U.S. patent application number 13/826454 was filed with the patent office on 2013-10-17 for method and system for eustachian tube dilation.
The applicant listed for this patent is ACCLARENT, INC.. Invention is credited to Randy S. Chan, Hung V. Ha, Ketan P. Muni, Andy Nguyen.
Application Number | 20130274715 13/826454 |
Document ID | / |
Family ID | 49325736 |
Filed Date | 2013-10-17 |
United States Patent
Application |
20130274715 |
Kind Code |
A1 |
Chan; Randy S. ; et
al. |
October 17, 2013 |
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.
Inventors: |
Chan; Randy S.; (San Jose,
CA) ; Ha; Hung V.; (San Jose, CA) ; Nguyen;
Andy; (San Jose, CA) ; Muni; Ketan P.; (San
Jose, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ACCLARENT, INC. |
Menlo Park |
CA |
US |
|
|
Family ID: |
49325736 |
Appl. No.: |
13/826454 |
Filed: |
March 14, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61623833 |
Apr 13, 2012 |
|
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|
Current U.S.
Class: |
604/514 ;
604/275; 606/196 |
Current CPC
Class: |
A61B 17/22 20130101;
A61M 25/1036 20130101; A61B 17/24 20130101; A61M 25/0105 20130101;
A61M 29/00 20130101; A61M 25/01 20130101; A61M 25/0662 20130101;
A61M 25/10 20130101; A61M 25/0053 20130101; F04C 2270/0421
20130101; A61M 25/0052 20130101; A61M 25/005 20130101; A61B
2017/00787 20130101; A61B 2017/22051 20130101; A61F 11/004
20130101; A61M 2025/0681 20130101; A61M 2210/0675 20130101; A61M
29/02 20130101 |
Class at
Publication: |
604/514 ;
604/275; 606/196 |
International
Class: |
A61M 29/02 20060101
A61M029/02; A61M 25/10 20060101 A61M025/10 |
Claims
1. A device for dilating a Eustachian tube of a patient, the device
comprising: a guide catheter having an first elongate shaft, the
first elongate shaft having a proximal end and a distal end and a
lumen therebetween, the guide catheter having a proximal hub
attached to the proximal end of the first elongate shaft; and a
balloon dilation catheter having a second elongate shaft, the
second elongate shaft having a proximal end and a distal end, the
balloon dilation catheter having an actuator for one-handed
advancement of the catheter coupled to the second elongate shaft
between the second elongate shaft proximal end and the second
elongate shaft distal end and that separates the second elongate
shaft into a proximal portion and a distal portion, the actuator
having a proximal side and a distal side; wherein 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.
2. The device of claim 1, wherein the balloon dilation catheter
comprises an inflatable balloon and a proximal connecter, and
wherein the proximal connector comprises an inflation port in fluid
communication with an inflation lumen of the balloon catheter.
3. The device of claim 2, wherein the proximal connector further
comprises an injection port.
4. The device of claim 3 wherein 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.
5. The device of claim 1, wherein the guide catheter elongate shaft
has a bend with an angle of between about 45 degrees and about 65
degrees.
6. The device of claim 1, wherein the guide catheter elongate shaft
has a bend with an angle of about 55.
7. The device of claim 1, wherein a distal end of the balloon
dilatation catheter shaft has a bulbous tip.
8. The device of claim 1, wherein the balloon dilation catheter
comprises: a flexible proximal portion a rigid middle portion; and
a flexible distal portion.
9. The device of claim 8, wherein the rigid distal portion
comprises a hypotube.
10. A method for dilating a Eustachian tube of a patient, the
method comprising: advancing a guide catheter having an first
elongate shaft, the first elongate shaft having a proximal end and
a distal end and a lumen therebetween, the guide catheter having a
proximal hub attached to the proximal end of the first elongate
shaft through a nasal passage of the patient to position the guide
catheter adjacent the Eustachian tube; and advancing a balloon
dilation catheter having a second elongate shaft and a balloon
attached to the second elongate shaft, the second elongate shaft
having a proximal end and a distal end, the balloon dilation
catheter having an actuator coupled to the second elongate shaft
between the second elongate shaft proximal end and the elongate
shaft distal end and that separates the second elongate shaft into
a proximal portion and a distal portion, the actuator having a
proximal side and a distal side through the lumen of the guide
catheter until the distal side of the actuator is adjacent to the
proximal end of the guide catheter; expanding the balloon to dilate
a portion of the Eustachian tube; collapsing the balloon; and
removing the guide catheter and balloon dilation catheter from the
patient, wherein the dilated portion of the Eustachian tube remains
at least partially dilated after removal of the device.
11. The method of claim 10, wherein the guide catheter includes a
distal portion with bend of between about 45 degrees and about 65
degrees.
12. The method of claim 10, wherein the opening of the Eustachian
tube comprises a pharyngeal ostium of the Eustachian tube, and
wherein the balloon dilation catheter is advanced to position the
balloon in the pharyngeal ostium.
13. The method of claim 10, 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.
14. The method of claim 13, wherein viewing includes viewing a
marker on the balloon dilation catheter, and wherein the method
further comprises approximating a location of the balloon dilation
catheter relative to the opening of the Eustachian tube based on a
distance of the marker from a proximal end of the dilator.
15. The method of claim 10, further comprising applying at least
one substance to the Eustachian tube using the balloon dilation
catheter.
16. A method for dilating a Eustachian tube of a patient having a
nostril, the method comprising: advancing a balloon dilation
catheter having an elongate shaft and a balloon attached to the
elongate shaft, the elongate shaft having a proximal end and a
distal end, the balloon dilation catheter having an actuator
coupled to the elongate shaft between the elongate shaft proximal
end and the elongate shaft distal end and that separates the
elongate shaft into a proximal portion and a distal portion, the
actuator having a proximal side and a distal side, through the
nostril of the patient until the distal side of the actuator is
adjacent to the nostril of the patient; expanding the balloon to
dilate a portion of the Eustachian tube; collapsing the balloon;
and removing the balloon dilation catheter from the nostril of the
patient, wherein the dilated portion of the Eustachian tube remains
at least partially dilated after removal of the device.
