U.S. patent application number 10/074861 was filed with the patent office on 2002-06-20 for apparatus and method for isolated lung access.
This patent application is currently assigned to PULMONX. Invention is credited to Kotmel, Robert, Perkins, Rodney A., Soltesz, Peter P..
Application Number | 20020077593 10/074861 |
Document ID | / |
Family ID | 32234041 |
Filed Date | 2002-06-20 |
United States Patent
Application |
20020077593 |
Kind Code |
A1 |
Perkins, Rodney A. ; et
al. |
June 20, 2002 |
Apparatus and method for isolated lung access
Abstract
Apparatus, systems, methods, and kits are provided for isolating
a target lung segment and treating that segment, usually by drug
delivery or lavage. The systems include at least a lobar or
sub-lobar isolation catheter which is introduced beyond a second
lung bifurcation (i.e., beyond the first bifurcation in a lobe of
the lung) and which can occlude a bronchial passage at that point.
An inner catheter is usually introduced through the isolation
catheter and used in cooperation with the isolation catheter for
delivering and/or removing drugs or washing liquids from the
isolated lung region. Optionally, the inner catheter will also have
an occluding member near its distal end for further isolation of a
target region within the lung.
Inventors: |
Perkins, Rodney A.;
(Woodside, CA) ; Soltesz, Peter P.; (San Jose,
CA) ; Kotmel, Robert; (Burlingame, CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Assignee: |
PULMONX
Palo Alto
CA
|
Family ID: |
32234041 |
Appl. No.: |
10/074861 |
Filed: |
February 11, 2002 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10074861 |
Feb 11, 2002 |
|
|
|
09425272 |
Oct 21, 1999 |
|
|
|
Current U.S.
Class: |
604/96.01 ;
600/116 |
Current CPC
Class: |
A61M 25/0032 20130101;
A61M 25/0662 20130101; A61M 16/0484 20140204; A61M 16/0486
20140204; A61M 1/0058 20130101; A61M 16/0479 20140204; A61M 16/0459
20140204; A61M 2025/1052 20130101; A61M 1/85 20210501; A61M
2205/587 20130101; A61M 2025/0036 20130101; A61M 25/003 20130101;
A61M 16/0463 20130101; A61M 2025/0034 20130101; A61M 1/77 20210501;
A61M 16/0404 20140204; A61M 2210/1039 20130101 |
Class at
Publication: |
604/96.01 ;
600/116 |
International
Class: |
A61M 029/00 |
Claims
What is claimed is:
1. An isolation catheter comprising: a catheter body having a
proximal end, a distal end, and a main lumen therethrough; an
expansible occlusion member disposed on the catheter body near the
distal end thereof; optical and illumination fibers disposed in the
catheter body to image a region distal to the distal end of the
catheter body; and a hub attached to the proximal end of the
catheter body, said hub having a connector port for at least the
main lumen.
2. An isolation catheter as in claim 1, wherein the catheter body
has a length in the range from 20 cm to 90 cm, an outer diameter in
the range from 2 mm to 7 mm and the main lumen has a diameter from
1 mm to 6 mm.
3. An isolation catheter as in either claim 1 or 2, wherein the
expansible occlusion member is an inflatable cuff having an
expanded diameter in the range from 4 mm to 18 mm and a length in
the range from 5 mm to 30 mm.
4. An isolation catheter as in claim 3, wherein the catheter body
further comprises an inflation lumen disposed to deliver and remove
an inflation medium to the inflatable cuff and wherein the hub has
an additional connector port for the inflation lumen.
5. An isolation catheter as in either claim 1 or 2, wherein the
catheter body further comprises a lumen disposed to direct a
washing fluid over a distal tip of the optical fiber.
6. An isolation lung infusion/aspiration system, said system
comprising: an isolation catheter according to either of claims 1
and 2; and an inner catheter having a proximal end, a distal end,
and a central lumen therethrough, said inner catheter being
positionable within the main lumen of the sub-lobar isolation
catheter to form an annular lumen within the main lumen.
7. A system as in claim 6, wherein the hub has an additional
connector port for the annular lumen.
8. A system as in claim 6, further comprising an adaptor
connectable to the hub, wherein the adaptor has a connector port
for the annular lumen.
9. A system as in claim 6, wherein the inner catheter has an outer
diameter in the range from 0.5 mm to 4.5 mm, an inner diameter in
the range from 0.1 mm to 3.5 mm, and a length at least 10 cm longer
than the isolation catheter.
10. A system as in claim 9, wherein the inner catheter has a length
in the range from 50 cm to 200 cm.
11. A system as in claim 6, wherein the inner catheter has an
expansible occlusion member disposed near its distal end.
12. A system as in claim 11, wherein the expansible occlusion
member on the inner catheter is an inflatable cuff having an
expanded diameter in the range from 4 mm to 18 mm, and a length in
the range from 5 mm to 30 mm.
13. A system as in claim 11, wherein the inner catheter further
comprises an inflation lumen disposed to deliver and remove an
inflation medium to the inflatable cuff on the inner catheter.
14. A system as in claim 6, wherein the inner catheter further
comprises an infusion/aspiration lumen having at least one distal
port positioned proximally of the inflatable cuff on the inner
catheter.
15. A system as in claim 6, wherein the inner catheter further
comprises a vibratory element near the distal end thereof.
