U.S. patent application number 14/812271 was filed with the patent office on 2015-11-19 for device and method for dilating an airway stenosis.
The applicant listed for this patent is Acclarent, Inc.. Invention is credited to Randy S. Chan, Sivette Lam, Ketan P. Muni, Shrirang V. Ranade.
Application Number | 20150328420 14/812271 |
Document ID | / |
Family ID | 46604067 |
Filed Date | 2015-11-19 |
United States Patent
Application |
20150328420 |
Kind Code |
A1 |
Muni; Ketan P. ; et
al. |
November 19, 2015 |
Device and Method for Dilating an Airway Stenosis
Abstract
A medical device and a system and for dilating a stenotic airway
of a patient are described. The medical device comprises a proximal
end, a distal end, and a shaft system having an inflation lumen and
a ventilation lumen the proximal end. The shaft system has a
proximal shaft section and a distal shaft section. An inflatable
balloon is attached to the distal shaft section in a position that
is proximal to the distal end. The ventilating tip is distal to the
balloon on the distal shaft section and has one or more radially
facing openings. A method for treating a stenotic airway includes
inserting the medical device into a patient's airway, and dilating
and ventilating the airway.
Inventors: |
Muni; Ketan P.; (San Jose,
CA) ; Chan; Randy S.; (San Jose, CA) ; Lam;
Sivette; (Milpitas, CA) ; Ranade; Shrirang V.;
(Foster City, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Acclarent, Inc. |
Menlo Park |
CA |
US |
|
|
Family ID: |
46604067 |
Appl. No.: |
14/812271 |
Filed: |
July 29, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13551849 |
Jul 18, 2012 |
9095364 |
|
|
14812271 |
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|
61512673 |
Jul 28, 2011 |
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Current U.S.
Class: |
600/424 ;
128/200.26; 128/204.18; 128/207.15 |
Current CPC
Class: |
A61M 16/0463 20130101;
A61B 6/12 20130101; A61M 16/0488 20130101; A61M 2205/32 20130101;
A61M 16/0486 20140204; A61B 17/24 20130101; A61M 29/02 20130101;
A61M 16/0438 20140204; A61M 16/0445 20140204; A61M 16/044 20130101;
A61M 2205/6081 20130101; A61M 16/04 20130101; A61M 16/0057
20130101; A61M 25/0026 20130101; A61M 16/0816 20130101; A61M 25/007
20130101 |
International
Class: |
A61M 16/04 20060101
A61M016/04; A61M 16/08 20060101 A61M016/08; A61M 16/00 20060101
A61M016/00 |
Claims
1-12. (canceled)
13. A connector for connecting a medical device to a ventilation
source and an inflation source; said connector comprises a
ventilation port and an inflation port, wherein the ventilation
port and the inflation port are selected from the groups consisting
of ports of different sizes, ports of different shapes and ports of
different connection types; wherein the inflation source is
selected from the group consisting of water, saline and contrast
agent; and wherein the ventilation source is selected from the
group consisting of oxygen and air.
14. The connector of claim 13 wherein when the inflation port
comprises a threaded connector, the ventilation port comprises a
non-threaded connector and when the inflation port comprises a
non-threaded connector, the ventilation port comprises a threaded
connector.
15. The connector of claim 13 wherein the ventilation port is
larger in diameter than the inflation port.
16. The connector of claim 13 wherein when the inflation port
comprises a right-handed threaded connector, the ventilation port
comprises a left-handed threaded connector and when the ventilation
port comprises a right-handed threaded connector, the inflation
port comprises a left-handed threaded connector.
17. A packaged kit for treating an airway stenosis, the kit
comprising: a medical device comprising an inflation lumen, a
ventilating lumen, an inflatable balloon and a ventilating tip, the
inflation lumen and the ventilating lumen being adjacent lumens and
the ventilating tip comprising at least one radially facing
opening; an optional balloon insertion stylet for insertion of the
medical device into the anatomy; and ventilating tubing for
connecting the medical device to a ventilation source.
