Method and articles for treating the sinus system

• US 9,370,650 B2
• Filed: 08/26/2014
• Issued: 06/21/2016
• Est. Priority Date: 06/05/2009
• Status: Active Grant

• Current Assignee: Entellus Medical Incorporated (Stryker Corporation)
• Original Assignee: Entellus Medical Incorporated (Stryker Corporation)
• Inventors: Hanson, Anthony J., Drontle, John R., Harris, Chad, Higgins, Matthew
• Primary Examiner(s): Nguyen, Tuan V
• Assistant Examiner(s): EVERAGE, KEVIN D
• Application Number:
  US14/468,617
• Publication Number:
  US 20140364700A1
• Time in Patent Office: 665 Days
• Field of Search: 606191-199, 604/532, 604/96.01, 604/101.04, 604 9701-10003, 604/103.09, 600/199, 600/101, 600/178, 600/182, 362/572
• US Class Current: 1/1
• CPC Class Codes: A61B 1/06 with illuminating arrangements
• 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: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2034/102 Modelling of surgical devices, implants or prosthesis
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/304 using chemi-luminescent materials
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/309 using white LEDs
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61F 5/08 Devices for correcting deformities of the nose ; Devices for enlarging the nostril, e.g. for breathing improvement
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A method of treating a sinus cavity of a subject includes advancing a distal portion of a light source through a drainage pathway of a sinus cavity and into the sinus cavity and visually observing a transdermal light emitted from the light source. A distal portion of a substantially rigid inner guide member of a balloon dilation catheter is advanced into the drainage pathway, the balloon dilation catheter including a movable shaft including a balloon that is slidably mounted on the substantially rigid inner guide member. The movable shaft and balloon are advanced distally over the substantially rigid inner guide member to place a portion of the balloon in the drainage pathway whereby the balloon is inflated.

Claims

1. A method of treating a sinus cavity of a subject using a balloon dilation catheter, the method comprising:

providing a lighted instrument and illuminating at least a portion of the sinus cavity;

providing a balloon dilation catheter that includes

a handle having a stationary inflation port located in a proximal end of the handle,

an inner guide member secured to the handle and extending distally from a distal end of the handle a pre-determined distance,

a balloon catheter slidably mounted on the inner guide member and including an inflatable balloon coupled to the stationary inflation port with an inflation lumen,

a shaft coupled to the balloon, wherein the shaft defines at least a portion of the inflation lumen and a rider lumen, and wherein the inflation lumen is longer than the rider lumen and wherein a proximal portion of the inflation lumen wraps around the inner guide member in a helical shape, and

a balloon advancement member disposed in a slot formed in the handle, the balloon advancement member configured to advance the balloon catheter over the inner guide member;

advancing the inner guide member to a desired location in a drainage pathway of the sinus cavity;

advancing the balloon over the inner guide member with the balloon advancement member, wherein advancing the balloon places the balloon at the desired location; and

inflating the balloon with an inflation device coupled to the inflation port.

2. The method of claim 1, further comprising tracking the movement of the inner guide member into a frontal recess using an image guided surgery system.

3. The method of claim 2, wherein the image guided surgery system comprises a CT guidance system.

4. The method of claim 1, wherein the inner guide member includes a lumen and, prior to inflating the balloon, a guide wire is inserted into the lumen and advanced until a distal portion of the guide wire extends from a distal end of the inner guide member.

5. The method of claim 1, wherein the handle is fixed to the inner guide member.

6. The method of claim 1, further including adjusting a shape of the inner guide member prior to advancing the inner guide member to the desired location.

7. The method of claim 6, wherein the shape is adjusted by replacing the inner guide member with a second inner guide member.

8. The method of claim 6, wherein the shape is adjusted by manually bending the inner guide member.

9. The method of claim 1, wherein the inner guide member defines a lumen and the method further includes coupling the lumen to an aspiration source and aspirating the sinus cavity.

10. The method of claim 1, wherein the sinus cavity is a maxillary sinus cavity.

11. The method of claim 1, wherein the sinus cavity is a sphenoid sinus cavity.

12. The method of claim 1, wherein a user grasps the handle with a first hand and the lighted instrument with a second hand.

13. The method of claim 1, wherein the inner guide member includes a lumen and, prior to inflating the balloon, the lighted instrument is advanced distally inside the lumen and illuminates at least a portion of the sinus cavity.