U.S. patent application number 11/231457 was filed with the patent office on 2007-03-22 for airway balloon dilator.
Invention is credited to Michael John Rutter.
Application Number | 20070066961 11/231457 |
Document ID | / |
Family ID | 37885203 |
Filed Date | 2007-03-22 |
United States Patent
Application |
20070066961 |
Kind Code |
A1 |
Rutter; Michael John |
March 22, 2007 |
Airway balloon dilator
Abstract
A medical apparatus for widening a stenosis in the airway of a
patient which includes a central hollow core, an inflatable outer
balloon, and at least one inner balloon inside the outer balloon.
The apparatus also can include a flexible support member mounted on
the external surface of the outer balloon with at least one
microsurgical blade. The outer balloon can be dumbbell-shaped to
keep the balloon in position over the stenosis when the balloon is
inflated. The hollow core allows the patient to be ventilated
during the procedure, the inner balloon(s) allow higher dilation
pressures to be generated from inside the outer balloon, and the
blade can form an effective cutting edge upon inflation of the
outer balloon.
Inventors: |
Rutter; Michael John;
(Cincinnati, OH) |
Correspondence
Address: |
HASSE & NESBITT LLC
8837 CHAPEL SQUARE DRIVE
SUITE C
CINCINNATI
OH
45249
US
|
Family ID: |
37885203 |
Appl. No.: |
11/231457 |
Filed: |
September 21, 2005 |
Current U.S.
Class: |
604/509 ; 604/22;
604/96.01 |
Current CPC
Class: |
A61M 2025/109 20130101;
A61M 2025/1086 20130101; A61M 25/104 20130101; A61M 2210/1028
20130101; A61M 2210/1032 20130101; A61M 2210/1035 20130101 |
Class at
Publication: |
604/509 ;
604/096.01; 604/022 |
International
Class: |
A61M 31/00 20060101
A61M031/00 |
Claims
1. An apparatus for performing an airway balloon dilation procedure
at the site of a stenosis in the airway of a patient, the apparatus
comprising: a central axis; a hollow core adapted to allow the
patient to be ventilated therethrough; an inflatable outer balloon
having an external surface; and at least one inflatable inner
balloon, the apparatus being insertable into the airway of a
patient for movement of the balloons therein between a deflated
configuration and an inflated configuration, the at least one inner
balloon configured to inflate inside the outer balloon yet
separately from the outer balloon.
2. The apparatus according to claim 1, wherein the inflatable outer
balloon is dumbbell-shaped to hold the outer balloon in position
over the stenosis.
3. The apparatus according to claim 1, comprising a plurality of
inner balloons.
4. The apparatus according to claim 3, wherein there are three
inner balloons including a first inner balloon contained inside a
second inner balloon, the second inner balloon being contained
inside a third inner balloon, all inner balloons being contained
inside the outer balloon and being separately inflatable.
5. The apparatus according to claim 1, further comprising a
flexible support member mounted along the central axis of the
apparatus and on the external surface of the outer balloon, the
flexible support member being substantially compliant with the
external surface of the outer balloon during movement therewith,
and at least one microsurgical blade attached to the support member
and adapted to form an effective cutting edge upon inflation of the
outer balloon.
6. The apparatus according to claim 5, wherein the apparatus
comprises a plurality of blades adapted to embed into the stenosis
at a substantially uniform depth.
7. The apparatus according to claim 5, wherein the support member
is made of a polyurethane material.
8. The apparatus according to claim 5, wherein the at least one
blade is made of stainless steel.
9. The apparatus according to claim 5, wherein the at least one
blade includes a blade axis, the at least one blade being elongated
and mounted on the support member with the blade axis substantially
parallel to the central axis of the apparatus.
10. A method for performing an airway balloon dilation procedure at
the site of a stenosis in the airway of a patient, the method
comprising: (1) inserting an apparatus into the airway, the
apparatus including a central axis, a hollow core adapted to allow
the patient to be ventilated therethrough, an inflatable outer
balloon having an external surface, and at least one inflatable
inner balloon, the apparatus being insertable into the airway of a
patient for movement of the balloons therein between a deflated
configuration and an inflated configuration, the at least one inner
balloon configured to inflate inside the outer balloon yet
separately from the outer balloon; (2) advancing the apparatus
within the airway until the outer balloon is positioned within the
area of the stenosis; and (3) inflating the balloon to cause and
allow the external surface of the balloon to expand upon and dilate
the stenosis.