18. A packaged kit for treating an airway stenosis, the kit
comprising: a medical device comprising an inflation lumen, a
ventilating lumen, an inflatable balloon and a ventilating tip, the
inflation lumen and the ventilating lumen being adjacent lumens and
the ventilating tip comprising at least one radially facing
opening; and a balloon insertion stylet for insertion of the
medical device into the anatomy.
19. A method for treating a stenotic region in the airway of a
human patient, said method comprising: providing a medical device
comprising an inflation lumen, a ventilating lumen, an inflatable
balloon and a ventilating tip, the inflation lumen and the
ventilating lumen being adjacent lumens and the ventilating tip
comprising a tip opening and at least one radially facing opening;
inserting the medical device into the airway; positioning the
medical device at the stenotic region in the airway; inflating the
balloon to dilate the airway; deflating the balloon; optionally
repeating the inflating and deflating steps; withdrawing the
medical device from the airway; wherein oxygen is delivered through
the ventilating lumen before, during or after the inflating
step.
20. A method for treating a stenotic region in the airway of a
human patient, said method comprising: providing a medical device
comprising an inflation lumen, a ventilating lumen, an inflatable
balloon and a ventilating tip, the inflation lumen and the
ventilating lumen being adjacent lumens and the ventilating tip
comprising a tip opening and at least one radially facing opening;
inserting the medical device into the airway; positioning the
medical device at the stenotic region in the airway; inflating the
balloon to dilate the airway; deflating the balloon; optionally
repeating the inflating and deflating steps; withdrawing the
medical device from the airway; wherein air is inspired through the
ventilating lumen before, during or after the inflating step.
21. The method of claim 20 wherein the stenotic region is in the
airway portion selected from the group consisting of larynx,
trachea and bronchi.
22. The method of claim 19 wherein the stenotic region is in the
airway portion selected from the group consisting of larynx,
trachea and bronchi.
Description
FIELD OF THE INVENTION
[0001] The present invention relates, in general, to medical
devices and, in particular, to medical devices and related methods
for treating a stenosis in an airway of a patient.
BACKGROUND OF THE INVENTION
[0002] Airway stenosis (or "airway narrowing") is a medical
condition that occurs when some portion of a patient's airway
becomes narrowed or constricted, thus making breathing difficult. A
stenosis may occur in any part of the airway, i.e. larynx, trachea,
bronchi or a combination (laryngotracheal or tracheobroncial
stenosis) in adults or children and due to any of several different
causes. By far the most common airway stenoses (approximately 95%)
are acquired, meaning the patient is not born with the condition,
and the most common cause of airway stenosis is trauma caused by
intubation (a tube placed in the airway for ventilation/breathing
assistance in a patient who cannot breathe). Intubation for
prolonged periods of time may traumatize the airway, causing scar
tissue formation that forms the stenosis. Sometimes the cause of
stenosis is unknown, such as in idiopathic subglottic stenosis.
Managing airway stenosis is one of the most challenging problems
for an ENT (ear, nose and throat) surgeon.
[0003] Subglottic stenosis is one form of airway stenosis that
occurs in the larynx, below the glottis (the area of the larynx
around the vocal chords). The disorder can either be congenital or
acquired and can affect both adults and children. Acquired
subglottic stenosis is the most commonly acquired anomaly of the
larynx in children and the most common abnormality requiring
tracheotomy in children younger than one year. To correct
subglottic stenosis, the lumen of the cricoids area is expanded to
increase airflow during breathing. Surgical correction of
subglottic correction of subglottic stenosis has been performed
with various techniques over the years.
