Method and apparatus for endobronchial diagnosis

Abstract

The present invention provides systems, methods, devices and kits for assessing the level of pulmonary disease in individual lung compartments. A lung compartment comprises a subportion of a lung, such as a lobe, a segment or a subsegment, for example. By measuring individual lung compartments, the level of disease of the pulmonary system may be more precisely defined by determining values of disease parameters reflective of individual subportions or compartments of a lung. Likewise, compartments may be separately imaged to provide further measurement information. Once individual compartments are characterized, they may be compared and ranked based on a number of variables reflecting, for example, level of disease or need for treatment. Such comparison may be aided by simultaneous display of such variables or images on a visual display. Further, the same tests may be performed on the lung as a whole or on both lungs and to determine the affect of the diseased lung compartments on the overall lung performance. In addition, the diseased lung compartments may be temporarily isolated and the measurement tests performed to determine the affect of the isolation on overall lung performance. As a result, the most beneficial treatment options may be selected.

1 . 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. 
   
     
     
         2 . A system as in  claim 1 , 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. 
     
     
         3 . A system as in  claim 2 , wherein the data receiving component comprises a visual display which displays the pressure-volume curve. 
     
     
         4 . A system as in  claim 2 , wherein the analyzing means further comprises means for calculating a compliance value. 
     
     
         5 . A system as in  claim 2 , 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. 
     
     
         6 . A system as in  claim 1 , 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. 
   
     
     
         7 . A system as in  claim 6 , 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. 
     
     
         8 . A system as in  claim 6 , 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. 
     
     
         9 . A system as in  claim 6 , 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. 
     
     
         10 . A system as in  claim 1 , 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.   
     
     
         11 . A system as in  claim 10 , wherein the imaging unit or the device is connectable with a mechanism for generating at least one image of the compartment. 
     
     
         12 . A system as in  claim 11 , 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. 
     
     
         13 . A system as in  claim 11 , wherein the fluid or gas is radiopaque and the image is generated with the use of fluoroscopy. 
     
     
         14 . A system as in  claim 11 , wherein the fluid or gas is polarized and the image is generated with the use of magnetic resonance imaging. 
     
     
         15 . A system as in  claim 11 , wherein the fluid is ultrasonic imaging fluid and the image is generated with the use of ultrasound. 
     
     
         16 . A system as in  claim 11 , 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. 
     
     
         17 . 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.   
     
     
         18 . 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.   
     
     
         19 . A system as in  claim 18 , wherein the means for processing the measurement data comprises an analyzing means which analyzes the measurement data. 
     
     
         20 . A system as in  claim 19 , wherein the compartment comprises lung tissue and the means for analyzing means calculates the resistance of the lung tissue of the compartment. 
     
     
         21 . 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.   
     
     
         22 . A system as in  claim 21 , 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. 
     
     
         23 . A system as in  claim 22 , wherein the data receiving component comprises a visual display which displays the location of the sensor in visual form. 
     
     
         24 . 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.   
     
     
         25 . A method as in  claim 24 , wherein the compartment comprises a lung segment and introducing comprises advancing the distal end through a bronchial passageway to the lung segment. 
     
     
         26 . A method as in  claim 24 , wherein the compartment comprises a lung lobe and introducing comprises advancing the distal end through a bronchial passageway to the lung lobe. 
     
     
         27 . A method as in  claim 24 , 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. 
     
     
         28 . A method as in  claim 24 , 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. 
     
     
         29 . A method as in  claim 24 , wherein the measuring component comprises a gas dilution unit and the step of gathering measurement data comprises performing functional residual capacity testing. 
     
     
         30 . A method as in  claim 24 , 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. 
     
     
         31 . A method as in  claim 30 , wherein the step of gathering measurement data further comprises combining images to generate a composite three-dimensional image of the lung compartment. 
     
     
         32 . A method as in  claim 24 , 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. 
     
     
         33 . A method as in  claim 24 , 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. 
     
     
         34 . A method as in  claim 24 , 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.   
     
     
         35 . A method as in  claim 34 , 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. 
     
     
         36 . A method as in  claim 35 , wherein the step of displaying the data comprises simultaneously displaying the data characterizing the compartment and the other compartment. 
     
     
         37 . A method as in  claim 34 , further comprising comparing the data characterizing the compartment and the other compartment to each other. 
     
     
         38 . A method as in  claim 37 , further comprising ranking the compartments. 
     
     
         39 . A method as in  claim 24 , further comprising performing lung volume reduction treatment to reduce the compartment. 
     
     
         40 . 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.   
     
     
         41 . A method as in  claim 40 , 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. 
     
     
         42 . A method as in  claim 40 , wherein measurement data comprises images, spirometry data, or plethysmography data. 
     
     
         43 . A method as in  claim 40 , 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. 
     
     
         44 . A method as in  claim 40 , further comprising performing lung volume reduction treatment to reduce the isolated target compartment. 
     
     
         45 . 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.   
     
     
         46 . A kit as in  claim 45 , further comprising a pulmonary catheter. 
     
     
         47 . A kit as in  claim 46 , wherein the pulmonary catheter comprises an access catheter, microcatheter, or blockage catheter.