US20030051733A1 - Method and apparatus for endobronchial diagnosis - Google Patents

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.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS
• The present application claims benefit, under 37 C.F.R. §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.[0001]
STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
• NOT APPLICABLE[0002]
REFERENCE TO A “SEQUENCE LISTING,” A TABLE, OR A COMPUTER PROGRAM LISTING APPENDIX SUBMITTED ON A COMPACT DISK
• NOT APPLICABLE[0003]
BACKGROUND OF THE INVENTION
• 1. Field of the Invention[0004]
• 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.[0005]
• 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.[0006]
• 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.[0007]
• 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.[0008]
• 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.[0009]
• 2. Description of the Background Art[0010]
• 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.[0011]
• 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.[0012]
• 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.[0013]
• 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.[0014]
BRIEF SUMMARY OF THE INVENTION
• 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.[0015]
• 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.[0016]
• 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.[0017]
• 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.[0018]
• 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.[0019]
• 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.[0020]
• 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.[0021]
• 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[0022]₂and/or O₂concentration 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.
• 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.[0023]
• 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.[0024]
• 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.[0025]
• 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.[0026]
• 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.[0027]
• 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.[0028]
• 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.[0029]
• 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.[0030]
• 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.[0031]
• Other objects and advantages of the present invention will become apparent from the detailed description to follow, together with the accompanying drawings.[0032]
BRIEF DESCRIPTION OF THE DRAWINGS
• 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.[0033]
• 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.[0034]
• 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.[0035]
• FIGS.[0036]4-5 illustrate a preferred embodiment of an access catheter.
• FIGS.[0037]6A-6F are schematic cross sectional views of a catheter body of an embodiment of an access catheter.
• FIG. 7 illustrates a pulmonary catheter introduced through a visualizing endotracheal tube.[0038]
• 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.[0039]
• FIGS.[0040]9A-9D illustrate a number of different types of pressure sensors located on an access catheter.
• Fig. 10A shows example PV curves plotted on a graph.[0041]
• FIG. 10B illustrates regions of various lung compliances along a PV curve.[0042]
• FIG. 11 shows example flow-volume loops plotted on a graph.[0043]
• 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.[0044]
• FIG. 12A shows example velocity traces plotted on a graph.[0045]
• 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.[0046]
• 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.[0047]
• 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.[0048]
• 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.[0049]
• FIGS.[0050]17A-17D depict embodiments of a blockage catheter.
• 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.[0051]
• FIG. 19 illustrates a kit constructed in accordance with the principles of the present invention.[0052]
DETAILED DESCRIPTION OF THE INVENTION
• 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[0053]system100 is an Endobronchial Pulmonary Diagnostic (EPD)device102, as shown in FIGS.1-2. TheEPD device102 may include a variety of mechanisms and features, which will be described hereinafter, depending on its intended use. The device is connectable with apulmonary catheter120, as shown, which is configured for accessing a lung compartment through one or more lung passageways. Here, thecatheter120 is shown as having aproximal end122,distal end124, anoptional lumen126 therethrough and anoptional occlusion member128, thelumen126 andocclusion member128 shown in dashed-line. A variety of different types ofpulmonary catheters120 may be used, a few embodiments of which will be discussed in later sections.
• With the[0054]pulmonary catheter120 positioned in the desired lung passageway, measurement information can be obtained regarding the accessedcompartment154. Typically, this involves the use of at least one sensor. The sensors may include pressure sensors, temperature sensors, air flow sensors, CO₂sensors, O₂sensors, 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, thesensors140 may be located near thedistal end124 of thecatheter120. Alternatively, thesensors140 may be located at any point along thecatheter120 or within theEPD device102 or one ormore measuring components104.
