Systems and methods for performing image guided procedures within the ear, nose, throat and paranasal sinuses

• US 20070208252A1
• Filed: 05/17/2006
• Published: 09/06/2007
• Est. Priority Date: 04/21/2004
• Status: Abandoned Application

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Makower, Joshua
• Application Number:
  US11/436,892
• Publication Number:
  US 20070208252A1
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00787 Surgery of the ear
• 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 2034/2048 using an accelerometer or inertia sensor
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/2065 Tracking using image or pattern recognition
• CPC Class Codes: A61B 2034/2074 Interface software
• CPC Class Codes: A61B 2090/365 augmented reality, i.e. correlating a live optical image with another image
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• 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 5/062 using magnetic field
• CPC Class Codes: A61B 5/6851 Guide wires
• CPC Class Codes: A61B 50/13 Trolleys, e.g. carts
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/037 Emission tomography
• CPC Class Codes: A61B 6/463 characterised by displaying multiple images or images and diagnostic data on one display
• CPC Class Codes: A61B 90/16 : Bite blocks
• CPC Class Codes: A61B 90/36 : Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61B 90/361 : Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61M 2029/025 : characterised by the guiding element
• CPC Class Codes: A61M 2210/0681 : Sinus (maxillaris)
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

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.

Claims

1. A method for image guided performance of a treatment procedure to treat a disease or disorder of an ear, nose, throat or a paranasal sinus in a human or animal subject using an image guidance system having a navigation element assembly that comprises a plurality of navigation elements that is useable to determine the location of the working device within the ear, nose, throat or paranasal sinus of the subject on the basis of signals received from the navigation elements of the navigation element assembly and a working device that is useable to carry out or facilitate at least a portion of the treatment procedure, the working device having a distal end that becomes inserted into the subject'"'"'s body and a proximal end that remains outside of the subjects body, said method comprising the steps of:

A) attaching an extension member to the proximal end of the working device;

B) attaching the navigation element assembly to the extension member; and

C) using the image guidance system to detect the position of the working device within the subject'"'"'s body on the basis of signals received from the navigation elements of the navigation element assembly.

2. A method according to claim 1 wherein the navigation elements comprise light emitters and wherein Step C comprises using the image guidance system to detect the position of the working device within the subject'"'"'s body on the basis of light emitted by the navigation elements.

3. A method according to claim 2 wherein the navigation elements comprise light reflectors and wherein Step C comprises using the image guidance system to detect the position of the working device within the subject'"'"'s body on the basis of light reflected by the navigation elements.

4. A method according to claim 1 wherein the working device comprises an elongate shaft that is substantially rigid.

5. A method according to claim 1 wherein the working device comprises a tubular guide having a lumen through which one or more other working devices may be inserted.

6. A method according to claim 1 wherein the extension member has a lumen extending therethrough and wherein Step A comprises attaching the extension member to the proximal end of the tubular guide such that the lumen of the extension member is substantially continuous with the lumen of the tubular guide.

7. A method according to claim 1 further comprising the step of inserting a second working device through the lumen of the extension member and through the lumen of the tubular guide, wherein Step B comprises attaching the navigation element assembly to the extension member such that locations at which the navigation elements are positioned bear known spatial relationships to the distal end of the working device such that the locations of the navigation elements detected by the image guidance system provides a basis for determination of the location of the distal end of the working device within the subject'"'"'s body.

8. A system useable to perform a procedure in which a working device is inserted to a position within an ear, nose, throat or paranasal sinus of a human or animal subject, said system comprising:

a working device that has a proximal end and a distal end, said working device being insertable into an ear, nose, throat or paranasal sinus of a human or animal subject and useable to facilitate performance of a diagnostic or therapeutic procedure; and

an extender that is attachable to the proximal end of the working device.

9. The system of claim 8, further comprising:

a navigation element assembly that is attachable to or part of the extender, said navigation element assembly comprising a plurality of active or passive navigation elements; and

an image guidance system that is adapted to receive signals from the navigation elements and to determine, on the basis of said signals, the current position of the working device within the subject'"'"'s body.

10. A system according to claim 9 wherein the navigation elements emit or reflect light and wherein the image guidance system comprises i) one or more cameras that receive light that has been emitted by or reflected from the navigation elements and ii) a computing device that receives signals from the at least one camera and is programmed to use those signals to determine the location of the working device within the subject'"'"'s body.

11. A system according to claim 8 wherein at least a portion of the working device is curved or malleable.

12. A system according to claim 8 wherein the working device has a lumen extending therethrough and wherein the extender also has a lumen extending therethrough, and wherein the lumen of the extender is substantially continuous with the lumen of the working device when the extender is connected to the working device.

13. A system according to claim 8 wherein the working device is a tubular guide.

14. A system according to claim 9 wherein the navigation elements comprise light emitting diodes.

15. A system according to claim 9 wherein the navigation elements comprise reflectors.

16. A system according to claim 15 wherein the system further comprises a light emitter that emits light such that the light is reflected from the reflectors.

17. A system according to claim 16 wherein the light emitter emits infrared light.

18. A system according to claim 13 further comprising a second working device that is insertable through the tubular guide and useable to perform or facilitate the performance of a diagnostic or therapeutic procedure.

19. A system according to claim 18 wherein the second working device is selected from the group consisting of:

guidewires, balloon catheters, lavage catheters, needles, electrosurgical probes, stent delivery catheters, substance eluting implant delivery catheters, debriders, seekers, cannulae, tubes, dilators, balloons, substance injectors, penetrators, cutters, debriders, microdebriders, hemostatic devices, cautery devices, cryosurgical devices, heaters, coolers, scopes, endoscopes, phototherapy devices, drills, rasps, saws, punches, forceps and lasers.

20. A system according to claim 8 wherein the extender comprises an elongate body sized and configured to be grasped by a human hand.

21. A system according to claim 8 further comprising a clamp for attaching the navigation element assembly to the extender.

22. A system according to claim 8 wherein the extender comprises an elongate body having a lumen extending therethrough, a proximal end and a a distal end, the distal end of said elongate body having a connector thereon to facilitate connecting the extender to the proximal end of the working device, an opening being formed in said elongate body to permit a second working device or a fluid to be introduced into the lumen of the extender.

23. A system according to claim 22 wherein the working device has a lumen that is substantially continuous with the lumen of the extender when the extended is attached to the working device such that a second working device or a fluid that has been introduced into the lumen of the extender may further pass through the lumen of the working device.