Method and System for Accessing, Diagnosing and Treating Target Tissue Regions Within the Middle Ear and the Eustachian Tube

• US 20090163890A1
• Filed: 12/19/2008
• Published: 06/25/2009
• Est. Priority Date: 12/20/2007
• Status: Abandoned Application

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Morriss, John H., Makower, Joshua, Bright, Earl A. II, Goldfarb, Eric, Chang, John Y., Clifford, Anton, Vrany, Julia D.
• Application Number:
  US12/340,226
• Publication Number:
  US 20090163890A1
• Time in Patent Office: Days
• US Class Current: 604/514
• CPC Class Codes: A61B 1/227 for ears, i.e. otoscopes
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• 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: A61F 11/20 Ear surgery
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• 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 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/09 Guide wires
• 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
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

Method and systems for accessing a Eustachian tube of a patient are disclosed. The system includes a guide configured for passing into a nasal passage of the patient to position a distal tip of the catheter at or near a Eustachian tube, the guide having distal tip with a bend having an angle between 30 and 90 degrees; and a guidewire configured to pass through the guide into the Eustachian tube.

Claims

1. A method for accessing a Eustachian tube of a patient, the method comprising:

inserting a guide catheter into a nasal passage of the patient, the guide catheter having distal tip with a bend having an angle between 30 and 90 degrees; and

advancing the guide catheter in the nasal passage toward an opening of the Eustachian tube in the nasopharynx to place the distal tip adjacent the Eustachian tube opening.

2. The method of claim 1, further comprising advancing a diagnostic device through the guide catheter to place a distal tip of the diagnostic device adjacent the Eustachian tube opening.

3. The method of claim 2, wherein the diagnostic device comprises a diagnostic catheter.

4. The method of claim 2, wherein the diagnostic device comprises an endoscope.

5. The method of claim 2, further comprising introducing a diagnostic probe into the Eustachian tube to directly assess Eustachian tube function.

6. The method of claim 5, wherein the diagnostic probe is made from a flexible and Eustachian tube compatible material.

7. The method of claim 5, wherein the diagnostic probe comprises a pressure transducer located on a guidewire.

8. The method of claim 7, further comprising:

monitoring pressure within the Eustachian tube while the patient is swallowing; and

assessing an opening function of the patient'"'"'s Eustachian tube using the monitoring.

9. The method of claim 5, further comprising removing the guide catheter after the diagnostic probe is placed into the Eustachian tube.

10. The method of claim 5, wherein the diagnostic probe comprises an ultrasound probe.

11. The method of claim 1, further comprising advancing a treatment device through the guide catheter toward the Eustachian tube to place a distal tip of the treatment device adjacent the Eustachian tube opening.

12. The method of claim 11, wherein the treatment device comprises a distal radiopaque member.

13. The method of claim 11, wherein the treatment device comprises a catheter.

14. The method of claim 11, wherein the treatment device comprises a fluid introduction device for introducing a fluid into a middle ear space of the patient'"'"'s ear.

15. The method of claim 14, further comprising scanning the middle ear space using an ultrasound device.

16. The method of claim 14, wherein the fluid is selected from the group consisting of air, a contrast medium, an aspiration fluid, and a drug.

17. The method of claim 11, wherein the treatment device comprises an aspiration device for aspirating a substance from the middle ear space.

18. The method of claim 11, further comprising:

introducing a protective device proximal the Eustachian tube; and

monitoring advancement of the treatment device using the protective device.

19. The method of claim 18, wherein the protective device comprises a sensor positioned proximal the tympanic membrane to sense the position of the treatment device during the advancement.

20. The method of claim 18, wherein the protective device comprises an endoscope to visualize the advancement.

21. A method for indirectly assessing Eustachian tube function in a patient, the method comprising:

positioning an energy emitter in the nasopharynx adjacent a Eustachian tube;

positioning an energy receiver adjacent the tympanic membrane via the external ear canal;

directing energy from the emitter toward the receiver;

generating an emitter signal representative of the energy from the emitter;

generating a receiver signal representative of the energy received by the emitter;

forming a comparison between the emitter signal and the receiver signal; and

indirectly assessing function of the Eustachian tube during swallowing, using the comparison.

22. The method of claim 21, wherein the indirectly assessing comprises estimating the physical characteristics of Eustachian tube.

23. The method of claim 21, wherein the energy emitter emits energy in the form of a pressure wave or electromagnetic energy.

24. A method for treating a Eustachian tube in a patient, the method comprising:

placing a guidewire into a Eustachian tube of the patient via the patient'"'"'s nasopharynx;

introducing a debulking device along the guidewire into the Eustachian tube of the patient; and

removing edematous tissue including hypertropic mucosa from a surface along one side of the Eustachian tube.

25. The method of claim 24, wherein the guidewire includes markings and further comprising providing feedback related to the introducing into the Eustachian tube.

26. A method for treating a Eustachian tube in a patient, the method comprising:

introducing via the patient'"'"'s nasopharynx a guidewire submucosally between cartilage and a mucosal surface of a Eustachian tube;

introducing a debulking device along the guidewire into sub-mucosal tissue of the Eustachian tube, between the cartilage and the mucosal surface; and

removing some of the sub-mucosal tissue.

27. A method for treating muscular dysfunction or an anatomical disorder of a Eustachian tube in a patient, the method comprising creating a lesion in at least one of a tensor villi palatine muscle or a levator villi palatine muscle to affect a stiffening of the muscle(s) upon resorption of the lesion.

28. The method of claim 27, wherein the stiffening comprises at least one of a shortening and tensioning of the tensor villi palatine or the levator villi palatine.