• Measuring[0055]components104, shown schematically in FIG. I as dashed-lined boxes within theEPD device102, may take many forms and may perform a variety of functions. For example, thecomponents104 may include a pulmonary mechanics unit107, a physiological testing unit109, agas dilution unit106, animaging unit108, amapping unit112 or a treatment unit113, to name a few. Embodiments ofsuch components104 will be discussed in detail in later sections. As illustrated, thecomponents104 may be integral with or disposed within theEPD device102. Alternatively, as shown in FIG. 2, some or all of thecomponents104 may be external to and/or removably connectable with theEPD device102. In addition, adata receiving component115 may be integral with, disposed within or removably connectable with theEPD device102. Here, thedata receiving component115 is shown as avisual display110. However, thecomponent115 may alternatively take the form of a computer readable medium, a printer, or a chart recorder, to name a few.
• As illustrated in FIG. 3, the[0056]catheter120 is configured for introduction into thepulmonary anatomy150, particularly into a bronchial passageway. As shown, thecatheter120 may be introduced into the bronchial passageways of a lung LNG to various depths. For example, as shown in solid line, thecatheter120 may be introduced so that it'sdistal end124 is positioned within adistant lung segment152 of the branching passageways. In this position, thecatheter120 can optionally isolate and measure anindividual compartment154 of the lung LNG, illustrated by a shaded dashed-lined circle. Alternatively, as shown in dashed-line, thedistal end124 may be positioned in alarger lung segment156 of the branching passageways. In this position, thecatheter120 can measure anotherindividual compartment154 of the lung LNG, illustrated by a larger shaded dashed-lined circle. Similarly, thedistal end124 may be positioned in an evenlarger lung segment158 to measure an evenlarger compartment154, such as one or more lobes. By positioning thedistal end124 in amajor takeoff branch160 to the lung LNG, the lung LNG itself can be measured for comparison to the individual compartments. And, by positioning thedistal end124 in the trachea T, above thetakeoff branches160, the both of the lungs can be measured. Thus, it may be appreciated that any testing, imaging or other functions described in relation to acompartment154 may also be performed on an entire lung LNG or both lungs.
• With the[0057]pulmonary catheter120 positioned in the desired lung passageway as described, theisolated compartment154 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, theEPD device102 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 theEPD device102. In this case, the mechanisms for transferring the fluid or gas of theEPD device102 may simply comprise a conduit between the driving mechanisms and the pulmonary catheter.
• Generally, the[0058]sensors140 gather measurement data or information which is transmitted to theEPD device102. In this case, theEPD device102 has a mechanisms for receiving the measurement data. Often, theEPD device102 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.
• The processed data is then received by a[0059]data receiving component115. As mentioned, the receivingcomponent115 often comprises avisual display110. However, thecomponent115 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 ormore measuring components104 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.
• When more than one measuring component or a[0060]measuring component104 and adata receiving component115 are included in the pulmonarydiagnostic system100, theEPD device102 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.
• 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[0061]component104 infuses anisolated compartment154 with an imaging fluid or gas. Thelung compartment154 may be visualized externally, with the use of a fluoroscopy, nuclear, MRI or CT imaging system, or may be visualized with the use of anothercomponent104 within or attached to theEPD device102. This may also be the case in measuring perfusion parameters. The measurement information is then processed by theEPD device102 and received by a receivingcomponent115.
• Measurement information for a given[0062]lung compartment154 may be compared with measurement information from one or more other lung compartments154. 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, alung compartment154 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.
• 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[0063]visual display110 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.
• As generally described above, the[0064]EPD device102 performs a variety of functions which depend on the elements included in the pulmonarydiagnostic system100 and the functions in which thesystem100 is designed to perform.. Descriptive embodiments of possible elements comprising the pulmonarydiagnostic system100 are presented below.
• I. ACCESS CATHETER[0065]