16. A system as in claim 6, wherein the inner catheter comprises at
least two lumens which are joined near a distal end of the inner
catheter and which have a common outlet port.
17. An isolation catheter as in claim 1 or 2, further comprising a
vibratory element near the distal end thereof.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a division of application Ser. No.
09/425,272, filed on Oct. 21, 1998, now U.S. Pat. No. ______, the
full disclosure of which is incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to medical
apparatus, systems, methods, and kits. More particularly, the
present invention relates to methods and apparatus for isolating
sub-bronchial regions of the lung and delivering or retrieving
substances from such isolated regions.
[0004] Lung access and isolation is of interest in numerous
therapeutic and diagnostic medical procedures. In particular,
access to the lungs is useful for both local and systemic drug
delivery, lung lavage, visual assessment and diagnosis of lung
function, and the like.
[0005] For drug delivery, access is most simply achieved by
introducing an aerosol to the lungs through the mouth or nose, and
a variety of inhalers, nebulizers, metered dose inhalers (MDIs),
nasal sprayers, and the like, have been developed over the years.
While very effective for many drugs, delivery through the mouth or
nose can be very inefficient, often with less than 20% of the drug
reaching circulation or a targeted local treatment region.
Moreover, inhalation through the mouth or nose is not able to
target drug delivery to a particular region of the lungs. While
this may not be a problem for systemic delivery, it can be a
significant drawback in the treatment of localized disease where a
highly controlled delivery profile would be preferred.
[0006] In an effort to overcome at least some of these
shortcomings, a variety of endotracheal drug delivery and lung
lavage systems have been developed. Most simply, an endotracheal or
tracheostomy tube having an inflatable cuff at its distal end may
be placed in a patient's trachea and used to deliver a drug aerosol
to the whole of the lungs. While this can improve the efficiency of
drug delivery (reducing the amount of drug deposited in the nasal
passages or throat), it helps little in targeting treatment within
any particular region of the lungs. Thus, it has been further
proposed to use a secondary catheter placed through an endotracheal
or tracheostomy tube for selectively isolating the left or right
bronchus. For example, the secondary catheter can have an
inflatable cuff which is positioned immediately beyond the main
branching between the left and right bronchi. One of the bronchi
can then be accessed through the secondary catheter while the other
is accessed through the tracheal tube. Such systems are described,
for example, in U.S. Pat. Nos. 5,285,778 and 5,660,175. While such
systems offer significant benefits over the use of an endotracheal
tube by itself, they still do not permit isolation of sub-bronchial
regions of the lung for drug delivery, lavage, or any other
purpose.
[0007] A system for bronchoalveolar lavage which can isolate a
sub-bronchial region of the lung is described in published
Application No. WO 92/10971. A co-axial catheter system is placed
through an endotracheal tube, with the inner most catheter having
an isolation wedge or balloon which can be positioned in a remote
bronchiole to effect isolation of a distal region of the lung. The
outer catheter has no capability for isolating the lung and is
used, for example, for ventilating the lung proximal to the
isolation cuff. While potentially an improvement over prior
systems, the apparatus of WO 92/10971 will be very difficult to
position, making targeting of particular sub-bronchial regions very
difficult. Moreover, the inability to isolate a bronchus upstream
from the distal isolation cuff limits the ability to selectively
treat different regions of the bronchus in different ways. That is,
while the particular sub-bronchial region which is isolated by the
distal isolation cuff may be treated in one way, the remainder of
that bronchus as well as the entire other lung must be ventilated
and treated in a common manner through either the endotracheal tube
or the outer catheter of the co-axial catheter pair.
[0008] For these reasons, it would be desirable to provide improved
apparatus, systems, methods, and kits for the treatment and
diagnosis of selected regions of a patient's lungs, particularly a
lobar or targeted sub-lobar regions of the patient's lungs. The
present invention should provide for the efficient delivery of
pharmaceutical and other substances to the targeted sub-lobar
regions of the lung. Moreover, in some embodiments, the present
invention should be able to provide at least a second level of
isolation within a particular bronchus and/or the ability to
instill the pharmaceuticals or other substances at a point
significantly distal to a point of isolation within the bronchus.
The systems and apparatus of the present invention should be
capable of being positioned precisely to a targeted bronchi within
the bronchus, preferably providing on-board visualization while
components of the system are positioned over a guidewire.
Additionally, the apparatus, systems, methods, and kits of the
present invention should be suitable for a wide variety of
purposes, including pharmaceutical drug delivery, lung lavage
(optionally in combination with drug delivery), diagnosis
(optionally in combination with lung lavage), and the like. In
particular, the present invention should be useful for localized
drug delivery where a particular drug or other therapeutic agent
can be delivered to a well-defined, isolated sub-bronchial region
of the lung (as defined hereinafter) with little or no delivery to
other regions of the lung. At least some of these objectives will
be met by the inventions described hereinafter.
[0009] 2. Description of the Background Art
[0010] WO 92/10971 describes a bronchoalveolar lavage catheter
system having an outer catheter and an inner catheter with an
enlarged (optionally inflatable) tip which is advanced until the
tip wedges in a bronchiole of the patient. A region of the lungs
distal to the enlarged tip may then be lavaged to retrieve sample.
