U.S. patent application number 10/241733 was filed with the patent office on 2003-03-20 for method and apparatus for endobronchial diagnosis.
This patent application is currently assigned to Pulmonx. Invention is credited to Kotmel, Robert, Perkins, Rodney, Soltesz, Peter, Wondka, Anthony.
Application Number | 20030051733 10/241733 |
Document ID | / |
Family ID | 23238603 |
Filed Date | 2003-03-20 |
United States Patent
Application |
20030051733 |
Kind Code |
A1 |
Kotmel, Robert ; et
al. |
March 20, 2003 |
Method and apparatus for endobronchial diagnosis
Abstract
The present invention provides systems, methods, devices and
kits for assessing the level of pulmonary disease in individual
lung compartments. A lung compartment comprises a subportion of a
lung, such as a lobe, a segment or a subsegment, for example. By
measuring individual lung compartments, the level of disease of the
pulmonary system may be more precisely defined by determining
values of disease parameters reflective of individual subportions
or compartments of a lung. Likewise, compartments may be separately
imaged to provide further measurement information. Once individual
compartments are characterized, they may be compared and ranked
based on a number of variables reflecting, for example, level of
disease or need for treatment. Such comparison may be aided by
simultaneous display of such variables or images on a visual
display. Further, the same tests may be performed on the lung as a
whole or on both lungs and to determine the affect of the diseased
lung compartments on the overall lung performance. In addition, the
diseased lung compartments may be temporarily isolated and the
measurement tests performed to determine the affect of the
isolation on overall lung performance. As a result, the most
beneficial treatment options may be selected.
Inventors: |
Kotmel, Robert; (Burlingame,
CA) ; Soltesz, Peter; (San Jose, CA) ; Wondka,
Anthony; (Mountain View, CA) ; Perkins, Rodney;
(Woodside, CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Assignee: |
Pulmonx
1049 Elwell Court
Palo Alto
CA
94303
|
Family ID: |
23238603 |
Appl. No.: |
10/241733 |
Filed: |
September 10, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60318539 |
Sep 10, 2001 |
|
|
|
Current U.S.
Class: |
128/207.14 |
Current CPC
Class: |
A61B 5/085 20130101;
A61M 16/0459 20140204; A61B 5/082 20130101; A61B 6/481 20130101;
A61B 5/087 20130101; A61B 6/485 20130101; A61M 25/0026 20130101;
A61M 16/04 20130101; A61B 5/6853 20130101; A61B 5/742 20130101;
A61M 16/0486 20140204; A61M 16/0404 20140204; A61M 2025/1052
20130101; A61B 8/12 20130101; A61B 5/7278 20130101; A61M 16/0434
20130101; A61B 5/0813 20130101; A61B 5/055 20130101; A61M 25/10
20130101; A61B 2562/0247 20130101; A61B 5/083 20130101; A61B 5/08
20130101; A61M 2016/0413 20130101 |
Class at
Publication: |
128/207.14 |
International
Class: |
A61M 016/00 |
Claims
What is claimed is:
1. A pulmonary diagnostic system comprising: at least one sensor
which generates measurement data reflecting a respiratory feature
of a lung compartment; an endobronchial pulmonary diagnostic device
connectable with a pulmonary catheter which is configured for
accessing the lung compartment, the device comprising means for
transferring fluid or gas to or from the lung compartment through
the pulmonary catheter, means for receiving the measurement data
from the sensor, and means for processing the measurement data; and
at least one data receiving component which receives the processed
data.
2. A system as in claim 1, wherein the respiratory feature
comprises pressure, flow rate, velocity, oxygen concentration,
carbon dioxide concentration, or noble gas concentration.
3. A system as in claim 1, wherein the means for processing the
measurement data comprises an analyzing means which analyzes the
measurement data.
4. A system as in claim 3, wherein the measuring component
comprises a visual display which displays the processed data in
visual form.
5. A system as in claim 4, wherein the visual form includes graphs,
charts, tables, numbers, images, or figures.
6. A system as in claim 3, wherein the analyzing means calculates
an average pressure value, a volume value, compliance value, an
average tidal volume value, and a resistance value.
7. A system as in claim 1, wherein the means for processing the
measurement data converts the measurement data into a computer
readable format.
8. A system as in claim 7, wherein the data receiving component
comprises a recording means which records the measurement data onto
computer readable medium.
9. A system as in claim 8, wherein the computer readable medium
comprises disks, diskettes, CD-ROMs and tapes.
10. A system as in claim 1, further comprising at least one
measuring component comprising a source of the fluid or gas and a
means for generating flow of the fluid or gas.
11. A system as in claim 10, wherein the means for transferring
fluid or gas comprises a conduit between the means for generating
flow and the catheter.
12. A system as in claim 10, wherein the gas comprises air, oxygen,
carbon dioxide, noble gas, radiopaque gas, polarized gas or a
mixture of any of these.
13. A system as in claim 10, wherein the fluid comprises radiopaque
contrast solution, water, or ultrasonic imaging fluid.
14. A system as in claim 1, wherein the means for transferring
fluid or gas comprises a source of the fluid or gas and a means for
generating flow of the fluid or gas.
15. A system as in claim 14, wherein the gas comprises air, oxygen,
carbon dioxide, noble gas, radiopaque gas, polarized gas or a
mixture of any of these.
16. A system as in claim 14, wherein the fluid comprises radiopaque
contrast solution, water, or ultrasonic imaging fluid.
17. A system as in claim 1, further comprising the pulmonary
catheter.
18. A system as in claim 17, wherein the sensor is disposed on or
in the pulmonary catheter.
19. A system as in claim 18, wherein pulmonary catheter has a
proximal end connectable with the device and a distal tip and
wherein the sensor is disposed near the distal tip.
20. A system as in claim 1, wherein the sensor is disposed within
the device.
21. A system as in claim 1, further comprising at least one
measuring component and wherein the sensor is disposed within the
measuring component.
22. A pulmonary diagnostic system comprising: at least one pressure
sensor which generates pressure measurement data reflecting the
pressure within a lung compartment; at least one flow sensor which
generates flow measurement data reflecting flow to or from the lung
compartment; a physiological testing unit comprising a source of
fluid or gas, means for generating flow of the fluid or gas, means
for receiving the pressure and flow measurement data from the
sensors, and means for processing the pressure and flow measurement
data; a data receiving component which receives the processed
pressure and flow measurement data; and an endobronchial pulmonary
diagnostic device connectable with the physiological testing unit,
the measuring component and a pulmonary catheter which is
configured for accessing the lung compartment, the device
comprising means for transferring the fluid or gas to or from the
lung compartment, and means for controlling the generation of flow
and the receiving of pressure and flow measurement data by the
physiological testing unit and the receiving of processed pressure
and flow measurement data by the measuring component.
23. A system as in claim 22, wherein the means for processing the
pressure and flow measurement data comprises an analyzing means
comprising means for calculating volume measurement data from the
flow measurement data and means for generating a pressure-volume
curve from the pressure and volume measurement data.
24. A system as in claim 23, wherein the data receiving component
comprises a visual display which displays the pressure-volume
curve.
25. A system as in claim 23, wherein the analyzing means further
comprises means for calculating a compliance value.
26. A system as in claim 23, wherein the analyzing means further
comprises means for calculating a compliance value, average tidal
volume value or resistance value with the use of the pressure and
volume measurement data.
27. A system as in claim 22, further comprising a sensor which
measures the concentration of a gas, a gas dilution unit
connectable with the device comprising a source of noble gas, means
for generating flow of the noble gas, means for receiving the gas
concentration measurement data from the sensor, and means for
processing the gas concentration measurement data.
28. A system as in claim 27, wherein the measuring component
further receives the processed gas concentration measurement data,
and the device further comprises means for controlling the
generation of flow of the noble gas and the receiving of gas
concentration measurement data by the gas dilution unit and the
receiving of processed gas concentration measurement data by the
measuring component.
29. A system as in claim 27, wherein the sensor which measures the
concentration of gas comprises a membrane chemical transfer sensor,
a photochemical reaction sensor, an electropotential sensor, a
microchip, a laser diode, an optical transmittance sensor or a
piezoelectric sensor.
30. A system as in claim 27, wherein the means for processing the
gas concentration measurement data comprises an analyzing means
comprising means for calculating the initial volume of air in the
compartment using the gas concentration measurement data.
31. A system as in claim 22, further comprising an imaging unit
connectable with the device comprising a source of imaging fluid or
gas, and means for generating flow of the imaging fluid or gas.
32. A system as in claim 31, wherein the imaging unit or the device
is connectable with a mechanism for generating at least one image
of the compartment.
33. A system as in claim 32, wherein the measuring component
further comprises means for receiving the image and the device
further comprises means for controlling the generation of flow of
the imaging fluid or gas and the receiving of the image by the
measuring component.
34. A system as in claim 32, wherein the fluid or gas is radiopaque
and the image is generated with the use of fluoroscopy.
35. A system as in claim 32, wherein the fluid or gas is polarized
and the image is generated with the use of magnetic resonance
imaging.
36. A system as in claim 32, wherein the fluid is ultrasonic
imaging fluid and the image is generated with the use of
ultrasound.
37. A system as in claim 32, wherein the mechanism generates more
than one image of the compartment and the measuring component
further comprises means for generating a three dimensional
composite image of the compartment from the images.
38. A pulmonary diagnostic system comprising: a pulmonary catheter
configured for accessing a lung compartment through a lung
passageway; at least one velocity sensor disposed near the tip of
the catheter which generates air velocity measurement data
characterizing the lung compartment; an endobronchial pulmonary
diagnostic device connectable with the catheter comprising means
for receiving the measurement data from the sensor, and means for
processing the measurement data; and at least one data receiving
component which receives the processed data.
39. A pulmonary diagnostic system comprising: a pulmonary catheter
configured for accessing a lung compartment through a lung
passageway; at least one signal emitting sensor disposed on the
catheter; at least one receiver positionable on the exterior of a
body which receives the signal emitted from the sensor to generate
resistivity measurement data; an endobronchial pulmonary diagnostic
device connectable with the catheter and the receiver comprising
means for receiving the measurement data from the receiver, and
means for processing the measurement data; and at least one data
receiving component which receives the processed data.
40. A system as in claim 39, wherein the means for processing the
measurement data comprises an analyzing means which analyzes the
measurement data.
41. A system as in claim 40, wherein the compartment comprises lung
tissue and the means for analyzing means calculates the resistance
of the lung tissue of the compartment.
