US2019246953A1PendingUtilityA1

System and methods for the measurement of lung volumes

Assignee: PULMONE ADVANCED MEDICAL DEVICES LTDPriority: Jul 26, 2007Filed: Apr 23, 2019Published: Aug 15, 2019
Est. expiryJul 26, 2027(~1 yrs left)· nominal 20-yr term from priority
A61B 5/097A61B 5/087A61B 5/091
48
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Claims

Abstract

A system and method for determining FRC, TGV, TLC, and RV includes a hand-held unit with a shutter assembly designed to minimize measure air displacement due to shuttering. Measurement of flow and pressure are used to derive the lung parameters.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 . A respiratory measurement device to measure lung volumes, comprising:
 a respiration module for inhalation or exhalation, including:
 an electric motor, 
 a motor-controlled shutter positioned within the respiration module and movable via the electric motor, 
 a flow measurement component, and 
 a pressure measurement component; and 
   a control unit, including:
 a converter to: (i) convert analog data received from the flow measurement component and the pressure measurement component into a digital format, (ii) convert digital signals into commands for the electric motor, and 
 a processor in electrical communication with the electric motor, the flow measurement component, and the pressure measurement component via the converter, wherein the processor is to:
 command the electric motor to occlude air flow with the motor-controlled shutter during an inhalation or exhalation, 
 obtain by the low measurement component a mouth flow curve in at least one of a time duration prior to said occlusion or a time duration subsequent to said occlusion, wherein the processor measures said time duration based at least in part on when the command was provided to the electric motor, 
 obtain by the pressure measurement component a mouth pressure curve in a time duration during said occlusion, wherein the processor measures said time duration based at least in part on when the command was provided to the electric motor, 
 calculate a rate of pressure change, 
 determine a baseline flow prior to said occlusion, 
 calculate an absolute lung volume during said occlusion based on said rate of pressure change and said baseline flow, and 
 output said calculated absolute lung volume for a pulmonary diagnosis. 
 
   
     
     
         2 . The device of  claim 1 , wherein said occlusion of air flow is accomplished in one of: (1) less than 25 ms, (2) less than 5 ms, or (3) less than 2 ms. 
     
     
         3 . The device of  claim 1 , wherein obtaining a mouth flow curve in at least one of a time duration prior to said occlusion or a time duration subsequent to said occlusion comprises:
 measuring a plurality of differential pressures between a portion of the respiration module and an ambient environment;   determining, with the processor, a plurality of volumetric flow rates based on the measured plurality of differential pressures; and   determining, with the processor, the mouth flow curve based on the determined plurality of volumetric flow rates.   
     
     
         4 . The device of  claim 1 , wherein the processor is further to:
 calculate an additional lung volume parameter based on said calculated absolute volume.   
     
     
         5 . The device of  claim 4 , wherein said additional lung volume parameter comprises at least one of: TGV, FRC, RV or TLC. 
     
     
         6 . The device of  claim 1 , wherein calculating a rate of pressure change comprises at least one of:
 calculating said rate of pressure change immediately subsequent to an initiation of said occlusion;   calculating said rate of pressure change within 100 ms subsequent to an initiation of said occlusion;   calculating said rate of pressure change at a beginning of a rise of pressure subsequent to an initiation of said occlusion; or   calculating said rate of pressure change at a point in which a lung pressure is equal to a mouth pressure.   
     
     
         7 . The device of  claim 1 , wherein said determined baseline flow comprises a rate of change of lung volume. 
     
     
         8 . The device of  claim 7 , wherein determining a baseline flow prior to said occlusion comprises determining said rate of change of lung volume just prior to said occlusion. 
     
     
         9 . The device of  claim 8 , wherein determining said rate of change of lung volume just prior to said occlusion comprises determining an average rate of change of lung volume over about 20 ms prior to said occlusion. 
     
     
         10 . The device of  claim 1 , wherein calculating a rate of pressure change comprises at least one of:
 performing a smooth curve fit to about 30 ms of said mouth pressure curve; performing an exponential curve fit to said mouth pressure curve; or performing a sinusoidal curve fit to said mouth pressure curve.   
     
     
         11 . The device of  claim 1 , wherein calculating said absolute volume based on said rate of pressure change and said baseline flow comprises determining a ratio of said baseline flow to said rate of pressure change. 
     
     
         12 . The device of  claim 1 , wherein the calculated absolute lung volume is associated with a patient and said output from the respiratory measurement device is received by a user who performs the pulmonary diagnosis of the patient. 
     
