Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose, and/or Throat

• US 20090187098A1
• Filed: 01/16/2009
• Published: 07/23/2009
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Chang, John Y., Morriss, John, Makower, Joshua, Facteau, William M., Goldfarb, Eric
• Granted Patent: US 9,101,384 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 1/0661 Endoscope light sources
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• 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 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2090/3945 Active visible markers, e.g. light emitting diodes
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 5/107 Measuring physical dimensions, e.g. size of the entire body or parts thereof
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 : Details of catheter construction
• CPC Class Codes: A61B 90/36 : Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/0037 : characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/004 : characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0087 : Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/0096 : being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/109 : having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/003 : characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies, endoscopic studies and transillumination studies. Devices and methods for visually confirming the positioning of a distal end portion of an illuminating device placed within a patient include inserting a distal end portion of an illuminating device internally into a patient, emitting light from the distal end portion of the illuminating device, observing transillumination resulting from the light emitted from the distal end portion of the illuminating device that occurs on an external surface of the patient, and correlating the location of the observed transillumination on the external surface of the patient with an internal location of the patient that underlies the location of observed transillumination, to confirm positioning of the distal end portion of the illuminating device.

Claims

1. (canceled)

2. A method of confirming the location of an elongate member configured for placement within a patient'"'"'s sinus cavity comprising:

introducing the elongate member through a nasal passageway to place a distal tip of the elongate member in a test position, the elongate member configured to emit illuminating light via the distal end of the elongate member; and

viewing the location of the light through the patient'"'"'s skin to confirm the positioning of the elongate member.

3. The method of claim 2, wherein the elongate member comprises a lumen extending there through.

4. The method of claim 2, wherein a wire guide is slidably disposed within the lumen of the elongate member.

5. A method of confirming the location of a wire guide intended to be positioned within a patient'"'"'s sinus cavity comprising:

introducing a wire guide through a nasal passageway to place a distal tip of the wire guide in a test position;

advancing an elongate member over the wire guide to place a distal end at or adjacent to the distal tip of the wire guide, the elongate member emitting illuminating light via the distal end of the elongate member; and

viewing the location of the light through the patient'"'"'s skin to confirm the positioning of the wire guide.

6. The method of claim 5, further comprising the step of removing the elongate member from the wire guide and advancing a balloon catheter over the wire guide.

7. The method of claim 5, further comprising the step of repositioning the wire guide based at least in part on the viewed location of the light.

8. A method of confirming the location of an elongate member intended to be positioned within a patient'"'"'s sinus cavity comprising:

introducing the elongate member through a nasal passageway to place a distal tip of the elongate member in a test position, the elongate member including a detection element positioned at or adjacent to the distal tip of the elongate member; and

placing a detector device external to the patient'"'"'s skin adjacent to the intended sinus cavity so as to detect the presence or absence of the detection element.

9. The method of claim 8, wherein the detection element is formed from a magnetic material.

10. The method of claim 9, wherein the detector comprises a magnetic field detector.

11. The method of claim 8, wherein the detection element is formed from a metallic material.

12. The method of claim 8, wherein the elongate member comprises a wire guide.

13. A method of placing an elongate member into the ostium of a paranasal sinus comprising:

introducing a directable endoscope into the nasal cavity;

introducing a guide catheter into the nasal cavity to position a distal tip near the sinus ostium;

manipulating the endoscope to move the viewing field toward the sinus ostium;

inserting the elongate member through a lumen in the guide catheter; and

manipulating the elongate member to place the elongate member at least partially within or adjacent to the sinus ostium.

14. The method of claim 13, wherein the elongate member comprises a wire guide.

15. The method of claim 14, further comprising the steps of advancing a balloon catheter over the wire guide so as to position the balloon at least partially within the sinus ostium and expanding the balloon.

16. The method of claim 14, further comprising the steps of removing the guide catheter from the nasal cavity and subsequently advancing a balloon catheter over the wire guide so as to position the balloon at least partially within the sinus ostium and expanding the balloon.

17. The method of claim 14, further comprising the step of introducing a light transmitter into the sinus to aid in visualization.

18. A method of placing an elongate member into the ostium of a paranasal sinus comprising:

introducing a retrograde viewing rigid endoscope into the nasal cavity;

introducing a guide catheter into the nasal cavity to position a distal tip near the sinus ostium;

orienting the endoscope to move the viewing field toward the sinus ostium;

inserting the elongate member through a lumen in the guide catheter; and

manipulating the elongate member to place the elongate member at least partially within or adjacent to the sinus ostium.

19. The method of claim 18, wherein the elongate member comprises a wire guide.

20. The method of claim 19, further comprising the steps of advancing a balloon catheter over the wire guide so as to position the balloon at least partially within the sinus ostium and expanding the balloon.

21. The method of claim 19, further comprising the steps of removing the guide catheter from the nasal cavity and subsequently advancing a balloon catheter over the wire guide so as to position the balloon at least partially within the sinus ostium and expanding the balloon.

22. The method of claim 19, further comprising the step of introducing a light transmitter into the sinus to aid in visualization.

24. The method of claim 22, further comprising the steps of removing the flexible visualization scope from the wire guide and advancing a balloon catheter over the wire guide so as to position the balloon at least partially within the sinus ostium;

and expanding the balloon.

23. A method of placing a wire guide into the ostium of a paranasal sinus comprising:

introducing a guide catheter into the nasal cavity to position a distal tip near the sinus ostium;

inserting a wire guide through a lumen in the guide catheter;

manipulating the wire guide to place the wire guide at least partially beyond a distal tip of the guide catheter;

introducing a flexible visualization scope over the wire guide to position a viewing field toward the sinus ostium; and

manipulating the wire guide to place the wire guide at least partially within the sinus ostium.

25. A method of placing a wire guide into the ostium of a paranasal sinus comprising:

introducing a directable endoscope sheath into the nasal cavity, the endoscope sheath including at least one working lumen therein;

manipulating the endoscope to move the viewing field toward the sinus ostium;

inserting a wire guide through the lumen in the endoscope sheath; and

manipulating the wire guide to place the wire guide at least partially within or adjacent to the sinus ostium.

26. The method of claim 25, further comprising the steps of removing the flexible visualization scope from the wire guide and advancing a balloon catheter over the wire guide so as to position the balloon at least partially within the sinus ostium;

and

expanding the balloon.

27. A method comprising:

introducing an elongate member through a nasal passageway to place a distal tip of the elongate member within a sinus cavity of a patient;

emitting illuminating light via the placed distal end of the elongate member; and

viewing the light through direct observation from outside the body of the patient.