U.S. Pat. Nos. 5,660,175; 5,653,231; 4,716,896; and 4,453,545,
describe single and co-axial catheter systems for accessing a
patient's lungs. U.S. Pat. No. 5,285,778, describes a co-axial
endoscopic lung access system. U.S. Pat. Nos. 5,309,903 and
5,207,220 describe systems for administering liquid pharmaceutical
formulations to an isolated lung.
BRIEF SUMMARY OF THE INVENTION
[0011] The present invention provides improved apparatus, systems,
methods, and kits for isolating lobar and sub-lobar regions of a
patient's lungs. The isolated region will be a portion (not the
whole) of the right or left lung, and isolation will be
accomplished by occluding a bronchial passage at at least one
location in the lobar, segmental, and subsegmental bronchus. Thus,
a primary occlusion will be formed after both the main bifurcation
of the trachea and a further bifurcation into the lobar bronchus.
Optionally, the lobar and/or sub-lobar region can be further
isolated at at least one secondary location distal to the primary
point of isolation and usually after further branching of the
bronchial passages. Isolation at the primary location and optional
additional locations within the bronchial passages will usually be
effected by expansion of an occlusion member, such as an inflatable
cuff, inflatable balloon, or the like.
[0012] Once the lobar or sub-lobar region has been isolated, a
variety of therapeutic and diagnostic procedures can be performed
within the isolated region. For example, pharmaceutical
formulations including small molecule drugs, biological
macromolecular drugs, and the like, can be specifically delivered
to the isolated region with minimal or no cross-delivery to other
regions of the lungs. Similarly, lavage may be performed within the
isolated region with minimal impact on adjacent regions of the
lungs. Isolation of the lobar or sub-lobar region permits such drug
delivery and lavage procedures to be further controlled by control
of the volumes, rates, pressures, temperatures, repetitions,
retention times, and other method and system parameters. For
example, the pressure within the isolated region can be controlled
separately from the pressure or pressures maintained outside of the
isolated region. In this way, a variety of delivery parameters can
be controlled. By elevating pressure within the isolated region
above that in the surrounding regions of the lung, the isolated
lobar or sub-lobar region will be expanded which may, in some
cases, enhance delivery of a drug or permit more efficient lavage
of the region. Alternatively, by elevating pressure within the
"other" lung regions above that within the isolated region, the
risk of migration of toxic therapeutic or other agents away from
the isolated region can be greatly reduced.
[0013] According to the present invention, an isolation catheter
comprises a catheter body having a proximal end, a distal end, and
a main lumen therebetween. An expansible occlusion member is
disposed at or near the distal end of the catheter body, and
optical and illumination fibers are disposed in the catheter body
to permit imaging of a region distal to the distal end of the
catheter body when the catheter is in use. Usually, a hub will be
attached to the proximal end of the catheter and include at least
one connection port for the main lumen of the catheter. Optionally,
the hub will contain a second connection port for the optical and
illumination fibers, and may contain further connection ports for
other lumens and capabilities of the catheter, as described
hereinafter.
[0014] The catheter body of the isolation catheter will be adapted
and sized to allow advancement of the distal end of the catheter
body to a target bronchial passage within the lung which is located
distal to a first branching of the right or left main stem
bronchus. Usually, at least a distal region of the catheter body
will have an outer diameter which is sufficiently small and
flexible to be advanced into bronchioles having a diameter below
about 12 mm, preferably below about 10 mm, and often below about 8
mm. Exemplary catheter bodies will have a length in the range from
40 cm to 150 cm, preferably from 50 cm to 90 cm, an outer diameter
in the range from 2 mm to 7 mm, preferably from 3 mm to 6 mm, and a
main lumen diameter in the range from 1 mm to 6 mm, preferably from
2 mm to 4 mm. The expansible occlusion member will typically be an
inflatable cuff or balloon having an expanded diameter in the range
from 4 mm to 18 mm, preferably from 6 mm to 15 mm, and a length in
the range from 5 mm to 30 mm, preferably from 10 mm to 15 mm.
Usually, the catheter body will include at least one additional
lumen for inflation of the inflatable cuff, and the additional
lumen will be connected to an additional connector port on the
catheter hub. Further optionally, the catheter body may include an
additional lumen disposed to direct a washing fluid over a distal
tip of the optical fiber which terminates at or near the distal end
of the catheter body.
[0015] In a preferred aspect, systems according to the present
invention comprises an isolation catheter as described above
combined with an inner catheter to form a lung infusion/aspiration
system. The inner catheter has a proximal end, a distal end, and a
central lumen extending between the proximal end and distal end.
The inner catheter is positionable within the main lumen of the
isolation catheter so that the catheters may be used together in a
co-axial fashion and further so that an annular lumen is formed
within the main lumen of the isolation catheter, i.e., between an
inner surface of the main lumen of the isolation catheter and an
outer surface of the inner catheter. Optionally, the connector port
on the isolation catheter has an additional connector port for the
annular lumen. Alternatively, the system may comprise an adapter
connectable to the hub on the isolation catheter, where the adapter
has a connector port for the annular lumen. The dimensions and
physical characteristics of the inner catheter will be chosen to
permit introduction through the main lumen of the isolation
catheter and further to permit advancement of the inner catheter
beyond the distal end of the isolation catheter into bronchial
passages or bronchioles distal to the isolation catheter when in
use.