42. A pulmonary diagnostic system comprising: a pulmonary catheter
configured for accessing a lung compartment through a lung
passageway; at least one signal emitting sensor disposed on the
catheter; a mapping unit connectable with the device comprising
means for receiving the signal from the sensor, and means for
processing the signal; at least one data receiving component which
receives the processed signal; and an endobronchial pulmonary
diagnostic device connectable with the catheter, the mapping unit
and the data receiving component comprising means for controlling
the receiving of the processed signal by the data receiving
component.
43. A system as in claim 42, wherein the means for processing the
signal comprises analyzing means which analyzes the signal to
determine the location of the sensor when within the lung
passageway.
44. A system as in claim 43, wherein the data receiving component
comprises a visual display which displays the location of the
sensor in visual form.
45. A method for assessment of a lung compartment comprising the
steps of: providing a pulmonary diagnostic system comprising an
endobronchial pulmonary diagnostic device and at least one
measuring component connected with the device; connecting a
pulmonary catheter to the device, said catheter having a proximal
end and a distal end; introducing the distal end of the catheter to
a compartment of a lung; and generating measurement data
characterizing the compartment of the lung with the pulmonary
diagnostic system.
46. A method as in claim 45, wherein the compartment comprises a
lung segment and introducing comprises advancing the distal end
through a bronchial passageway to the lung segment.
47. A method as in claim 45, wherein the compartment comprises a
lung lobe and introducing comprises advancing the distal end
through a bronchial passageway to the lung lobe.
48. A method as in claim 45, wherein the measuring component
comprises a pulmonary mechanics unit and the step of generating
measurement data comprises generating pressure data or volume data
characterizing the compartment.
49. A method as in claim 45, wherein the measuring component
comprises a physiological testing unit and the step of generating
measurement data comprises generating airflow movement data
characterizing airflow into or out of the compartment, generating
oxygen saturation data, generating carbon dioxide saturation data,
or generating electrophysiological measurements characterizing the
lung compartment.
50. A method as in claim 45, wherein the measuring component
comprises a gas dilution unit and the step of gathering measurement
data comprises performing functional residual capacity testing.
51. A method as in claim 45, wherein the measuring component
comprises an imaging unit and the step of gathering measurement
data comprises generating at least one image of the lung
compartment.
52. A method as in claim 51, wherein the step of gathering
measurement data further comprises combining images to generate a
composite three-dimensional image of the lung compartment.
53. A method as in claim 45, wherein the measuring component
comprises a mapping unit and the step of generating measurement
data comprises generating positioning data reflecting the position
of the catheter in the compartment.
54. A method as in claim 45, wherein the pulmonary diagnostic
system further comprises a data receiving component comprising a
visual display and the step of generating measurement data
comprises displaying the measurement data characterizing the
compartment on the visual display.
55. A method as in claim 45, further comprising: repositioning the
catheter to another compartment of the lung; and generating
measurement data characterizing the another compartment of the lung
with the use of the pulmonary diagnostic system.
56. A method as in claim 55, wherein the pulmonary diagnostic
system further comprises a data receiving component comprising a
visual display, the method further comprising displaying the data
characterizing the compartment and the other compartment on the
visual display.
57. A method as in claim 56, wherein the step of displaying the
data comprises simultaneously displaying the data characterizing
the compartment and the other compartment.
58. A method as in claim 55, further comprising comparing the data
characterizing the compartment and the other compartment to each
other.
59. A method as in claim 58, further comprising ranking the
compartments.
60. A method as in claim 45, further comprising performing lung
volume reduction treatment to reduce the compartment.
61. A method for assessment of a lung comprising the steps of:
providing a pulmonary diagnostic system comprising an endobronchial
pulmonary diagnostic device and at least one measuring component
connected with the device; connecting a blockage catheter to the
device, said catheter having a proximal end and a distal end;
introducing the distal end of the blockage catheter to a target
compartment of the lung and isolating the target compartment; and
generating measurement data characterizing the lung having the
isolated target compartment with the pulmonary diagnostic
system.
62. A method as in claim 61, wherein the blockage catheter has
multiple distal ends and the introducing step comprises introducing
each distal end to a different target compartment of the lung and
isolating the target compartments.
63. A method as in claim 61, wherein measurement data comprises
images, spirometry data, or plethysmography data.
64. A method as in claim 61, further comprising introducing an
access catheter to a larger compartment of the lung which includes
the target compartment and performing the generating step with the
access catheter.
65. A method as in claim 61, further comprising performing lung
volume reduction treatment to reduce the isolated target
compartment.
66. A kit comprising: a pulmonary diagnostic system comprising an
endobronchial pulmonary diagnostic device and at least one
measuring component connected with the device; and instructions for
use setting forth methods including the steps of: connecting a
pulmonary catheter to the device, said catheter having a proximal
end and a distal end; introducing the distal end of the catheter to
a compartment of a lung; and gathering measurement data
characterizing the compartment of the lung with the use of the
pulmonary diagnostic system.
67. A kit as in claim 66, further comprising a pulmonary
catheter.
68. A kit as in claim 67, wherein the pulmonary catheter comprises
an access catheter, microcatheter, or blockage catheter.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application claims benefit, under 37 C.F.R.
.sctn.1.78, to U.S. Provisional Patent Application No. 60/318,539,
filed Sep. 10, 2001, the complete disclosure of which is
incorporated herein by reference.
STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED
RESEARCH OR DEVELOPMENT
[0002] NOT APPLICABLE
REFERENCE TO A "SEQUENCE LISTING," A TABLE, OR A COMPUTER PROGRAM
LISTING APPENDIX SUBMITTED ON A COMPACT DISK
[0003] NOT APPLICABLE
BACKGROUND OF THE INVENTION
[0004] 1. Field of the Invention
[0005] The present invention relates generally to medical methods,
systems, and kits. Particularly, the present invention relates to
methods and apparatus for performing diagnostic testing on
individual subsections or segments of a lung. Further, the present
invention provides methods and apparatus for more accurate
evaluation of the extent and severity of pulmonary disease in the
subsections and segments and the effectiveness of various treatment
options.
[0006] Chronic obstructive pulmonary disease (COPD) is a
significant medical problem affecting 16 million people or about 6%
of the U.S. population. Specific diseases in this group include
chronic bronchitis, asthmatic bronchitis, and emphysema. In
general, two types of diagnostic tests are performed on a patient
to determine the extent and severity of COPD: 1) imaging tests and
2) functional tests. Imaging tests, such as chest x-rays, CT scans,
MRI, perfusion scans, and bronchograms, provide a good indicator of
the location, homogeneity and progression of the diseased tissue.
However, these test do not give a direct indication of how the
disease is affecting the patient's overall lung function and
respiration capabilities. This can be measured with functional
testing, such as spirometry, plethysmography, oxygen saturation,
and oxygen consumption stress testing, to name a few. Together,
these diagnostic tests are used to determine the course of
treatment for the patient.
[0007] Treatment for emphysema may include a variety of options,
one such option is Lung Volume Reduction which typically involves
resecting diseased portions of the lung. Resection of diseased
portions of the lungs both promotes expansion of the non-diseased
regions of the lung and decreases the portion of inhaled air which
goes into the lungs but is unable to transfer oxygen to the blood.
Lung reduction is conventionally performed in open chest or
thoracoscopic procedures where the lung is resected, typically
using stapling devices having integral cutting blades. While
effective in many cases, conventional lung reduction surgery is
significantly traumatic to the patient, even when thoracoscopic
procedures are employed. Such procedures often result in the
unintentional removal of relatively healthy lung tissue or leaving
behind of relatively diseased tissue, and frequently result in air
leakage or infection. Consequently, alternative therapies have been
developed which utilize minimally invasive techniques to isolate
target lung tissue segments from other regions of the lung.
Isolation is usually achieved by introducing an access catheter
endotracheally or thorascopically to the target air passage of the
lung. The target lung tissue segment is then collapsed by
aspirating air (and any other gases or liquids that may have been
introduced) from the segment and optionally sealed off. Exemplary
methods and systems to perform such isolation procedures are
described U.S. patent application 09/606320 (Attorney Docket No.
017534-000710), incorporated herein by reference.
[0008] Currently, the diagnostic tests are limited in the amount
and type of information that may be generated. For example,
diagnostic imaging may provide information to the physician
regarding which lung segments "appear" more diseased, but in fact a
segment that appears more diseased may actually function better
than one that appears less diseased. Functional testing is
performed on the lungs as a whole. Thus, the information provided
to the physician is generalized to the whole lung and does not
provide information about functionality of individual lung
segments. Thus, physicians may find difficulty targeting
interventional treatments to the segments most in need and to avoid
unnecessarily treating segments that are not in need of treatment
or less in need. In general, the diseased segments cannot be
differentiated, prioritized for treatment or assessed after
treatment for level of response to therapy.
[0009] For these reasons, it would be desirable to provide systems,
methods, devices and kits which would overcome at least some of the
shortcomings discussed above. In particular, it would be desirable
to provide systems and methods for monitoring, assessing or
measuring the functional state of individual lung compartments;
such compartments could be an entire lobe, a segment or a
subsegment and beyond, hereinafter subsegments and beyond will be
referred to simply as segments. It would be further desirable to
provide systems and methods of comparing measured data of
individual lung compartments to other individual lung compartments
and/or to measured data of the lung as a whole. In addition, it
would be desirable to provide systems and methods of estimating or
predicting the outcome of treatment options prior to actual
treatment and also to assess the state of disease and functionality
post-treatment. At least some of these objectives will be met by
the inventions described hereinafter.
[0010] 2. Description of the Background Art
[0011] Patents and applications relating to lung access, diagnosis,
and/or treatment include U.S. Pat. Nos. 6,174,323, 6,083,255,
5,972,026, 5,752,921; 5,707,352; 5,682,880; 5,660,175; 5,653,231;
5,645,519; 5,642,730; 5,598,840; 5,499,625; 5,477,851; 5,361,753;
5,331,947; 5,309,903; 5,285,778; 5,146,916; 5,143,062; 5,056,529;
4,976,710; 4,955,375; 4,961,738; 4,958,932; 4,949,716; 4,896,941;
4,862,874; 4,850,371; 4,846,153; 4,819,664; 4,784,133; 4,742,819;
4,716,896; 4,567,882; 4,453,545; 4,468,216; 4,327,721; 4,327,720;
4,041,936; 3,913,568 3,866,599; 3,776,222; 3,677,262; 3,669,098;
3,498,286; 3,322,126; EP 1078601, WO 01/13908, WO 01/13839, WO
01/10314, WO 00/62699, WO 00/51510, WO 00/03642, WO 99/64109, WO
99/34741, WO 99/01076, WO 98/44854, WO 95/33506, and WO
92/10971.
