U.S. patent application number 10/254392 was filed with the patent office on 2004-03-25 for device and method for measuring the diameter of an air passageway.
This patent application is currently assigned to Spiration, Inc.. Invention is credited to DeVore, Lauri J., Dillard, David H., Kutsko, James M., Sirokman, William A., Westman, Peter R..
Application Number | 20040059263 10/254392 |
Document ID | / |
Family ID | 31993358 |
Filed Date | 2004-03-25 |
United States Patent
Application |
20040059263 |
Kind Code |
A1 |
DeVore, Lauri J. ; et
al. |
March 25, 2004 |
Device and method for measuring the diameter of an air
passageway
Abstract
The invention provides a device for measuring an inside diameter
of a body lumen, such as an air passageway. The device includes a
flexible catheter having an inflation lumen, a fluid dispenser in
fluid communication with the inflation lumen and operable to
communicate a measurable fluid volume change with the inflation
lumen, and an expandable member in fluid communication with the
inflation lumen and having a known relationship between volume and
a changeable transverse dimension, the transverse dimension being
changeable in response to fluid volume changes of the fluid
dispenser and arranged for placement adjacent to opposing portions
of an interior wall of the air passageway. The expandable member
may be dimensioned for transoral placement into the air passageway,
and may comprise a balloon that includes a complaint material.
Inventors: |
DeVore, Lauri J.; (Seattle,
WA) ; Sirokman, William A.; (Kirkland, WA) ;
Kutsko, James M.; (Woodinville, WA) ; Dillard, David
H.; (Redmond, WA) ; Westman, Peter R.;
(Seattle, WA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Assignee: |
Spiration, Inc.
|
Family ID: |
31993358 |
Appl. No.: |
10/254392 |
Filed: |
September 24, 2002 |
Current U.S.
Class: |
600/587 |
Current CPC
Class: |
A61B 5/1076
20130101 |
Class at
Publication: |
600/587 |
International
Class: |
A61B 005/103 |
Claims
What is claimed is:
1. A device for measuring an inside diameter of a body lumen, the
device comprising: a flexible catheter; and a member carried on a
distal tip of the catheter, the member having a known transverse
dimension and arranged for placement adjacent to opposing portions
of an interior wall of the body lumen.
2. A device for measuring an inside diameter of an air passageway,
the device comprising: a flexible catheter having an inflation
lumen; a fluid dispenser in fluid communication with the inflation
lumen and operable to communicate a measurable fluid volume change
with the inflation lumen; and an expandable member in fluid
communication with the inflation lumen and having a known
relationship between fluid volume and a changeable transverse
dimension, the transverse dimension being changeable in response to
fluid volume changes of the fluid dispenser and arranged for
placement adjacent to opposing portions of an interior wall of the
air passageway.
3. The device of claim 2, wherein the expandable member includes
dimensioning for transoral placement into the air passageway.
4. The device of claim 2, wherein the catheter further includes a
purge lumen.
5. The device of claim 2, wherein the catheter is adapted to be
steerable within bronchi.
6. The device of claim 2, wherein the expandable member comprises a
balloon that includes a complaint material.
7. The device of claim 2, wherein the transverse dimension of the
expandable member is arranged to have a maximum transverse
dimension of between 3 mm and 12 mm.
8. The device of claim 2, wherein the expandable member has a
collapsed configuration for placement in the air passageway and an
expanded configuration for measuring a diameter of the air
passageway.
9. The device of claim 7, wherein the expandable member is arranged
to transition from the expanded configuration to the collapsed
configuration while in the air passageway, and then to transition
from the collapsed configuration to a re-expanded configuration for
measuring the diameter of another air passageway.
10. The device of claim 2, wherein the fluid dispenser comprises a
syringe.
11. The device of claim 2, wherein the fluid dispenser includes a
piston and a proximal portion of the inflation lumen cooperatively
acting as a piston/cylinder combination arranged to communicate a
measurable fluid volume change with the remainder of the inflation
lumen.
12. The device of claim 2, wherein the fluid dispenser comprises a
syringe pump.
13. The device of claim 2, wherein the fluid dispenser further
comprises gradations corresponding to air passageway diameters.
14. The device of claim 2, wherein fluid communicated to the
expandable member includes a radiopaque contrast substance.
15. The device of claim 2, wherein the expandable member includes a
radiopaque contrast marker arranged for visualization of the
changeable transverse dimension by fluoroscopy.
16. The device of claim 2, wherein the catheter has a distal end,
and the expandable member is carried on the catheter proximal to
the distal end.
17. The device of claim 2, wherein the expandable member includes a
balloon of compliant material.
18. The device of claim 2, further including a visualization device
for observing adjacency of the transverse dimension and opposing
portions of the interior wall of the air passageway.
19. The device of claim 16, wherein the visualization device
includes a bronchoscope.
20. The device of claim 16, wherein the visualization device
includes a fluoroscope.
21. A device for measuring an inside diameter of an air passageway,
the device comprising: a flexible catheter having an inflation
lumen and a purge lumen; a fluid dispenser in fluid communication
with the inflation lumen and operable to communicate a measurable
fluid volume change with the inflation lumen; and an expandable
member in fluid communication with the inflation lumen and having a
known relationship between fluid volume and a changeable transverse
dimension, the transverse dimension being changeable in response to
fluid volume changes of the fluid dispenser and arranged for
placement adjacent to opposing portions of an interior wall of the
air passageway.