[0016] An exemplary inner catheter has an outer diameter in the
range from 0.5 mm to 4.5 mm, preferably from 1.5 mm to 3.5 mm, an
inner lumen diameter in the range from 0.1 mm to 3.5 mm, preferably
from 1 mm to 3 mm, and a length which is at least 10 cm longer than
the isolation catheter in the system. Typically, the inner catheter
will have a length in the range from 50 cm to 200 cm, preferably
from 60 cm to 110 cm. Optionally, the inner catheter may have an
expansible occlusion member disposed near its distal end to permit
selective isolation of a lobar or sub-lobar region between proximal
and distal points along the bronchial passages of the lung.
Typically, the expansible occlusion member on the inner catheter is
an inflatable cuff having an expanded diameter in the range from 4
mm to 18 mm, preferably from 6 mm to 15 mm, and a length in the
range from 5 mm to 30 mm, preferably from 10 mm to 15 mm.
[0017] When including an inflatable cuff, the inner catheter will
usually further comprise an inflation lumen disposed to deliver and
remove an inflation medium to the inflatable cuff. Moreover, when
provided with an inflatable cuff, the inner catheter will usually
comprise an infusion/aspiration lumen having a distal port position
proximally of the inflatable cuff so that substances, washing
fluids, or the like, may be delivered or aspirated through the
lumen between the inflatable cuff on the isolation catheter and the
inflatable cuff on the inner catheter. Still further optionally,
the inner catheter may comprise a vibratory element, such as an
ultrasonic transducer, near its distal end to assist in dissolution
of occlusive materials, enhance drug uptake, or the like. Still
further optionally, the inner catheter may comprise two or more
lumens, where at least two of the lumens are joined near a distal
end to permit mixing of two or more gas or liquid streams which are
being delivered through the catheter. The mixed streams are then
released through a common outlet port on the inner catheter.
Alternatively, the two streams may be delivered in parallel from
the distal tip of the inner catheter for a variety of purposes.
[0018] The systems of the present invention may comprise further
elements, such as guidewires, tracheal tubes with integral
visualization (including both endotracheal and tracheostomy tubes),
therapeutic or diagnostic reagents, and/or other system components
intended to cooperate in performing the methods of the present
invention as described in more detail below. Additionally, the
systems of the present invention may be incorporated into kits
where one or more system components are packaged together with
instructions for use setting forth the methods described in more
detail below. Such kits will usually further comprise packages for
holding the system component(s) together with the instructions for
use.
[0019] Methods according to the present invention comprise using an
isolation catheter and an inner catheter (generally as described
above) for isolating a lobar or sub-lobar region of the lung and
then performing a procedure within the isolated region. In a first
instance, the methods are used for delivering a substance,
typically a drug or other pharmaceutically active substance, to the
isolated region. In a second instance, the methods are used for
ravaging the isolated region, i.e., introducing and removing a
washing liquid such as isotonic saline, alcohol, mucolytic agents,
or the like, to the region. Optionally, the lavage and substance
delivery methods can be combined where a drug or other active agent
is included in the washing liquid which is being used for lavage.
The methods of the present invention comprise positioning a distal
end of the isolation catheter within a bronchial passage beyond a
first branching within the right or left lung. The inner catheter
is then positioned through the main lumen of the isolation catheter
so that a distal end of the inner catheter lies in a bronchial
passage distally beyond the distal end of the isolation catheter.
At least one occlusion element near the distal end of the isolation
catheter is expanded within the bronchial passage to isolate a
target lobar or sub-lobar region. Thereafter, in the case of drug
or other substance delivery, the substance may be delivered through
the inner catheter to the isolated region of the lung. In the case
of lavage, the washing liquid may be infused through either (or
both) of the inner catheter or the isolation catheter and aspirated
through the other (or both) of the two catheters. Infusion and
aspiration may be performed sequentially or concurrently, or in
combinations of both sequential and concurrent infusion and
aspiration. Often, it will be preferred to infuse the washing
liquid through the inner catheter so that it enters the isolated
region generally in a distal portion thereof and diffuses or
migrates back toward the isolation catheter where it is collected
and removed. In some instances, the washing liquid drug, or other
substance may be introduced as a bolus and held or retained within
the isolated sub-lobar region for a pre-selected retention time
prior to initiating aspiration. In other instances, it may be
desirable to continuously both infuse and aspirate the washing
liquid drug, or other substance to get a "circulation" of the
substance through the isolated lobar or sub-lobar region.
Optionally, the washing liquid may comprise a drug or other
biologically active substance to perform a therapeutic action while
the region is being ravaged.
[0020] In the case of substance delivery, the substance may
comprise any one of a wide variety of pharmaceutical agents,
including small molecule drugs, protein drugs, carbohydrate drugs,
nucleic acid drugs (genes, optionally in combination with delivery
vectors and/or expression control segments), and the like. The
delivered substances may be in the form of an aerosol, optionally
produced within the inner catheter or prior to introduction to the
inner catheter. Still further optionally, the substance may
comprise a liquid which is instilled through the inner catheter.
For both substance delivery and lavage, it will frequently be
preferred to position the isolation catheter and inner catheter
through a visualizing endotracheal or tracheostomy tube which has
been previously placed in the patient's trachea. Suitable
visualizing endotracheal tubes are described, for example, in U.S.