29. The method of claim 27, wherein the creating a lesion comprises applying a therapy selected from the group consisting of mechanical, laser, radio frequency and chemical therapies.

30. A method for treating a Eustachian tube in a patient, the method comprising:

placing a dual lumen pressure equalization tube through the tympanic membrane of the patient, the tube having a distal extension for location in a region of the Eustachian tube;

providing a medication to the region of the Eustachian tube through a first lumen of the dual lumen tube in fluid communication with the distal extension; and

providing ventilation across the tympanic membrane through a second lumen of the dual lumen tube.

31. The method of claim 30, wherein the medication is configured to reduce edema in the Eustachian tube region.

32. The method of claim 30, wherein the medication comprises a surfactant configured to modify a surface tension of a mucosal layer of the Eustachian tube to affect an enhanced wetting of the mucosal surface with the medication.

33. The method of claim 30, wherein the medication comprises particles configured for capturing by mucosal tissue of the Eustachian tube to affect an extended release of the medication.

34. An apparatus for treating a Eustachian tube in a patient, the apparatus comprising:

a dual lumen tube for insertion into a tympanic membrane of the patient'"'"'s ear, the tube having;

a distal extension for placement in a region of the Eustachian tube;

a first lumen for providing a medication to the region of the Eustachian tube through the distal extension; and

a second lumen for providing ventilation across the tympanic membrane.

35. The apparatus of claim 34, wherein the first lumen is disposed within the second lumen.

36. The apparatus of claim 34, wherein the second lumen is disposed within the first lumen.

37. The apparatus of claim 34, wherein the first lumen is disposed adjacent the second lumen.

38. The apparatus of claim 34, wherein the dual lumen tube comprises a biodegradable bioresorbable material.

39. A method for treating a Eustachian tube in a patient, the method comprising:

accessing a Eustachian tube region via the nasopharynx, using a guide having a lumen;

introducing a guidewire through the lumen of the guide to position it submucosally between cartilage and a mucosal surface of the Eustachian tube;

passing a temporary intraluminal implant having a drug delivery reservoir along the guidewire to position the implant submucosally in a posterior cushion of the Eustachian tube region between the lumen and the cartilage; and

delivering a drug to the Eustachian tube region from the drug delivery reservoir.

40. The method of claim 39, further comprising contemporaneously delivering a drug to adenoids and the Eustachian tube region from the drug delivery reservoir.

41. The method of claim 39, wherein the drug delivery reservoir comprises a coating layer disposed on the implant.

42. The method of claim 39, wherein the guide comprises a biodegradable bioresorbable material.

43. A method for treating a Eustachian tube in a patient, the method comprising:

obtaining access to a Eustachian tube region via the nasopharynx;

introducing via the patient'"'"'s nasopharynx a hollow guidewire dimensioned to reach into the Eustachian tube region, the hollow guidewire comprising a plurality of apertures disposed at or near its distal end; and

delivering a drug to at least one of the Eustachian tube or a middle ear region of the patient'"'"'s ear through the apertures.

44. A system for accessing a Eustachian tube of a patient, the system comprising:

a guide configured for passing into a nasal passage of the patient to position a distal tip of the catheter at or near a Eustachian tube, the guide having distal tip with a bend having an angle between 30 and 90 degrees; and

a guidewire configured to pass through the guide into the Eustachian tube.

45. The system of claim 44, wherein the guide comprises a catheter.

46. The system of claim 44, wherein the guide comprises a dual lumen tube.

47. The system of claim 44, further comprising a diagnostic device configured for passage through the guide.

48. The system of claim 44, further comprising a treatment device configured for passage through the guide.

49. A device for treating a Eustachian tube, comprising

an elongated rigid shaft;

an elongated and flexible insert coupled to the shaft, the insert including a therapeutic device for treating an elongated portion of a Eustachian tube, the insert including a lateral stiffness which deflects in accordance with the Eustachian tube, and a column stiffness which allows the insert to be pushed into the Eustachian tube without buckling.

50. The device of claim 49, wherein the elongated rigid shaft includes a distal end with a bend ranging from 30 to 90 degrees.

51. The device of claim 49, wherein the elongated rigid shaft includes a proximal end including at least one fluid fitting for supplying a fluid to the insert.

52. The device of claim 49, wherein the elongated rigid shaft includes a lumen for passage of a guidewire.

53. The device of claim 49, wherein the insert includes a flexible core wire.

54. The device of claim 53, wherein flexible core wire is constructed from a super-elastic alloy.

55. The device of claim 53, wherein the flexible core wire includes an atraumatic tip at a distal most portion of the insert.

56. The device of claim 49, wherein the therapeutic device includes a balloon.

57. The device of claim 56, wherein balloon includes a microporous structure.

58. The device of claim 56, wherein balloon is expandable to a preformed shape which matches a profile of a Eustachian tube.

59. The device of claim 56, wherein balloon includes a drug coating.

60. The device of claim 59, wherein the drug coating is one of a steroid, antibiotic, antifungal, nonsteroidal anti-inflammatory, steroidal anti-inflammatory, surfactant, or anti-mucoidal substance

61. The device of claim 49, wherein the therapeutic device is detachable from the rigid shaft.

62. The device of claim 61, wherein therapeutic device includes a lumen.

63. The device of claim 61, wherein the therapeutic device is biodegradable and includes a therapeutic substance.

64. The device of claim 63, wherein the therapeutic substance is one of a steroid, antibiotic, antifungal, nonsteroidal anti-inflammatory, steroidal anti-inflammatory, surfactant, or anti-mucoidal substance.

65. The device of claim 49, wherein the therapeutic device includes an expandable stent.

66. The device of claim 65, wherein the expandable stent includes a therapeutic substance.