11. The method according to claim 10, wherein the apparatus further
comprises a flexible support member mounted along the central axis
of the apparatus and on the external surface of the outer balloon,
the flexible support member being substantially compliant with the
external surface of the outer balloon during movement therewith,
and at least one microsurgical blade attached to the support member
and adapted to form an effective cutting edge upon inflation of the
outer balloon, wherein the inflating step allows the at least one
blade to form an effective cutting edge upon inflation of the outer
balloon.
12. The method according to claim 11, wherein the apparatus
comprises a plurality of blades adapted to embed into the stenosis
at a substantially uniform depth.
13. The method according to claim 10, wherein the advancing step
comprises the steps of: (i) inserting a guidewire into the airway
of the patient; and (ii) tracking the guidewire with the apparatus
to position the outer balloon across the stenosis.
14. The method according to claim 10, further comprising the steps
of: (4) deflating the balloons after a predetermined amount of
time; (5) repeating steps (1) through (4) if airway narrowing
remains after the initial attempt to dilate the stenosis fails; and
(6) removing the apparatus from the patient.
15. An apparatus for performing an airway balloon dilation
procedure at the site of a stenosis in the airway of a patient, the
apparatus comprising: a central axis; a hollow core adapted to
allow.the patient to be ventilated therethrough; an inflatable,
dumbbell-shaped outer balloon having an external surface; at least
one inflatable inner balloon; a flexible support member mounted
along the central axis of the apparatus and on the external surface
of the outer balloon, the flexible support member being
substantially compliant with the external surface of the outer
balloon during movement therewith; and at least one microsurgical
blade attached to the support member and adapted to form an
effective cutting edge upon inflation of the outer balloon, the
apparatus being insertable into the airway of a patient for
movement of the balloons therein between a deflated configuration
and an inflated configuration, the at least one inner balloon
configured to inflate inside the outer balloon yet separately from
the outer balloon, the dumbbell shape of the outer balloon adapted
to hold the outer balloon in position over the stenosis, and the at
least one blade adapted to form an effective cutting edge upon
inflation of the outer balloon.
16. The apparatus according to claim 15, wherein the apparatus
comprises a plurality of blades adapted to embed into the stenosis
at a substantially uniform depth.
17. The apparatus according to claim 15, wherein the support member
is made, of a polyurethane material.
18. The apparatus according to claim 15, wherein the at least one
blade is made of stainless steel.
19. The apparatus according to claim 15, wherein the at least one
blade includes a blade axis, the at least one blade being elongated
and mounted on the support member with the blade axis substantially
parallel to the central axis of the apparatus.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to medical care for the
larynx, trachea or bronchi to relieve a stenosis. In particular,
the invention relates to a device for performing dilation of the
larynx, trachea or bronchi.
BACKGROUND OF THE INVENTION
[0002] Management of stenosis of the trachea and bronchi, including
laryngotracheal and subglottic stenosis, is one of the most
challenging problems for the head and neck surgeon. Subglottic
stenosis is a congenital or acquired narrowing of the subglottic
airway. In the early twentieth century subglottic stenosis was
rare, and most cases occurred in adults. In the 1960's the
incidence of acquired subglottic stenosis began to dramatically
increase in the neonatal population, most likely the result of
increased survival of low-birth-weight infants and the increased
use of intubation in this population. In addition, long term
intubation has become an accepted alternative to tracheotomy,
leading to more and more incidences of tracheal stenosis.
Accordingly, the management of this condition has undergone a
revolution, and reconstructive surgery efforts have been directed
towards this population.
[0003] Most patients with stenosis of the airway are referred to
and are treated at large academic centers by physicians specialty
trained in this area. There is a wide range of presentation of
subglottic stenosis with similarities and differences in the
pediatric age group compared to adults. If the stenosis is severe
and congenital, the patient will show signs of airway distress at
birth. More commonly, the pediatric patient with subglottic
stenosis is a neonate in the intensive care unit who has failed
extubation, usually multiple times. Occasionally patients will
present in clinic with a tracheotomy and the report of some airway
obstruction. Infants with mild subglottic stenosis may present with
recurrent croup-like illnesses and poor feeding. Adults usually
have a history of prior intubation with symptoms of progressive
shortness of breath and noisy breathing.