     
         13 . A respiratory measurement device to measure lung volumes, comprising:
 a respiration module for inhalation or exhalation, including:
 an electric motor, 
 a motor-controlled shutter positioned with the respiration module and movable via the electric motor, 
 a flow measurement component, and 
 a pressure measurement component; and 
   a control unit, including:
 a converter to: (i) convert analog data received from the flow measurement component and the pressure measurement component into a digital format, (ii) convert digital signals into commands for the electric motor, and 
 a processor in electrical communication with the electric motor, the flow measurement component, and the pressure measurement component via the converter, wherein the processor is to:
 command the electric motor to occlude air flow by the motor-controlled shutter during an inhalation or exhalation, 
 obtain by the flow measurement component a mouth flow curve in a time duration subsequent to said occlusion, wherein the processor measures said time duration based at least in part on when the command was provided to the motor-controlled shutter, 
 obtain by the pressure measurement component a mouth pressure curve in a time duration during said occlusion, wherein the processor measures said time duration based at least in part on when the command was provided to the electric motor, 
 determine a first pressure at a first point along said pressure curve; 
 
 determining a second pressure at a second point along said pressure curve;
 calculate a pressure change by calculating a difference between said first pressure and said second pressure; 
 determine a first flow point along said flow curve, wherein said first flow point is a first point which reaches a baseline flow value following said occlusion of air flow, 
 determine a second flow point along said flow curve, wherein said second flow point is a second point which reaches said baseline flow value following said first flow point, 
 calculate a volume change by integrating said flow curve from said first flow point to said second flow point, 
 calculate an absolute lung volume during said occlusion from said pressure change and said volume change, and 
 output said calculated absolute lung volume for a pulmonary diagnosis. 
 
   
     
     
         14 . The device of  claim 13 , wherein the processor is further to:
 calculate an additional lung volume parameter based on said calculated absolute volume.   
     
     
         15 . The device of  claim 14 , wherein said additional lung volume parameter comprises at least one of: TGV, FRC, RV or TLC. 
     
     
         16 . The device of  claim 13 , wherein said occlusion of air flow is accomplished in one of: (1) less than 25 ms, (2) less than 5 ms, or (3) less than 2 ms. 
     
     
         17 . The device of  claim 13 , wherein said first point along said pressure curve is approximately at a start of said occlusion of air flow and said second point along said pressure curve is approximately or exactly at an end of said occlusion of air flow. 
     
     
         18 . The device of  claim 13 , wherein obtaining a mouth flow curve in a time duration subsequent to said occlusion comprises:
 measuring a plurality of differential pressures between a portion of the respiration module and an ambient environment;   determining, with the processor, a plurality of volumetric flow rates based on the measured plurality of differential pressures; and   determining, with the processor, the mouth flow curve based on the determined plurality of volumetric flow rates.   
     
     
         19 . A respiratory measurement device to measure lung volumes, comprising:
 a respiration module for inhalation or exhalation, including:
 an electric motor, 
 a motor-controlled shutter positioned with the respiration module and movable via the electric motor, 
 a flow measurement component, and 
 a pressure measurement component; and 
   a control unit, including:
 a converter to: (i) convert analog data received from the flow measurement component and the pressure measurement component into a digital format, (ii) convert digital signals into commands for the electric motor, and 
 a processor in electrical communication with the electric motor, the flow measurement component, and the pressure measurement component via the converter, wherein the processor is to:
 command the electric motor to occlude air flow with the motor-controlled shutter during an inhalation or exhalation, 
 obtain by the flow measurement component, a mouth flow curve in a time duration prior to said occlusion and a time duration subsequent to said occlusion, wherein the processor measures said time duration based at least in part on when the command was provided to the electric motor, 
 obtain by the pressure measurement component of said device, a mouth pressure curve in a time duration during said occlusion, wherein the processor measures said time duration based at least in part on when the command was provided to the electric motor, 
 determine a first pressure at a first point along said pressure curve, 
 determine a second pressure at a second point along said pressure curve 
 calculate a pressure change by calculating a difference between said first pressure and said second pressure, 
 determine a first flow point along said flow curve, wherein said first flow point is a first point which reaches a baseline flow value following said occlusion of air flow, 
 determine a second flow point along said flow curve, wherein said second flow point is a second point which reaches said baseline flow value following said first flow point, 
 calculate a volume change by integrating said flow curve from said first flow point to said second flow point, 
 calculate an absolute lung volume during said occlusion from said pressure change and said volume change, and output said calculated absolute lung volume for a pulmonary diagnosis. 
 
   
     
     
         20 . The device of  claim 19 , wherein the processor is further to:
 calculate an additional lung volume parameter based on said calculated absolute volume.   
     
     
         21 . The device of  claim 20 , wherein said additional lung volume parameter comprises at least one of: TGV, FRC, RV or TLC. 
     
