Method and System for Eustachian Tube Dilation

Abstract

A device and method for dilating a Eustachian tube of a patient is disclosed. The device includes a guide catheter and a balloon dilation catheter. The balloon dilation catheter has an actuator that prevents injury to the middle ear. The balloon dilation catheter is slidably coupled with the guide catheter through the guide catheter lumen and is fully inserted into the guide catheter lumen when the distal side of the actuator is adjacent to the proximal end of the guide catheter. The method involves advancing the guide catheter and balloon dilation catheter through a nasal passage of the patient to dilate a portion of the Eustachian tube.

What is claimed is: 
     
         1 . A device for dilating a Eustachian tube of a patient, the device comprising:
 a guide catheter having an first elongate shaft, the first elongate shaft having a proximal end and a distal end and a lumen therebetween, the guide catheter having a proximal hub attached to the proximal end of the first elongate shaft; and   a balloon dilation catheter having a second elongate shaft, the second elongate shaft having a proximal end and a distal end, the balloon dilation catheter having an actuator for one-handed advancement of the catheter coupled to the second elongate shaft between the second elongate shaft proximal end and the second elongate shaft distal end and that separates the second elongate shaft into a proximal portion and a distal portion, the actuator having a proximal side and a distal side;   wherein the balloon dilation catheter is slidably coupled with the guide catheter through the guide catheter lumen and is fully inserted into the guide catheter lumen when the distal side of the actuator is adjacent to the proximal end of the guide catheter.   
     
     
         2 . The device of  claim 1 , wherein the balloon dilation catheter comprises an inflatable balloon and a proximal connecter, and wherein the proximal connector comprises an inflation port in fluid communication with an inflation lumen of the balloon catheter. 
     
     
         3 . The device of  claim 2 , wherein the proximal connector further comprises an injection port. 
     
     
         4 . The device of  claim 3  wherein the inflation port comprises a first type of connector and the injection port comprises a second type of connector different from the first type of connector. 
     
     
         5 . The device of  claim 1 , wherein the guide catheter elongate shaft has a bend with an angle of between about 45 degrees and about 65 degrees. 
     
     
         6 . The device of  claim 1 , wherein the guide catheter elongate shaft has a bend with an angle of about 55. 
     
     
         7 . The device of  claim 1 , wherein a distal end of the balloon dilatation catheter shaft has a bulbous tip. 
     
     
         8 . The device of  claim 1 , wherein the balloon dilation catheter comprises:
 a flexible proximal portion   a rigid middle portion; and   a flexible distal portion.   
     
     
         9 . The device of  claim 8 , wherein the rigid distal portion comprises a hypotube. 
     
     
         10 . A method for dilating a Eustachian tube of a patient, the method comprising:
 advancing a guide catheter having an first elongate shaft, the first elongate shaft having a proximal end and a distal end and a lumen therebetween, the guide catheter having a proximal hub attached to the proximal end of the first elongate shaft through a nasal passage of the patient to position the guide catheter adjacent the Eustachian tube; and   advancing a balloon dilation catheter having a second elongate shaft and a balloon attached to the second elongate shaft, the second elongate shaft having a proximal end and a distal end, the balloon dilation catheter having an actuator coupled to the second elongate shaft between the second elongate shaft proximal end and the elongate shaft distal end and that separates the second elongate shaft into a proximal portion and a distal portion, the actuator having a proximal side and a distal side through the lumen of the guide catheter until the distal side of the actuator is adjacent to the proximal end of the guide catheter;   expanding the balloon to dilate a portion of the Eustachian tube;   collapsing the balloon; and   removing the guide catheter and balloon dilation catheter from the patient, wherein the dilated portion of the Eustachian tube remains at least partially dilated after removal of the device.   
     
     
         11 . The method of  claim 10 , wherein the guide catheter includes a distal portion with bend of between about 45 degrees and about 65 degrees. 
     
     
         12 . The method of  claim 10 , wherein the opening of the Eustachian tube comprises a pharyngeal ostium of the Eustachian tube, and wherein the balloon dilation catheter is advanced to position the balloon in the pharyngeal ostium. 
     
     
         13 . The method of  claim 10 , further comprising:
 advancing an endoscope through the nasal passage; and   viewing at least one of the advancing, expanding, collapsing or removing steps using the endoscope.   
     
     
         14 . The method of  claim 13 , wherein viewing includes viewing a marker on the balloon dilation catheter, and wherein the method further comprises approximating a location of the balloon dilation catheter relative to the opening of the Eustachian tube based on a distance of the marker from a proximal end of the dilator. 
     