[0004] Therapies for treating airway stenosis range from endoscopic
treatments, such as dilation and laser resection, to open
procedures such as laryngotracheal reconstruction. In one
technique, a series of rigid dilators of increasing diameter are
pushed down the airway, gradually expanding the constriction but
also applying unwanted shear forces to the airway. More recently,
balloon catheters have been used to perform airway dilation. Such a
balloon procedure is described, for example, in US Patent
Publication No. 2010/0168511 which is incorporated herein by
reference in its entirety. The system described in that patent
application is configured for use in an airway and describes a
system for dilating a stenotic region with a catheter shaft having
an overall length of less than 70 cm, an inflatable balloon
disposed along a distal portion of the catheter shaft, and a
stylet. The method for dilating a stenotic region in an airway
includes advancing a balloon catheter through the airway of a
patient to position an inflatable balloon of the catheter within at
least a portion of the stenotic region, maintaining a position of
the catheter relative to the patient and inflating the balloon to
dilate the stenotic region.
[0005] Methods and devices for improved patient comfort would allow
for patient ventilation during dilation of the stenotic region in
the airway and increased flexibility for the physician with regard
to duration of dilation and number of inflation and deflation
cycles. These objectives are addressed by the embodiments described
in this application.
SUMMARY OF THE INVENTION
[0006] Accordingly, in one aspect the invention is directed to
medical device for dilating an airway stenosis. The device
comprises a proximal end, a distal end and a shaft system. The
shaft system has an inflation lumen and a ventilating lumen between
the proximal and distal ends of the device. The shaft system has a
proximal shaft section and a distal shaft section with an
inflatable balloon on the distal shaft section, proximal to the
distal end of the medical device. The distal shaft section further
has a ventilating tip distal to the inflatable balloon, the
ventilating tip having a tip opening and one or more radially
facing openings.
[0007] In one embodiment, the medical device of has four radially
facing openings. In another embodiment the radially facing openings
have a diameter of between 1 mm and 2 mm and may be spaced 90
degrees apart.
[0008] In other embodiments, the inflation and ventilating lumens
are adjacent lumens. In still other embodiments the medical device
has an atraumatic tip portion, and may incorporate direct
visualization markers and/or one or more radiographic markers. In
some embodiments, the markers are located on the shaft system and
in other embodiments the markers are located on the balloon. In
some embodiments, the ventilating tip comprises a soft and
atraumatic tip portion, and in other embodiments the soft and
atraumatic tip portion is a slanted soft and atraumatic tip
portion.
[0009] In another aspect, the invention is directed to a connector
for connecting a medical device to a ventilation source and an
inflation source. The connector has a ventilation port and an
inflation port. The ventilation port and the inflation port are
either ports of different sizes, ports of different shapes or ports
of different connection types. The inflation source is water,
saline or contrast agent and the ventilation source is oxygen or
air.
[0010] In one embodiment of the connector, the inflation port has a
threaded connector and the ventilation port has a-non-threaded
connector or in another embodiment, the inflation port has a
non-threaded connector and the ventilation port has a threaded
connector. In other embodiments, the inflation port has a
right-handed threaded connector and the ventilation port has a
left-handed threaded connector or the inflation port has a
left-handed threaded connector and the ventilation port has a
right-handed threaded connector. In another embodiment of the
connector, the ventilation port is larger in diameter than the
inflation port
[0011] In another aspect, the invention is directed to a packaged
kit for treating an airway stenosis. The kit contains a medical
device having an inflation lumen, a ventilating lumen, an
inflatable balloon and a ventilating tip, the inflation lumen and
the ventilating lumen being adjacent lumens and the ventilating tip
comprising at least one radially facing opening, an optional
balloon insertion stylet for insertion of the medical device into
the anatomy, and ventilating tubing for connecting the medical
device to a ventilation source. In another embodiment, the packaged
kit contains a medical device having an inflation lumen, a
ventilating lumen, an inflatable balloon and a ventilating tip, the
inflation lumen and the ventilating lumen being adjacent lumens and
the ventilating tip comprising at least one radially facing opening
and a balloon insertion stylet for insertion of the medical device
into the anatomy
[0012] In a further aspect, the invention is directed to a method
for treating a stenotic region in the airway of a human patient.
