Delivery System for Implanting Nasal Ventilation Tube

Abstract

Delivery systems and methods of creating an accessory maxillary ostium and implanting a ventilation tube for purposes of ventilation, irrigation, infusion or procedural work are described. The delivery systems include an introducer and an associated ventilation tube. An irrigation and/or infusion catheter may be advanced through the ventilation tube in order to irrigate or express the contents of the sinus cavities. A secondary irrigation and/or infusion catheter or a balloon catheter may be advanced through an outer irrigation and/or infusion catheter, deeply into the sinus cavity, in order to irrigate or express the contents of the sinus cavities. Moreover, the balloon catheter may alternatively or additionally be employed to for dilation of the natural ostium. Still further, a device for delivering drugs, fluids or the like, may be coupled to the ventilation tube for delivery of same.

1 . A delivery system comprising:
 an introducer having a first proximal end and a first distal end;   a cannula slidably disposed over the introducer, the cannula having a second proximal end, a second distal end, and an outside diameter, the cannula moveable along the introducer between a first position and a second position;   a ventilation tube releasably disposed on the first distal end of the introducer, the ventilation tube having a third proximal end, a third distal end, and a ventilation tube wall defining a channel extending between the third proximal end and the third distal end, the channel having a resting diameter and a loaded diameter;   wherein the outside diameter of the cannula is greater than the loaded diameter of the channel; and   wherein movement of the cannula from the first position to the second position advances the ventilation tube distally along the introducer to release the ventilation tube from the introducer.   
     
     
         2 . The delivery system of  claim 1 , wherein the introducer defines a bend between the first proximal end and the first distal end. 
     
     
         3 . The delivery system of  claim 2 , wherein the ventilation tube is disposed on the introducer distal to the bend. 
     
     
         4 . The delivery system of  claim 1 , wherein the first distal end of the introducer defines a first introducer diameter; and
 wherein the first introducer diameter is greater than the resting diameter of the ventilation tube.   
     
     
         5 . The delivery system of  claim 4 , wherein the first distal end of the introducer is tapered. 
     
     
         6 . The delivery system of  claim 4 , wherein the first distal end of the introducer defines a circumferential recess; and
 further comprising an o-ring disposed within the recess.   
     
     
         7 . The delivery system of  claim 4 , wherein the introducer defines a second introducer diameter greater than the first introducer diameter; and
 wherein the introducer defines a shoulder that transitions from the first introducer diameter to the second introducer diameter.   
     
     
         8 . The delivery system of  claim 1 , wherein the introducer is formed of a malleable material adapted to allow a user to bend the introducer to conform to actual or expected anatomy of a bodily passage. 
     
     
         9 . The delivery system of  claim 8 , wherein the cannula is formed of a malleable material adapted to allow a user to bend the cannula to conform to actual or expected anatomy of a bodily passage. 
     
     
         10 . A delivery system comprising:
 an introducer having a first proximal end and a first distal end;   a cannula slidably disposed over the introducer, the cannula having a second proximal end, a second distal end, and an outside diameter, the cannula moveable along the introducer between a first position and a second position;   a ventilation tube releasably disposed on the first distal end of the introducer, the ventilation tube having a third proximal end, a third distal end, a proximal flange, a distal flange, and a ventilation tube wall defining a channel extending between the third proximal end and the third distal end, the channel having a first resting diameter and a loaded diameter;   wherein the distal flange of the ventilation tube is frusto-conical;   wherein the outside diameter of the cannula is greater than the loaded diameter of the channel; and   wherein movement of the cannula from the first position to the second position advances the ventilation tube distally along the introducer to release the ventilation tube from the introducer.   
     
     
         11 . The delivery system of  claim 10 , wherein the channel of the ventilation tube is tapered. 
     
     
         12 . The delivery system of  claim 10 , wherein the first distal end of the introducer defines an introducer diameter; and
 wherein the introducer diameter is greater than the first resting diameter of the ventilation tube.   
     
     
         13 . The delivery system of  claim 12 , wherein the channel of the ventilation tube defines a second resting diameter greater than the first resting diameter;
 wherein the channel defines a shoulder that transitions from the first resting diameter to the second channel diameter; and   wherein the second resting diameter is greater than the introducer diameter.   
     
     
         14 . The delivery system of  claim 10 , wherein the proximal flange defines a passageway extending through a thickness of the proximal flange. 
     
     
         15 . The delivery system of  claim 10 , wherein the ventilation tube comprises a drug eluting material. 
     
     
         16 . The delivery system of  claim 15 , wherein the drug eluting material comprises one of antithrombogenics, antiproliferatives, antibiotics, antivirals, antifungals, or anti-inflammatories. 
     
     
         17 . The delivery system of  claim 10 , wherein the ventilation tube comprises a resorbable material. 
     
     
         18 . The delivery system of  claim 1 , further comprising a handle disposed on the introducer; and
 further comprising a drum disposed within the handle, the drum slidably disposed over the introducer and having a fourth proximal end and a fourth distal end attached to the second proximal end of the cannula, the drum moveable along the introducer between a first position and a second position;   wherein movement of the drum between its first and second positions moves the cannula between its first and second positions.   
     
     
         19 . The delivery system of  claim 10 , further comprising a handle disposed on the introducer; and
 further comprising a drum disposed within the handle, the drum slidably disposed over the introducer and having a fourth proximal end and a fourth distal end attached to the second proximal end of the cannula, the drum moveable along the introducer between a first position and a second position;   wherein movement of the drum between its first and second positions moves the cannula between its first and second positions.   
     
     
         20 . A delivery system comprising:
 an introducer having a first proximal end and a first distal end;   a cannula slidably disposed over the introducer, the cannula having a second proximal end, a second distal end, and an outside diameter, the cannula moveable along the introducer between a first position and a second position;   a ventilation tube releasably disposed on the first distal end of the introducer, the ventilation tube having a third proximal end, a third distal end, and a ventilation tube wall defining a channel extending between the third proximal end and the third distal end, the channel having a resting diameter and a loaded diameter;   a handle disposed on the introducer;   a drum disposed within the handle, the drum slidably disposed over the introducer and having a fourth proximal end and a fourth distal end directly attached to the second proximal end of the cannula, the drum moveable along the introducer between a first position and a second position;   wherein the outside diameter of the cannula is greater than the loaded diameter of the channel;   wherein movement of the drum between its first and second positions moves the cannula between its first and second positions; and   wherein movement of the cannula from the first position to the second position advances the ventilation tube distally along the introducer to release the ventilation tube from the introducer.