METHOD AND APPARATUS FOR ENDOBRONCHIAL DIAGNOSIS
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:
a pulmonary catheter configured for accessing a lung compartment, wherein the pulmonary catheter comprises an occlusion member configured to isolate the lung compartment;
at least one pressure sensor which generates pressure measurement data reflecting the pressure within the isolated lung compartment;
at least one flow sensor which generates flow measurement data reflecting flow to or from the isolated 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 comprising an analyzing means configured to analyze 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, and the pulmonary catheter, the device comprising
means for transferring the fluid or gas to or from the isolated lung compartment,
means for coordinating the functioning of the endobronchial pulmonary diagnostic device, wherein the coordinating means is configured to coordinate transfer of the fluids or gases between the components of the endobronchial pulmonary diagnostic device and the lung, passage of data between the sensors and the endobronchial pulmonary diagnostic device and passage of data between the endobronchial pulmonary diagnostic device and the data receiving component, 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 data receiving component;
wherein the system is configured to compare the pressure and flow measurement data from the lung compartment with pressure and flow measurement data from another lung compartment;
wherein the system is configured to determine pressure and flow of the isolated lung compartment; and wherein the analyzing means is configured to calculate a resistance value of the isolated lung compartment based on the pressure and flow measurement data; and
wherein the data receiving component comprises a visual display which displays the processed data in visual form; wherein the data receiving component is configured to simultaneously display resistance values corresponding to multiple lung compartments.
2 . A system as in claim 1 , wherein the analyzing means comprises means for calculating volume measurement data from the flow measurement data and means for generating a pressure-volume curve the pressure and volume measurement data.
3 . A system as in claim 2 , wherein the data receiving component is configured to display via the visual display pressure-volume curves corresponding to multiple lung compartment simultaneously.
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 at an upper inflection point or peak inspiratory pressure, 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 data receiving 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 data receiving 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 data receiving 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 data receiving 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 mechanism generates more than one image of the compartment and the data receiving component further comprises means for generating a three dimensional composite image of the compartment from the images.
16 . A pulmonary diagnostic system comprising:
a pulmonary catheter configured for accessing a lung compartment, wherein the pulmonary catheter comprises an occlusion member configured to isolate the lung compartment;
at least one pressure sensor which generates pressure measurement data reflecting the pressure within the isolated lung compartment;
at least one flow sensor which generates flow measurement data reflecting flow to or from the isolated lung compartment;
a physiological testing unit comprising
means for receiving the pressure and flow measurement data from the sensors, and
means for processing the pressure and flow measurement data comprising n analyzing means configured to analyze the pressure and flow measurement data;
a data receiving component which receives the processed pressure and flow measurement data, wherein the data receiving component comprises a visual display which displays the processed data in visual form; wherein the data receiving component is configured to simultaneously display pressure and flow measurement data corresponding to multiple lung compartments; and
an endobronchial pulmonary diagnostic device connectable with the physiological testing unit, and the pulmonary catheter, the device comprising
means for transferring the fluid or gas to or from the isolated lung compartment, and
means for receiving the processed pressure and flow measurement data from the physiological testing unit;
means for coordinating the functioning of the endobronchial pulmonary diagnostic device, wherein the coordinating means is configured to coordinate transfer of the fluids or gases between the components of the endobronchial pulmonary diagnostic device and the lung, passage of data between the sensors and the endobronchial pulmonary diagnostic device and passage of data between the endobronchial pulmonary diagnostic device and the data receiving component;
wherein the system is configured to compare the pressure and flow measurement data from the lung compartment with pressure and flow measurement data from another lung compartment;
wherein the system is configured to determine pressure and flow of the isolated lung compartment; and wherein the analyzing means is configured to calculate a resistance value of the isolated lung compartment based on the pressure and flow measurement data.
17 . A system as in claim 16 , wherein the analyzing means comprises means for calculating volume measurement data from the flow measurement data and means for generating a pressure-volume curve the pressure and volume measurement data.
18 . A system as in claim 16 , wherein the data receiving component is configured to simultaneously display compliance data corresponding to multiple lung compartment.
19 . A system as in claim 17 , wherein the analyzing means further comprises means for calculating a compliance value at an upper inflection point or peak inspiratory pressure, average tidal volume value or resistance value with the use of the pressure and volume measurement data.
20 . A system as in claim 18 , wherein the data receiving component is configured to simultaneously display flow versus volume data corresponding to multiple lung compartments.
21 . A system as in claim 18 , wherein the data receiving component is configured to simultaneously display velocity versus time data corresponding to multiple lung compartments.