[0012] WO 99/01076 describes devices and methods for reducing the
size of lung tissue by applying heat energy to shrink collagen in
the tissue. In one embodiment, air may be removed from a bleb in
the lung to reduce its size. Air passages to the bleb may then be
sealed, e.g., by heating, to fix the size of the bleb. WO 98/49191
describes a plug-like device for placement in a lung air passage to
isolate a region of lung tissue, where air is not removed from the
tissue prior to plugging. WO 98/48706 describes the use of
surfactants in lung lavage for treating respiratory distress
syndrome.
[0013] Lung volume reduction surgery is described in many
publications, including Becker et al. (1998) Am. J. Respir. Crit.
Care Med. 157:1593-1599; Criner et al. (1998) Am. J. Respir. Crit.
Care Med. 157:1578-1585; Kotloff et al. (1998) Chest 113:890-895;
and Ojo et al. (1997) Chest 112:1494-1500.
[0014] The use of mucolytic agents for clearing lung obstructions
is described in Sclafani (1999) AARC Times, January, 69-97. Use of
a balloon-cuffed bronchofiberscope to reinflate a lung segment
suffering from refractory atelectasis is described in Harada et al.
(1983) Chest 84:725-728.
BRIEF SUMMARY OF THE INVENTION
[0015] The present invention provides systems, methods, devices and
kits for assessing the level of pulmonary disease in individual
lung compartments. A lung compartment comprises a subportion of a
lung, such as a lobe or a segment, for example. By testing
individual lung compartments and determining values of disease
parameters reflective of individual subportions or compartments of
a lung, the level of disease of the pulmonary system may be more
precisely defined. Likewise, compartments may be separately imaged
to provide further diagnostic information. Once individual
compartments are characterized, they may be compared and ranked
based on a number of variables reflecting, for example, level of
disease or need for treatment. Such comparison may be aided by
simultaneous display of such variables or images on a visual
display. Further, the same diagnostic tests may be performed on the
lung as a whole or on both lungs and to determine the effect of the
diseased lung compartments on the overall lung performance. In
addition, the diseased lung compartments may be temporarily
isolated and the diagnostic tests performed on the remainder of the
lung to determine the affect of the isolation on lung performance.
As a result, the most beneficial treatment options may be
selected.
[0016] In a first aspect of the present invention, a pulmonary
diagnostic system is provided comprising an Endobronchial Pulmonary
Diagnostic (EPD) device. The EPD device is connectable with a
pulmonary catheter configured for introduction into a compartment
of a lung. The pulmonary catheter may take a variety of forms, each
suitable for acquiring measurement data to characterize the lung
compartment or to perform a treatment on the lung compartment. In
some cases, such measurement is aided by one or more sensors
positioned on the catheter, often near the catheter tip. In a first
embodiment, the pulmonary catheter comprises an access catheter.
Typical access catheters comprise a catheter body having a
relatively large inner diameter to allow sufficient flow of gas or
air through the catheter to and/or from the lung compartment. In
addition, access catheters often include an occlusion member, such
as an inflatable occlusion balloon, near its distal end to seal off
the lung passageway around the access catheter leading to the
compartment. This provides direct communication with the lung
compartment, isolated from the remainder of the lung. In addition,
the access catheter may have a number of additional features, such
as a guidewire lumen, optical imaging capability and steering
capability, to name a few. Additional embodiments of the pulmonary
catheter will be described later in conjunction with their use.
[0017] As mentioned, a sensor may be disposed on the catheter for
generating measurement data reflecting a respiratory feature of the
lung compartment. However, such a sensor may be disposed anywhere
in the system, including with the EPD device or within connected
devices or components. The EPD device typically comprises
mechanisms for transferring fluid or gas to or from the lung
compartment through the pulmonary catheter. This may be performed
to pressurize the lung compartment, a state desired during many
testing or measurement procedures. In some embodiments, this
mechanisms for transferring may comprise a pump or other driving
mechanisms and appropriate tubing or conduits for passage of the
fluid or gas. In other embodiments, a pump or other driving
mechanisms may be disposed outside of the EPD device. In this case,
the mechanisms for transferring the fluid or gas of the EPD device
may simply comprise a conduit between the driving mechanisms and
the pulmonary catheter.
[0018] Generally, the sensors gather measurement data or
information which is transmitted to the EPD device. In this case,
the EPD device has a mechanisms for receiving the measurement data.
Often, the EPD device also comprises mechanisms for processing the
measurement data. Processing may comprise converting the
measurement data into a form which may be visually displayed, such
as in graphs, charts, tables, numbers, images or figures. Or,
processing may comprise analyzing the data wherein the data is used
to determine or calculate secondary information or data such as an
average pressure value, a volume value, a compliance value, an
average tidal volume value and/or a resistance value, to name a
few. Alternatively, processing may comprise converting the
measurement data into a computer readable format. Such conversion
may be of the measurement data itself or of secondary data derived
from the measurement data.
[0019] The processed data is then received by a data receiving
component. The receiving component often comprises a visual
display. However, the component may alternatively take the form of
a computer readable medium, a printer, or a chart recorder, to name
a few. The computer readable medium may comprise, for example,
disks, diskettes, CD ROMs and tapes.
[0020] A variety of measuring components may be used in connection
with or disposed within the EPD device. The components include
mechanical, electrical, chemical or other means to generate
measurement data which characterizes the compartment of the lung
which is being measured. For example, a component may include a gas
source and a pump which are used to fill the compartment with the
gas for pressure or volume measurement. Typically, a component
works in conjunction with one or more sensors which are located at
any location within the pulmonary diagnostic system. The component
may collect data from the sensor and utilize the data in further
calculations and measurement functions. Or, the component may
simply display the data on a visual display or readout. In any
case, the EPD device serves as a central feature of the measurement
system, providing user input to control the measurement procedures,
coordinating the activities of the measuring components, and
transmitting the measurement data between the sensors, for
example.
[0021] A number of embodiments of the measuring components will be
presented. In a first embodiment, the measuring component comprises
a pulmonary mechanics unit. The pulmonary mechanics unit is used
for measuring a number of variables related to the pulmonary
mechanics of the lung compartment. Typically the pulmonary
mechanics unit includes mechanisms for generating pressure and
volume data of the lung compartment. Pressure is measured by a
pressure sensor and volume is derived from measurement by a flow
sensor. As mentioned, the sensors may be located near the distal
end of the catheter or at any other locations throughout the
pulmonary diagnostic system. The pressure and volume data may be
plotted on a graph, the pressure data plotted along an x-axis and
the volume plotted along a y-axis. The resulting pressure-volume
(PV) curve provides information regarding physical characteristics
and corresponding level of disease of the lung compartment which is
being measured. Based on information provided by the PV curve, the
pulmonary mechanics unit or the EPD device may be used to calculate
a variety of data values related to the physical characteristics of
the lung compartment. For example, the unit or device may include
mechanisms for calculating a compliance value for the lung
compartment, mechanisms for calculating an average tidal volume
value, and mechanisms for calculating a resistance value
corresponding to the lung compartment.
[0022] In another embodiment the measuring component comprises a
physiological testing unit. The physiological testing unit is used
for measuring a number of variables related to the physiology of
the lung compartment. For example, the physiological testing unit
may include mechanisms for measuring ventilation or air flow
movement in and out of the lung compartment. In this case the
pulmonary catheter may comprise a microcatheter having a velocity
sensor mounted on its distal end. After the microcatheter is
positioned such that the sensor is located in the passageway
entering the compartment to be measured, the velocity sensor
measures the movement of airflow into and out of the compartment.
Comparison of these values to standard values or values from other
compartments in the lung gives an indication of the degree of air
trapping or bulk gas exchange in the compartment. Alternatively or
in addition, the physiological testing unit may include mechanisms
to measure CO.sub.2 and/or O.sub.2 concentration in the compartment
in real time during a breathing cycle to provide an indication of
gas exchange. The physiological testing unit may include mechanisms
for measuring electrophysiology characteristics of the lung
compartment. In one embodiment the mechanisms includes mechanisms
for measuring the electrical resistance of the tissue in the
compartment and in another embodiment mechanisms includes
mechanisms for measuring the electrical activity of the musculature
of the tissue in the compartment. Graphical or numerical
representation of these values generated by the physiological
testing unit or the EPD device may be stored for later use or
displayed on the visual display.
[0023] In another embodiment, the measuring component comprises a
gas dilution unit. The gas dilution unit includes mechanisms for
performing Functional Residual Capacity (FRC) testing. FRC testing
typically involves introducing a known volume of a noble gas, such
as helium, to the lung compartment through, for example, an access
catheter. The known volume of noble gas is allowed to mix with the
unknown volume of air in the compartment. A sensor then measures
the concentration of one of the gases in the system and the volume
of air that was initially in the compartment is then calculated.
Determining the volume of air initially in the compartment may be
useful information used during later treatment.
[0024] In some embodiments, the measuring component comprises an
imaging unit. The imaging unit may include mechanisms for
generating at least one image of a lung compartment. Typically the
image includes an X-ray image, a fluoroscopic image, a computed
tomography (CT) image, a positron emission tomography (PET) image,
a single-photon emission computed tomography (SPECT) image,
magnetic resonance image (MRI), or an ultrasonic image. Often
traditional external imaging equipment is used while the imaging
unit provides, for example, mechanisms for transferring various
gases to the lung compartment, including a gas having radiopaque
properties, a polarized gas as in the case of MRI, or a liquid as
in the case of ultrasonic imaging. Such transfer of gas or liquid
may be accomplished with the use of any pulmonary catheter. The
resulting images may be individual views of the lung compartment or
the views may be combined to generate a composite three-dimensional
image of the lung compartment. Alternatively, the views may be of
the entire lung minus an isolated compartment or compartments.
[0025] In yet another embodiment, the measuring component comprises
a mapping unit. The mapping unit is used for determining the
position of the pulmonary catheter as it is introduced to the lung
and advanced through the bronchial passageways. Due to the multiple
branchings of the bronchial anatomy, the position of the catheter
within the passageways may be difficult to determine. Thus, the
mapping unit can be used to locate the catheter at any time. Often
a sensor is mounted on the catheter tip and the unit may include
mechanisms for locating the sensor and imaging the position of the
sensor within the passageways, reflecting the real time position of
the catheter in the lung passageways Optionally, the sensor may
track directional movements. The positioning images may be shown on
the visual display for user ease.