22. The device of claim 21, wherein the expandable member includes
dimensioning for transoral placement into the air passageway.
23. An assembly for use in measuring the inside diameter of an air
passageway, the assembly comprising: a flexible catheter having an
inflation lumen, the inflation lumen being arranged for fluid
coupling with a fluid dispenser operable to communicate a
measurable fluid volume change with the inflation lumen; and an
expandable member in fluid communication with the inflation lumen
and having a known relationship between fluid volume and a
changeable transverse dimension, the transverse dimension of the
expandable member being changeable in response to fluid volume
changes of the fluid dispenser and arranged for placement adjacent
to opposing portions of an interior wall of the air passageway.
24. The assembly of claim 23, wherein the expandable member is
carried on the catheter.
25. The assembly of claim 24, wherein the catheter has a distal
end, and the expandable member is carried proximate to the distal
end of the catheter.
26. The assembly of claim 23, wherein the expandable member
comprises a complaint material.
27. The assembly of claim 23, wherein the expandable member
includes a balloon of compliant material.
28. The assembly of claim 23, further including a visualization
device for observing adjacency of the transverse dimension and
opposing portions of the interior wall of the air passageway.
29. The assembly of claim 28, wherein the visualization device
includes a bronchoscope.
30. The assembly of claim 28, wherein the visualization device
includes a fluoroscope.
31. A method of measuring an inside diameter of a body lumen, the
method including the steps of: placing a member having a known
transverse dimension in the body lumen; and determining that the
known transverse dimension is adjacent to opposing portions of an
inner periphery of the body lumen.
32. A method of measuring an inside diameter of an air passageway,
the method including the steps of: placing an expandable member in
the air passageway, the expandable member changeable in a
transverse dimension and having a known relationship between fluid
volume and changeable transverse dimension; changing the changeable
transverse dimension of the expandable member to a known transverse
dimension by changing the fluid volume of the expandable member;
and determining that the known expanded transverse dimension is
adjacent to opposing portions of an inner periphery of the air
passageway.
33. The method of claim 32, including the further step of placing a
fluid dispenser operable to communicate a measurable fluid volume
change into fluid communication with the expandable member, and the
step of changing to a known transverse dimension includes the
further step of measurably changing the volume of fluid in the
expandable member with the fluid dispenser.
34. The method of claim 32, wherein the fluid dispenser comprises a
syringe.
35. The method of claim 32, wherein the fluid dispenser comprises
gradations related to air passageway diameter, and the step of
determining air passageway diameter includes the further step of
observing the gradations.
36. The method of claim 32, wherein the step of placing an
expandable member in the air passageway includes the further step
of transorally placing the expandable member in the air
passageway.
37. The method of claim 32, wherein the step of determining
includes the further step of visually observing adjacency.
38. The method of claim 37, wherein the step of visually observing
adjacency includes using a visualization device
39. The method of claim 38, wherein the visualization device
includes a bronchoscope.
40. The method of claim 38, wherein the visualization device
includes a fluoroscope.
41. The method of claim 32, wherein the expandable member includes
a radiopaque contrast substance arranged to enhance viewing the
changeable transverse dimension.
42. The method of claim 32, wherein the expandable member includes
a radiopaque contrast substance arranged to enhance viewing the
changeable transverse dimension, and further wherein the step of
determining adjacency uses fluoroscopy.
43. The method of claim 32, wherein the expandable member includes
a balloon of compliant material.
44. A device for measuring an inside diameter of an air passageway,
the device comprising: means for placing a member having a known
transverse dimension in the air passageway; and means for
determining that the known transverse dimension is adjacent to
opposing portions of an inner periphery of the air passageway.
45. A device for measuring an inside diameter of an air passageway,
the device comprising: means for placing an expandable member in
the air passageway, the expandable member changeable in a
transverse dimension and having a known relationship between volume
and changeable transverse dimension; means for changing the
changeable transverse dimension to a known transverse dimension by
changing the volume of the expandable member; and means for
determining that the known transverse dimension is adjacent to
opposing portions of an inner periphery of the air passageway.
Description
BACKGROUND
[0001] The present invention is generally directed to a device and
method for measuring the inside diameter of a body lumen and, more
particularly, of air passageways. The present invention is more
particularly directed toward measuring an inside diameter of an air
passageway by transorally inserting a balloon having a known
volume-to-diameter relationship in the air passageway, expanding
the balloon with a volume of fluid to a known transverse diameter,
and determining that the transverse diameter is adjacent to
opposing portions of an interior wall of the air passageway.
[0002] Several emerging technologies employ devices placed in the
air passageways to diagnose and treat conditions of the lung,
conditions of organs and body structures that are in proximity to
the lungs, and conditions that are systemic. For example, a
treatment for Chronic Obstructive Pulmonary Disease (COPD) involves
placing obstructing devices in selected air passageways to collapse
lung portions distal of the obstructing devices. The devices are
typically placed in air passageways between approximately 4 and 10
mm in diameter.
[0003] The performance of intra-bronchial devices may be enhanced
by sizing the device to fit the air passageway. However, no method
or device presently exists for determining the inside diameter of
an air passageway. There is a need in the art for quickly and
economically measuring the inside diameter of an air passageway to
assist in selecting the size of an obstructing device.