Pat. No. 5,285,778, the full disclosure of which is incorporated
herein by reference. Usually, a visualizing endotracheal or
tracheostomy tube will include an inflatable cuff or other
occlusion element so that the whole lungs may be isolated from the
upper regions of the trachea. In this way, the patient may be
ventilated through the tracheal tube while other regions of the
lung are isolated. Moreover, direct visualization at the
bifurcation between the left and right lungs helps position in
place the isolation catheter to the target region to be isolated.
Additionally, the regions of the lung above or proximal to the
occlusion element on the isolation catheter may be ventilated and
maintained at a different pressure through the tracheal tube. Thus,
by employing isolation cuffs on the tracheal tube, the isolation
catheter, and the inner catheter, at least three isolated zones
within the lung may be maintained with different pressures being
simultaneously maintained. Moreover, different substances can be
delivered to each of these regions through the lumens of the inner
catheter, isolation catheter, and the tracheal tube, respectively.
Often, pressure within the isolated region may be maintained higher
than that within the proximal regions of the lung (where pressure
is being controlled through the tracheal tube) resulting in
expansion of the isolated region which may be beneficial for a
variety of reasons. Alternatively, pressure within the isolated
region may be maintained below that of the proximal portions of the
lung, reducing the risk of release of materials from the isolated
region into the proximal portions of the lung. Moreover, when the
inner catheter has an isolation cuff, a third distal region of the
lung may be pressurized separately from the intermediate and
proximal regions.
[0021] Introduction of the isolation catheter and/or inner catheter
will preferably be performed over a guidewire. The guidewire will
first be introduced to a point beyond the location in a bronchial
passage where it is desired to position a distal end of the
isolation catheter and/or inner catheter. Preferably the isolation
catheter will comprise optical and illumination fibers which permit
direct visual observation of the guidewire as the guidewire and
isolation catheter are advanced. In particular, the guidewire and
isolation catheter can be advanced in tandem so that, as successive
bifurcations are approached, the physician can steer a curved end
of the guidewire into the desired branch bronchial passage. After
positioning the isolation catheter at its desired final location,
an occlusion cuff may be expanded and the inner catheter optionally
introduced over the guidewire or introduced directly through the
main lumen of the isolation catheter without a guidewire. While the
inner catheter may in some instances incorporate optical and
illumination fibers, it will usually not have such imaging
capabilities. Thus, positioning of the inner catheter will
frequently be done solely by observation from the isolation
catheter and/or under fluoroscopic or other external imaging. Of
course, positioning of an isolation catheter can also be performed
solely under fluoroscopic imaging (or in combination with both
direct visual and fluoroscopic imaging), particularly when the
isolation catheter does not include imaging capability.
[0022] In a further specific aspect of the methods of the present
invention, the inner catheter may be moved and repositioned within
the bronchial passages of the isolated region to deliver a
substance or release a washing fluid for lavage at different points
within the region. Optionally, the inner catheter can be moved
(i.e., advanced distally or drawn proximally) while the substance
or washing liquid is being released in order to better distribute
the material within the isolated region. Further optionally, the
inner catheter could also be moved through the isolated region in
order to aspirate materials which have been introduced, either
alone or in combination with aspiration through the main lumen of
the isolation catheter.
[0023] Kits according to the present invention include at least an
isolation catheter, and optionally include an inner catheter, a
tracheal tube, and/or a guidewire. Other components including
medical and bioactive reagents, e.g., drugs, washing liquids, or
the like, may also be provided within the kits. In addition to the
isolation catheter and optional other system components, the kits
will comprise instructions for use setting forth a method of the
present invention as generally set forth above. The kits will
usually be packaged together in conventional medical packaging,
such as a pouch, tray, tube, box, bag, or the like. Instructions
for use may be provided on a separate printed sheet, or may printed
in whole or in part on the packaging materials. When printed
separately, the instructions are commonly referred to as a package
insert. Usually, at least the isolation catheter and other
components of the kit which would be used in the procedure will be
packaged in a sterile manner within the kit.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 is a side view of a sub-lobar isolation catheter
constructed in accordance with the principles of the present
invention.
[0025] FIG. 1A is a cross-sectional view taken along line 1A-1A in
FIG. 1.
[0026] FIG. 1B is an alternative cross-sectional view similar to
that shown in FIG. 1A.
[0027] FIG. 2 is a side view of a first alternative construction of
a sub-lobar catheter constructed in accordance with the principles
of the present invention.
[0028] FIG. 2A is a cross-sectional view taken along line 2A-2A of
FIG. 2.
[0029] FIG. 3 is a side view of a second alternative construction
of a sub-lobar catheter constructed in accordance with the
principles of the present invention.
[0030] FIG. 3A is a cross-sectional view taken along line 3A-3A of
FIG. 3.
[0031] FIG. 4 illustrates a system comprising a sub-lobar isolation
catheter and an inner catheter constructed in accordance with the
principles of the present invention.
[0032] FIG. 5 is a side view of the inner catheter of FIG. 4
mounted within the sub-lobar isolation catheter, with portions
broken away.
[0033] FIG. 6 illustrates a first alternative construction of the
inner catheter of the present invention.
[0034] FIG. 6A is a cross-sectional view taken along line 6A-6A of
FIG. 6.
[0035] FIG. 7 is a second alternative construction of the inner
catheter of the present invention.