[0026] As mentioned, the EPD device may be connected with a data
receiving component comprising a visual display that is suitable
for displaying various acquired data and graphical outputs. It may
be appreciated that the information provided by the visual display
may be presented in a number of formats and may include a limitless
number and type of measurement information. For example,
information collected and generated from one or many measuring
components may be compiled and displayed on the visual display.
Such combination of data may allow the operator or physician to
more readily compare information related to various compartments in
the lung anatomy, compare data related to an individual patient's
lung compartments to other patient's data, compare current
measurement data to baseline or previous values, and compare
individual compartments to whole lung data. Such display may be
graphical, numerical or any other type. The multiple sets of
information may be displayed simultaneously or individually,
wherein viewing is controlled by the user. Such display may more
easily allow the user to rank the compartments in order of level of
disease or in order of need for treatment. Likewise, it may be
appreciated that images generated from the imaging unit may also be
displayed on the visual display.
[0027] Once the lung compartments have been sufficiently assessed
to determine level of disease, treatment options for the patient
may be determined. In some cases, lung volume reduction may be
prescribed as the desired treatment protocol. To test the effects
of such reduction prior to actual treatment, the lung passageway
which leads to the lung compartment to be reduced may be
temporarily occluded with a blockage catheter. Typically, the
blockage catheter comprises a catheter body having an occlusion
member mounted near its distal end. The blockage catheter is
advanced through the lung passageways to the compartment that is to
be reduced. At this point the lung passageway is occluded by the
occlusion member and the lung compartment is effectively isolated
from the remainder of the lung. Testing, imaging and evaluation of
the overall lung performance may be undertaken to measure the
effects of such isolation. This can be performed with multiple
permutations of compartments being isolated, either by
repositioning the blockage catheter in various passageways or
introducing a blockage catheter configured to block numerous
passageways at once. If such effects are satisfactory, the
physician may choose to reduce the targeted compartment(s) as the
treatment option. This technique of temporary occlusion with a
blockage catheter may also be employed as a stand alone diagnostic
tool wherein a compartment or compartments are isolated and the
remainder of the lung is functionally measured or imaged to assess
level of disease.
[0028] Finally, the measuring component may comprise a treatment
unit. The treatment unit is used to perform a lung volume reduction
procedure on a lung compartment or any other treatment option.
Minimally invasive lung volume reduction typically involves
aspirating the contents of the compartment after isolating the
compartment from the remainder of the anatomy. This is typically
achieved with the use of the an access catheter introduced
endotracheally to the target compartment. Once in position, the
compartment is isolated by occluding the air passageway, typically
by inflating an occlusion balloon mounted on the access catheter.
The target compartment is then collapsed by aspirating air and any
other gases or liquids that may have been introduced, from the
compartment, typically through a lumen in the access catheter. The
passageway may then be sealed, for example by deploying a plug
within the air passageway.
[0029] In a third aspect of the present invention, methods are
provided for assessing a lung compartment. Providing a pulmonary
diagnostic system as described above, including an EPD device and
at least one measuring component connected with the device, a
pulmonary catheter is connected to the EPD device for introduction
into the lung anatomy of the patient. The distal end of the
catheter is introduced through the bronchial passageways of the
lung to the compartment of the lung to be measured. Measurement
data is generated characterizing the compartment of the lung with
the use of the pulmonary diagnostic system. Any of the above
described measuring components and/or pulmonary catheters may be
used to generate such measurement data. As previously described in
relation to each of the components, the generated information and
images may be displayed on the visual display. The pulmonary
catheter may then be repositioned to another compartment of the
lung and measurement data characterizing the other compartment of
the lung may then be generated using the pulmonary diagnostic
system. As before, the data and/or images may be displayed on the
visual display unit. Further, data characterizing the compartment
and the other compartments may be simultaneously displayed on the
visual display. These steps may be repeated for any number of
compartments in the patient's lung and the results may be
simultaneously or individually displayed for comparison purposes.
Methods may further include ranking the compartments based on level
of disease or need for treatment.
[0030] If treatment is desired at one or more locations, the
effects of treatment may be determined prior to actual treatment.
To accomplish this, a blockage catheter may be introduced to the
compartment or compartments targeted for possible treatment. The
compartment is then isolated from the remainder of the lung by
occluding the lung passageway leading to the compartment with an
occlusion member on the blockage catheter. A pulmonary catheter may
then be positioned or repositioned in a lung passageway leading to
the whole lung or a portion of the lung having the isolated
compartment within. The pulmonary catheter may then be used to
generate measurement data characterizing the whole lung (or portion
having the isolated compartment therein) with the use of the
pulmonary diagnostic system. It may be appreciated that
conventional measurement systems, such as CT or plethysmography,
can alternatively be used with the blockage catheter in place to
generate such data. If the generated measurement data reflects
improved pulmonary function, the isolated compartment may then be
reduced by any method. Such treatment may be performed with the use
of the pulmonary diagnostic system, specifically with the use of
the treatment unit.
[0031] In a fourth aspect of the present invention, the methods and
devices may be provided in one or more kits. The kits may include a
pulmonary diagnostic system comprising an EPD device and optionally
at least one measuring component connectable with the device. In
addition, the kit shall include instructions for use, setting forth
methods according to the present invention. For example, such
methods may include connecting a pulmonary catheter to the EPD
device, introducing the distal end of the catheter to a compartment
of a lung and generating measurement data characterizing the
compartment of the lung with the use of the pulmonary diagnostic
system. Such kits may further include any of the other system
components described in relation to the present invention, any of
the other materials or items relevant to the present invention.
[0032] Other objects and advantages of the present invention will
become apparent from the detailed description to follow, together
with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] FIG. 1 is a schematic illustration of an EPD device, wherein
the measuring components are housed within the EPD device, having a
typical pulmonary catheter removably attached.
[0034] FIG. 2 is a schematic illustration of the EPD device,
wherein the measuring components are external and removably
attached to the EPD device, having a typical pulmonary catheter
removably attached.
[0035] FIG. 3 illustrates a patient's lung wherein the pulmonary
catheter is introduced to various locations in the bronchial tree
isolating a variety of different sized lung compartments for
diagnosis and/or treatment.
[0036] FIGS. 4-5 illustrate a preferred embodiment of an access
catheter.
[0037] FIGS. 6A-6F are schematic cross sectional views of a
catheter body of an embodiment of an access catheter.
[0038] FIG. 7 illustrates a pulmonary catheter introduced through a
visualizing endotracheal tube.
[0039] FIG. 8 illustrates an EPD device and a measuring component
comprising a pulmonary mechanics unit, wherein an access catheter
is attached to the EPD device.
[0040] FIGS. 9A-9D illustrate a number of different types of
pressure sensors located on an access catheter.
[0041] Fig. 10A shows example PV curves plotted on a graph.
[0042] FIG. 10B illustrates regions of various lung compliances
along a PV curve.
[0043] FIG. 11 shows example flow-volume loops plotted on a
graph.
[0044] FIG. 12 is a schematic illustration of an EPD device and a
measuring component comprising a physiological testing unit. In
addition, a microcatheter is shown removably attached to the EPD
device.
[0045] FIG. 12A shows example velocity traces plotted on a
graph.
[0046] FIG. 13 is a schematic illustration of an EPD device and
measuring components comprising physiological testing units which
include mechanisms for measuring electrophysiology characteristics
of a lung compartment.
[0047] FIG. 14 is a schematic illustration of an EPD device and a
measuring component comprising a gas dilution unit, wherein a
pulmonary catheter is shown attached to the EPD device.
[0048] FIG. 15 is a schematic illustration of an EPD device and a
measuring component comprising an imaging unit, wherein a pulmonary
catheter is shown attached to the EPD device.
[0049] FIG. 16 is a schematic illustration of an EPD device and a
measuring component comprising a mapping unit, wherein a pulmonary
catheter is shown attached to the EPD device and advanced through
the bronchial tree to a location in the patient's lungs.
[0050] FIGS. 17A-17D depict embodiments of a blockage catheter.
[0051] FIG. 18 is a schematic illustration of an EPD device and a
measuring component comprising a treatment unit, wherein a
treatment catheter is shown attached to the EPD device.
[0052] FIG. 19 illustrates a kit constructed in accordance with the
principles of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0053] The present invention provides for a pulmonary diagnostic
system for measuring one or more of a number of parameters related
to pulmonary function and/or appearance which may be used in
diagnosis, treatment and monitoring or occasional assessment of a
patient's disease level. Central to such a system 100 is an
Endobronchial Pulmonary Diagnostic (EPD) device 102, as shown in
FIGS. 1-2. The EPD device 102 may include a variety of mechanisms
and features, which will be described hereinafter, depending on its
intended use. The device is connectable with a pulmonary catheter
120, as shown, which is configured for accessing a lung compartment
through one or more lung passageways. Here, the catheter 120 is
shown as having a proximal end 122, distal end 124, an optional
lumen 126 therethrough and an optional occlusion member 128, the
lumen 126 and occlusion member 128 shown in dashed-line. A variety
of different types of pulmonary catheters 120 may be used, a few
embodiments of which will be discussed in later sections.
[0054] With the pulmonary catheter 120 positioned in the desired
lung passageway, measurement information can be obtained regarding
the accessed compartment 154. Typically, this involves the use of
at least one sensor. The sensors may include pressure sensors,
temperature sensors, air flow sensors, CO.sub.2 sensors, O.sub.2
sensors, infrared Doppler devices, current or resistivity sensors,
laser diode sensors, pulse emitting diode sensors, and/or frequency
emitting diodes, to name a few. As shown in FIG. 1, the sensors 140
may be located near the distal end 124 of the catheter 120.
Alternatively, the sensors 140 may be located at any point along
the catheter 120 or within the EPD device 102 or one or more
measuring components 104.
[0055] Measuring components 104, shown schematically in FIG. I as
dashed-lined boxes within the EPD device 102, may take many forms
and may perform a variety of functions. For example, the components
104 may include a pulmonary mechanics unit 107, a physiological
testing unit 109, a gas dilution unit 106, an imaging unit 108, a
mapping unit 112 or a treatment unit 113, to name a few.
Embodiments of such components 104 will be discussed in detail in
later sections. As illustrated, the components 104 may be integral
with or disposed within the EPD device 102. Alternatively, as shown
in FIG. 2, some or all of the components 104 may be external to
and/or removably connectable with the EPD device 102. In addition,
a data receiving component 115 may be integral with, disposed
within or removably connectable with the EPD device 102. Here, the
data receiving component 115 is shown as a visual display 110.
However, the component 115 may alternatively take the form of a
computer readable medium, a printer, or a chart recorder, to name a
few.
