Devices and methods for transnasal irrigation or suctioning of the sinuses

Abstract

An irrigation catheter for the treatment of the sinus anatomy is described. The catheter comprises a proximal portion, a rigid middle portion, and a flexible distal portion. The flexible distal portion comprises an irrigation tip and the proximal portion has a stiffness that is intermediate the stiffness of the rigid middle portion and the flexible distal portion. The irrigation tip has a tip opening and one or more radially facing openings. A method for irrigating or suctioning the sinus anatomy includes inserting an irrigation catheter into a patient's anatomy and irrigating or suctioning a target space.

What is claimed is: 
     
         1 . An irrigation catheter for the treatment of a sinus, the catheter having an irrigation lumen, said catheter comprising:
 a proximal portion:   a rigid middle portion ; and   a flexible distal portion;   wherein the flexible distal portion comprises an irrigation tip and   wherein the proximal portion has a stiffness that is intermediate the stiffness of said rigid middle portion and said flexible distal portion.   
     
     
         2 . The catheter of  claim 1  wherein the irrigation tip comprises a tip opening and one or more radially facing openings. 
     
     
         3 . The catheter of  claim 2  wherein the one or more radially facing openings comprise  3  openings. 
     
     
         4 . The catheter of  claim 3  wherein the radially facing openings have a diameter of between 0.020 inches and 0.050 inches. 
     
     
         5 . The catheter of  claim 4  wherein the radially facing openings have a diameter of 0.026 inches. 
     
     
         6 . The catheter of  claim 1  wherein the rigid middle portion comprises a stiffening member that surrounds the irrigation lumen. 
     
     
         7 . The catheter of  claim 6  wherein the stiffening member is a hypotube. 
     
     
         8 . The catheter of  claim 1  wherein the proximal portion comprises a nylon sleeve that surrounds the irrigation lumen. 
     
     
         9 . The catheter of  claim 1  wherein the medical device further comprises one or more direct visualization markers. 
     
     
         10 . The catheter of  claim 1  wherein the medical device further comprises one or more radiographic markers. 
     
     
         11 . The catheter of  claim 1  wherein the medical device further comprises a dual-use connector selected from the group consisting of a y-connector and a valve. 
     
     
         12 . The catheter of  claim 1  wherein the rigid middle portion further comprises an actuator. 
     
     
         13 . A system for treatment of a target space in the nasal anatomy, said system comprising:
 a handle;   a guide catheter for attachment to the handle, said guide catheter having an inner diameter; and   an irrigation catheter having an outer diameter, the outer diameter of the irrigation catheter being smaller than the inner diameter of the guide catheter,   wherein said irrigation catheter having an irrigation lumen, said irrigation catheter comprising a proximal portion, a rigid middle portion; and a flexible distal portion having an irrigation tip, said proximal portion having a stiffness that is intermediate the stiffness of said rigid middle portion and said flexible distal portion.   
     
     
         14 . The system of  claim 13  wherein the proximal portion comprises a luer connector. 
     
     
         15 . The system of  claim 13  wherein the luer connector comprises a slanted positioner. 
     
     
         16 . The system of  claim 13  further including a guidewire. 
     
     
         17 . A method for treating a target space in the nasal anatomy, said method comprising:
 positioning an irrigation catheter having an irrigation lumen, said catheter comprising a proximal portion, a rigid middle portion and a flexible distal portion in the nasal anatomy, wherein the flexible distal portion comprises an irrigation tip and wherein the proximal portion has a stiffness that is intermediate the stiffness of said rigid middle portion and said flexible distal portion;   connecting a fluid source to the irrigation catheter;   delivering fluid to the target space from the fluid source though the irrigation lumen.   
     
     
         18 . The method of  claim 17  wherein the delivering the fluid occurs at a flow rate of between 50 ml/min and 200 ml/min 
     
     
         19 . The method of  claim 18  wherein the flow rate is between 75 ml/min and 125 ml/min. 
     
     
         20 . The method of  claim 17  wherein the target space is selected from the group consisting of the frontal sinus, the maxillary sinus, the ethmoid sinus, and the sphenoid sinus opening. 
     
     
         21 . The method of  claim 17  wherein the fluid is selected from the group consisting of water, saline, contrast agents, antimicrobial agents anti-inflammatory agents, decongestants , mucous thinning agents, anesthetic agents, analgesic agents, anti-allergenic agents, allergens, anti-proliferative agents, hemostatic agents, cytotoxic agents, and biological agents or combinations of any of the above. 
     