[0036] FIG. 7A is a cross-sectional view taken along line 7A-7A of
FIG. 7.
[0037] FIG. 8 is a third alternative construction of the inner
catheter of the present invention.
[0038] FIG. 8A is a cross-sectional view taken along line 8A-8A of
FIG. 8.
[0039] FIG. 8B is a detailed view of the distal end of the catheter
of FIG. 8 taken along line 8B-8B of FIG. 8.
[0040] FIG. 9 is a fourth alternative construction of the inner
catheter of the present invention.
[0041] FIG. 9A is a cross-sectional view taken along line 9A-9A of
FIG. 9.
[0042] FIG. 10 illustrates introduction of a sub-lobar isolation
catheter to a diseased region within a lung according to the method
of the present invention.
[0043] FIG. 11 is a detailed view of the introduction of FIG. 10
shown with the isolation catheter being passed through a
visualizing endotracheal tube.
[0044] FIGS. 12A-12C illustrate use of the various inner catheters
for performing particular procedures in accordance with the
principles of the present invention.
[0045] FIG. 13 illustrates a kit constructed in accordance with the
principles of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0046] Isolation of a lobar or sub-lobar region of the lung is
accomplished by occluding a lumen of a bronchial passage
(bronchiole) at a location distal to a first branch in the network
of bronchial passages within the right or left lung. Substances may
be delivered to and/or a washing fluid may be used to lavage the
isolated lobar or sub-lobar region of the lung by introducing or
exchanging materials through a lumen of an isolation catheter,
usually in combination with delivery or exchange through a lumen of
an associated inner catheter. An inflatable cuff or other
expansible isolation element on the isolation catheter is
positioned at an isolation location within the bronchial passage,
and the cuff inflated. The inner catheter is then positioned at a
desired location distal to the end of the isolation catheter, and
the isolated region is thus accessible through at least two access
lumens, i.e., one lumen through the inner catheter and a second
annular lumen between the exterior of the inner catheter and the
interior luminal wall of the isolation catheter. These access
lumens may be used separately or in combination in a variety of
ways to perform the methods of the present invention. The apparatus
and methods of the present invention will now be described in
greater detail.
[0047] Referring to FIGS. 1 and 1A, an isolation catheter 10
comprises a catheter body 12 having a proximal end 16 and a distal
end 14. An inflatable isolation cuff 18 is disposed near the distal
end 14 of the catheter body 12, and an inflation lumen 20 extends
through the catheter body from a proximal port 22 on proximal hub
24 to the balloon 18. The catheter 10 further comprises an optical
fiber or bundle 24 and an illumination fiber or bundle 26, both of
which are brought out to a suitable connector 28 through a
connecting cable 30. The optical fiber 24 and illuminating fiber 26
may be plugged into a variety of conventional imaging consoles
which can provide a real time, visual image looking forwardly from
the distal end 14 of the catheter body 12. Suitable commercial
imaging consoles are available from suppliers, such as Pulmonx,
Palo Alto, Calif., assignee of the present application as well as
Olympus, Pentax and Stryker. The catheter body 12 further includes
a main lumen 32 which extends the entire length of the catheter
body and passes through connector hub 36 to proximal connector 34.
As will be discussed in more detail below, the main lumen 32 can be
used for introducing and/or aspirating materials which are
introduced to or withdrawn from an isolated lobar or sub-lobar
region of the lung. Most usually, the main lumen 32 will receive an
inner catheter (FIGS. 4 and 5 below), and the isolation catheter
and inner catheter will be utilized together for delivering,
collecting, and removing materials from an isolated sub-lobar
region of the lung.
[0048] As shown in FIGS. 1 and 1A, the catheter body 12 of the
isolation catheter 10 is a single extrusion having four lumens or
passages formed therein. Two of the lumens form the inflation lumen
20 and the main lumen 32, while the other two lumens house the
optical fiber bundle 24 and the illumination fiber bundle 26. The
catheter body 12 could also be formed from a plurality of separate
tubular members which are held together by an outer cover, as
illustrated in FIG. 11B. For example, an inner tube 40 can be
disposed in parallel with the optical fiber bundle 24 and the
illuminating fiber bundle 26. A separate tubular member 42 can also
be placed co-axially on the exterior of tube 40, and all of the
components held together by a cover 44 which may, for example, be
shrink-wrapped over the assembly. An inflation lumen 46 is then
provided in the space under the cover 44 which is unoccupied by the
optical and tubular components. A variety of other specific
construction designs may also be provided.
[0049] The catheter body 12 may be formed from conventional
materials, such as polyamides (nylons), polyethylenes,
polyurethanes, polytetrafluoroethylenes (PTFEs), polyimides, and
the like. The inflatable cuff can be formed from other conventional
materials, such as polyvinylchloride, polyurethanes, high density
polyethylenes, low density polyethylenes, nylons, PTFEs, and the
like. Exemplary and preferred dimensions for the catheter body 12
of the isolation catheter 10 have been set forth above.