[0004] In view of the foregoing, there is a need in the art for a
new and improved apparatus and method for measuring the inside
diameter of air passageways.
SUMMARY
[0005] The invention provides a device for measuring an inside
diameter of a body lumen, such as an air passageway. The device
includes a flexible catheter, and a member carried on a distal tip
of the catheter, the member having a known transverse dimension and
arranged for placement adjacent to opposing portions of an interior
wall of the air passageway.
[0006] The invention further provides a device for measuring the
diameter of an air passageway. The device includes a flexible
catheter having an inflation lumen, a fluid dispenser in fluid
communication with the inflation lumen and operable to communicate
a measurable fluid volume change with the inflation lumen, and an
expandable member in fluid communication with the inflation lumen
and having a known relationship between fluid volume and a
changeable transverse dimension, the transverse dimension being
changeable in response to fluid volume changes of the fluid
dispenser and arranged for placement adjacent to opposing portions
of an interior wall of the air passageway. The expandable member
may include a balloon of compliant material. The expandable member
may be dimensioned for transoral placement into the air passageway.
The expandable member may have a collapsed configuration for
placement in the air passageway and an expanded configuration for
measuring a diameter of the air passageway. The expandable member
may be arranged to transition from an expanded configuration to a
collapsed configuration while in the air passageway, and then to
transition from the collapsed configuration to a re-expanded
configuration for measuring the diameter of another air passageway.
The catheter may include configuration to be steerable within
bronchi. The catheter may include an expansion lumen and a purge
lumen. The transverse dimension of the expandable member may be
arranged to have a maximum transverse dimension of between 3 mm and
12 mm. The fluid dispenser may comprise a syringe or a syringe
pump, and may further include gradations corresponding to air
passageway diameters. The fluid dispenser may include a piston and
a proximal portion of the inflation lumen cooperatively acting as a
piston/cylinder combination arranged to communicate a measurable
fluid volume change with another portion of the inflation lumen in
communication with the expandable member. The fluid communicated to
the expandable member may include a radiopaque contrast substance.
The expandable member may include a radiopaque contrast marker
arranged for visualization of the changeable transverse dimension
by fluoroscopy. The catheter may have a distal end, and the
expandable member may be carried on the catheter proximal to the
distal end. The device may further include a visualization device
for observing adjacency of the transverse dimension and opposing
portions of the interior wall of the air passageway. The
visualization device may include a bronchoscope or a
fluoroscope.
[0007] The invention still further provides an assembly for
measuring an inside diameter of an air passageway. The assembly
includes a flexible catheter having an inflation lumen, the
inflation lumen being arranged for fluid coupling with a fluid
dispenser operable to communicate a measurable fluid volume change
with the inflation lumen, and an expandable member in fluid
communication with the inflation lumen and having a known
relationship between fluid volume and a changeable transverse
dimension, the transverse dimension of the expandable member being
changeable in response to fluid volume changes of the fluid
dispenser and arranged for placement adjacent to opposing portions
of an interior wall of the air passageway. The expandable member
may be carried on the catheter. The catheter may have a distal end,
and the expandable member may be carried proximate to the distal
end of the catheter. The expandable member may comprise a complaint
material, and may be a balloon. The assembly may further include a
visualization device for observing adjacency of the transverse
dimension and opposing portions of the interior wall of the air
passageway. The visualization device may include a bronchoscope or
a fluoroscope.
[0008] The invention also provides a method of measuring an air
passageway diameter. The method includes the steps of placing a
balloon member in the air passageway having a known transverse
dimension, and determining that the known transverse dimension is
adjacent to opposing portions of an inner periphery of the air
passageway.
[0009] In accordance with one embodiment, the method includes the
steps of placing an expandable member in the air passageway, the
expandable member changeable in a transverse dimension and having a
known relationship between fluid volume and changeable transverse
dimension, changing the changeable transverse dimension of the
expandable member to a known transverse dimension by changing the
fluid volume of the expandable member, and determining that the
known expanded transverse dimension is adjacent to opposing
portions of an inner periphery of the air passageway. The method
may include the further step of placing a fluid dispenser operable
to communicate a measurable fluid volume change into fluid
communication with the expandable member, and the step of changing
to a known transverse dimension includes the further step of
measurably changing the volume of fluid in the expandable member
with the fluid dispenser. The fluid dispenser may comprise a
syringe. The fluid dispenser may include gradations related to air
passageway diameter, and the step of determining air passageway
diameter may include the further step of observing the gradations.
The step of placing an expandable member in the air passageway may
include the further step of transorally placing the expandable
member in the air passageway. The step of determining may include
the further step of visually observing adjacency, which may include
using a visualization device or a fluoroscope. The expandable
member may include a radiopaque contrast substance arranged to
enhance viewing the changeable transverse dimension, and the step
of determining adjacency may use fluoroscopy. The expandable member
may include a balloon of compliant material.
[0010] The invention further provides a device for measuring an
inside diameter of a body lumen is provided. The device includes
means for placing an expandable member having a known transverse
dimension in the air passageway, and means for determining that the
known transverse dimension is adjacent to opposing portions of an
inner periphery of the air passageway.
[0011] The invention still further provides a device for measuring
an inside diameter of an air passageway. The device includes means
for placing an expandable member in the air passageway, the
expandable member changeable in a transverse dimension and having a
known relationship between volume and changeable transverse
dimension, means for changing the changeable transverse dimension
to a known transverse dimension, and means for determining that the
known transverse dimension is adjacent to opposing portions of an
inner periphery of the air passageway.
