Sinus dilation catheter

• US 9,486,614 B2
• Filed: 06/27/2012
• Issued: 11/08/2016
• Est. Priority Date: 06/29/2011
• Status: Active Grant

• Current Assignee: Entellus Medical Incorporated (Stryker Corporation)
• Original Assignee: Entellus Medical Incorporated (Stryker Corporation)
• Inventors: Drontle, John R., Hanson, Anthony J., Lesch, Paul
• Primary Examiner(s): Nguyen, Tuan V
• Assistant Examiner(s): Everage, Kevin
• Application Number:
  US13/535,076
• Publication Number:
  US 20130030458A1
• Time in Patent Office: 1,595 Days
• Field of Search: 606/196, 604/891.1, 604/891.2, 604/500, 604506-510, 604514-516
• US Class Current: 1/1
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61M 1/76 Handpieces specially for suction-irrigation A61M1/774, aspiration tips A61M1/84
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A balloon dilation catheter includes a substantially rigid inner guide member and a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide member. To treat a sinus cavity of a subject using the balloon dilation the substantially rigid inner guide member is advanced into a drainage pathway of the sinus (e.g., frontal recess or maxillary sinus) of the subject via a nasal passageway. The shaft and balloon are advanced in a distal direction over the substantially rigid inner guide member to place the balloon in the drainage pathway. The balloon is inflated to expand or otherwise remodel the drainage pathway.

Claims

1. A method of treating a sinus cavity of a subject using a balloon dilation catheter having a substantially rigid inner guide member and a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide member comprising:

directing a distal tip of the substantially rigid inner guide member through a nostril of the subject;

positioning the distal tip of the substantially rigid inner guide member behind an uncinate process to place the distal tip within an ethmoidal infundibulum;

riding the distal tip along a lateral side of the uncinate process to both avoid a nasal fontanelle and guide the distal tip directionally toward a maxillary ostium, wherein the distal tip is directed along the lateral side of the uncinate process until the distal tip is positioned behind a lower aspect of the uncinate process within the ethmoidal infundibulum;

directing the distal tip into the maxillary sinus ostium;

advancing the shaft and balloon in a distal direction over the substantially rigid inner guide member to place the balloon across the maxillary sinus ostium; and

inflating the balloon.

2. The method of claim 1, further including determining a position of the distal tip behind the uncinate process, wherein determining the position of the distal tip includes observing through the uncinate process a light emitted from the distal tip while the distal tip is within the ethmoidal infundibulum.

3. The method of claim 2, wherein the light is emitted from a light fiber positioned within the substantially rigid inner guide member.

4. The method of claim 3, wherein the light fiber includes a ball tip on a distal end of the light fiber.

5. The method of claim 1, wherein a distal portion of the substantially rigid inner guide member includes a bend with a distal leg that is between about 10 and about 12 millimeters in length.

6. The method of claim 5, wherein the substantially rigid inner guide member is directed into a nasal cavity of the subject in a tip up orientation.

7. The method of claim 1, further including inserting a distal portion of a maxillary seeker into the maxillary sinus ostium prior to positioning the distal tip of the substantially rigid inner guide member behind the uncinate process and within the ethmoidal infundibulum.

8. The method of claim 1, wherein a distal portion of the substantially rigid inner guide member includes a bend of between about 115 and 125 degrees and about 10 to 12 millimeters of the substantially rigid inner guide member is distal to the bend.

9. The method of claim 1, wherein a distal portion of the substantially rigid inner guide member includes a bend of about 135 degrees and about 10 to 12 millimeters of the substantially rigid inner guide member is distal to the bend.

10. The method of claim 1, wherein directing the distal tip along a lateral side of the uncinate process includes directing the distal tip to a position next to the lowest 20% of the uncinate process.

11. The method of claim 1, further including, after directing the distal tip into the maxillary sinus ostium but before inflating the balloon, pulling the substantially rigid inner guide member anteriorly and inferiorly such that the uncinate process is further deflected.

12. The method of claim 1, further including inflating the balloon a second time when the balloon lies across the maxillary sinus ostium.

13. The method of claim 1, wherein the balloon dilation catheter includes a handle attached to a proximal portion of the substantially rigid inner guide member, wherein the handle includes a suction vent port configured to increase or decrease a suction force at the distal tip of the inner guide member.

14. The method of claim 13, wherein the balloon dilation catheter is configured to allow a single hand to grasp the handle and position the substantially rigid inner guide member within the anatomy, advance the shaft and balloon over the substantially rigid inner guide member, and alter the amount of suction force at the distal tip of the inner guide member without the single hand releasing the handle.

15. The method of claim 1, wherein the balloon dilation catheter includes a handle attached to the proximal end of the substantially rigid inner guide member and an inflation lumen extending through the handle, wherein a portion of the inflation lumen extending through the handle is folded back upon itself to form an S-shape.

16. The method of claim 1, further including, before directing the distal tip into a maxillary sinus ostium, inflating the balloon while a distal end portion of the balloon is within the ethmoidal infundibulum.