[0050] A second exemplary isolation catheter 50 constructed in
accordance with the principles of the present invention is
illustrated in FIGS. 2 and 2A. The construction of isolation
catheter 50 is generally the same as that for isolation catheter
10, and like components will be given like numbers. The principal
difference between the catheters 50 and 10 is that catheter 50
includes a lens washing lumen 52 which extends from lens washing
port 54 in the hub 56 to a position at the distal tip of the
catheter body which lies immediately over a lens (not shown) formed
at the distal end of the optical fiber or bundle 26. Because of the
humid and contaminating nature of the lungs, it will be a
significant benefit to be able to wash the optical viewing lens
whenever the lens becomes obscured to do condensation or
fouling.
[0051] A third exemplary construction of the isolation catheter of
the present invention is illustrated in FIGS. 3 and 3A. There, an
isolation catheter 60 comprises generally the same components as
catheters 10 and 50, except that catheter body 12 further includes
a lumen 62 which receives a guidewire (or alternatively an
articulating steering mechanism) and which extends from port 64 on
hub 66 to the distal end 14 of the catheter body 12. Thus,
isolation catheter 60 is specially adapted for introduction over a
guidewire (or other steering mechanism) according to the methods of
the present invention and as described in more detail below. It
will be appreciated, of course, that the earlier embodiments could
also be introduced over a guidewire where the guidewire is passed
through the main lumen 32, but in such cases the main lumen would
have to be emptied i.e., the inner catheter (if used) would have to
be removed from the isolation catheter. Optionally, the isolation
catheter 60 can also include a vibratory element 66 near its distal
end. The vibratory element could be a mechanically driven surface,
but will usually comprise an ultrasonic transducer intended to
deliver vibratory energy to disrupt blockages in the bronchus,
enhance drug delivery, or the like.
[0052] Systems 70 according to the present invention comprise an
isolation catheter 10 (or any of the other isolation catheters
described above or which would come within the principles of the
present invention) and an inner catheter 80. As illustrated in
FIGS. 4 and 5, the inner catheter 80 is sized and adapted to fit
within the main lumen 32 of the isolation catheter 10. The inner
catheter 80 has a distal end 82 and a proximal end 84 which
terminates in a connecting hub 86. The isolation catheter 10
includes a hub 96 which is similar to the previously described
hubs, except that a proximal end has been modified to slidably
receive the inner catheter 80. As shown, an O-ring 90 is provided
to provide a sliding pneumatic or hydraulic seal about the inner
catheter. Additionally, an access port 92 is provided in the hub 96
to permit communication with the annular lumen 94 disposed between
the exterior of inner catheter 80 and the interior of the main
lumen 32 of the isolation catheter 10. In this way, materials can
be withdrawn or introduced through the isolation catheter 10 as
well as through the lumen of the inner catheter 80. More
particularly, it permits two spaced-apart access points, i.e., at
the distal ends of the isolation catheter 10 and inner catheter 80,
respectively, to be established within an isolated lobar or
sub-lobar region of the lungs. Using two access points, a variety
of substance delivery and lavage protocols can be run, as described
in more detail below.
[0053] A first alternative embodiment of an inner catheter 100 is
illustrated in FIGS. 6 and 6A. Inner catheter 100 includes catheter
body 102 having an inflatable isolation cuff 104 near its distal
end. A plurality of infusion/aspiration ports 106 are also formed
near the distal end 103 of the catheter body 102 and are connected
by a lumen 108 to an aspiration/infusion port 110 in proximal hub
112. The inflatable cuff 104 may be inflated by connecting a
suitable inflation source to connector 114 which delivers the
inflation medium through lumen 116 to the cuff 104. A central lumen
120 extends the length of the catheter body from its distal end 103
to a connection port 122 in the hub 112. By providing the
infusion/aspiration ports 106 proximal to the inflatable cuff 104,
it will be appreciated that substances may be delivered or removed
from a region which is proximal to the cuff 104 but distal to the
isolation cuff on the isolation catheter with which the inner
catheter 100 is used.
[0054] Yet a further alternative embodiment of an inner catheter
130 is illustrated in FIGS. 7 and 7A. The inner catheter 130
includes an ultrasonic or other vibratory element 132 (shown in
broken line) at or near its distal end 134. The ultrasonic element
132 may be positioned at the distal end of a lumen 136 which
extends through the length of the catheter 130. The lumen 136 may
thus hold wires necessary to power the ultrasonic transducer, where
the wires are brought out through a connecting cable 140 and
terminate in a plug 142. An aspiration/infusion lumen 150 also
extends the length of the catheter 130 and terminates in a luer or
other connector 152 at the proximal end of the catheter.
Optionally, a similar ultrasonic or other vibratory element may be
disposed on the isolation catheter, either in addition to or in
place of the vibration element 132 on the inner catheter. Although
shown proximal to cuff 18, the vibratory element 66 may also be
placed distal to the cuff to deliver energy into an isolated
region.
[0055] Referring now to FIGS. 8, 8A, and 8B, still a further
embodiment of an inner catheter 160 will be described. The catheter
160 comprises a catheter body 162 having a distal end 164 and a
proximal end 166. A pair of lumens 168 and 170 extend the length of
the catheter body 162 from ports 172 and 174, respectively, and
proximal hub of 176 to each of the lumens 168 and 170 is suitable
for delivering a material, either liquid, aerosol, or solid (in
some flowable form), from the ports 172 and 174 to a mixing region
180 near a distal instillation port 182 at a distal tip of the
catheter. For example, air or other gas may be delivered through
the larger lumen 170 so that it flows the mixing area 180. By
delivering a liquid or powder through the smaller lumen 168, the
airflow can act as a Venturi in suspending an aerosolizing material
which is delivered to the mixing area. In this way, droplets or
particulates can be delivered or instilled directly within an
isolated lobar or sub-lobar region of the lung. By properly
controlling the particulate or droplet size, i.e., to arrange
generally between 0.1 .mu.m to 5 .mu.m, absorption of these
materials into the alveolar regions of the lungs can be enhanced.
