Methods and devices for paranasal sinus delivery
Described herein are methods and devices for delivering a drug to the frontal sinus system. An inflatable implant is positioned within the frontal sinus system using an anchoring means secured within the frontal sinus cavity. A drug-containing fluid is released directly into the frontal sinus drainage system.
1. A method of delivering a fluid to the frontal sinus system of a mammal, the method comprising:
directing an implant into a frontal sinus system of the mammal, the implant including at least one fluid reservoir, at least one anchoring structure, and at least one dispensing structure, wherein the dispensing structure is in fluid communication with the fluid reservoir, wherein the fluid reservoir is an inflatable structure, wherein the at least one anchoring structure is distal of a distalmost end of the at least one fluid reservoir;
positioning the implant so that (i) the anchoring structure is located within a frontal sinus cavity of the frontal sinus system, (ii) an entirety of the dispensing structure is located within a frontal sinus drainage pathway, and (iii) an entirety of the fluid reservoir is located within the frontal sinus drainage pathway;
expanding an outer diameter of the anchoring structure within the frontal sinus cavity;
after expanding the outer diameter of the anchoring structure, inflating the fluid reservoir; and
while the entirety of the dispensing structure and the entirety of the fluid reservoir are located within the frontal sinus drainage pathway, directing a fluid from the fluid reservoir through the dispensing structure, thereby delivering the fluid directly to the frontal sinus drainage pathway of the mammal over a period of time of at least a day.
2. The method of claim 1 , wherein the inflatable structure is a balloon, the dispensing structure is a plurality of holes disposed within an outer surface of the balloon, and the holes are in fluid communication with an interior portion of the balloon.
3. The method of claim 1 , wherein the inflatable structure is a balloon, the dispensing structure is a plurality of holes disposed within an outer surface of a tube connected to the balloon, and the holes are in fluid communication with an interior portion of the balloon.
4. The method of claim 1 , further including expanding the inflatable structure by directing the fluid to an interior portion of the inflatable structure.
5. The method of claim 4 , wherein the inflatable structure is positioned within the frontal sinus drainage pathway.
6. The method of claim 4 , wherein the inflatable structure is not cylindrical when expanded.
7. The method of claim 6 , wherein the inflatable structure is a lobed balloon.
8. The method of claim 1 , wherein the anchoring structure includes two or more retention wings and expanding the outer diameter includes directing the two or more retention wings radially outward relative to a major axis of the implant.
9. The method of claim 1 , wherein the fluid comprise a pharmaceutical agent.
10. The method of claim 1 , wherein the anchoring structure is secured in a hollow lumen when the implant is directed into the frontal sinus system.
11. The method of claim 10 , wherein the inflatable structure is secured in the hollow lumen when the implant is directed into the frontal sinus system.
12. The method of claim 1 , further including directing a fluid into the fluid reservoir after the period of time of at least a day.
13. The method of claim 1 , wherein the fluid is directed through a one-way valve member prior to being directed into the inflatable structure.
14. The method of claim 1 , positioning the implant includes adjusting a relative distance between the fluid reservoir and the anchoring structure.
15. The method of claim 1 , wherein the implant comprises a cap coupled to the distalmost end of the at least one fluid reservoir, and wherein the at least one anchoring structure is coupled to the cap.
16. The method of claim 1 , wherein the at least one fluid reservoir is coupled to a catheter shaft, and wherein the method further comprises:
after expanding an outer diameter of the anchoring structure within the frontal sinus cavity, cutting the catheter shaft; and
removing a portion of the catheter shaft while retaining the at least one fluid reservoir in the frontal sinus drainage pathway.
17. The method of claim 1 , wherein directing a fluid from the at least one fluid reservoir through the dispensing structure comprises weeping the fluid from the at least one fluid reservoir.