Methods and apparatus for treating disorders of the ear nose and throat

• US 9,167,961 B2
• Filed: 10/31/2007
• Issued: 10/27/2015
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Makower, Joshua, Chang, John Y., Muni, Ketan P., Morriss, John H., Ha, Hung V., Kim, Isaac J., Vrany, Julia D.
• Primary Examiner(s): Nguyen, Anhtuan T
• Assistant Examiner(s): NEAL, TIMOTHY JAY
• Application Number:
  US11/930,716
• Publication Number:
  US 20080281156A1
• Time in Patent Office: 2,918 Days
• Field of Search: 600/117, 600/118, 600/103, 600/104, 600/114
• US Class Current: 1/1
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• CPC Class Codes: A61B 1/267 for the respiratory tract, e.g. laryngoscopes, bronchoscopes
• 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 17/2804 with two or more pivotal connections A61B17/29 takes precedence
• CPC Class Codes: A61B 17/282 Jaws
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3447 Linked multiple cannulas
• 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 2090/063 for measuring volume
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3941 Photoluminescent markers
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• 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 90/361 : Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61B 90/50 : Supports for surgical instruments, e.g. articulated arms
• 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

Methods and apparatus for treating disorders of the ear, nose, throat or paranasal sinuses, including methods and apparatus for dilating ostia, passageways and other anatomical structures, endoscopic methods and apparatus for endoscopic visualization of structures within the ear, nose, throat or paranasal sinuses, navigation devices for use in conjunction with image guidance or navigation system and hand held devices having pistol type grips and other handpieces.

Claims

1. A method for adapting a device that is insertable into the body of a human or animal subject to render that device useable in conjunction with a navigation system such that the navigation system may determine the location of the device within the subject'"'"'s body, said method comprising the steps of:

(a) attaching an adapter to a proximal portion of a working device, wherein the proximal portion of the working device remains outside of the subject'"'"'s body, wherein the working device has a distal portion that is insertable into the subject'"'"'s nasal cavity and a reference location on said distal portion, wherein the working device comprises a tubular guide having a malleable or rigid curved distal end, wherein the working device is configured to accommodate a balloon catheter therethrough, wherein the working device is configured such that a balloon of the balloon catheter is extendable beyond the distal portion of the tubular guide, wherein the adapter comprises, or is attachable to, a navigation unit that is useable by a navigation system to determine the position of the reference location within the subject'"'"'s nasal cavity, wherein the navigation unit comprises one or more navigation elements that are useable by the navigation unit to dynamically determine the position of the reference location relative to the adapter;

(b) inserting the distal portion of the working device through a nostril of the subject and into the subject'"'"'s nasal cavity;

(c) using the navigation system in conjunction with the navigation unit to determine the position of the reference location within the subject'"'"'s nasal cavity and to orient the curved distal end of the working device within the nasal cavity of a patient;

(d) inserting a balloon catheter through the tubular guide;

(e) advancing the balloon catheter further through the tubular guide to advance an inflatable balloon of the balloon catheter beyond the distal end of the tubular guide;

(f) using the navigation system in conjunction with the navigation unit to approximate the location of the balloon of balloon catheter relative to a sinus ostium of the patient;

(g) maneuvering the balloon of the balloon catheter into the sinus ostium using the navigation system in conjunction with the navigation unit; and

(g) enlarging the sinus ostium with the balloon catheter by expanding the balloon of the balloon catheter.

2. A method according to claim 1 wherein the navigation unit is integrated into or mounted on the adapter before the adapter is attached to the working device.

3. A method according to claim 2 wherein the adapter is constructed to permit attachment of a navigation unit to the adapter and wherein the method further comprises the step of attaching the navigation unit to the adaptor.

4. A method according to claim 1 further comprising the step of calibrating or registering the reference location with the navigation system.

5. A method according to claim 1, wherein the navigation adapter comprises, or is attachable to, an identification module providing information to the navigation system regarding the navigational adapter.