By controlling the particulate or droplet size outside this range,
usually above 5 .mu.m, preferably above 10 .mu.m, local delivery
(i.e., not systemically absorbed) of a drug or other substance can
be achieved.
[0056] Referring now to FIGS. 9 and 9A, still yet a further
embodiment of an inner catheter 200 constructed in accordance with
the principles of the present invention will be described. The
inner catheter 200 comprises a catheter body 202 having a distal
end 204 and a proximal end 206. The catheter body includes a
central lumen 210 and a pair of instillation lumens 212 and 214.
The catheter would be suitable for aerosolization of substances,
particularly by delivering a liquid or solid powder substance
through one of the lumens 212 and air or other aerosolization gas
through the other lumen 214. The central lumen 210 could be used
for aspiration, delivery of other drug materials, or the like.
[0057] Referring now to FIGS. 10, 11, and 12A-12C, methods
according to the present invention will be described. Most
generally, an isolation catheter 10 may be introduced through the
mouth, the trachea T and into a lobe L of the lung until it reaches
a diseased region DR. Alternatively, the isolation catheter 10
could be introduced through an incision in the neck, usually
through a tracheostomy tube. At that point, cuff 18 may be inflated
to isolate regions of the lung distal to the inflated cuff in the
bronchial passage. As illustrated in FIG. 11, catheter 10 may
optionally be delivered through a visualizing endotracheal tube
VETT (or visualizing tracheostomy tube), where a cuff C on the tube
is inflated within the trachea T at a region just above the main
lung bifurcation into the right and left lungs RL and LL. Further
optionally, the isolation catheter 10 may be advanced over a
guidewire GW, where visualization of the guidewire immediately
ahead of the catheter may be observed on the video screen V
attached to the optical and illumination fibers within the catheter
10. In particular, the guidewire may be advanced just ahead of the
distal end of the catheter 10 in tandem so that the guidewire can
be observed as it is rotated and introduced selectively into the
bronchial passages at bifurcations. Alternatively, or additionally,
advancement of the catheter 10 may be observed fluoroscopically or
using any other available external imaging systems.
[0058] Once the catheter 10 is in place beyond a second bifurcation
SB in the bronchial passages, as illustrated in FIG. 12A, the
inflatable cuff 18 may be inflated to both anchor the distal end of
the catheter and isolate regions of the lung distal thereto. After
the cuff 18 is inflated, the inner catheter 80 may be advanced
through the main lumen 34 so that the distal end 82 of the inner
catheter progresses distally into a desired bronchial passage.
Advancement of the distal end 82 may optionally be over a guidewire
and will usually be performed under visual imaging using the
optical illuminating fibers in the isolation catheter 10. Once the
inner catheter has been properly positioned, as shown in FIG. 12B,
a desired procedure can be performed. For example, a drug can be
delivered through the distal end 82 of the inner catheter to treat
a target region TR, shown in broken line in FIG. 12B, additionally
or alternatively, the target region TR can be lavaged by
introducing a washing fluid through either catheter 10 or 80 and/or
collecting the fluid through either of catheter 10 or 80.
[0059] Alternatively, as shown in FIG. 12C, inner catheter 100
having inflatable cuff 104 at its distal end may be introduced
through the isolation catheter 10. By then inflating cuff 104
distally relative to cuff 18 on isolation catheter 10, a modified
target region MTR can be defined. In particular, the target region
MTR in FIG. 12C will be more limited in volume than that formed in
FIG. 12B where there is no distal isolation. Use of the second
isolation cuff 104 on the inner catheter 100 permits much more
specifically focused treatment protocols, both drug delivery and
lavage, to be performed. By delivering or aspirating the materials
through the ports 106, it will be appreciated that the treatment is
substantially limited to between the two cuffs 18 and 104.
[0060] Referring now to FIG. 13, a kit 300 according to the present
invention will comprise at least a lobar or sub-lobar isolation
catheter 10 and an inner catheter 80 together with instructions for
use IFU. Optionally, the kits may further include other system
components as described above, such as a visualizing endotracheal
tube VET, a guidewire GW, and/or various reagents (not shown). The
instructions for use IFU will set forth any of the methods as
described above, and all kit components will usually be packaged
together in a suitable package 350, such as a pouch, tray, tube,
box, bag, or the like. Usually, those kits components, such as the
isolation catheter 10 and inner catheter 80, which will be used in
performing the procedure on the patient, will be sterilized and
maintained sterilely within the kit. Optionally, separate pouches,
bags, trays, or other packaging materials may be provided within a
larger package, where the smaller packs may be separately opened
and will separately maintain the components in a sterile
fashion.
[0061] While the above is a complete description of the preferred
embodiments of the invention, various alternatives, modifications,
and equivalents may be used. Therefore, the above description
should not be taken as limiting the scope of the invention which is
defined by the appended claims.
* * * * *