Devices, Systems and Methods for Treating Disorders of the Ear, Nose and Throat

Abstract

Sinusitis, mucocysts, tumors, infections, hearing disorders, choanal atresia, fractures and other disorders of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat and mouth structures are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies and endoscopic studies. Access and occluding devices may be used to facilitate insertion of working devices such asendoscopes, wires, probes, needles, catheters, balloon catheters, dilation catheters, dilators, balloons, tissue cutting or remodeling devices, suction or irrigation devices, imaging devices, sizing devices, biopsy devices, image-guided devices containing sensors or transmitters, electrosurgical devices, energy emitting devices, devices for injecting diagnostic or therapeutic agents, devices for implanting devices such as stents, substance eluting or delivering devices and implants, etc.

1 . A device for occluding a nostril of a human or animal subject while permitting a catheter, guidewire or other working device to be inserted through that nostril, said device comprising:
 an occluder member that conforms to the shape of the nostril in which it is inserted; and   a passageway that extends through said occluder member to permit the catheter, guidewire or other working device to be inserted through the occluder member when the occluder member is positioned within the nostril.   
     
     
         2 . A device according to  claim 1  wherein the occluder member comprises a resilient material that may be compressed, inserted into the nostril while in a compressed state and subsequently allows to re-expand to a non-compressed state wherein it conforms to the shape of the nostril in which it is positioned. 
     
     
         3 . A device according to  claim 1  wherein the occluder member comprises a balloon that is sufficiently compliant to conform to the shape of the nostril in which it is positioned. 
     
     
         4 . A device for occluding a nostril of a human or animal subject while permitting a catheter, guidewire or other working device to be inserted through that nostril, said device comprising:
 an occluder balloon that occludes the nostril, said balloon being configured to resist pulling of the device out of the nostril; and   a passageway that extends through said occluder balloon to permit the catheter, guidewire or other working device to be inserted through the occluder balloon when the occluder balloon is positioned within the nostril.   
     
     
         5 . A device according to  claim 1  wherein the occluder balloon has one or more ribs formed on its outer surface to frictionally engage the adjacent anatomical wall of the nostril in which it is positioned to resist pulling of the device out of the nostril. 
     
     
         6 . An adhesive device useable to resist pulling of a device out of a nostril of a human or animal subject, said device comprising:
 a flexible article having an inner adhesive surface and an outer non-adhesive surface, said flexible article being shaped such that a portion of the device may be positioned over the nares to deter pulling of the device from the nostril and at least a portion of the inner adhesive surface is adhered to skin to hold the device in place.   
     
     
         7 . A device according to  claim 6  wherein the article has upper wings that adhere to the skin in the sides of the nose and/or cheeks adjacent to the nose. 
     
     
         8 . A device according to  claim 6  wherein the article has lower wings that adhere to the skin of the upper lip and/or face adjacent to the upper lip. 
     
     
         9 . A device according to  claim 6  wherein an opening is formed in the portion of the device that is positioned over the nares to permit insertion of a catheter, guidewire or other working device through said opening and through the nostril. 
     
     
         10 . A device for occluding the nasal cavity or nasopharynx of a human or animal subject, posterior to the intranasal septum, said device comprising:
 a tube having a proximal portion of a first diameter and a distal portion of a second diameter that is larger than said first diameter;   a balloon mounted on the distal portion of the tube;   said tube being insertable through a nostril to a position where the distal portion of the tube is posterior to the intranasal septum, said balloon being thereafter inflatable to substantially block the nasal cavity or nasopharynx posterior to the nasal septum.   
     
     
         11 . A device according to  claim 10  further comprising at least one aperture formed in the tube proximal to the balloon to facilitate suctioning of matter from the nasal cavity proximal to the balloon. 
     
     
         12 . A device according to  claim 10  further comprising an anterior occluder on the proximal portion of the tube for occluding the nostril through which the tube is inserted.
 a dilator located proximal to the intrasinus balloon, said dilator being useable to dilate the ostium. 
 
     
     
         13 . A sinusitis treatment system, comprising:
 a first working device having a proximal end and a distal end, the distal end of the working device configured for insertion through a nostril and through an opening into a paranasal sinus of a patient; and   a stabilizing device removably couplable with the first working device to stabilize the first working device positioned within the nostril.   
     
     
         14 . The system of  claim 13 , wherein the stabilizing device comprises a first orifice through which the first working device may be inserted into through the nostril. 
     
     
         15 . The system of  claim 14 , further comprising a second working device for use in conjunction with the first working device. 
     
     
         16 . The system of  claim 15 , wherein the second working device is inserted through a second orifice of the stabilizing member, and the stabilizing member is configured to stabilize the second working device. 
     
     
         17 . The system of  claim 14 , wherein the stabilizing device includes an inflatable member. 
     
     
         18 . The system of  claim 14 , wherein the stabilizing device includes a foam material. 
     
     
         19 . The system of  claim 14 , wherein the stabilizing device includes a moldable material. 
     
     
         20 . The system of  claim 14 , wherein the stabilizing device includes an adhesive element. 
     
     
         21 . The system of  claim 20 , wherein the stabilizing device includes a flexible article having an inner adhesive surface and an outer non-adhesive surface, the flexible article being shaped such that a portion of the device may be positioned over nares to deter pulling of the first working device from the nasal cavity and at least a portion of the inner adhesive surface is adhered to skin to hold the stabilizing device in place.