[0056] As illustrated in FIG. 3, the catheter 120 is configured for
introduction into the pulmonary anatomy 150, particularly into a
bronchial passageway. As shown, the catheter 120 may be introduced
into the bronchial passageways of a lung LNG to various depths. For
example, as shown in solid line, the catheter 120 may be introduced
so that it's distal end 124 is positioned within a distant lung
segment 152 of the branching passageways. In this position, the
catheter 120 can optionally isolate and measure an individual
compartment 154 of the lung LNG, illustrated by a shaded
dashed-lined circle. Alternatively, as shown in dashed-line, the
distal end 124 may be positioned in a larger lung segment 156 of
the branching passageways. In this position, the catheter 120 can
measure another individual compartment 154 of the lung LNG,
illustrated by a larger shaded dashed-lined circle. Similarly, the
distal end 124 may be positioned in an even larger lung segment 158
to measure an even larger compartment 154, such as one or more
lobes. By positioning the distal end 124 in a major takeoff branch
160 to the lung LNG, the lung LNG itself can be measured for
comparison to the individual compartments. And, by positioning the
distal end 124 in the trachea T, above the takeoff branches 160,
the both of the lungs can be measured. Thus, it may be appreciated
that any testing, imaging or other functions described in relation
to a compartment 154 may also be performed on an entire lung LNG or
both lungs.
[0057] With the pulmonary catheter 120 positioned in the desired
lung passageway as described, the isolated compartment 154 can be
assessed. In some instances, fluid or gas is transferred to or from
the lung compartment through the pulmonary catheter. This may be
performed to pressurize the lung compartment, a state desired
during many testing or measurement procedures. In some embodiments,
the EPD device 102 comprises mechanisms for transferring such fluid
or gas. In some instances, this mechanisms for transferring may
comprise a pump or other driving mechanisms and appropriate tubing
or conduits for passage of the fluid or gas. In other instances, a
pump or other driving mechanisms may be disposed outside of the EPD
device 102. In this case, the mechanisms for transferring the fluid
or gas of the EPD device 102 may simply comprise a conduit between
the driving mechanisms and the pulmonary catheter.
[0058] Generally, the sensors 140 gather measurement data or
information which is transmitted to the EPD device 102. In this
case, the EPD device 102 has a mechanisms for receiving the
measurement data. Often, the EPD device 102 also comprises
mechanisms for processing the measurement data. Processing may
comprise converting the measurement data into a form which may be
visually displayed, such as in graphs, charts, tables, numbers,
images or figures. Or, processing may comprise analyzing the data
wherein the data is used to determine or calculate secondary
information or data such as an average pressure value, a volume
value, a compliance value, an average tidal volume value and/or a
resistance value, to name a few. Alternatively, processing may
comprise converting the measurement data into a computer readable
format. Such conversion may be of the measurement data itself or of
secondary data derived from the measurement data.
[0059] The processed data is then received by a data receiving
component 115. As mentioned, the receiving component 115 often
comprises a visual display 110. However, the component 115 may
alternatively take the form of a computer readable medium, a
printer, or a chart recorder, to name a few. The computer readable
medium may comprise, for example, disks, diskettes, CD-ROMs and
tapes. In other cases, one or more measuring components 104 receive
the processed data. The processed data may then be used in
conjunction other mechanisms within the components. For example, a
component may perform a testing function while maintaining the lung
compartment at a specific level of pressurization. Thus, the
component may utilize measurement data from a pressure sensor while
performing testing functions.
[0060] When more than one measuring component or a measuring
component 104 and a data receiving component 115 are included in
the pulmonary diagnostic system 100, the EPD device 102 comprises
mechanisms for coordinating the functioning of the measuring
components, such as the transfer of gas or fluid between the
components and the lung compartment, the passage of information or
measurement data between the measuring components, between the
sensors and the measuring components or between the measuring
components and the data receiving components, to name a few. Such
control of activities may result from pre-programming, user input
or both.
[0061] In other embodiments, measurement simply involves one or
more measuring components without the use of a sensor. This may be
the case in pulmonary imaging in which a component 104 infuses an
isolated compartment 154 with an imaging fluid or gas. The lung
compartment 154 may be visualized externally, with the use of a
fluoroscopy, nuclear, MRI or CT imaging system, or may be
visualized with the use of another component 104 within or attached
to the EPD device 102. This may also be the case in measuring
perfusion parameters. The measurement information is then processed
by the EPD device 102 and received by a receiving component
115.
[0062] Measurement information for a given lung compartment 154 may
be compared with measurement information from one or more other
lung compartments 154. For example, information from a distant lung
segment may be compared to information from another distant lung
segment. By comparing a number of lung segments, the segments can
be ranked in terms of level of disease, for example. Or,
information from a lobe can be compared with information from a
distant lung segment within the lobe. In this way, the affect of
the lung segment on overall performance of the lobe can be
compared. Further, a lung compartment 154 may be treated, such as
by reduction and/or isolation, and remaining areas of the lung or
lungs can be measured to determine the effect of the treatment. To
determine such effects prior to actual treatment, a blockage
catheter may be used which is introduced to a target compartment,
the compartment which has been targeted for treatment. With the
blockage catheter in place, such treatment is simulated and the
effect of the treatment may be determined by measuring the
untreated areas, such as a larger compartment which encompasses or
contains the target compartment, using, for example, CT imaging or
plethysmography. Thus, more effective treatments may be achieved by
pinpointing the most efficient compartments to treat.
[0063] As mentioned, the above described measurement data or
information may be provided to the user in various formats.
Typically, such information will be displayed on the visual display
110 in visual form. This may include graphs, charts, tables, number
images or figures, to name a few. Alternatively, the data can be
recorded in a computer readable format onto computer readable
medium, such as diskettes, CD-ROMs, tapes, etc. The data may then
be utilized by a computer, a printer, a visual display or any other
accessory. In any case, measurement data or information from a
number of compartments may be directly compared by simultaneous
display of the information from each compartment . Or, multiple
imaging views of a compartment may be obtained to establish a
three-dimensional composite view of the compartment. In addition,
other types of displays may be provided.
[0064] As generally described above, the EPD device 102 performs a
variety of functions which depend on the elements included in the
pulmonary diagnostic system 100 and the functions in which the
system 100 is designed to perform.. Descriptive embodiments of
possible elements comprising the pulmonary diagnostic system 100
are presented below.
[0065] I. ACCESS CATHETER
[0066] In a number of embodiments, the pulmonary catheter 120
comprises an access catheter 10. An exemplary access catheter 10 is
illustrated in FIG. 4 and comprises a catheter body 12 having a
distal end 14, a proximal end 16, an inflatable occlusion balloon
18 near its distal end, and at least one lumen therethrough.
Usually, the catheter will have at least two lumens, and catheter
10 includes both a central lumen 20 and an annular lumen 22 defined
by inner body member 24 and outer body member 26 which is coaxially
disposed about the inner body member. The annular lumen 22 opens to
port 30 on a proximal hub 31 and provides for inflation of balloon
18. The central lumen 20 opens to port 36 on hub 31 and provides
for multiple functions, including optional introduction over a
guidewire, aspiration, introduction of secondary catheters, such as
sealing catheters, measurement catheters and the like.
[0067] The access catheter 10 may be modified in a number of ways,
some of which are illustrated in FIGS. 6A-6F. For example, instead
of a inner and outer coaxial tube construction, the catheter can be
a single extrusion having a catheter body 30 with a circular main
lumen 32 and a crescent-shaped inflation lumen 34, as illustrated
in FIG. 6A. Alternatively, shown in FIG. 6B, the catheter body 40
may be formed as a single extrusion having three lumens, i.e., a
primary lumen 42 for receiving a guidewire, applying aspiration,
delivering secondary catheters, and/or other functions. A second
lumen 44 can be provided for inflating the occlusion balloon, and a
third lumen 46 can be provided as an alternative guidewire or
functional lumen. Catheter body 50 comprising a main tubular body
52 having an outer layer 54 fused thereover to define a lumen 56
suitable for balloon inflation as shown in FIG. 6C. A primary lumen
58 is formed within the main tubular member 52. As a slight
alternative, catheter body 60 can be formed from a primary tubular
member 62, and a secondary tubular member 64, where the tubular
members are held together by an outer member 66, such as a layer
which is applied by heat shrinking. The primary tubular member 62
provides the main lumen 68 while secondary tube 64 provides a
secondary lumen 70. The secondary lumen 70 will typically be used
for balloon inflation, while the primary lumen 68 can be used for
all other functions of the access catheter.
[0068] The dimensions and materials of access catheter 10 are
selected to permit endotracheal introduction and intraluminal
advancement through the lung bronchus, optionally over a guidewire,
and/or through a primary tracheal tube structure and/or inside the
working channel of a bronchoscope. Suitable materials include low
and high density polyethylenes, polyamides, nylons, PTFE, PEEK, and
the like, particularly for the inner tubular member 24. The outer
member, including the occlusion balloon, can be made from
elastomeric materials, such as polyurethane, low density
polyethylene, polyvinylchloride, silicone rubber, latex, and the
like. Optionally, portions of the outer tubular member 26 proximal
to the inflatable balloon can be made thicker and/or reinforced so
that they do not dilate upon pressurization of the balloon.
Exemplary dimensions for the access catheter 10 are dependent on
its use. A multi-purpose access catheter 10 should have a working
lumen, such as a central lumen 20, main lumen 32, primary lumen 42
or similar such lumen, adequately sized for a number of procedures.
If the catheter 10 is to be used in procedures such as functional
residual capacity testing or the generation of pressure vs. volume
curves, the working lumen should be approximately 1.5-3.5 mm ID,
assuming a catheter 10 length of approximately 45-80 cm. In other
situations, however, the working lumen may be smaller.
[0069] Optionally, the access catheter in the present invention can
be provided with optical imaging capability. As shown in FIG. 6E,
catheter body 80 can be formed to include four lumens, typically by
conventional extrusion processes. Lumen 82 is suitable for passage
over a guidewire. Lumens 84 and 86 both contain light fibers 88 for
illumination. Lumen 90 carries an optical wave guide or image fiber
92. Lumen 82 can be used for irrigation, aspiration or other
functions, typically after the guidewire is withdrawn. Balloon
inflation can be effected through the space remaining and lumens 84
and 86 surrounding the light fibers 88. Referring to FIG. 6F, an
alternative embodiment of the catheter body 71 is formed as a
coaxial arrangement of a number separate tubes. Outer tube 72
contains a separate guidewire tube 74 defining lumen 76 which
permits introduction over a guidewire as well as perfusion and
aspiration after the guidewire is removed. Second inner tubular
member 75 will carry an optical image fiber 77 and a plurality of
light fibers 78 are passed within the remaining space 79 within the
outer tubular member. In both catheter constructions 80 and 70,
forward imaging can be effected by illuminating through the light
fibers and detecting an image through a lens at the distal end of
the catheter. The image can be displayed on conventional
cathode-ray or other types of imaging screens. In particular,
forward imaging permits a user to selectively place the guidewire
for advancing the catheters through a desired route through the
branching bronchus. In some cases in which the working lumen is
particularly large, as described above in relation to use in
functional residual capacity testing, an alternative
cross-sectional design will be implemented to provide the necessary
dimensions.