• In a number of embodiments, the[0066]pulmonary catheter120 comprises anaccess catheter10. Anexemplary access catheter10 is illustrated in FIG. 4 and comprises acatheter body12 having adistal end14, aproximal end16, aninflatable occlusion balloon18 near its distal end, and at least one lumen therethrough. Usually, the catheter will have at least two lumens, andcatheter10 includes both acentral lumen20 and anannular lumen22 defined byinner body member24 andouter body member26 which is coaxially disposed about the inner body member. Theannular lumen22 opens to port30 on aproximal hub31 and provides for inflation ofballoon18. Thecentral lumen20 opens to port36 onhub31 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.
• The[0067]access catheter10 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 acatheter body30 with a circularmain lumen32 and a crescent-shapedinflation lumen34, as illustrated in FIG. 6A. Alternatively, shown in FIG. 6B, thecatheter body40 may be formed as a single extrusion having three lumens, i.e., aprimary lumen42 for receiving a guidewire, applying aspiration, delivering secondary catheters, and/or other functions. Asecond lumen44 can be provided for inflating the occlusion balloon, and athird lumen46 can be provided as an alternative guidewire or functional lumen.Catheter body50 comprising a maintubular body52 having anouter layer54 fused thereover to define a lumen56 suitable for balloon inflation as shown in FIG. 6C. Aprimary lumen58 is formed within the maintubular member52. As a slight alternative,catheter body60 can be formed from aprimary tubular member62, and asecondary tubular member64, where the tubular members are held together by anouter member66, such as a layer which is applied by heat shrinking. Theprimary tubular member62 provides themain lumen68 whilesecondary tube64 provides asecondary lumen70. Thesecondary lumen70 will typically be used for balloon inflation, while theprimary lumen68 can be used for all other functions of the access catheter.
• The dimensions and materials of[0068]access catheter10 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 theinner tubular member24. 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 outertubular member26 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 theaccess catheter10 are dependent on its use. Amulti-purpose access catheter10 should have a working lumen, such as acentral lumen20,main lumen32,primary lumen42 or similar such lumen, adequately sized for a number of procedures. If thecatheter10 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 acatheter10 length of approximately 45-80 cm. In other situations, however, the working lumen may be smaller.
• Optionally, the access catheter in the present invention can be provided with optical imaging capability. As shown in FIG. 6E,[0069]catheter body80 can be formed to include four lumens, typically by conventional extrusion processes.Lumen82 is suitable for passage over a guidewire.Lumens84 and86 both containlight fibers88 for illumination.Lumen90 carries an optical wave guide orimage fiber92.Lumen82 can be used for irrigation, aspiration or other functions, typically after the guidewire is withdrawn. Balloon inflation can be effected through the space remaining andlumens84 and86 surrounding thelight fibers88. Referring to FIG. 6F, an alternative embodiment of thecatheter body71 is formed as a coaxial arrangement of a number separate tubes.Outer tube72 contains aseparate guidewire tube74 defininglumen76 which permits introduction over a guidewire as well as perfusion and aspiration after the guidewire is removed. Second innertubular member75 will carry anoptical image fiber77 and a plurality oflight fibers78 are passed within the remainingspace79 within the outer tubular member. In bothcatheter constructions80 and70, 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.
• As previously described, the[0070]catheter10 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 theaccess catheter10 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 visualizingendotracheal tube130 includes anocclusion cuff132 which may be inflated within the trachea just above the branch of the left bronchus and right bronchus LB and RB, respectively. The visualizingendotracheal tube130 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 visualizingendotracheal tube130 and optionally theaccess catheter10 itself. Theaccess catheter10 is advanced until itsdistal end14 reaches a region in the bronchus which leads directly into the lung compartment. Theaccess catheter10 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, thecatheter10 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.
• In addition, it may be appreciated that the[0071]access catheter10 can be a modular system or a multi-component system. For instance, theaccess catheter10 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.
• Further, the[0072]access catheter10 may comprise one or more sensors to measure a variety of variables related to pulmonary function. Such sensors will typically be located near thedistal end14 of thecatheter10, however they may be located at any location along the length of thecatheter body12. Individual sensor types will be described in relation to each type of measurement described below.
• I. PULMONARY MECHANICS UNIT[0073]