     
         22 . The device of  claim 19 , wherein said occlusion of air flow is accomplished in one of: (1) less than 25 ms, (2) less than 5 ms, or (3) less than 2 ms. 
     
     
         23 . The device of  claim 19 , wherein said first point along said pressure curve is approximately at a start of said occlusion of air flow and said second point along said pressure curve is approximately or exactly at an end of said occlusion of air flow. 
     
     
         24 . The device of  claim 19 , wherein obtaining a mouth flow curve in a time duration prior to said occlusion and a time duration subsequent to said occlusion comprises:
 measuring a plurality of differential pressures between a portion of the respiration module and an ambient environment;   determining, with the processor, a plurality of volumetric flow rates based on the measured plurality of differential pressures; and   determining, with the processor, the mouth flow curve based on the determined plurality of volumetric flow rates.   
     
     
         25 . The device of  claim 19 , wherein obtaining a mouth flow curve in a time duration prior to said occlusion comprises determining a baseline flow that comprises a rate of change of lung volume. 
     
     
         26 . The device of  claim 25 , wherein determining a baseline flow that comprises a rate of change of lung volume comprises determining said rate of change of lung volume just prior to said occlusion. 
     
     
         27 . The device of  claim 26 , wherein determining said rate of change of lung volume just prior to said occlusion comprises determining an average rate of change of lung volume over about 20 ms prior to said occlusion. 
     
     
         28 . A respiratory measurement device to measure lung volumes, comprising:
 respiration module for inhalation or exhalation, the respiration module including:
 an electric motor, 
 a motor-controlled shutter positioned with the respiration module and movable via the electric motor, 
 a flow measurement component, and 
 a pressure measurement component; and 
   a control unit, including:
 a converter to: (i) convert analog data received from the flow measurement component and the pressure measurement component into a digital format, (ii) convert digital signals into commands for the electric motor, and 
 a processor in electrical communication with the electric motor, the flow measurement component, and the pressure measurement component via the converter, wherein the processor is to:
 command the electric motor to occlude air flow with the motor-controlled shutter during an inhalation or exhalation, 
 obtain with the flow measurement component a mouth flow curve in a time duration subsequent to said occlusion, wherein the processor measures said time duration based at least in part on when the command was provided to the electric motor, 
 obtaining, by the processor with a pressure measurement component of said device, a mouth pressure curve in a time duration during said occlusion, wherein the processor measures said time duration based at least in part on when the command was provided to the electric motor, 
 determine a first pressure at a first point along said pressure curve, 
 determine a second pressure at a second point along said pressure curve, 
 calculate a pressure change by calculating a difference between said first pressure and said second pressure, 
 determine a first flow point along said flow curve, wherein said first flow point is a first point which reaches a baseline flow value following said occlusion of air flow, 
 determine a second flow point along said flow curve, wherein said second flow point is substantially equivalent in time to a point along said pressure curve at a local minimum of pressure, 
 calculate a volume change by integrating said flow curve from said first flow point to said second flow point, 
 calculate am absolute lung volume during said occlusion from said pressure change and said volume change, and 
 output said calculated absolute lung volume for a pulmonary diagnosis. 
 
   
     
     
         29 . The device of  claim 28 , wherein the processor is further to:
 calculate an additional lung volume parameter based on said calculated absolute volume.   
     
     
         30 . The device of  claim 29 , wherein said additional lung volume parameter comprises at least one of: TGV, FRC, RV or TLC. 
     
     
         31 . The device of  claim 28 , wherein said occlusion of air flow is accomplished in one of: (1) less than 25 ms, (2) less than 5 ms, or (3) less than 2 ms. 
     
     
         32 . The device of  claim 28 , wherein obtaining a mouth flow curve in a time duration subsequent to said occlusion comprises:
 measuring a plurality of differential pressures between a portion of the respiration module and an ambient environment;   determining, with the processor, a plurality of volumetric flow rates based on the measured plurality of differential pressures; and   determining, with the processor, the mouth flow curve based on the determined plurality of volumetric flow rates.   
     
     
         33 . The device of  claim 28 , wherein said first point along said pressure curve is approximately at a start of said occlusion of air flow and said second point along said pressure curve is approximately or exactly at an end of said occlusion of air flow. 
     