[0012] These and various other features as well as advantages which
characterize the present invention will be apparent from reading
the following detailed description and a review of the associated
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The features of the present invention which are believed to
be novel are set forth with particularity in the appended claims.
The invention, together with further objects and advantages
thereof, may best be understood by making reference to the
following description taken in conjunction with the accompanying
drawings, in the several figures of which like referenced numerals
identify like elements, and wherein:
[0014] FIG. 1 is a sectional view of a healthy respiratory
system;
[0015] FIG. 2 is a perspective view of the bronchi emphasizing the
upper right lung lobe;
[0016] FIG. 3 illustrates a respiratory system suffering from
COPD;
[0017] FIG. 4 illustrates an air passageway inside diameter
measuring device in accordance with the present invention;
[0018] FIG. 5 illustrates an initial step in measuring an inside
diameter of an air passageway at a measuring location with the
measuring device of FIG. 4, in accordance with an aspect of the
invention;
[0019] FIG. 6 illustrates intermediate step in measuring an inside
diameter of an air passageway at measuring location with the
measuring device of FIG. 4, in accordance with an aspect of the
invention;
[0020] FIG. 7 illustrates a final step in measuring an inside
diameter of an air passageway at measuring location with the
measuring device of FIG. 4, in accordance with an aspect of the
invention; and
[0021] FIG. 8 illustrates an air passageway inside diameter
measuring device with a partial cross-section illustrating an
integral fluid dispenser, in accordance with the present
invention;
[0022] FIG. 9 illustrates an air passageway inside diameter
measuring device with a catheter having a plurality of lumens, in
accordance with the present invention. FIG. 10 is cross-sectional
view of the catheter 310: and
[0023] FIG. 10 is a cross-sectional view of the catheter of FIG. 9
illustrating the plurality of lumens.
DETAILED DESCRIPTION
[0024] In the following detailed description of exemplary
embodiments of the invention, reference is made to the accompanying
drawings, which form a part hereof. The detailed description and
the drawings illustrate specific exemplary embodiments by which the
invention may be practiced. These embodiments are described in
sufficient detail to enable those skilled in the art to practice
the invention. It is understood that other embodiments may be
utilized, and other changes may be made, without departing from the
spirit or scope of the present invention. The following detailed
description is therefore not to be taken in a limiting sense, and
the scope of the present invention is defined only by the appended
claims.
[0025] Throughout the specification and claims, the following terms
take the meanings explicitly associated herein unless the context
dictates otherwise. The meaning of "a", "an", and "the" include
plural references. The meaning of "in" includes "in" and "on."
Referring to the drawings, like numbers indicate like parts
throughout the views. The term "coupled" means either a direct
connection between the things that are coupled, or an indirect
connection through one or more intermediary devices. Additionally,
a reference to the singular includes a reference to the plural
unless otherwise stated or inconsistent with the disclosure herein.
Additionally, the term "fluid" means a substance that has no fixed
shape and yields easily to external pressure, such as a gas and
especially a liquid.
[0026] FIG. 1 is a sectional view of a healthy respiratory system.
The respiratory system 20 resides within the thorax 22 that
occupies a space defined by the chest wall 24 and the diaphragm
26.
[0027] The respiratory system 20 includes trachea 28; left mainstem
bronchus 30 and right mainstem bronchus 32 (primary, or first
generation); and lobar bronchial branches 34, 36, 38, 40, and 42
(second generation). FIG. 1 also illustrates segmental branches 44,
46, 48, and 50 (third generation). Additional sub-branches are
illustrated in FIG. 2. The respiratory system 20 further includes
left lung lobes 52 and 54 and right lung lobes 56, 58, and 60. Each
bronchial branch and sub-branch communicates with a different
portion of a lung lobe, either the entire lung lobe or a portion
thereof. As used herein, the term "air passageway" is meant to
denote either a bronchi or bronchioli, and typically means a
bronchial branch of any generation.
[0028] A characteristic of a healthy respiratory system is the
arched or inwardly arcuate diaphragm 26. As the individual inhales,
the diaphragm 26 straightens to increase the volume of the thorax
22. This causes a negative pressure within the thorax. The negative
pressure within the thorax in turn causes the lung lobes to fill
with air. When the individual exhales, the diaphragm returns to its
original arched condition to decrease the volume of the thorax. The
decreased volume of the thorax causes a positive pressure within
the thorax, which in turn causes exhalation of the lung lobes.
[0029] FIG. 2 is a perspective view of the bronchi emphasizing the
upper right lung lobe 56. In addition to the bronchial branches
illustrated in FIG. 1, FIG. 2 illustrates subsegmental bronchial
branches 80, 82, 84, 86, 88, and 89 (fourth generation) providing
air circulation to superior right lung lobe 56. The fifth- and
sixth-generation bronchial branches are illustrated, but not given
reference numbers.
[0030] The air passageways branch out, much like the roots of a
tree. The bronchial segments branch into six generations or orders,
and the bronchioles branch into approximately another three to
eight generations or orders. Typically, each generation has a
smaller diameter than its predecessor. The inside diameter of a
generation varies depending on the particular bronchial branch, and
further varies between individuals. For example, a typical lobar
bronchus 42 (third generation) providing air circulation to the
upper right lobe 56 has an internal diameter of approximately 1 cm.