• In some embodiments, a[0074]measuring component104 of the pulmonarydiagnostic system100 comprises apulmonary mechanics unit200, as shown in FIG. 8. For clarity, thepulmonary mechanics unit200 is illustrated as a separate attachable unit, however it may be appreciated that theunit200 may be internal to theEPD device102. Thepulmonary mechanics unit200 is used for measuring a number of variables related to the pulmonary mechanics of acompartment154 of a lung LNG.
• For example, the[0075]pulmonary mechanics unit200 may includemechanisms202 for generating pressure and volume data of thelung compartment154. Generation of such data is achieved by slowly inflating thelung compartment154 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 thecompartment154 through anaccess catheter10 which is removably attached to theEPD device102. In this case, thedistal end14 of thecatheter10 is inserted into the lung passageway leading to thecompartment154 to be measured and theballoon18 is inflated to occlude the passageway. In this way, all inflation medium is delivered to thecompartment154 and cannot escape to other areas of the lung.
• Pressure is measured by a[0076]pressure sensor204 and volume is derived from measurement by aflow sensor206. As mentioned previously, thesensors204,206 may be disposed near thedistal end14 of thecatheter10 or at other locations, including within theEPD device102 and/or thepulmonary mechanics unit200. A number of different types ofpressure sensors204 are shown in FIGS.9A-9D. Referring to FIG. 9A, one embodiment of thepressure sensor204 comprises asecondary cuff210 disposed at thedistal end14 of theaccess catheter10, distal to theocclusion balloon18. Another embodiment, shown in FIG. 9B, comprises a Wheatstone bridge, microbellows pressure transducer, oroptical fiber212 imbedded in the wall of thedistal end14. The embodiment of apressure sensor204 in FIG. 9C comprises ultrasonic or fiberoptic pressure transducers with asend element214 and a receiveelement216. And the embodiment shown in FIG. 9D comprises a bellows orWheatstone bridge218 protruding from achannel219 in thecatheter10.
• Pressurization of the[0077]compartment154 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.
• 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[0078]PV curve220 provides information regarding the health and level of disease of thecompartment154. FIG. 10A shows three such PV curves220, the difference in the curves are due to various disease states as stated.
• One type of information which can be derived from a[0079]PV curve220 is compliance. Compliance refers to the distensibility of an elastic structure (such as a lung compartment154) 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 aPV curve220 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 thehigh compliance area222. 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 area224. Typically, the compliance will be calculated at an upper inflection point or peak inspiratory pressure PIP, identified in FIG. 10A.Mechanisms226 for calculating a compliance value from the pressure and volume data is depicted within thepulmonary mechanics unit200 in FIG. 8, howeversuch mechanisms226 may alternatively be disposed within theEPD device102.. The PV curves220 and compliance values will typically be displayed on thevisual display110.
• 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[0080]arrow221 . During expiration, volume decreases as flow increases and then declines, as indicated byarrow223. The resulting trace is aloop225 indicative of the flow volume characteristics of thecompartment154 accessed. Theloop225 provides information regarding the health and level of disease of thecompartment154. FIG. 11 shows threesuch loops225, each corresponding to adifferent compartment154 or to thesame compartment154 over time as disease progresses.
• Additional respiratory parameters may also be derived from pressure and volume data. For example, the average tidal volume can be measured for a given[0081]lung compartment154. Tidal volume may be described as the volume of air inhaled and exhaled with each breath. Thus, thepulmonary mechanics unit200 or theEPD device102 may comprisemechanisms228 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, theEPD device102 or thepulmonary mechanics unit200 may comprisemechanisms230 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. TheEPD device102 or thepulmonary mechanics unit200 may also comprisemechanisms234 for calculating an average work of breathing value. Graphical or numerical representation of these values may be received by adata receiving component115 for visual display.
• II. PHYSIOLOGICAL TESTING UNIT[0082]
• In some embodiments, a[0083]measuring component104 comprises aphysiological testing unit300, as shown in FIGS.12-15. Again, for clarity, thephysiological testing unit300 is illustrated as a separate attachable unit, however it may be appreciated that theunit300 may be integral or internal to theEPD device102. Thephysiological testing unit300 is used for measuring a number of variables related to the physiology of acompartment154 of a lung LNG.
