Spacing devices for releasing active substances in the paranasal sinus

Abstract

The invention relates to a spacing device (stent) for use in fenestrations of the paranasal sinus. Said device consists of a sheath which forms a hollow body, surrounding an internal cavity. An active substance, which is released in a controlled manner by the spacing device, is contained in the sheath or in at least one layer of the sheath. The relationship q of the external diameter of the hollow body to the internal diameter of the hollow body is expressed by 1.2≦q≦3.0.

1 . A method for treating a disorder that affects a paranasal sinus, middle ear or trachea, said method comprising the steps of:
 A) providing a substance delivering device that is implantable in an opening of a paranasal sinus, middle ear or trachea, said device comprising a tubular body having a wall, a lumen, first and second open ends, an outer surface, an inner surface and a substance containing layer, the substance containing layer comprising a matrix that contains therapeutic substance such that a therapeutically effective amount of the substance will elute from the device while implanted, wherein said therapeutic substance comprises at least one steroid; and   B) implanting the device in an opening of a paranasal sinus, middle ear or trachea such that a therapeutic amount of the therapeutic substance is delivered to the paranasal sinus, middle ear or trachea in which the device is implanted.   
     
     
         2 . A method according to  claim 1  wherein Step B comprises implanting the device in an opening of a paranasal sinus. 
     
     
         3 . A method according to  claim 1  wherein Step B comprises implanting the device in an opening of a frontal sinus. 
     
     
         4 . A method according to  claim 1  wherein Step B comprises implanting the device in an opening of a paranasal sinus that has been dilated. 
     
     
         5 . A method according to  claim 1  wherein Step B comprises implanting the device in an opening of a paranasal sinus that has been surgically altered. 
     
     
         6 . A method according to  claim 5  wherein the device is implanted in a surgically created fenestration. 
     
     
         7 . A method according to  claim 1  wherein the device is capable of being radially expanded and wherein Step B comprises radially expanding the device at an intended site of implantation. 
     
     
         8 . A method according to  claim 7  wherein the device is radially expanded by inflating a balloon positioned within the device. 
     
     
         9 . A method according to  claim 1  further comprising the step of:
 C) removing the device.   
     
     
         10 . A method according to  claim 9  wherein the device is removed approximately 2 to 12 weeks after implantation.