The method comprises providing a medical device having an inflation
lumen, a ventilating lumen, an inflatable balloon and a ventilating
tip, the inflation lumen and the ventilating lumen being adjacent
lumens and the ventilating tip comprising a tip opening and at
least one radially facing opening, inserting the medical device
into an airway, positioning the medical device in the airway at the
stenosis, inflating the balloon to dilate the airway, deflating the
balloon, and optionally repeating the inflating and deflating steps
and withdrawing the medical device from the airway. The oxygen is
delivered through the ventilating lumen before, during or after the
inflating step.
[0013] In another embodiment, the method comprises providing a
medical device having an inflation lumen, a ventilating lumen, an
inflatable balloon and a ventilating tip, the inflation lumen and
the ventilating lumen being adjacent lumens and the ventilating tip
comprising a tip opening and at least one radially facing opening,
inserting the medical device into an airway, positioning the
medical device in the airway at the stenosis, inflating the balloon
to dilate the airway, deflating the balloon, and optionally
repeating the inflating and deflating steps and withdrawing the
medical device from the airway. Air is inspired through the
ventilating lumen before, during or after the inflating step.
[0014] In a further embodiment, the stenotic region is in the
airway portion selected from the group consisting of larynx,
trachea and bronchi.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is a simplified side view of a medical device
according to an embodiment of the present invention.
[0016] FIG. 1A is a cross section view through line 1A-1A of FIG.
1.
[0017] FIG. 1B is an enlarged side view of the distal end of the
medical device of FIG. 1.
[0018] FIG. 2 is a perspective view of a second embodiment of the
medical device of the present invention.
[0019] FIG. 2A is an enlarged top view of the distal end of the
medical device of FIG. 2.
[0020] FIG. 2B is an enlarged side view of the distal end of the
medical device of FIG. 2.
[0021] FIG. 2C is an enlarged side view of the connector of the
medical device of FIG. 2.
DETAILED DESCRIPTION
[0022] 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, alternatives and uses of the invention, including what
is presently believed to be the best mode of carrying out the
invention.
[0023] As used herein, the terms "about" or "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.
[0024] Medical devices according to embodiments of the present
invention are beneficial in that, for example, their configuration
provides for a particularly efficient preparation and treatment of
a patient's airway and is mechanically simple. Moreover, the
simplicity of the medical devices provides for them to be
manufactured in a cost effective manner. In addition, the medical
device according to embodiments of the present invention is
sufficiently stiff that it can be beneficially employed to access
the airway with or without the additional use of a stylet.
[0025] FIG. 1 is a simplified side view of a medical device 100 for
the treatment of an airway stenosis according to an embodiment of
the present invention. The medical device 100 is an airway dilation
and ventilating catheter with an integrated shaft system 102. The
shaft system 102 has a distal shaft portion 116 and a proximal
shaft portion 118 and the medical device has a distal end 120 and a
proximal end 122. The distal shaft portion 116 is surrounded by a
high pressure balloon 104 located near the ventilating tip 106. The
shaft system 102 contains adjacent dual lumen tubing (see FIG. 1A).
By adjacent dual lumen tubing is intended that the lumens are next
to each other and are spaced apart, one from the other. The
inflation lumen 108 is used for inflation of the balloon with
water, contrast medium or saline through inflation port 150 located
near the proximal end 122 of medical device 100, and the
ventilating lumen 110 permits passage of oxygen from the
ventilation port located near the proximal end 122 of medical
device 100 to facilitate ventilation of the patient and prevent
negative pressure pulmonary edema due to attempted breathing during
the dilation procedure and the resultant airway blockage. The inner
diameter of the ventilation lumen is between about 2 mm and about 4
mm, and is often about 4 mm. The ventilation lumen is patent during
inflation of the balloon, that is, the shaft may be made of pebax
72D or nylon 12 or similar non-collapsing materials to ensure that
the ventilation lumen does not collapse during balloon inflation.
In an alternative embodiment, a third lumen may be included as a
separate stylet insertion lumen, such that the shaft system
comprises an inflation lumen, a ventilating lumen, and a stylet
insertion lumen. Alternative designs wherein the inflation lumen
and the ventilating lumen are coaxial lumens, or all three lumens
are coaxial lumens are also contemplated herein.