• Referring to FIG. 12, the[0084]physiological testing unit300 may includemechanisms400 for measuring ventilation or velocity of air movement in and out of acompartment154. Here, thepulmonary catheter120 comprises amicrocatheter402 having aproximal end404, adistal end406, alumen408 therethrough and at least onesensor410 mounted on itsdistal end406. Thesensor410 may be a velocity sensor. In this instance, themicrocatheter402 is positioned such that itsdistal end406 is entering acompartment154 to be measured. Themicrocatheter402 is sized so that thecompartment154 is not isolated and air movement is not retarded. Thevelocity sensor410 measures the velocity of airflow into and out of thecompartment154. 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 aninspiratory peak421 and then decreases over time. During expiration, velocity increases to anexpiratory peak423 and then decreases over time. The resultingtrace425 is indicative of the characteristics of thecompartment154 accessed. Thetrace425 provides information regarding the health and level of disease of thecompartment154. FIG. 12A shows twosuch traces425, each corresponding to adifferent compartment154 or to thesame compartment154 over time as disease progresses.
• In other embodiments, the[0085]sensor410 may be an oxygen and/or carbon dioxide sensor. When thedistal end406 of themicrocatheter402 is introduced to a lung compartment, thesensor410 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 overtime using sensor410. 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.
• Referring to FIG. 13, the[0086]physiological testing unit300 may also includemechanisms450 for measuring electrophysiology characteristics of alung compartment154. In one embodiment, themechanisms450 includes measuring the resistance of the tissue in thecompartment154. Here, apulse emitting sensor452 is mounted on thedistal end124 of thepulmonary catheter120. Theproximal end122 of thecatheter120 is removably attached to theEPD device102 and thedistal end124 is inserted into alung compartment154. Areceiver454 is positioned at a second location, for example on the outside of the patient P, and is connected to theEPD device102. A pulse is emitted from thesensor452 and a signal is measured by thereceiver454. 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.
• In another embodiment, the[0087]mechanisms450 for measuring electrophysiology characteristics of alung compartment154 includes measuring the electrical activity of the musculature of the tissue in thecompartment154. 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.
• In another embodiment, the[0088]sensor410 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.
• Graphical or numerical representation of these values generated by the[0089]EPD device102 orphysiological testing unit300 may be displayed on thevisual display110.
• III. GAS DILUTION UNIT[0090]
• In some embodiments, a[0091]measuring component104 of the pulmonarydiagnostic system100 comprises agas dilution unit500, as shown in FIG. 14. Again, for clarity, thegas dilution unit500 is illustrated as a separate attachable unit, however it may be appreciated that theunit500 may be internal to theEPD device102. Thegas dilution unit500 is used primarily for Functional Residual Capacity (FRC) testing and/or residual volume (RV) testing of acompartment154 of a lung LNG, since these parameters reflect level of disease.
• Typically, the[0092]access catheter10 is used as thepulmonary catheter120 attached to theEPD device102, as shown. After thedistal end14 of thecatheter10 is inserted in alung compartment154 and the lung passageway is occluded by theballoon18, thecompartment154 is inflated to the PIP, as previously determined by themechanisms202 for generating pressure and volume data. This can be achieved by thepulmonary mechanics unit200, if available, or it may be achieved bymechanisms504 for generating pressure and volume data within thegas dilution unit500 or theEPD device102. Then, a known volume of a noble gas, such as helium, is introduced from a source ofnoble gas506 to thecompartment154 through theaccess catheter10. The known volume of noble gas is allowed to mix with the unknown volume of air in the compartment154 (at PIP). Thorough mixing is accomplished by using apump508 that moves gas back and forth through theaccess catheter10 in an oscillatory motion. Due to the low volume of theaccess catheter10 compared to that of thecompartment154, complete mixing should be accomplished in approximately 1-5 minutes, depending on the mixing efficiency of the incoming noble gas.
• A[0093]sensor502 measures the concentration of one of the gases in the system. In some embodiments, thesensor502 is mounted on thedistal end14 of thecatheter10 as shown. Thesensor502 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, thegas dilution unit500 orEPD device102 may includemechanisms510 for determining the concentration of a gas, such as helium, in the system andmechanisms512 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.
• IV. IMAGING UNIT[0094]
• In some embodiments, a[0095]measuring component104 of the pulmonary diagnostic system comprises animaging unit600, as shown in FIG. 15. Again, for clarity, theimaging unit600 is illustrated as a separate attachable unit, however it may be appreciated that theunit600 may be integral or internal to theEPD device102. Theimaging unit600 is used for generating or assisting in the generation of two-dimensional or three-dimensional images of acompartment154 of a lung LNG. Often traditional external imaging equipment is used to generate the images while theimaging unit600 assists in the visualization of individual compartments, as will be described below. In this case, theimaging unit600 may also serve to transmit and optionally manipulate the images for display in thevisual display110.