A typical segmental bronchi 48 (fourth generation) has an internal
diameter of approximately 4 to 7 mm. The fifth and sixth
generations (no reference numbers) are each proportionately
smaller. The bronchial segments include annular ligaments and
irregularly located cartilages that provide structure and
resilience. The cartilages become increasingly sparse as the
bronchial segments become smaller in diameter. The bronchioles do
not have ligaments and cartilages.
[0031] FIG. 3 illustrates a respiratory system suffering from COPD.
In contrast to the lobes of FIG. 1, here it may be seen that the
lung lobes 52, 54, 56, 58, and 60 are enlarged and that the
diaphragm 26 is not arched but substantially straight. Hence, this
individual is incapable of breathing normally by moving diaphragm
26. Instead, in order to create the negative pressure in thorax 22
required for breathing, this individual must move the chest wall
outwardly to increase the volume of the thorax. This results in
inefficient breathing causing these individuals to breathe rapidly
with shallow breaths.
[0032] It has been found that the apex or segmental portions 62 and
66 of the upper lung lobes 52 and 56, respectively, are most
affected by COPD. Hence, bronchial sub-branch obstructing devices
are generally employed for treating the apex 66 of the right, upper
lung lobe 56. The insertion of an obstructing member or a plurality
of obstructing members treats COPD by deriving the benefits of lung
volume reduction surgery without the need of performing the
surgery. The intra-bronchial obstructions may be anchored in the
air passageway to prevent movement or expulsion. In addition to
treating COPD, it is presently contemplated that the
intra-bronchial obstructions will be used for other purposes,
including delivery of therapeutic substances.
[0033] The COPD treatment contemplates permanent collapse of a lung
portion using at least one intra-bronchial obstruction. The
collapse leaves extra volume within the thorax for the diaphragm to
assume its arched state for acting upon the remaining healthier
lung tissue. This should result in improved pulmonary function due
to enhanced elastic recoil, correction of ventilation/perfusion
mismatch, improved efficiency of respiratory musculature, and
improved right ventricle filling. The treatment of COPD may include
several intra-bronchial obstructing members being inserted in air
passageways to form a redundant array. For example, if the volume
of apex 66 of the right, upper lung lobe 56 were to be reduced,
obstructing devices may be deployed in the four, fifth-generation
air passageways branching off of the fourth-generation bronchial
branches 80 and 82, redundant obstructing members placed in the
fourth-generation bronchial branches 80 and 82, and another
redundant obstructing member placed in the third-generation branch
50.
[0034] The physical characteristics of the obstructing devices
currently available limit the range of air passageway diameters
that a particular device can obstruct. The limiting characteristics
include both the range of air passageway diameters that a single
device can obstruct, and the range of air passageway diameters that
can be engaged by anchors of the obstructing device. Use of anchors
can allow the obstructing member to be relatively loosely fitted
against the air passageway wall, which may preserve mucociliary
transport of mucus and debris out of the collapsed lung portion.
Thus, obstructing devices are provided in a variety of sizes for
the various sizes of air passageways.
[0035] The present invention supports the use of intra-bronchial
obstructing devices by enabling the inside diameter of the air
passageway to be measured so that an appropriately sized
obstructing device may be selected. As will be appreciated by those
skilled the in art, the present invention may be used in
conjunction with placing any type of obstructing member in an air
passageway, including a plug, or a member that allows air passage
in one direction but not another.
[0036] FIG. 4 illustrates an air passageway inside diameter
measuring device 100, in accordance with the present invention.
Measuring device 100 includes a fluid dispenser 102, a fluid 108, a
flexible catheter 110, stopcocks 111 and 113, a junction fitting
116, and an expandable member 120.
[0037] The fluid dispenser (illustrated as a syringe 102) may be
any device known in the art suitable for ejecting a measurable
volume of the fluid 108 in amounts necessary to fill the expandable
member 120. The fluid dispenser may be manually, mechanically, or
electrically operated, or some combination thereof. The fluid
dispenser may include a syringe, a syringe pump, or other
piston/cylinder arrangement, or may be a deformable compartment or
chamber. The fluid dispenser may be a separate device from the
flexible catheter 110, or may be incorporated into it. The syringe
102 of FIG. 4 includes visually readable gradations 106 that
correspond to air passageway diameters, and is illustrated with air
passageway diameters ranging between zero and 10 mm. The gradations
106 may reflect any range of anticipated air passageway diameters.
The syringe 102 also includes a handle 104 connected to a piston
105, and arranged such that moving the handle 104 transmits the
motion to the piston 105, and the motion is further transmitted to
the fluid 108.
[0038] The fluid 108 may be any fluid suitable for use within the
human body, such as a saline solution. A gas may be used, but a
liquid is preferred to provide ease of use and readability in the
syringe 102. The fluid 108 may include a radiopaque contrast
substance, such as diatrizoates and lohexol.
[0039] The flexible catheter 110 may be any flexible, steerable,
elongated tubular member arranged for transoral or transnasal
insertion into an air passageway, and may be made from any suitable
material known in the art, such as polyethylene. The catheter 110
includes an inflation lumen 112 arranged to be in fluid
communication with the syringe 102. The catheter 110 is also
arranged to carry and be in fluid communication with the expandable
member 120. In an embodiment, catheter 110 has an external diameter
of approximately 2 mm. The catheter 110 may include opaque markings
visible under fluoroscopy, such as gold or stainless steel, or
other markings visible under other visualization methods.