17. The method of claim 16, wherein the opening of the Eustachian
tube comprises a pharyngeal ostium of the Eustachian tube, and
wherein the balloon dilation catheter is advanced to position the
balloon in the pharyngeal ostium.
18. The method of claim 16, 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.
19. The method of claim 16, wherein viewing includes viewing a
marker on the balloon dilation catheter, and wherein the method
further comprises approximating a location of the balloon dilation
catheter relative to the opening of the Eustachian tube based on a
distance of the marker from a proximal end of the dilator.
20. The method of claim 16, further comprising applying at least
one substance to the Eustachian tube using the balloon dilation
catheter.
21. The method of claim 20 wherein the substance is selected from
the group consisting of contrast agents, antimicrobials,
anesthetics, vasoconstrictors, analgesics, agent, a
corticosteroids, anti-inflammatories, decongestants, mucous
thinners, expectorants, mucolytics, surfactants, antihistamines,
cytokine inhibitors, leucotriene inhibitors, IgE inhibitors,
immunomodulators, allergens, hemostatic agents, antiproliferatives,
cytotoxic agents, proteins, stem cells, genes and gene therapy
preparations
22. A device for dilating a Eustachian tube of a patient, the
device comprising: a guide catheter having a first elongate shaft,
the first elongate shaft having a proximal end and a distal end and
a lumen therebetween, the guide catheter having a proximal hub
attached to the proximal end of the elongate shaft; and a balloon
dilation catheter having a second elongate shaft, the second
elongate shaft having a proximal end and a distal end, the balloon
dilation catheter having an actuator for one-handed advancement of
the catheter coupled to the second elongate shaft between the
second elongate shaft proximal end and the second elongate shaft
distal end and that separates the second elongate shaft into a
proximal portion and a distal portion; wherein the balloon dilation
catheter is slidably coupled with the guide catheter through the
guide catheter lumen and is fully inserted through the guide
catheter lumen when the actuator is fully deployed.
23. The device of claim 22 wherein the proximal hub comprises a
handle.
24. A device for accessing the Eustachian tube through the nose of
a human patient, said device comprising: a guide catheter
comprising an elongate shaft has a bend angle of between about 45
degrees and about 65 degrees, and having a proximal end and a
distal end and a lumen therebetween, and a proximal hub attached to
the proximal end of the elongate shaft; wherein the proximal hub is
positioned on the elongate shaft such that when the guide catheter
is positioned fully within the nose of the human patient, the
proximal hub abuts the nose of the human patient.
25. The device of claim 24 wherein the lumen of the elongate shaft
is further adapted for delivering at least one substance
therethrough.
26. A balloon dilation catheter for accessing and treating the
Eustachian tube through the nose of a human patient, said the
balloon dilation catheter comprising: an elongate shaft, the
elongate shaft having a proximal end and a distal end and inflation
lumen therebetween; an actuator for one-handed advancement of the
catheter coupled to the elongate shaft between the elongate shaft
proximal end and the elongate shaft distal end, the actuator
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; an
inflatable balloon; and a proximal connecter comprising an
inflation port in fluid communication with an inflation lumen of
the elongate shaft and an injection port.
27. The catheter of claim 26 wherein 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.
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), 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.
[0003] The Eustachian tube 26 is a narrow, two to two-and-a-half
centimeter long channel, measured from the ostium 28 to the bony
isthmus 29, 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.
[0004] 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 referred to as 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.
[0005] 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.
[0006] Chronic serous otitis media may result from longstanding
Eustachian tube blockage, or from thickening of the fluid 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.
[0007] 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 which may cause the patient not to 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.
[0008] 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.
[0009] Antibiotic treatment of middle ear infections typically
results 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.
[0010] 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.
[0011] 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 ensure 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.
[0012] 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.
[0013] 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.
[0014] In connection with the above surgical treatments of FIGS. 3
and 4, Eustachian tube 26 inflation is also employed to relieve the
pressure build-up and fluid accumulation as shown in FIG. 5. The
hypodermic syringe 46 (shown with a flexible tip 48) is inserted
into a nostril or into the mouth until the tip 48 is positioned
adjacent the distal opening 28 of the Eustachian tube 26 in the
nasopharynx region 30 of the throat 32. Air is blown through the
tip 48 via the syringe 46 into the obstructed Eustachian tube 26
and, thus, into the middle ear 14 to help relieve the congestion
and reestablish middle ear ventilation. This procedure is often
referred to as politzerization. Politzerization is most effective
when one of the nostrils is pinched shut (as shown in FIG. 6),
while the patient simultaneously swallows. This procedure forces
air into the Eustachian tube 26 and the middle ear 14. This
technique is good for opening the Eustachian tube 26 but it does
not clear accumulated fluid away.
[0015] Another method for clearing the middle ear 14 (at least
temporarily) is referred to as the "valsalva" maneuver,
accomplished by forcibly blowing air into the middle ear 14 while
holding the nose, often called popping the ear. This method is also
good for opening the Eustachian tube 26 but it does not clear the
accumulated fluid away either.
[0016] Typical disorders associated with the middle ear and the
Eustachian tube include perforated ear drums, tympanosclerosis,
incus erosion, otitis media, cholesteotoma, mastoiditis, patulous
Eustachian tube, and conductive hearing loss. To treat some of
these disorders, ear surgery may be performed. Most ear surgery is
microsurgery, performed with an operating microscope. Types of ear
surgery include stapedectomy, tympanoplasty, myringotomy and ear
tube surgery.
[0017] One of the simplest ear surgeries is the myringotomy or the
incision of the ear drum. However, ear surgery can also require the
removal of the tympanic membrane for the visualization of the
middle ear space. Often surgeons will try to preserve the integrity
of the membrane by making incisions in the skin of the ear canal
and removing the tympanic membrane as a complete unit.
Alternatively, middle ear access is achieved via the mastoids. This
method approaches the middle ear space from behind the ear and
drills through the mastoid air cells to the middle ear. Whether the
bony partition between the external ear canal and the mastoid is
removed or not depends on the extent of the disease.