• Referring to FIG. 15, the[0096]access catheter10 is typically used as thepulmonary catheter120 attached to theEPD device102, as shown. After thedistal end14 of thecatheter10 is inserted in alung compartment154 the compartment may be visualized by imaging. Such imaging may be enhanced by occluding the lung passageway with theballoon18 prior to visualization. Theimaging unit600 may includemechanisms602 for transferring a fluid or gas having radiopaque properties to thelung compartment154. Such a fluid or gas may be radiopaque or be labeled with radiopaque markers, for example. Thecompartment154 is inflated with the fluid or gas to the PIP, as previously determined by themechanisms202 for generating pressure and volume data. This can be achieved by thepulmonary mechanics unit200 orEPD device102, if available, or it may be achieved bymechanisms604 for generating pressure and volume data within theimaging unit600. Theimaging unit600 may further includemechanisms606 for generating an ultrasound or MRI image of thelung compartment154. Or, an image may be taken with equipment external to the pulmonarydiagnostic system100 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.
• Multiple images of the[0097]lung compartment154 may be generated, each image having a different view. This may be achieved externally or by mechanisms608 for generating multiple images.Mechanisms610 for generating a three-dimensional composite image of thecompartment154 from the individual views may also be included in theimaging unit600 or theEPD device102. Alternatively, multiple images of thelung compartment154 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.
• Alternatively or in addition, the[0098]imaging unit600 may includemechanisms612 for transferring a polarized gas to thelung compartment154. Again, thecompartment154 is inflated with the gas to the PIP, either with themechanisms202 or themechanisms604 for generating pressure and volume data. Theimaging unit600 may further includemechanisms614 for generating at least one magnetic resonance image (MRI) of thelung compartment154. 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, theimaging unit600 may further includemechanisms616 for generating multiple magnetic resonance images of thelung compartment154 and mechanisms618 for generating a three-dimensional composite image of thecompartment154. It may be appreciated that some of these mechanisms may be included in theEPD device102. These images may provide even more diagnostic information regarding the status the compartment and its level of disease.
• Alternatively or in addition, the[0099]imaging unit600 may includemechanisms620 for transferring a liquid such as perfluroban to thelung compartment154. Theimaging unit600 may further includemechanisms622 for generating an ultrasonic image of thelung compartment154. 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.
• 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.[0100]
• V. MAPPING UNIT[0101]
• In some embodiments, a[0102]measuring component104 of the pulmonarydiagnostic system100 comprises anmapping unit700, as shown in FIG. 16. Again, for clarity, themapping unit700 is illustrated as a separate attachable unit, however it may be appreciated that theunit700 may be integral or internal to theEPD device102. Themapping unit700 is used for determining the position of thepulmonary catheter120 as it is introduced and advanced through the bronchial passageways. Due to the multiple branchings of the bronchial anatomy, the position of thecatheter120 within the passageways may be difficult to determine and thus thelung compartment154 to be measured may also be difficult to determine. With the use of themapping unit700, the position of thecatheter120 may be more readily visualized.
• In one embodiment, a[0103]sensor702 is used to track the position of thecatheter120 in the bronchial passageways. Thesensor702 is mounted on thecatheter120, typically near itsdistal end124. Thesensor702 can be a simple magnetic type device or a frequency emitting device, to name a few. In another example, thesensor702 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. Themapping unit700 may includemechanisms704 for receiving the signal from the sensor andmechanisms706 for processing the signal. Mechanisms for processing the signal include mechanisms for generating positioning data of thesensor702 within the passageways and mechanisms for generating an image of the sensor positioned within the passageways reflecting the positioning data of thesensor702. This is illustrated in FIG. 16. Here, thecatheter120 is attached to theEPD device102 and itsdistal end124 is introduced to a lung passageway of a patient P. A computer generatedpulmonary anatomy image708 is shown on thevisual display110. Further, acatheter positioning image710 is shown within theanatomy image708 reflecting the real-time position of thecatheter120 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.
• VI. DATA RECEIVING COMPONENTS[0104]