[0004] Airway balloon dilation has been shown to be a safe and
effective palliative procedure for treatment of mild congenital and
acquired stenosis of the trachea and bronchi. Dilation of luminal
human anatomy to treat stenoses can be dated back to the 16.sup.th
Century with esophageal "bougie" dilation. Specific medical
applications of luminal balloon dilation range from alimentary
canal and airway dilation to dilation of the vasculature. Airway
dilation dates back over 100 years ago with the invention and
subsequent use of the first beveled rigid bronchoscopes for
stricture management. The use of balloons to dilate airway
strictures emerged in the mid-1980's with reports describing more
specific utility of this procedure exclusively and in combination
with other treatment modalities for airway stenosis. It was not
until the early 1990's that the first balloon dilation involving
flexible bronchoscopy was described.
[0005] Airway balloon dilation can be used to quickly re-establish
tracheal or bronchial luminal patency to restore airflow in a way
that doesn't cause excessive trauma to the patient. According to
Poiseuille's Law, an increase in a tube's radius (such as the
trachea or bronchus) can increase airflow by a power of 4 (airflow
=radius of the tube.sup.4). That is, very small increases in the
luminal diameter of the airway can lead to large increases in
airflow through the lungs. Literature has reported the use of
balloon dilation for the treatment of benign strictures of the
airway. Fibrotic strictures, such as those secondary to
tuberculosis, long-term endotracheal or tracheostomy tube
placement, berylliosis, Wegener's granulomatosis, or sarcoidosis
have been shown to be treatable with airway balloon dilation
therapy with general success. Additionally, balloon dilation has
been useful in treating strictures secondary to major surgical
interventions such as lung transplantation, sleeve resection,
bronchial re-implantation, and lobectomy. For the purpose of
treating strictures secondary to malignant obstruction, dilation
therapy can be used alone or in combination with other techniques
such as surgical resection, cryotherapy, laser therapy, and stent
placement, depending on the desired outcome for the patient.
[0006] Treatment with airway dilation can involve the clinician
inserting increasingly larger tubes into the airway (e.g.
endotracheal tubes or cat-tail (bougie) dilators), which creates
significant shear forces on the airway mucosa. Although safe when
performed by a skilled clinician, such a procedure sometimes
induces unwanted trauma to the airway in the form of deep
lacerations and hemoptysis. Further, current dilation practices do
not permit dilation of a tracheal stenosis that is distal to a
narrowing of the proximal airway (i.e. a mild subglottic
stenosis).
[0007] Current airway balloon dilation procedures are typically
carried out using angioplasty balloons; however, several
limitations to the use of angioplasty balloons become evident when
used on the airway. For example, it may be difficult to adequately
ventilate the patient during the dilation period, since the typical
angioplasty balloon does not include a connection to an oxygen
source. Further, the shape of the angioplasty balloon may
predispose the balloon to slide out of place during dilation, or
the balloon may be limited to the amount of pressure that can be
applied before the balloon bursts. Also, the typical angioplasty
balloon can usually stretch the airway lumen but not permanently
dilate it. Other factors associated with failure of airway balloon
dilation include previous attempts at endoscopic repair,
circumferential scarring, and loss of cartilaginous support.
[0008] In light of the foregoing, it would be advantageous to
provide a balloon dilator for the airway of a patient that is able
to allow ventilation of the patient during balloon inflation. It
would also be helpful to provide an airway balloon dilator that can
provide increased inflation pressures during balloon dilation of
the airway without balloon rupture. Further, it would be beneficial
to provide a balloon that will not slip out of place in the
patient's airway during balloon inflation. Finally, it is desirable
to provide an airway balloon dilator that is capable of controlled
cutting of scar tissue.
SUMMARY OF THE INVENTION
[0009] The present invention provides an airway balloon dilator for
use to quickly re-establish laryngeal, tracheal or bronchial
luminal patency to restore airflow in a way that avoids excessive
trauma to the patient.
[0010] One aspect of the invention provides an apparatus for
performing an airway balloon dilation procedure at the site of a
stenosis in the airway of a patient, the apparatus comprising a
central axis, a hollow core adapted to allow the patient to be
ventilated therethrough, an inflatable outer balloon having an
external surface, and at least one inflatable inner balloon, the
apparatus being insertable into the airway of a patient for
movement of the balloons therein between a deflated configuration
and an inflated configuration, the at least one inner balloon
configured to inflate inside the outer balloon yet separately from
the outer balloon.