Canal-wall-down refers to the removal of this bony partition.
Canal-wall-up refers to keeping this bony partition intact. The
term modified radical mastoidectomy refers to an operation where
this bony partition is removed and the eardrum and ossicles are
reconstructed. A radical mastoidectomy is an operation where this
bony partition is removed and the ear drum, malleus and incus bones
are permanently removed so that the inner lining of the large
cholesteotoma sac can be safely cleaned. This operation is done
when an extensive cholesteotoma is encountered or one that is
adherent to the inner ear or facial nerve.
[0018] 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. Although a number of treatments have been
developed, as described above each of them have shortcomings.
Therefore, a need exists for improved methods and systems for
accessing, diagnosing and treating target tissue regions within the
middle ear and the Eustachian tube. Ideally, such methods and
systems would be minimally invasive and pose very little risk of
damage to healthy ear tissue.
[0019] US Patent Publication No. 2010/0274188 which is incorporated
by reference herein in its entirety is directed toward methods and
systems for accessing, diagnosing and treating target tissue
regions within the middle ear and the Eustachian tube. One
particular method described in the publication is for dilating a
Eustachian tube of a patient. A guide catheter may be advanced
through a nasal passage of the patient to position a distal end of
the guide catheter at or near an opening of the Eustachian tube of
the patient. A distal portion of the guide catheter may include a
bend having an angle between 30 and 90 degrees. The distal portion
may be more flexible than a proximal portion of the guide catheter.
A guidewire may be advanced through the guide catheter such that a
distal end of the guidewire enters the Eustachian tube. A dilation
catheter may be advanced over the guidewire to position a dilator
of the dilation catheter within the Eustachian tube. The dilator
may be expanded to dilate the Eustachian tube. The dilation
catheter and guidewire may be removed from the patient.
[0020] Improvement in the devices described above would provide a
system for dilation of the Eustachian tube that would be ergonomic
and easy to use and would safely and effectively access the
Eustachian tube without the need for a guidewire.
SUMMARY OF THE INVENTION
[0021] The present invention provides devices and methods for
accessing and treating the Eustachian tube of a patient.
[0022] In one aspect, a medical device is provided for dilating a
Eustachian tube of a patient. The device includes a guide catheter
and a balloon dilation catheter. The guide catheter has an elongate
shaft that has a proximal end and a distal end and a lumen
therebetween. The guide catheter further has a proximal hub
attached to the proximal end of the elongate shaft. The balloon
dilation catheter has an elongate shaft. The elongate shaft has a
proximal end and a distal end. The balloon dilation catheter has an
actuator for one-handed advancement of the catheter coupled to the
elongate shaft between the elongate shaft proximal end and the
elongate shaft distal end. The actuator separates the elongate
shaft into a proximal portion and a distal portion. The actuator
has a proximal side and a distal side. 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.
[0023] In one embodiment, the balloon dilation catheter comprises
an inflatable balloon and a proximal connecter. The proximal
connector has an inflation port in fluid communication with an
inflation lumen of the balloon catheter.
[0024] In another embodiment, the proximal connector further
includes an injection port.
[0025] In yet another embodiment the guide catheter elongate shaft
has a bend with an angle of between about 45 degrees and about 65
degrees. In one embodiment, the guide catheter elongate shaft has a
bend with an angle of about 55.
[0026] In still another embodiment, the distal end of the balloon
dilatation catheter shaft has a bulbous tip.
[0027] In a further embodiment, the balloon dilation catheter has a
flexible proximal portion and a rigid distal portion. In one
embodiment, the rigid distal portion comprises a hypotube.
[0028] In another aspect, the invention includes a method for
dilating a Eustachian tube of a patient. The method includes
advancing a guide catheter through a nasal passage of the patient
to position the guide catheter adjacent the Eustachian tube. The
guide catheter has an elongate shaft, the elongate shaft has a
proximal end and a distal end and a lumen therebetween. The guide
catheter has a proximal hub attached to the proximal end of the
elongate shaft. The method further includes advancing a balloon
dilation catheter through the lumen of the guide catheter until the
distal side of the actuator is adjacent to the proximal end of the
guide catheter. The balloon dilation catheter has an elongate shaft
and a balloon attached to the elongate shaft. The elongate shaft
has a proximal end and a distal end. The balloon dilation catheter
has an actuator coupled to the elongate shaft between the elongate
shaft proximal end and the elongate shaft distal end. The actuator
separates the elongate shaft into a proximal portion and a distal
portion. The actuator has a proximal side and a distal side. The
method further includes expanding the balloon to dilate a portion
of the Eustachian tube, collapsing the balloon; and removing the
guide catheter and balloon dilation catheter from the patient. The
dilated portion of the Eustachian tube remains at least partially
dilated after removal of the device.
[0029] In one embodiment of the method, the guide catheter includes
a distal portion with bend of between about 45 degrees and about 65
degrees.
[0030] In a further embodiment, the opening of the Eustachian tube
includes a pharyngeal ostium of the Eustachian tube, and the
balloon dilation catheter is advanced to position the balloon in
the pharyngeal ostium.
[0031] In yet another embodiment, the method of claim includes
advancing an endoscope through the nasal passage and viewing at
least one of the advancing, expanding, collapsing or removing steps
using the endoscope.
[0032] In a further embodiment, the viewing includes viewing a
marker on the balloon dilation catheter, and further includes
approximating a location of the balloon dilation catheter relative
to the opening of the Eustachian tube based on a distance of the
marker from a proximal end of the dilator.
[0033] In still another embodiment, the method includes applying at
least one substance to the Eustachian tube using the balloon
dilation catheter.
[0034] In a further aspect, the method for dilating a Eustachian
tube of a patient having a nostril includes advancing a balloon
dilation catheter through the nostril of the patient until the
distal side of the actuator is adjacent to the nostril of the
patient. The balloon dilation catheter has an elongate shaft and a
balloon attached to the elongate shaft. The elongate shaft has a
proximal end and a distal end. The balloon dilation catheter has an
actuator coupled to the elongate shaft between the elongate shaft
proximal end and the elongate shaft distal end. The actuator
separates the elongate shaft into a proximal portion and a distal
portion, and the actuator has a proximal side and a distal side.
