Systems and Methods for Performing Image Guided Procedures Within the Ear, Nose, Throat and Paranasal Sinuses

Abstract

Devices, systems and methods for performing image guided interventional and surgical procedures, including various procedures to treat sinusitis and other disorders of the paranasal sinuses, ears, nose or throat.

Description

RELATED APPLICATION[0001]This application is a continuation of U.S. patent application Ser. No. 11 / 436,892, filed May 17, 2006, which is a continuation-in-part of U.S. patent application Ser. No. 11 / 116,118, filed Apr. 26, 2005 which is a continuation in part of four earlier-filed applications, namely 1) U.S. patent application Ser. No. 10 / 829,917, filed on Apr. 21, 2004, 2) U.S. patent application Ser. No. 10 / 912,578, filed on Aug. 4, 2004, 3) U.S. patent application Ser. No. 10 / 944,270, filed on Sep. 17, 2004 and 4) U.S. patent application Ser. No. 11 / 037,548, filed Jan. 17, 2005, the entireties of each such parent application being expressly incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention relates generally to medical devices, systems and methods and more particularly to methods and devices for performing image guided interventional procedures to treat disorders of the paranasal sinuses, ears, nose or throat (ENT).BACKGROUND OF THE INVENTIONA. Re...

AI Technical Summary

Benefits of technology

[0018]Further in accordance with the invention, there are provided sensor-equipped working devices (e.g., guidewires, catheters, cannula, tubes, dilators, balloons, substance injectors, needles, penetrators, cutters, debriders, microdebriders, hemostatic devices, cautery devices, cryosurgical devices, heaters, coolers, scopes, endoscopes, light guides, phototherapy devices, drills, rasps, saws, etc.) useable to perform image guided FTSI procedures or other image guided ENT procedures. These image guided working devices of the present invention generally comprise an elongate shaft that is insertable through the nose to a location within a paranasal sinus, ear, nose or throat of the subject and one or more sensor(s) is / are positioned on or in the device at a location that becomes inserted into the subject's body during the procedure. In some embodiments, a sensor may be located at the distal tip of the device. Additionally or alternatively, sensor(s) may be located at other locations on the shaft of the device, such as at the location of a particular working element (e.g., a dilator, balloon, substance injector, needle, penetrator, cutter, debrider, microdebrider, hemostatic device, cautery device, cryosurgical device, heater, cooler, scope, lense, port, endoscope, light guide, phototherapy device, drill, rasp, saw, etc.). In some embodiments, the shaft of the working device proximal to the sensor(s) may be flexible or malleable. Such flexibility or malleability may allow the working device to be advanced though tortuous regions of the intra nasal anatomy and / or to be positioned behind obstructive anatomical structure(s) (e.g., behind the uncinate process) without traumatizing or requiring removal or surgical modification of the obstructive anatomical structure(s).

[0019]Still further in accordance with the present invention, there is provided a system of working devices specifically useable to perform an image guided FTSI procedure. Such system generally comprises a flexible guidewire that is advanceable into the ostium of a paranasal sinus and a dilation catheter that is advanceable over the guidewire and useable to dilate the ostium of the paranasal sinus. A sensor is located on a portion of the guidewire and / or dilation catheter that becomes positioned within the subject's body. The sensor communicates with the image guidance system to provide real time indicia of the position of the guidewire and / or dilation catheter such that the operator may precisely position the dilator within the desired sinus ostium without the need for obtaining direct line-of-sight endoscopc view of that sinus ostium. Optionally, the system may additionally comprise a tubular guide through which the guidewire and / or dilation catheter may be advanced. The tubular guide may be rigid, flexible or malleable and may be specifically configured to be advanced through the nose to a position within or near the ostium of the affected paranasal sinus.

[0020]Still further in accordance with the present invention, there are provided fiducial marker devices that may be precisely and reproducibly positioned within the mouth of a human subject. In some embodiments, these fiducial marker devices may incorporate brackets, projection of other configurational attributes for mounting of a transmitter useable in conjunction with an electromagnetic image guidance system.

Problems solved by technology

In some cases, such dilation of the ostium may fracture, move or remodel bony structures that surround or are adjacent to the ostium.

Electromechanical systems have not been widely used in ENT or sinus surgery.

This is so because a typical endoscopic image is a spatially limited, two dimensional, line-of-sight view.

However, in the new FTSI procedures and other new ENT procedures that use flexible and / or malleable catheters and instruments, it is no longer suitable to mount the sensors on proximal portions of the surgical instruments such that the sensors remain outside of the body.

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