ENDOSCOPIC METHODS AND DEVICES FOR TRANSNASAL PROCEDURES

• US 20090030274A1
• Filed: 07/31/2008
• Published: 01/29/2009
• Est. Priority Date: 09/15/2006
• Status: Abandoned Application

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Wisted, Thomas J., Vo, Tom T., Kim, Isaac J., Goldfarb, Eric, Jenkins, Thomas R.
• Application Number:
  US12/184,166
• Publication Number:
  US 20090030274A1
• Time in Patent Office: Days
• US Class Current: 600/106
• CPC Class Codes: A61B 1/0014 Fastening element for attaching accessories to the outside of an endoscope, e.g. clips, clamps or bands
• CPC Class Codes: A61B 1/00154 using guiding arrangements for insertion
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• CPC Class Codes: A61B 1/01 Guiding arrangements therefore
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• 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 2017/246 for cleaning of the nose
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61M 2025/09083 having a coil around a core

Abstract

Medical devices, systems and methods that are useable to facilitate transnasal insertion and positioning of guidewires and various other devices and instruments at desired locations within the ear, nose, throat, paranasal sinuses or cranium. Direct viewing of such placements via an endoscope.

Claims

1. :

A method for positioning a guide device useful for delivering at least one working device therethrough to deliver a working end portion of the at least one working device to a desired location within the ear, nose, throat or cranium of a human or animal patient, said method comprising the steps of;

inserting an endoscope into or through an endoscope channel of the guide device that includes an elongated shaft;

inserting the guide device into an internal space of the patient; and

viewing through the endoscope to guide positioning and delivery of the guide device to an intended location in the patient.

3. :

The method of claim 1, wherein the endoscope has a rigid shaft.

4. :

The method of claim 1, wherein the endoscope has a flexible shaft.

5. :

The method of claim 1, wherein the endoscope is semi-rigid.

6. :

The method of claim 1, further comprising cleaning a lens of the endoscope using at least one of irrigation and suction, while the lens is located in the internal space of the patient.

7. :

The method of claim 1, further comprising;

inserting a guidewire through a working device lumen of the guide device;

advancing a distal end portion of the guidewire distally of a distal end of the working device lumen; and

viewing, via the endoscope, advancement of the guidewire distally of the guide device.

8. :

The method of claim 7, further comprising viewing, via the endoscope, entry of the distal end portion of the guidewire into a sinus ostium.

9. :

The method of claim 8, further comprising identifying the sinus ostium as a sinus ostium other than a target sinus ostium, retracting the distal end of the guidewire out of the sinus ostium, and redirecting the guidewire, wherein said identifying, retracting and redirecting steps are visualized via the endoscope.

10. :

The method of claim 9, further comprising viewing, via the endoscope, entry of the distal end portion of the guidewire into the target sinus ostium upon said redirecting and advancing the distal end portion of the guidewire into the target ostium facilitated by visualization through the endoscope.

11. :

The method of claim 7, wherein the guidewire is an illuminating guidewire.

12. :

The method of claim 11, wherein visualization through the endoscope is enhanced by light emitted by the illuminating guidewire.

13. :

The method of claim 8, further comprising advancing a working device over the guidewire and visualizing, via the endoscope, advancement of a working end portion of the working device distally of the guide device.

14. :

The method of claim 13 further comprising viewing, via the endoscope, entry of the working end portion of the working device into a sinus ostium.

15. :

The method of claim 14 wherein the working device comprises a balloon catheter and the working end portion comprises a balloon, said method further comprising visualizing, via the endoscope, inflation of the balloon to dilate the sinus ostium.

16. :

The method of claim 15 further comprising visualizing, via the endoscope, deflation of the balloon and retraction of the balloon from the sinus ostium.

17. :

The method of claim 16 further comprising visualizing, via the endoscope, the sinus ostium having been dilated by the balloon.

18. :

The method of claim 17 further comprising determining, after said visualizing the sinus ostium having been dilated, whether the sinus ostium has been dilated sufficiently, or whether the balloon needs to be reinserted and inflated to perform additional dilation.

2. :

The method of claim 2, wherein the guide device is inserted through a nostril of the patient.

19. :

A method for locating a sinus ostium, said method comprising the steps of;

inserting an endoscope through a nostril of a patient and advancing the endoscope toward a location of the sinus ostium;

inserting a guidewire through the nostril and advancing a distal end portion of the guidewire distally of a distal end of the endoscope; and

viewing, through the endoscope, the advancement of the distal end portion of the guidewire to facilitate guidance of the advancement of the guidewire along a desired path.

20. :

The method of claim 19 further comprising directing the distal end portion of the guidewire, under guidance facilitated by visualization of the distal end portion via the endoscope, into the sinus ostium.

21. :

The method of claim 20, wherein the guidewire is an illuminating guidewire, and visualization through the endoscope is enhanced by light emitted by the illuminating guidewire.