[0026] The medical device 100 has a ventilating tip 106 with both a
forward facing tip opening 114 and radially facing openings 112a,
112b, 112c and 112d to facilitate oxygen flow through the
ventilating lumen 110. The medical device 100 is intended to dilate
an airway stenosis and to provide a means to ventilate the airway
during the dilation procedure. The medical device 100 is designed
to ventilate through the tip opening 114 and four radially facing
openings 112a, 112b, 112c and 112d in the ventilating tip 106, by
delivering oxygen via the ventilating lumen 110 for delivery
before, during, or after dilation of the airway stenosis. By
radially facing openings is intended that the flow through the
openings may be at 90 degrees from the flow through the tip
opening, but is may also be at 30, 45 or 60 degrees or other angles
between 0 and 90 degrees, and the openings may be round or
non-round such as oval or slot-shaped. The ventilating tip 106 is
located on the distal shaft section 116, distal to the distal end
of the balloon 104.
[0027] The balloon 104 is designed to be non-compliant or
semi-compliant, but in certain embodiments may also be compliant.
The diameter of the non-compliant balloon does not vary
significantly with inflation pressure and that of the
semi-compliant balloon will vary only to the extent that it will
"hourglass" or "dog-bone" about a target region. The balloon itself
may be any shape such as round, triangular, oval or square. In the
embodiment shown in FIG. 1, the balloon is round and
semi-compliant.
[0028] In some embodiments, direct visualization markers and/or
radiographic markers may be disposed along the integrated shaft
system 102. Generally, "direct visualization markers" refers to
markers that may be viewed during use with the naked eye or by use
of an endoscope, while "radiographic markers" include radiopaque
material and are viewed using a radiographic device such as
intra-operative fluoroscopy. Direct visualization markers can be
positioned in a number of locations along the integrated shaft
system 102, including the segment of the shaft system inside the
balloon and may also be incorporated onto the balloon itself. A
shaft system 102 may have a dark color, such as black, dark blue,
dark grey or the like, and markers may have a light color, such as
white, yellow, green, red or the like. In some embodiments, markers
may have different colors and/or different widths to facilitate
distinguishing the markers from one another during use. This
contrast in colors may facilitate viewing the markers in a darkened
operation room and/or when using an endoscope inside a patient in
the presence of blood. The endoscope may be inserted into the
ventilation lumen at any time before, during, or after the
procedure to aid in visualization of the airway and of the stenosis
and/or to aid in insertion of the medical device. Radiographic
markers are often used to ensure proper alignment of the balloon
with the stenosis.
[0029] The medical device 100 may be packaged with a balloon
insertion stylet and ventilation tubing. The insertion stylet
assists with insertion of the medical device 100 into the airway
and is removed from the device 100 prior to inflation of the
balloon. The ventilation tubing incorporates standard connectors on
each end and is used to attach a source of oxygen to the
ventilation port 152 of the medical device 100 for airway
ventilation. The medical device 100 may also be packaged with an
insertion stylet alone where the ventilation source is the ambient
air.
[0030] Airway access is achieved by inserting the medical device
100 into the airway, advancing the medical device and positioning
the balloon 104 at the site of the stenosis. The medical device 100
is then inflated to dilate the airway. Following dilation, the
balloon is deflated. The process of inflation and deflation may be
repeated 2, 3, 4 or more times. An oxygen source is connected to
the ventilation port 152 of the medical device 100. Oxygen is
delivered to the ventilation lumen through the ventilation tip 106
via the distal tip opening 114 and four radially facing openings
112a, 112b, 112c and 112d of the medical device 100, each side port
having a diameter of 0.157 inches (4 mm). Oxygen may be delivered
before, during or after inflation of the balloon. Alternatively,
the ventilation source may be the ambient air, and the ventilation
port 152 may be open to the atmosphere. Upon completion, the
medical device 100 is removed from the anatomy. Ventilation of the
patient during the procedure allows for prolonged duration of
balloon inflation, and the ability to repeat the inflation,
deflation procedure multiple times while maintaining oxygen
saturation of the patient. While the procedure may be done in the
operating suite of a hospital, it may also be done in an
out-patient surgery center or a doctor's office.
