Devices and methods for transnasal dilation and irrigation of the sinuses
A medical device, and a system and packaged kit containing the medical device for the treatment of a sinus opening is described. The medical device comprises a proximal end, a distal end, and a shaft system having an inflation lumen and an irrigation lumen the proximal and. The shaft system has a proximal shaft section and a distal shaft section. An inflatable balloon is attached to the distal shaft section in a position that is proximal to said distal end. The irrigation tip is distal to the balloon on the distal shaft section and has a tip opening and one or more radially facing openings. A method for treating a sinus opening includes inserting a system that includes the medical device, a sinus guide catheter and a sinus guide element into a patient's anatomy, dilating the sinus opening and irrigating a target in the nasal anatomy.
1. A medical device for the treatment of a sinus opening, the medical device comprising:
a proximal end:
a distal end;
a shaft system having an inflation lumen, a guide element lumen and an irrigation lumen between said proximal end and said distal end, said shaft system having a proximal shaft section and a distal shaft section;
an inflatable balloon having an inflation diameter of between 3.5 mm and 7 mm and an inflation length of between 12 mm and 24 mm on said distal shaft section and proximal to said distal end; and
an irrigation tip on said distal shaft section, distal to the inflatable balloon, said irrigation tip comprising a tip opening and one or more radially facing openings
wherein the guide element lumen merges into the irrigation lumen in the distal shaft section of the shaft system.
2. The medical device of claim 1 wherein the one or more radially facing openings comprise 3 openings.
3. The medical device of claim 2 wherein the radially facing openings have a diameter of between 0.020 inches and 0.050 inches.
4. The medical device of claim 3 wherein the radially facing openings have a diameter of 0.026 inches.
5. The medical device of claim 2 wherein the radially facing opening are spaced 120 degrees apart.
6. The medical device of claim 1 wherein the inflation lumen and the irrigation lumen are adjacent lumens.
7. The medical device of claim 1 wherein the irrigation tip comprises an atraumatic tip portion.
8. The medical device of claim 7 wherein the irrigation tip has an irrigation tip lumen proximal of the atraumatic tip, said irrigation tip lumen having an irrigation tip lumen diameter; and
wherein the tip opening has a tip opening diameter; and
wherein the irrigation tip lumen diameter is greater than the tip opening diameter.
9. The medical device of claim 8 wherein the tip opening diameter is 0.037 inches and the irrigation lumen diameter is 0.042 inches.
10. The medical device of claim 1 wherein the proximal shaft section further comprises a stiffening member.
11. The medical device of claim 10 wherein the stiffening member comprises a hypotube.