Measuring lung function and lung disease progression at a lobar/segmental level
Inventors
Radhakrishnan, Srikanth • Mantri, Surag • Olivera, Ryan
Assignees
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Publication Number
US-11937913-B2
Publication Date
2024-03-26
Expiration Date
Abstract
A method for determining lung function in a patient is disclosed, in which a multi-lumen catheter with an expandable occluding element at its end is used to isolate a targeted lung compartment, and respiratory characteristics at the targeted lung compartment are measured over multiple respiratory cycles. The relation between various characteristics of the respiratory cycle is used to determine compliance of lung tissue within the targeted lung compartment.
Core Innovation
The invention provides a minimally invasive catheter-based method for determining a disease state of a portion of a lung in a patient. A catheter is introduced into an airway leading to a targeted lung compartment, where the distal end comprises an expandable occluding element configured to sealingly engage the airway. The occluding element is expanded using an inflation port to isolate the targeted lung compartment, and a lumen in-line with at least one sensor measures flow or volume to or from the targeted lung compartment.
During inhalation, air is allowed to pass through the lumen and into the targeted lung compartment, and flow or volume is measured to the targeted lung compartment. During exhalation, air exhaled from the targeted lung compartment is allowed to pass through the lumen, and flow or volume is measured from the targeted lung compartment. The method determines a peak volume at an end of inhalation, and determines an expiratory volume and a rate of change in volume based on the measured flow or volume during exhalation.
A disease state of the targeted lung compartment is determined by comparing the expiratory volume and the rate of change in volume for the peak volume for the targeted lung compartment to expiratory volume and rate of change in volume for the peak volume for one or more additional lung compartments within the same patient, or to corresponding expiratory volume and rate of change in volume for the peak volume within a general population. The disease state is a monitored state if the expiratory volume for the peak volume falls within a threshold range in a determined time period and the rate of change in volume remains below a threshold value in the determined time period.
Claims Coverage
The patent includes three independent claims (a method, an alternative method, and a system) that share the same core inventive sequence: catheter-based isolation of a targeted lung compartment using an expandable occluding element, measurement of flow or volume during inhalation and exhalation, derivation of peak volume plus expiratory volume and rate of change in volume, and classification of a disease state using threshold-based comparison.
Catheter-based isolation with expandable occluding element and inline flow/volume sensing
introducing a catheter into an airway leading to a targeted lung compartment, the distal end comprising an expandable occluding element configured to sealingly engage the airway and expanded using an inflation port, with a lumen in-line with at least one sensor for measuring flow or volume to or from the targeted lung compartment.
Peak volume and expiratory volume with rate of change during exhalation
measuring flow or volume to the targeted lung compartment during inhalation and measuring flow or volume from the targeted lung compartment during exhalation, determining a peak volume at an end of inhalation, and determining an expiratory volume and a rate of change in volume based on the measured flow or volume from the targeted lung compartment during exhalation.
Disease-state determination via intra-patient compartment comparison and monitored-state threshold logic
determining a disease state of the targeted lung compartment by comparing the expiratory volume and the rate of change in volume for the peak volume for the targeted lung compartment to the expiratory volume and the rate of change in volume for the peak volume for one or more additional lung compartments within a same patient, wherein the disease state of the targeted lung compartment is a monitored state if the expiratory volume for the peak volume for the targeted lung compartment falls within a threshold range in a determined time period and the rate of change in volume for the targeted lung compartment remains below a threshold value in the determined time period.
Catheter-based isolation with expandable occluding element and inline flow/volume sensing using general-population comparison
introducing a catheter into an airway leading to a targeted lung compartment, the distal end comprising an expandable occluding element configured to sealingly engage the airway and expanded using an inflation port, with a lumen in-line with at least one sensor for measuring flow or volume to or from the targeted lung compartment; isolating the targeted lung compartment; measuring flow or volume during inhalation and exhalation; determining a peak volume at an end of inhalation; determining an expiratory volume and a rate of change in volume based on the measured flow or volume during exhalation; and determining a disease state by comparing the expiratory volume and the rate of change in volume for the peak volume for the targeted lung compartment to the expiratory volume and the rate of change in volume for the peak volume within a general population.
System with display and control unit performing compartment isolation measurements and monitored-state threshold logic
a catheter configured to be introduced into an airway leading to a targeted lung compartment with an expandable occluding element sealingly engaging the airway and expanded via an inflation port, and a lumen in-line with at least one sensor; a display configured to display data generated from a diagnostic procedure performed with the catheter; and a control unit coupled to the catheter and the display, configured to measure flow or volume during inhalation and exhalation, determine a peak volume at end of inhalation, determine an expiratory volume and a rate of change in volume based on measured flow or volume during exhalation, and determine a disease state by comparing expiratory volume and the rate of change in volume for the peak volume for the targeted lung compartment to expiratory volume and rate of change in volume for the peak volume for one or more additional lung compartments within a same patient, wherein the disease state is a monitored state if an expiratory volume for the peak volume falls within a threshold range in a determined time period and a rate of change in volume remains below a threshold value in the determined time period.
Across the independent claims, disease state classification is grounded in catheter-isolated, sensor-measured inhalation/exhalation flow or volume, the derived peak volume and exhalation expiratory volume with rate of change in volume, and a threshold-based monitored-state determination. The comparison basis differs by claim: one uses intra-patient additional lung compartments, and another uses general population corresponding values, while the system claim adds a display and control unit to present and compute these diagnostic outputs.
Stated Advantages
Allows determination of a disease state of a targeted lung compartment using catheter-based isolation and localized flow or volume measurement.
Provides a monitored state classification based on expiratory volume falling within a threshold range and a rate of change in volume remaining below a threshold value during a determined time period.
Documented Applications
Diagnosing and monitoring a disease state of a portion of a lung by determining localized lung compartment metrics (expiratory volume, rate of change in volume) after sealing and catheter-based measurement during inhalation and exhalation.
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