[0031] The medical device 100 may have any number of suitable
sizes, shapes and configurations. For example, the balloon 104 may
have different lengths and diameters in different embodiments, to
accommodate different patient anatomies. The overall catheter
length and diameter may also vary. In some embodiments, for
example, the overall length of the medical device 100 from the
proximal end 122 to the distal end 120 is about 35-70 cm, often
less than or equal to about 50 cm, and often about 45 cm.
[0032] The working length of the balloon 104 may be about 40 mm. By
"working length" it is meant the length between the two tapered
portions of the balloon 104 may range from between about 10 mm to
about 60 mm and often from about 16 mm to about 45 mm. A variety of
lengths may be provided, including about 16 mm, 24 mm and 40 mm.
The outer diameter of the fully inflated working length of the
balloon 104 may also vary. The balloon may have inflated diameter
in the range of about 3 mm to about 24 mm and often about 5 mm to
about 20 mm. In one embodiment, a variety of diameters may be
provided, including about 5 mm, about 7 mm, about 10 mm, about 14
mm, about 20 mm and about 24 mm. For example, a combination of
balloon sizes and lengths may be provided, such that a physician
may choose an appropriate size for an adult or pediatric patient.
In one example, the following combinations may be provided (first
dimension is diameter, second is length): 5 mm.times.24 mm; 7
mm.times.24 mm; 8 mm.times.24 mm, 8.5 mm.times.24 mm, 8.5
mm.times.40 mm, 10 mm.times.40 mm; and 14 mm.times.40 mm. Of
course, any of a number of other combinations of sizes of balloons
104 may be provided.
[0033] The balloon 104 is made of any suitable material known in
the art for inflation balloons and may be constructed of
semi-compliant or non-compliant materials such as nylon
(semi-compliant) and polyethylene terepththalate (PET)
(non-compliant). The atraumatic tip portion 106 is made of nylon
with 20% barium sulfate and is approximately 10 mm in length (it
may be between about 5 mm and 20 mm in length) and may contain a
radiopaque marker for fluoroscopic visualization in the patient
anatomy. The combination of materials (the nylon balloon and the
adjacent dual lumen design) provides for ease of insertion of the
medical device into and removal from the airway. The soft and
atraumatic nature of the tip further prevents injury of the airway
during deployment of the medical device 100 and allows for collapse
and low profile of the tip during insertion of the medical device
100.
[0034] Referring now to FIG. 1, in one embodiment, medical device
100 may include a forward facing tip opening 114 and four radially
facing openings 112 a, 112b, 112c and 112d, on irrigation tip 106
spaced 90 degrees apart, with the inner diameter of the forward
facing tip opening being 0.157 inches (4 mm) and each of the side
openings having a inner diameter of between about 1 and 2 mm and
the outer diameter of the integrated shaft system 102 being about
0.236 inches (6 mm). Alternative embodiments may include any
suitable alternative number of side openings (1 to 4, 5, 6 or more)
distributed in any suitable pattern such as a helical pattern. Each
side opening may have any suitable diameter in various alternative
embodiments. For example, in one embodiment, each side opening may
have a diameter of between about 0.5 mm and about 3 mm and often
between about 1 and 2 mm.
[0035] Referring now to FIG. 2, in a second embodiment, medical
device 200 is an airway dilation and ventilating catheter and may
include an integrated shaft system 202, a balloon 204 and a
ventilating tip 206. The integrated shaft system 202 includes a
distal shaft portion 216 and a proximal shaft portion 218 and the
medical device has a distal end 220 and a proximal end 222. The
distal shaft portion 216 is surrounded by a high pressure balloon
204 located near the ventilating tip 206. The ventilating tip 206
is soft and atraumatic for easy navigation to the site of the
airway stenosis and protection of the airway from damage during
insertion of the catheter. The shaft system 202 contains adjacent
dual lumen tubing as described earlier with regard to FIG. 1A.