The method further includes expanding the balloon to dilate a
portion of the Eustachian tube, collapsing the balloon and removing
the balloon dilation catheter from the nostril of the patient. The
dilated portion of the Eustachian tube remains at least partially
dilated after removal of the device.
[0035] In one embodiment the balloon dilation catheter is advanced
to position the balloon in the pharyngeal ostium.
[0036] In another embodiment, the method further includes advancing
an endoscope through the nasal passage, and viewing at least one of
the advancing, expanding, collapsing or removing steps using the
endoscope.
[0037] In yet another embodiment the method includes viewing a
marker on the balloon dilation catheter and approximating a
location of the balloon dilation catheter relative to the opening
of the Eustachian tube based on a distance of the marker from a
proximal end of the dilator.
[0038] In still another embodiment the method includes applying at
least one substance to the Eustachian tube using the balloon
dilation catheter.
[0039] In another aspect, the invention is directed to a device for
accessing the Eustachian tube through the nose of a human patient.
The device includes a guide catheter having an elongate shaft with
a bend angle of between about 45 and 65 degrees and with a proximal
end and a distal end. A proximal hub is attached to the proximal
end of the shaft. The proximal hub is positioned on the elongate
shaft such that when the guide catheter is positioned fully within
the nose of a human patient the proximal hub abuts the nose. In one
embodiment the lumen of the elongate shaft is adapted for
delivering a substance therethrough.
[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.
[0041] For a further understanding of the nature and advantages of
the invention, reference should be made to the following
description taken in conjunction with the accompanying figures.
Each of the figures is provided for the purpose of illustration and
description only and is not intended to limit the scope of the
embodiments of the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0042] FIG. 1 is a cross-section of a human ear showing the inner,
middle and outer ear portions and the Eustachian tube connecting
the middle ear with the nasopharynx region of the throat via a
distal opening thereof.
[0043] FIG. 2 is a cross-section of a human head showing the
nasopharynx region of the throat illustrated in FIG. 1 containing
the distal opening of the Eustachian tube illustrated in FIG.
1.
[0044] FIG. 3 is a cross-section of a human ear in the orientation
shown in FIG. 1 showing a prior art surgical method for relieving
fluid in the middle ear in which a ventilation tube is placed
within an incision in the eardrum.
[0045] FIG. 4 is a cross-section of a human ear in the orientation
shown in FIG. 1 showing a prior art surgical method for relieving
fluid in the middle ear in which a syringe is shown having a needle
perforating the eardrum.
[0046] FIGS. 5-6 show a cross-section of a human head in the
orientation shown in FIG. 2 showing a prior art politzeration
method for relieving fluid in the middle ear in which a syringe is
shown having a flexible tip extending into the nose and/or throat
area so that the tip abuts the distal opening of the Eustachian
tube while the nose is plugged.
[0047] FIG. 7A is a simplified side view of a guide catheter useful
for positioning the catheter of FIG. 9A.
[0048] FIG. 7B is a cross-sectional view of the guide catheter
shown in FIG. 7A through line B-B of FIG. 7A.
[0049] FIG. 8 is an enlarged view of the distal end of the guide
catheter shown in FIG. 7A.
[0050] FIG. 9A is a simplified side view of a balloon dilation
catheter according to an embodiment of the present invention.
[0051] FIG. 9B is a cross-sectional view of the balloon dilation
catheter shown in FIG. 9A and 10 through line B-B of FIG. 10.
[0052] FIG. 10 is an enlarged view of the distal end of the balloon
dilation catheter shown in FIG. 9A.
[0053] FIG. 11 is a simplified view of a guide catheter according
to a further embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0054] The following detailed description should be read with
reference to the drawings, in which like elements in different
drawings are identically numbered. The drawings, which are not
necessarily to scale, depict exemplary embodiments for the purpose
of explanation only and are not intended to limit the scope of the
invention. The detailed description illustrates by way of example,
not by way of limitation, the principles of the invention. This
description will clearly enable one skilled in the art to make and
use the invention, and describes several embodiments, adaptations,
variations, alternative and uses of the invention, including what
is presently believed to be the best mode of carrying out the
invention.
[0055] As used herein, the terms "about" and "approximately" for
any numerical values or ranges indicate a suitable dimensional
tolerance that allows the part or collection of components to
function for its intended purpose as described herein.
[0056] The embodiments of the present invention are directed toward
methods and systems for easily accessing and treating target tissue
regions within the middle ear and the Eustachian tube using a
system that can be operated with one hand and without damaging
structures in the middle ear.
[0057] In various alternative embodiments the invention includes a
guide catheter 100 and a balloon dilation catheter 200 operable in
combination with a single hand.
[0058] One embodiment of the guide catheter 100 of the invention is
shown in FIG. 7A. As shown, the guide catheter 100 includes an
elongate tubular shaft 102 that has a proximal end 104, a distal
end 106 and a lumen 108 therebetween. The guide catheter 100 may
have any suitable length, diameter, angle of bend, and location of
the bend along the length of the catheter 100, to facilitate
accessing a Eustachian tube opening. In some embodiments, for
example, the guide catheter 100 may have a length between about 8
cm and about 20 cm, and more preferably between about 10 cm and
about 15 cm and often about 11 cm.
[0059] FIG. 7B is a cross-sectional view of the guide catheter
elongate tubular shaft 102. As can be seen, the shaft has an outer
shaft tube 110, an inner shaft tube 112 and a lumen 108. The outer
shaft tube 110 may be constructed of a stiff material such as
stainless steel and the inner shaft tube 112 may be constructed of
a more flexible material such as a polymeric material including but
not limited to nylon and further including a PTFE liner. The lumen
108 has a diameter of between about 2 mm and 3 mm preferably
between about 2.5 mm and 2.6 mm such that the balloon dilation
catheter 200 can be easily inserted into the lumen 108 for dilation
of the Eustachian tube 26. The combination guide catheter 100 and
balloon catheter 200 may a compact system that is designed for a
one-handed procedure. By compact is intended that the length of the
guide catheter shaft that is distal of the bend in the guide
catheter is between about 0.5 and 2.0 cm, often between about 1 and
2 cm and often about 1 cm. The compactness helps reduce
interference with other instruments, such as an endoscope that may
be used to help in visualizing the positioning of the system.