[0070] As previously described, the catheter 10 can be advanced to
a compartment within a lung through a patient's trachea.
Advancement through the trachea T is relatively simple and will
optionally employ a guidewire to select the advancement route
through the branching bronchus. As described above, steering can be
effected under real time imaging using the imaging access catheters
illustrated in FIGS. 6E-6F. Optionally, the catheter may be
inserted through the working channel of a bronchoscope, using the
bronchoscope vision for navigation. Or the access catheter 10 may
be introduced through a visualizing tracheal tube, such as that
described in U.S. Pat. No. 5,285,778, licensed to the assignee of
the present application and incorporated by reference for all
purposes. As shown in FIG. 7, the visualizing endotracheal tube 130
includes an occlusion cuff 132 which may be inflated within the
trachea just above the branch of the left bronchus and right
bronchus LB and RB, respectively. The visualizing endotracheal tube
130 includes a forward-viewing optical system, typically including
both illumination fibers and an image fiber to permit direct
viewing of the main branch between the left bronchus LB and right
bronchus RB. Thus, initial placement of access catheter can be made
under visualization of the visualizing endotracheal tube 130 and
optionally the access catheter 10 itself. The access catheter 10 is
advanced until its distal end 14 reaches a region in the bronchus
which leads directly into the lung compartment. The access catheter
10 may have elements or accessories for steering and sufficient
torque response and pushability to make advancement and navigation
through the bronchial tree possible. In addition, the catheter 10
may include positioning sensors so as to determine the location of
the catheter with respect to the complete lung anatomy. This will
be described in detail in a later section.
[0071] In addition, it may be appreciated that the access catheter
10 can be a modular system or a multi-component system. For
instance, the access catheter 10 may comprise a viewing scope and a
sheath for use with the viewing scope as described in co-pending
Application No. 09/699313 (Attorney Docket No. 17534-001300), the
full disclosure of which is incorporated herein by reference. The
viewing scope includes or consists essentially of a flexible
elongated body, an optical viewing fiber or video chip, and a light
transmitting bundle. The viewing scope may be in the form of
conventional bronchoscope or a conventional articulated flexible
scope having dimensions suitable for introduction in and through
the lung passageways. The sheath comprises a flexible tubular body
having a proximal end, a distal end, and at least a first lumen
therethrough. The sheath will further comprise an inflatable cuff
disposed near its distal end, where the inflatable cuff may be
inflated through a lumen which is present in the tubular body
itself or formed in a separate inflation tube. The viewing scope is
introduced into the lumen of the flexible tubular body of the
sheath to form an assembly where a viewing end of the viewing scope
is located at the distal end of the sheath. The assembly of the
viewing scope and sheath may then be introduced to a lung
passageway so that the inflatable cuff lies adjacent to a target
location in the passageway. The cuff may then be inflated to
temporarily occlude the target location. The sheath may also have
additional working channels in order to perform aspects of the
diagnostic testing, such as carbon dioxide sensing or polarized gas
delivery.
[0072] Further, the access catheter 10 may comprise one or more
sensors to measure a variety of variables related to pulmonary
function. Such sensors will typically be located near the distal
end 14 of the catheter 10, however they may be located at any
location along the length of the catheter body 12. Individual
sensor types will be described in relation to each type of
measurement described below.
[0073] I. PULMONARY MECHANICS UNIT
[0074] In some embodiments, a measuring component 104 of the
pulmonary diagnostic system 100 comprises a pulmonary mechanics
unit 200, as shown in FIG. 8. For clarity, the pulmonary mechanics
unit 200 is illustrated as a separate attachable unit, however it
may be appreciated that the unit 200 may be internal to the EPD
device 102. The pulmonary mechanics unit 200 is used for measuring
a number of variables related to the pulmonary mechanics of a
compartment 154 of a lung LNG.
[0075] For example, the pulmonary mechanics unit 200 may include
mechanisms 202 for generating pressure and volume data of the lung
compartment 154. Generation of such data is achieved by slowly
inflating the lung compartment 154 and measuring volume delivered
and real-time pressure. The inflation process is performed slowly
to minimize the affect of any system resistance on the pressure
readings. The inflation medium is delivered to the compartment 154
through an access catheter 10 which is removably attached to the
EPD device 102. In this case, the distal end 14 of the catheter 10
is inserted into the lung passageway leading to the compartment 154
to be measured and the balloon 18 is inflated to occlude the
passageway. In this way, all inflation medium is delivered to the
compartment 154 and cannot escape to other areas of the lung.
[0076] Pressure is measured by a pressure sensor 204 and volume is
derived from measurement by a flow sensor 206. As mentioned
previously, the sensors 204, 206 may be disposed near the distal
end 14 of the catheter 10 or at other locations, including within
the EPD device 102 and/or the pulmonary mechanics unit 200. A
number of different types of pressure sensors 204 are shown in
FIGS. 9A-9D. Referring to FIG. 9A, one embodiment of the pressure
sensor 204 comprises a secondary cuff 210 disposed at the distal
end 14 of the access catheter 10, distal to the occlusion balloon
18. Another embodiment, shown in FIG. 9B, comprises a Wheatstone
bridge, microbellows pressure transducer, or optical fiber 212
imbedded in the wall of the distal end 14. The embodiment of a
pressure sensor 204 in FIG. 9C comprises ultrasonic or fiberoptic
pressure transducers with a send element 214 and a receive element
216. And the embodiment shown in FIG. 9D comprises a bellows or
Wheatstone bridge 218 protruding from a channel 219 in the catheter
10.
[0077] Pressurization of the compartment 154 can be performed while
the rest of the lung is at an expiratory hold to truly isolate the
target compartment and eliminate extraneous events. Alternatively,
pressurization can be performed during an inspiratory hold, during
regular ventilation or during a pressure hold that is in between
end-expiratory pressure and peak inspiratory pressure. These
options may provide useful information as to the pulmonary
mechanics of the compartment.
[0078] Typically, the pressure and volume data is plotted on a
graph wherein the pressure data is plotted along an x-axis X and
the volume is plotted along a y-axis Y, as illustrated in FIG. 10A.
The resulting PV curve 220 provides information regarding the
health and level of disease of the compartment 154. FIG. 10A shows
three such PV curves 220, the difference in the curves are due to
various disease states as stated.
[0079] One type of information which can be derived from a PV curve
220 is compliance. Compliance refers to the distensibility of an
elastic structure (such as a lung compartment 154) and is defined
as the change in volume of that structure produced by a change in
pressure across the structure. In other words, compliance can be
defined as the slope of a PV curve 220 at a given point along the
curve. As shown in Fig. 10B, in a normal healthy lung compartment
at low volume, relatively little positive pressure needs to be
applied to increase the volume of the lung quite a bit, as shown by
the high compliance area 222. Lung compliance decreases with
increasing volume so as the lung compartment is further inflated,
more pressure must be applied to get the same increase in volume.
This corresponds to the low-compliance area 224. Typically, the
compliance will be calculated at an upper inflection point or peak
inspiratory pressure PIP, identified in FIG. 10A. Mechanisms 226
for calculating a compliance value from the pressure and volume
data is depicted within the pulmonary mechanics unit 200 in FIG. 8,
however such mechanisms 226 may alternatively be disposed within
the EPD device 102.. The PV curves 220 and compliance values will
typically be displayed on the visual display 110.
[0080] Alternatively, volume and flow data may be plotted on a
graph as in FIG. 11. Here, flow data is plotted along an x-axis X
and volume is plotted along a y-axis Y. During inspiration, volume
increases as flow increases and then declines, as indicated by
arrow 221 . During expiration, volume decreases as flow increases
and then declines, as indicated by arrow 223. The resulting trace
is a loop 225 indicative of the flow volume characteristics of the
compartment 154 accessed. The loop 225 provides information
regarding the health and level of disease of the compartment 154.
FIG. 11 shows three such loops 225, each corresponding to a
different compartment 154 or to the same compartment 154 over time
as disease progresses.
[0081] Additional respiratory parameters may also be derived from
pressure and volume data. For example, the average tidal volume can
be measured for a given lung compartment 154. Tidal volume may be
described as the volume of air inhaled and exhaled with each
breath. Thus, the pulmonary mechanics unit 200 or the EPD device
102 may comprise mechanisms 228 for calculating an average tidal
volume value. Here, pressure is set to the PIP and the compartment
is ventilated at that pressure. This may be performed while the
rest of the lung is in an expiratory hold. Volume is typically
measured for three to five breaths over approximately 30 seconds
and an average is taken of these values to determine the average
tidal volume. In addition, the resistance of a compartment can be
derived from pressure and volume data. Resistance may be described
as the pressure divided by the volumetric flow rate. In this case,
the EPD device 102 or the pulmonary mechanics unit 200 may comprise
mechanisms 230 for calculating a resistance value. Further, work of
breathing of a compartment can be derived from pressure and volume
data. This is done by converting pressure and volume into
Joules/liter. The EPD device 102 or the pulmonary mechanics unit
200 may also comprise mechanisms 234 for calculating an average
work of breathing value. Graphical or numerical representation of
these values may be received by a data receiving component 115 for
visual display.
[0082] II. PHYSIOLOGICAL TESTING UNIT
[0083] In some embodiments, a measuring component 104 comprises a
physiological testing unit 300, as shown in FIGS. 12-15. Again, for
clarity, the physiological testing unit 300 is illustrated as a
separate attachable unit, however it may be appreciated that the
unit 300 may be integral or internal to the EPD device 102. The
physiological testing unit 300 is used for measuring a number of
variables related to the physiology of a compartment 154 of a lung
LNG.
[0084] Referring to FIG. 12, the physiological testing unit 300 may
include mechanisms 400 for measuring ventilation or velocity of air
movement in and out of a compartment 154. Here, the pulmonary
catheter 120 comprises a microcatheter 402 having a proximal end
404, a distal end 406, a lumen 408 therethrough and at least one
sensor 410 mounted on its distal end 406. The sensor 410 may be a
velocity sensor. In this instance, the microcatheter 402 is
positioned such that its distal end 406 is entering a compartment
154 to be measured. The microcatheter 402 is sized so that the
compartment 154 is not isolated and air movement is not retarded.