[0040] The stopcocks 111 and 113 can be opened and closed by
operating handles 115 and 114 respectively. The stopcocks 111 and
113 may be made from any material suitable for extracorporeal use.
Tubular member 118 is used to direct any fluid 108 drained from the
device 100.
[0041] The expandable member (illustrated as expandable balloon
120) includes a changeable transverse dimension 126, an outer
periphery 122 of the changeable transverse dimension 126, and an
interior inflatable cavity (not shown). The inflatable balloon 120
is generally arranged for intra-bronchial use, and may be made of
any thin, flexible complaint or elastic surgical material suitable
for use in air passageways known in the art, such as polyurethane,
silicone, and natural latex used for low pressure balloons. The
compliant material provides a measurable or determinable
relationship between balloon volume and the changeable transverse
dimension 124. Balloon 120 may have any transverse cross-sectional
shape that can be expanded adjacent to opposing portions of an air
passageway wall. For example, while balloon 120 is generally
described herein as having a round, expanded cross-section with a
generally uniform single transverse dimension, the balloon 120 may
be any shape having a transverse dimension that can be expanded to
contact opposing portions of an interior wall of an air passageway.
For example, the balloon 120 may be an ellipsoidal transverse
cross-section having a changeable transverse dimension that is
expandable adjacent to opposing portions of an interior wall of air
passageway 81. For purposes of clarity, aspects of the invention
are described herein using a balloon 120 that expands into a round
cross-section having an expanded transverse dimension that is a
diameter. However, as stated above, the invention is not so
limited. The balloon 120 may be carried on the distal end of the
catheter 110, or proximate to the distal end of the catheter
110.
[0042] In FIG. 4, the balloon 120 is illustrated in a partially
expanded state. The balloon 120 and the catheter 110 are arranged
for transoral placement into an air passageway using minimally
invasive methods, such as a working lumen of a bronchoscope. The
balloon 120 has a deflated configuration for insertion and passage
through a working lumen, and for movement within air passageways.
In its deflated state, the balloon 120 is approximately 10 mm in
length and has a collapsed diameter suitable for passage through a
working channel of a bronchoscope, which presently is approximately
2-3 mm. In its expanded state, the balloon 120 should be capable of
expanding to more than the anticipated cross-sectional area of the
air passageway being measured. Typically, the air passageway inside
diameters being measured are not expected to exceed 10 mm in
diameter, so the balloon 120 may have an maximum expanded diameter
of approximately 12 mm. Because the air passageway diameter changes
noticeably over a short distance, both the deflated and inflated
lengths of the balloon are minimized so that a measurement for a
particular location is not affected by the distal narrowing or
proximal widening.
[0043] Junction fitting 116 has a single lumen that fluid couples
the lumen 112 of catheter 110 to the lumens of stopcocks 111 and
113. The fluid 108 contained in syringe 102 is fluid coupled to the
interior cavity of balloon 120 through the lumen of stopcock 113
and the lumen 112 of catheter 110. The fluid coupling creates fluid
communication between the syringe 102 and the balloon 120 such
that, when stopcock 113 is open, any change in the fluid volume of
the syringe 102 is inversely translated into a change in the fluid
volume of the balloon 120. The fluid 108 and any air contained in
the interior cavity of balloon 120 or lumen 112 may be drained
through the lumen of stopcock 111 and out tubular member 118 by
moving handle 115 to an open position.
[0044] The air passageway diameter gradations 106 may be marked in
millimeter gradations on the syringe 102 because the compliant
material used for the balloon 120 provides a known relationship
between the volume of the balloon 120 and its. transverse dimension
124. The known relationship continues to at least when the balloon
120 is initially expanded adjacent to opposing portions of an
interior wall of the air passageway. The gradations 106 may start
at "0" or another convenient increment such as 2 mm, and are
calibrated to correspond to the transverse dimension of the
expanded balloon 120, and thus the air passageway. As the handle
104 is pushed from the starting gradation, a measurable volume of
the fluid 108, reflected by the other gradations of the gradations
106, is ejected from the syringe 102 and forced into the balloon
120 through fluid communication by the lumen 112 of catheter 110.
Because the relationship between the volume and the changeable
transverse dimension of the balloon 120 is known, the transverse
dimension 124 of the expanded balloon 120 is known from the volume
of the fluid 108 ejected from the syringe 102. The transverse
dimension 124 is known or determined by observing the location of
the syringe piston 105 with respect to the gradations 106. The
gradations 106 may be marked in volume gradations, such as
milliliters, and a conversion table used to convert volume to
transverse dimension 124.
[0045] Correlation between volume and transverse dimension 124 for
a particular balloon configuration may be established using a test
bench. Balloon 120 is expanded in a series of openings with several
known diameters, and a correlation is established between the
expanded volumes of the test balloon 120 and the several known
diameters. The syringe gradations 106 are established correlating
the volume of the fluid 108 displaced by movement from the "0"
gradation with the known diameter. Each individual measuring device
100 may have its gradations determined on a test bench.
Alternatively, the physical parameters of the syringe 102 and the
balloon 120 may be standardized, allowing standardized gradation
markings 106.