• Certain aspects of the[0105]data receiving components115 have been presented above. Thedata receiving component115 receives processed data from theEPD device102 or any of thecomponents104 for output to the user. When thecomponent115 is thevisual display110, the processed data is presented in visual form. Alternatively, thecomponent115 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 anotherEPD device102 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.
• 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[0106]visual display110 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 thevisual display110 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 thevisual display110 simultaneously for this purpose.
• In addition, as described in relation to the[0107]imaging unit600 andmapping unit700, visual images of the lung anatomy can be displayed on thevisual display110 as noted above. This may be useful in both diagnosis of disease, positioning of thepulmonary catheter120 and determining the affect of treatment.
• VII. BLOCKAGE CATHETER[0108]
• Once sufficient diagnostic testing, imaging and evaluation has been performed on the lung compartments[0109]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 theblockage catheter750 as comprising acatheter body752 having a proximal end756, adistal end754, and aninflatable occlusion balloon758 near itsdistal end754. Theblockage catheter750 may have a smaller outer diameter than theaccess catheter10 or otherpulmonary catheters120 which have lumens of significant diameter for various testing purposes. Here, lumens may simply be sized for inflation of theocclusion balloon758 or passage of a guidewire. Another embodiment, shown in FIGS.17B-D, illustrates theblockage catheter750 as comprising acatheter body770 having aproximal end772 and a multiplicity ofdistal ends774, eachdistal end774 having aninflatable occlusion balloon776 mounted thereon. Typically, aseparate guidewire lumen780 andballoon inflation lumen782 within thecatheter body770 are present from theproximal end772 to eachdistal end774.End connectors784 may be present near theproximal end772 for access to eachlumen780,782. In addition, anouter sleeve786 encasing thecatheter body770 unites the distal ends774 for introduction purposes. FIG. 17C shows a cross-section of the distal ends774 of thecatheter body770. It may be appreciated that thecatheter body770 may comprise separate catheters, each having aguidewire lumen780,inflation lumen782 andocclusion balloon776, which are held together by theouter sleeve786 or other means. Referring to FIG. 17D, placement of theblockage catheter750 involves positioning eachdistal end774 into a different lung passageway. Eachdistal end774 may be independently positioned with the use of a guidewire. Thus, a number oflung compartments154 may be simultaneously isolated by theblockage catheter750.
• When the[0110]blockage catheter750 is in place and the lung passageway(s) occluded by the balloon(s), the affectedlung compartment154 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 apulmonary catheter120 while theblockage catheter750 is in place is illustrated. Theblockage catheter750 may be introduced through a lumen in thepulmonary catheter120 or theblockage catheter750 may simply lie in parallel with thepulmonary catheter120. If thepulmonary catheter120 utilizes anocclusion member128, themember128 may seal against the lumen and thecatheter body752 of theblockage catheter750. Both theblockage catheter750 andpulmonary catheter120, or any additional catheters, may be simultaneously connected to theEPD device100 if desired. The results of such assessment may determine the most effective course of treatment.
• VIII. TREATMENT UNIT[0111]
• In some embodiments, a[0112]measuring component104 of the pulmonarydiagnostic system100 may comprise atreatment unit800, as shown in FIG. 18. Again, for clarity, thetreatment unit800 is illustrated as a separate attachable unit, however it may be appreciated that theunit800 may be integral or internal to theEPD device102. Thetreatment unit800 may be used to perform a lung volume reduction procedure on alung compartment154. In this case, theunit800 would includemechanisms802 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 thedistal end14 of theaccess catheter10 endotracheally to thetarget compartment154. Once in position, the compartment may be isolated by occluding the air passageway, such as by inflating theocclusion balloon18 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 theaccess catheter10. 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]Kits900 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 kits900 typically include theEPD device102 and instructions for use IFU setting forth methods according to the present invention. TheEPD device102 may have one or more measuring components disposed internally, however thekit900 may also include one ormore measuring components104 as shown. Optionally, thekits900 may further include any of the other system components described above, such as one or morepulmonary catheters120,guidewires902, or a variety of accessories, such as areceiver454. Some or all kit components will usually be packaged together in apouch905 or other conventional medical device packaging. Usually, those kit components, such as apulmonary catheter120, 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.
• 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.[0114]