The velocity sensor 410 measures the velocity of airflow into and
out of the compartment 154. Comparison of these values to other
compartments gives an indication of the degree of disease of the
compartment. For example, as shown in FIG. 12A, velocity versus
time data is plotted wherein time is plotted along an x-axis X and
velocity is plotted along a y-axis Y. During inspiration, velocity
increases to an inspiratory peak 421 and then decreases over time.
During expiration, velocity increases to an expiratory peak 423 and
then decreases over time. The resulting trace 425 is indicative of
the characteristics of the compartment 154 accessed. The trace 425
provides information regarding the health and level of disease of
the compartment 154. FIG. 12A shows two such traces 425, each
corresponding to a different compartment 154 or to the same
compartment 154 over time as disease progresses.
[0085] In other embodiments, the sensor 410 may be an oxygen and/or
carbon dioxide sensor. When the distal end 406 of the microcatheter
402 is introduced to a lung compartment, the sensor 410 can measure
the amount of, for example, carbon dioxide retained in the
compartment. Carbon dioxide is indicative of trapped air.
Therefore, data derived from such a sensor may provide information
as to the level of disease in the compartment. Similarly, a sensor
that measures the amount of oxygen retained in the compartment may
indicate the level of disease affecting gas transfer through the
alveolar sacs. Oxygen sensors can also be used in the performance
of oxygen wash-out tests. Here, the air in a lung compartment is
replaced as much as possible with 100% oxygen. Then, the decay of
oxygen concentration is measured over time using sensor 410. Such
decay indicates how well a compartment contributes to ventilation.
Further, the ratio of carbon dioxide to oxygen can be determined
which is also indicative of disease state.
[0086] Referring to FIG. 13, the physiological testing unit 300 may
also include mechanisms 450 for measuring electrophysiology
characteristics of a lung compartment 154. In one embodiment, the
mechanisms 450 includes measuring the resistance of the tissue in
the compartment 154. Here, a pulse emitting sensor 452 is mounted
on the distal end 124 of the pulmonary catheter 120. The proximal
end 122 of the catheter 120 is removably attached to the EPD device
102 and the distal end 124 is inserted into a lung compartment 154.
A receiver 454 is positioned at a second location, for example on
the outside of the patient P, and is connected to the EPD device
102. A pulse is emitted from the sensor 452 and a signal is
measured by the receiver 454. The signal determines the resistance
of the tissue and therefore the state of the disease. For example,
diseased tissue will have a different conductivity because of the
breakdown of elasticity and/or because of edema/inflammation of the
tissue.
[0087] In another embodiment, the mechanisms 450 for measuring
electrophysiology characteristics of a lung compartment 154
includes measuring the electrical activity of the musculature of
the tissue in the compartment 154. Here, two or more leads are
mounted on the pulmonary catheter. The leads measure a
characteristic voltage signal of the tissue which determines the
state of the disease. For example, diseased tissue will have weaker
signals due to the breakdown of elasticity.
[0088] In another embodiment, the sensor 410 is an infrared sensor
which is positioned against the bronchial tissue and a venous
oxygen saturation measurement is made. Because blood perfusing
diseased lung compartments will have lower oxygenation, disease
level can be determined.
[0089] Graphical or numerical representation of these values
generated by the EPD device 102 or physiological testing unit 300
may be displayed on the visual display 110.
[0090] III. GAS DILUTION UNIT
[0091] In some embodiments, a measuring component 104 of the
pulmonary diagnostic system 100 comprises a gas dilution unit 500,
as shown in FIG. 14. Again, for clarity, the gas dilution unit 500
is illustrated as a separate attachable unit, however it may be
appreciated that the unit 500 may be internal to the EPD device
102. The gas dilution unit 500 is used primarily for Functional
Residual Capacity (FRC) testing and/or residual volume (RV) testing
of a compartment 154 of a lung LNG, since these parameters reflect
level of disease.
[0092] Typically, the access catheter 10 is used as the pulmonary
catheter 120 attached to the EPD device 102, as shown. After the
distal end 14 of the catheter 10 is inserted in a lung compartment
154 and the lung passageway is occluded by the balloon 18, the
compartment 154 is inflated to the PIP, as previously determined by
the mechanisms 202 for generating pressure and volume data. This
can be achieved by the pulmonary mechanics unit 200, if available,
or it may be achieved by mechanisms 504 for generating pressure and
volume data within the gas dilution unit 500 or the EPD device 102.
Then, a known volume of a noble gas, such as helium, is introduced
from a source of noble gas 506 to the compartment 154 through the
access catheter 10. The known volume of noble gas is allowed to mix
with the unknown volume of air in the compartment 154 (at PIP).
Thorough mixing is accomplished by using a pump 508 that moves gas
back and forth through the access catheter 10 in an oscillatory
motion. Due to the low volume of the access catheter 10 compared to
that of the compartment 154, complete mixing should be accomplished
in approximately 1-5 minutes, depending on the mixing efficiency of
the incoming noble gas.
[0093] A sensor 502 measures the concentration of one of the gases
in the system. In some embodiments, the sensor 502 is mounted on
the distal end 14 of the catheter 10 as shown. The sensor 502 may
be any of the following: a membrane chemical transfer sensor, a
photochemical reaction sensor, an electropotential sensor, a
microchip, a laser diode, an optical transmittance sensor, or a
piezoelectric sensor. When the concentration of this measured gas
equilibrates, simple volume mixing laws are used to calculate the
volume of air that was initially in the compartment. Thus, the gas
dilution unit 500 or EPD device 102 may include mechanisms 510 for
determining the concentration of a gas, such as helium, in the
system and mechanisms 512 for calculating the initial volume of air
in a lung compartment. Determining the volume of air initially in
the compartment may be useful information used during later
treatment. For example, the compartment may be treated by
aspirating trapped air in the compartment. By comparing the
measured volume of air aspirated with the calculated initial volume
of air in the compartment, the effectiveness of the treatment may
be determined.
[0094] IV. IMAGING UNIT
[0095] In some embodiments, a measuring component 104 of the
pulmonary diagnostic system comprises an imaging unit 600, as shown
in FIG. 15. Again, for clarity, the imaging unit 600 is illustrated
as a separate attachable unit, however it may be appreciated that
the unit 600 may be integral or internal to the EPD device 102. The
imaging unit 600 is used for generating or assisting in the
generation of two-dimensional or three-dimensional images of a
compartment 154 of a lung LNG. Often traditional external imaging
equipment is used to generate the images while the imaging unit 600
assists in the visualization of individual compartments, as will be
described below. In this case, the imaging unit 600 may also serve
to transmit and optionally manipulate the images for display in the
visual display 110.
[0096] Referring to FIG. 15, the access catheter 10 is typically
used as the pulmonary catheter 120 attached to the EPD device 102,
as shown. After the distal end 14 of the catheter 10 is inserted in
a lung compartment 154 the compartment may be visualized by
imaging. Such imaging may be enhanced by occluding the lung
passageway with the balloon 18 prior to visualization. The imaging
unit 600 may include mechanisms 602 for transferring a fluid or gas
having radiopaque properties to the lung compartment 154. Such a
fluid or gas may be radiopaque or be labeled with radiopaque
markers, for example. The compartment 154 is inflated with the
fluid or gas to the PIP, as previously determined by the mechanisms
202 for generating pressure and volume data. This can be achieved
by the pulmonary mechanics unit 200 or EPD device 102, if
available, or it may be achieved by mechanisms 604 for generating
pressure and volume data within the imaging unit 600. The imaging
unit 600 may further include mechanisms 606 for generating an
ultrasound or MRI image of the lung compartment 154. Or, an image
may be taken with equipment external to the pulmonary diagnostic
system 100 using CT, MRI, PET, x-ray, ultrasound, fluoroscopy or a
perfusion scan. While the compartment is filled with an imaging gas
or fluid as described above, the remainder of the lung may be
filled with a gas or fluid having a stronger or weaker imaging
capability. For example, the lung compartment may be filled with a
radiopaque gas and the remainder of the lung filled with a weaker
concentration of radiopaque gas. As a result, the complete lung
will be visible under fluoroscopy with the lung compartment
"highlighted" by the stronger concentration of radiopaque gas. It
may be appreciated that the concentrations may be reversed wherein
the lung is filled with a gas or fluid having a higher
concentration than the lung compartment and the lung compartment is
highlighted by the weaker concentration of radiopaque gas.
Similarly, an individual lung compartment may be blocked or
isolated and the remainder of the lung imaged by the methods
described above. In any case, the individual compartments may be
evaluated which may provide information as to its level of
disease.
[0097] Multiple images of the lung compartment 154 may be
generated, each image having a different view. This may be achieved
externally or by mechanisms 608 for generating multiple images.
Mechanisms 610 for generating a three-dimensional composite image
of the compartment 154 from the individual views may also be
included in the imaging unit 600 or the EPD device 102.
Alternatively, multiple images of the lung compartment 154 may be
generated so that a three-dimensional image is obtained by
combining image "slices" of the compartment. This may provide even
more diagnostic information regarding the status of the compartment
and its level of disease.
[0098] Alternatively or in addition, the imaging unit 600 may
include mechanisms 612 for transferring a polarized gas to the lung
compartment 154. Again, the compartment 154 is inflated with the
gas to the PIP, either with the mechanisms 202 or the mechanisms
604 for generating pressure and volume data. The imaging unit 600
may further include mechanisms 614 for generating at least one
magnetic resonance image (MRI) of the lung compartment 154. Or, an
image may be taken with external MRI equipment. In either case, the
anatomy of the compartment may be visualized which may provide
information as to its level of disease. Additionally, the imaging
unit 600 may further include mechanisms 616 for generating multiple
magnetic resonance images of the lung compartment 154 and
mechanisms 618 for generating a three-dimensional composite image
of the compartment 154. It may be appreciated that some of these
mechanisms may be included in the EPD device 102. These images may
provide even more diagnostic information regarding the status the
compartment and its level of disease.
[0099] Alternatively or in addition, the imaging unit 600 may
include mechanisms 620 for transferring a liquid such as
perfluroban to the lung compartment 154. The imaging unit 600 may
further include mechanisms 622 for generating an ultrasonic image
of the lung compartment 154. Or, an image may be taken with
external ultrasound equipment. In either case, the anatomy of the
compartment may be visualized which may provide information as to
its level of disease.