Referring now to FIG. 2A as well as to FIG. 2, the inflation lumen
208 is used for inflation of the balloon with water, contrast
medium or saline through inflation port 250 located near the
proximal end 222 of medical device 200, and the ventilating lumen
210 permits passage of oxygen or air from the ventilation port 252
located near the proximal end 222 of medical device 200 to
facilitate ventilation of the patient and prevent negative pressure
pulmonary edema due to attempted breathing during the dilation
procedure and the resultant airway blockage. The medical device 200
has a ventilating tip 206 with a slanted distal end 220 (in this
case a 45 degree slant, but may be slanted between about 15 and 75
degrees and often between about 25 and 65 degrees), a forward
facing tip opening 214 (with a diameter of between about 2 mm and 5
mm, often between about 3 mm, and 4 mm and in this case about 4 mm)
and a radially facing opening 212 with a diameter of between about
2 mm and 6 mm, often between about 3 mm, and 5 mm and in this case
about 4 mm) to facilitate air or oxygen flow through the
ventilating lumen 210 for delivery before, during, or after
dilation of the airway stenosis. The ventilating tip 206 is located
on the distal shaft section 216, distal to the distal end of the
balloon 204.
[0036] In the embodiment shown in FIGS. 2, 2A and 2B, direct
visualization markers and/or radiographic markers may be disposed
along the integrated shaft system 202 and in this case are disposed
on the portion of the shaft that is surrounded by the balloon. The
first shaft marker 260 is located at the mid-point of the balloon
and may be positioned at the stenosis. The second shaft marker 262
is located in the proximal taper 264 of the balloon 202 and may be
located proximally of the stenosis prior to inflation of the
balloon and dilation of the stenosis. Any number of shaft markers
may be located along the integrated shaft system inside or outside
of the balloon and may be of the same or different lengths, and may
be a single integral marker or may be single and double or even
triple markers with the same or different colors to differentiate
one from the other. In addition, the balloon may be marked or
colored in order to more clearly visualize the position of the
balloon in the patient's airway.
[0037] The connector 270 of the device of FIG. 2 is shown in an
enlarged view in FIG. 2C. The connector 270 has an inflation port
250 and a ventilation port 252. In order to ensure that the
inflation medium (water, contrast medium or saline) is connected to
the inflation port 250 and the ventilation port 252 is connected to
the ventilation source (oxygen or air), the inflation port 250 and
the ventilation port 252 are of different size, shape or type of
connection. For example the inflation port 250 may be a threaded
connector and the ventilation port 252 may be a non-threaded
connector, or vise versa. One of the connectors may be a
right-handed threaded connector, and the other may be a left-handed
threaded connector. As shown in FIG. 2C, the inflation port 250 is
much smaller in diameter (approximately 6 mm outer diameter) than
the ventilation port 252 (approximately 20 mm outer diameter) and
therefore could not be connected incorrectly. The difference in
size of the different ports is that one port is at least about 10%
larger than the other port, often at least about 50% larger and
often about 100% larger than the other port.
[0038] The invention has been described with reference to certain
examples or embodiments of the invention, but various additions,
deletions, alterations and modifications may be made to those
examples and embodiments without departing from the intended spirit
and scope of the invention. For example, any element or attribute
of one embodiment or example may be incorporated into or used with
another embodiment or example, unless otherwise specified or if to
do so would render the embodiment or example unsuitable for its
intended use. Also, where the steps of a method or process have
been described or listed in a particular order, the order of such
steps may be changed unless otherwise specified or unless doing so
would render the method or process unworkable for its intended
purpose. All reasonable additions, deletions, modifications and
alterations are to be considered equivalents of the described
examples and embodiments and are to be included within the scope of
the following claims.
* * * * *