed flange and pushing the device body in a second direction opposite the first out of the opening. 
     
     
       9. The method of  claim 8  wherein the wall has a first side and a second side, and further comprising the step of pushing the device body, resiliently folded flange first, from the first side into the puncture  opening so that the resiliently folded flange lies on the esophageal  second side of the tracheoesophageal  wall. 
     
     
       10. The method of  claim 8  wherein the wall has a first side and a second side, and further comprising the step of pulling the device body, resiliently folded flange first, from the second side into the puncture  opening so that the resiliently folded flange lies on a tracheal  the first side of the tracheoesophageal  wall. 
     
     
       11. In combination, a device for insertion into a puncture in a tracheoesophageal wall, the device including a cylindrical body and a flexible first flange provided on an outside surface of the body, the flange having a use orientation in which it projects generally outwardly from the outside surface of the body and an insertion orientation in which it is resiliently folded toward the axis of the body, and means for retaining the flange in its resiliently folded orientation, the retaining means being removable to permit deployment of the flange to its use orientation. 
     
     
       12. The apparatus of  claim 11  wherein the first flange is positioned adjacent a first end of the body which is inserted through the puncture. 
     
     
       13. The apparatus of  claim 12  and further comprising a second flange spaced along the body from the first flange toward a second end of the body. 
     
     
       14. The apparatus of  claim 13  wherein the second flange is a flexible flange. 
     
     
       15. A method for inserting into a puncture in a tracheoesophageal wall a device including a cylindrical device body having a longitudinal axis and a flexible flange provided on an outside surface of the device body and having a use orientation in which it projects generally outwardly from the outside surface of the device body comprising the steps of resiliently deflecting the flange toward the axis of the device body, placing over the resiliently folded flange a retainer for retaining the flange in a folded non-use orientation, inserting the device with the retainer in place into the puncture, and removing the retainer to permit deployment of the flange to its use orientation. 
     
     
       16. The method of  claim 15  wherein the wall has a first tracheal side and a second esophageal side, and the step of inserting the device with the retainer in place into the puncture comprises the step of pushing the device body, resiliently folded flange first, into the puncture so that the resiliently folded flange lies on an esophageal  the second side of the tracheoesophageal  wall. 
     
     
       17. The method of  claim 15  wherein  A method for inserting into an opening in a wall of a human body a device including a cylindrical device body having a longitudinal axis and a flexible flange provided on an outside surface of the device body and having a use orientation in which it projects generally outwardly from the outside surface of the device body comprising the steps of resiliently deflecting the flange toward the axis of the device body, placing over the resiliently folded flange a retainer for retaining the flange in a folded non- use orientation, inserting the device with the retainer in place into the opening, and removing the retainer to permit deployment of the flange to its use orientation, the wall having a first side and a second side,  the step of inserting the device with the retainer in place into the puncture comprises  opening comprising the step of pulling the device body, resiliently folded flange first, into the puncture  opening so that the resiliently folded flange lies on a tracheal  the first side of the tracheoesophageal  wall. 
     
     
       18. The method of  claim 15  wherein  A method for inserting into an opening in a wall of a human body a device including a cylindrical device body having a longitudinal axis and a flexible flange provided on an outside surface of the device body and having a use orientation in which it projects generally outwardly from the outside surface of the device body comprising the steps of resiliently deflecting the flange toward the axis of the device body, placing over the resiliently folded flange a retainer for retaining the flange in a folded non- use orientation, inserting the device with the retainer in place into the opening, and removing the retainer to permit deployment of the flange to its use orientation,  the steps of resiliently deflecting the flange toward the axis of the device body and placing over the resiliently folded flange a retainer comprise  comprising the steps of inserting the device body in a first direction into an opening of an instrument having a cross section slightly larger than a cross section of the device body transverse to its longitudinal axis far enough that contact with a wall of the opening of an  the instrument collapses the flange, placing the retainer over the collapsed flange and pushing the device body in a second direction opposite the first out of the opening. 
     
     
       19. The method of  claim 18  wherein the wall has a first side and a second side, and further comprising the step of pushing the device body, resiliently folded flange first, into the puncture  opening so that the resiliently folded flange lies on an esophageal  the second side of the tracheoesophageal  wall. 
     
     
       20. The method of  claim 18  wherein the wall has a first side and a second side, and further comprising the step of pulling the device body, resiliently folded flange first, into the puncture  opening so that the resiliently folded flange lies on a tracheal  the first side of the tracheoesophageal  wall.