     
         22 . A method for treating a target space in the nasal anatomy, said method comprising:
 positioning an irrigation catheter having an irrigation lumen, said irrigation catheter comprising a proximal portion, a rigid middle portion and a flexible distal portion in the nasal anatomy, wherein the flexible distal portion comprises an irrigation tip and wherein the proximal portion has a stiffness that is intermediate the stiffness of said rigid middle portion and said flexible distal portion;   connecting a vacuum source to the irrigation catheter;   suctioning the target space though the irrigation lumen.   
     
     
         23 . The method of  claim 22  wherein the target space is selected from the group consisting of the frontal sinus, the maxillary sinus, the ethmoid sinus, and the sphenoid sinus opening. 
     
     
         24 . An irrigation catheter having an irrigation lumen, said catheter comprising:
 a proximal portion;   a rigid middle portion; and   a flexible distal portion;   wherein the flexible distal portion comprises an irrigation tip and   wherein the middle portion comprises an actuator.   
     
     
         25 . The catheter of  claim 24  wherein the proximal portion is a rigid proximal portion and further comprises an irrigation connector. 
     
     
         26 . The irrigation catheter of  claim 24  wherein the actuator comprises a distal actuator flange and a proximal actuator flange. 
     
     
         27 . The irrigation catheter of  claim 24  wherein the irrigation tip comprises a tip opening and one or more radially facing openings. 
     
     
         28 . The irrigation catheter of  claim 24  wherein the rigid middle portion comprises a stiffening member that surrounds the irrigation lumen. 
     
     
         29 . The irrigation catheter of  claim 25  wherein the rigid proximal portion comprises a stiffening member that surrounds the irrigation lumen. 
     
     
         30 . A system for treatment of a target space in the nasal anatomy, said system comprising:
 a handle;   a guide catheter for attachment to the handle, said guide catheter having an inner diameter and   an irrigation catheter having an outer diameter, the outer diameter of the irrigation catheter being smaller than the inner diameter of the guide catheter;   wherein said irrigation catheter has an irrigation lumen and wherein said irrigation catheter comprises a proximal portion, a rigid middle portion, and a flexible distal portion having an irrigation tip, said middle portion comprising an actuator.   
     
     
         31 . The system of  claim 30  wherein the irrigation catheter proximal portion is a rigid proximal portion and further comprises an irrigation connector. 
     
     
         32 . The system of  claim 30  wherein the irrigation catheter actuator comprises a distal actuator flange and a proximal actuator flange. 
     
     
         33 . The system of  claim 30  wherein the irrigation tip or the irrigation catheter comprises a tip opening and one or more radially facing openings. 
     
     
         34 . The system of  claim 30  wherein the irrigation catheter rigid middle portion comprises a stiffening member that surrounds the irrigation lumen. 
     
     
         35 . The system of  claim 31  wherein irrigation catheter rigid proximal portion comprises a stiffening member that surrounds the irrigation lumen. 
     
     
         36 . A method for treating a target space in the nasal anatomy, said method comprising:
 positioning an irrigation catheter having an irrigation lumen, said catheter comprising a proximal portion, a rigid middle portion and a flexible distal portion in the nasal anatomy, wherein the flexible distal portion comprises an irrigation tip and the rigid middle portion comprises an actuator;   connecting a fluid source to the irrigation catheter;   delivering fluid to the target space from the fluid source though the irrigation lumen.   
     
     
         37 . The method of  claim 36  wherein the delivering the fluid occurs at a flow rate of between 50 ml/min and 200 ml/min 
     
     
         38 . The method of  claim 36  wherein the target space is selected from the group consisting of the frontal sinus, the maxillary sinus, the ethmoid sinus, and the sphenoid sinus opening. 
     
     
         39 . The method of  claim 36  wherein the fluid is selected from the group consisting of water, saline, contrast agents, antimicrobial agents anti-inflammatory agents, decongestants , mucous thinning agents, anesthetic agents, analgesic agents, anti-allergenic agents, allergens, anti-proliferative agents, hemostatic agents, cytotoxic agents, and biological agents or combinations of any of the above. 
     
     
         40 . A method for treating a target space in the nasal anatomy, said method comprising:
 positioning an irrigation catheter having an irrigation lumen, said irrigation catheter comprising a proximal portion, a rigid middle portion and a flexible distal portion in the nasal anatomy, wherein the flexible distal portion comprises an irrigation tip and wherein the rigid middle portion comprises an actuator;   connecting a vacuum source to the irrigation catheter;   suctioning the target space though the irrigation lumen.   
     
     
         41 . The method of  claim 40  wherein the target space is selected from the group consisting of the frontal sinus, the maxillary sinus, the ethmoid sinus, and the sphenoid sinus opening.