Surgery – Miscellaneous – Methods
Reexamination Certificate
2001-09-07
2003-06-17
DeMille, Danton D. (Department: 3764)
Surgery
Miscellaneous
Methods
C606S169000, C604S514000
Reexamination Certificate
active
06578581
ABSTRACT:
BACKGROUND OF INVENTION
1. Field of the Invention
This invention relates to an apparatus and a method for draining the eustachian tube and middle ear of fluid when there is a blockage of the opening of the eustachian tube in the nasopharynx region of the throat.
2. Related Art
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
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), incus
36
(anvil) and stapes
38
(stirrup). These bones
34
-
38
transmit sound vibrations to the inner ear
16
and thereby act as a transformer, converting sound vibrations in the canal
20
of the external ear
12
into fluid waves in the inner ear
16
. These fluid waves stimulate several nerve endings
40
that, in turn, transmit sound energy to the brain where it is interpreted.
The eustachian tube
26
is a narrow, one-and-a-half inch long channel connecting the middle ear
14
with the nasopharynx
30
, the upper throat area just above the palate, in back of the nose. The eustachian tube
26
functions as a pressure equalizing valve for the middle ear
14
which is normally filled with air. When functioning properly, the eustachian tube
26
opens for a fraction of a second periodically (about once every three minutes) in response to swallowing or yawning. In so doing, it allows air into the middle ear
14
to replace air that has been absorbed by the middle ear lining (mucous membrane) or to equalize pressure changes occurring on altitude changes. Anything that interferes with this periodic opening and closing of the eustachian tube
26
may result in hearing impairment or other ear symptoms.
Obstruction or blockage of the eustachian tube
26
results in a negative middle ear pressure
14
, with retraction (sucking in) of the eardrum
22
. 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). There may be no symptoms in children. If the obstruction is prolonged, fluid may be drawn from the mucous membrane of the middle ear
14
, creating a condition we call serous otitis media (fluid in the middle ear). This occurs frequently in children in connection with an upper respiratory infection and accounts for the hearing impairment associated with this condition.
A lining membrane (mucous membrane) of the middle ear
14
and eustachian tube
26
is connected with, and is the same as, the membrane of the nose
42
, sinuses
44
and throat
32
. Infection of these areas results in mucous membrane swelling which in turn may result in obstruction of the eustachian tube
26
. This is referred to as serous otitis media, i.e., essentially a collection of fluid in the middle ear
14
that can be acute or chronic, usually the result of blockage of the distal opening
28
of the eustachian tube
26
which allows fluid to accumulate in the middle ear
14
. In the presence of bacteria, this fluid may become infected leading to an acute suppurative otitis media (infected or abscessed middle ear). When infection does not develop, the fluid remains until the eustachian tube
26
again begins to function normally, at which time the fluid is absorbed or drains down the tube into the throat
32
through the eustachian tube opening
28
.
Chronic serous otitis media may result from longstanding eustachian tube blockage, or from thickening of the fluids so that it cannot be absorbed or drained down the eustachian tube
26
. This chronic condition is usually associated with hearing impairment. There may be recurrent ear pain, especially when the individual catches a cold. Fortunately, serous otitis media may persist for many years without producing any permanent damage to the middle ear mechanism. 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.
When the eustachian tube
26
contains a build-up of fluid, a number of things will occur. First, the body absorbs the air from the middle ear
14
, causing a vacuum to form which tends to pull the lining membrane and ear drum
22
inward causing pain. Next, the body replaces the vacuum with more fluid which tends to relieve the pain, but the patient can experience a fullness sensation in the ear
10
. Treatment of this condition with antihistamines and decongestants can take many weeks to be fully effective. Finally, the fluid can become infected which is painful and makes the patient feel ill and may not be able to hear well. If the inner ear
14
is affected, the patient may feel a spinning or turning sensation (vertigo). The infection is typically treated with antibiotics.
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
.
Antibiotic treatment of middle ear infections typically result in normal middle ear function within three to four weeks. 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. Resolution of the infection occasionally leaves the patient with uninfected fluid in the middle ear
14
, localized in the eustachian tube
26
.
Fluid build-up caused by these types of infections has been treated surgically in the past. The primary objective of surgical treatment of chronic serous otitis media is to reestablish ventilation of the middle ear, keeping the hearing at a normal level and preventing recurrent infection that might damage the eardrum membrane and middle ear bones.
For example, as shown in
FIG. 3
, a myringotomy can be performed to relieve fluid in the middle ear
14
. A myringotomy is an incision
42
in the eardrum
22
performed to remove fluid in the middle ear
14
. A hollow plastic tube
44
, referred to as a ventilation tube, is inserted and lodged in the incision
42
to prevent the incision
42
from healing and to insure ventilation of the middle ear
14
. The ventilation tube
44
temporarily takes the place of the eustachian tube
26
in equalizing the pressure in the middle ear
14
. The ventilation tube
44
usually remains in place for three to nine months during which time the eustachian tube
26
blockage subsides. When the tube
44
dislodges, the eardrum
22
heals; the eustachian tube
26
then resumes its normal pressure equalizing function.
Another method of relieving the pressure in the middle ear
14
is shown in
FIG. 4
in which a hypodermic needle
46
is driven through the eardrum
22
through which any accumulated fluid can be withdrawn from typically only the upper portion of the eustachian tube
26
.
The methods of
FIGS. 3 and 4
involve rupturing the eardrum
22
to relieve the fluid accumulation and pressure increase in the middle ear. Neither of these methods, in addition to the sometimes permanent puncture created in the eardrum
22
, is especially effective in removing all of the fluid in the eustachian tube
26
since often the lower end
28
thereof is blocked and dammed with fluid.
In connection with the above surgica
DeMille Danton D.
McGarry Bair PC
Thanh Quang D.
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