6. A method of adapting a dilation system to render the dilation system usable in conjunction with a navigation system such that the navigation system may determine the location of a dilation instrument of the dilation system within a human or animal subject'"'"'s body, the method comprising the steps of:

(a) attaching a working device of the dilation system to a navigation adapter of the navigation system;

(b) inserting the working device of the dilation system in the subject'"'"'s body, such that a navigation unit of the navigation adapter is positioned external to the subject;

(c) operating the navigation system to determine the position of the working device from the relative position of at least one energy emitter attached to the navigation unit;

(d) tracking movement of the working device in the subject relative to a sinus ostium of the subject based on the position of the at least one energy emitter as determined by the navigation system;

(e) determining a need to bend a malleable distal tip of the working device based on the tracking of movement of the working device in the subject relative to the sinus ostium;

(f) removing the working device from the subject;

(g) reconfiguring the working device by bending the malleable distal tip of the working device to conform to a nasal passageway of the subject as determined based on the tracking of movement of the working device in the subject relative to the sinus ostium;

(h) re-calibrating the navigation system after removal from the subject to determine the position of the working device from the relative position of at least one energy emitter in response to the bending of the distal tip of the working device;

(i) reinserting the reconfigured working device of the dilation system in the subject'"'"'s body;

(j) operating the navigation system to determine the position of the reconfigured working device from the relative position of the at least one energy emitter attached to the navigation unit; and

(k) tracking movement of the reconfigured working device in the subject relative to the sinus ostium of the subject based on the position of the at least one energy emitter as determined by the navigation system.

7. The method of claim 6, wherein the navigation system is configured to optically detect the navigation unit.

8. The method of claim 7, wherein the at least one energy emitter comprises a reflective element, wherein the navigation system is configured to detect light reflected by the reflective element.

9. The method of claim 7, wherein the at least one energy emitter is configured to emit light.

10. The method of claim 9, wherein the at least one energy emitter is configured to emit infrared light.

11. The method of claim 7, wherein the navigation system comprises a camera.

12. The method of claim 6, wherein the at least one energy emitter is configured to emit electromagnetic energy.

13. The method of claim 12, wherein the at least one energy emitter is configured to emit radiofrequency energy.

14. The method of claim 6, wherein the working device comprises a radiopaque marker.

15. The method of claim 6, further comprising the step of inserting a balloon catheter through the working device and into a passageway inside the subject, detecting the location of the balloon catheter with the navigation system.

16. The method of claim 15, wherein the passageway in the subject comprises an opening of a paranasal sinus in the subject.

17. A method of adapting a dilation working device to render a dilation instrument usable in conjunction with a navigation system such that the navigation system may determine the location of the dilation instrument within a patient'"'"'s body during a procedure to dilate an anatomical structure within the patient, the method comprising the steps of:

(a) attaching the dilation working device to a navigation adapter of the navigation system, wherein the dilation working device comprises an open distal end and an open proximal end, wherein the dilation working device comprises a hollow interior configured to receive a dilation instrument;

(b) inserting a distal portion of the dilation working device into the patient, wherein the dilation working device further includes a proximal portion located external to the patent after the distal portion of the dilation working device is inserted into the patent;

(c) inserting a distal portion of the dilation instrument into the nose of the patient through the open proximal end of the dilation working device, wherein the distal portion of the dilation instrument comprises an expandable member, wherein the dilation instrument further includes a proximal portion located external to the patient after the distal portion is inserted in the patient;

(d) operating the navigation system to observe a navigation element located on the proximal portion of the dilation working device that is located external to the patient, wherein the position of the navigation element is indicative of the position of the distal portion of the dilation working device in the patient;

(e) positioning the distal portion of the dilation working device using the navigation system within a nasal cavity of the patient to advance the distal end of the dilation working device adjacent to a sinus ostium of the patient;

(f) operating the distal portion of the dilation instrument in conjunction with the dilation working device and the navigation system to approximate the location of the distal end of the dilation working device such that the expandable member of the dilation instrument is positioned in the sinus ostium of the patient; and

(g) expanding the expandable member within the sinus ostium to thereby dilate the sinus ostium.