[0011] Another aspect of the invention provides a method for
performing an airway balloon dilation procedure at the site of a
stenosis in the airway of a patient, the method comprising: (1)
inserting an apparatus into the airway, the apparatus including a
central axis, a hollow core adapted to allow the patient to be
ventilated therethrough, an inflatable outer balloon having an
external surface, and at least one inflatable inner balloon, the
apparatus being insertable into the airway of a patient for
movement of the balloons therein between a deflated configuration
and an inflated configuration, the at least one inner balloon
configured to inflate inside the outer balloon yet separately from
the outer balloon; (2) advancing the apparatus within the airway
until the outer balloon is across the stenosis; and (3) inflating
the balloon to cause and allow the external surface of the balloon
to expand upon and dilate the stenosis.
[0012] Another aspect of the invention provides an apparatus for
performing an airway balloon dilation procedure at the site of a
stenosis in the airway of a patient, the apparatus comprising a
central axis, a hollow core adapted to allow the patient to be
ventilated therethrough, an inflatable, dumbbell-shaped outer
balloon having an external surface, at least one inflatable inner
balloon, a flexible support member mounted along the central axis
of the apparatus and on the external surface of the outer balloon,
the flexible support member being substantially compliant with the
external surface of the outer balloon during movement therewith,
and at least one microsurgical blade attached to the support member
and adapted to form an effective cutting edge upon inflation of the
outer balloon, the apparatus being insertable into the airway of a
patient for movement of the balloons therein between a deflated
configuration and an inflated configuration, the at least one inner
balloon configured to inflate inside the outer balloon yet
separately from the outer balloon, the dumbbell shape of the outer
balloon adapted to hold the outer balloon in position over the
stenosis, and the at least one blade adapted to form an effective
cutting edge upon inflation of the outer balloon.
[0013] The nature and advantages of the present invention will be
more fully appreciated from the following drawings, detailed
description and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The accompanying drawings illustrate embodiments of the
invention and, together with a general description of the invention
given above, and the detailed description given below, serve to
explain the principles of the invention.
[0015] FIG. 1 is a perspective view of one embodiment of the
balloon dilator of the present invention.
[0016] FIG. 2 is a perspective view of one embodiment of the
balloon dilator in which the outer balloon has a dumbbell shape and
multiple inner balloons.
[0017] FIG. 3 is a perspective view of a flexible support member
having microsurgical blades, the support member adapted to fit over
the outer balloon according to one aspect of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0018] As illustrated in FIG. 1, one embodiment of the present
invention is an apparatus 10 for performing an airway balloon
dilation procedure at the site of a stenosis in the airway of a
patient, the apparatus comprising an inflatable outer balloon 12
which has an external surface 14. The apparatus also comprises a
central axis 16, a hollow core 18, and at least one inflatable
inner balloon 20 adapted to inflate inside the outer balloon. The
apparatus 10 is typically insertable into the airway of a patient
for movement of the balloons 12, 20 between a deflated
configuration and an inflated configuration. Further, the inner
balloon 20 is designed to inflate inside the outer balloon 12 yet
separately from the outer balloon, adding the ability of the
apparatus to produce high dilation pressures without balloon
rupture.
[0019] As shown in FIG. 1, the hollow core 18 traverses the entire
apparatus 10. Typically the hollow core connects via a proximal ISO
connector to an oxygen source such as an anesthesia circuit or the
like, and is designed to allow the patient to be ventilated upon
inflation of the balloons during the procedure, when the airway is
otherwise occluded. The hollow core 18 is typically in the form of
a central ventilating tube which is necessarily strong to prevent
the pressure of the balloons from crushing the ventilating tube.
The structure of the hollow core 18 is typically similar to a small
endotracheal tube with a dilating cuff, and the tube may be
reinforced, e.g. with wire, in the area of the cuff.
[0020] As illustrated in FIG. 2, one embodiment of the invention is
a balloon dilator apparatus 30 in which the inflatable outer
balloon 32 is dumbbell-shaped. This dumbbell shape typically has a
variable thickness at the proximal 34 and distal 36 ends of the
balloon which allows the outer balloon 32 to stay in position over
the stenosis during inflation. In the embodiment of FIG. 2, the
apparatus 30 can include a plurality of inner balloons 40, 42, 44,
wherein inner balloon 44 is contained inside inner balloon 42,
which is contained inside inner balloon 40. All of the inner
balloons 40, 42, 44 are contained inside outer balloon 32, and are
typically separately inflatable. Such an embodiment could be used
with larger diameter outer balloons, e.g. between about 10 to about
20 mm. In this embodiment, the inner balloons 40, 42, 44 can be
either dumbbell shaped or a "double cone" shape as seen with most
angioplasty type balloons, and are inflated sequentially if higher
pressures cannot be achieved by the outer balloon. Having a balloon
dilator that incorporates multiple interconnected smaller balloons
can achieve the desired pressure without risking balloon rupture
during inflation.