[0060] The distal portion 120 of guide catheter 100 is shown in an
enlarged view in FIG. 8. The distal portion 120 of the guide
catheter 100 may have a bend 122 with an angle between about 45
degrees and about 65 degrees, and more preferably between about 50
degrees and about 60 degrees and often about 55 degrees to
facilitate access into the Eustachian tube 26. The distal portion
120 of the guide catheter 100 is made of a transparent material
such as a polymer including but not limited to nylon and PTFE such
that the balloon dilation catheter is visible within the distal
portion 120 and is more flexible than the elongate shaft 102. The
distal tip 124 of the distal portion 120 of the guide catheter 100
is made of pebax such that it provides for atraumatic access to the
Eustachian tube, and may contain 20% barium sulfate or other
similar radiopaque materials for visualizable access.
[0061] Referring again to FIG. 7A, the proximal portion 130 of
guide catheter 100 includes a proximal hub 132 to aid in insertion
of the balloon catheter into the Eustachian Tube 26. The hub 132
has a larger diameter proximal end 134 and a smaller diameter
middle section 136 to facilitate stabilization of the guide
catheter 100 in the nose, rotation of the guide catheter 100 and
insertion of the balloon catheter 200 as will be described in
further detail below. The hub 132 is ergonomically designed for
insertion, location and rotation with slight manipulations with one
hand.
[0062] A further embodiment of the guide catheter 300 according to
the invention is shown in FIG. 11. In this embodiment, the proximal
hub is a handle. The guide catheter comprises an elongate shaft 302
and a handle 304 to aid in insertion of the balloon catheter (not
shown) into the Eustachian Tube 26 in a manner similar to that
described below with regard to the guide catheter shown in FIG. 7A.
In the embodiment shown in FIG. 11, the actuator 302 comprises a
slider that is attached to the balloon catheter that is contained
within the handles 304 and is slidably contained within the
elongate shaft 302 of the guide catheter. In use, the guide
catheter is inserted into the sinus of the patient and the balloon
catheter is advanced into the Eustachian tube via thumb or single
finger advancement of the actuator 302 along the handle 304. The
advancement of the balloon catheter is continued until a visual
marker indicates that advancement is complete, or until the
enlarged tip of the balloon catheter abuts the isthmus of the
Eustachian tube or the actuator abuts the distal end 308 of the
opening 310 in the handle 304 and is therefore fully deployed.
[0063] The balloon dilation catheter of the invention is shown in
FIG. 9A. The balloon dilation catheter 200 generally includes an
elongate shaft 202 having a proximal end 214 and a distal end 218.
The balloon dilation catheter 200 further includes a balloon 204 on
the distal end 218 of the elongate shaft 202. The balloon 204 may
be a polymer balloon (compliant, semi-compliant or non-compliant).
In one embodiment, the balloon may be a suitable non-compliant
material such as but not limited to polyethylene terepthalate
(PET), PEBAX, nylon or the like. The balloon catheter may include
any size of balloon including but not limited to balloons of 2 mm
to 8 mm in diameter or of between about 5 mm and 6 mm (when
inflated) and 12 mm to 24 mm in working length (for example 2 mm
.times.12 mm, 3.5 mm.times.12 mm, 5 mm.times.16 mm, 5 mm.times.24
mm, 6 mm.times.16 mm, 6 mm.times.20 mm, 6 mm.times.24 mm, 7
mm.times.16 mm and 7 mm.times.24 mm) The balloon dilation catheter
200 generally includes a proximally located connection 230 for
inflating/activating the balloon 204.
[0064] The balloon 204 may be expanded to dilate the Eustachian
tube ET after it is placed in a desirable location therein. For
example, the opening area of the Eustachian tube ET includes a
pharyngeal ostium, and the dilation catheter 200 may be advanced to
position the balloon in the pharyngeal ostium. An endoscope may be
used to assist in positioning the dilation catheter 200. The
endoscope may be advanced through the nasal passage to view the
dilation catheter 200. A marker 208 on a shaft of the dilation
catheter 200 can be viewed from the endoscope to approximate a
location of the balloon 204 relative to the opening of the
Eustachian tube ET based on a distance of the marker 208 from a
proximal end of the balloon 204. Accordingly, the dilation catheter
200 can be moved to place the marker in a desirable location before
expansion of the balloon 204 in the Eustachian tube ET.
[0065] The balloon dilation catheter further includes an actuator
210. The actuator 210 has a proximal side 220 and a distal side
222. In the embodiment shown in FIG. 9A, the actuator 210 is
secured by an adhesive to the elongate shaft 202. The portion 240
of the elongate shaft 202 that is distal of the actuator 210 is
sufficiently stiff to be guided through the nasal cavity and into
the Eustachian Tube and is constructed of stainless steel and
preferably includes a stainless steel hypotube. The portion 238 of
the elongate shaft 202 that is proximal of the actuator 210 and
that portion 250 that is distal of portion 240 is more flexible
than the portion 240 and is constructed of a polymeric material
including but not limited to pebax. In this way, the proximal
portion 238 of the elongate shaft 202 will not interfere with the
endoscope described above as it is advanced through the nasal
passage such that the dilation catheter 200 can be easily viewed.
The actuator 210 allows for easy, ergonomic one-handed advancement
of the dilation 200 catheter through the guide catheter 100 and
into the Eustachian Tube ET. The actuator 210 may be used to
advance or retract in alternative ways including but not limited to
use of the thumb, the index finger, or a combination of fingers
(i.e. the index and middle fingers) or the thumb and the index or
middle finger.