[0100] It may be appreciated that imaging may be undertaken with
the use of any contrast media appropriate for the imaging
technique. In addition, such imaging may be performed at different
points in the breathing cycle, such as at the end of normal
inspiration and exhalation and/or at the end of forced inspiration
and exhalation. These images can then be used to calculate lung
volumes relevant to disease, such as residual volume (RV), total
lung capacity (TLC) and RV/TLC. In addition, imaging may be
performed on any number of lung compartments and imaging results
may be compared for diagnostic or other purposes.
[0101] V. MAPPING UNIT
[0102] In some embodiments, a measuring component 104 of the
pulmonary diagnostic system 100 comprises an mapping unit 700, as
shown in FIG. 16. Again, for clarity, the mapping unit 700 is
illustrated as a separate attachable unit, however it may be
appreciated that the unit 700 may be integral or internal to the
EPD device 102. The mapping unit 700 is used for determining the
position of the pulmonary catheter 120 as it is introduced and
advanced through the bronchial passageways. Due to the multiple
branchings of the bronchial anatomy, the position of the catheter
120 within the passageways may be difficult to determine and thus
the lung compartment 154 to be measured may also be difficult to
determine. With the use of the mapping unit 700, the position of
the catheter 120 may be more readily visualized.
[0103] In one embodiment, a sensor 702 is used to track the
position of the catheter 120 in the bronchial passageways. The
sensor 702 is mounted on the catheter 120, typically near its
distal end 124. The sensor 702 can be a simple magnetic type device
or a frequency emitting device, to name a few. In another example,
the sensor 702 could be an optical imaging element and coupled with
artificial intelligence that tracks successive directional
movements of the catheter tip, hence knowing its position at any
given time. The mapping unit 700 may include mechanisms 704 for
receiving the signal from the sensor and mechanisms 706 for
processing the signal. Mechanisms for processing the signal include
mechanisms for generating positioning data of the sensor 702 within
the passageways and mechanisms for generating an image of the
sensor positioned within the passageways reflecting the positioning
data of the sensor 702. This is illustrated in FIG. 16. Here, the
catheter 120 is attached to the EPD device 102 and its distal end
124 is introduced to a lung passageway of a patient P. A computer
generated pulmonary anatomy image 708 is shown on the visual
display 110. Further, a catheter positioning image 710 is shown
within the anatomy image 708 reflecting the real-time position of
the catheter 120 within the actual patient's anatomy. In this way,
the target lung compartment may be more easily located and
identified for later access if desired.
[0104] VI. DATA RECEIVING COMPONENTS
[0105] Certain aspects of the data receiving components 115 have
been presented above. The data receiving component 115 receives
processed data from the EPD device 102 or any of the components 104
for output to the user. When the component 115 is the visual
display 110, the processed data is presented in visual form.
Alternatively, the component 115 may be a computer readable medium,
such as disks, diskettes, CD-ROMs, tapes or the like. The computer
readable medium may then be transported to another device, such as
a computer, workstation or even another EPD device 102 for use. In
any case, at some point the processed data is typically displayed
in visual form. It may be appreciated that the possibilities of
displaying measurement information in visual form are limitless. A
few embodiments are presented as examples.
[0106] As previously described, the pulmonary diagnostic system is
used to measure compartments of a lung, wherein a compartment could
be an entire lobe, a segment or a subsegment and beyond. Although
information generated from a compartment may be used in determining
the level of disease of the compartment itself, comparison of the
generated information to other information is also useful in
diagnosis and assessment of disease. For example, information
generated from a compartment may be compared with baseline
information from the patient or to information from a healthy
patient. For ease in comparison, both or multiple sets of
information may be displayed in the visual display 110
simultaneously. Such display may be graphical, numerical or any
other type. Further, information generated from one compartment may
be compared with information from another similar compartment
within the same patient. This concept may be extended to numerous
compartments. Again, for ease in comparison, multiple sets of
information may be displayed in the visual display 110
simultaneously. This in turn may allow the physician to rank the
compartments in order of level of disease or in order of need for
treatment. Similarly, information generated from one compartment
may be compared with information from other types or sizes of
compartments to determine the affect of each compartment on the
others. Again, multiple sets of information may be displayed in the
visual display 110 simultaneously for this purpose.
[0107] In addition, as described in relation to the imaging unit
600 and mapping unit 700, visual images of the lung anatomy can be
displayed on the visual display 110 as noted above. This may be
useful in both diagnosis of disease, positioning of the pulmonary
catheter 120 and determining the affect of treatment.
[0108] VII. BLOCKAGE CATHETER
[0109] Once sufficient diagnostic testing, imaging and evaluation
has been performed on the lung compartments 154, a treatment
protocol may be determined. In some cases, lung volume reduction
may be prescribed. To test the effects of such reduction prior to
actual treatment, the lung passageway which leads to the lung
compartment to be reduced may be temporarily occluded with a
blockage catheter. Optionally this temporary occlusion with a
blockage catheter may itself be the diagnostic test. One
embodiment, shown in FIG. 17A, illustrates the blockage catheter
750 as comprising a catheter body 752 having a proximal end 756, a
distal end 754, and an inflatable occlusion balloon 758 near its
distal end 754. The blockage catheter 750 may have a smaller outer
diameter than the access catheter 10 or other pulmonary catheters
120 which have lumens of significant diameter for various testing
purposes. Here, lumens may simply be sized for inflation of the
occlusion balloon 758 or passage of a guidewire. Another
embodiment, shown in FIGS. 17B-D, illustrates the blockage catheter
750 as comprising a catheter body 770 having a proximal end 772 and
a multiplicity of distal ends 774, each distal end 774 having an
inflatable occlusion balloon 776 mounted thereon. Typically, a
separate guidewire lumen 780 and balloon inflation lumen 782 within
the catheter body 770 are present from the proximal end 772 to each
distal end 774. End connectors 784 may be present near the proximal
end 772 for access to each lumen 780, 782. In addition, an outer
sleeve 786 encasing the catheter body 770 unites the distal ends
774 for introduction purposes. FIG. 17C shows a cross-section of
the distal ends 774 of the catheter body 770. It may be appreciated
that the catheter body 770 may comprise separate catheters, each
having a guidewire lumen 780, inflation lumen 782 and occlusion
balloon 776, which are held together by the outer sleeve 786 or
other means. Referring to FIG. 17D, placement of the blockage
catheter 750 involves positioning each distal end 774 into a
different lung passageway. Each distal end 774 may be independently
positioned with the use of a guidewire. Thus, a number of lung
compartments 154 may be simultaneously isolated by the blockage
catheter 750.
[0110] When the blockage catheter 750 is in place and the lung
passageway(s) occluded by the balloon(s), the affected lung
compartment 154 will be isolated from the remainder of the lung. At
this point, testing, imaging and evaluation of the overall lung
performance may be undertaken to measure the effects of the
isolation. Such techniques would include, for example, CT scanning,
spirometry, or plethysmography to obtain images, spirometry data or
plethysmography data, respectively. This in turn reflects the
effect of reduction of that isolated compartment. Similarly, such
testing and evaluation may be performed on specific segments of the
lung for assessing particular regions of the lung. Referring back
to FIG. 17A, such testing with a pulmonary catheter 120 while the
blockage catheter 750 is in place is illustrated. The blockage
catheter 750 may be introduced through a lumen in the pulmonary
catheter 120 or the blockage catheter 750 may simply lie in
parallel with the pulmonary catheter 120. If the pulmonary catheter
120 utilizes an occlusion member 128, the member 128 may seal
against the lumen and the catheter body 752 of the blockage
catheter 750. Both the blockage catheter 750 and pulmonary catheter
120, or any additional catheters, may be simultaneously connected
to the EPD device 100 if desired. The results of such assessment
may determine the most effective course of treatment.
[0111] VIII. TREATMENT UNIT
[0112] In some embodiments, a measuring component 104 of the
pulmonary diagnostic system 100 may comprise a treatment unit 800,
as shown in FIG. 18. Again, for clarity, the treatment unit 800 is
illustrated as a separate attachable unit, however it may be
appreciated that the unit 800 may be integral or internal to the
EPD device 102. The treatment unit 800 may be used to perform a
lung volume reduction procedure on a lung compartment 154. In this
case, the unit 800 would include mechanisms 802 for performing lung
volume reduction. This typically involves aspirating the contents
of the compartment after isolating the compartment from the
remainder of the anatomy. This is typically achieved by introducing
the distal end 14 of the access catheter 10 endotracheally to the
target compartment 154. Once in position, the compartment may be
isolated by occluding the air passageway, such as by inflating the
occlusion balloon 18 within the passageway. The target compartment
may then be collapsed by aspirating air, and any other gases or
liquids that may have been introduced, from the compartment, such
as through a lumen in the access catheter 10. Optionally, the
passageway may then be sealed, for example by deploying a plug
within the air passageway. Some sealing methods include the use of
tissue adhesives, occlusive balloons, expanding occlusive
structures, the use of energy-induced tissue fusion and the like.
Preferred embodiments of various types of treatments are described
in copending U.S. patent application Ser. Nos. 09/425,272 (Attorney
Docket No. 017534-000600), 09/347,032 (Attorney Docket No.
017534-000700), 09/606,320 (Attorney Docket No. 017534-000710),
09/523,016 (Attorney Docket No. 017534-001000), 09/699,302
(Attorney Docket No. 017534-001200), all of which are incorporated
as a reference herein for all purposes. After treatment, the affect
of treatment may be evaluated by some of the measurement methods
described above.
[0113] Kits 900 according to the present invention comprise any
number of items related to the pulmonary diagnostic system
described and instructions for use IFU. As shown in FIG. 19, such
kits 900 typically include the EPD device 102 and instructions for
use IFU setting forth methods according to the present invention.
The EPD device 102 may have one or more measuring components
disposed internally, however the kit 900 may also include one or
more measuring components 104 as shown. Optionally, the kits 900
may further include any of the other system components described
above, such as one or more pulmonary catheters 120, guidewires 902,
or a variety of accessories, such as a receiver 454. Some or all
kit components will usually be packaged together in a pouch 905 or
other conventional medical device packaging. Usually, those kit
components, such as a pulmonary catheter 120, which will be used in
performing the procedure on the patient will be sterilized and
maintained within the kit. Optionally, separate pouches, bags,
trays or other packaging may be provided within a larger package,
where the smaller packs may be opened separately to separately
maintain the components in a sterile fashion.
[0114] Although the foregoing invention has been described in some
detail by way of illustration and example, for purposes of clarity
of understanding, it will be obvious that various alternatives,
modifications and equivalents may be used and the above description
should not be taken as limiting in scope of the invention which is
defined by the appended claims.
* * * * *