Claims (68)

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 inclaim 1, wherein the respiratory feature comprises pressure, flow rate, velocity, oxygen concentration, carbon dioxide concentration, or noble gas concentration.

3. A system as inclaim 1, wherein the means for processing the measurement data comprises an analyzing means which analyzes the measurement data.

4. A system as inclaim 3, wherein the measuring component comprises a visual display which displays the processed data in visual form.

5. A system as inclaim 4, wherein the visual form includes graphs, charts, tables, numbers, images, or figures.

6. A system as inclaim 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 inclaim 1, wherein the means for processing the measurement data converts the measurement data into a computer readable format.

8. A system as inclaim 7, wherein the data receiving component comprises a recording means which records the measurement data onto computer readable medium.

9. A system as inclaim 8, wherein the computer readable medium comprises disks, diskettes, CD-ROMs and tapes.

10. A system as inclaim 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 inclaim 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 inclaim 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 inclaim 10, wherein the fluid comprises radiopaque contrast solution, water, or ultrasonic imaging fluid.

14. A system as inclaim 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 inclaim 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 inclaim 14, wherein the fluid comprises radiopaque contrast solution, water, or ultrasonic imaging fluid.

17. A system as inclaim 1, further comprising the pulmonary catheter.

18. A system as inclaim 17, wherein the sensor is disposed on or in the pulmonary catheter.

19. A system as inclaim 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 inclaim 1, wherein the sensor is disposed within the device.

21. A system as inclaim 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 inclaim 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 inclaim 23, wherein the data receiving component comprises a visual display which displays the pressure-volume curve.

25. A system as inclaim 23, wherein the analyzing means further comprises means for calculating a compliance value.

26. A system as inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 32, wherein the fluid or gas is radiopaque and the image is generated with the use of fluoroscopy.

35. A system as inclaim 32, wherein the fluid or gas is polarized and the image is generated with the use of magnetic resonance imaging.

36. A system as inclaim 32, wherein the fluid is ultrasonic imaging fluid and the image is generated with the use of ultrasound.

37. A system as inclaim 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 inclaim 39, wherein the means for processing the measurement data comprises an analyzing means which analyzes the measurement data.

41. A system as inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 56, wherein the step of displaying the data comprises simultaneously displaying the data characterizing the compartment and the other compartment.

58. A method as inclaim 55, further comprising comparing the data characterizing the compartment and the other compartment to each other.

59. A method as inclaim 58, further comprising ranking the compartments.

60. A method as inclaim 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 inclaim 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 inclaim 61, wherein measurement data comprises images, spirometry data, or plethysmography data.

64. A method as inclaim 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 inclaim 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 inclaim 66, further comprising a pulmonary catheter.

68. A kit as inclaim 67, wherein the pulmonary catheter comprises an access catheter, microcatheter, or blockage catheter.

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