[0066] The distal end 218 of the balloon catheter 200 further
includes a tip 212 and a flexible shaft portion 250 that is
constructed of a polymeric material including but not limited to
pebax that extends from the distal end of the elongate shaft 202 to
the proximal end of the balloon 204. In the embodiment shown in
FIG. 9A, the tip 212 is a bulbous polymeric blueberry shaped tip
that is atraumatic and is about 1.5 mm to 2 mm in length with an
outer diameter of between about 2 mm and 3 mm. The smoothness and
roundness of tip 212 facilitates advancement of the balloon
catheter 200 by helping it glide smoothly through the Eustachian
Tube ET. The tip further acts as a safety stop. The isthmus 29 of
the Eustachian Tube, shown in FIG. 1 is approximately 1 mm in
diameter. The tip diameter is larger than the outer diameter 233 of
the elongate shaft 202 shown in cross-section in FIG. 9B such that
the tip 212 size will prevent the balloon catheter 200 from passing
through the isthmus 29 into the middle ear 14.
[0067] The balloon 204 may be held in location while in an expanded
state for an extended period of time (e.g. several seconds or
minutes). The balloon catheter 200 may also deliver a substance to
the Eustachian tube ET, such as one or more of the therapeutic or
diagnostic agents described herein. The balloon 204 may also carry
an expandable stent for delivery into the Eustachian tube upon
expansion of the balloon 204. The balloon dilation catheter 200 and
the guide catheter may be removed from the patient after the
balloon 204 has been deflated/unexpanded. The Eustachian tube will
resume functioning, normally opening and closing to equalize
atmospheric pressure in the middle ear and protect the middle ear
from unwanted pressure fluctuations and loud sounds.
[0068] In use, the guide catheter 100 may be advanced into a
nostril and through a nasal cavity to position a distal end of the
catheter 100 at, in or near an opening into the Eustachian tube. In
one embodiment, the guide catheter 100 may be passed through a
nostril to the Eustachian tube on the ipsilateral (same side) of
the head. In an alternative embodiment, the guide catheter 100 may
be passed through a nostril to the Eustachian tube on the
contralateral (opposite side) of the head. A guiding element such
as a guidewire or illuminating fiber may be used to aid in
accessing the Eustachian Tube.
[0069] After the guide catheter 100 is in a desired position, a
balloon catheter 200 is advanced through the guide catheter 100 to
position a balloon 204 of the balloon catheter 200 within the
Eustachian tube ET. The physician/user may place the index and
middle fingers on either side of the smaller diameter middle
section 136 of the proximal hub 132 of the guide catheter 100. The
physician/user will then place the thumb on the proximal side 220
of the actuator 210 or within both sides of the actuator 210 and
will use the thumb to slide the balloon dilation catheter 200
through the guide catheter 100 to position the balloon within the
Eustachian tube ET. Alternatively, the user may grasp the proximal
hub 132 of the guide catheter 100 and use the index finger placed
on the proximal side 220 of the actuator 210 or in between the
distal side 222 and the proximal side 220 of the actuator 210 to
advance the balloon catheter 200. The larger diameter tip 212
prevents the balloon catheter 200 from advancing too far into the
middle ear. Further, the distal side 222 of the actuator 210 will
bottom out against the proximal end 104 of the guide catheter 100,
such that the balloon catheter cannot advance any further. The
actuator 210 prevents the catheter from reaching too far into the
middle ear, which can cause damage to structures in the middle ear.
Further the actuator 210 can be positioned at the appropriate
distance along the elongate shaft 202 such that access to the
Eustachian tube may be from the contralateral or the ipsilateral
side.
[0070] In an alternative embodiment, a balloon catheter 200 is
advanced into a nostril of a patient without the use of a guide
catheter. The balloon 204 of the balloon catheter 200 is placed
within the Eustachian tube ET. The physician/user will advance the
balloon catheter 200 until the proximal side 220 of the actuator
210 is adjacent the patient's nostril. The distal side 222 of the
actuator 210 will bottom out against the patient's nostril, such
that the balloon catheter cannot advance any further. The actuator
210 prevents the catheter from reaching too far into the middle
ear, which can cause damage to structures in the middle ear.
Further the actuator 210 can be positioned at the appropriate
distance along the elongate shaft 202 such that access to the
Eustachian tube may be from the contralateral or the ipsilateral
side.
[0071] Following placement of the balloon catheter into the desired
position any number of procedures may be carried out. The elongate
shaft 202 contains adjacent dual lumen tubing (see FIG. 9B). By
adjacent dual lumen tubing is intended that the lumens are next to
each other but are spaced apart, one from the other. The inflation
lumen 232 is used for inflation of the balloon with water, contrast
medium or saline through inflation port 230 to a pressure of
between about 3 and 15 atmospheres, or of between about 6 and 12
atmospheres. The injection lumen 234 permits the optional injection
of water, medicament, or even the introduction of a guidewire
through the injection port 236 at the proximal end 216 of the
proximal connector 206. In order to ensure that the inflation port
230 is used for balloon inflation only, the inflation port 230 and
the injection port 236 may optionally be different type connectors.
For example, the inflation port may be a female connector whereas
the injection port is a male connector or vice versa.
Alternatively, the injection port may be a right-handed thread
connected and the inflation port may have a left-handed thread
connector or vice versa. It may be desirable to inject solutions
containing contrast agents, pharmaceutically acceptable salt or
dosage form of an antimicrobial agent (e.g. antibiotic, antiviral,
anti-parasitic, antifungal, etc.), an anesthetic agent with or
without a vasoconstriction agent (e.g. Xylocaine with or without
epinephrine, Tetracaine with or without epinephrine, etc.), an
analgesic agent, a corticosteroid or other anti-inflammatory (e.g.
an NSAID), a decongestant (e.g. vasoconstrictor), a mucus thinning
agent (e.g. an expectorant or mucolytic), a surfactant, an agent
that prevents or modifies an allergic response (e.g. an
antihistamine, cytokine inhibitor, leucotriene inhibitor, IgE
inhibitor, immunomodulator), an allergen or another substance that
causes secretion of mucous by tissues, hemostatic agents to stop
bleeding, antiproliferative agents, cytotoxic agents (e.g.
alcohol), biological agents such as protein molecules, stem cells,
genes or gene therapy preparations, or the like.