[0046] FIG. 5 illustrates an initial step in measuring an inside
diameter 126 of an air passageway 81 at a measuring location 128
with the measuring device 100 of FIG. 4, in accordance with an
aspect of the invention. In an embodiment, the measuring device 100
is provided with its elements fluid coupled together and filled
with fluid 108. The syringe 102, the lumen 112, and the collapsed
balloon 120 are filled with saline solution as fluid 108, and any
air bubbles in the fluid 108 have been removed. Further, the device
100 may be generally provided with the balloon 120 deflated to a
minimum transverse dimension 124 of about 2 mm for insertion and
movement, all air bubbles eliminated from the fluid 108, and the
syringe piston 105 aligned with a gradation 106 representing the
transverse dimension 124. For clarity, inside diameter 126 is
illustrated slightly displaced from measuring location 128.
However, it is contemplated that measuring device 100 will measure
the inside diameter 126 at the measuring location 128.
[0047] An initial step includes transorally placing the distal end
of catheter 110 and the balloon 120 into the trachea 28 and
steering them into the air passageway 81 of the bronchus 80 to the
measuring location 128. This may be accomplished by any method
and/or device known in the art. The catheter 110 may be steered
into air passageway 81 by being carried in a working lumen 134 of a
bronchoscope 130; associated with and then steered by the
bronchoscope 130; inserted after the bronchoscope 130 is proximate
to the measuring location 128 and steered adjacent to the shaft of
the bronchoscope 130; or steered using imaging/visualization
techniques, such as computed tomography or radiography.
[0048] Continuing with FIG. 5, an embodiment is illustrated where a
distal tip of the bronchoscope 134 has been steered into air
passageway 81 for dimensioning. Once the distal tip is in proximity
to measuring location 128, another step includes deploying the
balloon 120 and the distal end of the catheter 110 from the working
lumen 134. The deployment may be observed with viewing element 132
of the bronchoscope 130. A further initial step includes advancing
the balloon 120 until its transverse dimension 124 is about a
balloon length proximal of the measuring location 128.
[0049] FIG. 6 illustrates another step in measuring an inside
diameter 126 of an air passageway 81 at measuring location 128 with
measuring device 100 of FIG. 4, in accordance with an aspect of the
invention. An intermediate step includes expanding the balloon 120
in the air passageway 81 to a first trial transverse dimension of
the transverse dimension 124. The expansion is by opening stopcock
113 and advancing the handle 105 of the syringe 102 to eject a
known volume of the fluid 108 into the inflation lumen 112 and
correspondingly into the balloon 120. The ejected volume and
resulting first trial transverse dimension are known by the
gradations 106. The endoscopist may select the first trial
transverse dimension to be slightly less than an estimated air
passageway inside diameter 126. The endoscopist may estimate an air
passageway inside diameter 126 based on the particular bronchial
branch diameter to be measured. For example, if the targeted
bronchial branch usually has air passageway inside diameter 126
between five and six millimeters, a first trial transverse
dimension of four millimeters may be selected. In such a case, the
stopcock handle 114 is moved to an open position, and the handle
104 pressed until the plunger 105 aligns with the 4 mm gradient of
gradations 106. The stopcock handle 114 is then moved to a closed
position, preventing the compliant characteristic of balloon 120 or
contact with the air passageway 81 from forcing fluid 108 back into
the syringe 102.
[0050] Another step includes advancing the balloon 120 distally
within the air passageway 81 until the transverse dimension 124 is
proximate to the measuring location 128. The viewing element 132 is
used to visually examine the periphery 122 of the balloon 120 at
transverse dimension 124 to determine whether first trial
transverse dimension is adjacent to the inside wall of the air
passageway 81. As used herein, "adjacent" or "adjacency" means
closing the space between the periphery 122 of the balloon 120 at
transverse dimension 124 and an interior periphery of an interior
wall of the air passageway 81. FIG. 6 illustrates a situation where
the first trial transverse dimension of 4 mm does not result in the
transverse dimension 124 being adjacent to opposing portions of an
inner periphery of the air passageway wall 81. Failure of first
trial transverse dimension 124 to achieve adjacency is observed
through the viewing element 132. The endoscopist may select a
second trial transverse dimension, which may be 5 mm based on the
separation observed between the periphery 122 and the inner
periphery of the air passageway wall 81.
[0051] FIG. 7 illustrates a final step in measuring an inside
diameter 126 of an air passageway 81 at measuring location 128 with
measuring device 100 of FIG. 4, in accordance with an aspect of the
invention. The balloon 120 is retracted from measuring location 128
by about a balloon 120 length to allow room to change to the second
trial transverse dimension, which is 5 mm in the example being
illustrated herein. To change the transverse dimension 124 to the
second trial transverse dimension, the endoscopist changes the
volume of fluid 108 in the balloon 120 in substantially the same
manner as the first trial transverse dimension was established. If
the first trial transverse dimension had been larger than the
inside diameter 126, the handle 104 would be retracted until the
piston 105 aligns with a different second trial transverse
dimension.
[0052] Another step includes re-advancing the balloon 120 distally
within the air passageway 81 as before until the transverse
dimension 124 is located at the measuring location 128. The viewing
element 132 is used to visually examine the periphery 122 of the
balloon 120 at transverse dimension 124 to determine whether second
trial transverse dimension 124 is adjacent to the inside wall of
the air passageway 81. FIG. 7 illustrates the transverse dimension
124 adjacent to opposing portions of an inner periphery of the air
passageway 81. If adjacency is not achieved, the endoscopist
selects additional trial transverse dimensions and continues as
described above until adjacency is achieved.
