Implantable devices and methods for delivering drugs and other substances to treat sinusitis and other disorders

Abstract

Implantable devices and methods for delivering drugs and other substances to locations within the body of a human or animal subject to treat or diagnose sinusitis and a variety of other disorders. The invention includes implantable substance delivery devices that comprise reservoirs and barriers that control the rate at which substances pass out of the reservoirs. The delivery devices may be advanced into the body using guidewires, catheters, ports, introducers and other access apparatus. In some embodiments the delivery devices may be loaded with one or more desired substance before their introduction into the body. In other embodiments the delivery devices are loaded and/or reloaded with a desired substance after the delivery device has been introduced into the body.

What is claimed is: 
     
         1 . A method for delivering a diagnostic or therapeutic substance into a paranasal sinus or paranasal sinus ostium of a human or animal subject, said method comprising:
 advancing a substance delivery device into a paranasal sinus or paranasal sinus ostium, wherein the substance delivery device comprises:
 an expandable reservoir having a collapsed configuration during advancement into the paranasal sinus or paranasal sinus ostium, said reservoir being thereafter expandable to an expanded configuration; 
 a tube extending from said reservoir, said tube having a lumen through which the substance may be introduced into the reservoir; and 
 a barrier through which the substance passes from the reservoir, thereby causing the substance to be delivered into the paranasal sinus or paranasal sinus ostium; 
   introducing a substance through the tube and into the reservoir, thereby causing the reservoir to assume the expanded configuration; and   delivering the substance out of the reservoir into the paranasal sinus or paranasal sinus ostium by leaving the device implanted within the paranasal sinus or paranasal sinus ostium for a period of time such that the substance passes through the barrier.   
     
     
         2 . A method as in  claim 1 , wherein the substance delivery device further comprises a closure apparatus for preventing the substance from backflowing out of the tube after the substance has been introduced into the reservoir. 
     
     
         3 . A method as in  claim 2 , wherein the closure apparatus comprises apparatus for clamping, clipping, ligating, tying or compressing the tube after the substance has been introduced into the reservoir. 
     
     
         4 . A method as in  claim 1 , wherein the reservoir comprises a cavity into which the substance is introduced. 
     
     
         5 . A method as in  claim 4 , wherein at least a portion of said reservoir comprises a porous material that becomes laden with the substance. 
     
     
         6 . A method as in  claim 5 , wherein the porous material is selected from the group consisting of: a sponge flexible polymer foams; biodegradable polymer foams; non-biodegradable polymer foams; porous PLLA; porous PLGA;
 porous hydrogel; polyvinyl alcohols; silicone foams; polytetrafluoroethylene;   expanded polytetraflurorethylene; latex; and nylon.   
     
     
         7 . A method as in  claim 4 , further comprising a porous material disposed in the reservoir which will hold the substance. 
     
     
         8 . A method as in  claim 1 , further comprising cutting away a portion of the tube so that the tube does not protrude outside of the subject's nose. 
     
     
         9 . A method as in  claim 1 , further comprising removing the substance delivery device. 
     
     
         10 . A method as in  claim 9 , wherein removing the substance delivery device comprises grasping and pulling a graspable member of the substance delivery device. 
     
     
         11 . A method as in  claim 1 , wherein the device is configured such that, when in the expanded configuration, it includes at least one flow channel through which mucus or other biological fluid may drain, and wherein the device is advanced to a location such that mucus or other biological fluid drains through said at least one flow channel while the device is implanted. 
     
     
         12 . A method as in  claim 1 , wherein the substance delivery device further comprises:
 an intraostial portion including at least one indentation for receiving at least a portion of tissue forming a paranasal sinus ostium when the reservoir is in its expanded configuration; and   an intrasinus portion that resides within a paranasal sinus when the intraostial portion resides within the paranasal sinus ostium.   
     
     
         13 . A method as in  claim 1 , wherein advancing the substance delivery device comprises pushing the substance delivery device out of a distal end of a catheter using a pusher member disposed within the catheter.