[0072] Some nonlimiting examples of antimicrobial agents that may
be used in this invention include acyclovir, amantadine,
aminoglycosides (e.g., amikacin, gentamicin and tobramycin),
amoxicillin, amoxicillinlclavulanate, amphotericin B, ampicillin,
ampicillinlsulbactam, atovaquone, azithromycin, cefazolin,
cefepime, cefotaxime, cefotetan, cefpodoxime, ceflazidime,
ceflizoxime, ceftriaxone, cefuroxime, cefuroxime axetil,
cephalexin, chloramphenicol, clotrimazole, ciprofloxacin,
clarithromycin, clindamycin, dapsone, dicloxacillin, doxycycline,
erythromycin, fluconazole, foscamet, ganciclovir, atifloxacin,
imipenemlcilastatin, isoniazid, itraconazole, ketoconazole,
metronidazole, nafcillin, nafcillin, nystatin, penicillin,
penicillin G, pentamidine, piperacillinitazobactam, rifampin,
quinupristindalfopristin, ticarcillinlclavulanate,
trimethoprimlsulfamethoxazole, valacyclovir, vancomycin, mafenide,
silver sulfadiazine, mupirocin (e.g., Bactroban, Glaxo SmithKline,
Research Triangle Park, N.C.), nystatin, triamcinolonelnystatin,
clotrimazolelbetamethasone, clotrimazole, ketoconazole,
butoconazole, miconazole, tioconazole, detergent-like chemicals
that disrupt or disable microbes (e.g., nonoxynol-9, octoxynol-9,
benzalkonium chloride, menfegol, and N-docasanol); chemicals that
block microbial attachment to target cells and/or inhibits entry of
infectious pathogens (e.g., sulphated and sulphonated polymers such
as PC-515 (carrageenan), Pro-2000, and Dextrin 2 Sulphate);
antiretroviral agents (e.g., PMPA gel) that prevent retroviruses
from replicating in the cells; genetically engineered or naturally
occurring antibodies that combat pathogens such as anti-viral
antibodies genetically engineered from plants known as
"plantibodies;" agents which change the condition of the tissue to
make it hostile to the pathogen (such as substances which alter
mucosal pH (e.g., Buffer Gel and Acid form); non-pathogenic or
"friendly" microbes that cause the production of hydrogen peroxide
or other substances that kill or inhibit the growth of pathogenic
microbes (e.g., lactobacillus); antimicrobial proteins or peptides
such as those described in U.S. Pat. No. 6,716,813 (Lin et al.,)
which is expressly incorporated herein by reference or
antimicrobial metals (e.g., colloidal silver).
[0073] Additionally or alternatively, in some applications where it
is desired to treat or prevent inflammation the substances
delivered in this invention may include various steroids or other
anti-inflammatory agents (e.g., nonsteroidal anti-inflammatory
agents or NSAIDS), analgesic agents or antipyretic agents. For
example, corticosteroids that have previously administered by
intranasal 10 administration may be used, such as beclomethasone
(Vancenase.RTM. or Beconase), flunisolide (Nasalid.RTM.),
fluticasone proprionate (Flonase.RTM.), triamcinolone acetonide
(Nasacort.RTM.), budesonide (Rhinocort Aqua.RTM.), loterednol
etabonate (Locort) and mometasone (Nasonex.RTM.). Other salt forms
of the aforementioned corticosteroids may also be used. Also, other
non-limiting examples of steroids that may be useable in the
present invention include but are not limited to aclometasone,
desonide, hydrocortisone, betamethasone, clocortolone,
desoximetasone, fluocinolone, flurandrenolide, mometasone,
prednicarbate; amcinonide, desoximetasone, diflorasone,
fluocinolone, fluocinonide, halcinonide, clobetasol, augmented
betamethasone, diflorasone, halobetasol, prednisone, dexarnethasone
and methylprednisolone. Other anti-inflammatory, analgesic or
antipyretic agents that may be used include the nonselective COX
inhibitors (e.g., salicylic acid derivatives, aspirin, sodium
salicylate, choline magnesium trisalicylate, salsalate, diflunisal,
sulfasalazine and olsalazine; para-aminophenol derivatives such as
acetaminophen; indole and indene acetic acids such as indomethacin
and sulindac; heteroaryl acetic acids such as tolmetin, dicofenac
and ketorolac; arylpropionic acids such as ibuprofen, naproxen,
flurbiprofen, ketoprofen, fenoprofen and oxaprozin; anthranilic
acids (fenamates) such as mefenamic acid and meloxicam; enolic
acids such as the oxicams (piroxicam, meloxicam) and alkanones such
as nabumetone) and Selective COX-2 Inhibitors (e.g.,
diaryl-substituted furanones such as rofecoxib; diaryl-substituted
pyrazoles such as celecoxib; indole acetic acids such as etodolac
and sulfonanilides such as mmesulide).
[0074] Additionally or alternatively, in some applications, such as
those where it is desired to treat or prevent an allergic or immune
response and/or cellular proliferation, the substances delivered in
this invention may include a) various cytokine inhibitors such as
humanized anti-cytokine antibodies, anti-cytokine receptor
antibodies, recombinant (new cell resulting from genetic
recombination) antagonists, or soluble receptors; b) various
leucotriene modifiers such as zafirlukast, montelukast and
zileuton; c) immunoglobulin E (IgE) inhibitors such as Omalizumab
(an anti-IgE monoclonal antibody formerly called rhu Mab-E25) and
secretory leukocyte protease inhibitor) and d) SYK Kinase
inhibitors such as an agent designated as "R-112" manufactured by
Rigel Pharmaceuticals, Inc, South San Francisco, Calif.