22. :

The method of claim 21, further comprising confirming that the distal end portion of the guidewire has been inserted into a desired sinus by observing transillumination effects produced by the illumination from the distal end portion of the guidewire having been inserted through the sinus ostium and into the sinus.

23. :

The method of claim 20, further comprising advancing a working device over the guidewire and performing a diagnostic or therapeutic step with regard to at least one of the sinus ostium and a sinus that the sinus ostium opens to.

24. :

A method for treating a patient;

said method comprising the steps of;

inserting an endoscope into or through an endoscope channel of a guide device that includes an elongated shaft;

inserting the guide device through a nostril of the patient;

advancing a distal end portion of the guide device toward a sinus ostium of the patient;

advancing a distal end portion of the endoscope distally of the distal end portion of the guide device, and navigating the distal end portion of the endoscope through the sinus ostium, said navigating being assisted by visualization through the endoscope.

25. :

The method of claim 24, wherein said advancing a distal end portion of the guide device is assisted by visualization of the distal end portion through the endoscope.

26. :

The method of claim 24, wherein the distal end portion of the endoscope is navigated through the sinus ostium after dilation of the sinus ostium, and wherein a procedure to dilate the ostium is visualized via the endoscope.

27. :

The method of claim 24, wherein the distal end portion of the endoscope is navigated through the sinus ostium without first dilating the sinus ostium.

28. :

The method of claim 24, further comprising viewing the sinus cavity that the sinus ostium opens to, via the endoscope, to assess efficacy of a previously preformed therapy or perform a diagnosis.

29. :

The method of claim 24, further comprising;

inserting a working device through a working device channel of the guide device;

advancing a working end portion of the working device distally of a distal end of the guide device and into the sinus ostium; and

performing at least one therapeutic step in the sinus cavity that the sinus ostium opens to.

30. :

The method of claim 29, wherein the at least one therapeutic step is selected from one or more of;

local during delivery, regional drug delivery, suction, irrigation, biopsy, polyp removal, fungal ball removal, or removal of mass.

31. :

The method of claim 29, wherein said advancing a working end portion is visualized via the endoscope, prior to navigating the distal end of the endoscope into the sinus ostium.

32. :

The method of claim 29, wherein the working device is selected from at least one of;

guidewires, graspers, cutters, punches, flexible microdebriders, dissectors, electrodes, lasers, suction catheters, irrigation catheters and balloon catheters.

33. -37. (canceled)

38. :

A guide device useable to position a working device at a desired location within the ear, nose, throat or cranium of a human or animal subject, said device comprising;

a transnasally insertable elongate shaft having a proximal end and a distal end;

a first channel into which an endoscope may be inserted so that the endoscope may be used to view at least an area beyond the distal end of the shaft; and

a second channel through which the working device may be advanced, wherein said first channel is statically located relative to said second channel.

39. :

The device of claim 38, wherein said first channel is removably fixed to said second channel.

40. :

The device of claim 38, further comprising a proximally located handle, wherein proximal end portions of said first and second channels extend through said handle.

41. :

The device of claim 40, wherein said proximal end portions diverge away from one another in a direction from a distal end of said handle to a proximal end of said handle.

42. :

The device of claim 40, wherein said second channel is rotatable within said handle and said first channel is fixed to said handle, prevent rotation of said first channel relative to said handle.

43. :

The device of claim 40, further comprising a second handle mounted on one of said first and second channels, proximal of said first handle.

44. :

The device of claim 43, wherein said second handle is mounted on said second channel.

45. :

The device of claim 42, further comprising a second handle mounted on said second channel, proximal of said first handle, wherein said second handle is fixed to said second channel to prevent rotation of said second channel relative to said second handle.

46. :

The device of claim 38, further comprising an overlamination or heat shrink tube surrounding said first and second channels.

47. :

The device of claim 38, wherein a distal end of said first channel is set back proximally of a distal end of said second channel by a predetermined distance.

48. :

The device of claim 38, where a distal tip portion of said first channel is colored with a color that contrasts with a color of a portion of said first channel proximally adjacent said distal tip portion.

49. :

The device of claim 38, where a distal tip portion of said second channel is colored with a color that contrasts with a color of a portion of said second channel proximally adjacent said distal tip portion.

50. :

The device of claim 38, wherein said first channel comprises a scooped distal tip.

51. :

The device of claim 38, wherein a proximal end of at least one of said first and second channels is fitted with a luer connector.

52. :

The device of claim 41, wherein a channel in said handle directing said proximal end portion of said first channel away from said second channel comprises a bend, said bend creating frictional resistance on an endoscope inserted in said first channel as the endoscope passes through said bend.

53. :

The device of claim 47, wherein said distal end of said first channel comprises a scooped distal tip.

54. -64. (canceled)