     
         34 . A respiratory measurement device to measure lung volumes, the method comprising:
 a respiration module for inhalation or exhalation, the respiration module including:
 an electric motor, 
 a motor-controlled shutter positioned with the respiration module and movable via the electric motor, 
 a flow measurement component, and 
 a pressure measurement component; and 
   a control unit, including:
 a converter to: (i) convert analog data received from the flow measurement component and the pressure measurement component into a digital format, (ii) convert digital signals into commands for the electric motor, and 
 a processor in electrical communication with the electric motor, the flow measurement component, and the pressure measurement component via the converter, wherein the processor is to:
 command the electric motor to occlude air flow with the motor-controlled shutter during an inhalation or exhalation, 
 obtain with the flow measurement component a mouth flow curve in a time duration prior to said occlusion and a time duration subsequent to said occlusion, wherein the processor measures said time duration based at least in part on when the command was provided to the electric motor, 
 obtain with the pressure measurement component a mouth pressure curve in a time duration during said occlusion, wherein the processor measures said time duration based at least in part on when the command was provided to the electric motor, 
 determine a first pressure at a first point along said pressure curve, 
 determine a second pressure at a second point along said pressure curve, 
 calculate a pressure change by calculating a difference between said first pressure and said second pressure, 
 determine a first flow point along said flow curve, wherein said first flow point is a first point which reaches a baseline flow value following said occlusion of air flow, 
 determine a second flow point along said flow curve, wherein second flow point is substantially equivalent in time to a point along said pressure curve at a local minimum of pressure, 
 calculate a volume change by integrating said flow curve from said first flow point to said second flow point, 
 calculate an absolute lung volume during said occlusion from said pressure change and said volume change, and 
 output said calculated absolute lung volume for a pulmonary diagnosis. 
 
   
     
     
         35 . The method of  claim 34 , wherein the processor is further to:
 calculate an additional lung volume parameter based on said calculated absolute volume.   
     
     
         36 . The device of  claim 35  wherein said additional lung volume parameter comprises at least one of: TGV, FRC, RV or TLC. 
     
     
         37 . The device of  claim 34 , wherein said occlusion of air flow is accomplished in one of: (1) less than 25 ms, (2) less than 5 ms, or (3) less than 2 ms. 
     
     
         38 . The device of  claim 34 , wherein obtaining a mouth flow curve in a time duration prior to said occlusion and a time duration subsequent to said occlusion comprises:
 measuring a plurality of differential pressures between a portion of the respiration module and an ambient environment;   determining, with the processor, a plurality of volumetric flow rates based on the measured plurality of differential pressures; and   determining, with the processor, the mouth flow curve based on the determined plurality of volumetric flow rates.   
     
     
         39 . The device of  claim 34 , wherein obtaining a mouth flow curve in a time duration prior to said occlusion comprises determining a baseline flow that comprises a rate of change of lung volume. 
     
     
         40 . The device of  claim 39 , wherein determining a baseline flow that comprises a rate of change of lung volume comprises determining said rate of change of lung volume just prior to said occlusion. 
     
     
         41 . The device of  claim 40 , wherein determining said rate of change of lung volume just prior to said occlusion comprises determining an average rate of change of lung volume over about 20 ms prior to said occlusion. 
     
     
         42 . The device of  claim 34 , wherein said first point along said pressure curve is approximately at a start of said occlusion of air flow and said second point along said pressure curve is approximately or exactly at an end of said occlusion of air flow. 
     
     
         43 . A respiratory measurement device to measure lung volumes, comprising:
 a respiration module for inhalation or exhalation, the respiration module including:
 an electric motor, 
 a motor-controlled shutter positioned with the respiration module and movable via the electric motor, 
 a flow measurement component, and 
 a pressure measurement component; and 
   a control unit, including:
 a converter to: (i) convert analog data received from the flow measurement component and the pressure measurement component into a digital format, (ii) convert digital signals into commands for the electric motor, and 
 a processor in electrical communication with the electric motor, the flow measurement component, and the pressure measurement component via the converter, wherein the processor is to:
 command the electric motor to occlude air flow with the motor-controlled shutter during an inhalation or exhalation, 
 obtain with the flow measurement component a mouth flow curve in a time duration prior to said occlusion and a time duration subsequent to said occlusion, wherein obtaining a mouth flow curve in a time duration prior to said occlusion comprises determining a baseline flow that comprises a rate of change of lung volume, and determining a baseline flow that comprises a rate of change of lung volume comprises determining said rate of change of lung volume just prior to said occlusion, and determining said rate of change of lung volume just prior to said occlusion comprises determining an average rate of change of lung volume over about 20 ms prior to said occlusion, wherein the processor measures said time duration based at least in part on when the command was provided to the electric motor, 
 obtain with the pressure measurement component a mouth pressure curve in a time duration during said occlusion, wherein the processor measures said time duration based at least in part on when the command was provided to the electric motor; 
 calculate the absolute volume in the lungs during said occlusion based on parameters of said mouth flow curve and said mouth pressure curve, and 
 output said calculated absolute lung volume with said device for a pulmonary diagnosis.

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