[0075] Additionally or alternatively, in some applications, such as
those where it is desired to shrink mucosal tissue, cause
decongestion, or effect hemostasis, the substances delivered in
this invention may include various vasoconstrictors for
decongestant and or hemostatic purposes including but not limited
to pseudoephedrine, xylometazoline, oxymetazoline, phenylephrine,
epinephrine, etc.
[0076] Additionally or alternatively, in some applications, such as
those where it is desired to facilitate the flow of mucous, the
substances delivered in this invention may include various
mucolytics or other agents that modify the viscosity or consistency
of mucous or mucoid secretions, including but not limited to
acetylcysteine. In one particular embodiment, the substance
delivered by this invention comprises a combination of an
anti-inflammatory agent (e.g. a steroid or an NSAID) and a
mucolytic agent.
[0077] Additionally or alternatively, in some applications such as
those where it is desired to prevent or deter histamine release,
the substances delivered in this invention may include various mast
cell stabilizers or drugs which prevent the release of histamine
such as crornolyn (e.g., Nasal Chroma) and nedocromil.
[0078] Additionally or alternatively, in some applications such as
those where it is desired to prevent or inhibit the effect of
histamine, the substances delivered in this invention may include
various antihistamines such as azelastine (e.g., Astylin)
diphenhydramine, loratidine, etc.
[0079] Additionally or alternatively, in some embodiments such as
those where it is desired to dissolve, degrade, cut, break or
remodel bone or cartilage, the substances delivered in this
invention may include substances that weaken or modify bone and/or
cartilage to facilitate other procedures of this invention wherein
bone or cartilage is remodeled, reshaped, broken or removed. One
example of such an agent would be a calcium chelator such as EDTA
that could be injected or delivered in a substance delivery implant
next to a region of bone that is to be remodeled or modified.
Another example would be a preparation consisting of or containing
bone degrading cells such as osteoclasts. Other examples would
include various enzymes of material that may soften or break down
components of bone or cartilage such as collagenase (CGN), trypsin,
trypsinlLEDTA, hyaluronidase, and tosyllysylchloromethane
(TLCM).
[0080] Additionally or alternatively, in some applications such as
those wherein it is desired to treat a tumor or cancerous lesion,
the substances delivered in this invention may include antitumor
agents (e.g., cancer chemotherapeutic agents, biological response
modifiers, vascularization inhibitors, hormone receptor blockers,
cryotherapeutic agents or other agents that destroy or inhibit
neoplasia or tumorigenesis) such as; alkylating agents or other
agents which directly kill cancer cells by attacking their DNA
(e.g., cyclophosphamide, isophosphamide), nitrosoureas or other
agents which kill cancer cells by inhibiting changes necessary for
cellular DNA repair (e.g., carmustine (BCNU) and lomustine (CCNU)),
antimetabolites and other agents that block cancer cell growth by
interfering with certain cell functions, usually DNA synthesis
(e.g., 6 mercaptopurine and 5-fluorouracil (5FU), antitumor
antibiotics and other compounds that act by binding or
intercalating DNA and preventing RNA synthesis (e.g., doxorubicin,
daunorubicin, epirubicin, idarubicin, mitomycin-C and bleomycin)
plant (vinca) alkaloids and other antitumor agents derived from
plants (e.g., vincristine and vinblastine), steroid hormones,
hormone inhibitors, hormone receptor antagonists and other agents
which affect the growth of hormone-responsive cancers (e.g.,
tamoxifen, herceptin, aromatase inhibitors such as
aminoglutethamide and formestane, trriazole inhibitors such as
letrozole and anastrazole, steroidal inhibitors such as
exemestane), antiangiogenic proteins, small molecules, gene
therapies and/or other agents that inhibit angiogenesis or
vascularization of tumors (e.g., meth-I, meth-2, thalidomide),
bevacizumab (Avastin), squalamine, endostatin, angiostatin,
Angiozyme, AE-941 (Neovastat), CC-5013 (Revimid), medi-522
(Vitaxin), 2-methoxyestradiol (2ME2, Panzem), carboxyamidotriazole
(CAI), combretastatin A4 prodrug (CA4P), SU6668, SU11248,
BMS-275291, COL-3, EMD 121974, 1MC-IC11, 1M862, TNP-470, celecoxib
(Celebrex), rofecoxib (Vioxx), interferon alpha, interleukin-12
(IL-12) or any of the compounds identified in Science Vol. 289,
Pages 1197-1201 (Aug. 17, 2000) which is expressly incorporated
herein by reference, biological response modifiers (e.g.,
interferon, bacillus calmetteguerin (BCG), monoclonal antibodies,
interluken 2, granulocyte colony stimulating factor (GCSF), etc.),
PGDF receptor antagonists, herceptin, asparaginase, busulphan,
carboplatin, cisplatin, carmustine, cchlorambucil, cytarabine,
dacarbazine, etoposide, flucarbazine, fluorouracil, gemcitabine,
hydroxyurea, ifosphamide, irinotecan, lomustine, melphalan,
mercaptopurine, methotrexate, thioguanine, thiotepa, tomudex,
topotecan, treosulfan, vinblastine, vincristine, mitoazitrone,
oxaliplatin, procarbazine, streptocin, taxol, taxotere,
analogslcongeners and derivatives of such compounds as well as
other antitumor agents not listed here.
[0081] Additionally or alternatively, in some applications such as
those where it is desired to grow new cells or to modify existing
cells, the substances delivered in this invention may include cells
(mucosal cells, fibroblasts, stem cells or genetically engineered
cells) as well as genes and gene delivery vehicles like plasmids,
adenoviral vectors or naked DNA, mRNA, etc. injected with genes
that code for anti-inflammatory substances, etc., and, as mentioned
above, osteoclasts that modify or soften bone when so desired,
cells that participate in or effect mucogenesis or ciliagenesis,
etc.
[0082] In one embodiment, a local anesthetic, such as Lidocaine is
injected through the injection lumen 234 prior to dilation of the
Eustachian Tube. The injection lumen 234 can be used for venting
during dilation so that pressure in the middle ear does not
increase or decrease.
[0083] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that devices and methods
within the scope of these claims and their equivalents be covered
thereby.
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