Method and System for Treating Target Tissue Within the Eustachian Tube

• US 20100274188A1
• Filed: 05/11/2010
• Published: 10/28/2010
• Est. Priority Date: 12/20/2007
• Status: Abandoned Application

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Goldfarb, Eric, Chang, John Y.
• Application Number:
  US12/777,856
• Publication Number:
  US 20100274188A1
• Time in Patent Office: Days
• US Class Current: 604/96.10
• 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 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• 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 25/0054 with regions for increasing flexibility
• 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 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0102 : Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0105 : Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• 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 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 31/00 : Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• 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 1/30 : Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A method for dilating a Eustachian tube of a patient is disclosed. In one embodiment, the method may involve advancing a dilation device through a nasal passage of the patient to position a dilator of the device at least partially in a Eustachian tube of the patient, expanding the dilator to an expanded configuration to dilate a portion of the Eustachian tube, collapsing the dilator, and removing the dilation device from the patient. The dilated portion of the Eustachian tube remains at least partially dilated after removal of the device.

Claims

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

advancing a dilation device through a nasal passage of the patient to position a dilator of the device at least partially in a Eustachian tube of the patient;

expanding the dilator to dilate a portion of the Eustachian tube;

collapsing the dilator; and

removing the dilation device from the patient, wherein the dilated portion of the Eustachian tube remains at least partially dilated after removal of the device.

2. The method of claim 1, wherein a distal portion of the dilation device is malleable, the method further comprising forming, by a user of the dilation device, a bend in the distal portion.

3. The method of claim 1, a distal portion of the dilation device includes a bend of between about 30 degrees and about 90 degrees.

4. The method of claim 1, wherein the opening of the Eustachian tube comprises a pharyngeal ostium of the Eustachian tube, and wherein the dilation device is advanced to position the dilator in the pharyngeal ostium.

5. The method of claim 1, wherein the dilation device includes a guide portion slidably coupled with the dilator, and wherein advancing the dilation device comprises:

advancing the dilation device into the nasal cavity to position a distal end of the device at or near the opening of the Eustachian tube; and

advancing the dilator relative to the guide portion to position the dilator in the opening.

6. The method of claim 5, wherein the guide portion comprises an inner shaft coupled with a handle of the dilation device, and wherein the dilator is advanced over the inner shaft.

7. The method of claim 6, wherein the inner shaft is malleable, the method further comprising forming, by a user of the dilation device, a bend in the inner shaft.

8. The method of claim 1, wherein the dilator comprises a balloon, and wherein expanding the dilator comprises inflating the balloon.

9. The method of claim 3, wherein inflating the balloon expands a stent within the Eustachian tube.

10. The method of claim 3, wherein the balloon includes cutting members, and wherein expanding the dilator further comprises cutting the Eustachian tube wall with the cutting members.

11. The method of claim 1, further comprising:

advancing an endoscope through the nasal passage; and

viewing at least one of the advancing, expanding, collapsing or removing steps using the endoscope.

12. The method of claim 11, wherein viewing includes viewing a marker on the dilation device, and wherein the method further comprises approximating a location of the dilator relative to the opening of the Eustachian tube based on a distance of the marker from a proximal end of the dilator.

13. The method of claim 1, further comprising applying at least one substance to the Eustachian tube using the dilator.

14. The method of claim 13, wherein the dilator comprises a porous balloon for delivering the substance.

15. The method of claim 13, wherein the dilator comprises a balloon with a plurality of needles for delivering the substance.

16. A device for dilating a Eustachian tube of a patient, the device comprising:

a handle;

a guide member coupled with the handle;

a dilator slidably coupled with the handle and disposed over at least part of the guide member;

an actuator on the handle for advancing the dilator along the guide member; and

an expansion member coupled with the handle for allowing expansion of the dilator.

17. The device of claim 16, wherein the dilator comprises a balloon catheter including an inflatable balloon, and wherein the expansion member comprises an inflation port in fluid communication with an inflation lumen of the balloon catheter.

18. The device of claim 17, wherein the balloon includes multiple apertures through which one or more drugs may be passed to contact the Eustachian tube.

19. The device of claim 17, wherein the balloon includes at least one cutting member for cutting tissue within the Eustachian tube upon expansion.

20. The device of claim 16, wherein the guide member comprises a shaft over which the dilator slides.

21. The device of claim 20, wherein the shaft is malleable.

22. The device of claim 20, wherein the shaft has a bend with an angle of between about 30 degrees and about 90 degrees.

23. The device of claim 20, wherein a distal end of the shaft has a ball tip.

24. The device of claim 16, wherein the advancement member comprises a slide.

25. The device of claim 16, wherein the dilator comprises:

a rigid proximal portion; and

a flexible distal portion.

26. The device of claim 25, wherein the rigid proximal portion comprises a hypotube.

27. The device of claim 16, wherein the guide member comprises a tubular shaft through which the dilator slides.

28. The device of claim 27, wherein the shaft is malleable.

29. The device of claim 27, wherein the shaft has a bend with an angle of between about 30 degrees and about 90 degrees.

30. The device of claim 16, further comprising a suction port disposed on the handle and in fluid communication with a suction lumen passing through the guide member or the dilator.

31. The device of claim 16, further comprising an endoscope connection member for coupling an endoscope with the device.