[0021] During inflation, the proximal 34 and distal 36 ends of the
outer balloon 32 inflate first, forming the "dumbbell" shape,
thereby trapping the stenotic airway segment at the central portion
38 of the balloon 32, so that the outer balloon 32 does not slip
out of position. Then, as the pressure in the balloon is increased,
the central portion 38 of the balloon fully inflates at the site of
the stenosis.
[0022] As illustrated in FIG. 3, one embodiment of the invention
can include a flexible support member 50 that can fit over the
apparatus, specifically fitting over the outer balloon. The
flexible support member 50 is typically made of a polyurethane
material and includes a central axis 56 mounted along the central
axis of the apparatus. The support member is adapted to fit over
the external surface of the outer balloon, and is typically
substantially compliant therewith during inflation and deflation.
Support member 50 also includes at least one microsurgical blade,
and in FIG. 3 two surgical blades 52 are attached. Blades 52 form
an effective cutting edge upon inflation of the outer balloon.
Blades 52 are typically made of stainless steel, and are elongated
and permanently mounted on the flexible support member 50. In use,
when the support member 50 is placed over the outer balloon, the
blade axis 54 is parallel to the central axis 56 of the support
member 50, which is substantially parallel to the central axis of
the apparatus.
[0023] Having surgical blades 52 present on the apparatus during
dilation typically permits controlled cutting or lysis of any scar
tissue present in the patient's airway. The blades 52 should be
clearly marked so that users can avoid inadvertently cutting
themselves during placement of the support member 50 over the outer
balloon. In one embodiment, the blades 52 lay flat on the surface
of the support member prior to use and prior to inflation of the
outer balloon 12, and then when the outer balloon reaches a certain
pressure upon inflation the blades 52 will typically "stand up" or
otherwise protrude or expose their cutting edge atop the flexible
support member 50. Once fully deployed, the exposed edge of the
blade 52 typically only protrudes between about 0.2 to about 0.4
mm, and the length of the blade is typically less than the length
of the outer balloon 12. Typically there are a plurality of blades
which are able to work together to embed into the stenosis or scar
at a substantially uniform depth. For example, three blades could
be permanently mounted on the flexible support member, each of the
blades being separated from the other blades so that each blade is
free to move from a relatively flat position to a cutting position
on the flexible support member upon inflation of the outer
balloon.
[0024] In practice, the airway balloon dilation procedure is
typically performed at the site of a stenosis in the airway of a
patient (i.e. the larynx, trachea or bronchi). Using the apparatus
shown in FIG. 1, the surgeon or clinician first inserts the
apparatus 10 into the airway, then advances the apparatus within
the airway until the outer balloon 12 is across the stenosis. At
this point, the surgeon or clinician inflates the outer balloon 12
to cause and allow the external surface 14 of the outer balloon 12
to expand upon and dilate the stenosis. To increase dilation
pressures, the inner balloon 20 is then slowly inflated. Typically
the inner balloon 20 is inflated after the inflation of the outer
balloon 12. Under direct visualization, the balloons are typically
inflated from between about 30 to about 120 seconds. The apparatus
10 can also be threaded over a guidewire (not shown) which fits
through the hollow core 18 and is positioned across the stenosis.
Repeat inflation-deflation cycles can be done if airway narrowing
remains after the initial attempt.
[0025] During balloon dilation, the size of the balloon is first
selected by the clinician, which depends upon the size of the
stenosis in the patient's airway. The balloon size is typically
between about 10 mm to about 40 mm in length. The outer balloon is
positioned over the stenosis and then each balloon is individually
dilated to the desired pressure with a balloon pump, typically to
between about 8 to about 20 atmospheres. After these pressures are
maintained for a predetermined period of time, typically between
about 60 to about 180 seconds, the balloons are deflated and the
clinician determines if repeat inflation is necessary. Repeat
inflation can be safely performed if there is no obvious trauma to
the airway.
[0026] While the present invention has been illustrated by the
description of embodiments and examples thereof, it is not intended
to restrict or in any way limit the scope of the appended claims to
such detail. Additional advantages and modifications will be
readily apparent to those skilled in the art. Accordingly,
departures may be made from such details without departing from the
scope or spirit of the invention.
* * * * *