Method and System for Eustachian Tube Dilation

Abstract

A device and method for dilating a Eustachian tube of a patient is disclosed. The device includes a guide catheter and a balloon dilation catheter. The balloon dilation catheter has an actuator that prevents injury to the middle ear. The balloon dilation catheter is slidably coupled with the guide catheter through the guide catheter lumen and is fully inserted into the guide catheter lumen when the distal side of the actuator is adjacent to the proximal end of the guide catheter. The method involves advancing the guide catheter and balloon dilation catheter through a nasal passage of the patient to dilate a portion of the Eustachian tube.

Description

FIELD OF THE INVENTION[0001]The present invention is related to methods and systems for accessing and treating target tissue regions within the middle ear and the Eustachian tube.BACKGROUND OF THE INVENTION[0002]Referring to FIGS. 1-2, the ear 10 is divided into three parts: an external ear 12, a middle ear 14 and an inner ear 16. The external ear 12 consists of an auricle 18 and ear canal 20 that gather sound and direct it towards a tympanic membrane 22 (also referred to as the eardrum) located at an inner end 24 of the ear canal 20. The middle ear 14 lies between the external and inner ears 12 and 16 and is connected to the back of the throat by a Eustachian tube 26 which serves as a pressure equalizing valve between the ear 10 and the sinuses. The Eustachian tube 26 terminates in a distal opening or ostium 28 in the nasopharynx region 30 of the throat 32. In addition to the eardrum 22, the middle ear 14 also consists of three small ear bones (ossicles): the malleus 34 (hammer), i...

AI Technical Summary

Benefits of technology

[0040]In yet another aspect, the invention is directed to a balloon dilation catheter for accessing and treating the Eustachian tube through the nose of a human patient. The balloon dilation catheter includes an elongate shaft, an actuator, an inflatable balloon and a proximal connecter. The elongate shaft has a proximal end and a distal end and an inflation lumen therebetween. The actuator is useful for one-handed advancement of the catheter and is coupled to the elongate shaft between the elongate shaft proximal end and the distal end, and is positioned on the elongate shaft such that when the balloon dilation catheter is positioned fully within the nose of the human patient, the actuator abuts the nose of the human patient. The proximal connecter comprises an inflation port in fluid communication with lumen of the elongate shaft and an injection port. In one embodiment, the inflation port comprises a first type of connector and the injection port comprises a second type of connector different from the first type of connector.

Problems solved by technology

Anything that interferes with this periodic opening and closing of the Eustachian tube 26 may result in hearing impairment or other ear symptoms.

In adults, this is usually accompanied by some ear discomfort, a fullness or pressure feeling and may result in a mild hearing impairment and head noise (tinnitus).

Infection of these areas results in mucous membrane swelling which in turn may result in obstruction of the Eustachian tube 26.

In the presence of bacteria, this fluid may become infected, leading to an acute suppurative otitis media (infected or abscessed middle ear).

There may be recurrent ear pain, especially when the individual catches a cold.

The presence of fluid in the middle ear 14, however, makes it very susceptible to recurrent acute infections.

These recurrent infections may result in middle ear damage.

Finally, the fluid can become infected, which is painful and makes the patient feel ill and which may cause the patient not to be able to hear well.

However, even if antihistamines, decongestants and antibiotics are used to treat an infection or other cause of fluid build-up in the middle ear 14, these treatments will typically not immediately resolve the pain and discomfort caused by the buildup of fluid in the middle ear 14; i.e. the most immediate relief will be felt by the patient if the fluid can be removed from the Eustachian tube 26.

During the healing period, the patient can experience varying degrees of ear pressure, popping, clicking and fluctuation of hearing, occasionally with shooting pain in the ear.

Afflictions of the middle ear and Eustachian tube are very prevalent and a serious medical problem, afflicting millions of people and causing pain, discomfort and even hearing loss or permanent ear damage.

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