Methods and devices for paranasal sinus drug delivery

Patent metadata

Field	Value
Publication number	US-9333327-B2
Application number	US-76658610-A
Country	US
Kind code	B2
Filing date	Apr 23, 2010
Priority date	Apr 24, 2009
Publication date	May 10, 2016
Grant date	May 10, 2016

Abstract

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.

First claim

What is claimed is:

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 a mammal, the implant including a catheter including a shaft and a core frictionally engaged within a lumen of the shaft, a fluid reservoir secured to a distal portion of the shaft, an anchoring structure secured to a distal tip of the core at a position that is distal to the fluid reservoir, and a dispensing structure, wherein the dispensing structure is in fluid communication with the fluid reservoir and wherein the anchoring structure is configured to move with the core relative to the fluid reservoir and the shaft;
positioning the implant so that the anchoring structure is located within a frontal sinus cavity of the frontal sinus system and most or all of the dispensing structure and the fluid reservoir are located within the frontal sinus drainage pathway;
applying a force to move the shaft relative to the core so as to adjust the relative position between the fluid reservoir and the anchoring structure;
directing a dose of fluid from the fluid reservoir through the dispensing structure, thereby delivering the dose of fluid to the frontal sinus system of the mammal over a period of time of at least a day, at least a portion of the fluid entering the frontal sinus drainage pathway directly from the dispensing structure.

2. The method of claim 1 , wherein the entire dispensing structure is located within the frontal sinus drainage pathway.

3. The method of claim 2 , wherein all of the fluid enters the frontal sinus drainage pathway directly from the dispensing structure.

4. The method of claim 1 , wherein the fluid reservoir is an inflatable structure.

5. The method of claim 4 , 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.

6. The method of claim 4 , 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.

7. The method of claim 4 , further including expanding the inflatable structure by directing the fluid to an interior portion of the inflatable structure.

8. The method of claim 7 , wherein the inflatable structure is positioned within the frontal sinus drainage pathway.

9. The method of claim 7 , wherein the inflatable structure is not cylindrical when expanded.

10. The method of claim 9 , wherein the inflatable structure is a lobed balloon.

11. The method of claim 1 , wherein positioning the implant includes expanding an outer diameter of the anchoring structure within the frontal sinus cavity.

12. The method of claim 11 , wherein the anchoring structure includes two or more retention wings and expanding the outer diameter includes directing the wings radially outward relative to a major axis of the implant.

13. The method of claim 1 , wherein the fluid comprise a pharmaceutical agent.

14. 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.

15. The method of claim 1 , wherein the inflatable structure is secured in a hollow lumen when the implant is directed into the frontal sinus system.

16. The method of claim 1 , further comprising recharging the fluid reservoir by directing a second dose of fluid into the fluid reservoir via a syringe and needle while the implant is positioned within the frontal sinus system of the mammal.

17. The method of claim 1 , wherein the fluid is directed through a valve member prior to being directed into the inflatable structure.

18. The method of claim 1 , wherein the at least one anchoring structure includes two retention wings and said retention wings extend from a distal tip of the implant.

19. The method of claim 1 , further including suturing a proximal cut end of a shaft to nasal mucosa.

20. The method of claim 1 , further including directing a proximal cut end of a shaft behind an uncinate process.

21. The method of claim 20 , further including directing the proximal cut end of a shaft into a maxillary ostium.

Assignees

• Setliff Iii Reuben C
• Keith Peter T
• Entellus Medical Inc

Inventors

• Setliff Iii Reuben C
• Keith Peter T

Classifications

• A61F2/186

  Nose parts · CPC title

• A61F2250/0068

  the pharmaceutical product being in a reservoir · CPC title

• A61M2025/1054

  having detachable or disposable balloons · CPC title

• A61M27/002 Primary

  Implant devices for drainage of body fluids from one part of the body to another (intraocular A61F9/00781; middle ear A61F11/202) · CPC title

• A61F2250/0059

  temporary · CPC title