     
         15 . The method of  claim 10 , further comprising applying at least one substance to the Eustachian tube using the balloon dilation catheter. 
     
     
         16 . A method for dilating a Eustachian tube of a patient having a nostril, the method comprising:
 advancing a balloon dilation catheter having an elongate shaft and a balloon attached to the elongate shaft, the elongate shaft having a proximal end and a distal end, the balloon dilation catheter having an actuator coupled to the elongate shaft between the elongate shaft proximal end and the elongate shaft distal end and that separates the elongate shaft into a proximal portion and a distal portion, the actuator having a proximal side and a distal side, through the nostril of the patient until the distal side of the actuator is adjacent to the nostril of the patient;   expanding the balloon to dilate a portion of the Eustachian tube;   collapsing the balloon; and   removing the balloon dilation catheter from the nostril of the patient, wherein the dilated portion of the Eustachian tube remains at least partially dilated after removal of the device.   
     
     
         17 . The method of  claim 16 , wherein the opening of the Eustachian tube comprises a pharyngeal ostium of the Eustachian tube, and wherein the balloon dilation catheter is advanced to position the balloon in the pharyngeal ostium. 
     
     
         18 . The method of  claim 16 , further comprising:
 advancing an endoscope through the nasal passage; and   viewing at least one of the advancing, expanding, collapsing or removing steps using the endoscope.   
     
     
         19 . The method of  claim 16 , wherein viewing includes viewing a marker on the balloon dilation catheter, and wherein the method further comprises approximating a location of the balloon dilation catheter relative to the opening of the Eustachian tube based on a distance of the marker from a proximal end of the dilator. 
     
     
         20 . The method of  claim 16 , further comprising applying at least one substance to the Eustachian tube using the balloon dilation catheter. 
     
     
         21 . The method of  claim 20  wherein the substance is selected from the group consisting of contrast agents, antimicrobials, anesthetics, vasoconstrictors, analgesics, agent, a corticosteroids, anti-inflammatories, decongestants, mucous thinners, expectorants, mucolytics, surfactants, antihistamines, cytokine inhibitors, leucotriene inhibitors, IgE inhibitors, immunomodulators, allergens, hemostatic agents, antiproliferatives, cytotoxic agents, proteins, stem cells, genes and gene therapy preparations 
     
     
         22 . A device for dilating a Eustachian tube of a patient, the device comprising:
 a guide catheter having a first elongate shaft, the first elongate shaft having a proximal end and a distal end and a lumen therebetween, the guide catheter having a proximal hub attached to the proximal end of the elongate shaft; and   a balloon dilation catheter having a second elongate shaft, the second elongate shaft having a proximal end and a distal end, the balloon dilation catheter having an actuator for one-handed advancement of the catheter coupled to the second elongate shaft between the second elongate shaft proximal end and the second elongate shaft distal end and that separates the second elongate shaft into a proximal portion and a distal portion;   wherein the balloon dilation catheter is slidably coupled with the guide catheter through the guide catheter lumen and is fully inserted through the guide catheter lumen when the actuator is fully deployed.   
     
     
         23 . The device of  claim 22  wherein the proximal hub comprises a handle. 
     
     
         24 . A device for accessing the Eustachian tube through the nose of a human patient, said device comprising:
 a guide catheter comprising an elongate shaft has a bend angle of between about 45 degrees and about 65 degrees, and having a proximal end and a distal end and a lumen therebetween, and a proximal hub attached to the proximal end of the elongate shaft;   wherein the proximal hub is positioned on the elongate shaft such that when the guide catheter is positioned fully within the nose of the human patient, the proximal hub abuts the nose of the human patient.   
     
     
         25 . The device of  claim 24  wherein the lumen of the elongate shaft is further adapted for delivering at least one substance therethrough. 
     
     
         26 . A balloon dilation catheter for accessing and treating the Eustachian tube through the nose of a human patient, said the balloon dilation catheter comprising:
 an elongate shaft, the elongate shaft having a proximal end and a distal end and inflation lumen therebetween;   an actuator for one-handed advancement of the catheter coupled to the elongate shaft between the elongate shaft proximal end and the elongate shaft distal end, the actuator positioned on the elongate shaft such that when the balloon dilation catheter is positioned fully within the nose of the human patient, the actuator abuts the nose of the human patient;   an inflatable balloon; and   a proximal connecter comprising an inflation port in fluid communication with an inflation lumen of the elongate shaft and an injection port.   
     
     
         27 . The catheter of  claim 26  wherein the inflation port comprises a first type of connector and the injection port comprises a second type of connector different from the first type of connector.