[0053] When the periphery 122 of transverse dimension 124 is
adjacent to an interior periphery 81 of the air passageway 80, the
expanded transverse dimension 124 of the balloon 120 is the same as
the inside diameter 126 of the air passageway 81. In the embodiment
illustrated in FIG. 7, adjacency between the periphery 122 of the
balloon 120 and the inside wall of the air passageway 81 at
measuring location 128 is visually confirmed by observation through
the viewing element 132 of the bronchoscope 130. When adjacency
exists, the diameter 126 at measuring location 128 is read by the
alignment of the syringe piston 105 with one or more of the
gradations 106, which would be 5 mm in the example. When the
balloon 120 has an expandable transverse cross-section that is not
round, the changeable transverse dimension 124 is expanded to a
point where a portion of its periphery 122 at the measuring
location 128 is adjacent to opposing portions of the interior
periphery 81 of the interior wall of the air passageway 80.
[0054] After the measurement is taken, the measuring device 100 is
arranged to allow the balloon 120 to be deflated by opening
stopcock 113 and drawing the fluid 108 back into the syringe 102
while the balloon 120 is within the air passageway 81. The catheter
110 and the deflated balloon 120 may then be steered to another
measuring location to measure another air passageway diameter
126.
[0055] FIG. 8 illustrates an air passageway inside diameter
measuring device 200 with a partial cross-section illustrating an
integral fluid dispenser 210, in accordance with the present
invention. Measuring device 200 is structurally, functionally, and
operationally similar to measuring device 100 of FIG. 4, except
that it includes an integral fluid dispenser 210 instead of an
external fluid dispenser.
[0056] Integral fluid dispenser 210 includes shaft 103, handle 104,
piston 105, visually readable gradations 106, a portion of the
proximal portion of lumen 112, and an index mark or point 107. The
structure for changing the fluid volume of the integral fluid
dispenser 210 is formed by the piston 105 and a proximal portion
lumen 112 cooperatively acting as a piston/cylinder combination for
communicating a measurable volume of fluid 108 into the interior
inflatable cavity of balloon 120. Shaft 103 rigidly couples handle
104 to piston 105. Gradations 106 are incorporated into shaft 103,
and read by alignment with index point 107 on the proximal end of
catheter 110 in substantially the same manner as the gradations 106
of device 100 are read by alignment with the piston 105.
[0057] In operation, measuring device 200 and fluid dispenser 210
are arranged and function substantially similarly to measuring
device 100 and its syringe as described in conjunction with FIGS.
4-7. When the handle 104 is advanced, the piston 105 communicates a
measurable fluid volume change with the balloon 120, which is
represented by gradations 106.
[0058] FIGS. 9 and 10 illustrate an air passageway inside diameter
measuring device 300 with a catheter 310 having a plurality of
lumens 312 and 314, in accordance with the present invention. FIG.
10 is a cross-sectional view of the catheter 310. Measuring device
300 is substantially similar in materials, arrangement, and
operation to measuring device 100. Catheter 310 of measuring device
300 includes two lumens, inflation lumen 312 and purge lumen 314.
Junction fitting 316 has two lumens that individually are in fluid
communication with lumens 312 and 314, one lumen arranged to fluid
couple the purge lumen 314 to the stopcock 111, and the other lumen
arranged to fluid couple the inflation lumen 312 to the stopcock
113.
[0059] In operation, the purge lumen 314 promotes flow of entrapped
air out of the syringe 102, catheter 310, and the balloon 120. A
source of fluid 108 for purging, which may be a syringe similar to
the syringe 102, is fluid coupled to junction fitting 316 and lumen
312. Stopcocks 111 and 113 are opened by appropriately moving
handles 115 and 114 respectively, and fluid 108 is ejected from the
syringe and flowed through collapsed balloon 120 to purge air from
measuring device 300. Air and fluid 108 are drained from the
measuring device 300 from the lumen of stopcock 111 at tubular
member 118. The presence of the lumen 312 for communicating fluid
108 into the balloon 120 and the lumen 314 for purging air and
fluid 108 from the balloon 120 facilitate purging entrapped air
from the device 300. Once all air is purged, stopcocks 111 and 113
are closed. The purging source of fluid 108 is removed from
junction fitting 316, and syringe 102 is then coupled. Measuring
device 300 can then be used to measure the inside diameter of a
body lumen as described in conjunction with measuring device 100.
The above description includes embodiments of the invention
providing a device and method for measuring an inside diameter of a
body lumen, such as an air passageway in conjunction with placing
an obstructing or valving device in the air passageway to reduce
lung volume. However, the invention is not so limited. Other
embodiments of the invention may be used to measure the inside
diameter of an air passageway for placing other types of devices
having other treatment objectives. Further, other embodiments of
the invention may be used to measure a diameter of any body lumen
for any procedure, including preparation for implanting a device or
other medical procedure.
[0060] Although the present invention has been described in detail
with reference to certain preferred embodiments, other embodiments
are possible. Therefore, the spirit or scope of the appended claims
should not be limited to the description of the embodiments
contained herein. It is intended that the invention resides in the
claims hereinafter appended.
* * * * *