Method and apparatus for endobronchial diagnosis

• US 10,413,244 B2
• Filed: 10/21/2015
• Issued: 09/17/2019
• Est. Priority Date: 09/10/2001
• Status: Expired due to Fees

• Current Assignee: Pulmonx Corp.
• Original Assignee: Pulmonx Corp.
• Inventors: Kotmel, Robert, Soltesz, Peter, Wondka, Anthony, Perkins, Rodney
• Primary Examiner(s): Jang, Christian
• Assistant Examiner(s): Toth, Karen E
• Application Number:
  US14/919,480
• Publication Number:
  US 20160038058A1
• Time in Patent Office: 1,427 Days
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0813 Measurement of pulmonary parameters by tracers, e.g. radioactive tracers
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/083 Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61B 6/485 involving fluorescence X-ray imaging
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0404 with means for selective or partial lung respiration
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: A61M 16/0459 one cuff behind another
• CPC Class Codes: A61M 16/0486 Multi-lumen tracheal tubes
• CPC Class Codes: A61M 2016/0413 with detectors of CO2 in exhaled gases
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0026 : Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

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.

Claims

1. A pulmonary diagnostic system comprising:

a multi-lumen pulmonary catheter having a proximal end and a distal end, wherein the distal end comprises an inflatable occlusion balloon configured to isolate a Iungcompartment from a remainder of the lung;

a pulmonary diagnostic device comprising a transferring component configured to transfer fluids or gases to or from the lung,

wherein the pulmonary diagnostic device is configured to receive measurement data from at least one sensor, and to coordinate the functioning of the pulmonary diagnostic device;

a data receiving component;

and one or more sensors disposed in or on the pulmonary catheter, said sensors generating measurement data reflecting respiratory features of the isolated lung compartment, wherein the respiratory features of the isolated lung compartment comprise pressure and flow;

wherein the pulmonary diagnostic device further comprises an analyzing component configured to analyze the measurement data to generate processed measurement data, enable values of disease parameters reflective of an individual isolated lung compartment to be determined, and to calculate a resistance value of the isolated lung compartment based on the measurement data reflecting pressure and flow;

wherein the pulmonary diagnostic device further is configured to coordinate the transfer of the fluids or gases between the components of the pulmonary diagnostic device and the lung, the passage of data between the sensor and the pulmonary diagnostic device, and the passage of data between the pulmonary diagnostic device and the data receiving component;

wherein the system is configured to determine pressure and flow of the isolated lung compartment during unassisted breathing; and

wherein the data receiving component is configured to receive the processed measurement data; and

wherein the data receiving component comprises a visual display which is configured to simultaneously display resistance values corresponding to multiple lung compartments in visual form; and

wherein the system is configured to rank the multiple lung compartments based on a level of disease or a need for treatment.

2. A system as in claim 1, wherein the respiratory features comprise velocity, oxygen concentration, or noble gas concentration.

3. A system as in claim 1, wherein the pulmonary diagnostic device converts the measurement data into a computer readable format.

4. A system as in claim 1, wherein the transferring component comprises a source of the fluid or gas and a means for generating flow of the fluid or gas.

5. A system as in claim 4, wherein the gas comprises air, oxygen, carbon dioxide, noble gas, radiopaque gas, polarized gas or a mixture of any of these.

6. A system as in claim 1, wherein the catheter is sized and has sufficient torque response and pushability to permit endotracheal introduction and intraluminal advancement through a bronchus of the lung.

7. A system as in claim 1, 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.

8. A system as in claim 1, wherein the sensor is disposed within the device.

9. The system of claim 1, wherein at least one lumen of the multi-lumen catheter is in fluid communication with the inflatable occlusion balloon.

10. The pulmonary diagnostic system of claim 1 further comprising:

an introducing element selected from the group consisting of a primary tracheal tube, a bronchoscope, a visualizing endotracheal tube and a guidewire, said introducing element being configured to introduce the catheter to a lung.

11. The pulmonary diagnostic system of claim 1, wherein the analyzing component is configured to calculate the resistance value of the isolated lung compartment based on pressure divided by volumetric flow rate.

12. The pulmonary diagnostic system of claim 11, wherein the analyzing component is configured to calculate volume data based on the measurement data reflecting flow.

13. The pulmonary diagnostic system of claim 1 further comprising a second inflatable occlusion balloon;

wherein the system is configured to simultaneously isolate the multiple lung compartments.

14. The pulmonary diagnostic system of claim 1, wherein the analyzing component is configured to calculate a compliance value of the isolated lung compartment.